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How to prepare for and survive a CLIA inspection.

If there is a complaint against your lab, inspectors can descend from the heavens without warning. Preparation is key.

INSPECTIONS, or as the Health Care Financing Administration (HCFA) calls them, surveys, are the key to insuring laboratory compliance with the requirements of CLIA '88. Under CLIA, HCFA can--without announcement--inspect your laboratory for any of the following five reasons:

1. As part of a biannual survey done either by HCFA surveyors or by inspectors from an organization approved by HCFA through its deeming (delegating) authority.

2. To investigate a complaint that has been made about the laboratory.

3. To gather information.

4. As part of a 5% verification of those laboratories that are inspected by organizations other than the Health Care Financing Administration.

5. When a public health hazard is believed to exist. All laboratories are subject to HCFA-approved surveys (including waivered labs when the matter at hand falls under items 2, 3, or 5 above). Under certain circumstances, the investigating agency may give no more than three working days' advance notice before conducting a survey. Complaint investigations will be conducted unannounced. Accusations can come from any source, including laboratory users, employees, the general public, or inspectors for other Federal programs.

* Fair warning. Surveys may be announced when special or extraordinary travel arrangements must be made due to the remote location of the laboratory or when there is a high probability that lab personnel will be absent or the facility will be closed. In a letter issued Sept. 1, 1992, the Secretary of Health and Human Services announced that inspections of physicians' office laboratories (POLs) may be done on an announced basis in order to avoid disrupting medical services.

The requirements and guidelines for conducting surveys are in subpart Q, 493.1775 through 493.1780 of the CLIA '88 regulations. The more extensive instructions quoted in this article were found in a draft of the State Operations Manual (HCFA Publication 7, the final version of which was scheduled for publication in February 1993, after this issue of MLO went to press), where HCFA directs surveyors to "make every effort to minimize the impact of the survey on the laboratory operations and patient care activities." In addition, surveyors are to "be flexible, accommodate staffing schedules and departmental workloads as much as possible. In facilities providing direct patient care (i.e., physician offices, clinics, residential care facilities, hospitals, etc.), respect patient privacy and do not interrupt or interfere with patient care."

A surveyor will attempt to evaluate each laboratory site. Make sure that your quality assurance program is designed to include all testing sites. Remember that sanctions may be levied against the entire laboratory.

* Survey protocols. The State Operations Manual (HCFA Publication 7) is a large compendium of which only Appendix C, Survey Protocols and Interpretive Guidelines for Laboratories and Laboratory Services, is directly applicable to the clinical lab. The guidelines are designed to provide guidance to surveying personnel that will make inspections more uniform. HCFA explains the purpose of the SOM this way:

The protocols "serve to clarify and/or explain the intent of the regulations and are required to be used by all surveyors assessing compliance with Federal requirements. The purpose of the protocols and guidelines is to provide suggestions, interpretations, checklists, and other tools for surveyors to use in preparation for the survey, in conducting the on-site survey, and for analysis and evaluation of survey findings."

* Establishing probes. The SOM explains how a survey is conducted and what questions (probes) will be asked to determine the laboratory's compliance with CLIA '88 and HCFA's administrative rules. The instructions place certain limitations on surveyors:

Requirements. "The guidelines do not establish requirements that must be met by laboratories certified under CLIA. They do not replace or supersede the law or regulations and, therefore, may not be used alone as the sole basis for a citation. All mandatory requirements for laboratories are set forth in relevant provisions of the Social Security Act and the Public Health Service Acts and in the CLIA regulations. However, the guidelines do contain authoritative interpretations and clarification of statutory and regulatory requirements and may be used to assist surveyors in making determinations about a laboratory's compliance."

