PURPOSE: This rule defines the maner in which the sampling and consultation for human immunodeficiency vim antibody resting is to be administered by persons aattwrized by the Department of Health and the repom’ng of positive *es* results.

1. (1) The following definitions shall be used in admiuistexing this rule:

   1. (A) Department means the Missouri Department of Health;
   2. (B) Health care professional means a state licensed professional involved in direct patient care, other than those persons licensed as physicians under Chapter 334, RSMo; and
2. (C) Wmdow period means the interval between exposure to human immunodcficiency virus (HIV) and development of a positive antibody test.
3. (2) To be authorized by the department to do HIV sampling, a person shall be a health care professional or able to provide accurate and current information about HIV serologic testing along with pretest and posttest consultation in accordance with this rule and shall provide or make provisions for pretest and posttest comultation in person to the person tested or his/her legal guardian or custodian. If after investigation by a department employee, the person responsible for sampling is determined not to be observing the provisions of this rule, the department shall deny autharization.
4. (A) Pretest consultation shall occur before sampling and include a risk assessment of the person to be tested to determine the person’s potential for exposure and infection. The person to be tested shall be advised of the etiology and methods of transmission of HIV, the testing methodology, the meaning of the test results and the type of behavior necessary to reduce the risk of exposure to the virus.
5. (B) POsttest consultation shall also be provided to all persons tested for HIV anti&bodies. It shall include the test results and their significance, information on good preventive and risk reduction practices and referral of the person for medical care and other support services as needed. If the test results are negative, the person tested shall be advised of the window period and possible need for retesting. If the test results are equivocal, the person shall also be advised of the possible need for retesting.
6. (C) If the test results are positive, the identity of the person tested along with related clinical and identifying information shall be reported to the department or its designated representative by the person who performs or conducts HIV sampling within seven (7) days of receipt of the test results on forms prwided by the Department of Health (see Form #l).

7. (D) Sites testing persons under the follow ing situations shall be exempt from reporting the identity of persons testing positive for HIV. These sites shall report HIV positive test results as well as other related clinical and identifying information within seven (7)

   CODE OF STATE REGULATlONS 19 CSR 20-26

days of receipt of the test results on forms provided by the Department of Health (see Form #l), but shall be exempt from reporting the patient’s name and street address-instead a unique patient identifier shall be used:

1. 1. Persons tested at depatment-designat-

ed anonymous testing sites;

1. 2. Persons tested as part of a research project at those sites participating in a research project approved by an institutional review board with notification of the board’s approval submitted to the department in writing; or
2. 3. Where prohibited by federal law or I~gUl~tiOll;
3. (E) laboratories which perform testing shall report identifying information as specified in 19 CSR 20-20.080; and
4. (F) All persons reported with HIV infection to the depaiment or its designated representative shall be treated as referrals for public health partner elicitation/notification services according to protocols and procedures established by the department.

Auth: sections 191.653 and 191.656, RSMo (Supp. 1988) and 192.005.2. and 192.020, RSMo (1986).* Original rule fikd March 14, 1989, qjktive July 13, 1989. Rescinded and readopted: Filed April 14, 1992. effective Dec. 3, 1992.

‘3

19CSR20.264iEALTH Division 2kDivision of Environmental Health and Epidemiology

(10131195)’ Rebecca McDowell Cook eew?taly Of State

1. (1) The fo*:owing definitions shall be used in administering this rule:

   1. (A) Conduct means ?o direc:, lead, order or undertake to perh;rm :x to provide guidance as a licensed physician to a patient; (B) Confirmed human immunodeficiexy virus

2. (HIV) infmtion means the ciinical diagnosis and c~incIusion that a patient is infected with HIV, made in the professioral judgment of the physician based upoc clinical history, physician examination, diagnostic or laboratory serological testing or other avaiitible clinical information which allows the physician to make clinical and therapeutic decisions based upon this infected status;

   1. (E) Physicians drlegzed repmenmive means statr liccnscd pnfessiunel involved iii direct padent care, other than those persons licensed as physicians under Chapter 334, RSMo; and

~., .

1. 2. * positive lymphocyte cultuic vcri-

tied by a specific HIV antigen :est ur by in situ hybridization using a deoxyribonucleic acid (DNA) probr;

1. 3. A positive result on any other highly

specific tat for HIV; 01

1. 4. A T-Helper (CD4> lymphocyte coiint

performed as a part of the clinical nanagemenf uf a person who in the professional judgmcn: of rbc physician is inRc:ed witb HIV.

