SYNOPOSUS OF CLIA REGULATIONS 1992
This synopsis contains the actual notations from the Federal Register. "NOTES" are comments made by POC Consultants, and do not appear in the regulations. This synopsis only outlines key points of the Feb.28th Federal
Register.
NOTE ☞: POC Consultants has made copies of all the Federal Registers with CLIA regulations for clients who would like to have their own complete copy of these documents. Please call our office for information on how to
purchase.
493.1101 Patient Test Management for Moderate or High Complexity testing
Each laboratory performing moderate or high complexity testing must employ and maintain a system that provides for; proper patient preparation, proper specimen collection, identification, preservation, transportation, processing and accurate result reporting.493.1103 Procedures for specimen submission and handling
(a) The laboratory must have available and follow written policies and procedures for each of the following: Methods used for the preparation of patients, specimen collection, specimen labeling, specimen preservation, conditions for specimen transportation. Such policies and procedures must assure positive identification and optimum integrity of patient specimens from the time the specimens are collected until testing has been completed and the results are reported.NOTE☞: This information is found in the Quality Assessment plan.
(c) Oral explanation of instruction to patients for specimen collection including patient preparation, may be used as a supplement to written instructions.
NOTE☞: This information is found in the specimen collection section of this manual.
493.1105 Test Requisition
The laboratory must perform test only at the written or electronic request of an authorized person. Records of test requisition or test authorization must be retained for a minimum of two years. The patient's chart may be used. If the patients chart is used as the test requisition, it must be retained for a minimum of two years. This information must be available to the HHS upon request.493.1107 Test Records
The laboratory must maintain a record system to ensure reliable identification of patient specimens as they are processed and tested. Test information must include: patients name (first and last) or I.D. number, person requesting the test, test requested, date of specimen collection and any additional information relevant and necessary to that test (i.e. fasting, timings).NOTE☞: This information is on your laboratory test accession log.
493.1109 Test Report
Reports will be sent promptly to the authorized person that initially requested the test. The original report or an exact duplicate of each final test report, including any preliminary reports, must be retained by the testing laboratory for a period of at least two years (immunohematology must be retained for 5 years). In the case of Pathology reports, the report may be retained in the patient's chart for a period of at least ten years.Test result report must include: name and address of the laboratory, information regarding the condition and disposition of the specimens that do not meet the acceptability criteria of the laboratory (i.e. hemolyzed, lipemic), normal ranges and panic values. The original report or exact duplicates of test report must be maintained by the laboratory in a manner that permits ready identification and timely accessibility.
NOTE☞: In an office setting the pathology report could include reports such as bone marrow.
Record Retention
Records must include test result, computer printout of result (if applicable) and personnel performing the test. Records must be kept for at least two years. Immunohematology records must be retained for no less than 5 years.493.1201 Conditions for General Q.C. in Moderate and High Complexity testing:
The laboratory must establish and follow written quality control procedures for monitoring and evaluating the quality of the analytical testing process for each method to assure the accuracy and reliability of patient test results and reports.NOTE☞: This is documented in the Quality Assessment Plan and in each individual procedure found in your laboratory procedure manual.
493.1202
For each test of high complexity performed, the laboratory must meet all applicable standards of this sub part. For each test of moderate complexity performed using a method developed in-house or using and instrument, kit or test system cleared by the FDA, the laboratory must meet all applicable standards of this sub part.Standards include:
☞ Following the manufacturers instruction for instrument test systems operation and test performance.☞ Have a procedure manual describing the processes for testing the reporting patient test results.
☞ Perform and document calibration procedures at least once every six months.
☞ Perform and document control procedures using at least two levels of control material each day of testing.
☞ Perform and document that corrective action has been taken when problems or errors are identified.
NOTE:☞ This information is outlined in the Quality Assessment Plan in your laboratory procedure manual. Specific instructions for quality controls and maintenance are found in the laboratory manual, operators manuals or in the individual test procedures.
493.1701 Quality Assessment
Each laboratory performing moderate or high complexity tests must establish and follow written policies and procedures for comprehensive quality assessment program which is designed to monitor and evaluate the ongoing and overall quality of the total testing process. As needed these polices will be revised. All quality assessment activities must be documented. The following items must be covered in a quality assessment plan:493.1704 Patient management
Patient preparation, specimen collection, labeling, preservation and transportation; any information relevant to the testing of patient specimens; criteria for specimen rejection; accuracy of test report information; timing of reporting of tests; accuracy and reliability of test reporting systems; appropriate storage of record and retrieval to test results.493.1705 Quality Control procedures as outlined in section 493.1218 to 493.1218.
493.1707 Proficiency testing participation, assessment and corrective actions taken for any unacceptable proficiency testing results.
