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Chapter 16     Entire Code
‹ Chapter 15  |  Chapter 17 › Printer Friendly Versions
Chapter 16  |  Article 16 - 5J  |  Section 2

1 - STATE PUBLIC HEALTH SYSTEM

1A - UNIFORM CREDENTIALING FOR HEAL

1B - SKILLED NURSING FACILITIES FOR

1C - HEALTH CARE PROVIDER TRANSPARE

2 - LOCAL BOARDS OF HEALTH

2A - ALTERNATIVE METHOD OF ORGANIZI

2B - FAMILY PLANNING AND CHILD SPAC

2C - HOME HEALTH SERVICES

2D - CERTIFICATE OF NEED

2E - BIRTHING CENTERS

2F - PARENTAL NOTIFICATION OF ABORT

2G - SPECIAL SUPPLEMENTARY FOOD PRO

2H - PRIMARY CARE SUPPORT PROGRAM

2I - WOMEN'S RIGHT TO KNOW ACT

2J - PREVENTIVE CARE PILOT PROGRAM

2K - PROGRAMS OF ALL-INCLUSIVE CARE

3 - PREVENTION AND CONTROL OF COMMU

3A - REPOSITORY OF INFORMATION ON M

3B - PERTUSSIS

3C - AIDS-RELATED MEDICAL TESTING A

3D - TUBERCULOSIS TESTING, CONTROL,

4 - SEXUALLY TRANSMITTED DISEASES

4A - PRENATAL EXAMINATION

4B - AUTOPSIES ON BODIES OF DECEASE

4C - EMERGENCY MEDICAL SERVICES ACT

4D - AUTOMATED EXTERNAL DEFIBRILLAT

4E - UNIFORM MATERNAL SCREENING ACT

5 - VITAL STATISTICS

5A - CANCER CONTROL

5B - HOSPITALS AND SIMILAR INSTITUT

5C - NURSING HOMES

5D - ASSISTED LIVING RESIDENCES

5E - REGISTRATION AND INSPECTION OF

5F - HEALTH CARE FINANCIAL DISCLOSU

5G - OPEN HOSPITAL PROCEEDINGS

5H - CHRONIC PAIN CLINIC LICENSING

5I - HOSPICE LICENSURE ACT

5J - CLINICAL LABORATORIES QUALITY
    16 - 5 J- 1
    16 - 5 J- 2
    16 - 5 J- 3
    16 - 5 J- 4
    16 - 5 J- 5
    16 - 5 J- 6
    16 - 5 J- 7
    16 - 5 J- 8
    16 - 5 J- 9
    16 - 5 J- 10

