Ronald D. Feld, Ph.D., Marian Schwabbauer, Ph.D., CLDir(NCA)*, John D. Olson, M.D., Ph.D.
1)List the organizations which have received deemed status for inspection of laboratories.
2)Describe the preparative steps taken by the HCFA inspectors prior to arriving on site.
3)List the 11 tasks which the inspector will perform during the inspection.
4)Describe the conditions which will lead to a cited deficiency.
5)Describe the conditions which will cause an immediate closure of the laboratory.
The Inspection Process
Another tool that CLIA uses for the assessment of laboratory quality
is the biannual inspection. Laboratories performing only waived or
physician performed microscopy are not subject to routine inspection
unless there is a complaint or suspicion of poor quality. There may
be a few inspections of these laboratories simply to check
enforcement and compliance.
Moderate and high complexity laboratories are subject to inspection. HCFA has awarded several organizations deemed status with respect to inspections. These organizations must have an inspection process that is at least as strict and comprehensive as the CLIA regulations dictate but may be stricter and more comprehensive. In addition, several states that have an inspection system in place have applied for an exemption.
If the laboratory is not regularly inspected by an organization with deemed status, it will be inspected by HCFA employed inspectors. Originally, inspections were to be unannounced but HCFA has decided that to minimize disruption to medical practice and to assure that appropriate personnel are present, routine inspections will be announced. Inspections prompted by complaints or revisits are not announced.
The inspection as designed by HCFA is outcome-oriented and places emphasis on outcome or performance measurements. The focus is on the services provided and the structures and processes that contribute to the quality of testing.
The inspector will rely on direct observation when possible. Selected specimens from each specialty and subspecialty will be tracked from receipt or collection through reporting of results. Observation of the preanalytic, analytic, and postanalytic phases of testing will occur. These include, but are not limited to, processing of patient specimens, performance of test analysis, and reporting of test results. Reliability and timeliness of test results, including quality control and calibration data, will be assessed. The leadership skills of testing and supervisory personnel and the adequacy of the facilities, equipment and supplies will be determined. Findings that indicate potential noncompliance will lead to a more detailed evaluation of specific and related requirements.
The inspection is divided into 11 tasks. Task 1 is performed before the actual on-site inspection and consists of reviewing the file for hours of operation, personnel qualifications, services offered, proficiency testing results, and records of complaints and sanctions. There is also a review of any changes that occurred since the previous inspection such as ownership, directorship, and complexity. Inspections are held during normal hours of operation; if there are multiple shifts, observation is scheduled on each shift if possible. Laboratories operating at multiple sites under a single license may not have each site directly inspected but a sample will be selected based on type of testing performed, location of proficiency testing, and the type of facilities.
Task 2 consists of the entrance interview. The inspector will verify the CLIA certificate with respect to complexity and kind of testing performed, current personnel including the laboratory director, and enrollment in approved proficiency testing programs. If there have been any changes since the original application was filed, the inspector may update the file or require a new application.
The inspector will inquire about the availability of the staff during the survey time schedule and explain the survey process to the staff. The inspector will inquire whether deficiencies are to be discussed with testing personnel. The laboratory can schedule an exit conference to discuss survey findings.
Documents needed to complete the survey are requested and any questions concerning the survey process are solicited and answered. Inspectors will try to the best of their ability to minimize the disruption of the practice and avoid any inconvenience to patients.
Task 3 consists of a tour of the facilities to familiarize the inspector with the physical plant, equipment, testing staff, and types of services offered. The type and size of the laboratory will govern the time of the tour and whether certain areas need to be revisited. The inspector will ask that a member of the technical staff accompany them on the tour to ensure that all areas concerned with all phases of testing are visited. During this tour, the inspector will be evaluating layout and organization, space utilization, equipment arrangement, storage, waste disposal, specimen handling and storage, reporting systems, and record storage.
Task 4 is concerned with sample selection and record review. The inspector will choose samples to follow through the various phases of testing that are representative of the specialties and subspecialties present in the laboratory. Records from each shift or site which relate to PT failures will be reviewed, including patient specimens that were analyzed at the same time as the PT failure.