493.1709 Comparison of test results
If the laboratory performs the same test using two different methods (i.e. automated WBC and manual WBC) the two systems must be tested twice a year to show correlation.493.1711 For internal quality control;
The patient results should appear consistent with relevant criteria found in patients history, examination or chart.493.1713 Personnel assessment;
personnel will be evaluated for effectiveness in complying with policies and competence in performing tests.493.1715 Communication;
The laboratory must have a system in place to document problems that occur as a result of breakdown in communication of test results..493.1717 Complaint Investigation;
All complaints and problem reports must be investigated, followed up and documented.493.1721 Quality Assessment Records;
Quality assessment will be reviewed and revised. All quality assessment records must be available to the HHS.NOTE☞: The Quality Assessment,
specimen collection, quality control and maintenance section of your procedure manual cover the above items. Please review it and add any relevant information that your particular practice has in place that supplements this information. QA must be monitored. Your manual contains charts needed to document this information.493.1216 Quality Control Procedures
Control procedures must be performed as defined below:
(The laboratory must at minimum, follow the manufacturer's instructions for control procedures, until Sept.1, 1994)
(1) For qualitative tests, the laboratory must include a positive and negative control with each run of patient specimens.
(2) For quantitative test, the laboratory must include at least two samples of different concentration of either calibration materials, control materials or a combination of both.
(3) Each day of use, that laboratory must evaluate the detection phase of direct antigen systems using an appropriate positive and negative control material.
(4) If control or calibration material is not available, the laboratory must have an alternate way to validate test results.
(5) Control samples must be tested in the same manner as patient specimens.
(6) When calibration or control materials are used, statistical parameter for each lot number of control/calibration material must be determined through repetitive testing.
(7) The stated values of assayed control material may be used as the target values provided the stated values correspond to the methodology and instrumentation employed.
(8) Control results must meet the laboratory's criteria for acceptability prior to reporting patient test results.
Quality Control of Reagents and Supplies
(1) The laboratory must check each batch or shipment of reagents, discs, stains, antisera and identification systems.
(2) Staining material will be checked for reactivity.
(3) Each batch or shipment of media must be checked for sterility, deterioration and ability to support growth. Manufacturer guidelines will be followed. Controls must meet the NCCLS standards for medial quality control.
NOTE☞: All clients have been supplied with reagent logs - they must be used!
493.1219 Corrective Action
Corrective action policies and procedures must be established by the laboratory for any time the test systems do not meet the laboratory's established performance.
✓ Corrective action must be taken any time equipment or methodologies perform outside the established operating parameters or performance specification.
✓ Corrective action must be taken any time the control or calibration materials fail to meet the laboratory's criteria for acceptability.
✓ Corrective action must be taken any time the patient test cannot be performed within the established time frames.
✓ Corrective action must be taken any time errors in the reported patient test results are detected. In this case promptly notify the authorized person ordering or individual being tested of the reporting errors. Issue a corrected report as soon as possible.
NOTE☞: All clients have been supplied with "Problem Report" and "Corrective Action" forms.
493.1204 Laboratory Facility
The laboratory must provide the space and environmental conditions necessary for conducting the services offered.
(a) The laboratory must be constructed, arranged and maintained to ensure the space, ventilation and utilities necessary for conducting all phases of testing, including the pre-analytic, testing and post-analytic as appropriate.
(b) Safety precautions must be established, posted and observed to ensure protection from physical hazards and biohazardous material.
NOTE☞: Your facility OSHA Manual addresses all the safety issues and procedures must be enforced.
☞ You must address all ventilation problems now!
☞ There must be sufficient counter space for laboratory equipment. The regulations will not permit the use of closets, or other cramped locations for this equipment.
493.1205 Test Methods, Equipment, Instrumentation, Reagents, Materials and Supplies
(a) Test methodologies and equipment must be selected and testing performed in a manner that provides test results within the laboratory's stated performance specifications for each test method.
(b) The laboratory must have appropriate and sufficient equipment, instrument, reagents, materials and supplies for the type and test volume.
(c) The laboratory must define criteria for those conditions that are essential for proper storage of the reagent and specimens for accurate and reliable test results.
NOTE☞: This information is written into every procedure in your manual. A master chart to record this is in the specimen collection section of this manual.
✓ Conditions also include (if applicable): Temperature, Humidity, Water quality, instrument protection (i.e. surge protectors) and corrective actions taken to correct problem conditions.
(d) Proper labeling of all reagents, solutions, culture media, control materials, calibration materials and other supplies as appropriate. Expiration dates must be recorded as well as lot numbers.
NOTE☞: Proper chemical labeling according to OSHA regulations is found in your OSHA Manual. Logs to record lots numbers and expiration dates can be found in the Quality Control section of the Procedure Manual.