5K - EARLY INTERVENTION SERVICES FO

5L - LONG-TERM CARE OMBUDSMAN PROGR

5M - OSTEOPOROSIS PREVENTION EDUCAT

5N - RESIDENTIAL CARE COMMUNITIES

5O - MEDICATION ADMINISTRATION BY U

5P - SENIOR SERVICES

5Q - THE JAMES TIGER MORTON CATASTR

5R - THE ALZHEIMER'S SPECIAL CARE S

5S - OLDER WEST VIRGINIANS ACT

5T - CARE HOME ADVISORY BOARD

5U - ARTHRITIS PREVENTION EDUCATION

5V - EMERGENCY MEDICAL SERVICES RET

5W - WEST VIRGINIA OFFICIAL PRESCRI

6 - HOTELS AND RESTAURANTS

7 - PURE FOOD AND DRUGS

8 - ELECTROLOGISTS

8A - NARCOTIC DRUGS

8B - DANGEROUS DRUGS ACT

9 - OFFENSES GENERALLY

9A - TOBACCO USAGE RESTRICTIONS

9B - IMPLEMENTING TOBACCO MASTER SE

9C - STATE TOBACCO GROWERS' SETTLEM

9D - ENFORCEMENT OF STATUTES IMPLEM

9E - DELIVERY SALES OF TOBACCO

9F - COUNTERFEIT CIGARETTES

10 - UNIFORM DETERMINATION OF DEAT

11 - SEXUAL STERILIZATION

12 - SANITARY DISTRICTS FOR SEWAGE

13 - SEWAGE WORKS AND STORMWATER W

13A - PUBLIC SERVICE DISTRICTS

13B - COMMUNITY IMPROVEMENT ACT

13C - DRINKING WATER TREATMENT REV

13D - REGIONAL WATER AND WASTEWATE

13E - COMMUNITY ENHANCEMENT ACT

14 - BARBERS AND COSMETOLOGISTS

15 - STATE HOUSING LAW

16 - HOUSING COOPERATION LAW

17 - NATIONAL DEFENSE HOUSING

18 - SLUM CLEARANCE

19 - ANATOMICAL GIFT ACT

20 - AIR POLLUTION CONTROL

21 - BLOOD DONATIONS

22 - DETECTION AND CONTROL OF PHEN

22A - TESTING OF NEWBORN INFANTS F

22B - BIRTH SCORE PROGRAM

23 - TRANSFUSION OF BLOOD; TRANSPL

24 - STATE HEMOPHILIA PROGRAM

25 - DETECTION OF TUBERCULOSIS, HI

26 - WEST VIRGINIA SOLID WASTE MAN

27 - STORAGE AND DISPOSAL OF RADIO

27A - BAN ON CONSTRUCTION OF NUCLE

28 - ASSISTANCE TO KOREAN AND VIET

29 - HEALTH CARE RECORDS

29A - WEST VIRGINIA HOSPITAL FINAN

29B - HEALTH CARE AUTHORITY

29C - INDIGENT CARE

29D - STATE HEALTH CARE

29E - LEGISLATIVE OVERSIGHT COMMIS

29F - UNINSURED AND UNDERINSURED P

29G - WEST VIRGINIA HEALTH INFORMA

29H - INTERAGENCY HEALTH COUNCIL

29I - WEST VIRGINIA HEALTH CARE AU

30 - WEST VIRGINIA HEALTH CARE DEC

30A - MEDICAL POWER OF ATTORNEY

30B - HEALTH CARE SURROGATE ACT

30C - DO NOT RESUSCITATE ACT

31 - COMMUNITY RIGHT TO KNOW

32. ASBESTOS ABATEMENT

33 - BREAST AND CERVICAL CANCER PR

34 - LICENSURE OF RADON MITIGATORS

35 - LEAD ABATEMENT

36 - NEEDLESTICK INJURY PREVENTION

37 - BODY PIERCING STUDIO BUSINESS

38 - TATTOO STUDIO BUSINESS

39 - PATIENT SAFETY ACT

40 - STATEWIDE BIRTH DEFECTS INFOR

41 - ORAL HEALTH IMPROVEMENT ACT

42 - COMPREHENSIVE BEHAVIORAL HEAL

43 - ENGINE COOLANT AND ANTIFREEZE

44 - THE PULSE OXIMETRY NEWBORN TE

45 - TANNING FACILITIES

WVC 16- CHAPTER 16. PUBLIC HEALTH.
WVC 16 - 5 J- ARTICLE 5J. CLINICAL LABORATORIES QUALITY ASSURANCE ACT.

WVC 16 - 5 J- 1 §16-5J-1. Legislative findings.

The Legislature finds that the diagnosis and treatment of human affliction is or may be largely determined by the results of laboratory testing and that inaccurate laboratory test results endanger the health and lives of the citizens of West Virginia. A due respect for the citizenry of the state requires that all such testing be done under the supervision of qualified and competent persons having sufficient expertise and experience to assure the quality and accuracy of clinical laboratory testing. Further, it is imperative that laboratories be regulated and licensed to ensure that the intent of this article be met.

WVC 16 - 5 J- 2 §16-5J-2. Definition.

The term "clinical laboratory" means any facility or place, however named, for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, crytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of human beings.

WVC 16 - 5 J- 3 §16-5J-3. Rules; recognized external standards.

The director of the department of health shall promulgate, pursuant to chapter twenty-nine-a of this code, rules required to implement this article, and such rules shall specifically address, among other things, training, education and experience requirements. The standards to be adopted by the department of health shall be equal to or higher than such standards currently applicable and as established by the college of American pathologists, the center for disease control, American Osteopathic Board of Pathology, American Osteopathic Hospital Association, the medicare program or the joint commission for the accreditation of hospitals: Provided, That any laboratory in this state accredited by or certified by one of these organizations or the medicare program shall be exempt from the requirements of licensure with no further inquiry by the department of health, and any such accredited or certified laboratory shall be exempt from the provisions of this article as long as such laboratories remain so accredited or certified: Provided, however, That all laboratories shall have five years from the effective date of this article to come into compliance.

WVC 16 - 5 J- 4 §16-5J-4. Powers and duties.

In addition to promulgating rules specified in section three of this article, the director of the department of health, with the advice of the advisory board created in section five of this article, has the power to:

(a) Adopt rules for clinical laboratory licensure;

(b) Establish rules for continued evaluation of laboratory testing, such rules and evaluations being at least equivalent to the appropriate section of the "Clinical Laboratory Improvement Act of 1967";

(c) Institute and administer a program of inspection to ensure compliance with standards established in this article and rules established pursuant to this article;

(d) Issue a license to those clinical laboratories which meet requirements for licensure under this article;

(e) Set a reasonable fee for application and licensure;

(f) Withhold, revoke or suspend or restrict the license of any clinical laboratory which fails to meet requirements for licensure or relicensure.

The cost of the initial inspection of any new laboratory constructed after July one, one thousand nine hundred ninety, shall be the responsibility of the prospective licensee.