Task 5 involves assessing the representative samples that were chosen for specimen integrity (Subpart J), skills of testing and supervisory staff (Subpart M), and the evaluation of equipment and testing supplies (Subpart K). Specimen integrity is observed for the following: collection practices, specimen handling including preservation and storage, labeling practices, rejection criteria, the system for less than optimal specimens, test ordering systems, and specimen referral.
Staff are observed for the following: staff interactions for consistency with their assigned duties, accessibility of supervisory staff, and actions taken when testing or competency problems occur. Direct questioning of the staff may occur during or after observation. Using the samples selected, the inspector will observe whether appropriate test kits, equipment, reagents, and supplies are available. The inspector will determine whether FDA cleared test systems are used appropriately, whether electrical sources are stable, and whether reagents are in date and stored appropriately. The inspector will also review procedure manuals and maintenance records.
Task 6 consists of the assessment of test performance (Subpart K) and reporting of results (Subparts K and P). The inspector will review quality control practices to determine if the laboratory is following its own or the manufacturer's quality control protocols. Evidence of corrective action when QC problems such as outliers, shifts, or trends occur will be sought. The inspector will also assess the QC and calibration materials used, source of QC limits, and monitoring of QC data.
The inspector will check worksheets, instrument printouts, and medical records for completeness. The inspector will compare the test requisition to the final report. The final report should be available to the ordering physician, consistent with the laboratory's policy on timeliness.
Task 7 consists of verification of personnel qualifications (Subpart M). The laboratory must have records which verify an individual's education, experience, and training. These records may include: diplomas, transcripts, letters from an institution of higher learning indicating Board eligibility or level of learning achieved, and letters from former employers. False or erroneous information may require the removal of a person from a particular position. The qualifications of the laboratory director, technical consultant, and clinical consultant will be reviewed.
Task 8 includes the verification of proficiency testing enrollment and review of PT results (Subparts H and Q). The inspector will verify that the laboratory is enrolled in an approved PT program, and that results were reported under the appropriate methodology or instrument. The inspector will compare PT sample results from instrument printouts to the results reported to the PT program and verify that PT samples were treated in the same manner as patient samples.
Task 9 concerns the analysis and evaluation of findings. In order to classify a finding as a deficiency, the inspector will analyze a finding on the basis of: type of requirement (statutory or regulatory), frequency of occurrence, impact on patient care, completeness of documentation, and impact on the number of areas of a laboratory's operation. If the inspector determines that there is immediate jeopardy (defined as a situation in which immediate corrective action is necessary because the noncompliance has caused or is likely to cause serious injury to individuals served by the laboratory), then the laboratory may be closed immediately.
Task 10 consists of an exit conference. At this conference, the inspector shares observations and findings and solicits additional information. If a plan of corrective action is needed, the instructions and time frame are explained. Each deficiency is discussed as well as suggestions that could improve the quality of the laboratory. The inspector should discuss any additional information that the laboratory might provide in an attempt to resolve differences regarding deficiencies. The inspector will inform the laboratory of the recommendation that will be made to the Regional Office regarding certification status.
Task 11 consists of a written statement of deficiencies. This will be done at the Regional Office after completion of the inspection.
New Inspection Rules
HCFA has ruled that laboratories having no deficiencies and
satisfactory PT testing performance will not have to be inspected on
their next two-year cycle. Instead they can perform a self-assessment
study called an Alternative Quality Assessment Survey (AQAS). Such
laboratories will not have another on-site inspection until four
years after their acceptable on-site inspection. About 5% of
laboratories will be inspected on-site to validate the AQAS.
