Tenn. Comp. R. & Regs. 1200-06-03-.15 - SPECIAL REGULATIONS FOR ASTC, BLOOD DONOR CENTERS, AND PLASMAPHERESIS CENTERS

(1) An exception to the requirements of 1200-06-03-.14 concerning direction and supervision may be made for a licensed Ambulatory Surgical Treatment Center (ASTC) providing the following are met:

(a) Condition: The laboratory is directed by a physician currently licensed in Tennessee.

(b) Condition: The facility employs a licensed technologist as laboratory supervisor.

(c) Condition: The facility participates successfully in an approved proficiency testing program

(d) Condition: The facility is in substantial compliance with laboratory regulations as determined by an on-site survey conducted by a representative of the Department.

(e) Condition: The facility performs only the following procedures: CBC, urinalysis, ABO grouping and Rh typing, Pregnancy tests, Gram's stain, wet mounts and Rh immune globulin testing. Performance of additional procedures will necessitate that the laboratory meet all regulatory requirements.

(2) An exception to the requirements of Rule 1200-06-03-.14 concerning direction, supervision and technical laboratory personnel may be made for Blood Donor Centers and Plasmaphersis Centers providing the following conditions are met:

(a) The laboratory is directed by a physician licensed in Tennessee who possesses a current Tennessee license.

(b) Screening tests for the purpose of determining donor suitability are limited to:

1. Hemogoblin or hematocrit.

2. Total serum protein.

3. Dipstick urine test for glucose and protein.

4. Urine drug screens for opiates and morphine.

5. Platelet pre-counts.

(c) Screening tests for educational purposes are limited to blood groups (ABO) and blood type (Rh).

(d) The personnel performing the screening tests shall be trained in the performance of these tests, quality control and recordkeeping duties. The Laboratory Director shall have on record at the facility where the "trained personnel" are employed, documentation of training with date(s) of training and signed by the person(s) administering the training. These "training personnel" shall not be required to have a medical laboratory personnel license.

(e) The facility is in compliance with Rules 1200-06-03-.01 through 1200-06-03-.11 and 1200-06-03-.13.

(f) The performance of additional testing that includes but is not limited to donor accessing (ABO, Rh, Antibody Detection and/or identification, STS, HIV, hepatitis tests, ALT, protein electrophoresis, etc.) shall require the facility to comply with Rule 1200-06-03-.14.

(g) The Donor Center/Plasmapheresis Center shall report the results of all positive tests for hepatitis to the Division of Communicable Disease Control of the Department within two (2) weeks after the last day of each month. The report shall contain the name, address, birth date and social security number of the donor and the name and address of the Center.

(h) Any inquiries and/or complaints referred to the Department in regard to donor selection, bleeding products, etc. will be referred to the U.S. Food and Drug Administration for investigation.

Notes

Tenn. Comp. R. & Regs. 1200-06-03-.15

Original rule filed October 26, 1979; effective December 10, 1979. Amendment filed December 14, 1981; effective January 28, 1982. Amendment filed September 30, 1987; effective November 14, 1987. Repeal and new rule filed January 7, 1997; effective March 23, 1997. Amendment filed February 14, 2000; effective April 29, 2000. Amendment filed December 1, 2000; effective February 14, 2001. Repeal and new rule filed June 18, 2002; effective September 1, 2002. Amendment filed August 25, 2003; effective November 8, 2003. Amendments filed May 16, 2005; effective July 30, 2005.

Authority: T.C.A. §§ 4-5-202, 4-5-204, 68-29-104, and 68-29-105.