Idaho Administrative Code
Title IDAPA 16 - Health and Welfare, Department of
Rule 16.03.14 - HOSPITALS
Section 16.03.14.350 - LABORATORY SERVICE

Universal Citation: ID Admin Code 16.03.14.350

Current through September 2, 2024

The hospital shall maintain a clinical laboratory with the necessary space, personnel and equipment to meet the needs of the services offered. Contractual services shall also meet the requirements of Subsection 200.08.

01. Laboratory Services. Basic laboratory service necessary for routine tests shall be maintained in the hospital. Clinical laboratory tests shall be performed, or arranged for, and shall include the following:

a. Chemistry; and

b. Microbiology; and

c. Hematology; and

d. Serology; and

e. Clinical microscopy; and

f. Immunohematology; and

g. Urinalysis.

02. Availability. Clinical laboratory services needed to meet medical needs shall be available at all times. Where services are provided outside the hospital, the conditions, procedures, and availability of work done must be written and available.

03. Clinical Laboratories. All hospital laboratories and other clinical laboratories shall comply with Idaho Department of Health and Welfare Rules, IDAPA 16.02.06, "Quality Assurance for Idaho Clinical Laboratories."

04. Personnel. The clinical laboratory shall be under the overall direction of a physician. If that physician is not a pathologist on a full-time or part-time basis, then a Board Certified Pathologist shall be available for consultation to assure performance by the staff.

a. There shall be sufficient technologists to meet the needs of the patients and medical staff.

b. The laboratory medical director shall be responsible for the qualifications and performance of the laboratory staff.

05. Education Programs. An ongoing educational program shall be developed, implemented and evaluated for laboratory personnel. Documentation of all orientation and education programs for each employee shall be maintained at the facility.

06. Routine Examinations. Any routine examinations that are required on all admissions shall be determined by the medical staff and there shall be a written policy regarding such tests.

07. Orders and Reports. Orders for tests shall be made only by those practitioners legally authorized to diagnose, treat and prescribe. The signed reports of all tests shall be made a part of the patient's medical record.

08. Tissues and Reports. A specimen of all tissue surgically removed will be sent to a pathologist for a report on such specimens, unless the medical staff, in consultation with the pathologist, adopts uniform exceptions to sending tissue specimens to the laboratory for analysis. All tissue reports shall be signed by the examining pathologist, contain findings and a diagnosis, and shall be on file.

09. Blood and Blood Products. Facilities for procurement, proper storage, and transfusion of blood and products shall be readily available. The blood program shall include at least the following:

a. A means of acquiring blood for emergencies; and

b. Written agreement on blood supply by outside resource; and

c. A written procedure for prompt typing and crossmatching, and transfusion reaction investigation; and

d. Blood storage shall be in a refrigerator with a recording thermometer and audible and visual alarms for temperature variance. There shall also be a mercury thermometer inside, and temperatures recorded daily; and

e. Records shall be kept of receipt and disposition of all blood; and

f. Samples of each unit of blood shall be kept seven (7) days in the event of a reaction; and

g. The medical staff or an appropriate committee shall review all transfusions, all reactions, and is responsible for establishing policies and procedures for the blood service.

10. Policies and Procedures. These shall be written and approved by the medical director, the medical staff (or appropriate committee) and the administration. Procedures shall cover at least the following:

a. A complete description of each test; and

b. Ordering of tests; and

c. Procedures for collection, storage, and preservation of all specimens; and

d. Procedures for patient and test identification, storage and preservation of specimens; and

e. There shall be written safety procedures for all potentially hazardous tests, specimens, cultures, or materials, including the disposal of such hazardous items, materials or equipment.

Effective March 17, 2022

Disclaimer: These regulations may not be the most recent version. Idaho may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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