10A NCAC 13M .0101. STATE CERTIFICATION FOR LABORATORIES CONDUCTING PAP SMEARS

(a)  All laboratories evaluating Pap smears shall be state certified by the Division of Health Service Regulation, Department of Health and Human Services, in accordance with this Rule.

(b)  To be state certified, all laboratories shall be licensed under the federal Clinical Laboratory Improvement Act as amended or certified by the Centers for Medicare and Medicaid Services for the specialty of cytology.

(c)  To be state certified, laboratories shall perform Pap smear examinations only on specimens submitted by a health care provider whose scope of practice includes the function of taking Pap smears.

(d)  An application for state certification shall be submitted to the Division of Health Service Regulation listing the name and location of the laboratory requesting certification, the name of the laboratory director and evidence that the laboratory meets the requirements listed in Paragraphs (b) and (c) of this Rule.  Laboratories will be notified in writing within 45 days of the receipt of the application that they have been certified or, if certification has been denied, of the reasons for denial.

(e)  State certification must be renewed by a facility when licensing or certification renewal is required by the program that established state certification eligibility pursuant to Paragraph (b) of this Rule.

(f)  If a laboratory's license or certification for one of these programs is suspended or revoked, the laboratory director shall immediately notify the Division of Health Service Regulation and the laboratory's state certification under this Rule shall be revoked.  The laboratory may apply for recertification when it can provide evidence that it meets the requirements listed in Paragraphs (a) ‑ (e) of this Rule.

(g)  Appeals of the Division's decisions regarding state certification shall be in accordance with the Administrative Procedures Act, G.S. 150B.

 

History Note:        Filed as a Temporary Adoption Eff. October 11, 1991 For a Period of 141 Days to Expire on February 29, 1992;

Authority G.S. 143B‑165;

Eff. March 1, 1992.