Deficiencies. "A deficiency must be based on a violation of the statute or the regulations; citation of a deficiency must not be based on a violation of a guideline alone. Surveyors should carefully consider how the practices of the laboratory relate to the examples within the Interpretive Guidelines and then compare these to the specific regulatory requirement before determining that a deficiency exists. When a surveyor observes that circumstances in a laboratory do not meet a particular guideline, that observation may be a significant indication that the applicable statutory or regulatory provision is not met. However, in each case the surveyor must determine, based on the facts and circumstances existing at the time and such further investigation as may be warranted, whether a deficiency exists based on the applicable statutory or regulatory provision."

* Survey outcomes. Figure 1 lists the 11 tasks that comprise HCFA's outcome-oriented survey process, which is used to evaluate a lab's service (outcome) for effectiveness and quality.

A survey focuses on each of the 50 condition-level rules in CLIA '88. These rules, delineated in the Federal Register of Feb. 28, 1992, are more basic and carry more penalty for violation--including the shutting down of the offending lab--than do standard-level rules.

The inspection process requirements are so large that HCFA surveyors, upon finding problems, will have to take samples that will lead to more extensive investigation. In their inspection, surveyors will focus on:

Accuracy of results. "Specimen integrity and the accuracy, reliability, and timeliness of test results, (including quality control and calibration data, test performance, and patient-specific information, as described under Task #6). This is the principal focus of the survey."

Skills of personnel. "Skills of testing and supervisory personnel (e.g., training, delegation of responsibilities, evaluation of test results, resolution of problems)."

Adequacy of facilities. "General adequacy of the facilities, equipment, and supplies with detailed surveys where apparent problems exist."

The State Operations Manual continues: "If, while examining records or interviewing and observing staff, there are findings which indicate potential noncompliance, the survey should be redirected to include more detailed evaluation of the specific and related requirements. Conversely, if a review of quality control records, patient reports, interviews and observations for a particular test or procedure do not reveal problems or potential deficiencies, it would not be necessary to review additional records related to the performance of that test/procedure. In addition, if there have been no changes in the laboratory's staff (i.e., directors, supervisors, testing personnel) since the last survey, it is not necessary to reevaluate personnel qualifications. However, if initial findings indicate problems or potential deficiencies, the degree to which the requirements are reviewed should increase proportionately."

* Finding deficiencies. Proficiency testing (PT) comparisons supplied by the lab's PT provider is a key element in establishing that the lab does quality work.

Deficiencies found in one area may lead to deficiencies in other areas. Failures in PT could indicate problems with performance specifications or in supervision.

The survey process will go better for you if you are prepared. In order to quickly identify and correct problems, all policies should clearly reflect the appropriate CLIA rules. All PT, QC, and calibration problems should be fully resolved and clearly documented. Complaints must be fully investigated and resolved. All records should be easily accessed. If the laboratory has the appearance of organization, the surveyors will only sample your records and move on. The following is a detailed rundown of HCFA's 11-task survey process. Figure 2 contains hints to help you prepare for an inspection, while Figure 3 lists forms used by surveyors.

* Task 1: Preparation. The first step in a survey is determining the size of the investigating team and examining the laboratory's past survey and PT performance. Any previous survey failures are noted by the team, which also focuses on changes in personnel and service.

* Task 2: Entrance interview. During the entrance interview, the survey team verifies the information in their files about the laboratory, its personnel, and the tests it offers. If significant variations are found from the file information, the laboratory director must fill out a new HCFA application to bring the agency's files up to date.

The director must also explain why the file information is out of date. It is the lab's responsibility to inform the surveying agency within 30 days of changes in ownership, location, directors, or (in the case of high-complexity testing labs) supervisors. Six months is the deadline for notification of changes in tests (either added tests or changed methodologies) or the addition of specialties or subspecialties.

During the entrance interview, the survey team establishes the availability of those laboratory personnel who may be needed to complete the survey.

* Task 3. Tour. During a tour of the entire facility, the team selects parts of the lab to survey.

* Task 4: Sample selection. The choice of what surveyors actually look at depends on the size and complexity of the lab, including the type of patients served, number of tests performed, and number of personnel. The team tries to avoid predictable sampling. If a pattern of deficiencies is found, if complaints have been lodged, or if PT failures have occurred, the sample size will be increased and any failed tests will be included.

