PURPOSE: This rule establishes the requirements for pathology and medical laboratory services in a hospital.

1. (1) Provision shall be made, either on the premises or by contract with a reference laboratory, for the prompt performance of adequate examinations in the fields of hematology, clinical chemistry, urinalysis, microbiology, immunology, anatomic pathology, cytology and immunohematology.
2. (2) The medical director of the pathology and medical laboratory services shall be a physician who is a member of the medical staff and appointed by the governing body. If the director is not a pathologist, a pathologist shall be retained on a part-time basis as a consultant on-site. Consultation shall be provided no less than monthly. A written report of the consultant’s evaluation and recommendations shall be submitted after each visit.
3. (3) Pathology and medical laboratory services shall be integrated with other hospital services. The pathologist(s) shall have an active role in in-service educational programs and in medical staff functions, the laboratory quality assurance program and shall participate in committees that review tissue, infection control, and blood usage.
4. (4) There shall be sufficient qualified laboratory technologists and supportive technical staff currently competent in their field to perform the tests required. Laboratory personnel shall have the opportunity for continuing education.
5. (5) The laboratory shall perform tests for and examine specimens from hospital patients only on the order of a medical staff member or authorized personnel as stated in the medical staff bylaws. The laboratory shall perform tests and examine specimens from other sources only on the order of a medical staff member or authorized personnel as stated in the medical staff bylaws. Test orders received by the laboratory shall clearly identify the patient, the source of the order, the tests required, and the date. Orders for examinations of surgical specimens shall contain necessary clinical information.
6. (6) The laboratory shall maintain complete written or electronic instructions for specimen collection and processing, storage, testing, and reporting of results. The instructions shall at a minimum follow the manufacturer’s recommendation and include, but not be limited to, a step-by-step description of the testing procedure, reagent use and storage, control and calibration procedures, and pertinent literature references.
7. (7) Dated reports of all laboratory examinations shall become a part of the patient’s medical record. If the original report from a reference laboratory is not part of the patient’s record, the original shall be retained and retrievable for a period of not less than two (2) years. Dated reports of tests on outpatients and from referring laboratories shall be sent promptly to the individual or facility ordering the test. Copies of all laboratory tests and examinations shall be retained and retrievable for at least two (2) years.
8. (8) Instruments and equipment shall be evaluated following the manufacturer’s recommendations at a minimum to insure that they function properly at all times. Records shall be maintained per hospital’s record retention policy for each piece of equipment, showing the date of inspection, calibration, performance evaluation, and action taken to correct deficiencies. Temperatures shall be recorded daily for all temperature-controlled instruments.
9. (9) Each section of the pathology and medical laboratory shall have a written quality control program to verify accuracy, measure precision, and detect error. Quality control results shall be documented and retained for at least two (2) years.
10. (10) The hospital laboratory shall successfully participate in a proficiency testing program covering all anatomical and clinical specialties in which the laboratory performs tests and in which proficiency testing is available. Laboratory tests without a proficiency testing 19 CSR 30-20

program shall be validated twice per year. Records shall be maintained for at least two (2) years.

1. (11) All specimens, except for teeth and foreign objects, removed during a surgical, diagnostic, or other procedure shall be submitted for pathologic examination, except for specimens that have been previously determined to be exempt. Specimens submitted for pathological examination shall be accompanied by pertinent clinical information. Specimens exempted from pathologic examination shall be those for which examination does not add to the diagnosis, treatment or prognosis, shall be determined by the medical staff in consultation with the pathologist, and shall be documented in writing. When the specimen is not submitted for pathological examination, a report of the removal must be present in the patient’s medical record. Specimens requiring only a gross description and diagnosis shall be determined by the medical staff in consultation with the pathologist and shall be documented in writing.
2. (12) An autopsy service shall be available to meet the needs of the hospital. Each autopsy shall be performed by, or under the supervision of, a pathologist or a physician whose credentials document his/her qualifications in anatomical pathology. All microscopic interpretations shall be made by a pathologist who is qualified in anatomical pathology.
3. (13) At all times there shall be an established procedure for obtaining a supply of blood and blood components. Facilities for the safekeeping and safe administration of blood and blood products shall be provided. Positive patient identification shall be provided through two (2) unique patient identifiers. The refrigerator used for the routine storage of blood for transfusion shall maintain a temperature between one degree and six degrees Celsius (1°–6° C) and this temperature shall be verified by an outside recording thermometer. This refrigerator shall be constantly monitored by an audible and visible alarm that is located in an area that is staffed at all times. The alarm shall be battery-operated or powered by a circuit different from the one supplying the refrigerator. This refrigerator shall be on the power line supplied by the emergency generator.
4. (14) The hospital shall provide safety equipment for laboratory employees that includes, but is not limited to, appropriate personal protective equipment.
5. (15) Laboratories employing quantities of flammable, combustible, or hazardous materials which are considered a severe hazard SENIOR SERVICES

shall be protected in accordance with the Safety Standards for Laboratories in Health- Related Institutions 1980 which are incorporated by reference in this rule and is published by the National Fire Protection Association, Chapter 8 of NFPA 101 Life Safety Code, 2000 Edition, NFPA Headquarters, 1 Batterymarch Park, Quincy, MA 02169. This rule does not incorporate any subsequent amendments or additions.

1. (16) The hospital shall provide reports to the department as required by 19 CSR 10-33.050 and section 192.131, RSMo.

AUTHORITY: section 192.006, RSMo 2000, and sections 197.080 and 197.154, RSMo Supp. 2013.* This rule previously filed as 19 CSR 30-20.021(3)(F). Original rule filed June 27, 2007, effective Feb. 29, 2008. Amended: Filed June 6, 2013, effective Jan. 30, 2014.

*Original authority: 192.006, RSMo 1993, amended 1995; 197.080, RSMo 1953, amended 1993, 1995, 2013; and 197.154, RSMo 2004.