10.10.02.03

.03 Surveys.

A. General.

(1) A licensee shall allow an on-site survey by the OHCQ or, when applicable, by the laboratory's approved accrediting organization, at any time during the laboratory's normal hours of operation, to evaluate the laboratory's compliance with the applicable requirements, conditions, and standards of this subtitle.

(2) A survey may include but is not limited to:

(a) Observation and examination of laboratory facilities;

(b) Equipment;

(c) Quality assurance and quality control program records;

(d) Operating procedures;

(e) Personnel;

(f) Personnel records;

(g) Proficiency testing;

(h) Patient reports; and

(i) Other records and files pertinent to this subtitle.

(3) Laboratory employees shall make data and records accessible within a reasonable time during the on-site survey.

B. Excepted Laboratory. A licensee operating a laboratory under a letter of exception, other than a mobile or temporary laboratory, is:

(1) Not subject to routine, on-site surveys;

(2) Subject to surveys resulting from complaints or periodic validations, or both, conducted by the Secretary or CMS, or both, to determine regulatory compliance; and

(3) Required to make available, pursuant to a survey, records the Secretary may reasonably require to determine regulatory compliance.

C. Permitted Laboratory. A licensee operating a laboratory under a permit shall:

(1) Be subject to routine surveys conducted by OHCQ;

(2) Undergo a routine annual survey for 2 consecutive years after the laboratory:

(a) Begins operating;

(b) Undergoes a change in ownership;

(c) Fails to complete or submit to the Department an acceptable quality assurance self-assessment on forms provided by the OHCQ; or

(d) Has imposed on it a principal or alternative sanction; and

(3) Undergo a routine biennial survey when the laboratory:

(a) Does not fall under one of the categories set forth in §C(2) of this regulation; and

(b) Completes and submits to the OHCQ an acceptable quality assurance self-assessment on forms provided by the OHCQ on the years when the OHCQ does not conduct an on-site survey, except as provided in §D of this regulation.

D. Accredited Laboratory. An accredited laboratory:

(1) Undergoing routine on-site surveys conducted by an accrediting organization approved by the Secretary, except as provided in §D(2) and (3) of this regulation, is not subject to routine surveys conducted by the OHCQ;

(2) Is subject to surveys conducted by the OHCQ to investigate a complaint or to determine regulatory compliance; and

(3) Holding a permit in the discipline of forensic toxicology, subdiscipline of job-related testing, is subject to routine surveys of the laboratory's alcohol and controlled dangerous substances testing areas conducted by the OHCQ.

E. Temporary or Mobile Laboratory. The OHCQ may survey each testing event site when a temporary or mobile laboratory licensee offers to perform or performs testing services.

F. Excepted Laboratory — Limited Testing for Rare Diseases. A licensee operating a laboratory under a letter of exception — limited testing for rare diseases is subject to the survey requirements stated in §B of this regulation.