CLIA POINT-OF-CARE TESTING and the CLIA SURVEY Gary Yamamoto Centers for Medicare & Medicaid...

CLIACLIA

POINT-OF-CARE POINT-OF-CARE TESTINGTESTINGand the and the

CLIA SURVEYCLIA SURVEYGary YamamotoGary Yamamoto

Centers for Medicare & Medicaid ServicesCenters for Medicare & Medicaid Services

San Francisco Regional OfficeSan Francisco Regional Office

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CLIACLIARegulatory RequirementsRegulatory Requirements

• Waived Tests:Waived Tests:– 42 CFR § 493.15(e)(1)42 CFR § 493.15(e)(1)

• Follow manufacturers’ instructions for Follow manufacturers’ instructions for performing the testperforming the test

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CLIACLIARegulatory RequirementsRegulatory Requirements

• Non-Waived Tests (Moderate, PPMP, and Non-Waived Tests (Moderate, PPMP, and High):High):– Proficiency Testing Proficiency Testing (42 CFR § 493.801)(42 CFR § 493.801)

– Facility Administration Facility Administration (42 CFR § 493.1100)(42 CFR § 493.1100)

– General Systems General Systems (42 CFR § 493.1230)(42 CFR § 493.1230)

– Preanalytic Systems Preanalytic Systems (42 CFR § 493.1240)(42 CFR § 493.1240)

– Analytic Systems Analytic Systems (42 CFR § 493.1250)(42 CFR § 493.1250)

– Postanalytic Systems Postanalytic Systems (42 CFR § 493.1290)(42 CFR § 493.1290)

– Personnel Personnel (42 CFR § 493.1351)(42 CFR § 493.1351)

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CLIACLIACMS’ Current Survey ApproachCMS’ Current Survey Approach

• Survey approach remains educational, but Survey approach remains educational, but deficiencies identified are citeddeficiencies identified are cited– Laboratory has opportunity to correctLaboratory has opportunity to correct– Regulatory explanation &/or resources providedRegulatory explanation &/or resources provided

• In 2006, GAO stated survey consistency In 2006, GAO stated survey consistency concernsconcerns

• Training & guidance provided to surveyorsTraining & guidance provided to surveyors• ““Mandatory” citations determinedMandatory” citations determined• Accelerated enforcement for repeat offendersAccelerated enforcement for repeat offenders• Slight increases in citations occurredSlight increases in citations occurred

– Due to mandatory citations & areas of training focusDue to mandatory citations & areas of training focus

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• The primary objective of the CLIA The primary objective of the CLIA survey process is to determine survey process is to determine whether or not the laboratory whether or not the laboratory meets the CLIA requirements.meets the CLIA requirements.

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• The surveyor meets this objective The surveyor meets this objective by employing an by employing an outcome-oriented outcome-oriented survey processsurvey process or approach. or approach.– The intent of which is to focus the The intent of which is to focus the

surveyor on the overall performance surveyor on the overall performance of the laboratory and the way it of the laboratory and the way it monitors itself, rather than on a monitors itself, rather than on a methodical evaluation of each methodical evaluation of each standard level regulatory standard level regulatory requirementrequirement..

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ONSITE CLIA SURVEYSONSITE CLIA SURVEYS

• NOT subject to biennial NOT subject to biennial inspections:inspections:– Certificate of WaiverCertificate of Waiver– Certificate of PPMPCertificate of PPMP

• Subject to biennial inspections:Subject to biennial inspections:– Certificate of ComplianceCertificate of Compliance– Certificate of AccreditationCertificate of Accreditation

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ONSITE CLIA SURVEYSONSITE CLIA SURVEYSCertificate of Waiver/PPMPCertificate of Waiver/PPMP

• Pursuant to 42 CFR § 493.1775(b):Pursuant to 42 CFR § 493.1775(b):– CMS/agent may conduct an CMS/agent may conduct an

inspection to:inspection to:• Determine if the laboratory is operated Determine if the laboratory is operated

and testing is performed in a manner that and testing is performed in a manner that does not constitute an imminent and does not constitute an imminent and serious risk to public healthserious risk to public health

• Evaluate a complaintEvaluate a complaint

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ONSITE CLIA SURVEYSONSITE CLIA SURVEYSCertificate of Waiver/PPMPCertificate of Waiver/PPMP

• Determine whether the laboratory is Determine whether the laboratory is performing tests beyond the scope of the performing tests beyond the scope of the certificate held by the laboratorycertificate held by the laboratory

• Collect information regarding the Collect information regarding the appropriateness of tests specified as appropriateness of tests specified as waived tests or PPMPwaived tests or PPMP

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ONSITE CLIA SURVEYSONSITE CLIA SURVEYSCertificate of ComplianceCertificate of Compliance

• The inspection sample for review The inspection sample for review may include testing in the may include testing in the categories of waived tests and categories of waived tests and PPMP.PPMP.