493.1211 Procedure Manual
(a) A written procedure manual for the performance of analytical methods used by the laboratory must be readily available and followed by the laboratory personnel. Textbooks may be use as supplements to these written procedure but not to be used in lieu of the laboratory's written procedures.
(b) The Procedure Manual must include (when applicable to test procedure):
1. Requirements for specimen collection, processing and rejection.
2. Procedures for microscopic examination.
3. Step by step procedure.
4. Preparation of solutions, calibrators, controls, reagent, stains, solutions.
5. Calibration and calibration verification
6. Reportable range for patient results
7. Control procedures
8. Corrective action to be taken when calibration or control results fail to meet acceptable criteria.
9. Limitation of methodologies.
10. Normal Range
11. Panic Values
12. Specimen Storage
13. Protocol for reporting patient results and panic values.
14. Course of action if system is inoperable.
15. Pertinent references and literature.
NOTE☞: All this information is written into all procedures found in the test section of the procedure manual.
NOTE☞: Manufacturer's package inserts or operator manuals may be used, when applicable, to meet all of the above requirements (1-12). HOWEVER - if any of those items are not provided by the manufacturer, they MUST be provided by the laboratory. Supplemental information is found in the test section..
All procedures must be approved, signed and dated by the director. Procedures must be re-approved if the director changes. Any changes must be approved, signed and dated by the director. The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance. These records must be retained for two years after a procedure has been discontinued.
493.1213 Verification of Method Performance
Prior to reporting patient test results, the laboratory must verify or establish for each method the performance specification for the following: accuracy, precision, analytical sensitivity and specificity (if applicable), reportable range, reference range (normal values) and any other applicable performance characteristics.
(a) The provisions of this section are not retroactive. Laboratories are not required to verify or establish performance specification for ANY test method of moderate or high complexity in use prior to September 1, 1992.
(b) After September 1, 1992 a laboratory that introduces a new procedure for patient testing using a moderate of high complexity method must demonstrate that, prior to reporting patient test results it can obtain the performance specification for accuracy, precision, reportable range of patient test results, comparable to those established by the manufacturer. It must also be verified that the manufacturer's range is appropriate for the laboratory's patient population.
(c) After September 1, 1992 a laboratory introducing a new procedure using a method developed in-house, or a modification of a manufacturer's test must meet the CLIA requirement for general quality control, prior to reporting patient test results. Method performance must be established for accuracy, precision, analytical sensitivity, analytical specificity, reportable range, reference range and any other performance characteristic required for the test performance. The laboratory must document and verify the above.
NOTE☞: Linearity verification, if needed, can be done by running a calibration and taking a blank reading and three levels of calibration verification reagents.
493.1215 Equipment Maintenance and Function Checks
The laboratory must perform equipment maintenance and function checks necessary for proper test performance and test result reporting.
(a) Maintenance as defined by the manufacturer, including frequency must be documented.
(b) Function checks as defined by the manufacturer, including frequency must be performed and documented.
(c) Establish maintenance protocols that ensure equipment performance when necessary.
NOTE☞: Follow the maintenance guidelines found in your laboratory procedure manual or instrument operators manual and record all maintenance.
493.1217 Calibration
Calibration and calibration verification procedures are required to substantiate the continued accuracy of the test method throughout the laboratory's reportable range for patient test results.
(a) The laboratory must, at a minimum, follow the manufacturer's instructions for calibration and calibration verification procedures using calibration materials specified by the manufacturer.
NOTE☞ Verification can be running the calibration material after calibration.
(b) For In-house methods, calibration materials must be used if available and performed with at least the frequency recommended by the manufacturer.
In accordance with the above criteria, the following must be documented:
A. Number of, type and concentration of calibration materials, acceptable limits for calibration and the frequency of calibration.
B. Use calibration materials appropriate for the methodology. A zero value, mid-point value and maximum value should be used. Verify calibration.
C. Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification, perform calibration again and verify procedure.
Calibration will be performed:
1. According to manufacturers schedule.
2. At lease once very six months.
3. Whenever the following occur;
(a) Complete change of reagents for procedure is introduced, unless the changing reagent lot numbers does not affect the range used to report patient test results and control values are not adversely affected by reagent lot number changes.
(b) Whenever there is major preventive maintenance or replacement of critical parts that may influence test performance.
(c) Controls reflect an unusual trend or shift.
(d) Laboratory establishes a more frequent schedule needed.
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REMEMBER THE KEY TO COMPLYING WITH CLIA AND PASSING AN INSPECTION IS DOCUMENTATION! CLIA REVISIONS - 1/24/03
On January 24, 2003, CLIA published new regulations for Quality Control, personnel, laboratory information systems (LIS) and terminology. Key area’s published are found at the end of the chapter.