1. (2) The physician or the physicims delegated

   Rebecca McDorvell Cook (10131145) SeCiefay Of state

representative shall provide consultation with the patient or bisiner legal guardiaD “I C”StO- dim prior to cmducting HIV blood smpling. ad to tlx patient, guardian ur custodian during the reporting oi the tat results or diagnosis.

1. (A) The physician or the physicians delegad representative sbaii only be allowed to provide consuitation through the 3% of prutocols and standing orders which shall be Witi%Xl, signed ad dated by the physician prior to their i:rplemer:aciion or, in the case of a haspital, :he policies and procrdures as approved 1-j the medical staff.
2. (B) The stop:: of tb: consulraiion shall bc governed by the physicians professional judgmai based on tine dinid situatiuo, including rk pnqmsc of and need for HIV resting, and shall bc at ieasn as comprehensive as the type of comttliation provided for o’&er diagn&c tests or procedures.

1. (3) ‘fhe physician shsil rqmrt to the department or its designated representative the identify o? any person with confirmed HIV inlection along with r&ted clinical and identifying information within seven (7) days of receipt of the test results on form provided by the department (see Fom fi fot!owing 19 CSR Zci,.26.030).

2. (4) Physicians testing persons under the fullowing situations shali be exempt from reporting the identity of tie person testing positive for Hi%‘. In lhese siOmions, physicians shali repcr! HiV posi:ive test remits as well as olher :eiated clinica! and identifying infimmtion within wren (7) days of receipt oi the test results un foms provided by the departmen! (see i7om dl fol- Iwing 19 CSR 20.26.030), b3c shall be exempt from reporting the patients mme and sireef address_instcad a miqne pa?icnl idexlitkr &Ii he used.

   1. (A) Persons :ested solely as part of a research projeci at those situ participating in a research projecl approved by amixtitutiona! review board with notification of tbbt: bards apprwai submitted to ffie department in writing; or :B) Wherr prohibited hy federal law or regulation.

3. (5) A!1 persons reported witKIlN infection to the department or its designated repmentative &ail be treated as refrrrais for public heaith partner elicitadonlnotificalion services according I” protOcols and FKlCdU~S establishcd by the depamnmt.

   CODE OF STATE REGUtATiONS 5 19CSR20-26-HEALTH

RSMo;

1. (H) HIV means human immunodeficiency virus; and
2. (I) Invasive procedures shall be defined as in 191.650(9), RSMo. Phlebotomy and insertion of intravenous lines which do not involve surgical incision are not considered invasive procedures.

1. (2) Health care professionals in both health care facility-based and community-based practice settings shall adhere to the training requirements contained in section 191.694, RSMo. The department shall investigate complaints of noncompliance in facilitybased practice settings. Complaints of noncompliance in community-based practice settings shall be referred to the appropriate licensing authority.
2. (3) Health care professionals performing invasive procedures who do not receive training in a health care facility regarding infection control procedures, universal precautions and prevention of percutaneous injuries shall obtain that training elsewhere on an annual basis. Training shall be in compliance with Safety and Health Occupational Administration (OSHA) requirements in 29 CFR 1910.1030. Training shall also be in compliance with section 191.694, RSMo and with recommendations published by the Centers for Disease Control and Prevention in the Morbidity and Morrality Weekly Repon: Recommendations for Prevention of HIV Transmission in HenNh-Care settings, August 21, 1987; Update: Universal Precautions for Prevention of Transmission of Human lmmunodeficienq Virus, Hepatitis B Virus, and Other Bloodborne Pathogens in Health-Care Senings, June 24, 1988; and Guidelines for Prevention of Transmission of Human Immunodejicienq Virus and Hepatiris B Virus to Health-Care and Publicsafety Workers, June 23, 1989. L?ocuments that validate the completion of that training shall be maintained by the health care professional for a period of three (3) years and shall be made available to the department upon *tq”eSt.

3. (4) This rule expires on June 30, 2002.

   Auth: section 191.694.4., RSMo (1994j. * Original rule filed April 17, 1995, effective Nov. 30, 1995. Division 2O-Division of Environmental Health and Epidemiology