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ONSITE CLIA SURVEYSONSITE CLIA SURVEYSRegulatory RequirementsRegulatory Requirements

• Non-Waived Tests (Moderate, PPMP, and Non-Waived Tests (Moderate, PPMP, and High):High):– Proficiency Testing Proficiency Testing (42 CFR § 493.801)(42 CFR § 493.801)

– Facility Administration Facility Administration (42 CFR § 493.1100)(42 CFR § 493.1100)

– General Systems General Systems (42 CFR § 493.1230)(42 CFR § 493.1230)

– Preanalytic Systems Preanalytic Systems (42 CFR § 493.1240)(42 CFR § 493.1240)

– Analytic Systems Analytic Systems (42 CFR § 493.1250)(42 CFR § 493.1250)

– Postanalytic Systems Postanalytic Systems (42 CFR § 493.1290)(42 CFR § 493.1290)

– Personnel Personnel (42 CFR § 493.1351)(42 CFR § 493.1351)

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FACILITY FACILITY ADMINISTRATIONADMINISTRATION

• FacilitiesFacilities• Requirements for transfusion Requirements for transfusion

servicesservices• Retention requirementsRetention requirements

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FACILITY FACILITY ADMINISTRATIONADMINISTRATIONRetention RequirementsRetention Requirements

• Test Reports:Test Reports:– Retain or be able to retrieve a copy of Retain or be able to retrieve a copy of

the original report (including final, the original report (including final, preliminary, and corrected reports) at preliminary, and corrected reports) at least 2 years after the date of reportingleast 2 years after the date of reporting(42 CFR §493.1105(a)(6))(42 CFR §493.1105(a)(6))

• A copy, A copy, either paper or electroniceither paper or electronic, includes , includes all information sent to the individual all information sent to the individual requesting the test or using the test requesting the test or using the test result(s).result(s).

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PROFICIENCY TESTINGPROFICIENCY TESTING

• CLIA proficiency testing CLIA proficiency testing requirements pertain to non-waived requirements pertain to non-waived tests only.tests only.

• Proficiency is required for only the Proficiency is required for only the test system, assay, or examination test system, assay, or examination used as the primary method for used as the primary method for patient testing during the proficiency patient testing during the proficiency testing event. testing event. (42 CFR § 493.801(b)(6))(42 CFR § 493.801(b)(6))

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• If a laboratory performs the same test If a laboratory performs the same test using different methodologies or using different methodologies or instruments, or performs the same test instruments, or performs the same test at multiple testing sites, the laboratory at multiple testing sites, the laboratory must have a system that twice a year must have a system that twice a year evaluates and defines the relationship evaluates and defines the relationship between test results using the different between test results using the different methodologies, instruments, or testing methodologies, instruments, or testing sites. sites. (42 CFR § 493.1281(a))(42 CFR § 493.1281(a))

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• Each laboratory must enroll in a Each laboratory must enroll in a proficiency testing program that proficiency testing program that meets the criteria in subpart I.meets the criteria in subpart I.

• At least twice annually, the At least twice annually, the laboratory must verify the laboratory must verify the accuracy of any test or procedure accuracy of any test or procedure it performs that is not included in it performs that is not included in subpart I. subpart I. (42 CFR § 493.1236(c)(1))(42 CFR § 493.1236(c)(1))

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GENERAL SYSTEMSGENERAL SYSTEMS

• Confidentiality of patient informationConfidentiality of patient information• Specimen identification and integritySpecimen identification and integrity• Complaint investigationsComplaint investigations• CommunicationsCommunications• Personnel competency assessment Personnel competency assessment

policiespolicies• Evaluation of proficiency testingEvaluation of proficiency testing• Quality assessment programQuality assessment program

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GENERAL SYSTEMSGENERAL SYSTEMSSpecimen Identification and IntegritySpecimen Identification and Integrity

• The laboratory must establish and The laboratory must establish and follow written policies and follow written policies and procedures that ensure positive procedures that ensure positive identification and optimum integrity identification and optimum integrity of a patient’s specimen from the of a patient’s specimen from the time of collection or receipt of the time of collection or receipt of the specimen through completion of specimen through completion of testing and reporting of results. testing and reporting of results. (42 (42 CFR § 493.1232)CFR § 493.1232)

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GENERAL SYSTEMSGENERAL SYSTEMSPersonnel Competency Assessment Personnel Competency Assessment

PoliciesPolicies

• As specified in the personnel As specified in the personnel requirements in subpart M, the requirements in subpart M, the laboratory must establish and laboratory must establish and follow written policies and follow written policies and procedures to asses employee procedures to asses employee and, if applicable, consultant and, if applicable, consultant competency. competency. (42 CFR § 493.1235)(42 CFR § 493.1235)

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PREANALYTIC SYSTEMSPREANALYTIC SYSTEMS

• Test requisitionTest requisition• Specimen submission, handling, Specimen submission, handling,

and referral policies and and referral policies and proceduresprocedures

• Quality assessment programQuality assessment program

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PREANALYTIC SYSTEMSPREANALYTIC SYSTEMSTest RequisitionsTest Requisitions

• Test requisitions must include:Test requisitions must include:– The name and address or other The name and address or other

suitable identifiers of the authorized suitable identifiers of the authorized person requesting the test and, if person requesting the test and, if appropriate, the individual responsible appropriate, the individual responsible for using the test results, or the name for using the test results, or the name and address of the laboratory and address of the laboratory submitting the specimen. . .submitting the specimen. . .(42 CFR § 493.1241(c)(1))(42 CFR § 493.1241(c)(1))

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PREANALYTIC SYSTEMSPREANALYTIC SYSTEMSTest RequisitionsTest Requisitions

• 42 CFR § 493.1241(c)(1) 42 CFR § 493.1241(c)(1) Interpretation:Interpretation:– The test requisition must provide the The test requisition must provide the

information necessary to identify and information necessary to identify and send test results to the individual who send test results to the individual who ordered the test (the ordered the test (the authorized authorized personperson), or, where applicable, to the ), or, where applicable, to the authorized person’s authorized person’s agentagent..

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PRETANALYTIC SYSTEMSPRETANALYTIC SYSTEMSTest RequisitionsTest Requisitions

• ““Authorized person”Authorized person”– An individual authorized under State An individual authorized under State

law to order tests or received test law to order tests or received test results, or bothresults, or both

• ““Agent”Agent”– An individual or entity legally acting An individual or entity legally acting

on behalf of the authorized person to on behalf of the authorized person to receive test resultsreceive test results

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ANALYTIC SYSTEMSANALYTIC SYSTEMS

• Procedure manualProcedure manual• Test systems, equipment, instruments, Test systems, equipment, instruments,

reagents, materials, and suppliesreagents, materials, and supplies• Performance specificationsPerformance specifications• Maintenance and function checksMaintenance and function checks• Calibration and calibration verification Calibration and calibration verification

proceduresprocedures• Control proceduresControl procedures• Test recordsTest records• Quality assessment programQuality assessment program

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ANALYTIC SYSTEMSANALYTIC SYSTEMSPerformance SpecificationsPerformance Specifications

• 42 CFR § 493.1253:42 CFR § 493.1253:– Establishment and Verification of Establishment and Verification of

Performance SpecificationsPerformance Specifications•VERIFICATIONVERIFICATION•ESTABLISHMENTESTABLISHMENT

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• VERIFICATION of Performance VERIFICATION of Performance SpecificationsSpecifications– Each laboratory that introduces an Each laboratory that introduces an

unmodified, FDA-cleared or approved unmodified, FDA-cleared or approved test system must do the following test system must do the following before reporting patient test results:before reporting patient test results:

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• Demonstrate that it can obtain Demonstrate that it can obtain performance specifications comparable to performance specifications comparable to those established by the manufacturer for those established by the manufacturer for the following performance characteristics:the following performance characteristics:

– AccuracyAccuracy– PrecisionPrecision– Reportable range of test results for the test Reportable range of test results for the test

system.system.

• Verify that the manufacturer’s reference Verify that the manufacturer’s reference intervals (normal values) are appropriate intervals (normal values) are appropriate for the laboratory’s patient population.for the laboratory’s patient population.

