10.10.02.02

.02 Accredited Laboratory and Accrediting Organization.

A. Accredited Laboratory — Determination. The Secretary shall accept as meeting the survey requirements of this chapter a laboratory accredited by an organization approved by the Secretary, as set forth in §C of this regulation, if the OHCQ determines that the standards of the laboratory's accrediting organization are equivalent to those under this subtitle.

B. Accredited Laboratory — Requirements. In addition to meeting the requirements for its certificate of accreditation, as set forth by its accrediting organization, an accredited laboratory shall:

(1) Obtain and maintain a valid license issued by the Secretary; and

(2) Be subject to survey by the OHCQ for the purpose of investigating complaints or validating findings of the laboratory's accrediting organization.

C. Accrediting Organization.

(1) A private, nonprofit laboratory accrediting organization may inspect and accredit laboratories in the State for the purpose of Maryland State licensure only after applying for and receiving approval of the OHCQ.

(2) The OHCQ shall base approval of a laboratory accrediting organization on a review of that organization, when the review includes but is not limited to an evaluation of:

(a) Documentation of current accrediting status issued by CMS and of compliance with CMS reporting requirements;

(b) Accreditation policies and standards;

(c) Copies of survey forms and guidelines;

(d) Surveying and deficiency writing policies;

(e) Surveyor qualifications;

(f) Complaint investigation policies;

(g) Proficiency test monitoring policies;

(h) Procedures the accrediting organization will follow when notifying the OHCQ that the organization:

(i) Is denying, withdrawing, suspending, or revoking a laboratory's accreditation;

(ii) Finds serious patient jeopardy or identifies a hazard to public safety;

(iii) Accredits a new laboratory;

(iv) Imposes an adverse or corrective action on a laboratory; or

(v) Is initiating a complaint investigation; and

(i) The accrediting organization's compliance with the requirements of §C of this regulation.

(3) In addition to requirements set forth elsewhere in this regulation, an accrediting organization shall:

(a) Provide to the OHCQ:

(i) Annually, an updated list containing the names, addresses, and accreditation expiration dates of all accredited laboratories in the State;

(ii) Within 30 days after conducting a survey, a certified written or electronic copy of each survey report covering each laboratory applying for or maintaining accreditation in the State;

(iii) Written notice of any proposed change to requirements for laboratory accreditation, at least 30 days before the effective date of the change;

(iv) Within 30 days after a laboratory's certificate of accreditation expires, written or electronic notice when the laboratory does not renew its certificate; and

(v) Within 24 hours after taking an action, telephonic or electronic notice whenever an accredited laboratory's certificate of accreditation is limited, suspended, revoked, or surrendered;

(b) Evaluate compliance, when applicable, with State regulations pertaining to:

(i) Cholesterol testing;

(ii) Gynecological cytology;

(iii) Dermatopathology;

(iv) Forensic toxicology;

(v) Laboratory reporting of test results covering contagious disease, blood lead, cancer, and other tests as required by law or regulation;

(vi) Proficiency testing;

(vii) Special medical waste disposal; and

(viii) Testing performed at a temporary or mobile laboratory;

(c) Evaluate compliance with State regulations by:

(i) Employing a checklist provided by the Department;

(ii) Incorporating an evaluation of compliance with State regulatory requirements into its own survey process; or

(iii) Demonstrating that its existing survey process adequately evaluates compliance with State regulations; and

(d) On request, provide to OHCQ a copy of:

(i) A complaint investigation;

(ii) Surveyor qualifications;

(iii) A change in a laboratory's disciplines, subdisciplines, or specialties; and

(iv) Other information the Secretary may require relating to approval of a laboratory accrediting organization.