Within the limit of available funds, the department of health shall inspect clinical laboratories on a periodic basis to ensure compliance with standards and regulations.

WVC 16 - 5 J- 5 §16-5J-5. Advisory board.

There is hereby created an advisory board which shall be composed of the following persons:

(a) Two board certified pathologists licensed and currently practicing in this state;

(b) A board certified physician or doctor of osteopathy, licensed and currently practicing in this state in a specialty other than pathology;

(c) Two clinical laboratory practitioners who hold professional certification from an agency acceptable to the department of health. These two must have had a minimum of three years experience in a clinical laboratory setting during the five years preceding appointment. One of the two must hold a minimum of a baccalaureate degree;

(d) One lay person to represent the interests of the people of this state.

The advisory board shall be appointed by the governor, with the advice and consent of the Senate. Appointments of professional members shall be made from lists of candidates submitted from among their peers. These lists may be solicited from the West Virginia association of pathology, the West Virginia state society for medical technology, the West Virginia state medical association, the West Virginia society of state American medical technologists and other similar professional organizations. The lists submitted shall contain at least one name in excess of the number of appointments to be made. Appointments shall be for a term of three years beginning the first day of July of the year of appointment, except for the first board appointed, whose terms shall be as follows:

(a) The pathologists and one baccalaureate clinical practitioner shall serve a one-year term;

(b) The nonpathologist physician or doctor of osteopathy, and the other clinical practitioner shall serve for a two-year term;

(c) The lay person shall serve for a three-year term.

Successors to those first board members will serve three-year terms. Board members may succeed themselves once, but may not serve for a total period in excess of six years. In the event of a vacancy on the advisory board the governor shall appoint a successor in the same manner as the original appointment was made. The successor will serve for the unexpired term and may be eligible for reappointment: Provided, That any member shall serve until such time as his or her successor is appointed.

WVC 16 - 5 J- 6 §16-5J-6. Hearing and judicial review.

If a license is withheld, suspended or revoked, the laboratory is entitled to a hearing before representatives of the department of health within sixty days of the withholding, suspension or revocation decision. Such laboratory may be represented at the hearing by counsel and may present evidence in its defense. The final order of the director will be based on a record of the hearing and shall contain findings of fact and conclusions of law. The laboratory may appeal an adverse order to the circuit court of Kanawha County or the circuit court of the county in which the laboratory is located to determine whether the director abused his discretion or exceeded his jurisdiction. The department of health has the power to obtain an injunction during the time preceding the hearing against any laboratory which fails to meet licensure requirements and whose continued operation poses a significant threat to the public health.

WVC 16 - 5 J- 7 §16-5J-7. Exemptions.

This article does not include or apply to any laboratory or laboratories maintained and operated by the federal government or to any laboratory or laboratories maintained and operated purely for research or teaching purposes nor to any laboratory operated by a primary health care center having tax exempt status and receiving contributions which are deductible to the contributor under provisions of federal law. All county health departments shall be exempt from this article.

WVC 16 - 5 J- 8 §16-5J-8. Unlawful conduct; penalties.

It is a misdemeanor for any person to solicit, receive, accept, deliver or transmit, by mail or otherwise, material originating from the human body on behalf of any person operating a laboratory not in possession of a license under this article regardless of whether such laboratory is located in this state and, upon conviction thereof, such person shall be fined not less than five hundred dollars. The provisions of this section do not apply to transactions with any person operating a laboratory located in another state, which laboratory has been issued a license or permit in conformity with the "Clinical Laboratories Improvement Act of 1967," and related statutes. Neither does this section apply to transactions with laboratories operated in this state which are exempt from the license requirements of this article.

WVC 16 - 5 J- 9 §16-5J-9. Interpretation of article; severability.

The provisions of this article are severable and if any of its provisions shall be held unconstitutional, the decision of the court shall not affect or impair any of the remaining provisions of this article. It is hereby declared to be the legislative intent that this article would have been adopted had such unconstitutional provisions not been included herein.

WVC 16 - 5 J- 10 §16-5J-10. Licensure of technicians; fee; rules and regulations.

(a) The director of the department of health shall promulgate rules and regulations for the licensure and certification of lab technicians and lab technologists. All such persons being so employed on the effective date of this article shall be automatically certified and exempt from this requirement: Provided, That any technologist and technician who is certified by the American medical technologists or the American society of clinical pathologists or the national certification agency for medical laboratory personnel or any federal certification program shall be considered certified.

(b) All laboratory technicians or technologists shall pay an annual license fee of twenty-five dollars to the director of the department of health to cover the costs of licensure.

(c) All rules and regulations required under this section or other provisions of this article may not be filed as emergency rules until after the set of rules is approved by the Legislature.

(d) All fees and interest earned or collected by the department under this article shall be used to pay for the implementation of this article.

Note: WV Code updated with legislation passed through the 2014 1st Special Session
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