Laboratories performing cytology, cytogenetics or histocompatibility testing will undergo on-site inspection every two years. Also laboratories with unsatisfactory PT, who have had a complaint filed or who undergo significant changes like a new laboratory director, will undergo inspection on a two-year cycle. A copy of the AQAS follows:
Clinical Laboratory Improvement Amendments (CLIA)
Alternate Quality Assessment Survey
General Information
CLIA Identification Number Date Telephone Number (include area code) ____D______________________________ ________________________________
Laboratory Name Name of Director _____________________________________________________________________
Laboratory Address Mailing Address (if different) _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________
Waived Provider-Performed Microscopy Moderate High
2. Please put an X by the types of tests the laboratory
is currently performing below:
Bacteriology
Mycobacteriology
Mycology
Parasitology
Virology - List all procedures performed below:
Diagnostic Immunology
Cytogenetics
Histocompatibililty
Radiobioassay
Chemistry
Hematology
Immunohematology
Pathology
3. a) Has the laboratory added any new tests or made any changes
in the current primary test systems, e.g., change in instrument or
test method, since its last inspection?
Y N N/A
b) If so, what test(s) were added?
Test Equipment Used Annual Volume CPT Code, If Available
c) If so, what changes were made?
4. What is the estimated annual (not counting waived tests or
those derived from calculation only) test volume for the current
year?
5. a) If the the laboratory has multiple testing sites under one
CLIA certificate, have any new testing sites been added since the
last CLIA survey?
Y N N/A
b) Do these new sites perform any non-waived testing not previously performed in the existing sites?
Y N N/A
c) Please list the name and address of the new test sites encompassed by the laboratory's current CLIA number, the non-waived test(s) performed, and include the estimated annual total volume for each (site and test). Use additional sheets as necessary.
Site Address Type of Testing Performed
6. Are there any changes in laboratory personnel since the laboratory's last inspection?
Y N N/A
a) For laboratories performing no higher than moderate complexity testing:
1) Laboratory Director?....Y....N....N/A
2) Technical Consultant?...Y....N....N/A
3) Clinical Consultant?....Y....N....N/A
4) Testing Personnel?......Y....N....N/A
b) For laboratories performing high complexity testing:
1) Laboratory Directory?...Y....N....N/A
2) Technical Supervisor?..Y....N....N/A
3) Clinical Consultant?...Y....N....N/A
4) General Supervisor?....Y....N....N/A
5) Testing Personnel?.....Y....N....N/A
Please submit a copy of the documentation demonstrating the qualifications of personnel newly hired or changing positions since the last CLIA on-site survey. This documentation may include licenses, diplomas, degrees, certificates, and education/experience. Indicate the job or position held and effective date. Do not send original documents.
7. Has the laboratory made any changes in name, ownership or location since its last inspection?
Y N N/A
If yes, please list those changes here:
Patient Test Management
a) Routinely review policies and procedures for specimen collection, labeling, preservation, and handling for completeness and accuracy?
Y N N/A
b) Train laboratory personnel responsible for specimen handling and processing to follow these policies?
Y N N/A
c) Verify that these policies are available and followed?
Y N N/A
9. a) Using a representative number of specimens processed, does the laboratory review specimen processing for accuracy (e.g., specimen identification, tests ordered, correct specimen type), appropriate handling, and storage?
Y N N/A
b) What is the date of the last review?
10. a) Does the laboratory routinely review specimen rejection criteria,policies, and procedures for actions to be taken if criteria are not met?
Y N N/A
b) Approximately what percentage of specimens are rejected each year?
c) Has the laboratory investigated the cause of specimens that were rejected and taken action to prevent recurrences, as appropriate?
Y N N/A
11. Does the laboratory routinely review a representative number of requisitions or medical charts -
a) For completeness relevant to the testing performed and information requested?
Y N N/A
b) To assure that the information on the requisitions has beenaccurately transferred to the test report?
Y N N/A
c) To assure tests ordered were performed and test results reported to the authorized person?
Y N N/A
d) What is the date of the last review?
12. a) Does the laboratory routinely review a representative number of test reports or medical charts to assure that test results from worksheets, instrument printouts or electronic transmissions were accurately reported?
Y N N/A
b) Are test result data and reports maintained for 2 years?
Y N N/A
c) What is the date of the last review?
13. a) Does the laboratory routinely review its reporting system to assure that panic values (i.e., values that are abnormally low or high as to be considered alarming) have been brought to the attention of the authorized person, and that contact is documented?
Y N N/A
b) How does the laboratory assure the results are reported promptly and accurately to the authorized person? Please explain or attach policy.
c) What is the date of the last review?
