Sec. 14-100. - Health assessment program permit required.

No person, firm, corporation or other entity shall operate a program of nondiagnostic general health assessment in the unincorporated areas of Sonoma County, or in the unincorporated areas therein where the cities have conferred enforcement authority upon the Sonoma County public health officer, without holding a valid nondiagnostic general health assessment program permit.

For the purpose of implementation and enforcement of this ordinance, the public health officer delegates authority to the director of the public health laboratory.

(Ord. No. 4703 § 2, 1993.)

Sec 14-101. - Documentation required.

The operator of the nondiagnostic general health assessment program shall submit the following documentation to the public health officer no later than thirty (30) days prior to commencing operation of its program:

(a)

Documentation that the purpose of the program is to refer individuals to licensed sources of care as indicated;

(b)

Documentation that the permittee's program utilizes only those devices which comply with all of the following:

(1)

Meet all applicable state and federal performance standards pursuant to Section 26605 of the Health and Safety Code,

(2)

Are not adulterated as specified in Article 2 (commencing with Section 26610) of Chapter 6 of Division 21 of the Health and Safety Code,

(3)

Are not misbranded as specified in Article 3 (commencing with Section 26630) of Chapter 6 of Division 21 of the Health and Safety Code,

(4)

Are not new devices unless they meet the requirements of Section 26670 of the Health and Safety Code;

(c)

The permittee's program maintains a supervisory committee consisting of, at a minimum, licensed physician and surgeon and a laboratory licensed microbiologist pursuant to this chapter;

(d)

The supervisory committee for the permittee's adopts written protocols which shall be followed in the program and which shall contain all of the following:

(1)

Provision of written information to individuals to be assessed which shall include but not be limited to, the following:

(i)

The potential risk and benefits of assessment procedures to be performed in the program,

(ii)

The limitations, including the nondiagnostic nature of assessment examinations of biological specimens performed in the program,

(iii)

Information regarding the risk factors or markers targeted by the program,

(iv)

The need for follow-up with licensed sources of care for confirmation, diagnosis and treatment as appropriate,

(2)

Proper use of each device utilized in the program including the operation of analyzers, maintenance of equipment and supplies and performance of quality control procedures including the determination of both accuracy reproducibility of measurements in accordance with instructions provided by the manufacturer of the assessment device used,

(3)

Proper procedures to be employed in when drawing blood, if blood specimen are not obtained,

(4)

Proper procedures to be employed in handling and disposing of all biological specimens to be obtained and material contaminated by those biological specimens,

(5)

Proper procedures to be employed in response to fainting, excessive bleeding or other medical emergencies,

(6)

Reporting of assessment results to the individual being assessed,

(7)

Referral and follow-up to licensed sources of care as indicated,

(8)

The written protocols adopted by the permittee's supervisory committee shall be maintained for at least one year following completion of the assessment program during which period they shall be subject to review by the director of the public health laboratory, as well as by State Department of Health Services representatives.

(Ord. No. 4703 § 2, 1993.)

Sec. 14-102. - Skin puncture requirements.

(a)

If skin puncture to obtain a blood specimen is to be performed in a program of nondiagnostic general health assessment, the individual performing the skin puncture shall be either:

(1)

Authorized to perform skin puncture under state law;

(2)

Any person who possesses a statement signed by a licensed physician and surgeon which attests that the named person has received adequate training in the proper procedure to be employed in skin puncture.

(b)

Disposal of medical wastes.

(1)

Sharps containers must be disposed of, once filled, within seven (7) days by a licensed medical waste hauler or by using a mail-back system. In addition to the above systems, a medical waste generating facility may use an Isolyzer system in which the container is disposed of into the trash once the proper activating catalyst is used on the sharps container contents. All materials are supplied with the Isolyzer system.

(2)

No permit for medical waste is required from this office as long as the sharps containers are not autoclaved.

(Ord. No. 4703 § 2, 1993.)

Sec. 14-103. - Continuing education required.

In evaluation the renewal of licenses issued pursuant to this article, the director of the public health laboratory shall satisfy himself that the mandatory continuing education requirements which were set forth in regulations adopted by the State Department of Health Services on January 1, 1992, have been met.

(Ord. No. 4703 § 2, 1993.)

Sec. 14-103.1. - Permit issuance, revocation and appeal.

Upon compliance with the requirements set forth above, successful completion of the requirements for continuing education for relicensure, if any, and payment of the requisite permit fee, the county public health officer will issue a program permit. In the event any of the requirements set forth above have not been complied with, the public health officer or his designee may revoke the program's permit immediately. A hearing before the public health officer may be requested within three (3) days after notification of permit denial or revocation. A hearing shall be conducted within five days after a request for hearing has been made. The hearing may be held by the public health officer or his designee. The determination by the public health officer or his designee regarding the program's entitlement to a permit shall be final. Appeals from such a decision may be sought pursuant to the provisions of Section 1094 et seq. of the Code of Civil Procedure.

(Ord. No. 4703 § 2, 1993.)

Sec. 14-104. - Criminal penalties for failure to comply.

Failure to possess a program permit while operating a nondiagnostic general health assessment program shall be a continuing misdemeanor. Failure to immediately terminate activities of such a program upon notice by the public health officer or his designee shall be a separate misdemeanor.

(Ord. No. 4703 § 2, 1993.)