LABORATORY

REGULATIONS

A. Clinical Laboratory Improvements Amendments of 1988 (CLIA 88)

1. BACKGROUND:
Intended to establish regulations for all laboratories, regardless of size and location, where clinical testing is performed for the purpose of diagnosis, treatment, monitoring of patient s health.

Published on FEBRUARY 28, 1992 issue of FEDERAL REGISTER Effective on SEPTEMBER 1, 1992
MODIFICATIONS TO THE LAW: list the complexity of tests ADDITIONAL MODIFICATIONS: define alternative routes for personnel qualifications

2. LABORATORY ACCREDITATION
A)ALL LABORATORIES MUST HAVE A CLIA CERTIFICATE to perform testing B)CERTIFICATIONS IS BASED ON THE LEVEL OF TEST COMPLEXITY:

Ex. Moderately complex testing:

Hematology , chemistry, serology, coagulation, TDM, blood gases, urine colony counts, Blood type and Rh factor, limited immunology, manual differential, Gram s stain

High complex testing:

Microbiology, immunohematology, bacteriology, cytology, histopathology, mycology, manual hematology counts, manual differential

C) CERTIFICATE FEE AND INSPECTION FEE -which are based on the size of the laboratory and number of tests performed annually, must be paid.
D) ACCREDITATION BY A PRIVATE ORGANIZATION Is an alternative option for certification.
A. deemed status by HEALTH CARE FINANCING ADMINISTRATION (HCFA) B. state laboratory programs

3. PERSONNEL REQUIREMENTS MUST BE MET

Moderately complex laboratories: laboratory director Technical consultant Clinical consultant Testing personnel
*must have documented training in all areas of testing performed

Highly complex lab:

Additional General supervisor and Technical supervisor

4. Quality Control
General QC: performed on all as specified by Federal Register performed on procedures not found in FR which must be conducted according to manufacturer s protocol. Establish and follow written QC procedures Documentation of all calibration procedures Minimum of 2 levels of control materials are run each day of testing All QC records must be retained for 2 years QC must be tested Must have sufficient instruments, reagents, supplies Criteria for proper storage of reagents and specimens Lot numbers are not to be interchanged

5. Proficiency testing
Mandatory for tests listed on: Compiled list of clinical laboratory systems, assays, and examinations categorized by complexity Published in the FR Laboratories are required to score 80% on all analytes to be considered in compliance Blood bank specimens require a score of 100%

6) Procedure manuals
A. Must include: Principle and methodology of each test Pre-analytical steps(processing, collection, rejection) Instructions for microscopic examinations Test procedures (analytical)
Step-by-step instructions Result interpretation

Preparation of materials Calibration procedures Control procedures

 Actions taken- when results deviate from expected value

Recalibration Troubleshooting Repeats Dilutions

Limitations
Interfering substances Common sources of error

Result reporting (post-analytical)

Reference ranges
For different specimens Demographic values

panic values
-life-threatening results -critical results

Specimen retention
Storage time, place, temp

System for reporting patients results (postanalytical)

Unacceptable results How to report to physician Protocol for panic and critical values

Course of action fro problems Specimen referral

B. must be APPROVED
Signed by laboratory director Reviewed by all personnel Reviewed and updated by the supervisor or director

C. must be rewritten when new procedures are implemented D. must be retained for future references

7. Inspections
-conducted every 2 years by he Department of Health and Human Services or its designee Inspectors have the right to: a. Interview all employees b. Access all areas of a facility c. Observe all testing d. Review all information and data records e. Determine that the laboratory is operated in a safe manner f. Determine that the laboratory is performing tests only within their complexity category g. Evaluate any complaints from the public

Inspector may also: -conduct unannounced inspections at any time during hours of operation - ask personnel to perform testing on test samples that the inspector supplies - re-inspect a lab at any time to evaluate accurate and reliable results

8. sanctions
For those out of compliance Suspension, limitations, or revocation of a certificate Civil suit Imprisonment or fines Publishing of labs that have been sanctioned

B. OSHA REGULATIONS FOR OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS

-require laboratories to establish workplace safety practices to prevent accidental exposure to etiologic agents in blood 1. The regulations limit occupational exposure to blood and other potentially infectious materials that can transmit bloodborne pathogens and include but are not limited to: HBV and HIV 2. The basis is the practice of universal precautions. -recommended by the CDC a. must treat all human blood and other potentially infectious body fluids as if they were infected with bloodborne pathogens b. this includes materials contaminated with blood

3. Written exposure control plan

-describes the procedure established to minimize employee exposure to bloodborne pathogens a. Identification of job classification,tasks, and proedures in which there is the potential exposure b. PPE- should be available and be used Must be supplied to employees Equipment is considered appropriate only if it does not permit blood or other potentially infectious materials (PIM) to pass through Types of PPE- labgowns, gloves, masks, eye protection Employers are responsible for maintaining these PPE

To be continued