* Task 5: Integrity. Your personnel's skill at performing laboratory processes is evaluated, including: how the lab prepares the patient, obtains specimens, handles test requests, processes and stores specimens, performs tests, and maintains confidential records. Surveyors look at specimen transport, labeling, acceptance (and rejection when that is the case). Investigators look at how your lab sends specimens to other labs, and will check whether the referral laboratory is certified and that it is identified, along with its address, on the final report.

* Task 6: Performance and reporting. Surveyors follow specimens from request to final report to insure that only authorized personnel perform tests and that results are properly and confidentially reported. Specimen and patient identification, specimen processing, method calibration, and QC must all assure quality results.

Surveyors determine if the lab follows policies for handling patient specimens on a routine as well as a priority (Stat, for example) basis. Test results must be appropriate for the patient population. QC data must demonstrate how the process insures quality. Investigators ascertain how you determine, handle, and document out-of-control situations (outliers, shifts, or trends, for example). Evidence must show that the lab understands how anomalous results impact patient testing.

Results may be evaluated for correctness by comparing the instrument tape output with the final reported results. The relationship of test results to other reported tests and the patient's demographic and medical parameters are examined. The laboratory's reporting system must provide a confidential report that has been made in an appropriate time frame.

* Task 7: Personnel. Surveyors evaluate the education and experience of lab personnel. Investigators confirm that each lab director, technical consultant, technical supervisor, clinical consultant, supervisor (including technical, general, and cytology), and a sample of testing personnel (including cytotechnologists) are qualified and effective in their assigned duties. The team probably will not reevaluate those who have already had their credentials examined unless they have changed duties. The object is to assure that all workers have the right education, experience, and training. New directors, consultants, or supervisors must be evaluated, however.

* Task 8: PT enrollment. Proficiency testing is the key to HCFA's evaluation of laboratory performance. Enrollment and successful participation for each specialty and subspecialty is required by CLIA '88. The survey team reviews all records necessary to evaluate your history of performance. Your records must show how any failures have been resolved to insure that the problem doesn't recur and that the results were reviewed by your staff. The proficiency test specimens must be handled in the same manner as patient specimens.

* Task 9: Analysis of findings. All data gathered during the survey are evaluated to determine overall lab compliance. Surveyors will ascertain if any problems constitute a deficiency and, if so, whether a serious condition-level violation exists.

The decision to cite the lab with a deficiency is based on all the evidence gathered. That decision may be reviewed by a survey team supervisor. An allegation of deficiency made by the lab staff is handled like a complaint and must be verified before being given credence. Allegations may require follow-up investigation.

The seriousness of a deficiency depends on its frequency and its impact on the lab's services to patients. Small deficiencies may not be cited and, therefore, are left to the laboratory to correct without follow-up. There are three screening tests that help surveyors determine if a deficiency must be cited. A fourth test helps surveyors establish if a condition-level deficiency exists. Investigators may also use other screens developed from their experience. These are the screens available to surveyors:

1. Performance and documentation. Is the task being performed but not being documented completely?

Is the task not being performed but is being falsely documented?

Is the task not performed and not documented?

2. Frequency or pervasiveness of the problem. Is the finding a one-time occurrence?

Is the finding sporadic or occasional with no pattern?

Is there a pattern in the frequency of occurrence (on certain days, shifts, or tests, for example)?

3. Seriousness of the problem. Is a finding strictly related to one area?

Does it occur across several areas of the laboratory's operation?

Does it reflect on the overall management of the lab?

4. Impact or influence on other areas. (This screen is used to determine condition-level deficiencies).

Does or could the finding impact on the quality of the test results?

Is the test critical in the diagnosis and treatment of the patient?

Surveyors will use their professional judgment to evaluate the impact of deficiencies in citing the laboratory.

