California Code of Regulations
Title 22 - Social Security
Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies
Chapter 1 - General Acute Care Hospitals
Article 3 - Basic Services
Section 70243 - Clinical Laboratory Service General Requirements

(a) Clinical laboratories shall be operated in conformance with the California Business and Professions Code, Division 2, Chapter 3 (Sections 1200 to 1322, inclusive) and the California Administrative Code, Title 17, Chapter 2, Subchapter 1, Group 2 (Sections 1030 to 1057, inclusive).

(b) All hospitals shall maintain clinical laboratory services and equipment for routine laboratory work, such as urinalysis, complete blood counts, blood typing, cross matching and such other tests as are required by these regulations.

(c) All hospitals shall maintain or make provision for clinical laboratory services for performance of tests in chemistry, microbiology, serology, hematology, pathology and such other tests as are required by these regulations.

(d) Written policies and procedures shall be developed and maintained by the person responsible for the service in consultation with other appropriate health professionals and administration. Policies shall be approved by the governing body. Procedures shall be approved by the administration and medical staff where such is appropriate.

(e) The responsibility and the accountability of the clinical laboratory service to the medical staff and administration shall be defined.

(f) The director of the clinical laboratory shall assure that:

(g) Tissue specimens shall be examined by a physician who is certified or eligible for certification in anatomical and/or clinical pathology by the American Board of Pathology or possesses qualifications which are equivalent to those required for certification. Oral specimens may be examined by a dentist who is certified or eligible for certification as an oral pathologist by the American Board of Oral Pathology. A record of his findings shall become a part of the patient's medical record.

(h) The use, storage and disposal of radioactive materials shall comply with the California Radiation Control Regulations, Subchapter 4, Chapter 5, Title 17, California Administrative Code.

(i) Where the hospital depends on outside blood banks, there shall be a written agreement governing the procurement, transfer and availability of blood.

(j) Periodically, an appropriate committee of the medical staff shall evaluate the services provided and make appropriate recommendations to the executive committee of the medical staff and administration.