Section 410IAC15-1.5-3. Laboratory services

 

                (a) The hospital shall have, or make available, those pathology and medical laboratory services and consultation to meet the needs of patients served as determined by the medical staff which include the following:

(1) Emergency laboratory services shall be available twenty-four (24) hours a day as determined by the medical staff.

(2) The laboratory performs tests and examines specimens on the written request of individuals and practitioners allowed to order such evaluations and receive the results of the evaluations to the extent permitted by law and authorized by the governing body.

(3) A written description of available laboratory services, reference values, critical values, and expected turnaround time shall be available to the medical and nursing staff.

(4) Frozen section shall be provided where surgical procedures are performed which require immediate pathological examination.

                (b) The hospital shall assure that all laboratory services provided to its inpatients and outpatients 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.

                (c) The medical staff and a pathologist shall determine which tissue specimens require a macroscopic examination only and which require both macroscopic and microscopic examinations. Categories of specimens removed during surgical procedures which are determined to require only macroscopic examination shall be specified in the laboratory policies and the medical staff rules. The medical staff and a pathologist shall determine the qualified licensed health professional responsible for macroscopic examination.

                (d) Laboratory supervisory and testing personnel qualifications shall be consistent with the work assignments and in compliance with 42 CFR 493.

                (e) All nursing and other hospital personnel performing out-of-laboratory testing shall have annually updated performance certification maintained in the employee file for the procedures being performed.

                (f) If sufficient or suitable outside facilities are not provided by undertakers or others, the hospital shall have a morgue or a low temperature body holding room. Policies covering appropriate refrigeration requirements and length of holding bodies shall be approved by the medical staff. If autopsies are performed in the hospital, there shall be a refrigerated storage unit designed for holding bodies, along with hand washing facilities and other necessary personal hygiene facilities available.

                (g) The hospital shall maintain a minimum supply of blood and blood products or have an agreement with licensed blood sources which are in compliance with state law to obtain blood and blood products as quickly as needed.

                (h) If donor blood is drawn in the hospital, the blood center shall be:

(1) in compliance with state law;

(2) appropriately licensed or registered by the Food and Drug Administration (FDA); and

(3) in compliance with 21 CFR 640 and 21 CFR 606.

(Indiana State Department of Health; 410 IAC 15-1.5-3; filed Dec 21, 1994, 9:40 a.m.: 18 IR 1268; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234; readopted filed May 22, 2007, 1:44 p.m.: 20070613-IR-410070141RFA; readopted filed Jul 14, 2011, 11:42 a.m.: 20110810-IR-410110253RFA)