The State Operations Manual instructs surveyors this way: "The number of deficiencies does not necessarily relate to whether or not a Condition should be found out of compliance but rather its impact or potential impact on the quality of laboratory services and the results reported. A Condition may be considered out of compliance for one or more deficiencies if, in your judgment, the deficiency(ies) constitutes a significant or a serious problem that adversely affects patient test results or has the potential for adversely affecting patient test results."

Furthermore: "If the findings are of a nature that if not immediately corrected would result in harm, serious injury, or death to individuals served by the laboratory, then a situation or immediate jeopardy probably exists."

Declaring a state of immediate jeopardy is a serious decision that will greatly affect how penalties are applied to the lab. It is defined as "a situation in which immediate corrective action is necessary because the laboratory's noncompliance with one or more condition-level requirements has already caused, is causing, or is likely to cause at any time serious injury or harm or death to individuals served by the laboratory or to the health or safety of the general public. This term is synonymous with imminent and serious risk to human health and significant hazard.

"A determination of immediate jeopardy requires the application of termination procedures, which are addressed specifically in the adverse action section of this manual," the SOM says.

* Task 10: Exit conference. Requesting an exit conference can give you an excellent chance to find out what the surveyors think of your lab's operations. You also can present extra information during this conference. Either at this meeting or in a written report (HCFA form 2567), surveyors will provide instructions and a timetable for achieving necessary quality improvements.

Each state may choose whether to present form 2567 at the conference or after review. The process will usually require a plan of correction written by the lab (either voluntarily or at the request of the surveyors) to resolve any problems. Because subsequent surveys focus on problems identified in the previous inspection, the plan of correction should help insure that the problem doesn't recur. Your lab will be informed if it will be certified, recertified, or denied certification.

* Task 11: Statement of deficiencies. Surveyors will write the statement of deficiencies in a manner that makes requirements understandable to a "reasonably knowledgeable person." The inspectors don't speculate why the lab's policies failed, only identify deficiencies.

* Follow-up. The formulation of a plan of corrective action is the lab's best response to a survey deficiency.

Surveyors are instructed to conduct follow-up investigations to determine that the plan is carried out. The follow-up may be made by mail, telephone, or through on-site revisits. Condition-level deficiencies may require an on-site revisit to evaluate the validity of the correction.

Other reasons for on-site revisits are to insure correction of physical hazards, of unacceptable personnel practices, or of deficiencies relating to QC, or when evidence is inconclusive as to the corrective actions taken.

The mandate to regulate clinical labs is taken seriously by HCFA. Surveys are a keystone of that mandate. Through the survey mechanism, HCFA is empowered to penalize deficient labs. And it will do so.

The author is professor of pathology, University of Oklahoma Health Sciences Center, and director of clinical chemistry, Oklahoma Medical Center, Oklahoma City. Chairholder of the committee that formulated EP6-P for the National Committee for Clinical Laboratory Standards, he has been presenting CLIA workshops for several years for the NCCLS and the American Association for Clinical Chemistry.

Figure 1

The lab surveyor's 11 tasks

1. Pre-survey preparation

2. Entrance interview

3. Tour and assessment of facilities

4. Sample selection for observation, personnel interview, and record review

5. Assessment of specimen integrity, observations of skills and abilities of testing and supervisory staff, and evaluation of equipment and testing supplies

6. Assessment of test performance and reporting of test results

7. Verification of personnel qualifications

8. Verification of proficiency testing enrollment and review of results

9. Analysis and evaluation of findings

10. Exit conference

11. Formation of the statement of deficiencies

The series so far

How to obtain a CLIA certificate (August 1992)

How to meet the new personnel requirements (September 1992)

How to read the Federal Register (October 1992)

A master plan for implementing CLIA (November 1992)

How to prepare for a proficiency testing event (December 1992)

How to follow the rules for patient test management (January 1993)

Walking the straight and narrow on quality control (February 1993)

Still to come

* Quality assurance

* Avoiding penalties

* Method validation

Figure 2

Tips for survey survival

A self-inspection can greatly increase your success with the survey process. The following items should be considered in a self-inspection.

