lab regulations

8/6/2019 Lab Regulations

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REGULATIONS

LABORATORY


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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 patients health.

Published on FEBRUARY 28, 1992 issue of FEDERALREGISTER

Effective on SEPTEMBER 1, 1992

MODIFICATIONS TO THE LAW: list the complexity of tests

ADDITIONAL MODIFICATIONS: define alternative routes forpersonnel qualifications


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2. LABORATORY ACCREDITATION A)ALL LABORATORIES MUST HAVE A CLIA CERTIFICATE to

perform testing

B)CERTIFICATIONS IS BASED ON THE LEVEL OF TESTCOMPLEXITY:

Ex. Moderately complex testing: Hematology , chemistry, serology, coagulation, TDM,

blood gases, urine colony counts, Blood type and Rhfactor, limited immunology, manual differential,

Grams stainHigh complex testing:

Microbiology, immunohematology, bacteriology,cytology, histopathology, mycology, manual

hematology counts, manual differential


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C) CERTIFICATE FEE AND INSPECTION FEE-which are based on the size of the

laboratory and number of tests performedannually, 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


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3. PERSONNEL REQUIREMENTS MUST BE METModerately 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


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4. Quality ControlG

eneral QC:performed on all as specified by Federal Register

performed on procedures not found in FR which must beconducted according to manufacturers protocol.

Establish and follow written QC proceduresDocumentation of all calibration procedures

Minimum of 2 levels of control materials are run each day oftesting

All QC records must be retained for 2 yearsQC must be tested

Must have sufficient instruments, reagents, supplies

Criteria for proper storage of reagents and specimens

Lot numbers are not to be interchanged


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5. Proficiency testingMandatory 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 analytesto be considered in compliance

Blood bank specimens require a score of 100%


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6) Procedure manualsA. Must include:

Principle and methodology of each test

Pre-analytical steps(processing, collection, rejection)

Instructions for microscopic examinationsTest procedures (analytical)Step-by-step instructions

Result interpretation

Preparation of materialsCalibration procedures

Control procedures


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Actions taken- when results deviate from expected

value Recalibration

Troubleshooting

Repeats

Dilutions

Limitations

Interfering substances

Common sources of errorResult reporting (post-analytical)

Reference ranges panic values

For different specimens -life-threatening results

Demographic values -critical results


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Specimen retention Storage time, place, temp

System for reporting patients results (post-analytical)

Unacceptable results How to report to physician

Protocol for panic and critical values

Course of action fro problemsSpecimen referral


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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 proceduresare implemented

D. must be retained for future references


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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 onlywithin their complexity category

g. Evaluate any complaints from the public


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Inspector may also:

-conduct unannounced inspections at any timeduring hours of operation

- ask personnel to perform testing on testsamples that the inspector supplies

- re-inspect a lab at any time to evaluateaccurate and reliable results


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8. sanctionsFor those out of compliance

Suspension, limitations, or revocation of acertificate

Civil suitImprisonment or fines

Publishing of labs that have been sanctioned


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B. OSHA REGULATIONS FOR OCCUPATIONALEXPOSURE TO BLOODBORNE PATHOGENS

-require laboratories to establish workplace safetypractices to prevent accidental exposure to etiologic agents inblood

1. The regulations limit occupational exposure to blood and

other potentially infectious materials that can transmitbloodborne pathogens and include but are not limited to:HBV and HIV

2. The basis is the practice of universal precautions.

-recommended by the CDCa. must treat all human blood and other potentially

infectious body fluids as if they were infected with bloodbornepathogens

b. this includes materials contaminated with blood


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3. Written exposure control plan-describes the procedure established to minimize

employee exposure to bloodborne pathogens

a. Identification of job classification,tasks, and proedures inwhich 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 notpermit 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


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To be continued.

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