14. a) Does the laboratory reporting system detect and document reporting errors?
Y N N/A
b) When reporting errors are detected, are corrected reports issued,documented, and maintained?
Y N N/A
15. Does the laboratory examine its record storage system for the ability to maintain and readily retrieve -
a) Patient test results or reports?
Y N N/A
b) Requisitions or test orders?
Y N N/A
c) Worksheets, instrument printouts, etc?
Y N N/A
Note: A patient chart or medical record (provided all the information specified in the regulations for test requisition and report are satisfied) meets these requirements.
16. Does the laboratory maintain records for -
a) 2 years for test requisitions, worksheets, reports, and patient charts (if used as a test record)?
Y N N/A
b) 5 years for immunohematology (blood bank) records and reports?
Y N N/A
c) 10 years for pathology reports?
Y N N/A
d) 2 years for quality control activities?
Y N N/A
17. If errors are detected during the assessment of laboratory quality in any of the above reviews, did the laboratory document corrective action(s) taken?
Y N N/A
Please submit an example of an assessment of laboratory quality that resulted in corrective actions being taken since our last CLIA inspection and a description of the actions taken.
18. Does the specimen processing mechanism allow the laboratory to track a specimen from test order through test report?
Y N N/A
Quality Control(QC)
Y N N/A
b) Are policies and procedures for quality control (QC) for each test the laboratory performs available to ensure accurate and reliable test results?
Y N N/A
Note: In lieu of a written procedure manual, manufacturers'package inserts are sufficient as long as, when applicable, they are supplemented with any laboratory specific instructions.
c) Does the laboratory have a mechanism in place to determine whether testing personnel follow these policies and procedures correctly?
Y N N/A
20. a) Are all procedures current and approved by the current laboratory director?
Y N N/A
b) What is the date of the last review?
21. Are all test modifications or changes approved by the laboratory director and included in the manual?
Y N N/A
22. For new tests or test systems added since the last CLIA survey, did the laboratory -
a) Verify the accuracy of the method?
Y N N/A
b) How?
c) Verify that it met the manufacturer's performance specifications?
Y N N/A
23. Does the laboratory follow manufacturer's instructions regarding operation, maintenance and test performance for instruments or test systems?
Y N N/A
24. Does the laboratory review a representative sample of records for all instruments requiring calibration to assure that calibration and/or calibration verification is performed -
a) In accordance with manufacturers' recommendations and/or in accordance with the laboratory's QC policies?
Y N N/A
b) At least every 6 months?
Y N N/A
b) What is the date of the last review?
25. a) If calibration fails, does the laboratory follow its policy for corrective action?
Y N N/A
b) What is the date of the last review?
26. a) Does the laboratory review a representative sample of tests performed to ensure that at least two levels of control material are run each day of testing for each test system, unless the CLIA requirements allow for an alternate method (e.g., germ tubes, urine microscopic examinations, wet mounts) of verifying test accuracy?
Note: Some types of testing require more frequent QC than each day of use, regardless of complexity, e.g., hematology.
Y N N/A
b) What is the date of the last review?
27. Are controls tested in the same manner and at the same time as patient specimens?
Y N N/A
28. Does the laboratory review QC records to assure that when QC values fail to meet the criteria for acceptability, the laboratory -
a) Does not report patient results?
Y N N/A
b) Follows its policy for remedial or corrective action?
Y N N/A
Please submit a copy of remedial action taken when QC results failed to meet the criteria for acceptability.
29. Based on the laboratory's QC evaluations, is there assurance that ineffective policies and procedures are revised and approved by the laboratory director?
Y N N/A
Proficiency Testing (PT)
Y N N/A
31. Are PT samples treated in the same manner as patient samples when possible, for example -
a) Tested the same number of times?
Y N N/A
b) Tested using personnel who routinely perform testing?
Y N N/A
c) Tested using routine methods (i e, the laboratory's primary method for testing)?
Y N N/A
d) Tested during patient testing, if possible?
Y N N/A
32. a) Has the laboratory received reports of any unacceptable PT results since the last CLIA survey?