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• ESTABLISHMENT of Performance ESTABLISHMENT of Performance SpecificationsSpecifications– Each laboratory that modifies an FDA-Each laboratory that modifies an FDA-

cleared or approved test system, or cleared or approved test system, or introduces a test system not subject introduces a test system not subject to FDA clearance or approval to FDA clearance or approval (including methods developed in-(including methods developed in-house and standardized methods house and standardized methods such as text book procedures)., OR. . .such as text book procedures)., OR. . .

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. . .uses a test system in which . . .uses a test system in which performance specifications are not performance specifications are not provided by the manufacturer must, provided by the manufacturer must, before reporting patient test results, before reporting patient test results, establish for each test system the establish for each test system the performance specifications for the performance specifications for the following performance characteristics, following performance characteristics, as applicable:as applicable:

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• AccuracyAccuracy• PrecisionPrecision• Analytical sensitivityAnalytical sensitivity• Analytical specificity to include interfering Analytical specificity to include interfering

substancessubstances• Reportable range of test results for the Reportable range of test results for the

test systemtest system• Reference intervals (normal values)Reference intervals (normal values)• Any other performance characteristics Any other performance characteristics

required for test performance.required for test performance.

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• Establish/Verify Performance Establish/Verify Performance Specification:Specification:– When MULTIPLE INSTRUMENTS When MULTIPLE INSTRUMENTS

(including the same make and model, (including the same make and model, e.g., point-of-care instruments) are e.g., point-of-care instruments) are used to perform the same test, the used to perform the same test, the laboratory must establish or verify, as laboratory must establish or verify, as applicable, performance applicable, performance specifications for specifications for eacheach instrument. instrument.

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• When a temporary replacement When a temporary replacement (loaner) instrument is received (loaner) instrument is received which is identical (i.e., same make which is identical (i.e., same make and model, and method for the and model, and method for the same analyte) to the instrument same analyte) to the instrument which is being replaced. . .which is being replaced. . .

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. . .the laboratory must verify . . .the laboratory must verify comparable performance by comparable performance by comparing, at a minimum, results comparing, at a minimum, results of two or more levels of controls of two or more levels of controls ANDAND either previously tested either previously tested proficiency testing samples or proficiency testing samples or previously tested patient previously tested patient specimens.specimens.

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ANALYTIC SYSTEMSANALYTIC SYSTEMSQuality Control ProceduresQuality Control Procedures

• Quality Control Procedures must Quality Control Procedures must detect immediate errors that occur detect immediate errors that occur due to:due to:– Test System FailuresTest System Failures– Environmental ConditionsEnvironmental Conditions– Operator PerformanceOperator Performance

(42 CFR § 493.1256(c)(1))(42 CFR § 493.1256(c)(1))

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• Test System FailuresTest System Failures– Reagent contamination or deteriorationReagent contamination or deterioration– Reagent lot variationReagent lot variation– Reaction temperature fluctuationsReaction temperature fluctuations– Inadequate samplingInadequate sampling– Improper or loss of calibrationImproper or loss of calibration– Electronic or mechanical failureElectronic or mechanical failure– Power supply variancesPower supply variances

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• Environmental Condition ChangesEnvironmental Condition Changes– TemperatureTemperature– AirflowAirflow– Light intensityLight intensity– HumidityHumidity– AltitudeAltitude

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• Operator PerformanceOperator Performance– Improper specimen preparation and Improper specimen preparation and

handlinghandling– Incorrect test interpretationIncorrect test interpretation– Failure to follow the manufacturer’s Failure to follow the manufacturer’s

test system instructionstest system instructions

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• Operator training prior to testing is Operator training prior to testing is critical and competency critical and competency assessment over time is necessary assessment over time is necessary to ensure continued appropriate to ensure continued appropriate test performance.test performance.

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• In general, at least ONCE each day patient In general, at least ONCE each day patient specimens are assayed or examined perform the specimens are assayed or examined perform the following for –following for –– Each Each quantitativequantitative procedure, include 2 control procedure, include 2 control

materials of different concentrations;materials of different concentrations;– Each Each qualitativequalitative procedure, include a negative procedure, include a negative

and positive control material;and positive control material;– Test procedures producing graded/titered Test procedures producing graded/titered

results, include a negative control material and results, include a negative control material and a control material with graded/titered reactivity a control material with graded/titered reactivity respectively. respectively. (42 CFR § 493.1256(d)(3)(i-iii))(42 CFR § 493.1256(d)(3)(i-iii))

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• For CLIA purposes, “control For CLIA purposes, “control materials” are defined as:materials” are defined as:– ExternalExternal quality control materials quality control materials– Have a similar matrix to that of patient Have a similar matrix to that of patient

specimensspecimens– Treated in the same manner as patient Treated in the same manner as patient

specimensspecimens– Go through all analytic phases of testingGo through all analytic phases of testing

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ANALYTIC SYSTEMSANALYTIC SYSTEMSQuality Control Procedures - EQCQuality Control Procedures - EQC

• However, a laboratory can perform However, a laboratory can perform EQUIVALENT QUALITY TESTING EQUIVALENT QUALITY TESTING (EQC) as specified in Appendix C of (EQC) as specified in Appendix C of the State Operations Manual (CMS the State Operations Manual (CMS Pub.7)Pub.7)(42 CFR § 493.1256(d))(42 CFR § 493.1256(d))

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• EQC may only be used for laboratory EQC may only be used for laboratory testing subject to the following control testing subject to the following control procedure requirements:procedure requirements:– 42 CFR § 493.1256(d)(3)(i-iii)42 CFR § 493.1256(d)(3)(i-iii)– 42 CFR § 493.1256(d)(3)(iv) – test 42 CFR § 493.1256(d)(3)(iv) – test

procedures that include an extraction phase procedures that include an extraction phase (limited to Options 1 and 2)(limited to Options 1 and 2)

– 42 CFR §§ 493.1267 to 493.1269 – control 42 CFR §§ 493.1267 to 493.1269 – control requirements for routine chemistry and requirements for routine chemistry and hematology (limited to Options 1 and 2)hematology (limited to Options 1 and 2)

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• OPTIONOPTION 1 1 – Test system uses one or – Test system uses one or more internal/procedural control(s) to more internal/procedural control(s) to monitor monitor allall of its analytic components of its analytic components– Evaluation Process:Evaluation Process:

• For For tenten (10) consecutive days of testing, perform (10) consecutive days of testing, perform the test system’s internal control procedures per the test system’s internal control procedures per the manufacturer’s instructions the manufacturer’s instructions andand test two levels test two levels of external control material daily. If acceptable. . .of external control material daily. If acceptable. . .

• The laboratory may reduce the frequency of The laboratory may reduce the frequency of testing two levels of external control material from testing two levels of external control material from daily to once per calendar daily to once per calendar monthmonth..

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• OPTIONOPTION 2 2 – Test system uses some – Test system uses some internal/procedural controls to monitor internal/procedural controls to monitor only certain componentsonly certain components– Evaluation Process:Evaluation Process:

• For For thirtythirty (30) consecutive days of testing, perform (30) consecutive days of testing, perform the test system’s internal control procedures per the test system’s internal control procedures per the manufacturer’s instructions the manufacturer’s instructions andand test two levels test two levels of external control material daily. If acceptable. . .of external control material daily. If acceptable. . .

• The laboratory may reduce the frequency of testing The laboratory may reduce the frequency of testing two levels of external control material from daily to two levels of external control material from daily to once per calendar once per calendar weekweek..

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• OPTIONOPTION 3 3 – Test systems without – Test systems without internal/procedural controlsinternal/procedural controls– Evaluation Process:Evaluation Process:

• For For sixtysixty (60) consecutive days of testing, (60) consecutive days of testing, perform the test system’s control procedures per perform the test system’s control procedures per the manufacturer’s instructions the manufacturer’s instructions andand, at a , at a minimum, test two levels of external control minimum, test two levels of external control material daily. If acceptable. . .material daily. If acceptable. . .

• The laboratory may reduce the frequency of The laboratory may reduce the frequency of testing two levels of external control material testing two levels of external control material from daily to once per calendar from daily to once per calendar weekweek..

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• If any internal/external control results are If any internal/external control results are unacceptable during the evaluation process unacceptable during the evaluation process OR after the laboratory has reduced the OR after the laboratory has reduced the frequency for testing external control frequency for testing external control materials, the laboratory must repeat the materials, the laboratory must repeat the testing of the unacceptable control.testing of the unacceptable control.– If repeat control result is acceptable, no further If repeat control result is acceptable, no further

corrective action is necessary. Resume corrective action is necessary. Resume evaluation process or reduced external control evaluation process or reduced external control testing frequency.testing frequency.

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– If repeat control result is NOT acceptable, If repeat control result is NOT acceptable, the laboratory must:the laboratory must:• Identify the problem and take appropriate Identify the problem and take appropriate

corrective action.corrective action.• Evaluate all patient test results obtained in the Evaluate all patient test results obtained in the

unacceptable test run and since the last unacceptable test run and since the last acceptable test run to determine if patient test acceptable test run to determine if patient test results have been adversely affected. (42 CFR results have been adversely affected. (42 CFR 493.1282(b)(2))493.1282(b)(2))

• Restart and successfully complete the evaluation Restart and successfully complete the evaluation process before reducing the frequency of testing process before reducing the frequency of testing external control materials.external control materials.

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• Remember, the following ongoing Remember, the following ongoing assessment activities are also required:assessment activities are also required:– Proficiency testing results MUST demonstrate Proficiency testing results MUST demonstrate

acceptable/satisfactory performanceacceptable/satisfactory performance– Analytic system quality assessment activities Analytic system quality assessment activities

must demonstrate problems are not occurringmust demonstrate problems are not occurring– Competency assessment evaluations must Competency assessment evaluations must

demonstrate testing personnel are accurately demonstrate testing personnel are accurately performing testingperforming testing

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• If unacceptable results are obtained If unacceptable results are obtained for any of these assessment for any of these assessment activities, the laboratory must:activities, the laboratory must:– InvestigateInvestigate– Identify the problemIdentify the problem– Document the corrective action(s) Document the corrective action(s)

takentaken– RESTART the evaluation processRESTART the evaluation process

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• If the laboratory chooses to If the laboratory chooses to implement the reduced QC implement the reduced QC frequency (EQC) for MULTIPLE frequency (EQC) for MULTIPLE INSTRUMENTS (including the same INSTRUMENTS (including the same make and model used to perform the make and model used to perform the same test) a successful evaluation same test) a successful evaluation process must be performed for process must be performed for eacheach instrument for which the QC instrument for which the QC frequency applies.frequency applies.

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OTHER POSSIBLE OTHER POSSIBLE OPTIONS???OPTIONS???

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POSTANALYTIC SYSTEMSPOSTANALYTIC SYSTEMSTest ReportsTest Reports

• The laboratory must have an The laboratory must have an adequate manual or electronic adequate manual or electronic system(s) in place to ensure test system(s) in place to ensure test results and other patient-specific data results and other patient-specific data are accurately and reliably sent from are accurately and reliably sent from the point of data entry (whether the point of data entry (whether interfaced or entered manually) to interfaced or entered manually) to final report destination, in a timely final report destination, in a timely manner. manner. (42 CFR § 493.1291(a))(42 CFR § 493.1291(a))

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• Test results must be released only Test results must be released only to authorized persons and, if to authorized persons and, if applicable, the individual applicable, the individual responsible for using the test responsible for using the test results and the laboratory that results and the laboratory that initially requested the test.initially requested the test.(42 CFR § 493.1291(f))(42 CFR § 493.1291(f))

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• 42 CFR § 493.1291(f) Interpretation:42 CFR § 493.1291(f) Interpretation:– Test results must be released to the Test results must be released to the

authorized person, or, if applicable, authorized person, or, if applicable, their agent.their agent.

– Test results must also be released to Test results must also be released to any additional individuals/entities any additional individuals/entities designated on the test requisition.designated on the test requisition.• These entities are understood to be These entities are understood to be

“responsible for using” the test results.“responsible for using” the test results.

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• For CLIA purposes, when the For CLIA purposes, when the authorized person, designated authorized person, designated agent, or individual responsible for agent, or individual responsible for using the test result receives the using the test result receives the results, whichever is last, the results, whichever is last, the laboratory’s CLIA responsibility laboratory’s CLIA responsibility ends.ends.

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CLIA WEBSITECLIA WEBSITE

Information can be found at Information can be found at the CMS Website:the CMS Website:www.cms.gov/cliawww.cms.gov/clia

CLIA POINT-OF-CARE TESTING and the CLIA SURVEY Gary Yamamoto Centers for Medicare & Medicaid...

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Transcript of CLIA POINT-OF-CARE TESTING and the CLIA SURVEY Gary Yamamoto Centers for Medicare & Medicaid...