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HomeMy WebLinkAboutResolution - 5384 - Amendments To Contract - TDH - Health Services Contract #756000590697 - 01_09_1997RESOLUTION NO. 5384 Item #16 January 9, 1997 I BE IT RESOLVED BY THE CITY COUNCIL OF THE CITY OF LUBBOCK: THAT the Mayor of the City of Lubbock BE and is hereby authorized and directed to execute for and on behalf of the City of Lubbock Amendments to Contract No. 756000590697 with the Texas Department of Health to provide preventive, health promotion and direct services in the areas of Epidemiology, Immunizations, Tuberculosis Control, Milk and Dairy testing, Sexually Transmitted Diseases, Cancer prevention activities, HIV/AIDS Surveillance, and Laboratory services, attached herewith, by and between the City of Lubbock, and Texas Department of Health, and any associated documents, which Amendment shall be spread upon the minutes of the Council and as spread upon the minutes of this Council shall constitute and be a part of this Resolution as if fully copied herein in detail. Passed by the City Council this 9th day of ATTEST: /64L-.' Kaythi arnell, City Secretary APPROVED AS TO CONTENT: Doug GoodTNU,Managing Director of Health & C unity Services APPROVED AS TO IlDfald G. Vandiver, First Assistant City Attorney DGV :gs/ccdocs/txhith. res December 19, 1996 STATE OF TEXAS COUNTY OF TRAVIS f m s H TEXAS DEPARTMENT OF HEALTH 1100 WEST 49TH STREET AUSTIN, TEXAS 78756-3199 RESOLUTION NO. 5384 Item #16 January 9, 1997 CONTRACT CHANGE NOTICE NO. 01 The Texas Department of Health, hereinafter referred to as RECEIVING AGENCY, did heretofore enter into a contract in writing with LUBBOCK CITY HEALTH DEPARTMENT hereinafter referred to as PERFORMING AGENCY. The parties thereto now desire to amend such contract attachment(s) as follows: SUMMARY OF TRANSACTION: ATT. NO. 02: MILK AND DAIRY ATT. NO. 03: IMMUNIZATION - EPIDEMIOLOGY All terms and conditions not hereby amended remain in full force and effect. EXECUTED IN DUPLICATE ORIGINALS ON THE DATES SHOWN. Authorized Contracting Entity (type above if different from PERFORMING AGENCY) for and in behalf of: PERFORMING AGENCY: LIM By: authorized to sign contracts) Alex "Tv" Cooke. Mavor Pro—Tempore (N= nd Title) ATTEST: ILL 1 1, AA 14 111) Kayt4VDarnell, City Secretary Date: January'9, 1997 RECOMMENDED: By: (PERFOROPIG AGENCY Director, if different from per authorized to sign contract) RECEIVING AGENCY: TEXAS DEPARTMENT OF By: of person authorized to sign contracts) Linda Farrow, Chief Bureau of Financial Services (Name and Title) Date: U — c /I - `I APPROVED AS TO FORM: By: Vw4a- VZZ;5—AM1 6 Office of General Counsel - Rev. I Cover Page 1 RECEIVED 1.)s) CCT 28 AM It: 28 GRANTS MANAGEMENT DIY. i i C3 --i rr] �- C-) M rrn rri rn C".) --a cn a> co DETAILS . OF ATTACHMENTS Att/ TDH Term Financial Assistance Direct Total Amount Amd Program/ Assistance (TDH Share) Begin End Source of Amount No. ID, Funds* 01 HIV/GHC 01/01/96 12/31/96 93.940 35,000.00 0.00 35,000.0( 02 M&D 09/01/96 08/31/97 State 0.00 0.00 0.0( 03 IMM/EPI 09/01/96 08/31/97 State 93.268 68,356.00 140,011.00 208,367.0( TDH Document No.7560005906 97 Totals $103,356.00 $140,011.00 $243,367.0( Change No. 01 *Federal funds are indicated by a number from the Catalog of Federal Domestic Assistance (CFDA), if applicable. REFER TO BUDGET SECTION OF ANY ZERO AMOUNT ATTACHMENT FOR DETAILS. Cover Page 2 GENERAL PROVISIONS FOR TEXAS DEPARTMENT OF HEALTH CONTRACTS PERFORMING AGENCY and RECEIVING AGENCY (the parties) agree to snake and enter into this contract, to faithfully perform the duties prescribed by this contract, and to uphold and abide by the terms and provisions of this contract. PERFORMING AGENCY and RECEIVING AGENCY agree that this contract consists of receiving and performing agency data, authorized signatures, general and/or special provisions, exhibit(s), if any, Attachment(s) with detailed scope(s) of work and budget(s), as applicable, and Derails of Attachment(s). This contract represents the complete and entire understanding and agreement of the parties. No prior agreement or understanding, oral or otherwise, of the parties or their agents will be valid or enforceable unless embodied in this contract. The person or persons signing and executing this contract on behalf of PERFORMING AGENCY, or representing themselves as signing and executing this contract on behalf of PERFORMING AGENCY, warrant and guarantee that he, she, or they have been duly authorized by PERFORMING AGENCY to execute this contract on behalf of PERFORMING AGENCY and to validly and legally bind PERFORMING AGENCY to all of its terms, performances, and provisions. PERFORMING AGENCY assures compliance with the following terms and conditions unless otherwise specified in the Attachment(s) hereto: ARTICLE 1. Senpe of Work PERFORMING AGENCY will perform the work outlined in the Scope(s) of Work contained in the Attachment(s) hereto which is/are referenced in the Details of Attachments and hereby incorporated into this contract for all purposes as though it were set out word-for-word in this document along with amendments which may be added by additional Attachment(s) from time to time as set out in the Amendments Article. Satisfacctory performance of this contract will be measured in part by (1) adherence to the contract; (2) results of CPA or State Auditor reports; (3) timeliness, completeness, and accuracy of required reports, and (4) achievement of performance measures. ARTICLE 2. Term The time period of this contract will be governed by the term(s) on the Attachment(s). No commitment of contract funds is permitted prior to the first day or subsequent to the last day of the term. The term may be extended or shortened by amendment(s). F—V go KkW� This contract is contingent upon funding being available for the term of the Attachment(s) and PERFORMING AGENCY will have no right of action against RECEIVING AGENCY in the event that RECEIVING AGENCY is unable to perform its obligations under this contract as a result of the suspension, termination, withdrawal, or failure of funding to RECEIVING AGENCY or lack of sufficient funding of RECEIVING AGENCY for any Attachments) to this contract. If funds become unavailable, provisions of the Termination Article will apply. ARTICLE 4. Amendments No different or additional services, work, or products shall be authorized or performed except pursuant to an amendment or modification of this contract that is executed in compliance with this Article. No waiver of any term, covenant, or condition of this contract shall be valid unless executed in compliance with this Article. The PERFORMING AGENCY shall not be entitled to payment for any services, work, or products which are not authorized by a properly executed contract amendment or modification. (LNS) 1997 GENERAL PROVISIONS - Page 1 (5/96) This contract may be modified unilaterally under the terms of the Sanctions Article. Otherwise, this contract may not be amended or modified unless such amendment or modification is in writing and signed by individuals with authority to bind the parties. ARTICLE 5. Revue►Lty If any provision of this contract is construed to be illegal or invalid, this will not affect the legality or validity of any of its other provisions The illegal or invalid provision will be deemed stricken and deleted to the same extent and effect as if never incorporated herein, but all other provisions will continue. ARTICLE 6. Anplienhlp Laws and S nndnrs Ibis contract will be governed by the laws of the State of Texas and enabling state/federal regulations, including federal gram requirements applicable to funding sources. If, PERFORMING AGENCY is a local governmental public health entity, this contract will also be governed by the Local Public Health Reorganization Act, Chapter 121, Health and Safety Code. PERFORMING AGENCY agrees the Uniform Grant and Contract Management Act (UGCMA), Chapter 783, Texas Government Code, and the Uniform Grant and Contract Management Standards (UGCMS) as amended by revised federal circulars and incorporated in UGCMS by the Governor's Budget and Planning Office, apply as terms and conditions of this contract, and the Standards are adopted by reference in their entirety. If a conflict arises between the provisions of this contract, UGCMA and UGCMS, the provisions of UGCMA and UGCMS will prevail unless expressly stated otherwise. A copy of the UGCMS manual and its references will be provided to PERFORMING AGENCY by RECEIVING AGENCY upon request. PERFORMING AGENCY must obtain prior written approval from RECEIVING AGENCY for major project changes which are specified in the applicable Administrative Requirements and Cost Principles as set out in Article 10, below. Copies of these documents will be provided to PERFORMING AGENCY by RECEIVING AGENCY upon request and are incorporated by reference as a condition of this contract. In accordance with 31 U.S.C. §1352 (§1352 of Public Law (P.L.] 101-121 effective December 22, 1989), PERFORMING AGENCY is prohibited from using funds granted under this contract for lobbying Congress or any agency in connection with a particular contract. In addition, if at any time a contract exceeds $100,000, the law requires certification that none of the funds provided by RECEIVING AGENCY to PERFORMING AGENCY have been used for payment to lobbyists. Regardless of funding source, if a contract Attachment exceeds $100,000, PERFORMING AGENCY will provide to RECEIVING AGENCY a certification of the names of any and all registered lobbyists with whom PERFORMING AGENCY has an agreement. This certification form is available upon request and must be forwarded to RECEIVING AGENCY along with the names of any lobbyists, if applicable, within 90 days of receipt of the executed contract. PERFORMING AGENCY certifies by execution of this contract that its payment of franchise taxes is current or, if PERFORMING AGENCY is exempt from payment of franchise taxes, that it is not subject to the State of Texas franchise tax. A false statement regarding franchise tax status will be treated as a material breach of this contract and may be grounds for termination at the option of RECEIVING AGENCY. If franchise tax payments become delinquent during the Attachment term, payments under this contract will be held until PERFORMING AGENCY's delinquent franchise tax is paid in full. PERFORMING AGENCY agrees to comply with the requirements of the Immigration Reform and Control Act of 1986 and Immigration Act of 1990, 8 USC §§1101, et seq., regarding employment verification and retention of verification forms for any individual(s) hired on or after November 6, 1986, ;who will perform any labor or services under this contract. (LHS) 1997 GENERAL PROVISIONS - Page 2 (5/96) ARTICLE 7. PERFORMING AGENCY further certifies by execution of this contract that it is not ineligible for participation in federal or state assistance programs under Executive Order 12549, Debarment and Suspension. PERFORMING AGENCY certifies, by submission of this contract, that neither it nor its principals is presently debarred, suspended, proposed for debarment, declared ineligible. or voluntarily excluded from participation in this transaction by any federal department or agency. Where the PERFORMING AGENCY is unable to certify to any of the statements in this certification, PERFORMING AGENCY shall attach an explanation. PERFORMING AGENCY specifically asserts that it has not knowingly failed to pay a single substantial debt or a number of outstanding debts to a federal or state agency and it is not subject to an outstanding judgment in a suit against PERFORMING AGENCY for collection of the balance. A false statement regarding PERFORMING AGENCY's status will be treated as a material breach of this contract and may be grounds for termination at the option of RECEIVING AGENCY. ARTICLE 8. Aar yrnnees PERFORMING AGENCY will establish safeguards to prohibit employees from using their positions for a purpose that constitutes or presents the appearance of personal or organizational conflict of interest, or personal gain. To the extent such provisions are applicable to PERFORMING AGENCY, PERFORMING AGENCY agrees to fully comply with the following: Title VI of the Civil Rights Act of 1964, 28 USC §1447, 42 USC §§2000d to 2000d-4 (P.L. 88-352); §504 of the Rehabilitation Act of 1973, 29 USC §794 (P.L. -93-112); The Americans with Disabilities Act of 1990, 29 USC §706, 42 USC §§12101, et seq., 47 USC §§152, 221, 225, 611 (P.L. 101-336); and all amendments to each, and all requirements imposed by the regulations issued pursuant to these acts, especially 45 CFR Part 80 (relating to race, color and national origin), 45 CFR Part 84 (relating to handicap), 45 CFR Part 86 (relating to sex), and 45 CFR Part 91 (relating to age). Collectively, such requirements obligate RECEIVING AGENCY to provide services without discrimination on the basis of race, color, national origin, age, sex, disability, or political or religious beliefs; PERFORMING AGENCY agrees that in carrying out the terms of this contract, it will do so in a manner which will assist RECEIVING AGENCY to comply with such obligations to the fullest extent of PERFORMING AGENCY's ability. PERFORMING AGENCY will use its best efforts to make available employment opportunities for qualified disabled individuals. PERFORMING AGENCY agrees to comply with the non-discriminatory requirements of Texas Labor Code, Chapter 21, which requires that certain employers not discriminate on the basis of race, color, disability, religion, sex, national origin, or age. PERFORMING AGENCY agrees to comply with the Pro -Children Act of 1994, 20 USC §§6081 to 6084 (P.L. 103-227; 108 Stat 271 § 104) regarding the provision of a stroke -free workplace and promoting the non-use of all tobacco products. PERFORMING AGENCY will comply with environmental standards which may be prescribed pursuant to the following: (a) institution of environmental quality control measures under the National Environmental Policy Act of 1969, 42 USC §§4321 to 4332 (P.L. 91- 190) and "Protection and Enhancem= of Environmental Quality," Executive Order (EO) 11514; (b) notification of violating facilities pursuant to "Providing for Administration of the Clean Air Act and the Federal Water Pollution Control Act with Respect to Federal Contracts, Grants, or Loans," EO 11738, (c) conformity of Federal actions to State (Clear Air) Implementation Plans under §176(c) of the Clean Air Act of 1955. as amended (42 U.S.C. §§ 7401 - 7642 ); and (d) protection of underground sources of drinking water under the Safe Drinking Water Act of 1974, as amended, 21 USC §349, 42 USC §§300f to 300j-9 (P.L. 93-523). If applicable. PERFORMING AGENCY will comply with National Research Service Award Act of 1971, 42 USC §289L-1, 20 USC §§2080 - 6081 (P.L. 93-348 regarding the protection of human subjects involved in research, development, and related activities supported by any applicable award of federal assistance.. (IRS) 1997 GENERAL PROVISIONS - Page 3 (5/96) If applicable, PERFORMING AGENCY will comply with the Clinical Laboratory Improvement Amendments -of 1988 (CLIA), 42 U.S.C. §263a (P.L. 100-578) which establish federal requirements for the regulation and certification of clinical laboratories. If applicable, PERFORMING AGENCY will comply with the OSHA Regulations on Bloodborne Pathogens, 56 Fed. Reg. 64175 (1991), 29 CFR 1919.030, which set safety standards for those workers and facilities who may handle bloodborne pathogens. PERFORMING AGENCY assures it will not transfer or assign its interest in this contract without the written consent of the RECEIVING AGENCY. ARTICLE 9. Standards Fnr Financial and Prngrammatir Mnnagpm rt PERFORMING AGENCY will develop, implement, and maintain financial management and control systems that meet or exceed the requirements of UGCMS. Those requirements include at a minimum: 1. Financial planning, including the development of budgets that adequately reflect all functions and resources necessary to carry out authorized activities and the adequate determination of costs; 2. Financial management systems including accurate, correct, and complete payroll, accounting, and financial reporting records; cost source documentation; effective internal and budgetary controls; determination of reasonableness, allowability, and allocability of costs; and timely and appropriate audits and resolution of any findings; and, 3. Billing and collection policies, including a charge schedule, a system for discounting or adjusting charges based on a person's income and family size, and a mechanism capable of billing and malting reasonable efforts to collect from patients and third parties. In addition, PERFORMING AGENCY agrees to bill third parry payors, at no cost to the client, for services provided under the Attachment(s). These potential payors include, but are not limited to, Medicaid, private insurance carriers, other available federal, state, local and private funds, etc. PERFORMING AGENCY is required to become a Medicaid provider for applicable program activities funded in the Attachment(s) hereto, and will maximize efforts to obtain payment from Medicaid and all other available sources. PERFORMING AGENCY, if designated a 501(c)(3) organization as defined in the Internal Revenue Code or a for -profit organization, and its governing board, shall bear full responsibility for the integrity of the fiscal and programmatic management of the organization. Such management shall include accountability for all funds and materials received from the RECEIVING AGENCY; compliance with RECEIVING AGENCY rules, policies, and procedures, and applicable federal and state laws and regulations; and correction of fiscal and program deficiencies identified through self -evaluation and the RECEIVING AGENCY's monitoring processes. Ignorance of any contract provisions or other requirements contained or referenced in the contract shall not constitute a defense or basis for waiving or appealing such provisions or requirements. Further, PERFORMING AGENCY's governing board shall ensure separation of powers, duties, and functions of board members and staff. ARTICLE 10. Allowshle Cncts and Audit Requir m n s Only those costs allowable under UGCMS and any revisions thereto plus any applicable federal cost principles are eligible for reimbursement under .this contract. Applicable cost principles, audit requirements and administrative requirements are as follows: Audit Administrative Applieahle Cost Prinri les Re iiirements Re-giiirements A-87, State & Local Governments Circular A-128 UGCMS (LHS) 1997 GENERAL PROVISIONS - Page 4 (5/96) To be eligible for reimbursement under this contract, a cost roust have been incurred and paid by PERFORMING AGENCY within the applicable Attachment term prior to claiming reimbursement from RECEIVING AGENCY. Costs encumbered by the last day of the applicable Attachment term must be liquidated no later than 45 days after the end of the applicable Attachment term. Effective July 1, 1996, each PERFORMING AGENCY/AUTHORIZED CONTRACTING ENTITY receiving $300,000 or more in total federal/state financial assistance during its fiscal year shall arrange for a financial and compliance audit of the PERFORMING AGENCY's/AUTHORIZED CONTRACTING ENTITY's fiscal year. The audit must be conducted by an independent CPA and must be in accordance with the applicable OMB Circulars, Government Auditing Standards, and UGCMS. For the purposes of this contract, the audit provisions of OMB Circular A-133 shall apply to for -profit contracting entities. Procurement of audit services will comply with state procurement procedures, as well as the provisions of UGCMS. If PERFORMING AGENCY is receiving less that $300,000 in total federal/state financial assistance during their fiscal year, RECEIVING AGENCY will provide PERFORMING AGENCY written audit requirements. OMB Circulars shall be applied with the following modifications: All references to "Federal Grantor Agency(ies)" shall be expanded to read "Federal or -State Grantor Agcncy(ics)." All references to "Federal Grant Funds" or "Federal Assistance" shall be expanded to read "Federal and State Assistance;" °Federal Law" shall be expanded to read "Federal or State Law;" and all references to "Federal Government" shall be expanded to read "Federal or State Government," as applicable. Within 30 days of receipt of the audit report, PERFORMING AGENCY/AUTHORIZED CONTRACTING ENTITY will submit a copy to RECEIVING AGENCY's internal Audit Division. ARTICLE 11. Overtime Compengntion None of the fttnds provided by this contract will be used to pay overtime. PERFORMING AGENCY will be responsible for any obligations of overtime pay due employees. ARTICLE 12. Terms and Conditions of Pa en For services satisfactorily performed pursuant to the Scope(s) of Work, PERFORMING AGENCY will receive reimbursement for allowable costs. Reimbursements will not exceed the total of each Attachment(s) hereto and are contingent on a signed contract. Claims for reimbursement will be made on a State of Texas Purchase Voucher (TDH Form B-13). Vouchers for reimbursement of actual expenses will be submitted monthly within 20 days following the end of the month covered by the bill. A make-up claim may be submitted as a final close-out bill not later than 45 days following the end of the applicable Attachment term(s). Advance payment may be requested in accordance with the applicable provisions of this contract. Payments made for approved claims or notice of denial of claims submitted against Attachmcnt(s) to this contract will be mailed not later than 60 days after receipt of monthly vouchers. Payment is considered made on the date postmarked. Any reimbursements made by PERFORMING AGENCY to subcontractors will be made in accordance with Chapter 2251, Texas Government Code . PERFORMING AGENCY may request, in writing, to be placed on Direct Deposit status. If this request is approved by RECEIVING AGENCY, PERFORMING AGENCY will no longer receive copies of reimbursement vouchers. Funding from this contract will not be used to supplant state or local funds, but PERFORMING AGENCY will use such funds to increase state or local funds currently available to PERFORMING AGENCY for a particular activity. PERFORMING AGENCY further agrees to maintain its current level of support, if any. (LUS) 1997 GENERAL PROVISIONS - Page 5 (5/96) PERFORMING AGENCY will refund to RECEIVING AGENCY any funds PERFORMING AGENCY claims and receives from RECEIVING AGENCY for the reimbursement of costs which are determined by RECEIVING AGENCY to be ineligible for reimbursement. RECEIVING AGENCY will have the right to withhold all or part of any future payments to PERFORMING AGENCY to offset any reimbursement made to PERFORMING AGENCY for any ineligible expenditures not refunded to RECEIVING AGENCY by PERFORMING AGENCY. Repayment may be taken from this contract Attachment or other active contract Attachments with the same funding source between the parties in amounts necessary to fulfill PERFORMING AGENCY repayment obligations. Payment may be denied for noncompliance if required financial reports are not on file for previous quarters or for the final period, for failure to respond to financial compliance monitoring reports, for failure to submit independent audit reports as required by applicable OMB Circulars, or if program requirements are not met as specified in the Scope(s) of Work. ARTICLE 13. Advance Pnyments PERFORMING AGENCY may request, in writing, a one time advance per Attachment with written justification and the concurrence of RECEIVING AGENCY. Amount of advance will be determined by the amount and term of the applicable Attachment(s). For each twelve (12) month Attachment, the amount of the advance will not exceed one -sixth (1/6th) of the total reimbursable amount. Advance will be requested on a State of Texas Purchase Voucher at the beginning of the applicable Attachment period or at a single later time in the applicable Attachment period if circumstances so warrant and the request is approved. Advance funds will be liquidated during the applicable Attachment term so that, after final monthly billing, PERFORMING AGENCY will not have advance funds on hand. Advance funds may be drawn only to meet immediate cash needs for disbursement. Amendments to applicable Attachment(s) may require upward or downward adjustment to the allowable advance until it equates 1/6th of a twelve-month Attachment. In the case of a downward adjustment, PERFORMING AGENCY and RECEIVING AGENCY will agree on the amount of adjustment to the advance. RECEIVING AGENCY retains the option to reduce future claims by the required amount. In the case of an upward adjustment and if PERFORMING AGENCY needs additional funds to meet immediate operating expenses, PERFORMING AGENCY may submit to RECEIVING AGENCY a written justification and State of Texas Purchase Voucher in the amount necessary to correct the ratio. ARTICLE 14. Program Income PERFORMING AGENCY will develop a fee for service system and a schedule of fees for personal health services in accordance with the provisions of Chapter 12, Sub -chapter D, Health and Safety Code, and the Texas Board of Health rules covering Fees for Clinical Health Services, 25 TAC Section 1.91, and other applicable laws provided, however, that a patient may not be denied a service due to inability to pay. Both parties agree all revenues directly generated by an Attachment(s) supported activity or earned only as a result of the Attachment(s) during the term of the Attachments) are considered program income: This income will be identified and reported quarterly and annually utilizing the report forms identified in the Financial Reports Article of these provisions. PERFORMING AGENCY will retain the program income and use one of the following alternatives: 1. Where the PERFORMING AGENCY is reimbursed by RECEIVING AGENCY under a cost reimbursement method, the additive or deductive alternatives for program income may be used. Under the additive method, PERFORMING AGENCY will add the program income to the funds already committed to the project by both the RECEIVING AGENCY and PERFORMING AGENCY. PERFORMING AGENCY agrees program income will be used to further the program objectives of the State/Federal statute under which the Scope of Work for the Attachment(s) was made and trust be spent in the same project where it was generated. Program income earned in a current budget period and not expended in that budget period may be carried forward to the next (LHS) 1997 GENERAL PROVISIONS - Page 6 (5/96) budget period, but must be spent in the text budget period, or deducted from program expenditures. ,This policy will apply unless specifically stated otherwise in the Special Provisions of the applicable contract Attachment(s). Under the deductive method, the PERFORMING AGENCY will deduct the program income from the total allowable costs to determine the net allowable costs. Where the PERFORMING AGENCY is reimbursed by RECEIVING AGENCY under a fixed price arrangement, only the deductive alternative for program income will be used. PERFORMING AGENCY deducts the program income from the total allowable project costs to determine the net allowable costs. It is further understood that RECEIVING AGENCY will base future funding levels, in part, upon the PERFORMING AGENCY's proficiency in identifying, billing, collecting, and reporting income, and in utilizing it for the purposes and conditions of the applicable Attachment(s). ARTICLE 15. Financial Reports Financial reports are required as provided in UGCMS and will be filed by PERFORMING AGENCY regardless of whether or not expenses have been incurred. A Financial Status Report, State of Texas Supplemental Form 269a (TDH Form GC-4a), will be submitted within 30 days following the end of each of the first three quarters. A final financial report, State of Texas Supplemental Form 269a (TDH Form GC-4a), will be submitted not later than 45 days following the end of Attachment term(s). If necessary, a State of Texas Purchase Voucher will be submitted if all costs have not been recovered or a refund will be made of excess monies if costs incurred were less than funds received. ARTICLE 16. Rppnrts and Inspections PERFORMING AGENCY will submit financial, program, progress, and other reports as requested by RECEIVING AGENCY in the format agreed to by the parties hereto. RECEIVING AGENCY and, when federal funds are involved, any authorized representative(s) of the federal government have the right, at all reasonable times, to inspect or otherwise evaluate the work (including client or patient records) performed or being performed hereunder and the premises in which it is being performed, including subcontractors. PERFORMING AGENCY will participate in and provide reasonable access, facilities, and assistance to the representatives. All inspections and evaluations will be performed in such a manner as will not unduly delay the work. PERFORMING AGENCY agrees that RECEIVING AGENCY and the federal government, or any of their duly authorized representatives, will have access to any pertinent books, documents, papers, and client or patient records of PERFORMING AGENCY for the purpose of making audit, examination, excerpts, and transcripts of transactions related to contract Attachment(s). RECEIVING AGENCY will have the right to audit billings both before and after payment. Payment under Attachment(s) will not foreclose the right of RECEIVING AGENCY to recover excessive or illegal payments. Any deficiencies identified by RECEIVING AGENCY upon examination of PERFORMING AGENCY's records will be conveyed in writing to PERFORMING AGENCY. PERFORMING AGENCY's resolution of findings will also be conveyed in writing to RECEIVING AGENCY within 30 days of receipt of RECEIVING AGENCY's findings. A determination by RECEIVING AGENCY of either an inadequate or inappropriate resolution of the findings may result in the withholding of funds, as provided in Terms and Conditions of Payment Article. Any such withholding of funds will remain in effect until the findings are properly remedied as determined by RECEIVING AGENCY. PERFORMING AGENCY will retain all such records for a period of three years from the date of the last expenditure report submitted under contract Attachment(s) or until resolution of all audit questions, whichever time period is longer. ARTICLE 17. C'liPnt Reenrds PERFORMING AGENCY, or any subcontractor. shall not transfer an identifiable client record, including a patient record, to another entity or person without written consent from the client or patient, or someone authorized to act on his (LEIS) 1997 GENERAL PROVISIONS - Page 7 (5/96) or her behalf, however. the RECEIVING AGENCY may require the PERFORMING AGENCY. or any subcontractor, to transfer a client or patient record to another agency or to the RECEIVING AGENCY if the transfer is necessary to protect either the confidentiality of the record or the health and welfare of the client or patient. At the end of the Attachment term, all client or patient records are the property of PERFORMING AGENCY. RECEIVING AGENCY retains the right to have access to the records or obtain copies for audit, examination, evaluation, inspection, litigation, or other circumstances that may arise. If at any time during the Attachment term(s), PERFORMING AGENCY and/or RECEIVING AGENCY should decide to terminate the agreement, RECEIVING AGENCY may require the transfer of client or patient records upon written notice to PERFORMING AGENCY; either to another entity that agrees to continue the service or to RECEIVING AGENCY. Notwithstanding any other provision herein, if requested by RECEIVING AGENCY, the PERFORMING AGENCY shall share all patient information with the RECEIVING AGENCY when the contract involves patient care by the PERFORMING AGENCY. The PERFORMING AGENCY shall attempt to obtain a release of medical information from the client or patient or someone authorized to act on his or her behalf permitting the transfer of information outside the PERFORMING AGENCY on forms supplied by the RECEIVING AGENCY. If the patient refuses to sign the release of information form, the information will be shared with the RECEIVING AGENCY devoid of all identifiers of a personal nature, as specified by RECEIVING AGENCY. ARTICLE 18. PERFORMING AGENCY will have a system in effect to protect client or patient records and all other documents deemed confidential by law which are maintained in connection with the activities funded under contract. Any disclosure or transfer of confidential client or patient information by PERFORMING AGENCY, including information required by the Reports and Inspections Article, will be in accordance with applicable law. If providing direct client care, services, or programs, PERFORMING AGENCY agrees to implement workplace policies based on the model guidelines adopted by RECEIVING AGENCY and to educate employees and clients concerning the human immunodeficiency virus (HIV) and its related conditions including acquired immunodeficiency syndrome (AIDS) in accordance with §85.113 of the Health and Safety Code. ARTICLE 19. Equipment and Snpplios Equipment is defined as tangible nonexpendable property with an acquisition cost of over $1,000 and a useful life of more than one year with the following exceptions: Fax Machines, Stereo Systems, Cameras, Video Recorder/Players, Microcomputers, and Printers. These exception items will still be considered equipment if their unit cost is over $$00. In accordance with Health & Safety Code, §12.053, title to all equipment and supplies purchased from funds provided herein will be in the name of PERFORMING AGENCY throughout the Attachment(s) term(s). Unless initially listed and approved in the Attachment(s), prior written approval from RECEIVING AGENCY is required for any additions to or deletions of approved equipment purchases meeting the above equipment definition. To receive approval for data processing hardware and software, PERFORMING AGENCY trust submit a detailed justification which includes description of features, make and model, cost, etc. PERFORMING AGENCY will maintain a property inventory listing and submit an annual cumulative report (TDH Form GC-11) to RECEIVING AGENCY no later than October 15th of each year. PERFORMING AGENCY will administer a program of maintenance, repair, and protection of assets under this contract so as to assure their full availability and usefulness. In the event PERFORMING AGENCY is indemnified, reimbursed, or otherwise compensated for any loss of, destruction of, or damage to the assets provided under this contract, it will use the proceeds to repair or replace said assets. (LFIS) 1997 GENERAL PROVISIONS - Page 8 (5196) PERFORMING AGENCY agrees that upon termination of applicable Attachment(s), title to any remaining equipment and supplies purchased from funds as hereinabove provided will be transferred to the RECEIVING AGENCY or any other parry designated by the RECEIVING AGENCY; provided, however, that RECEIVING AGENCY may, at its option and to the extent allowed by law, transfer title to such property to the PERFORMING AGENCY. In the event of bankruptcy, PERFORMING AGENCY agrees to sever RECEIVING AGENCY property, equipment, and supplies in possession of PERFORMING AGENCY from the bankruptcy. ARTICLE 20. Snhenntrachng PERFORMING AGENCY may enter into agreements with subcontractors unless restricted or otherwise prohibited in specific Attachment(s). Subcontracts. if any, entered into by PERFORMING AGENCY must be in writing, 'be executed on an annual basis and include the following information: 1) name and address of all parties, 2) well defined scope of work, 3) treasurable method and rate of payment, 4) clearly defined and executable termination clause, and S) have beginning and ending dates coinciding with the dams of the applicable contract Attachment(s). PERFORMING AGENCY must ensure that 1) subcontracts include any clauses required by State/Federal statutes, executive orders. and their implementing regulations; and 2) subcontractors are aware of requirements imposed upon them by State/Federal statutes and regulations. PERFORMING AGENCY will pass down audit requirements referenced in Article 10 to subcontractors where appropriate and will maintain records sufficient to ensure that required audits have been completed in accordance with applicable OMB circulars. PERFORMING AGENCY agrees that it will be responsible to RECEIVING AGENCY for the performance of any subcontractor. In addition, if PERFORMING AGENCY elects to enter into an agreement which subcontracts out a substantial portion of PERFORMING AGENCY's Scope of Work, prior written approval must be obtained from RECEIVING AGENCY. ARTICLE 21. PERFORMING AGENCY understands and agrees that where activities supported by the contract Attachments(s) produce original books, manuals, films, or other original material, PERFORMING AGENCY may copyright such material subject to the royalty -free, nonexclusive, and irrevocable license which is hereby retained by the federal government (if federal funds have been used) and/or RECEIVING AGENCY, state government or any agency thereof to reproduce, publish or otherwise use, and to authorize others to use for government purposes (a) the copyright in any work developed under a grant, subgrant, or contract under a grant or subgrant, and (b) any rights of copyright to which a grantee, subgrantee or a contractor purchases ownership with grant support. Use of the copyright for government purposes includes the right to change the books, manuals, films, or other original material as necessary to use for governmental purposes. PERFORMING AGENCY may publish at its expense the results of contract performance with prior RECEIVING AGENCY review and approval. Any publication (written, visual, or sound) should include acknowledgment of the support received from RECEIVING AGENCY and the appropriate federal agency, if applicable. At least three copies of any such publication must be provided to RECEIVING AGENCY. RECEIVING AGENCY reserves the right to require additional copies before or after the initial review. PERFORMING AGENCY and any subcontractor, as appropriate, trust comply with the standard patent rights clauses in 37 CFR § 401.14 or FAR 52.227.11. ARTICLE 22. 14nld Harm] To the extent authorized by law, PERFORMING AGENCY, as an independent contractor, agrees to hold RECEIVING AGENCY and/or federal government harmless and to indemnify them from any and all liability, suits, claims, losses, (LFIS) 1997 GENERAL PROVISIONS - Page 9 (5/96) damages and judgments, and shall pay all costs, fees and damages to the extent that such costs, fees and damages arise from performance or non-performance of PERFORMING AGENCY under this contract. PERFORMING AGENCY, by acceptance of funds provided through contract Attachment(s), agrees and ensures that personnel paid from these funds are duly licensed and/or qualified to perform the required services. 23. Honding SEE NEW ARTICLE 23 ATTACFFD PERFORMING AGENCY 5-Mqaicarry a fidelity bond or insurance coverage equal to the amountL911unding provided under the contract Attachment(s) up to that protects each employee of NG AGENCY handling funds under this contract, including person(s) authorizing ym . The fidelity bond or insurance will provide for indemnification of losses occasion y fraudulent or act or acts committed by any of PERFORMING AGENCY' s either individually or in concert with others, and 2) failure of PERFORM or any of its employees to perform faithfully his/her dudes or to ac unt proper s and property received by virtue of his/her position or employment. ARTICLE 24. Hist� arienily Undprutili7ed Rngineccec RECEIVING AGENCY must comply with Texas Government Code, Chapter 2161, and 1 Texas Administrative Code (TAC) §§111.11-111.24, whereby state agencies are required to make a good.faith effort to assist historically underutilized businesses (HUBS) in receiving contract awards issued by the state to purchase "goods," which are defined as "supplies, materials, or equipment," services, or public works. PERFORMING AGENCY agrees to assist RECEMNG AGENCY by complying with the same requirements. A HUB is defined in the Texas Government Code §2161.001(2) as " (A) a corporation formed for the purpose of, making a profit in which 51 percent or more of all classes of the shares of stock or other equitable securities are owned by one or more socially disadvantaged persons who have a proportionate interest and actively participate in the corporation's control, operation, and management; (B) a sole proprietorship created for the purpose of making a profit that is completel)t owned, operated, and controlled by a socially disadvantaged person; (C) a partnership formed for the purpose of making a profit in which 51 percent or more of the assets and interest in the partnership are owned by one or more socially disadvantaged persons who have a proportionate interest and actively participate in the partnership's control, operation, and management; (D) a joint venture in which each entity in the venture is a historically underutilized business, as determined under another paragraph of this subdivision; or (I-) a supplier contract between a historically underutilized business as determined under another paragraph of this subdivision and a prime contractor under which the historically underutilized business is directly involved in the manufacture or distribution of the goods or otherwise warehouses and ships the goods." "Socially disadvantaged person" is defined in Texas Government Code §2161.001(3) as "...a person who is socially disadvantaged because of the person's identification as a member of a certain group, including Black Americans, Hispanic Americans, women, Asian Pacific Americans and Native Americans, and who has suffered the effects of discriminatory practices or other similar insidious circumstances over which the person has no control." PERFORMING AGENCY agrees to: 1) make a- good faith effort to subcontract with HUBs during the performance of its contract Attachment(s) with the RECEIVING AGENCY and will report HUB subcontract activity on a quarterly basis for each contract Attachment less than $100,000; and 2) comply with the requirements for good faith efforts found at 1 TAC §§111.11-111.114 as a condition of receiving the contract award and for continuation uation of each contract Attachment when either exceeds $100,000. In addition, (LHS) 1997 GENERAL PROVISIONS - Page 10 (5/96) PERFORMING AGENCY will report HUB subcontract activity on a quarterly basis for each contract Attachment. If PERFORMING AGENCY complied with this requirement during the competitive procurement process for the contract Attachment, no further action is necessary prior to the execution of this contract/amendment. If PERFORMING AGENCY has not complied with this requirement because there was no competitive procurement process, PERFORMING AGENCY must comply with the good faith effort process found at 1 TAC §§111.11-111.114 prior to contract execution. PERFORMING AGENCY is responsible for being familiar with the TAC requirements and noncompliance with these requirements will be grounds for termination. Copies of the applicable section of TAC are available upon request. ARTICLE 25. Sant tions PERFORMING AGENCY agrees and understands that sanctions may be imposed by RECEIVING AGENCY both for programmatic and financial noncompliance. RECEIVING AGENCY at its own discretion may impose one or more sanctions for each item of noncompliance and will determine sanctions on a case -by -case basis. Both parties agree that a state or federal statute, rule, regulation, or federal guideline will prevail over the provisions of this ARTICLE unless the statute, rule, regulation, or guideline can be read together with the provision(s) of this ARTICLE to give effect to both. RECEIVING AGENCY may: 1) terminate all or a part of the contract. Termination is the .permanent withdrawal of the PERFORMING AGENCY's authority to obligate previously awarded funds before that authority would otherwise expire, or the voluntary relinquishment by the PERFORMING AGENCY to obligate previously awarded funds. PERFORMING AGENCY costs resulting from obligations incurred by the PERFORMING AGENCY after termination of an award are not allowable unless expressly authorized by the notice of termination. 2) suspend all or part of the contract. Suspension is the temporary withdrawal of the PERFORMING AGENCY's authority to obligate funds pending compliance by the PERFORMING AGENCY or its subcontractor(s) or pending a decision to terminate or modify the contract. PERFORMING AGENCY costs resulting from obligations incurred by the PERFORMING AGENCY during a suspension are not allowable unless expressly authorized by the notice of suspension. 3) temporarily or permanently withhold cash payments. Withholding of cash payment means that the RECEIVING AGENCY retains funds claimed by the PERFORMING AGENCY in order to recover payments already made for undocumented, disputed, inaccurate, or erroneous claims; obtain refunds for overpayment for any reason; or obtain compliance. 4) deny contract renewal or future contract awards to a PERFORMING AGENCY for a certain period of time not to exceed five years. 5) delay contract execution with the PERFORMING AGENCY while other proposed sanctions are pending resolution. 6) amend all or a part of the contract as a result of the noncompliance. 'n place the PERFORMING AGENCY on probation. Probation means that the PERFORMING AGENCY will be placed on accelerated monitoring for a period not to exceed six months at which time items of noncompliance must be resolved or substantial improvement shown by the PERFORMING AGENCY. 8) conduct accelerated monitoring of the PERFORMING AGENCY. Accelerated monitoring means more frequent or more extensive monitoring will be performed by RECEIVING AGENCY than would routinely be accomplished. 9) require the PERFORMING AGENCY to obtain technical or management assistance. 10) disallow claims by rejecting costs or fees claimed for payment or reimbursement by PERFORMING AGENCY. 11) establish additional prior approvals for expenditure of funds by the PERFORMING AGENCY. 12) require additional, more detailed, financial and/or programmatic reports to be submitted by PERFORMING AGENCY. 13) demand repayment from the PERFORMING AGENCY. (LUS) 1997 GENERAL PROVISIONS - Page 11 (5/96) 14) reduce the contract funding amount for failure to achieve or maintain the proposed level of service, to expend funds appropriately and at a rate which will make full use of the award, or to provide services as set out in the contract. 15) talce any other action which is deemed appropriate. RECEIVING AGENCY will formally notify the PERFORMING AGENCY in writing when a sanction is imposed with the exception of accelerated monitoring, which may be unannounced. PERFORMING AGENCY is required to file, within 15 days of receipt of notice, a written response to the RECEIVING AGENCY's program/division that sent the notice, acknowledging receipt of such notice and how the PERFORMING AGENCY will correct the noncompliance. RECEIVING AGENCY may immediately terminate or suspend all or part of the contract, temporarily or permanently withhold cash payments, deny contract renewal or future contract awards, delay contract execution, or amend all or a part of the contract in an emergency by delivering a written notice to a PERFORMING AGENCY by any method stating the reason for the emergency action. The emergency may be a result of the PERFORMING AGENCY's noncompliance having a direct adverse impact on the public or client health or safety, failure to achieve a performance measure, being reimbursed for expenditures which are not in accordance with applicable federal or state laws and regulations or the provisions of the contract, or expending fiords inappropriately. PERFORMING AGENCY may request a review of the imposition of the following sanctions: termination of all or part of the contract, suspension of all or part of the contract, permanent withholding of cash payments, denial of contract renewal or future contact awards, and contract amendment as a result of the noncompliance. PERFORMING AGENCY must make the request for review in writing to RECEIVING AGENCY within fifteen (15) days from the date of notification. ARTICLE 26. Terminatinn In addition to other provisions herein allowing termination, this contract shall terminate upon full performance of all requirements contained herein, unless extended in writing, or prior to completion of the contract term, all or a part of this contract may be terminated for any of the following reasons: 1) Termination in the Best Interest of.the State. This contract may be terminated by RECEIVING AGENCY at any time when, in the sole determination of RECEIVING AGENCY, termination is in the best interests of the State of Texas. 2) Termination by Agreement. This contract may be terminated, in whole or in part, when both parties mutually agree that continuation of the contract would not achieve the objectives and goals of the contract and that continuation would not be mutually beneficial. 3) Termination for Cause. RECEIVING AGENCY reserves the right to terminate this contract, in whole or in part, upon the following conditions: (a) The PERFORMING AGENCY makes an assignment for the benefit of its creditors, or admits in writing its inability to pay its debts generally as they become due, or consents to the appointment of a receiver, trustee, or liquidator of the PERFORMING AGENCY or of all or any pan of its property; if judgment for the payment of money in excess of $50,000.00 (which is not covered by insurance) is rendered by any court or governmental body against the PERFORMING AGENCY, and the PERFORMING AGENCY does not discharge the judgment or provide for its discharge in accordance with its terms, or procure a stay of execution thereof within 30 days from the date of entry thereof, and within the 30-day period or a longer. period during which execution of the judgment shall have been stayed, appeal therefrom and cause the execution thereof to be stayed during such appeal while providing such reserves therefore as may be required under generally accepted accounting principles; or a writ or warrant of attachment or any similar process shall be issued by any court against all or any material portion of the property of the PERFORMING AGENCY, and such writ (LHS) 1997 GENERAL PROVISIONS - Page 12 (5/96) ar r or warrant of attachment or any similar process is not released or bonded within 30 days after its entry; or (b) A court of competent jurisdiction finds that the PERFORMING AGENCY has failed to adhere to any laws, ordinances, rules, regulations or orders of any public authority having jurisdiction; or (c) The PERFORMING AGENCY fails to communicate with the RECEIVING AGENCY as required by the contract; or (d) The PERFORMING AGENCY breaches a standard of confidentiality with respect to the services provided under this contract; or '(e) The RECEIVING AGENCY makes a written determination that the PERFORMING AGENCY has failed to substantially perform under this agreement, which determination specifies the events resulting in the state's determination that the PERFORMING AGENCY has failed to substantially perform under this agreement; or (f) Either parry makes a written determination that the other party has committed a material breach of any term(s) of this contract; or (g) The RECEIVING AGENCY determines that the PERFORMING AGENCY is without the personnel or resources to perform under the contract; or (h) A receiver, conservator, liquidator, or trustee of the PERFORMING AGENCY, or any of its property is appointed by order or decree of any court or agency or supervisory authority having jurisdiction; or an order for relief is entered against the PERFORMING AGENCY, under the Federal Banktuptcy Code; or the PERFORMING AGENCY is adjudicated bankrupt or insolvent; or any portion of the property of the PERFORMING AGENCY is sequestered by court order and the order remains in effect for more than 30 days after such parry obtains knowledge thereof; or a petition is filed against the PERFORMING AGENCY under any state, reorganization, arrangement, insolvency, readjustment of debt, dissolution, liquidation. or receivership law of any jurisdiction, whether now or hereafter in effect, and such petition is not dismissed within 30 days; or (i) The PERFORMING AGENCY files a case under the Federal Bankruptcy Code or is seeking relief under any provision of any bankruptcy, reorganization, arrangement, insolvency, readjustment of debt, dissolution, receivership or liquidation law of any jurisdiction, whether now or hereafter in effect, or consents to the filing of any case or petition against it under any such law; or (j) The PERFORMING AGENCY fails to comply with any of the terms, conditions or provisions of the agreement, in any manner whatsoever. Written notice will be provided at least 30 days prior to the intended date of termination unless an emergency exists. If either parry gives notice of its intent to terminate all or a pan of this contract, RECEIVING AGENCY and PERFORMING AGENCY will try to resolve any issues related to the anticipated termination in good faith during the nnot= period. Upon termination of all or a part of this contract. RECEIVING AGENCY and PERFORMING AGENCY will be discharged from any further obligation created under the applicable terms of this contract except for the equitable settlement of the respective accrued interests or obligations incurred prior to termination. Termination does not, however, constitute a waiver of any remedies for breach of this contract. In addition, the obligations of the PERFORMING AGENCY to retain records and maintain confidentiality of information shall survive this contract. ARTICLE 27. Percnnnel All personnel funded by Attachment(s) to this contract are employees of PERFORMING AGENCY which will be responsible for their direction and control and liable for any of their acts or omissions. PERFORMING AGENCY will have in place legally sufficient Due Process Hearing Procedures for all of its employees filling state budgeted positions. (LNS) 1997 GENERAL PROVISIONS - Page 13 (5/96) PERFORMING AGENCY will have full authority to employ, promote, suspend, demote, discharge, and transfer within its organization any and all state budgeted personnel funded by Attachment(s) to this contract provided, however, that any demotion, suspension, or discharge of such state budgeted employees will be in accordance with the Due Process Hearing Procedures as set out above. The only distinction between state budgeted and local paid employees is that employees on state budgeted positions receive state benefits and are subject to certain duties, obligations, and restrictions as state employees as contained in state law. One such restriction, as contained in the State Appropriations Act, is that no ,employee paid on a state budgeted position may receive a salary supplement from any source unless specifically authorized in the Appropriations Act or other state law. This prohibition includes, but is not limited to, the payment to such employee of a so-called "flat rate" car allowance or travel allowancc. Any such travel or per diem to these employees trust be on a reimbursement basis, supported by appropriate records, and may not exceed the reimbursement for mileage and/or per diem allowed under the Appropriations Act and current state travel regulations. This restriction will apply whether travel funds are provided in Attachment(s) under this contract or from any other source. PERFORMING AGENCY will utilize RECEIVING AGENCY's policies and procedures for hiring and promoting individuals into state budgeted positions funded by this contract. Qualifications of any individuals filling these positions will be subject to approval of RECEIVING AGENCY's Bureau of Personnel Management. The purpose of the approval is to ensure that individuals occupying these positions meet minimum cducational and experience requirements. PERFORMING AGENCY will maintain required records and submit documents necessary to process personnel, payroll, leave and time records, and travel claims on state budgeted positions. PERFORMING AGENCY will be furnished by RECEIVING AGENCY state warrants for salary compensation or travel reimbursement for issuance to employees on state budgeted positions. An independent audit is not required as a condition of this contract if the Attachment provides assistance through assignment of state budgeted positions and no funds are budgeted for local costs. PERFORMING AGENCY may be reimbursed for local personnel costs or other categories of expense used to fulfill the scope of work of applicable Attachment(s) in lieu of being furnished state payroll warrants after a state budgeted position becomes vacant. Reimbursement will not exceed the balance of funds on the state budgeted position after all benefits, obligations, and/or other entitlements arc met. PERFORMING AGENCY's Director, or other person(s) authorized elsewhere in this contract, may submit a request for conversion. RECEIVING AGENCY will transmit formal approval and a revised budget to PERFORMING AGENCY to complete the conversion if the request is granted. PERFORMING AGENCY agrees to defend and indemnify RECEIVING AGENCY for any and all claims and/or judgments taken against any employees, state or local, or against the RECEIVING AGENCY, arising out of any claims or cause of action against any such employees, except to the extent that employees on state budgeted positions may be indemnified and the state may be liable for certain acts pursuant to Chapter 104 of the Civil Practice and Remedies Code of Texas and any other applicable law. The PERFORMING AGENCY agrees to indemnify and hold harmless. the RECEIVING AGENCY for any and all claims and/or judgments taken against RECEIVING AGENCY by employees of the PERFORMING AGENCY that arc funded by the Attachment(s) to this contract. ARTICLE 28. PERFORMING AGENCY agrees funds provided through this contract will not be used for thatching purposes in securing other funding unless otherwise directed or approved by RECEIVING AGENCY. ARTICLE 29. Termination or expiration of this contract for any reason shall not release either parry from any liabilities or obligations set forth in this contract that (i) the parties have expressly agreed shall survive any such termination or expiration, or (ii) remain to be performed or by their nature would be intended to be applicable following any such termination or expiration. (LHS) 1997 GENERAL PROVISIONS - Page 14 (5/96) THE PARTIES EXPRESSLY AGREE THAT NO PROVISION OF THIS CONTRACT IS IN ANY WAY INTENDED TO CONSTITUTE A WAIVER BY RECEIVING AGENCY OR THE STATE OF TEXAS OF ANY IMMUNITIES FROM SUIT OR FROM LIABILITY THAT RECEIVING AGENCY OR THE STATE OF TEXAS MAY HAVE BY OPERATION OF LAW. (LHS) 1997 GENERAL PROVISIONS - Page 15 (5/96) Article 23. Bonding PERFORMING AGENCY is required to carry a fidelity bond, insurance coverage or self-insurance equal to the amount of funding provided under the contract Attachment(s) up to $100,000 that protects each employee of the PERFORMING AGENCY handling funds under this contract, including person(s) authorizing payment of such funds. The fidelity bond, insurance or self-insurance will provide for indemnification of losses occasioned by: (1) any fraudulent or dishonest act or acts committed by any of PERFORMING AGENCY'S employees either individually or in concert with others, and/or (2) failure of PERFORMING AGENCY or any of its employees to perform faithfully his/her duties or to account properly for all monies and property received by virtue of his/her position or employment. dditr/insbond.doc Z�1 DOCUMENT NO. 7560005906-97 ATTACHMENT NO. 02 PERFORMING AGENCY: LUBBOCK CITY HEALTH DEPARTMENT RECEIVING AGENCY PROGRAM: MILK AND DAIRY PRODUCTS DIVISION TERM: September 01, 1996 THRU: August 31, 1997 SECTION I. SCOPE OF WORK: PERFORMING AGENCY will provide analyses of milk samples. Analyses will meet laboratory proficiency standards as set by the National Conference of Interstate Milk Shipments and the 1993 U.S. Public Health Service Grade "A" Pasteurized Milk Ordinance, 25 TAC, Chapter 217. PERFORMING AGENCY will: 1. Perform to completion and report out by mail as soon as possible all required and/or requested tests. The date of completion of testing will not exceed 48 hours from the date of sample submission to PERFORMING AGENCY laboratory. (Mailers will be supplied by RECEIVING AGENCY). 2. Send original copies of laboratory results forms to RECEIVING AGENCY, Milk and Dairy Products Division, 1100 West 49th Street, Austin, Texas 78756, to be microfilmed and returned to PERFORMING AGENCY. 3. Submit monthly vouchers which include total number and kinds of tests performed to RECEIVING AGENCY, Milk and Dairy Products Division. PERFORMING AGENCY agrees to comply with: Chapter 435, Health and Safety Code, Dairy Products. PERFORMING AGENCY will provide an estimated 451 clients with services/units of service in or benefiting the county(ies)/area defined as:Lubbock. SECTION II. SPECIAL PROVISIONS: General Provisions, FINANCIAL REPORTS Article, does not apply to this Attachment. SECTION III. BUDGET: ATTACHMENT - Page 1 Laboratory analyses will be performed at a rate per §ample and per test not to exceed the following schedule: RAW SAMPLES PASTEURIZED SAMPLES SPC $ 3.00 SPC $ 3.00 Somatic Cell 5.00 Coliform 2.00 Growth Inhibitors 2.00 Growth Inhibitors 2.00 Freezing point 1.00 Phosphatase 3.00 Cryoscope 1.00 TOTAL $11.00 TOTAL $11.00 ATTACHMENT - Page 2 DOCUMENT NO. 7560005906-97 ATTACHMENT NO. 03 PERFORMING AGENCY: LUBBOCK CITY HEALTH DEPARTMENT RECEIVING AGENCY PROGRAM: IMMUNIZATION DIVISION TERM: September 01, 1996 THRU: August 31, 1997 SECTION I. SCOPE OF WORK: GOALS: The goal of the immunization program is to prevent, control, and eliminate indigenous vaccine -preventable diseases by providing and administering biologicals, promoting immunizations, and applying epidemiologic principles and outbreak control measures within budgetary constraints. PERFORMING AGENCY AGREES TO PERFORM THE FOLLOWING OBLIGATIONS: PERFORMING AGENCY will use direct assistance and financial assistance from RECEIVING AGENCY for the implementation of an immunization program with special emphasis on children two years old and younger. PERFORMING AGENCY will endeavor to achieve and maintain 90 % vaccine coverage levels for DTP, polio, MMR, and HibCV in pre-school age children. During the term of this Attachment the coverage level for hepatitis B is 80 % . ASSESSMENT, NOTICES, AND TRAINING: PERFORMING AGENCY will assess immunization levels in the clinical records of preschool age children. Immunization records will be randomly selected and assessed using the Center for Disease Control and Prevention (CDC) Clinic Assessment Software Application (CASA) available from RECEIVING AGENCY, Immunization Division. Two assessments using the criteria specified in attached Exhibit A must be completed during the term of this Attachment. One of these assessments may be conducted in cooperation with RECEIVING AGENCY. Assessment results must be reported to RECEIVING AGENCY Program, Director, Immunization Division, not more than two weeks after the assessments are completed for inclusion in a quarterly summary of immunization levels to be shared with local, state, and federal health agencies. The electronic file (either a backup or transfer file) for each clinic assessment should contain the following information: * Date of assessment * Name and address of assessment site (including county and TDH Region) * Contact name (preferably the name of individual that performed assessment) ATTACHMENT - Page 1 * Contact organization name * Site(s) covered by filing system * Description of files that were used for the assessment (e.g., card files, medical records) * Criteria for excluding records (if any) * Estimated "active" client population, sampling interval and sample size PERFORMING AGENCY will produce reminders of upcoming immunizations as well as recall for children who are due or overdue for doses of vaccine. The notifications may be automated or manual and may include mailed or telephone messages. Extra effort should be made to notify parents or guardians of children at high -risk of failure to complete the series on schedule (e.g. children who start their series late). PERFORMING AGENCY agrees to conduct at least one seminar or training session concerning immunization requirements in conjunction with the Licensing Division of the Texas Department of Protective and Regulatory Services (TDPRS) and the RECEIVING AGENCY Program. INVESTIGATIONS/CONTROL MEASURES PERFORMING AGENCY will investigate all reported cases and suspected cases of invasive Haemophilus influenzae disease in children < 5 years of age and all reported cases and suspected cases of measles, rubella, pertussis, paralytic poliomyelitis, and diphtheria within 24 hours of receipt of the initial case report. PERFORMING AGENCY will investigate all reported suspected cases of mumps and tetanus within 48 hours of receipt of the initial case report. PERFORMING AGENCY will complete all case investigation forms and provide complete epidemiologic data on all reported cases of invasive Haemophilus influenzae disease in children < 5 years of age, and all reported cases of measles, mumps, rubella, congenital rubella syndrome, pertussis, diphtheria, and paralytic poliomyelitis to the RECEIVING AGENCY, Immunization Division, within 30 days of the initial case report. PERFORMING AGENCY will provide copies of investigation forms to the RECEIVING AGENCY program. PERFORMING AGENCY will adhere to the Vaccine -Preventable Disease Surveillance Guidelines provided by the RECEIVING AGENCY program. PERFORMING AGENCY will implement the most current outbreak control procedures and measures as recommended and provided by the RECEIVING AGENCY program. REPORTING REQUIREMENTS PERFORMING AGENCY agrees to provide RECEIVING AGENCY,, Immunization Division, by January 31st of each year, a report detailing storage measures and methods used to control vaccine loss including methods to monitor and record daily vaccine storage temperatures. The ATTACHMENT - Page 2 report will be submitted in a format provided each year by RECEIVING AGENCY, Immunization Division. PERFORMING AGENCY agrees to provide RECEIVING AGENCY, Immunization Division, monthly reports of vaccine utilization/loss, within ten days after the end of each month, on forms provided by RECEIVING AGENCY (Forms C5, C33, C33A). Computer generated forms in the same format and containing the required information are acceptable. PERFORMING AGENCY further agrees to provide copies of each Biological Form (C-68) used to transfer vaccines to another agency or private provider. Vaccine lot numbers must be included on all Biological Forms used to transfer vaccines. Status reports of program activities must be submitted to the RECEIVING AGENCY quarterly, using the most current "Immunization Program Performance Indicators Report" format. PERFORMING AGENCY will be evaluated on: the number of doses administered, the number of DTP 4 administered to children who are two years old and younger and immunization levels of two year old children. PERFORMING AGENCY agrees to provide to RECEIVING AGENCY, Immunization Division, weekly reports of all immunizations given, detailed by client. demographic and dose information. The report will be submitted in a format provided by RECEIVING AGENCY, Immunization Division. Status reports of program activities must be submitted to the RECEIVING AGENCY using the most current "Immunization Program Performance Indicators Report". Immunization data (doses administered by age, schedule, and patient demographics) must be provided in a format that may be loaded directly into the electronic Immunization Tracking System (ImmTrac). Report formats have been supplied to PERFORMING AGENCY. PERFORMING AGENCY will be evaluated on both the number of doses administered and the number of DTP 4 administered to children who are two years old and younger. PERFORMING AGENCY agrees to comply with the following: Texas Immunization Laws, Rules, and Regulations,: §42.043 Texas Human Resources Code; §§38.001-38.002 Texas Education Code; §§81.023, 161.001-161.006 Texas Health and Safety Code; 25 T.A.C. §§97.61- 97.77, 97.101-97.102, and 42 U.S.C. §247b as amended. PERFORMING AGENCY agrees to implement the "Standards for Pediatric Immunization Practices," as recommended by the National Vaccine Advisory Committee, approved by the United States Public Health Service, and endorsed by the American Academy of Pediatrics. PERFORMING AGENCY agrees to provide immunization services outside usual clinic hours (8am to 5pm) or on weekends at least once each month or as needed to insure barrier free access to immunization clinics. PERFORMING AGENCY residency requirements are not applicable under this Attachment. PERFORMING AGENCY cannot deny vaccinations to recipients because they do not reside within PERFORMING AGENCY's jurisdiction. ATTACHMENT - Page 3 PERFORMING AGENCY will provide an estimated 13.871 doses of vaccine to clients in or benefiting the county(ies)/area defined as: Lubbock, and surrounding counties. SECTION H. SPECIAL PROVISIONS: PERFORMING AGENCY agrees to maintain an accurate, up-to-date list of clinics and sites where public sector (free or, low cost) immunization services are offered in PERFORMING AGENCY'S local area. PERFORMING AGENCY further agrees to update the clinic list monthly and provide the updates to local area AFDC offices and to RECEIVING AGENCY Program's Communication and Training Section to assist with client referrals. PERFORMING AGENCY agrees to assist in distributing state -supplied vaccines to "Texas Health Steps" providers, Medicaid providers, physicians, and other providers and organizations within PERFORMING AGENCY'S local area. PERFORMING AGENCY agrees that fees will be collected in accordance with 25 TAC § 1.91, and that no one may be denied immunization services because of inability to pay the fee. Fee schedules will not be based on vaccine type, formulation, or dose in series. PERFORMING AGENCY understands that travel funds are provided for use by persons assigned to the immunization project. All out-of-state travel and travel for persons not assigned to the immunization project (this Attachment) require prior approval by the RECEIVING AGENCY, Immunization Division Director. For Immunization activities performed under this Attachment, General Provisions, OVERTIME COMPENSATION Article, is not applicable and PERFORMING AGENCY agrees to comply with the following paragraphs: PERFORMING AGENCY is authorized to pay employees who are not exempt under the Fair Labor Standards Act (FLSA), 29 U.S.C. Chapter 8, §201 et seq., for overtime or compensatory time at the rate of time and one-half per FLSA. PERFORMING AGENCY is authorized to pay employees who are exempt under FLSA on a straight time basis for work performed on a holiday or for regular compensatory time hours when the taking of regular compensatory time off would be disruptive to normal business operations. Authorization for payment under this provision is limited to work directly related to immunization activities and has to be in accordance with the amount budgeted in this contract Attachment. ATTACHMENT - Page 4 PERFORMING AGENCY is responsible for documenting proper authorization or approval for any work performed by exempt or non-exempt employees in excess of 40 hours in a workweek. ATTACHMENT - Page 5 SECTION III. BUDGET: DIRECT ASSISTANCE Direct assistance involves the assignment of state funded positions or the provision of supplies such as vaccines in lieu of cash. PERSONNEL $0.00 TRAVEL 0.00 VACCINE 140,011.00 OTHER 0.00 TOTAL $140,011.00 If applicable, direct assistance for personnel is shown on the attached list of positions and budgetary amounts which is an integral part of this Attachment. State salary warrants for net earnings will be issued in accordance with state regulations. Financial status reports (FSRs) are not required on direct assistance. Program income generated from activities supported with direct assistance will be reported on FSRs required for financial assistance provided through this Attachment, if applicable, or through other program Attachments(s) benefitting from this assistance. RECEIVING AGENCY direct assistance will not exceed $ 140,011.00. ATTACHMENT - Page 6 FINANCIAL ASSISTANCE Financial assistance involves payment of funds to Performing Agency for costs incurred in carrying out approved activities. PERSONNEL $51,236.00 FRINGE BENEFITS 17,120.00 TRAVEL 0.00 EQUIPMENT 0.00 SUPPLIES 0.00 CONTRACTUAL 0.00 OTHER 0.00 TOTAL $68,356.00 RECEIVING AGENCY financial assistance will not exceed $68,356.00. TOTAL RECEIVING AGENCY assistance will not exceed $208,367.00. Financial status reports are due the 30th of December, 30th of _March, 30th of June, and the 15th of October. t A' J ATTACHMENT - Page 7 RECEIVED �j�F�T air 915 OCT 28 AM} It: 28 GRANTS MANAGEMENT DIV. 11- Assessments for these facilities can be automated using the (CASA) import feature. The following issues must be considered prior to an automated assessment: * Should be validated with at least one manual assessment. * Can only be used if complete immunization histories are entered into computer database. * Methodology used for an automated assessment must be approved by RECEIVING AGENCY meeting contract requirements. * Complete enumeration should be performed (i.e., CASA sampling feature is not used) Assessment Criteria #1 CASA Clinic/Provider Site Requirements Dare of Assessment Common Review Dote of 01102196 for Children 24 to 35 Months of Age Provider Type Name of Clinic/Provider Site Reviewer Initials City Estimated "Active" Client Population and Sample Size for Children Born in 1993 CASA Clinic!Provider Site Requirements CASA Client Information FULL Last and First Nance Date of Birth (Between 01/01/93 and 12131/93) Client Zipcode Moved or Gone Elsewhere Number of Visits (Medical Charts Only) Shot Type Shot Date Assessment Criteria #2 Dare of Assessment Common Review Dare of 01102196 for Children 12 to 24 Months of Age Provider Type Name of Clinic/Provider Site Reviewer Initials City Estimated "Active" Client Population and Sample Size for Children 12 to 15 Months of Age as of 01/02196 CASA Client Information FULL Last and First Name Date of Birth (Between 01/01/93 and 12/3l/93) Client Zipcode Moved or Gone Elsewhere Number of Visits (Medical Charts Only) Shot Type Shot Date CERTIFICATION REGARDING LOBBYING CERTIFICATION FOR CONTRACTS, GRANTS, LOANS AND COOPERATIVE AGREEMENTS The undersigned certifies, to the best of his or her knowledge and belief that: (1) No federal appropriated funds have been paid or will be paid, by or on behalf of the undersigned, to any person for influencing or attempting to influence an officer or an employee of any agency, a member of congress, an officer or employee of congress, or an employee of a member of congress in connection with the awarding of any federal contract, the making of any federal grant, the making of any federal loan, the entering into of any cooperative agreement, and the extension, continuation, renewal, amendment, or modification of any federal contract, grant, loan, or cooperative agreement. (2) If any funds other than federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a member of congress, an officer or employee of congress, or an employee of a member of congress in connection with this federal contract, grant, loan, or cooperative agreement, the undersigned shall complete and submit Standard Form-111, "Disclosure Form to Report Lobbying," in accordance with its instructions. (3) The undersigned shall require that the language of this certification be included in the award documents for all subawards at all tiers (including subcontracts, subgrants, and contracts under grants, loans and cooperative agreements) and that all subrecipients shall certify and disclose accordingly. This certification is a material representation of fact upon which reliance was placed when this transaction was made or entered into. Submission of this certification is a prerequisite for making or entering into this transaction im osed by Section 1352, Title 31, U.S. Code. Any person who fails to fil th required certification shall be subject to a civil penalty o n 1 than $10,000 and not more than $100,000 for each such failure. gnature Alex "TV Cooke, Mayor Pro Tempore Name of Authorized Individual January 9, 1997 Date 95l00010 s5ot 6)7- 03 App ication or Contract Rum er City of Lubbock Health Department, 1902 Texas Avenue, Lubbock, TX 79408 and Address of Organization ATTEST: KaythtelDarnell, City Secre STATE OF TEXAS COUNTY OF TRAVIS TEXAS DEPARTMENT OF HEALTH 1100 WEST 49TH STREET AUSTIN, TEXAS 78756-3199 RESOLUTION NO.5384 Itetri.#16 JanuAry g 1997 • *10 4 CONTRACT CHANGE NOTICE NO.02 The Texas Department of Health, hereinafter referred to as RECEIVING AGENCY, did heretofore enter into a contract in writing with LUBBOCK CITY HEALTH DEPARTMENT hereinafter referred to as PERFORMING AGENCY. The parties thereto now desire to amend such contract attachment(s) as follows: SUMMARY OF TRANSACTION: ATT. NO. 04: HIV - SURVEILLANCE All terms and conditions not hereby amended remain in full force and effect. EXECUTED IN DUPLICATE ORIGINALS ON THE DATES SHOWN. rr_ l 1:: . Authorized Contracting Entity (type above if different from PERFORMING AGENCY) for and in behalf of: PERFORMING AGENCY- LUBBOC� C HE By: _ {Sign f f person authorized to sign contracts) Alex "Tv" Cooke, Navor Pro—Temnore (Name and Title) ATTEST: ]am: 44011*0 Kayt i Darnell, City Secretary Date: Janu y 9, 1997 RECOMMENDED: By: (PERFO AGENCY Director, if different from personbuthorized to sign contract) A�ed as to fo m: ci.Y 1,ttorr)Ey RECEIVING AGENCY: t � t� •�it:t �: of person authorized to sign contracts) Linda Farrow, Chief Bureau of Financial Services (Name and Title) Date: 'a A APPROVED AS TO FORM: .; Office of General Counsel - Rev. Cover Page 1 RECEIVED RECEIVED 96 OCT 28 Aid I f : 27 06 AUG 29 Prl 3' 53 GRANTS MANAGEMENT DIV- GRANTS MANAGEMENT DIV. 1 r S }. 7 • • DETAILS OF ATTACHMENTS Att/ Amd No. TDH Pro9mm/ ID Term Financial Assistance Direct Assistance Total Amount (TDH Share) Begin End Source of Funds* Amount 01 HIV/GHC 01/01/96 1 12/31/96 93.940 35,000.00 0.00 35,000.00 02 M&D 09/01/96 08/31/97 State 0.00 0.00 0.00 03 IMM/EPI 09/01/96 08/31/97 State 93.268 68,356.00 140,011.00 208,367.00 04 HIV/SURV 09/01/96 08/31/97 1 State 35,398.00 0.00 35.398.00 TDH Document No.7560005906 97 Totals Change No. 02 $138,754.00 $140,011.00 $278,765.00 *Federal funds are indicated by a number from the Catalog of Federal Domestic Assistance (CFDA), if applicable. REFER TO BUDGET SECTION OF ANY ZERO AMOUNT ATTACHMENT FOR DETAII.S. Cover Page 2 DOCUMENT NO. 7560005906-97 ATTACHMENT NO. 04 PERFORMING AGENCY: LUBBOCK CITY HEALTH DEPARTMENT RECEIVING AGENCY PROGRAM: BUREAU OF HIV AND STD PREVENTION TERM: September 01, 1996 THRU: August 31, 1997 SECTION I. SCOPE OF WORK: PERFORMING AGENCY will conduct active surveillance and reporting activities for human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS). All information and education materials developed and provided by PERFORMING AGENCY will be accurate, comprehensive, and consistent with current findings of the United States Public Health Service. PERFORMING AGENCY agrees that all activities will be performed in accordance with PERFORMING AGENCY'S objectives, activities work plan, and detailed budget as approved by RECEIVING AGENCY. All of the above -named documents are incorporated herein by reference and made a part of this Attachment. All revisions to said documents will be approved by RECEIVING AGENCY and transmitted in writing to PERFORMING AGENCY. The activities required to carry out these projects are outlined in the Centers for Disease Control (CDC) and RECEIVING AGENCY'S program guidelines and protocols and RECEIVING AGENCY'S grant applications and awards by CDC which are the bases for this Attachment. Copies are available upon request. PERFORMING AGENCY will be responsible for soliciting reporting of HIV infections occurring in children 0-12 years of age. PERFORMING AGENCY agrees to: 1. initiate and maintain effective communications and working relationships with pediatricians, pediatric care facilities, and laboratories within PERFORMING AGENCY'S geographic jurisdiction, in an effort to solicit reporting. ATTACHMENT - Page 1 2. Assist RECEIVING AGENCY in conducting no -identified -risk (NIR) investigations for those cases in which mode of exposure is incomplete. 3. Follow-up and complete CDC data collection forms on unreported cases identified through RECEIVING AGENCY'S review of alternate record systems. PERFORMING AGENCY will be responsible to RECEIVING AGENCY for the design, maintenance and evaluation of an active surveillance system for AIDS cases. For the purposes of this Attachment, an AIDS case is defined by CDC in its December 18, 1992 MMWR publication, Vol. 41, No. RR 17. PERFORMING AGENCY agrees to: 1. REPORTING a. Establish and maintain communications with key community and medical groups/individuals and laboratories within PERFORMING AGENCY'S geographic jurisdiction. b. Collect reports of AIDS cases diagnosed and/or treated within PERFORMING AGENCY'S geographic jurisdiction. C. Report cases to RECEIVING AGENCY'S HIV/AIDS Surveillance Program on a weekly basis. 2. REGISTRY MAINTENANCE a. Maintain a case file on all confirmed and suspected cases of AIDS diagnosed and/or treated within PERFORMING AGENCY'S geographic jurisdiction. b. Maintain a current list of key reporting sources. 3. SYSTEM EVALUATION a. Review and provide thorough follow-up on a minimum of eighty percent (80%) of suspects identified by RECEIVING AGENCY'S alternate record review systems in order to enhance case ascertainment and validate the effectiveness of local surveillance efforts. ATTACHMENT Page 2 b. Track reporting by local sources in order to monitor the level of compliance to reporting laws and level of case ascertainment. 4. EPIDEMIOLOGIC INVESTIGATIONS a. Initiate epidemiologic investigations on newly reported NIR cases within five (5) days of receipt of case report through contact with appropriate health care provider or the review of medical records. b. Assist RECEIVING AGENCY with other epidemiologic investigations as deemed necessary by RECEIVING AGENCY or the Centers for Disease Control. 5. DATA ANALYSIS Demographic analyses of local data may be released as public information as long as an individual is not identified. 6. CONFIDENTIALITY a. Store all case files and computer diskettes containing patient information in a locking file cabinet when not in use. The locking file cabinet and surveillance computer must be kept in a locked room with limited, controlled access. b. Utilize passwords to access procedures for computer databases containing HIV/AIDS case data. Passwords should be changed monthly and known only to surveillance personnel C. Limit the number of persons who have keys to registry files to persons directly involved in case reporting. d. Require a statement of confidentiality to be signed by all personnel having access to HN/AIDS case files and computer diskettes and kept on file by PERFORMNG AGENCY. e. Shred any document to be disposed of that contains patient information. ATTACHMENT - Page 3 PERFORMING AGENCY will be responsible for conducting active surveillance for the reporting of confirmed HIV infections. PERFORMING AGENCY agrees to: 1. Establish and maintain communications with key community and medical groups/individuals and laboratories within PERFORMING AGENCY'S geographic jurisdiction. 2. Collect reports of confirmed HIV infections made by or under the standing orders of a physician, and which are based upon acceptable laboratory tests results. 3. Report HIV infections to RECEIVING AGENCY HIV/AIDS Surveillance Program on a weekly basis. PERFORMING AGENCY understands that RECEIVING AGENCY reserves the right to reallocate these funds in the event that the demand for service is less than projected by PERFORMING AGENCY. PERFORMING AGENCY agrees to comply with Chapters 81 and 85 of the Health and Safety Code and relevant portions of Chapter 6A (Public Health Service) of Title 42 (The Public Health and Welfare) of the United States Code, as amended. PERFORMING AGENCY will provide an estimated 0 clients with services/units of service in or benefiting the county(ies)/area defined as: Lubbock. SECTION II. SPECIAL PROVISIONS: PERFORMING AGENCY, or any subcontractor, shall not transfer a client record (including a patient record) to another entity or person without written consent from the client or patient, or someone authorized to act on his or her behalf; however, RECEIVING AGENCY (TEXAS DEPARTMENT OF HEALTH may require PERFORMING AGENCY, or any subcontractor, to transfer a client or patient record to RECEIVING AGENCY (TEXAS DEPARTMENT OF HEALTH) if the transfer is necessary to protect either the confidentiality of the record or the health and welfare of the client or patient. RECEIVING AGENCY (TEXAS DEPARTMENT OF HEALTH shall have access to a client record (including a patient record) in the possession of PERFORMING AGENCY, or any subcontractor, under authority of the Health and Safety Code, Chapters 81 and 85, and the Texas Revised Civil Statutes, Article 4495b (Medical Practice Act). In such cases, RECEIVING AGENCY (TEXAS DEPARTMENT OF HEALTH) shall keep confidential any information ATTACHMENT —Page 4 obtained from the client or patient record, as required by the Health and Safety Code, Chapter 81, and the Texas Revised Civil Statutes, Article 4495b. Due to the sensitive and highly personal nature of HIV/AIDS-related information, strict adherence to the General Provisions, CONFIDENTIALITY Article is required. PERFORMING AGENCY will submit quarterly activity reports within twenty (20) days after the end of each quarter, that are prepared in the format provided by RECEIVING AGENCY. PERFORMING AGENCY will authorize their staff to attend training, conferences, and meetings for which funds were budgeted and approved by RECEIVING AGENCY. ATTACHMENT Page 5 SECTION M. BUDGET: PERSONNEL FRINGE BENEFITS TRAVEL EQUIPMENT SUPPLIES CONTRACTUAL OTHER TOTAL DIRECT CHARGES INDIRECT CHARGES TOTAL Total reimbursements will not exceed $ 35,398.00. $34,008.00 1,390.00 $35,398.00 Financial status reports are due the 30th of December, 30th of March, 30th of June, and the 15th of October. Indirect cost is based on UGCMA, Table 1. Indirect charges to this contract may not exceed the amount shown above, except by prior written approval of RECEIVING AGENCY. ATTACHMENT Page 6 RECEIVED RECEIVED 96 OCT 28 All 11: 27 96 AUG 29 PH 3: 53 GRANTS MANAGEMENT DIV. GRANTS MA14AGEMENT DIV. a STATE OF TEXAS COUNTY OF TRAVIS RESOLUTION NO.5384 Item #16 - January 9, 1997 TEXAS DEPARTMENT OF HEALTH 1100 WEST 49TH STREET AUSTIN, TEXAS 78756-3199 CONTRACT CHANGE NOTICE NO. Q2 The Texas Department of Health, hereinafter referred to as RECEIVING AGENCY, did heretofore enter into a contract in writing with ,UBBOCK CITY HEALTH DEPARTMENT hereinafter referred to as PERFORMING AGENCY. The parties thereto now desire -o amend such contract attachment(s) as follows: SUMMARY OF TRANSACTION: ATT. NO. 05: REGIONAL ADMINISTRATIVE SERVICES ATT. NO. 06: TB - PREVENTION AND CONTROL All terms and conditions not hereby amended remain in full force and effect. EXECUTED IN DUPLICATE ORIGINALS ON THE DATES SHOWN. Authorized Contracting Entity (type above if different from PERFORMING AGENCY) for and in behalf of: PERFORMNG AGENCY: LUBBOCK CM D TMENT By: (Signature of ptson authorized to sign contracts) Alex "Ty" Cooke, Mayor Pro—t:emvore (Name and Title) ATTEST: 4�0�� 4'�Iux Kayt a Darnell, City Secretary Date: Janu7 _zy 9, 1997 RECOMMENDED: By: (PERFORMING.AFENCY Director, if different from person auWized to sign contract) A •ic �e u_ �> ;.,r. RECEIVING AGENCY: zz i TEXAS DEPARTMENT OF HEATH Y , B _ Sigr&6 of personauthorized to sign contracts) Linda Farrow, Chief Bureau of Financial Services (Name and Title) Date- q _ 1 " `7 (o APPROVED AS TO FORM: g �. ;Z;5— Office of General Counsel Cover Page 1 RECEIVED 96 OCT 28 AM l l : 27 GRANTS MANAGEMENT DIY. DETAILS OF ATTACHMENTS Attl Amd No. TDH Program/ M Term Financial Assistance Direct Assistance Total Amount (TDH Share) Begin End Source of Funds* Amount 01 HIV/GHC 01/01/96 12/31/96 93.940 35,000.00 0.00 35,000.00 02 M&D 09/01/96 08/31/97 State 0.00 0.00 0.00 03 IMM/EPI 09/01/96 08/31/97 State 93.268 68,356.00 140,011.00 208,367.00 04 HIV/SURV 09/01/96 08/31/97 State 35,398.00 0.00 35,398.00 05 ORAS 09t01/96 08/31/97 State 93.991 69,182.00 43,440.00 112,622.00 06 TB/PC 09/01/96 08/31/97 State 20,073.00 0.00 20,073.00 TDH Document No.7560005906 97 Totals Change No. 03 $228,009.00 $183,451.00 $411,460.00 *Federal funds are indicated by a number from the Catalog of Federal Domestic Assistance (CFDA), if applicable. REFER TO BUDGET SECTION OF ANY ZERO AMOUNT ATTACHMENT FOR DETAILS. Cover Page 2 DOCUMENT NO. 7560005906-97 ATTACHMENT NO. 05 PERFORMING AGENCY: LUBBOCK CITY HEALTH DEPARTMENT RECEIVING AGENCY PROGRAM: OFFICE OF REGIONAL ADMIN. SERVICES TERM: September 01, 1996 THRU: August 31, 1997 SECTION I. SCOPE OF WORK: ESSENTIAL PUBLIC HEALTH SERVICES PERFORMING AGENCY will use direct assistance and/or financial assistance, as specified in Section III, Budget, from RECEIVING AGENCY to deliver one or more of the following ten essential public health services: 1. Monitor health status to identify community health problems. 2. Diagnose and investigate health problems and health hazards in the community. 3. Inform, educate, and empower people about health status. 4. Mobilize community partnerships to identify and solve health problems. 5. Develop policies and plans that support individual and community health efforts. 6. Enforce laws and regulations that protect health and ensure safety. 7. Link people to needed personal health services and assure the provision of health care when otherwise unavailable. 8. Assure a competent public health and personal health care workforce. 9. Evaluate effectiveness, accessibility, and quality of personal and population -based health services. 10. Research for new insights and innovative solutions to health problems. Two types of support are provided under this program: (1) direct assistance in the form of State - paid positions and/or vaccines and/or (2) financial assistance from General Revenue funds and the Preventive Health and Health Services Block Grant. STATE -PAID POSITIONS PERFORMING AGENCIES receiving direct assistance funding for State -paid positions are required to submit to the appropriate Public Health Regional Director the following items by December 1, 1996: a current job description, an organizational chart depicting the position, ATTACHMENT - Page 1 identification of the position's direct supervisor, a current performance evaluation, and a statement of health outcomes toward which the position's activities are directed. These positions report to and are directly supervised by PERFORMING AGENCY administrative staff. Supervision authorization includes, but is not limited to, overseeing daily work assignments and duties, staff development, evaluations, daily supervision, leave approval, promotions, and disciplinary actions including termination of the employee. FINANCIAL ASSISTANCE PERFORMING AGENCIES receive 73.5 percent of their financial assistance from General Revenue funds and 26.5 percent from the Preventive Health and Health Services Block Grant. PERFORMING AGENCY is required to submit to the appropriate Public Health Regional Director a report detailing how these funds are currently being used by December 1, 1996. This report must identify activities and objectives toward which these funds are directed. For FY 1998, while General Revenue funds will continue to be directed toward the delivery of a broad range of essential public health services, the Preventive Health and Health Services Block Grant funds will be designated for activities directed solely toward the prevention of heart disease and cancer. During FY 1997, PERFORMING AGENCY agrees to develop two written plans for service delivery in FY 1998, one plan for the General Revenue support and one plan for the Preventive Health and Health Services Block Grant support. These plans must include a statement of outcome objectives, specific activities to be performed, and a budget that links these objectives and activities to the prescribed percentages. This plan must be submitted to the appropriate Public Health Regional Director by February 1, 1997. PERFORMING AGENCY will provide an estimated 6.500 clients with service/units of service in or benefiting the county(ies)/area defined as: Lubbock, SECTION H. SPECIAL PROVISIONS: General Provisions, REPORTS AND INSPECTIONS Article, is amended to include: PERFORMING AGENCY agrees to submit an Annual Expenditure Report to the appropriate Public Health Regional Director no later than sixty (60) days following the end of PERFORMING AGENCY'S fiscal year in a format prescribed by RECEIVING AGENCY. ATTACHMENT - Page 2 SECTION III. BUDGET: DIRECT ASSISTANCE Direct assistance involves the assignment of state funded positions or the provision of supplies such as vaccines in lieu of cash. PERSONNEL $43,440.00 TRAVEL 0.00 VACCINE 0.00 OTHER 0.00 TOTAL $43,440.00 If applicable, direct assistance for personnel is shown on the attached list of positions and budgetary amounts which is an integral part of this Attachment. State salary warrants for net earnings will be issued in accordance with state regulations. Financial status reports (FSRs) are not required on direct assistance. Program income generated from activities supported with direct assistance will be reported on FSRs required for financial assistance provided through this Attachment, if applicable, or through other program Attachments(s) benefitting from this assistance. RECEIVING AGENCY direct assistance will not exceed $ 43,440.00. ATTACHMENT - Page 3 FINANCIAL ASSISTANCE Financial assistance involves payment of funds to Performing Agency for costs incurred in carrying out approved activities. PERSONNEL $59,382.00 FRINGE BENEFITS 9,800.00 TRAVEL 0.00 EQUIPMENT 0.00 SUPPLIES 0.00 CONTRACTUAL 0.00 OTHER 0.00 TOTAL $699182.00 RECEIVING AGENCY financial assistance will not exceed $69,182.00. TOTAL RECEIVING AGENCY assistance will not exceed $112,622.00. Financial status reports are due the 30th of December, 30th of March, 30th of June, and the 15th of October. ATTACHMENT - Page 4 LUBBOCK CITY HEALTH DEPARTMENT PAGE 887 TEXAS DEPARTMENT OF HEALTH PHR 01 OPERATING BUDGET FOR YEAR ENDING AUGUST 31, 1997 AS OF MAY 31. 1996 BUDGET NO. LC000 H21311^13028 CATE- DESCRIPTION OR TITLE FUND END ITEM 108 PAY PAY EFFECTIVE MONTHLY BUDGETED ANT GORY DESC. MONTH NO. CLASS GP STP DATE RATE 1 LIC VOCATIONAL NURSE II STATE AUG 083 4412 10 04 SEP 96 1,839.00 22,068.00 ADMINISTRATIVE TECH I STATE AUG 104 1501 08 07 SEP 96 1,781.00 21,372.00 43,440.00 CERTIFICATION REGARDING LOBBYING CERTIFICATION FOR CONTRACTS, GRANTS, LOANS AND COOPERATIVE AGREEMENTS The undersigned certifies, to the best of his or her knowledge and belief that: (1) No federal appropriated funds have been paid or will be paid, by or on behalf of the undersigned, to any person for influencing or attempting to influence an officer or an employee of any agency, a member of congress, an officer or employee of congress, or an employee of a member of congress in connection with the awarding of any federal contract, the making of any federal grant, the making of any federal loan, the entering into of any cooperative agreement, and the extension, continuation, renewal, amendment, or modification of any federal contract, grant, loan, or cooperative agreement. (2) If any funds other than federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a member of congress, an officer or employee of congress, or an employee of a member of congress in connection with this federal contract, grant, loan, or cooperative agreement, the undersigned shall complete and submit Standard Form-111, "Disclosure Form to Report Lobbying," in accordance with its instructions. (3) The undersigned shall require that the language of this certification be included in the award documents for all subawards at all tiers (including subcontracts, subgrants, and contracts under grants, loans and cooperative agreements) and that all subrecipients shall certify and disclose accordingly. This certification is a material representation of fact upon which reliance was placed when this transaction was made or entered into. Submission of this certification is a prerequisite for making or entering into this transaction imposed by Section 1352, Title 31, U.S. Code. Any person who fails to file the required certification shall be subject to a civil penalty of no le than $10,000 and not more than $100,000 for each such W failure. 1 7 Ur UY "W� January_ 9_, _1997 ` Signature Date Alex "TV Cooke, Mayor Pro Tempore '15 (p Q 0 D S r7 V Cj '� —,2- D5 Name of Authorized Individual Application or Contract Number City of Lubbock Health Department, 1902 Texas Avenue, Lubbock, TX 79408 Yame and dress of Or an . tion ATTEST:/L&AJ �d+�`�,.�'n� 3�c Ray to a Darnell, City Secre AS proved is o four 1: r �' � DOCUMENT NO. 7560005906-97 ATTACHMENT NO. 06 PERFORMING AGENCY: LUBBOCK CITY HEALTH DEPARTMENT RECEIVING AGENCY PROGRAM: TUBERCULOSIS ELIMINATION DIVISION TERM: September 01, 1996 THRU: August 31, 1997 SECTION I. SCOPE OF WORK: PERFORMING AGENCY will develop and provide: (1) basic services for tuberculosis (TB) prevention and control throughout PERFORMING AGENCY'S jurisdiction and (2) expanded outreach services to individuals of identified sub -groups who have TB or who are at high risk of developing TB. PERFORMING AGENCY agrees to perform the following activities: A. Provide direct administrative and professional supervision of the PERFORMING AGENCY'S TB control program in accordance with local and state guidelines as developed by PERFORMING AGENCY. B. Provide services in compliance with RECEIVING AGENCY'S Standard of Performance First Edition, February 8, 1996 (Revision, June 20, 1996) which is attached to this Attachment as Exhibit A, and American Thoracic Society (ATS) and Centers for Disease Control and Prevention (CDC) "Joint Statements for Tuberculosis Prevention and Control," which is attached to this Attachment as Exhibit B. The following general objectives will be accomplished during the period of this Attachment in accordance with PERFORMING AGENCY'S approved plan. 1. Management of Cases and Suspects: PERFORMING AGENCY will assure that the following basic case management requirements are attained for all confirmed and suspected TB cases: • patient isolation until rendered non-infectious; • initial treatment of TB cases with ATS/CDC recommended four -drug therapy unless contraindicated and completed on therapy as prescribed. Cases not placed on Directly Observed Therapy (DOT) must have a documented justification in the patient's medical record or other patient information documented; ATTACHMENT - Page I • drug susceptibility testing and adjustment of treatment if resistance is found; • obtaining a consult with a TB expert on all drug resistant cases and indicate in the patient's record that the consult occurred and that adherence occurs; • obtaining a consult with a pediatric TB expert on all complicated TB cases in children less than 15 years of age; • monitoring of patients for drug reactions monthly; and, • provide HIV testing for all patients at high risk for HIV. 2. Management of Contacts and Positive Reactors: PERFORMING AGENCY will assure that the following minimal patient management procedures will be followed: • examination of all household and other close contacts to suspected infectious TB cases within 7 to 14 days of initial notification/diagnosis; • evaluation of all positive reactors; • use of Directly Observed Preventive Therapy (DOPT) for household contacts, especially children under 15 years of age, who require preventive treatment; and, • monthly monitoring for drug toxicity. 3. Surveillance: PERFORMING AGENCY will design and implement surveillance programs with local health care providers to ensure that all TB cases, suspects, and children less than 15 years of age with TB infection are reported to the appropriate local health authority as soon as identified. 4. Infection Control: PERFORMING AGENCY shall have policies, procedures, and facilities to prevent transmission of M. tuberculosis in accordance with current CDC recommendations and RECEIVING AGENCY guidelines/policies. Prevention measures shall include a hierarchy of controls, as specified in Exhibit A, including administrative, environmental and personal protection. ATTACHMENT - Page 2 5. Screening High Risk Populations: PERFORMING AGENCY will implement TB screening activities in identified high risk populations including, but not necessarily restricted to: • foreign -born persons from areas of high TB incidence; • medically underserved, low-income populations, including high -risk racial and ethnic groups; • persons with HIV infection or AIDS, and individuals at high risk of contracting HIV (e.g., injecting drug users, sex for drugs); and, • locally identified high -prevalence groups (e.g., migrant farm workers or homeless persons). These screening programs shall be linked to appropriate follow-up efforts to evaluate, diagnose, and place individuals on DOT or DOPT. Effective working relationships must be developed and maintained with drug treatment centers, homeless shelters, and community -based organizations, jails and prisons, and agencies providing services for migrants, foreign born, and HIV/AIDS high -risk groups. 6. Professional Education: PERFORMING AGENCY will assure that all new TB staff hired will receive 40 hours of tuberculosis program training relevant to their position within 60 days of employment. Each year, employees will receive 16 hours of continuing TB education or training relevant to their position. The CDC's Self -Study Modules on Tuberculosis shall be utilized in the initial training. Documentation of this training shall be available upon request by the RECEIVING AGENCY. RECEIVING AGENCY agrees to provide administrative and management assistance as well as any consultation necessary for the successful implementation and operation of the program. PERFORMING AGENCY agrees to comply with the following: Chapter 13, Subchapter B, Health and Safety Code, Texas Tuberculosis Code, and Chapter 81, Health and Safety Code, Communicable Disease Prevention and Control Act. ATTACHMENT - Page 3 PERFORMING AGENCY will provide an estimated =S clients with services/units of service in or benefiting the county(ies) defined as: Lubbock. SECTION H. SPECIAL PROVISIONS: General Provisions, REPORTS AND INSPECTIONS Article, is revised to include the following: PERFORMING AGENCY will maintain and submit to RECEIVING AGENCY the following records documenting program services provided by PERFORMING AGENCY pursuant to this Attachment. These reports include: 1. Quarterly Report: PERFORMING AGENCY will submit a quarterly program activity statistical report prepared in a format that has been provided by RECEIVING AGENCY. The reporting dates and applicable quarters are as follows: December 31 (September - November) March 31 .(December -February) June 30 (March - May) October 15 (Iune - August) 2. PERFORMING AGENCY will submit an activity plan and evaluation/assessment plan toward meeting the objectives described in this Attachment within thirty (30) days upon receipt of this contract. 3. Annual Narrative: PERFORMING AGENCY will submit a proposed program plan and budget for continuation of this agreement to the appropriate RECEIVING AGENCY Regional Director at least ninety (90) days prior to the end of this Attachment term. The plan will describe in narrative form PERFORMING AGENCY'S proposed activities toward meeting the objectives outlined in B above. The proposed budget will be submitted in a standard format that has been provided by RECEIVING AGENCY. 4. PERFORMING AGENCY will mail all reports of confirmed TB cases, suspected TB cases, and TB infection in children less than 15 years of age to RECEIVING AGENCY within five (5) working days of identification or notification and submit monthly updates of TB-400B. ATTACHMENT - Page 4 5. PERFORMING AGENCY will mail all reports of contacts on all Class 3 TB cases within 14 working days of identification or notification and submit information using the TB-340 standard form. PERFORMING AGENCY agrees that outreach workers employed under this Attachment should be recruited from the same linguistic, racial/ethnic, cultural, and social groups as the patients for whom outreach activities are directed, whenever possible. PERFORMING AGENCY agrees that vacant positions should be filled as soon as possible and will report utilization of salary savings from vacant positions quarterly to ensure funds are expended appropriately and as expeditiously as possible. RECEIVING AGENCY will notify PERFORMING AGENCY of projected savings each quarter. Vacant positions existing after 90 days may result in a reduction of funds. ATTACHMENT - Page 5 SECTION M. BUDGET: PERSONNEL $14,290.00 FRINGE BENEFITS 3,573.00 TRAM- 1,375.00 EQUIPMENT 0.00 SUPPLIES 0.00 CONTRACTUAL 0.00 OTHER 0.00 TOTAL DIRECT CHARGES $19,238.00 INDIRECT CHARGES 835.00 TOTAL $20,073.00 Total reimbursements will not exceed $ 20,073.00. Financial status reports are due the 30th of December, 30th of March, 30th of June, and the 15th of October. Indirect cost is based on UGCMA, Table 1. Indirect charges to this contract may not exceed the amount shown above, except by prior written approval of RECEIVING AGENCY. ATTACHMENT - Page 6 Emim A TUBERCULOSIS ELIMINATION DIVISION STANDARD OF PERFORMANCE First Edition, February 8, 1996 (Revision, June 20, 1996) Texas Department of Health Tuberculosis Elimination Division 1100 West 49th Street Austin, Texas 78756-3199 (512) 458-7447 (Office) (512) 458-7787 (Fax) Section One Introduction 1 Introduction .. .. ..... ............ 1 Components for Controlling and Eliminating Tuberculosis .......... i Program Area Contacts .......... ....................... 2 Section Two Management of TB Cases and Suspects 3 Management Requirements ............... ... ........... 3 Treatment Plan Components ................................ 3 Reporting Cases ....... ..................... ........3 Drug Resistant Cases ......... ....... ............... 4 Pediatric Consults ............ .............. .......... 4 Section Three Management of Contacts and Positive Reactors I 5 Identification .. ...... ..............................5 Concentric Circle ...... .......... ........ 5 Directly Observed Preventive Therapy (DOPT) .................. 5 Section Four Surveillance and Reporting 6 Surveillance Systems . ....... .................... . 6 Reporting Requirements ................................... 6, TIMS........ ........... ................ ..........6 Section Five Infection Control 7 Administrative Measures ..... .. ........ ...... ....... 7 Minimum Specifications For Isolation Spaces .................. 7-6 Section Six Programs to Reach High Risk Groups 9 Screening Programs . ............... .. 9 Targeted High Risk Groups ................................. 9 Interpreters .............................................. 9 Section Seven Section Eight Professional Education 10 Education and Training Requirements .. ...... .. 10 Suggested Training Topics ................................. 10 Basic Training Resource Material ................. ......... 10 Contracts / Budget Requirements 11 Allowable Cost Categories .............................. 11-12 Contract Renewals .... ... ............................ 12 Contract Amendments ................................. 12-13 Use of Federal/State Funds ... .... .. .. ......... 13 Funding Periods .. ...... ... ............... ...13 IS"tandardf Performance y Section One Introduction During fiscal year (FY) 1995, the Tuberculosis Elimination Division envisioned the concept of streamlining the contract development process to serve local health departments and other contracting entities more effectively. Our goal was to develop an improved contract with a distinct scope of work that would allow each contracting entity to establish measurable and precise performance objectives. This process would also promote the establishment of an activity plan and evaluation/ assessment tool from each contracting entity outlining their strategies and approaches to control and eliminate tuberculosis. The Tuberculosis Elimination Division convened a central office Performance Improvement Team (PIT) consisting of program managers and other TB personnel to generate a draft contract and standard of performance. Upon completion of the first draft documents, TB personnel from local health departments and regional offices statewide were appointed to the committee to finalize each component. The final scope of work combined all TB attachments (Outreach, Jail/Outreach, Minority Male, DOT, CBO, Binational, etc.) into one attachment per funding source. The Standard of Performance document was developed to establish a model for all programs, statewide to utilize when configuring their strategies and approaches for controlling and eliminating tuberculosis. Each contracting entity will be required to submit an activity plan and evaluation/assessment instrument related to the scheme for each funding period thirty (30) days prior to receiving the contract agreement for renewal. State (September 01 through August 31) Federal (January 01 through December 31) Plans should define new and continued effective approaches to control and eliminate tuberculosis with emphasis In the following areas: > Management of TB cases and suspects with emphasis on provision of Directly Observed Therapy (DOT) > Management of contacts and positive reactors with emphasis; on Directly Observed Preventive Therapy (DOPT) > Community surveillance to identify unreported cases of TB and individuals suspected of having TS infection > Infection control procedures > Targeted programs to screen high risk populations > Professional education programs to train new TB staff and update current staff Standard of Performance I 1 Introduction This Standard of Performance guide is based on documents published by the Centers for Disease Control and Prevention in conjunction with the American Thoracic Society including the "Core Curriculum on Tuberculosis: What the Clinician Should Know". The Tuberculosis Elimination Division acknowledges that documents prepared by other professional organizations may contain minor differences in recommendations. Deviations from the recommended standards defined in this guide must have a written justification placed In the patients medical or other legal record. For Information regarding specific program areas, please contact the following persons: Administrative Issues Charles E. Wallace, M.P.H./Thomas F. Walch, M.S.H.P. Automated Data Services Kurt Zeitler Case Management Isabel S. Vitek, R.N., M.S.NJMadlyn V. Metcalf, B.S., R.N. Contact Investigation Isabel S. Vitek, R.N., M.S.N. Correctional Facilities Phyllis Cruise, B.SJRay Silva, B.S., M.A. Cross -Cultural Provider and Interpreter Training Phuong Ngo, B.S. "Financial Services Usa C. Subia, B.A. Hansens Disease Program Isabel S. Vitek, R.N., M.S.N. Infection Control and Environmental Issues -Russ Jones, B.SJJeff Smedley, M.P.H. Medicaid Usa C. Subia, B.A./Rana Baughman,, B.S. Drug Resistance Marilyn V. Metcalf, B.S., R.N. Professional Education and Training Ann Tyree, M.S. Program Review Thomas F. Walch, M.S.H.P./Emmanuel lroanya, M.P.A. Refugee Health Screening / Sam Householder, Jr., M.P.H. Migrant, Foreign -Born Programs Special Populations/High`Risk Screening Emmanuel Iroanya, M.P.A. Surveillance and Reporting Joyce Cowles Standard of Performance 2 Section T Wo Management of TB Cases and Suspects A. Obtain a complete medical history on all patients suspected of having TB. This history must include symptoms, prior treatment, risk factors for TB, and history of exposure. All patients must receive a warning letter regarding court -ordered management at the beginning of the treatment phase of care. S. HIV testing and counseling must be recommended for all patients with risk factors for HIV infection. C. Patients with symptoms of pulmonary or laryngeal TB must be placed in respiratory isolation until infectiousness has been ruled out. This is determined when the patient has been receiving adequate treatment for 2 to 3 weeks, has shown improvement in symptoms,, and three (3) supervised consecutive sputum smears, collected on different days, have converted to negative. D. A complete bacteriologic workup, including drug susceptibility tests on initial isolates, should be requested. Baseline tests to monitor possible reactions to TB drugs should also be done prior to starting treatment when indicated and on subsequent clinical visits or as needed. E. Treatment should be initiated with four (4) TB drugs (INH, RIF, PZA, EMB) and continued until drug susceptibility results are reported. A consultation with a TB expert is mandatory in all cases where susceptibility studies indicate resistance to isoniazid or rifampin, or if the patient remains symptomatic, or If the smear or culture is positive after 3 months of therapy. F. A complete treatment plan must include: 1. Use of DOT on all cases and suspects. 2. Use of incentives and enablers to assure adherence to DOT when indicated. 3. Educating patients about adverse reactions, recurrence of symptoms, individuals to notify, compliance with treatment and consequences of non-compliance. 4. Referring patients for other medical and social services as required. G. Ali patients with tuberculosis must be given DOT either in the hospital setting or by the local health department until the recommended course of therapy is completed. H. All suspected/confirmed cases of TB must be reported within one working day to the local health authority or if there is no local health authority, the Texas Department of Health regional director. The local health authority of regional director must report to the Texas Department of Health Tuberculosis Elimination Division within ten working days after receiving a report [Texas Health & Safety Code ANN. §97.2 - §97.6(Vemon 1992)]. Management of TB Cases and Suspects I. Patients who are identified as non -compliant for treatment must be placed under court -ordered management (Texas Health & Safety Code ANN. §81.082(d)(2,3,&7)(Vemon 1992]. J. Management of drug -resistant TB. All cases with resistance to Isoniazid or Rifampin require the clinician to seek expert medical consultation within 3 days of laboratory confirmation. K. ; All TB cases and suspects must be thoroughly interviewed at the time of initial examination to identify household and other close contacts who may have been infected by the patient and also persons with TB symptoms from whom the patient may have received infection. Use the Contact Investigation Worksheet and TB-340 form to record this information. All reports of contacts on tuberculosis cases must be mailed to the Tuberculosis Elimination Division within 14 working days of identification/notification using the TB-340 foram. L All complicated pediatric cases should receive an expert consultation on or before initiation of treatment. Standard. Performance, Section Three Management of Contacts and Positive reactors A. Identification and examination of all household, social, occupational and other close contacts to suspected infectious TB cases within seven (7) days of notification/diagnosis. B. If the skin testing of household, social, occupational and other close contacts reveals that the rate of positive skin test results (the infection level) in this group exceeds that expected for the general population, the investigation should proceed to the next circle of contacts — those who come in contact with the patient, but less frequently than the close contacts. This may include frequent household visitors, close relatives, and friends. The investigation should stop when the rate of skin test positivity in the tested group is no higher than the expected rate for the general population in the community. C. Highest priority must be given to examining contacts who are children or who are HIV Infected or otherwise immunosuppressed. D. Directly Observed Preventive Therapy (DOPT) should be applied to all contacts less than 15 years of age and other contacts, as resources allow. E. Evidence that contact Investigation was completed within 90 days of the date contact was broken must be documented on the TB-340. Section Four Surveillance / Reporting A. Surveillance: Local health departments must demonstrate proactive community surveillance systems for tuberculosis in that A designated TB staff person contacts selected health care providers (hospitals, pulmonologists, ENT specialists, and other ciinic/hospital settings where individuals with TB symptoms would seek rmedical attention). Screening programs outlined are considered part of the surveillance system. B. Reporting:. Basic reporting requirements to the TBED include: 1. Reporting 100% of all TB cases and suspects on the TB-400, parts A and B with all data fields completed. 2. Dispositioning suspects within 90 days of report. 3. Submitting monthly updates of TB-400s (Part B) on all suspects and cases. 4. Utilizing the Tuberculosis Information Management System (TIMS) for automated storage and retrieval of TB cases, suspects, preventive therapy clients, and contact information when available Standard of Performance 6 Section Five Infection Control A. Administrative measures: 1. Suspected or confirmed infectious TB cases must be separated from other clinic patients (separate areas or appointments). 2. Suspected or confirmed infectious TB cases must be masked and given facial tissues. 3. Procedures that generate large amounts of droplet nuclei (bronchoscopy, sputum collection/induction) shall be conducted in negative pressure isolation rooms or booths. For clinics without these capabilities, sputa may be collected outside. 4. In areas without separate TS clinic facilities, TB patients must be scheduled when other clinic patients are not present. 5. A negative pressure isolation room shall be used for the examination, evaluation, and treatment of suspected or confirmed infectious patients. These rooms must meet the specifications outlined In 8 below. 6. TB staff with negative skin test results should be screened at least annually according to the 1994 CDC recommendations. 7. A respiratory protection program (respirators) shall be implemented for all employees who share the same air space with suspected or confirmed infectious cases. B. Minimum Specifications for isolation Spaces for Known or Suspected Contagious Tuberculosis 1. No fewer than 12 air changes per hour (ACH) with no recirculation of the unfiltered exhaust air from the isolation space(s) into the ventilation system. 2. Isolation space(s) must have negative pressure, which is achieved by either exhausting a minimum of 10% or 50 cubic feet per minute (CFM) more exhaust air than the amount of supply air for the isolated space(s), whichever is greater. 3. Isolation space(s) exhaust systems and air supply systems should be designed to maximize mixing within the isolation space(s). 4. Doors to isolation space(s) will have automatic door closures installed. 5. Air exhausted from the isolation space(s) shall be ducted directly outside the building and not pass unducted through other areas unless it has passed through a HEPA filtration system. Standard of Performance 7 I; Infection Control 6. Air exhausted from the isolation space(s) shall be discharged above the roof at a location and a minimum of 25 feet from any air intake with height and velocity sufficient to prevent reentry. 7. Air from the isolation space(s) shall be continuously exhausted through ducted systems maintained at a negative pressure relative to the pressure of normally occupied areas of the building. 8. The isolation space(s) exhaust system may have a speed control for the exhaust fan, so that the air exhaust flow can be decreased when the space is not being used as a means of isolation of patents. 9. The ducted exhaust system shall be labeled at minimum 10 foot intervals in accordance with NFPA 704. 10. Isolation space(s) should be sealed to the maximum extent possible to prevent air leakage. 11. Receptionist area(s) should be isolated from clients, preferably by means of a sneeze barrier, and be at a positive air pressure relative to the immediate surrounding area(s). Section Six Programs to Reach High Risk Groups A. Local health departments should develop effective working relationships with drug treatment centers, homeless shelters, community -based organizations, jails and other correctional facilities, and agencies providing services to migrants, refugees and other foreign -born, and individuals with HIV/AIDS, to assure screening of high risk groups in the community.* B. These screening programs must be linked to effective follow-up efforts to evaluate, diagnose, and place and maintain on DOT or preventive therapy as required individuals found to be infected or suspected of having tuberculosis. DOPT for household contacts and especially in children under 15 years of age should be administered as resources permit. C. Targeted high risk groups must include: 1. foreign -born persons from areas of high TB incidence Including immigrants arriving 'with Class A, 81 or B2 waiverstnotifications; 2. medically under served, low-income populations, including high -risk racial and ethnic groups; 3. persons with HIV infection or with AIDS, and individuals at high risk of contracting HIV (e.g., injecting drug users, sex for drugs); and, 4. locally identified high -prevalence groups (e.g., migrant farm workers or homeless persons). D. Evaluation of foreign -born and other ethnic populations may require the use of trained interpreters including contracting entity personnel or contractual interpreters from local organizations serving these populations. *County Jails of 100 beds or more are legislatively mandated by the Texas Health & Safety Code ANN. §89 (Vernon 1992 & Supp.1996) to conduct tuberculosis screening, treatment and reporting programs. Section Seven Professional Education and Training Professional education efforts have two aspects: (1) the education and training of new employees And (2) the continuing education of TB staff. This training should be provided for all employees involved in TB activities including physicians, nurses, investigators, outreach workers, medical records clerks, receptionists, and other support staff. Within 60 days of employment, all new employees will receive 40 hours of tuberculosis training specific to their duties and responsibilities. Each year employees will receive 16 hours of continuing education or training relevant to their position. Suggested topics for training of personnel may include the following: transmission and pathogenesis of tuberculosis epidemiology of tuberculosis diagnosis of tuberculosis infection and disease treatment of tuberculosis infection and disease infectiousness and infection control Interviewing, investigating and Influencing techniques record keeping and records management budgeting and fiscal management operations management List of basic training resource materials: Self -Study Modules on Tuberculosis, CDC Core Curriculum: What the Physician Should Know, CDC Interviewing, Investigating, Influencing Applications to Tuberculosis Control, CDC Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children, ATS Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health -Care Facilities, 1994, CDC Training and continuing education is also available through a variety of conferences, meetings or classes. Section Eight Contracts / Budget [requirements A. Allowable Cost Categories Personnel. Salary or wage compensation to employees of the contracting agency which includes all remuneration, paid currently or accrued, for services rendered during the period of performance under the contract will be reported in the personnel category. Fringe Benefits. Fringe benefits which are paid to external vendors, such as FICA payments, health insurance premiums, unemployment insurance, workers compensation Insurance, disability insurance, life insurance, employer contributions to pensions and retirement plans, and the like, which are granted under` approved plans and agency personnel policies and distributed equitably to all programs and activities, will be reported in the fringe benefit category. Travel. Expenditures for transportation, lodging, subsistence and related items incurred by employees traveling on the official business of the agency are allowable. The agency should ®stablish a written travel policy. In the absence of such a written agency policy, the contractor is required to use the state mileage reimbursement rate and maximum per diem rate. Equ/pmenb Items that are tangible, nonexpendable property with an acquisition cost of $1000.01 or more and having a useful life of more than one year (Exceptions: VCR's, cameras, fax machines, PC's, printers, cpu upgrades, and pre-recorded video tapes with a value of $500.01 or more), are to be reported as equipment. Supplies. Consumable items (medical supplies, drugs, janitorial supplies, office supplies, or laboratory supplies) and non -consumable items with a purchase price (including freight and installation) of less than $1000.01 (see Exceptions listed in Equipment above) are to be reported as supplies. Contractual. The costs incurred for professional and other contracted services rendered by Individuals or organizations independent of the primary contract agency are to be recorded as contractual if these services are for direct patient/client health related services. Only professional services performed by person(s) licensed, certified, registered or otherwise fully authorized under Texas state law to practice in all health or allied health professions are to be reported as contractual. Other. All allowable direct cost Items not Identified and explained in the above categories will be reported as Other. Some of the major items that would be in this category are: 1. Space and equipment rental 2. Utilities and telephone expenses 3. Data processing services 4. Printing and reproduction expenses S. Postage, shipping and handling costs Standard of Performance. 11 Contracts / Budget Requirements 6. Contracted clerical or other personnel services (not client services) 7. Contracted CPA or bookkeeping services 8. Equipment repairs or services and maintenance agreements 9. Books, periodicals, pamphlets 10. Patient transportation 11. Administrative costs rendered by a third party 12. Educational materials for staff, clients, or patients Indirect Costs Costs that are incurred by grantees for a common or joint purpose benefiting more than one costs objective, and not readily assignable to the cost objectives specifically benefitted without effort disproportionate to the results achieved, are considered indirect costs. The agency may negotiate an indirect cost rate with their federal or state cognizant agency. If TDH is the cognizant agency, the Fiscal Division will negotiate and approve an indirect cost rate. They will also maintain a listing of all agencies and their approved rates. Indirect costs may also be negotiated by TDH programs at a rate less than their approved rate. In lieu of the above, the agency may recover indirect costs based on the Indirect Cost Computation Table in the Uniform Grant and Contract Management Act, unless a lesser amount is negotiated in contract development. B. .- Contract Renewals Prior to the beginning of a new contract Fiscal Year, a GC-9 standard form will be sent from the Tuberculosis Elimination Division. The form will contain all current contract budgeting information in column (a). To request additional funds, equipment, or move funds between categories, please indicate the changes in column (b). If equipment is being requested, please include a detailed description of each item to be purchased (including model/make, vendor, etc.) with the unit cost and quantity. C. Institutional Prior Approvals (IPAYAmendments Institutional prior approvals are required when: 1. Cumulative transfers between direct cost categories exceed 10% of the total budget If the negative amounts in the balance column of your quarterly Financial Status Report Form 269a total more than 10% of the contract amount, you are required to submit a budget revision request (GC-9 standard form). Requests must be submitted in writing. Standard of Performance i2 I Contracts / Budget Requirement: 2. Equipment Is purchased that was not included In the original contract Contractors are required to submit a list of equipment to be purchased with budget revision request (GC-9 standard form). The list should include a detailed description of each item to be purchased (including model/make, vendor, etc.) with the unit cost and quantity. 3. Transfer of funds budgeted for direct costs to absorb Increases In Indirect costs or vice versa. Amendments are required when: 1. Total amount of funds received from TDH (Receiving Agency Share) Increases or decreases. 2. Term of contract Is shortened or extended. 3. Contractor name changes. D. Use of Federal Funds Cooperative Agreement funds may not be used to supplant state or local funds, for patient care and/or clinical activities, or to support construction or renovation of facilities. Surveillance, prevention, and controVelimination component funds may not be used to purchase anti -tuberculosis drugs. E. Use of State Funds State funds may not be used to supplant Cooperative Agreement funds or local funds, or support construction or renovation of facilities. Funds must be utilized to support the contract requirements and continue an effort of maintenance. F. Funding Periods State Contract Period: Federal Contract Period: September - August January - December Acknowledgments The Tuberculosis Elimination Division wishes to thank the Contract PIT Committee members below for their assistance and participation over the course of the development of this document. Gerry Burgess, R.N. TS Program Manager Forth Worth Oepartment of Public Health 1800 University Drive Fort Worth, Texas 76107 Joyce Cowles Surveillance and Reporting Tuberculosis Elimination Division Texas Department of Health 1100 West 49th Street Austin, Texas 78756 Shirley H. Cummings, R.N. Communicable Disease Program Manager Texas Department of Health Public Health Region 213 2561 Matlock Road Arlington, Texas 76015-1621 Emmanual froanya, M.S. Program Specialist . Tuberculosis Elimination bivision Program Review / Technical Assistance Texas Department of Health 1100 West 49th Street Austin, Texas 78756 Russ Jones, B.S. Environmental Quality Specialist Tuberculosis Elimination Division Ernrironmental and Nosocomial Program Texas Department of Health 1100 West 49th Street Austin, Texas 78756 Michael F. Kelley, M.D., M.P.H. State TB Controller Bureau of Communicable Disease Control Texas Department of Health 1100 West 49th Street Austin, Texas 78756 Marilyn V. Metcalf, B.S., R.N. Isabel S. Vitek, R.N., M.S.N. Director of Drug -Resistant Nurse Consultant TS Program Tuberculosis Elimination Division Tuberculosis Elimination Division TB Nursing Resources/ Texas Department of Health Hansen Disease Program 1100 West 49th Street Texas Department of Health Austin, Texas 78756 1100 West 49th Street Austin, Texas 78756 Carol Patwari, R.N. TB Program Manager Thomas F. Walch, M.S.H.P. Harris County Health Department Assistant Division Director P.O. Box 25249 Tuberculosis Elimination Division 223 W. Loop South Program Review / Houston, Texas 77027 Technical Assistance Texas Department of Health Kathy Penrose. R.N., M.P.H. 1100 West 49th Street Program Services Coordinator Austin, Texas 78756 Personal Health Services Health and Human Services Charles E. Wallace, M.P.H. Department Division Oireator 3901 Westheimer, Suite 200 Tuberculosis Elimination Division Houston, Texas 77027 Texas Department of Health 1100 West 49th Street Lisa C. Subia, B.A. Austin, Texas 78756 Executive Assistant Tuberculosis Elimination Division Financial Services and Medicaid Unit Texas Department of Health 1100 West 49th Street Austin, Texas 78756 Claudia Turner, R.N. TS Program Manager Texas Department of Health Public Hearth Region 9/10 2301 North Big Spring, #300 Midland, Texas 79705-7649 Ann B. Tyree, M.S. Information Education Specialist Tuberculosis Elimination Division Health Education Program Texas Department of Health 1100 West 49th Street Austin, Texas 78756 - EXHIBIT B d Aaam"00 ev the us. oEr"n*Ar oF "nrN a mum" san+naes /toner ►Huth. Sliry lie . � cprea�wtnwtt>a��G CDC �� rdMtytrnOr from AMERICAN REVIEW of RESPIRATORY DISEASE, Vol. 146. No. 6. 04cemoer 1992. 00- 1623.1633 American Thoracic Society MEDICAL SECTION OF THE AMERICAN LUNG ASSOCIATION" CONTROL OF TUBERCULOSIS IN THE UNITED STATES' Reprints may be requested frorn your state and local American Lt1ng Association 'I is Orn mAL STATmA rr cr mm AMaaus ThoRA= Soaarlr wws ADor m sy Tea ATS BoAao c r Dntscroxs. MAtrest 1992. T m n A Jotter STATMAMa of Tim ATS. 'rm Cbmw rox DtszAsz Comm- Atom Teo: Trrr�cn= DrsEAseSocmTyorAcY mucA. contents Introduction Current Epidemiology of Tuberculosis In the US. Identifying Persons with Clinically Active Tuberculosis Diagnostic Methods Case -finding Performing a Contact Investigation Controlling Transmission of Tuberculosis Treatment of Persons with Clinically Active Tuberculosis Envisoamental Aspects of infection Control for Tuberculosis Evaluation of Infection Control Practices in Institutions Identifying Persons with Tuberculous Infection Tuberculin Skin -Testing of High -Risk Groups Frequency of Tuberculin Skin -testing Prevention of Tuberculosis Isoniazid Preventive Therapy BCG Vaccination Compliance Recognizing Noncompliant Behavior Promoting Compliant Behavior Strategies to Manage Noncompliant Behavior Data Collection and Analysis Other Functions of Health Department Tuberculosis Control Programs Glossary References v Introductlon i7 awricai y the American Thoracic Sod - cry (ASS) and the Centers for Disease Con- trol (CDC) have provided guidance on the di- agnosis, treatment. prevention. and control of tuberculosis (TB) in the United States and Canada. The ATS4=C itxommendations on TB are contained, for the most part, in three official Joint statements: "Diagnostic Stan- dards and Classification of Tuberculosis." "Treatment of Tuberculosis and Tuberculo- sis Infection in Adults and Children," and "Control of T uberctriosis." In contrast to the "Diagnostic Standards" and "Treatment" statements, which emphasize individual pa- tient management, this "Control Statement" emphasizes the public health aspects of TB control. Because the epidemiology of TB in the United States is changing and the technology applicable to the dlagaosis, treatment, and control of T S continues to evolve, it is neces- sary to periodically revise these statements. The Infectious Diseases Society of Ameri- ca and the American Academy of Pediatrics have joined ATS and CDC in the develop - meat of this statement. This revision has been made in recognition of the fact that new populations at risk for developing TB, such as persons with human immunodeficiency vim (HIV) infecti= have been identified. necessitating new strategies for control. in the past several yeam a num- ber of outbreaks of multidrug-resistant TB (MDR TB) have been reported in a variety of settings, including hospitals where HIV infected persons receive treatment and cor- rectional facilities, highlighting the need for a more aggressive approach to TB control in such settings. In addition. the secretary of Health and Human Services has endorsed a national plan for the elimination of TB from the United States which calls for a rate of one case per million of the population by the year 2010. The first phase of this plan calls for an intensification of current prevention and con- trol strategies. It is the aim of this document to provide guidance for establishing TB prevention, con- tro4 and elimination activities. This guidance is intended for persons working in state. city, and county TB control programs; other health department or hospital outpatient programs, such as refugee programs, sexually transmit- ted disease clinics, HIV clinics; acute -care and attended -health care facilities; correctional facilities; substance abuse treatment pro- grams; shelters for the homeless; day-care centers; and other institutions. It should also benefit individual health care providers car- ing for persons with or at high risk for TB. Derailed recommendations for TB control in specific populations. such as correctional institutions, have been developed by the Ad- visory Council for Elimination of T1:bercu- losis (ACET), a national advisory committee to the secretary of Health and Human Ser- vices, and the Division of Tuberculosis Elimi- nation. CDC. These guidelines are published in Morbidity and Mortality Weekly Repora (see Appendix for a complete list of guide- lines). In addition. a listing of documents or articles eontainiag more detailed information on topics covered in this statement may be found in the SttoaEs = RaADnxos section. Current Epidemiology of TublereWosls In the United States In 1991. the number of reported cases of TB in the United States was 26.283 —an increase of 2% compared with the previous year. Al- though there had been an annual decline of approximately Selo in the number of TB cases since the 1950s and a 6 to 7419 annual decline in cases during the years 1981 to 1984, in 1985 to 1991 the number of cases increased by 184/o. Using the trend for 1981 to 1984 to estimate the expeaai number of cases for 1985 to 1991, it can be calculated that more than 39,000 ex- cess cases of TB occurred between 1985 and 1991 (figure 1). The occurrence of TB among persons with HIV infection is a major factor contributing to this change in the decades - long pattern of decline of TL Through i990.matching ofTBand the ac- quired immunodeficiency syndrome (AIDS) registries for 1=441 AIDS cases reported in the United States revealed that 4.3 Va were in- fected with TEL Patients with TB and AIDS have been predominantly young men. and a ThisStatemerc was prepared by an ad hoc com- mittee of the. Scientirsc Assembly on Microbiology Tuberculosis. and Pulmonary Infections. Members of the committee were: John Bass. MD (Chair): Lawrence Fares. MD; Philip Hopewell. MD; Richard Jacobs, MD; Bess Miller. MD; Edward Nardell. MD; Frederick Ruben. MD; DWe Snider. MD; George. Thornton, MQ ot993 AMEAICANLUNG ASSOCAr4N 1923 i 1624 AMERICA" rMORACIC EOCIM RatW100,000 chial washings, lung tissue. lymph node tis- (Log scale) sue, bone marrow, fiver. blood, urine, stool. • dbserved rate and cerebrospinal fluid. ---- Expected rats Although tuberculin skin testing should be routinely performed in all individuals suspect- 15 ed of having clinically active TB, its useful- ness is limited by false -negative reactions, especially in immunosuPPressed individuals such as those with -HIV infection. The in- tratutaneous administration of 5 U of purified protein derivative (PPD) tuberculin (Marto= test) is the preferred method Persons with symptoms suggestive of pul- 39,000 Excess Cases monary TB (eg, cough. hemoptysis) should S receive a chest radiograph regardless of the satin test results. If abnormalities are noted or if the person has symptoms suggestive of extrapulmonary TB. additional diagnostic studies should be undertaken. These may in- clude histologic staining and mycobacterial 80 81 82 83 84 85 .86 87 88 89 90 91 culture of sputum, other raptratory secre- . Year Lions. and a variety of biopsy specimens and body fluids. Drug susceptibility studies should ft 1. Expected and onserMed tuberculosis cases in the Linked Stares tram 1980 through 1991. be performed routinely on all positive culturm Although tuberculin testing is the standard method for screening asymptomatic popula- tions for TB and tuberculous infection, chat high proportion have been black or His =. States occur in persons in the middle- and radiography or sputum smear examinations ic. The major risk behavior for acquisition upper -income groups. eonuadiaiag the pOPu- are the initial screening method of choice of HIV infection in patients with TB and HIV lar notion that TB is a problem only of the when the objective is to rapidly identify per - infection has been injecting drug use. but TB poor. sons with clinically active disease. These in - has occurred in persons from all HIV trans• when we examine the mend from 1985 dude situations in which the tuberculin skin mission categories. HIV seroprevalenee sur- through 1991 by age, the iargest increase in test results may be unreliable. when appliea- veys in selected metropolitan TB clinics have TB eases in any age group occurred in the tion and reading of the test may be impracti- mvealed that among U.S.-born TB patients 25- to 44-yr-old cohort. Casa in this group cal. and/or when the consequences of art un- the median clinic HIV seropositivity rate was increased by 52074, and occurred largely among diagnosed arse may be severe- for example. 11%6 with some TB clinics reporting sero- non -Hispanic blacks and Hispania. There because elderly persons living in long-term prevalence rates as high as 57910 among US.- was also a 1947o increase in eases among 0- care facilities are at particularly high risk of born patients, to 4-yr-olds and a 40079 increase among chit- developing TB and may be anergic, all pa - Studies of untreated TB patients have dren aged 5 to 14 yr. tients admitted to such facilities should have .shown 4• to 5-yr rase fatality rates of approx. A majority of the cases reported annually a recent chest radiograph. Sputum smear ex- imately 50eI4. Chemotherapy has helped re- in the United States arises from the pool of aminations and culture for mycobacteria duce the mortality rate by 94914 since 1953. persons who have been infected in the remote should be performed on those with signs In 1989, the most recent year for which fmai past 'In the United States. the number of such and/or symptoms such as chronic cough. mortality data are available, the death rate persons with latent infection is estimated to "bronchitis." weight loss. or unexplained fe- ;. ;was 0.8 per 100,000. with 1,970deaths record- be between 10 and 15 enaction. Within the in- ver, regardless of chest radiograph findings. ed. The death rate from TB has remained sta- fected population them: are groups at varying Similar considerations may be applied in bie since 1984. Case fatality rates increase with risk for disease To achieve significant prog- screening persons with HIV infection who increasing age, and are higher in blacks than Tess toward reducing the number of future may be anergic (particularly those in institu- in whites. and in persons with underlying med. rases and deaths of TB, it will be nemsary tional settings). Chest radiography may be the ical conditionm such as cancer and HIV In- to identify high -risk groups. scmen them for screening method of choice in jails or shelters fection. In addition, death rates are higher the presence of tuberculous infection and for the homeless. where the time required to among patient with TB caused by drug- tuberculosis, and provide appropriate theta- apply and read the tuberculin skin test on resistant organisms.. py to those with infection and disease. large numbers of transient persons makes this More than two-thirds of reported TB cases method impractical. now occur among nonwhite racial and ethnic identifying Persons with Clinically groups. Compared with non -Hispanic whites, the overall risk of TB is five times higher Active Ibberculosls Case Finding among Hispania, five times higher among Diegnosrre Methods Evaluation of contacts to cases of infectious Native Americans and Alaskan Natives. eight The key to making the diagnosis of TB in a TB is one of the most productive methods times higher among blacks. and 10 times high- timely mamner is (1) to suspect the disease in of finding persons with disease (and infec- eramong Asians and Pacific Islanders. Nearly any person with signs or symptoms compati- tion). Among medically evaluated contacts one -quarter of all cases in the United States ble with the disease, and (2) to obtain appro- in 78 areas of the United States during 1990, occur in foreign -born persons. Others at high priate specimens for bacteriologic and histo- the rate of clinically active TB was 700 per risk for TB include persons with HIV infec. logic examination. Among the clinical find- 100,0W persons. Contact investigations are tion. substance abusers, low4ncome popula- ings that suggest TB are cough, hemoptysis, usually performed by the staff of health tiors, residents of correctional facilities and weight loss, fatigue, night sweats, and fever. department TB control programs, although nursing homes, and persons with certain med- Depending upon the location of the disease, hospital infection control officers and staff ical risk factors. It is noteworthy that nearly specimens from a variety of sites maybe ap- of correctional institutions and long-term one-third of the cases of TB in the United propriam to examine. including sputum, bran- care facilities may also conduct such investi- AY&CAN,Ti!ONLdC SOCIETY 1625 cations. A detailed description of how to per- form a contact investigation is described subsequently. In situations when the prevalence of TB is extremely high, such as in some homeless populations or certain immigrant or refugee populations from areas with a high prevalence of TB, or when the consequences of an undi- agnosed case of TB are severs, such as residen- tial facilities for HIV -infected persons, cor- rectional facilities. and nursing homes, rou- tine screening to identify persons with disease is justifiable Most persons with TB are identified be- cause they seek medical care for symptoms caused by'the diieasa In addition. persons already receiving health care for another con- dition may be found to have concurrent TEL Thus, patients themselves and providers of primary health care are among the most im- portant finders of TB. Because the manifesta- tions of TB are protean and nonspecific, health-care providers must maintain a high index of suspicion for TE. especially in those populations that art at greatest risk. A review of current literature reveals that excess mor. bidity and mortality from TB Is occurring be - cum the diagnosis of the disease is frequently not considered or is considered too late Performing a Contact Investigation Contacts of persons with infectious TB are at high risk of infection and disease. The risk to contacts is related to factors pertaining to the infectiousness of the source case. the char. acteristics of the contact, and the environment they share. Many facsors interact to influence the transmission of infectious particles (drop - In nuclei) from the source patient to the contact. M soon as the diagnosis of TB in the source ace is strongly suspected on laboratory and/ or *clinical bases. investigation of contacts should begin. This require dose coordina. tion between the health department and hospitals or other institutions so that as soon as there is a positive smear or other strong evidence that a patient has TB. the contact interview can take place Health-care person. nel should not wait for positive cultures if the history and other clinical findings are sug. gestive of TL Although prompt contact investigation has always been desirable, under the ci=m. stances that prevail currently. speed in evalu- ation of contacts is essential. In HIV -infected contacts who acquire a new tuberculous in- fection. clinically active disease can occur very rapidly. intervals as short as 20 days have been described. Moreover, in many areas. the high- est risk groups may have impermanent resi- deacm Such groups include the homeless who prove from shelter to shelter. injecting drug users, and migrant workers. For these reasons, rapid notification of health department per- sonnel, and prompt and thorough contact identification and evaluation are the keys to successful contact Investigation. Contact investigations should involve as few steps as possible and should be designed to identify persons with disease as well as those with tuberculous infection. Evaluations should be conducted at the convenience of the con- tact with. for example, tuberculin testing or sputum collection being performed in the field. and patients being transported for ra- diographic or other examinations. Because of the differences in the behavior of tuberculous infection in contacts with HIV infection, knowledge of the contact's HIV sta- tus would alter the approach both to investi- gation and to the use of preventive therapy. For this reason. appropriate counseling and HIV testing of tomato if their status is not known is advisable Devittopman of nt"SULSSiON Psto watt nor DATA When a source case has been identified, the appropriate procedure in a contact investiga. tion entails the development of a data base and an evaluation of each of the factors noted subsequently. These data are usually gathered by interviewing the source patient and by reviewing relevant medical and laboratory records. A visit to the source patient's home, place of employment. or both will usually be necessary to assemble a satisfactory initial da- ta base. Source patient chamcteristics influencing transmission Any person who is generating am osolized particles containing tubercle bacil- li is a transmitter of Mycobacterium tuber. culosix The presence of add -fast bacilli in the sputum smear is the main indicator of a potential for transmission. Other source pa. tient characteristics that increase the proba- bility of transmission are as follows: positive sputum culture for M. tuberculosis; presence of cavitation in the chest radiograph; presence of TE laryngitis; presence of cough (cough - inducing procedures such as bronchoscopy. enrlotraclteai suctioning. and aerosolized pen. tamidine treatment may contribute to trans. mission): unwillingness or inability of the source case to cover his or her cough; high volume and watery respiratory secretions; forceful exhalation (eg, singing or shouting): prolonged duration of respiratory symptoms; Inadequate anti TS chemotherapy. While most of these characteristics pertain to source patients with pulmonary or laryn- geal TB, droplet nuclei containing tubercle bacilli may rarely be generated from proce- dures that produce aerosols from infected soft tissues Environmental characteristics influencing transmission Air is the vehicle by which the droplet nucleus containing tubercle bacilli is transported from the source patient to sus. ceptible persons. The greater the concentra. tion of these droplet nuclei in air shared by the source patient and his or her associates. the greater the risk to these contact. The fol. lowing factors alter the concentration of in- fectious particles in the air. (i) The volume of air common to the source patient and con. tact. If low, the concentration of infectious particles is increased (eg, as in sharing a small room). (2) The degree of ventilation with out. side air. Fresh air dilutes the concentration of potentially infectious droplets. (3) The de gme of air recirculation. A high degree of air mcircuiati.on (as may occur in hospitals and other structures With dosed -circuit heating and cooling systems) may result in the ac- cumulation of high concentrations of infec. tious particles because droplet nuclei remain suspended in the' air. (4) The presence of ultraviolet (UV) light fixtures. Irradiation of the upper air within the shared space may re- duce the spread of infection by killing the tubercle bacilli contained in the droplet nuclei. (S) The` presence of high efficiency particu- late air (HEPA) filters. These filters placed within air duets are capable of removing air. borne particulates the size of droplet nuclei. The benefits of HEPA are limited by cost con- sideratiorts and the amount of air that can be moved past the filters without unaccept- able noise or drafts. Contact characteristics influencing trans- mission. Persons who have,ecaitly sham air with the source patient should be considered potentially infected contacts. The following factors influence the risk of infection for these perso= (n increased time in association with the sours: patient, which increases the prob- ability of infection; (2) physical closeness be. tween the source patient and the contact may increase the likelihood of infection; (3) pteven- tive therapy for TB taken by the contact at the time of exposure reduces the inkcuon risk (an example of primary prevention); (4) pri- or infection with M. ruberculosis, as indicat- ed by a significant tuberculin skin -test reac- tion befom exposure to the identified source case. reduces risk; (n host factom such as the contact's age. race. and immunologic sta- tus. can affect the likelihood of becoming infected. STRUCTURING A CONTACT INvEMCATION Fstablishment of priorities, The estimated probability of transmission, based on the in- formation described previously and a deter. mination of the consequences of infection should it occur, should influence the priority and rapidity with which a contact instiga- tion is conducted. cif lcation of contacts For each source patient. the contact investigation should pro- ceed in art orderly manner. starting with per- sons -who are most likely to have been infect. ed. Members of the immediate family or others who have recently shared the same in. door environment with the source patient for prolonged periods are commonly called close contacts. Contacts with less exposure are designated other than close contacts. ESTAsLtsuwG Ln= mR CONTACT INVEWCATIO14S The infectiousness of the source patient can be determined by initially evaluating the close contacts for evidence of tuberculous infec- tion and/or disease. The following are guide 4 1626 AYERMN THORACIC SOCIETY lines for limiting the extent'of a contact in- vestigation: (1) Initiate the investigation with close contacts. If there is no evidence of re- cent transmission of infection in this group, extending the investigation is usually not ap- propriate. Howeve4 priorities of the investi- gation should also be based on the cone- quenees of infection in the contact. For example, infection in a newborn or in an HIV - infected person could lead to rapid develop- ment of disseminated disease- Therefore. such individuals merit evaluation. regardless of their degree of exposure- (2) If data indicate recent infection in the close contacts, extend the limits of investigation to progressively lower -risk contacts until the levels of infec- tion detected approximate the levels of infec- tion in the local community. (3) At each stage of the investigation. establish the number and identity of contacts to be examined. Estab- lishing such a denominator helps to assure that no contact who should be examined is missed. Once contacts have been identified, a di- agnostic evaluation including medical histo- ry. tuberculin skin t= and. if indicated, chest radiograph and sputum examination should be performed Contacts with evid- of elin. seal disease should be placed on an appropri. ate multidrug treatment regimen. Contacts with a tuberculin reaction Z 5 mm should receive a chest radiograph.- those with- out evidence of clinical disease should be evaluated for preventive therapy. Persons with an initial tuberculin reaction < 5 mm should receive a chest radiograph and be considered for preventive therapy if (1) circumstances sug- gest a high probability of infection, (2) evalu- ation of other contacts with a similar degree of exposuredemonstrates a high prevalence of infection, or (3) the contact is a child, adolescent. or is immunosuppressed (eg. in- fected with HIV). Contacts who are initially skin -test negative should receive a repeat tuberculin skis tat 10 to 12 wk after the ini dal test. If the repeat skin test remains nega- tive and contact with the source case has been broken. preventive therapy may be stopped. If the repeat tuberculin test is positive. a chest radiograph should be obtained to exclude dis- ease. If there is no evidence of disease, a full course of preventive therapy should be given. If the repeat tuberculin test is negative. no further evaluation is indicated for persons with normal immunity. Contacts with HIV infection should be considered for preventive °therapy, regardless of tuberculin skin test results. Controlling 1l ansmisslon of Tuberculosis Trearmenr of Persons with Clinically Active ruberculvsir The preferred regimen for treatment of ac. tive TB includes an initial course of daily isoniazid (INH), rifampin (RIF), and pyra. zinamide (PZA) ,for 2 months (induction phase); followed by a continuation phase of INH and RIF for 4 months, for a total dura- tion of 6 months in most cases. Ethambutol (EMB) or streptomycin (SM) should be in- cluded in the initial regimen until drug sus- ceptibility studies are available, unless them is little possibility of primary resistance to isoniazid. Patients with disease due to drug - resistant organisms, coexisting HIV infection, or inability to take one or more of the previ- ously listed drugs will require a longer dura- tion of therapy and may require additional drugs. All patients with TB should be offered appropriate counseling and HIV -antibody testing - With adequate chemotherapy, almost all patients with organisms susceptible to the pri- mary antituberculous drugs (INH, RIF, PTA, EMB, and SM) will become bacteriological- ly negative. recover. and remain well. More than 90% of patients taking the 6-month regi- men will have bacteriologically negative spu- tum within 3 months. Among those complet- ing anti -TB treatment regimens prescribed. > 95% of immunocompetent patients treat- ed for the first time will be treated success- fully, provided that they are fully compliant with the prescribed regimen. For most patients who have successfully completed treatment, routine follow-up examinations for TB are unnecessary. Treatment for disease due to drug -resistant organisms is mots difficult. more toxic. more expensive, and not as successful. Surgery is rarely indicated, but may play a role, partic- ularly in treating well -localized disease due to drug -resistant organisms. Whether a patient should have his or her normal activities restricted, and the duration of those restrictions, depends upon the esti. mated degree of infectiousness, the response to treatment, the nature of the activities. and who will be exposed to him or her in the course of those activities. Some patients are never. infectious and have no need for restrictions. Many patients who are infectious can rerriain at home with those in the household who have already been exposed, as it has been shown that the risk of additional transmission of in- fcction in this setting is extremely low. These patients may also be able to continue normal activities (eg. work) if the environment in which those activities takes place is not con- ducive to transmission and there is little risk of exposure of new and/or highly susceptible contacts. For example, a patient who works predominantly outdoors would require little or no work restriction compared with a health- care provider who works in a closed indoor environment with susceptible persons. When a patient with infectious TB is hos- pitalized. appropriate infection control pre- cautions. including acid -fast bacillus (AFB) isolation. should be followed to protect em- ployees and other patients from infection. These must be maintained until the patient is judged to be noninfectious Although the exact point at which a patient becomes nonin- fectious is difficult to define, most patients with disease due to drug -susceptible organ. isms become noninfectious very rapidly of ter chemotherapy is started —within several days to a few weeks. Evidence such as de- creased cough, a sputum smear with fewer AFB (for patients with pulmonary TB), and improvement in other signs and symptoms, such as absence of fever and improved appe.. tim indicate that the patient has become much less infectious. AFB isolation precautions can be discontinued for such patients, and they can either be discharged or transferred to a private room. Three properly performed nega- tive sputum smear examinations on properly collected specimens on separate days in a pa- tient on anti TB therapy indicate an extreme- ly low potential for transmission of infection, and a negative culture virtually assures there is no potential for transmission. Patients with infectious TB should at a minimum have a negative sputum smear for AFB before be- ing placed in indoor environments conducive to transmission. such as shelters for the home- less. or in settings when highly susceptible persons, such as those with HIV infection, will be exposed When a patient fails to respond to treat- ment as expected, or if the response is not sustained. the cause of this treatment failure should be thoroughly investigated and the need for restriction of activities. including AFB isolation. should be reevaluated Con- tinuing transmission of infection eatr occur if restriuiom including AFB isolation. are, prematurely discontinued or not reinstituted for patients who fail to respond to therapy. Common reasons for a failure to respond to therapy are patient noncompliance with ther- apy and ineffective therapy for drug -resistant disease. Recently, several nosocomial and community outbreaks of MDR TB have oc- curred: these outbreaks were due in pan to the failure to institute. or the premature dis- continuation of. isolation precautions for MDR TB patients who were being treated with drugs to which their organisms were resistant. Diagnostic and treatment services for TB should be available to all persons in need of such care without consideration of the pa times ability to pay. Generation of third -party support for TB services is desirable, but the administrative process of billing third parties should not become a barrier to patient care. TB care can be provided by a variety of sources in the community, both private and public, including individual practitioners, health department clinics, community health clin- ics and migrant health centers, correctional facilities, hospitals. hospices, long-term care facilities, and shelters. Regardless of who pro- vides medical care. health department TB control programs play an important role in providing free medication and laboratory ser- vices, documenting the patient's response to therapy, and providing supervision of thera- py whenever necessary. It is important for all health-care workers caring for patients with TB, regardless of the clinical setting, to be knowledgeable about how TB is transmitted and to implement ANOWAK "%WA= aoaerr tneasums to minimize the risk of transmis- sion within the health-care facility. Environmental aspects of Injection Control for 7lrberculosis Mtn CONCSNTRA=N of DROPUT NUCLE AND T= R= of [NFEcnoN As described previously, the probability of TB transmission is a function of the concen- tration of infectious droplet nuclei in room air and the duration of exposure. Droplet nuclei remain suspended in air for prolonged periods and are rapidly distributed within the available space by room air currents and the buddines ventilation system. Therefore, drop- let nuclei containing virulent tubercle bacilli teniaia a potential source of infection within indoor environments until they are removed. dilutedor otherwise inactivated. There is great variation in the concentra- tions of droplet nuclei generated by various patients. estimated to range from as low as one per 11,000 fN to as high as one per 70 fe of air for a highly infectious patient. Be. cause humans inhale about 18 ft'/hour. the probability of a person becoming infected during a 1-h exposure can thus be estimated to range between one in four and one in 600. Therefore. although months of exposure are usually required for infection to Dear. un- der war ordinary circumstancm when the concentration of droplet nuclei has been much higher. extensive transmission has been ob- served during exposures as brief as 2 h. Air disinfection entails removing or inac- tivating infectious droplet nuclei. or diluting the concentration with outside air. When the concentration of droplet nuclei is already low, mrnoving just one infectious droplet nucleus by vetm3ation may require exhausting as much as 11.000 fN of roots air. Even to substantial- ly dslute the concentration of droplet nuclei, large volumes of outside air may be needed. Furthermore, as the concentration of drop- let nuclei is reduced by ventilation, ever larg. er volumes of outside air ate required to fur- ther reduce their concentration. Howeva. the volume of ventilation that can be achieved is limited in practice -by noise, discomfort, cost. and design factors. Therefore. although adequate 'room ventilation can reduce the chance of TB transmission. it cannot elimi- am the risk entirely. SOUMM CONTROL Because it is difficult to remove droplet midei. or dilute their concentration in room air. it Is far better to prevent their introduction into air at the source. Case finding and effective TB treatment is the ultimate form of source control. Patients can further assist in source control by covering the nose and mouth when coughing or sneezing. Larger respiratory drop- lets that might become droplet nuclei see thus stopped at their source. Patients unable to cooperate in covering coughs and sneezes can wear ordinary surgical masks for short peri- ods, for example. while being transported within institutions. For longer periods, masks on patients are stigmatizing, uncomfortable. and probably ineffective. Because masks on patients serve more as a physical barrier than as a filter, stopping large droplets like a hand or a tissue, their fit and filtration properties may be less critical than for masks used as personal protection. In addition. persons with symptoms con- sistent with clinically active infectious TB should be placed in an AFB isolation room before the diagnosis is certain. until there is objective evidence that they are unlikely to be contagious. Air from adjacent rooms and corridorsmust Plow into. not out of. AFB isolation rooms ("negative pressurcl, and ex- haust air must not be recirculated to other rooms or vented outside to sites near air in- takes. Six room air changes per hour. at least two of which are outside air. have been recom- mended for AFB isolation rooms. Cough -producing procedures such as pcn- tamidine aerosol treatments and diagnostic sputum inductions have been associated with TB transmission. Because clinically active TB cannot be reliably excluded before each pro- cedum it is recommended that these pmee- dures be performed in booths or isolation moms occupied by the patient along Several complete and partial enclosures marketed for this purpose use HEPA filters to obviate the need to exhaust large volumes of air to the outside. Asma11. Weil -ventilated room can be used for these procedures, but personnel may be exposed when they enter such a room to attend to patients. Bronchoscopy is another cough -producing procedure that may contrib- ute to TB transmission. If TB is a diagnostic possibility and btonehoscopy is required. it should be performed in a room designed to meet AFB isolation specifications. It should not be performed in an operating room that is designed with positive air pressure relative to adjacent areas —that is. where air moves from the room into the corridor. All person- nel in bronchoscopy rooms and in rooms where other cough -inducing procedures are taking place should wear specialized face masks known as disposable particulate respi- rators (PR) (see following). VENTMA=N The concentration of Infectious droplet nuclei within a building depends on the rate at which they are introduced by the source cast, their volume of distribution within the building. and the rate at which they are removed. inac- tivated. or diluted by the introduction of out- side air. A highly variable amount of outside au enters most free-standing homes and old. er buildings in the United States by infiltra- tion through leaks and open windows. In new- er buildings, which depend upon mechanical ventilation systems, most of the air is recir- culated. In such buildings, only a small, vari- able volume of mixed air is exhausted to the otitside and is replaced with an equal volume of outside air. National ventilation standards require enough outside air to assure the comfoc most occupants and to keep the coneentu tion of several common indoor pollutant at acceptably low levels. Unfortunately, a ven. tilation system may appear to be functioning well. effectively distributing a comfortable volume of cool. dehumidified air through. out a building. and still be recirculating high concentrations of infectious droplet nuclei. A critical element in assessing the risk of air- borne infection. therefore. is the amount of outdoor air ventilation. SUPPLEMENTAL APPaAACHES Health -case providers and visitors may be ex- posed to infectious droplet nuclei when they enter the isolation rooms of a patient with infectious TS 'Therefore. all health-care providers and visitors entering such rooms should wear a weir -fitting mask with filtra. tion properties effective for droplet nuclei. ie. a disposable PR. Disposable PR look like the cup -shaped surgical masks that are wide- ly used in hospitals. When worn correctly. dis- posable PR have a tighter face seal than sur- gical masks and less tendency for leakage of air around the side. Disposable PR can pro- vide intseased protection against inhalation of particles as snail as droplet nuclei. Ordi- nary surgical masks offer little or no such protections. In institutions where TS is prevalent. oth- er supplemental approaches may be consid- cmdL 1%vo such approaches are germicidal UV irradiation and HEPA filtration. HEPA filters within air ducts are capable of almost cam•. pletely removing airborne particulates the size of droplet nuclei. However. the benefits of HEPA filtration are limited bycost consider- ations and the amount of air that can be moved pet the filters without unacceptable noise or drafts. Germicidal UV radiation (254 ram wave length) h-ts been shown to inactivate virulent tubercle bacilli under experimental condi. tions. but its efficacy in reducing transmis- sion in actual practice is unknown. Never - thetas. UV lamps have long been used in hospitals and laboratories. UV lamps can sometimes be fitted into return air ducts, thereby disinfecting air before it is mcirculat. ed. Like outside air and HEPA filtered air. however. the ability.of duct -irradiated air to reduce the concentration of droplet nuclei in a room has practical limitations. A greater effect is theoretically possible when upper room air is irradiated by overhead UV fix• cures- However. because the effectiveness of overhead UV radiation is related to the vol. ume of zir between the futures and the ceil- ing, and because safety concerns dictate that the fixtures be placed no lower than 7 feet from the floor Ito prevent people from bump. ing their heads). overhead UV air disinfec• tion is often limited by the low ceiling height of many contemporary buildings. Proper in- stallation and maintenance of UV fixtures is necesian, to optimize effectiveness and min- imize the risk of keratoconjunctivitis and er- 1628 AMERICAN THORACIC s6OM' ythesna of the skin due to direct exposure to fixtures mounted too low or from reflected UV from fixtures mounted too close to the ceiling. UV air disinfection should not be used as a substitute for standard TB control practices, including source control. or ventilation with outside air. It is a supplemental intervention that may be appropriate for rooms where high -risk procedures are performed. isolation roo= intensive care areas, emergency rooms. and waiting areas in institutions serving popu- Lations at high risk for TB. D$CONTAMMATION nth the exception of bronchoscopes and m- spiratory and anesthesia equipment, surface contamination with tubercle bacilli is not con- sidered an important health risk for patients or health-care personnel. Equipment that could possibly introduce tubercle bacilli di- rectly into the airways is generally sterilized or cleaned with a high-level disinfectant. where- as other environmental surfaces need only be cleaned with low-level disinfectants. The same routine daily cleaning procedures used in oth- er hospital or facility rooms should be used to dean rooms of patient who are on AFB isolation precautions for TB. Evdluatfon of Infection Control Pmcdcer in institutions Institutions in which persons at high risk for TB work. live, or receive care should periodi- cally review their TB policies and procedures, and determine the actions necessary to mini- mize the risk of TB transmission in their par- ticular, settings. Specific actions to reduce the risk of TB transmission should include: screening patients or residents for active TB and tuberculous infection; providing rapid di- agnostic services; prescribing appropriate curative and preventive therapy: providing AFB isolation rooms for persons with. or sus- pected of having, clinically active infectious TB; screening personnel for tuberculous in- fection and TB; promptly investigating and controlling outbreaks. Periodic evaluations of the environmental aspects of TB control in institutions should be conducted. Health department can as- sist in identifying technical experts for this purpose. Data on the occurrence of TB and skin - ten conversions among patients or residents and personnel in institutions should be col- lected and periodically analyzed to estimate the risk of TB transmission in the facility and to evaluate the effectiveness of infection - control practices. On the basis of this analy- sis. infection control practices may need to be modified and the frequency of skin -testing staff and residents may have to be altered.. Identifying Persons with Tuberculous Infection Tuberculin Skin -Testing of High -Risk Croups Identifying persons with tuberculous infec. lion and providing preventive therapy when appropriate :art critical to the control and elimination of TB. Certain groups have a high- er incidence of TB than the general popuia- tion because (1) the group has a higher preva- lence of infection (eg, persons born in coun- tries with a high prevalence of TB) or (2) the group has a higher risk of disease for any giv- en prevalence of infection (eg. persons coin- fected with tubercle bacilli and HM. Table l lists the populations considered at high risk for TB in whom tuberculin testing is indicated. Each health department should assess the prevalence. incidence, and sociodemograph is characteristics of cases and infected per- sons in their community. On the basis of these data. tuberculin screening programs should be. targeted to each community's high -risk groups. It is extremely important that these screening programs undergo regular evalua- tion of their usefulness. Moreover, screening should not be given preference over higher priority activities such as treatment and can - tact identification. Screening in most groups noted previously is carried out by staff of health department or other facilities, such as drug treatment pro- gramm long-term rats facilities, and correc- tional institutions. However, all health-care providers should be aware of the patient in their communities and practices who are in one of these high -risk categories, and should skin -test these individuals as part of their rou- tine evaluation. Members of high -risk groups should be apprised of the problem of T8 in their community and should be involved in the implementation of screening and preven- tion programs. A negative tuberculin skin -ten reaction in an HIV4rifected or otherwise immunosup- pressed person may represent a true negative Fr false negative due to anergy. Anergy test- lag may be helpful in distinguishing those who are truly tuberculin negative from those who are unable to respond to the skin tat. Frequency of nbemulin Skin -testing Individuals at high risk for TB should have a tuberculin skin test at least once to assess their need for preventive therapy and to alert the health-care providers of those with posi- tive skin tests of this medical problem. In ii; - stitutional settings, baseline information on the tuberculin status of staff and residents is a means of identifying candidates for preventive therapy as well as determining whether transmission of TB is occurring in the facility. For this reason. tuberculin skin - testing upon employment or upon entry should be mandatory for staff and resident of all facilities for long-term care. The frequency of skin -testing for individ- uals in high -risk groups should be determined by the likelihood of exposure to infectious TB. For example. follow-up skin -testing should be conducted on at least an annual basis among the staffs of TB clinics, health- care facilities caring for patient with HIV infection. mycobaaeriology laboratories, shel- ters for the homeless. nursing homes. substance -abuse treatment centers, dialysis units, and correctional institutions. Annual testing is recommended for children in high - risk populations, such as those born abroad and those in medically undeserved low- income groups. Local health officials should make decisions on the frequency of tuber- culin -testing by using locally generated data. All individuals should be retested if exposure to an infectious case otxurs. For adults who will be screened periodi- cally (eg, staff of TB clinics) use of the two- step procedure for initial skin -testing should be considered. This involves applying an ini- tial skin test and then retesting within I to 3 wk for those initially negative. This second ten is to identify 'those who demonstrate "boosting" after the second test, and to avoid the possibility that such individuals would be considered "m=t corrymers" on subsequent testing. Decisions concerning the use of the two-step procedure should be made on the basis of data on the frequency of boosting in a particular institution. Persons found to be tuberculin -positive should have. a chest radiograph to rule out. clinically active TB or to detect the presence of fibrotic lesions suggestive of old. healed TB or silicosis; persons with these conditions should receive multidrug therapy. Once these conditions are ruled out, however. follow-up skin tau and chest radiographs for persons TABLE t PmoNs iN WHOM Tuam%cuuN SIGN.TesnNG is moiCATo t. Persona with algna, symptoms (txwgh hemoptysta. Weight loss. ete.l. ttndlor laboratory abromhatkiea (m radlograprrk abnormality) suggestive of aintealty atstw TEL 2. Recent contacts of persons It wm to have or suspected of having clinically am" T8. 3. Persons with MW Infection. a. Persona with abnormal cite. roentgenograms compatible with past TB. s Persons with other medical condition that Increase the risk of TB (atlkasis. tnjeCting drug use. diabetes mellitus. prolonged 00rdCCOterbid therapy, imnwnasuopressive therapy. some hematologic and tefiWoendothelial diseases. end -stage renal disease. and ciinicai situations associated with raohd weight toad. IL Groups at high risk of recent atfeeton with M. araerculmm such as immigrants from Asia. Africa. Cann America, and Oceania modestly unoerserved populations: personnel and long-term restoonts in some ft=ortals, nursing names, mental insttttuttons. and eorreotionat fam hies. AMUNC lri T"ORA C SOCIETY 1629 with a positive tuberculin skin tat are unnec- essary- Such persons should be offered preven- tive therapy. when appropriate. and should be instructed to seek medical attention should they experience symptoms suggestive of TB. Prevention Isoniazid Preventive Therapy The appropriate use of preventive therapy for TB is critical to the control and elimination of TB in the United States. The main pur- pose of preventive therapy is to keep latent infection from progressing to clinically active TB (secondary prevention). Therefore. per- sons with positive tuberculin skin mu who do not have clinically active disease should be evaluated for preventive therapy. Pmven- dw therapy may also be used to prevent ini- tial infection (primary prevention). When taken as prescribed. preventive ther- apy with 114H is highly effective In controlled trials conducted by the U.S. Public Health Service in ordinary clinical and public health seuimgs, 12 months of INH preventive them- py reduced the incidence of disease by 54- 88%. The main mason for the variation in efficacy appears to have been the amount of medication actually taken during the year in which WH was prescribed. In a trial conduct- ed in eastern Europe among infected adults with abnormal chest radiographs. a 12-month course of rNH preventive therapy was 75476 effective among all persons assigned to the reBitnen and 93% effective among those who were compliant with therapy; a 6-month course of INH was 469% effective among those com- pliant with therapy. INH preventive therapy has been shown to be effective for long peri- ods and to be relatively cost-effective when compared with preventive interventions for other diseases. Despite its proven efficacy, preventive ther- apy is less widely applied In the United States than it should be. Report submitted to the CDC by TB control programs in state and large cities indicate that < 60% of infected contacts of persons with newly diagnosed TB art being started on preventive therapy. In a study to determine why TB is not prevented. investigators found that although three - fourths of the TO patients surveyed had can - tact with a health-care provider within the 5 yr before diagnosis of TB. less than one- third of them had been tuberculin skin -tested, even though many had risk factors for TB. Of the persons who had positive skin tests and other factors placing them at increased risk of disease. only 594 had been offered preventive therapy. Certain groups within the infected popu- lation ass at greater risk than others and should receive high priority for preventive therapy (table 2). Persons infected with HIV or who are otherwise irnmunesllppfessed. who have negative tuberculin skin -test mac- tions (it- < J mm). may also need to be can- sidered for INH preventive therapy based on the likelihood of infection with At tubemu- knit Public health officials and other health- care providers should be sihi°t. for pother per- sons in their 'communides ' who Fare high - priority candidates for preventive therapy. For example, tuberculin -positive staff of facill- ties in which an individual with clinically ac- tive TB would pose a risk to large numbers of susceptible persons, eg. day-care centers, should also be considered high -priority can- didates for preventive therapy. If otherwise indicated, preventive therapy should be offered to tube=lin-positive indi- viduals. regardless of history of vaccination with baciile Caimette4uerin (BCG). The usual preventive therapy regimen is INH (10 mg/kg daily for children. up to a maximum adult dose of 300 mg daily). The recommended duration of INH preventive treatment varies from 6 to 12 months of con- tinuous therapy. Twelve months is recom- mended for persons with HIV infection and other fortes of immunosupptession. Other in- fected persons should receive a minimum of 6 continuous months of therapy. It is recom- mended that children receive 9 months of ther- apy. For persons at especially high risk of TB whose compliance is questionable, supervised preventive therapy may be indicated. When resources do not permit supervised daffy ther- apy INH may be given twice weekly at the dose of 13 tng/kg. There are occasional situations in which alternative forms of preventive therapy might be desirable. Although other drugs might also be effective for preventive therapy, there are currently no data available documenting the clinical efficacy of any drug other than INH. Patient should be thoroughly educated about signs and symptoms of toxicity to INH and should be monitored monthly by ap- propriately trained personnel. No more than a 1-manth supply of medicine should be dis- pensed at any visit. If signs or symptoms of toxicity appear. INH should be stopped im. mediatdy and the patient should be revalu- ated. INH preventive therapy should not be prescribed if monthly monitoring cannot be done. We or BCG vaccinaion Vaccination with BCG is not recommended for widespread use in the United States be- cause of the low risk of infection in the general population„ and because BCG vaccine has varied in effectiveness in eight major trials from zero to 76%. However. BCG vaccina- tion is recommended for long -tans protec- tion of infants and children with negative tuberculin skin tests who are at high risk of continuing exposure to persons with infec- tious TB and who cannot be placed cc long- term preventive therapy, or who are continu- ously exposed to persons with INH- and RIF resistant dutau BCG vaccination should also be corWdexed for tuberculin -negative infants and children in groups in which the rate of new infections exceeds 194/yr and for whom the usual treatment and control programs are not effective. These groups include persons without regular access to health care. those for whom luahh care is culturally or socially unacceptable. and groups who have demon- strated an inability to use cdWng health cart Compliance Noncompliance with therapy is a major prob- lem in TB control. To prevent relapses TB must be treated for many months —longer than many other infectious diseases. On the other hand, symptoms often disappear after TABLE 2 MGM PRIORMY CANDIDATES FOR TUBERCULOSIS PREVENTNE TM?RAPY Pteverulw l miw WwAa be meommtrndsd for the ftkwm 9 parsons wash a i>osmm uiowculln test, regardless of qMI: O Persons with known or atapeaed MV Infeetlont O Crone cW taw of persons with Weak= dtnieaty actlw TBt O Recent %9Wc Ain akin Mat Converters P to mm a uxos" witMn a Zjr pshod for ttwss < 35 yr alM i lei men ktersaso for Oft* A 35 yr aWl. AC children < 2 yr old w M a >• to nun skin Mat are , induced in this category. O Persons with ntedial ea ci t m that have been reported to r emaso the risk of TO Ng, diabata mel. ghm prda+ged corticostemid therapy, immunosuWmsw.* therapy. some hematologic and ntlaAoen. *XhO f QPsaasea. it OCUMQ " Yae. end-ataee MAI discs". and din" litltatfonl assodated with rapid weight loss►. Ptavendve We *W WXMW ba MCortanWW*d for CM folbwang pe;$= in high -incidence Smups with a paitiva k0wadin MM who are < 35 yr old and do not haw additional risk fa mt- O Non -I L-t onf persons from highVr*vWence Counums ft. countries in Utln Anterior. Arta, and C Medially underswwod ktw 4ncome popuiw* s. inducing hWwb* racial or ethnic poputaborkL @me- dvh btak. Mspanae. and Natlw Amman groups. o Residents of fa MWN for kxW-tarn are tog. eorreebonal Mstlawom. nursing homes. and ffm"M insti- kAW*) - Anapr ran ft ,F1e WWAW4ra/ an errat rae119raon siarys b ilwaa/n eta irwe / i am Mesa sYioasr .eo con ON my aonOOarad eww6wM for av/raaWr MraaY. WOM M M / WWM mum" 0"nMawaW (Slur Anf;tcce Tt"3- re/ra eta fmmt. f Plum In Mil cmogwlw MY be orM Wevoro / wwwv in ow amanei w a omaNe wbMarin ou in M" CoCWn- atanow. = S" a iaei M" a wmCn en o"WOUrr Wo saw" re wale Poi/ a nra ro W92 ft"Mm of Su0=01 ati owsom N4. Go^K. tbmt kdoh ML MUM" nonwa. nuroaa *001uham MW n"tl0eare ftco". ienoon. L,a emw_ear/ raumwa. "Y mo W oamea a nor orlr. "" "mmu Y. 1630 AMERICAN TFICRAC1C SOCIETY a few weeks of therapy and patients often dis- continue therapy at that time Compliance with preventive therapy is even more difficult to ensure as persons taking the medication do not have symptoms related to their infec- tion. Furthermore, the concept of taking preventive medication may be unfamiliar or initially unacceptable to many individuals who are infected with TB. Noncompliance can lead to treatment fail- ure. drug resistance, continuing transmission of infection. increasing disability. and death. To prevent these outcomm health-care pro- viders must learn how to recognize, prevent, and manage noncompliant behavior. Recognizing Noncompliant Behavior iiaditioually, health-care providers have at- tempted to predict compliance based on sub- jective judgments of behaviors or personali- ty traits. This approach is not reliable. In as- sessing compliance, the response to therapy is helpful, and may be inferred by evaluating whether the patient's sputum has converted to negative and chest radiograph has improved (for patients with pulmonary TB) and if the algae and symptoms have disappeared. Pa- tients who fail to keep their appointments and/or refill their prescriptions are. by defy- nition, noncomptianL Conducting a pill count on home visits or disk visits is an additional aid in assessing compliance. Asking about compliance in a nonthreatening manner may also be usefuL All of these indirect measures have limitations and none should be used as the sole method of assessing compliance. More direct measures can tell the health- care provider whether medications have ac- tually been taken by a patient These mea- sures include the measurement of drugs or their metabolites in a sample of the patient's urine. Several simple methods for testing urine for the presence of major anti -TB drugs or their metabolites have been published. A quick glance at a patient's urine -can detect %compliance with taking RIF. as in most pa- tients RIF turns urine an orange -red color. However.: factors such as the time that RIF was taken before urination and the patient's rate of metabolizing the drug can affect the usefulness of this "observational" test Promoting Compliant Behavior Consideration should be given to treating all patients with directly -observed therapy (DOT), which can be given on an intermit- tent schedule. DOT means observation of the patient by a health-care provider or other responsible person as the patient ingests anti TB medications. DOT can be achieved with daily, twice -weekly, or thrice weekly adminis- tration of medication. It may be administered to patients in the office or clinic setting. but is frequently given by a health department worker in the "field". ie. the patient's home, place of employment, school, or other mutu- ally agreed -upon place In some cases, staff of correctional facilities or drug treatment programs. home health-care workers, mater- nal and child health staff. or responsible com- munity or family members may administer DOT. There are many factors that can help pro- mote compliance. The interval between the time of referral and the time of appointment should be kept to a minimum. Waiting time in an office or clinic should be minimized. The hours of office or clinic operation should be convenient for the patients, and the clinic or office should be easily accessible by pub- lic transportation or transportation services should be available to patients. Costs of clin- ic services should not be a barrier to receiv- ing care. Clinic staff characteristics should be carefully assessed because patients may be snore inclined to cooperate with staff they perceive as being similar to themselves. le, of ; the same racial or ethnic group, the same so- cioeconomic status, etc The shortest possible treatment regimen should be used. To minimize the number of pills or capsules that must be taken. combined fixed -dose capsules (INH-RIF) should be used. Features of the patient's life-style, so- cial support system. and health beliefs should be elicited in order to help design a treatment strategy that is tailored to the patient's needs. Patient education is vital. The health-care provider must take the time to explain in sim- pie language when and how much medica- tion should be taken and assure that the ex- planation has been understood. Written in- structions should also be provided. Pictures may be useful for illiterate patients. An inter - prates may be required to communicate with those patient whose native language is not the same as that of the health-care provider. An approach that may be useful is to as- sign a specific health department employee the responsibility for the education of the pa - dent about TB and its treatment, thereby con- trolling the continuity of therapy and ensur- ing that contacts are examined. The health- care worker should visit the patient within 3 days of diagnosis to identify contacts and possible problems related to compliance with therapy. Stmiegies to Manage Noncompliant Behavior Patients who fail to keep an appointment should be contacted immediately. and the rea- son for this failure should be elicited. Meas- ures to prevent further absences should be discussed. Use of incentives and enablers may help restore compliance. Health departments have successfully used incentives, such as food and clothes to help previously noncompliant pa dents complete therapy. Enablers such as bus tokens and baby-sitting services may ensure that the patient can get to the clinic. A small but increasing number of patients remain noncompliant despite the use of all the compliance -enhancing methods listed pre- viously. Consideration should be given to con- fining these patients to it hospital or other institution for treatment. The exercise of this option depends on the existence of appropri. ate laws. cooperative court and law enforce- ment officials. and the availability of institu- tional cam. Data Collection and Analysis In order to establish priorities for TB control activities. evaluation of the extent of the prob. lem and of current activities should be con- ducted on a frequent basis by all institutions providing care to patients with or at risk of clinically active TB or tuberculous infection. To accomplish this, institutions should have ongoing surveillance systems, identifying and maintaining records on persons with TB and tuberculous infectim the demographic char- acteristics of these individuals, and the trends in disease and infection rates. Whatever the size or nature of the activity. each program should assess the efficacy of its activities and modify or abandon activities that are no longer productive Although data collected at all levels of the health-care system should be analyzed so that appropriate program adjustment can be made, the bulk of evaluation and assessment takes place at the health department. Report- ing of all cases of clinically active TB is re- quired by law in every state. Reporting makes the resources of the health department avail- able to health-care providers and institutions to assist them in proper management of the case and in evaluation of contacts to the case. All new TB cases and suspect cases should be reported promptly to the health depart- ment by physicians or other health-care providers and by infection control practition- ers in the hospitaL Laboratories should promptly report all sputum smears positive for AFB, positive cultures, and instances of drug resistance Pharmacy reporting of per- sons who receive a supply of anti TB drugs may be useful. State and local health depart- ments have different procedures for report- ing TB and other infectious diseases. Health- care providers should familiarize themselves with these procedures. Health department staff should conduct periodic reviews of . selected record systems (eg.laboratory reports, pharmacy reports. AIDS registries. and death certificates) to validate the surveillance sys- tern and to detect any failure to report cases. Health department TB control programs should maintain a'record system (case regis- ter) with up-to-date clinical and therapeutic information on all current clinically active and suspected TB cases in the community. Health- care providers attending to TB patients out- side of the health department must provide the health department with current informa- tion on the clinical status of the patient. in- cluding the names of the patient's medica- tions and the patient's bacteriologic status (es, sputum smear and/or culture positive or nega- tive). This information is important for the management of the patient and crucial for. the control of transmission of disease in the community. Health department TB control programs should also maintain records on the AUMCAh -trronaat: aoacm !. _.^•. �.., may!>-�" �, ..1't�:* � .- Y,^:+ _ examination and treatment status of contacts to infectious cases of TB and other high -risk groups of infected persons, such as persons eoinf cted with TB and HIV. Health department TB control programs as well as other programs such as hospital em- ployee health units, correctional facilities. schools, and places of employment. should periodically review scorning activities that are performed. Such programs should be evaluated in terms of productivity in iden- tifying infected persons and in assuring that such persons are completing courses of preventive therapy when appropriate. Mother method of assessing TB control involves reviewing each new TB case and each death due to T8 in order to determine whether the rase or death could have been prevented. Based on such a review. new policies should be developed and Implemented to reduce the number of preventable eases and deaths. At least annually. health department TB control program staff should assess progress toward achievement of program objectives, and assemble and analyze morbidity and pro- gram management data. Based on these as- sessments health departments should prepare annual reports in collaboration with interested constituend such as lung associations. comintmity-based organizations. and profes- sional societies. These reports should docu- ment the ettemt and nature of the TB problem in the area, assess the adequacy of preven- tion and control measures. and make recom- mendations for program improvements. Other Functions of Tuberculosis Control Programs Staff of TB control programs should moni- tor the level of knowledge about TB among health-care workers in their communities and identify training and educational needs. Health departments should' work whir local hang associations. local medical societies, and professional associations in meeting these training needs. High -risk groups in the community should be educated about the signs and symptoms of TB and the methods of diagnosis. treat- ment, and prevention. This may be a=m- plished through coalitions between the health department, lung associations, and commu- nity gmupL Patient with clinically active TB and tuber- culous infection may be eared for by health- care providers in a variety of settings. Ulti- mately, it is the responsibility of the state and local health department TB control program, however. to assure that the TB control pro- gram in the community is carried ouL This supervisory function should encompass all TB control activities. including case finding and treatment. data collection and analysis. and training. Summary TB continues to be a major public health problem in many areas of the United States. Elimination of this disease will require coor- dinated effort of plublic,health -agencies, voluntary health `associations, health-care providers, and community groups. TB control is comprised of a variety of ac- dvitieL Identification and treatment of pa. tients with clinically active disease should be the highest priority for all TB control pro. grams. Identification and preventive treat- ment of infected contacts and persons with tuberculous infation at greatest .risk for de. veloping disease (eg, HIV infect d, young chil- drem) should also receive high priority. At- tention should then be given to identifying other high -risk groups and administering preventive therapy to those infected. While TB control occurs in many different settings. the health department TB control program plays a pivotal role in providing din. icalservices, and performing contact investi- gations, tuberculin -testing and prevention ac- tivities. surveillance, and evaluation of the community's overall progress in TB elimi- nation. Health departments should receive strong and continuing support from medical care providers, voluntary health organiza- tions. and community groups if TB elimina- tion Is to be achieved. Glossary Acid -fast bacilII (AFB)—Organisms that re- tain certain stains. even after being washed with acid alcohol. Most add -fast organisms are mycobacteria. When seen on a stained smear of sputum or other clinical specimen. a diagnosis of tuberculosis should be considered Add -fast bacilli (AFB) Isolation precautions — Infection control procedures which should be applied when persons with known or suspect- ed infectious tuberculosis are hospitalized or residing in other inpatient facilities. These precautions include the use of a private room with negative pressure in relation to surround- ing area and exhaust of air from the room directly to the outside. Not the same as "in- spiratory isolation." which calls for a private moan, but does not require negative pressure and exhaust of room air to the outside. Ane gy—Inability to mount a delayed -type hypersensitivity response to one or several skin -test antigens as a result of immunosup- pression due to disease (eg.. HIV infection) or immunosuppressive drugs. Clinically active TB —Clinical and/or radio. graphic evidence of current tuberculosis. Es. tablished most definitively by isolation of M. tttherrulosis on culture Compliance -Refers to the completion by pa- tients of all aspect of the treatment regimen as prescribed by the medical provider. Contact —An individual who has shared the same air space with a person with infectious tuberculosis for a sufrWent period of time to make transmission of infection likely. Containment — Stopping the spread of tuber- culous infection. The primary methods of con- tainment of tuberculosis are treatment of p sons with disease. preventive treatment of pet sons with infection. and effective application of infection control measures. Dimtly Observed Therapy- A compliance. enhancing strategy in which each dolt of medication is given under the supervision of a health care worker or other responsible Verson. Disposable Particulate Respirator (PR) —A face mask that is designed to fit snugly and to filter out particles in the droplet nuclei size range (1-5 microns in diameter). Droplet nudes —Microscopic particles (1-5 microns) produced by expiratory maneuvers, such as coughing and sneezing. which carry tubercle bacilli and remain airborne by nor. mal air currents in a room. HEPA (Fllgh Efficiency Particulate Air) Filter —Specialized Pita, winch is capable of removing nearly all particles > 03 mi- crons in diameter. May be of assistance in en- viroamental control of tuberculosis transmis- sion. Requites expertise in installation and maintenarrca Myeobactw urn atbaratlasls complex -The complex of naycobacterial species which causes tuberculosis. Includes M. tube=do- srs. M. bavis. and M. africanum. Preventive! therapy —Chemotherapy of tuber- culous infection. primarily used to prevent progression of infection to clinically active diseases Pdmarr prevention of tuberculosis —Use of preventive therapy in persons heavily exposed. but not ya infected with tubercle bacilli. Secondary Prevention of tuberculosis —Use of preventive therapy in persons infected with tubercle bacilli who do not have clinically ac. tive disease: Soiree ease—A.a individual with infectious tuberculosis who is capable of or responsible for infecting others - Source control- Preventing infectious drop- let nuclei from being disseminated. Sputum smear-positive—AFB an visible af. ter staining when viewed under a microscope. Individuals with sputum smear -positive for AFB arse considered more infectious than those with smear -negative sputum. Surveillance —Activities related to finding cases, guicling them into the health care sys- tem, and maintaining records on such cases for such purposes as identifying high -risk groupsand trends in morbidity and related mortality. Includes activities related to iden- tifying and maintaining records on persons with tuberculous infection as well, in order to identify candidates for preventive therapy and. in institutional settings. to identify the quality of infection control practices. Tubercle bacilli — Term often used to refer to Myr obaeterium tuberculosis complex. . 1632 AMERICAN THORACIC SOCIET1f Tuberculin skin -test -A method for demon- strating infection with Mycobacterium tuber- culosis in which an antigenic protein from Af tuberculosis cultures is introduced into the skin. either intmdermally or percutaneously. Tuberculosis case -An individual with ciin- cally.active tuberculosis. Tuberculosis suspect -An individual likely to have clinically active tuberculosis. Should be started on multiple drug therapy. Contact in- vestigation should be started as soon as pa- tient is a suspect and not delayed until diag- nosis is confirmed. Tuberculous infection -Condition in which living tubercle bacilli are present in an in- dividual. without producing clinically active disease infected individual usually has a posi- tive tuberculin skin -test. but does not have symptoms related to the infection, and is not Infectious. Ultraviolet WV) lamps -Germicidal lamps which emit radiation predominantly in the 254 manometers range (intermediate between visible light and X-rays). Can be used in ceil- ing or wall fixtures or within air ducts of recir- culating ventilation systems. Effective in kill- ing many bacteria. including tubercle badUL Further information about tuberculosis con- trol may be obtained from your State and/or localTuber ulosis Control Program: local af- filiates of the American Lung Association; the Division of lkbaculotus Elimination. Na- tional Center for Prevention Services. Centers for Disease Control. Atlanta. CIA 30333 (404- 639-2508); or from the American Thoracic Society, I740 Broadway, New York, NY 10019- 4374 (212-3I5-8700). Appendix This statement is one of a series of three state- •ments on diagnosis, treatment, and control of TB For information on diagnostic methods refer to "Diagnostic Standards and Classifi- cation of Tuberculosis" (Am Rev Respir Dis 1"0. 142-725-35). For information on the treatment of TB and TB infection, refer to "heatment of iitberculosis and Tuberculo- sis Infection in Adults and C hiidrea" (Am Rev Respir Dis 1986;1340S-63). information on diagnosis and treatment of disease caused by nontubertmlous mycobacteria can be found in "Diagnosis and Treatment of Disease caused by Nontuberculous Mycobaaeria" (Am Rev Respir Dis 1990; 42140-53). Suggested Readings General American Academy of Pediatrics. Report of the Committee on Infectious DW=u (The "Red Book'). 22nd ad. Eck Grove Village. IL.• American Academy of Pediatrics. 1991. Brodney K. Dobkin J. Resurgent tuberculosis in New York City: human immunodeficiency virus. homelessness, and the decline of tuberculosis Con- trol programs. Am Rev Rapir Dig 1"1:1".*743-9. Centers for Disease Control/Advisory Committee for Elimination of Tuberculosis. A strategic plan for the elimination of tuberculosis in the United Statess, MMWR 1989; 38 (Suppl S-3). Centers for Disease Control. Core curriculum on tuberculosis. Atlanta. GA: Centers for Disease Con- trol, 1991. Centers for Disease Control. Initial therapy for tu- berculosis in the era of multidrug resistance: mcom- mendadons of the Advisory Committee for Elimi- nation of Tab=WO$iL MMWR 1992; 41 (RR-). Centers for Disease Control. Scmaing for tuber- culosis and tuberculous infection in high -risk Mu- lations, and the use of preventive thaw for tuber- culous infection in the United States: mcommen- dations of the Advisory Committer for Elimination of Tubaculosis. MMWR 1990; 39(RR-8). Cohn DL. Catlin BJ. Peterson KL. er eL A 62-dosc. 6-month therapy for pulmonary and extrapulmo. nary tuberculosis: a twice -weekly. directly observed and cost-effective regimen. Ann Intern Mad 1990, 112:407-15. Combs DL.OBrien RJ, Gaiter I.J. USPHS tuber- culosis short course chemotherapy trial 2I: effec- tiven= toxicity, and acceptability. Ann lntaa Mad 1990, 1L2397-406. GoblcM. Drug-n misram tuberculosis. Semis Rapir Infect 1986; 1:22D -9. XWner DG. Tuberculosis: missed opportunities. Arch iutem Mad 1997; 147:2037-40. McDonald RJ, Memon AM. Reichmaa L8. Suc- cessful supervised ambulatory management of tu- berculosis treatment failures. Ann lnurn Mad 1982; 96:297-30L Rachman L8. The National Tuberculosis Tula ing Initiative. Ann Intern Mod 1989; 111:4-3. Said DE. Hutton MD. Improving patient eom. pliaoce in tubemtlosis treauncru programs Atlanta. GA: Centers for Disease Control. 1989. Werhane W. Smukst Torbeck G. Schaufnasd DE. The tuberculosis -4-wr Chat 1989; 96.815-L Epidemiology Bloch AB. Ruder HL. Kdly GDI c1 aL The epidemi- ology of tuberculosis in the United States: impli- cations for diagnosis and treatment. Clin Chest Med 1989; 10:297-313. Braun MM, Truman 81. Maguire B. Increasing in. cidence of tuberculosis in a prison inmate popula- tion. JAMA 1989; 261:393-7. Centers for Disease Control. Nosoeomial uansmis. lion of multidrug-resistant tuberculosis among HIV. infected persons -Florida and New York. 1988- 1991. MMWR 1991; 4CU33-91. Centers for Disease Control. Transmission of MDR TB among persons in a correctional system -New York; 1991. MMWR 1"2; 41:507-9. Comstock GW. Frost revisited. the modern epidead- ology of tuberculosis Am J Epidemioi 1975; 101: 363-gZ Daley CL. Small PM. Schecter GF, a aL An out- break of tuberculosis with accelerated progression among persons infected with the human immuno. deficiency virus: an analysis using restriction' fagment4e ngth polymorphisms. N Engl J Mad 1992; 326231-5. Dooley SW. Warino ME. Mercedes L. er aL Nos. ocomial transmission of tuberculosis in a hospital unit for HIWnfected patients. JAMA 1"2; 267: 2632-4. Edlin OR. Tokars JI, Grieco MH. et oL An out- break of rnulddrug-resistant tuberculosis among hospitalized patients with the acquired immimo- deficiency syndrome. N Engl J Mad 1992; 326: 1514-21. Rieder HL, Cauthen GW, Comstock GW, er at Epidemiology of tuberculosis in the United States Epidemiol Rev 1989. 11-79-98. Studer DE. Salinas L. Wy GD. Tuberculosis: an incttasing problem among minorities in the Unit- ed States. Public Health Rep 1989; 104.645-54. Tuberculosis Control in Special Populations Centers for Disease Control. Prevention and con. trol of tuberculosis among homeless persons: recommendations of the Advisory Council forthe Elimination of Tuberculosis. MMWR 1992; 41(RR S):13-23. Can= for Disease Control. Prevention and con. trol of tuberculosis in correctional institutions: recommendations of the Advisory Committee for the Elimination of Tubezulosis. MMWR 1989: 38:313-20, 325. Centers for Disease Control. Prevention and con- trol of tuberculosis in facilities providing long-term care to the elderly: recommendations of the Advi- sort' Committee for Elimination of Tuberculosis. MMWR 1990. 39(RR-10). Centers for Disease Control. Prevention and con- ud of tuberculosis in migrant farm workers: rseam. mendations of the Advisory Council for the Elimi. cation of Tuberculosis. MMWR 1992; 41(RR40). Centers for Dina Control. Prevention and can. trol of tuberculosis in US communities with at. risk minority populations recommendations of the Advisory Council for the Elimination of Tubercu- Iosis. MMWR 1992; 41(RR-Ul-IL Centers for Disease Control. Tubertatlosis among foreign -born persons entering the United States: recommendations of the Advisory Committee for Elimination of Tuberculosis. MMWR 1990; 39(RR 18). Centers for Disease Control. Tuberculosis and hu- man immunodeficiam virus infection: recommen- dations of the Advisory Committee for the Elimi- nation of Tuberculosis. MMWR 1989. 392364. 243-50. Controlling Transmision of Mabenculosis California Indoor Air Quality Program. Using ultraviolet radiation and ventilation to control tuberculosis Berkeley. CA: Air and Industrial Hy- giene Laboratory and Tuberculosis Control and Refugee Health Programs Unit. 199(L Casters for Disease Control. Guidelines for prevent- ing the transmission of tuberculosis in health -cam settings. with special focus on HIV-rdaud issues. MMWR 1990; 39(RR 17). Gunnels JJ. Bata JH. Swindoll H. Infectivity of sputum -positive tuberculosis patients on chemo- therapy. Am Rev Respir. Dis 1974; 109323-30. Loudon RG. Spohn SK. Cough frequency and in- fectivity in patients with pulmonary tuberculosis. Am Rev Respir Dis 1%9; 99:109-11. National Institute for Occupational Safety and Health. Criteria for a recommended standard .. . occupational aposure to ultraviolet radiation. Washington. DC: National Institute for Occupa- tional Safety and Health. 1972. Publication No. (HSM)73-110009. Noble RC. Infectiousness of pulmonary tubercu- losis after staring chemotherapy: review of avail- able data on an unresolved question. Am 1 Infect Control 1981 9:6-10.' AAjV*CAN THORACC 80CWrr 1633 Riley-RL. NarddI EA. Clearing the air. the theory ono application of ultraviolet air disinfection. Am Rev Respir Dhs 1989; 1391236-94. Ruraha WA. APIC guidelines for selection and use of disinfectants Am J Infect Control 1990; 18: 99-I17. Shaw 1B. Wynn•williams N. Infectivity of puimo- nary tuberculosis in relation to sputum status. Am Rev Tub= 1954. 69:724-32. Prevention Centers for Disease Control. Use of BCG vaccines• in the control of tuberculosis: a joint statement by the ACID and the Advisory Committee for EIi=- nation of Taberculosis. MMWR 1988; 37:663-73. Fettbee SH. Controlled chemoprophyia= trials in tuberculosis. A general review. Adv Tubetc Res 1969; 17:28-106. Glasuoth J. Barley WC. Hopewell PC. et aL Why tuberculosis is not Wevented. Am Rev Res* Dis I990; 141:1236-40. IaternscionalUnion AgainstlWxmulosisComm t- tec on Prophyluhs$fficav of various durations of boniaad prevrndve therapy For tuberculosis five years of follow-up in'the MAT trial.' Bull WHO 1982. 60:355-64. Snider DE. Carers GJ. Kaplan JP. Preventive ther- apy with honiazid. Cost-effectiveness of different durations of therapy. LAMA 1986; 233:1379-83. Villanno ME. Dooley SW. Leiter U. sr aL Recom- mmdations for the management of persons atposed to muitidmg-resistant tuberculosis. MMWR 1992; 41(R&11):61-71. 7irbenaslmis and HIV Infection Barns PF, Bloch AS. Davidson PT. tt aL 'Tuber- culosis in patients with human immunodeficiency virtu infection. N Engi J Med 1991; 324: 1644-5M Centers for Disease Control. Purified protein derivative (PPD).tubaculin anergy and HIV in. hetiom Guidelines for anergy testing and manage- mem of anesgic persons at malt of tuberculosis. MMWR 1991: 40(RR-3r.27-32. Centers for Disease Control. National 14-IV scto- prerslence surveys: summary of results: data from serosurnillance activities through 1989. Washing. ton. DC; US. Government Printing Office.1990. DHHS Publication No. HIV/CM/9-90/006. Kramer F.ModikvskyT.WalianyA .eraLDelayed diagnosis of tuberculosis in patients with human Immunodeficiency virus infection. Am J Med 1990; 89:451-6. Selwyn PA. Hartd D. Lewis VA. er aL A prospec- tive study of the risk of tuberculosis among hntra- venous drug users with human immunodeficiency virus -infection. N Engl J Med 1989: 320:543-SM Small PM, Scheaer GF. Goodman PC. st aL 7 eat- ment of a»berculosis in patients with human im- munodefic,ictuy infection. N Engl J Med 1991; 324:289- L Them CP. Hopewell PC. Elias D. er aL Human immunodeficiency virus infection in tuberculosis patient. J Infect Die 1990; 162:8-12. 5A • ..,��'Q1.t:01ifjlti@rt!lIIftIIItiQllCh 1!ld.m«aonst , RECEIVED 96 OCT 28 AH 11: 27 .9s Ile, GRANTS MAINAGEMENTy, r I RESOLUTION NO. 5384 Item #16 January 9, 1997 STATE OF TEXAS COUNTY OF TRAVIS A TEXAS DEPARTMENT OF HEALTH 1100 WEST 49TH STREET AUSTIN, TEXAS 78756-3199 CONTRACT CHANGE NOTICE NO. 04 The Texas Department of Health, hereinafter referred to as RECEIVING AGENCY, did heretofore enter into a contract in writing with LUBBOCK CITY HEALTH DEPARTMENT hereinafter referred to as PERFORMING AGENCY. The parties thereto now desire to amend such contract attachment(s) as follows: SUMMARY OF TRANSACTION: ATT. NO. 07: LABORATORIES All terms and conditions not hereby amended remain in full force and effect. EXECUTED IN DUPLICATE ORIGINALS ON THE DATES SHOWN. • Authorized Contracting Entity (type above if different from PERFORMING AGENCY) for and in behalf of: PERFORMING AGENCY: RECEIVING AGENCY: LUBBOCK C IIE TH ARTMENT TEXAS DEPARTMENT OF IiE TH By: "'"--- B (Signature o person authorized to sign contracts) Si cure of person authoriz to sign contracts) Alex "Ty" Cooke, Mayor Pro-Tempore (Name d Tit(e) ATTEST: V1' x _Kav_th 1 1)arnel 1 , C-Lty__S_e_cre-tary___. Date: January 9, 1997 RECOMMENDED: Linda Farrow, Chief Bureau of Financial Services (Name and Title) Date: ` ) — -? — / APPROVED AS TO FORM: By7R-a--r" By: VZ4 NOY 5 gee (PERFO AGENCY Director, if different Office of General Counsel from per a thorized to sign contract) >: to form ; y h Guluy Cover Page 1 �FINIED GRA,ATS MAtiAGEMEllT prV. DETAILS OF ATTACHMENTS Att/ Amd No. TDH Program/ ID Term Financial Assistance Direct Assistance Total Amount (TDH Share) End Source of Funds* Funds* Amount 01 HIV/GHC 01/01/96 12/31/96 93.940 35,000.00 0.00 35,000.00 02 M&D 09/01/96 08/31/97 State 0.00 0.00 0.00 03 IMM/EPI 09/01/96 08/31/97 State 93.268 68,356.00 140,011.00 208,367.00 04 HIV/SURV 09/01/96 08/31/97 State 35,398.00 0.00 35,398.00 05 ORAS 09/01/96 08/31/97 State 93.991 69,182.00 43,440.00 112,622.00 06 TB/PC 09/01/96 08/31/97 State 20,073.00 0.00 20,073.00 07 1 LAB 09/01/96 08/31/97 State 4,500.00 76,000.00 80,500.00 TDH Document No.7560005906 97 Totals Change No. 04 $232,509.00 $259,451.00 $491,960.00 *Federal funds are indicated by a number from the Catalog of Federal Domestic Assistance (CFDA), if applicable. REFER TO BUDGET SECTION OF ANY ZERO AMOUNT ATTACHMENT FOR DETAILS. Cover Page 2 DOCUMENT NO. 7560005906-97 ATTACHMENT NO. 07 PERFORMING AGENCY: LUBBOCK CITY HEALTH DEPARTMENT RECEIVING AGENCY PROGRAM: BUREAU OF LABORATORIES TERM: September 01, 1996 THRU: August 31, 1997 SECTION I. SCOPE OF WORK: PERFORMING AGENCY laboratory agrees to provide testing services on specimens received in support of the following statewide programs: Milk and Dairy Products Division (Milk Bacteriology and Chemistry) Bureau of HIV/STD Prevention (Syphilis, Gonorrhea, and/or Chlamydia) TB Elimination Division (Tuberculosis Testing) Infectious Disease, Epidemiology & Surveillance Division (Outbreak Investigations) Women's Health Division (Health Screening) Seafood Safety Division (Shellfish Testing) PERFORMING AGENCY will provide a monthly activity report according to the attached format within ten days of the end of the reporting month. PERFORMING AGENCY agrees to meet standards for such analyses as set forth by RECEIVING AGENCY, Bureau of Laboratories, the Clinical Laboratory Improvement Act, the Safe Drinking Water Act, the National Conference of Interstate Milk Shippers, and/or the 1993 U. S. Public Health Service Grade "A" Pasteurized Milk Ordinance, 25 TAC, Chapter 217. PERFORMING AGENCY will provide specimens/samples in or benefiting the geographic area defined as Lubbock. SECTION II. SPECIAL PROVISIONS: General Provisions, PROGRAM INCOME Article, paragraph two, is not applicable to this Attachment. However, additional instructions regarding program income follow in the next three paragraphs. PERFORMING AGENCY is required to bill Medicaid for the following laboratory tests performed for Medicaid eligible patients: syphilis serology screening, syphilis serology confirmation, and gonorrhea and chlamydia diagnosis. PERFORMING AGENCY will use their own billing system or may use the automated system provided by NHIC, the Medicaid fiscal intermediary. ATTACHMENT - Page 1 In keeping with RECEIVING AGENCY'S entrepreneurial efforts, it is RECEIVING AGENCY program's intent to encourage the use of locally earned Medicaid funds to pay for or offset significantly the cost of the statewide syphilis, gonorrhea, and chlamydia testing programs. To accomplish this, PERFORMING AGENCY laboratories should bill Medicaid for eligible patients, and, in FY97, purchase testing reagents for syphilis, gonorrhea, and chlamydia, in part or whole, at a state negotiated price, to cover the current and expanding workload. Program income in excess of the reagent costs should be utilized by PERFORMING AGENCY to further the program objectives of the state statute under which the Scope of Work for the Attachment was made. General Provisions, FINANCIAL REPORTS Article is not applicable to this Attachment. Support for this Scope of Work is provided by RECEIVING AGENCY under financial assistance Supplies category and under direct assistance laboratory Support category for supplies through reagents drop -shipped. Funding provided under Supplies must be used for requisition of supplies to support RECEIVING AGENCY'S testing requirements. It is the PERFORMING AGENCY'S responsibility to maintain all appropriate records required for audits that may be performed by RECEIVING AGENCY. Any change in the allotment amount must be approved by RECEIVING AGENCY'S Chief, Bureau of Laboratories. ATTACHMENT - Page 2 SECTION III. BUDGET: DIRECT ASSISTANCE Direct assistance involves the assignment of state funded positions or the provision of supplies such as vaccines in lieu of cash. PERSONNEL $0.00 TRAVEL 0.00 LABORATORY SUPPORT 76,000.00 VACCINE 0.00 OTHER 0.00 TOTAL $76,000.00 If applicable, direct assistance for personnel is shown on the attached list of positions and budgetary amounts which is an integral part of this Attachment. State salary warrants for net earnings will be issued in accordance with state regulations. Financial status reports (FSRs) are not required on direct assistance. Program income generated from activities supported with direct assistance will be reported on FSRs required for financial assistance provided through this Attachment, if applicable, or through other program Attachments(s) benefitting from this assistance. RECEIVING AGENCY direct assistance will not exceed $ 76,000.00. ATTACHMENT - Page 3 f FINANCIAL ASSISTANCE Financial assistance involves payment of funds to Performing Agency for costs incurred in carrying out approved activities. PERSONNEL $0.00 FRINGE BENEFITS 0.00 TRAVEL 0.00 EQUIPMENT 0.00 SUPPLIES 4,500.00 CONTRACTUAL 0.00 OTHER 0.00 TOTAL RECEIVING AGENCY financial assistance will not exceed $4,500.00. TOTAL RECEIVING AGENCY assistance will not exceed $80,500.00. ATTACHMENT - Page 4 $49500.00 Monthly Laboratory Report For Month Year Reporting Laboratory: Milk Testing Number Performed Bulk Products Tested Raw Products Tested Dairy Water Tested Vater Testing Total Coliform Tests Fecal Coliform Tests wvibiu testing HIV Tests RPR Card Tests VDRL Tests MHA-TP Tests FTA-ABS Tests Gonorrhea Culture Tests Gonorrhea Genprobe Tests Chlamydia Genprobe Tests i uoercutosis i esttng Cultures Performed Culture Positive Drug Susceptibility Tests Outbreak Studies Food Outbreaks Investigated Infectious Disease Outbreaks Investigated Woman and Children Testing Number Health Screening Tests Performed Shellfish Analysis Number Shellfish Samples Analyzed RECEIVED 9 36NO'l-7 AM10:41 GRANTS MANAGEMENT DIY.