Section 410 IAC 15-2.5-2 - Laboratory servicesAuthority: IC 16-21-1-7
Affected: IC 16-21-1
Sec. 2.
(a) The center shall provide, or make available, those pathology and medical laboratory services and consultation 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 upon the written request of individuals and practitioners authorized by law and with governing body approval.(c) A written description of available laboratory services, reference values, critical values, and expected turnaround time shall be available to the patient care staff.(d) Frozen section shall be provided where surgical procedures are performed which require immediate pathological examination and if performed on site must meet 42 CFR 493 for high complexity pathology testing.(e) The medical staff and a pathologist shall determine, as specified by medical staff rules and laboratory policy, what tissue specimen examination will be utilized on each specimen as follows: (1) Microscopic examination only.(2) Macroscopic examination only.(3) Both microscopic and macroscopic examinations.(f) The center shall 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.(g) Laboratory supervisory and testing personnel qualifications must be consistent with the work assignments and in compliance with 42 CFR 493.(h) All nursing and other center personnel performing laboratory testing shall have competency assessed annually with documentation of assessment maintained in the employee file for the procedures performed.(i) The center shall maintain a minimum supply of blood and blood products in compliance with state and federal laws or have a written agreement with a licensed blood center or transfusion service that meets all state and federal laws pertaining to collection, storing, testing, and or transfusing.(j) The center shall 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 State Department of Health; 410 IAC 15-2.5-2; filed Dec 1, 1999, 3:44 p.m.: 23 IR 788; errata filed Feb 15, 2000, 8:05 a.m.: 23 IR 1657; readopted filed Jul 15, 2005, 8:00 a.m.: 28 IR 3661; readopted filed Jul 14, 2011, 11:42 a.m.: 20110810-IR-410110253RFAReadopted filed 9/13/2017, 4:08 p.m.: 20171011-IR-410170339RFAReadopted filed 11/28/2023, 12:13 p.m.: 20231227-IR-410230639RFA