Y N N/A
b) If yes, has the laboratory conducted and documented an investigation identifying the cause of the PT error(s)?
Y N N/A
c) If yes, did the laboratory take and document corrective action(s) to assure that the PT errors do not recur?
Y N N/A
Please submit a copy of the laboratory's corrective actions for this (these) incident(s).
33. Does the laboratory determine and document that corrective action(s)taken for inaccurate PT results is (are) effective?
Y N N/A
34. Does the laboratory review patient testing performed at the time PT samples were analyzed to determine and take corrective action(s) on any negative impact such testing errors had on the accuracy of patient testing?
Y N N/A
35. a) For tests where PT is not required or available, does the laboratory have a mechanism to verify, at least twice a year, that test results are accurate?
Y N N/A
b) What are the dates of the last 2 verifications?
Please submit an example of the laboratory's documentation of test accuracy when proficiency testing is not required or available for that test.
Comparison of Test Results
Y N N/A
b) What are the dates of the last 2 evaluations?
37. If individual test results performed on the same patient do not correlate with each other (e.g., hemoglobin/hematocrit, BUN/creatinine, electrolyte balance) does the laboratory investigate the cause and take corrective action?
Y N N/A
Relationship of Patient Information to Test Results
a) Check for arithmetic or clerical errors (transposed numbers/test results, misplaced decimals, etc.)?
Y N N/A
b) Retest the same specimen?
Y N N/A
c) Obtain another specimen?
Y N N/A
d) Investigate patient test management (e.g., record keeping) activities for errors?
Y N N/A
e) Notify the referral laboratory, as applicable?
Y N N/A
f) Investigate the test system used?
Y N N/A
g) Investigate the reporting system?
Y N N/A
Personnel Assessment
Y N N/A
40. Does the laboratory assure that testing personnel have a working knowledge of and can perform new tasks required to obtain accurate and reliable test results?
Y N N/A
41. a) Does the laboratory review personnel competency evaluations and training policies for effectiveness?
Y N N/A
b) Do evaluation and training policies correlate with job descriptions?
Y N N/A
c) What is the date of the last review?
d) Does the director meet all responsibility requirements (specified in the CLIA regulations at §093.1407 for moderate complexity testing and §5493.1445 for high complexity testing) for assuring quality testing in the laboratory as applicable or delegate to an appropriately qualified individual?
Y N N/A
Communications and Complaint Investigations
Y N N/A
43. Does the laboratory have a system to address problems that may occur with the reference laboratory used, including specimen handling, test results and reporting?
Y N N/A
44. Does the laboratory investigate complaints to determine the cause, and take timely actions to remedy the problem?
Y N N/A
45. If the laboratory's evaluation identifies problems, are -
a) Problems documented?
Y N N/A
b) Problems corrected?
Y N N/A
c) Policy or procedure changed?
Y N N/A
d) Changes evaluated to determine whether action was effective?
Y N N/A
e) The appropriate people notified?
Y N N/A
Quality Assurance Review
a) Have a mechanism to assess the findings of all quality assurance reviews referenced in this survey as well as any other specific review unique to the laboratory?
Y N N/A
b) Document problems identified and corrective actions taken during quality assurance reviews?
Y N N/A
c) Document communication of review findings with staff and clients (i.e. via memos, meeting agendas, meeting minutes, newsletters)?
Y N N/A
d) Assess whether the corrective actions taken to prevent recurrences are effective?
Y N N/A
Please submit an example of the laboratory's communication with staff and/or clients that addresses changes made in the laboratory's policies/procedures as a result of any quality assurance reviews referenced in this survey.
47. Are all quality assurance records maintained for 2 years?
Y N N/A
Attestation
__________________________________________________________ Signature of Laboratory Director (sign in ink please) Date __________________________________________________________ NotaryDate Comments:
College of American Pathologists (CAP)(312) 446-8800
Joint Commission on Accreditation of Healthcare Organizations (JCAHO)(708) 916-5600
The Commission on Office Laboratory (301) 588-5882 Accreditation (COLA)
A complete survey of a laboratory or laboratory services consists of the following tasks and an assessment of the principal components listed below: