Authority: IC 16-21-1-7; IC 16-21-2-2.5

Affected: IC 16-21-1

Sec. 1. (a) The center must provide, or make available, those pathology and medical laboratory services and consultations necessary to meet the needs of patients as determined by the medical staff.

(b) The laboratory performs tests, examines specimens, and reports the evaluation only:

1. (1) upon the written request of individuals and licensed health professionals authorized by law; and
2. (2) with governing body approval.

(c) The center must assure that all laboratory services provided to its patients are performed in a facility possessing a valid certificate, in accordance with 42 CFR 493 (excluding Subparts F, R, Q, and T) authorizing the performance of testing in the specialty or subspecialty of service for level of complexity in which the test is categorized.

(d) Laboratory supervisory and testing personnel qualifications must be:

1. (1) consistent with the work assignments; and
2. (2) in compliance with 42 CFR 493.

(e) All nursing and other center personnel performing laboratory testing must have competency assessed annually with documentation of assessment maintained in the employee file for the procedures performed.

(f) The center must develop, implement, and maintain written quality control and quality assurance policies and procedures for complexity of testing performed that are consistent with and include all standards found in 42 CFR 493.

(Indiana Department of Health; 410 IAC 27-15-1; filed Feb 3, 2006, 2:00 p.m.: 29 IR 1919; readopted filed Jul 12, 2012, 12:09 p.m.: 20120808-IR-410120265RFA; readopted filed Sep 26, 2018, 2:48 p.m.: 20181024-IR-410180328RFA; readopted filed Nov 14, 2024, 1:24 p.m.: 20241211-IR-410230798RFA)