La. Admin. Code tit. 48 § I-4555

Current through Register Vol. 50, No. 11, November 20, 2024

Section I-4555 - Laboratory Services

A. The ASC shall either provide a clinical laboratory directly or make contractual arrangements with a laboratory certified in accordance with the clinical laboratory improvement amendments to perform services commensurate with the needs of the ASC.

B. Contractual arrangements for laboratory services shall be deemed as meeting the requirements of this Section when those arrangements contain written policies and procedures defining the scope of services.

C. When laboratory services are provided directly by the ASC, the services shall be performed by a qualified and/or licensed person with documented training and experience to supervise and perform the testing.

1. The ASC shall have sufficient numbers of licensed clinical laboratory and supportive technical staff to perform the required tests.

2. The laboratory shall be of sufficient size and adequately equipped to perform the necessary services of the ASC.

D. Written laboratory policies and procedures shall be developed and implemented for all laboratory services provided directly by the center and/or by contractual arrangement. Policies shall define "stat" labs and the timelines for processing and reporting "stat" labs.

E. Written reports of all ASC performed and contractually performed lab results shall be made a part of the patients medical record.

F. Documentation shall be maintained for preventive maintenance and quality control programs governing all types of analyses performed in the laboratory.

G. The ASC shall make provisions for the immediate pathological examination of tissue specimens by a pathologist, if applicable. The pathology report shall be made part of the patients medical record.

H. Handling of Blood and Blood Products

1. Written policies and procedures shall be developed, approved by the governing body and implemented by the ASC, relative to the administration of blood and blood products as well as any medical treatment and notification of the treating physician in the event of an adverse reaction.

2. If the treating physician determines that blood and blood products shall be administered, the ASC shall provide for the procurement, safekeeping and transfusion of the blood and blood products so that it is readily available.

3. The administration of blood shall be monitored by the registered nurse to detect any adverse reaction. Prompt investigation of the cause of an adverse reaction shall be instituted and reported according to ASC policy and procedures.

4. If the ASC regularly uses the services of an outside blood bank, the ASC shall have a written agreement with the blood bank whereby the ASC is promptly notified by the blood bank of blood or blood products that have been determined at increased risk of transmitting infectious disease.

5. The ASC shall have a system in place which is defined in a "look back" policy and procedure for appropriate action to take when notified that blood or blood products that the ASC has received are at increased risk of transmitting infectious disease. The look back policy shall include, but not be limited to:

a. quarantine of the contaminated products;

b. documented notification to the patient or legal representative and the patients physician; and

c. the safe and sanitary disposal of blood and blood products not suitable for distribution.

La. Admin. Code tit. 48, § I-4555

Promulgated by the Department of Health, Bureau of Health Services Financing, LR 431745 (9/1/2017).

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:2131-2141.