1. Insure that your HCFA application (form 109 or its replacement forms 114, 115, and 116)is up to date and complete and accurate for:

a. Tests, specialties, and subspecialties of laboratory testing.

b. Personnel and job functions.

c. Name, location, ownership, laboratory director, and general supervisor (if highly complex).

2. Evaluate the completeness of your personnel records to make sure that:

a. Positions and responsibilities are stated clearly.

b. Education and experience of staff are consistent with pertinent CLIA '88 rules.

c. Training and authorization is documented for each of your personnel and each test he or she performs or supervises.

d. Documentation that duties of director(s), supervisor(s), and testing personnel are effectively carried out.

3. Review the appropriateness of your responses to proficiency testing failures, complaints, and previously identified deficiencies. Are complaints logged and handled to insure improvement of quality?

4. Insure that your policies and procedures are up to date and that changes have been approved by the laboratory director.

5. Conduct a self-inspection by following one or more test requests through the laboratory system. Establish that the test request was made by an authorized person, that if the specimen was rejected the reason was documented and the authorized person notified, and that the processing, storage, testing, and reporting were carried out according to laboratory policy. The documentation should also show that the reported results accurately reflect the instrument output. The self-evaluation should show that the lab reported results in a confidential manner.

6. Ascertain that work flow is smooth and that personnel interact with supervisors and directors in an appropriate manner resulting in accurate and timely testing and reporting.

7. Documentation kept and actions taken during quality control (QC) review must be complete and informative as to the problems addressed and their solutions. Were corrective actions recorded? Can you determine when calibrations were made, what lot number of calibrator was used, and when calibration was verified? Is calibration performed at the required intervals?

Be sure you have established realistic performance criteria, including accuracy, precision, analytical sensitivity, analytical specificity, reportable range, reference range, and any other specification required for operation. Your data should show that performance specifications are met during testing of patient specimens (precision must be adequate, for example). Do your maintenance records show when maintenance was done and indicate the resolution of all problems? Do your records show that function checks are within allowable limits for proper instrument operation?

8. Proficiency testing (PT) results must be evaluated for evidence that the reports and all corrective actions were reviewed with the laboratory staff. Are problems repeated? Do your test results show appropriate accuracy? Do you have evidence that PT specimens are handled in the same way as patient specimens? PT specimens must be done in the regular workload by personnel who routinely test patient specimens using an instrument or method that is regularly used for patient testing.

9. The physical facility must be designed and operated for safety and adequacy of space and instrumentation as well as for the storage of supplies. Check how supplies are stored and used at the bench. Have all out-of-date reagents and calibrators been removed from the laboratory testing area?

10. Review the quality assurance (QA) reports and activities for evidence that quality is built into your entire lab system. Your records must reflect consideration for the following required QA areas: patient test management, QC, PT, comparison of test results among different methods for the same analyte, relationship of patient information to patient test results, personnel assessment, communications, complaint investigations, review of QA with staff, and QA records.

Figure 3

Forms that may be used by surveyors

HCFA 1557 Survey Report Form (CLIA)

HCFA 209 Laboratory Personnel Report (CLIA)

HCFA 1513 Ownership and Control Interest Disclosure Statement

HCFA 462A CLIA Adverse Action Extract

HCFA 2567C Statement of Deficiencies and Plan of Correction (CLIA)

HCFA 2567D Post Certification Revisit Report (CLIA)

HCFA 1539 Certification and Transmittal

HCFA 670 Survey Team Composition and Workload Report

HCFA 282 Blood Bank Inspection Checklist and Report

HCFA 562 Medicare/Medicaid/CLIA Complaint Form

HCFA 197 Certification Recommendation--CLIA Laboratory
COPYRIGHT 1993 Nelson Publishing
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1993 Gale, Cengage Learning. All rights reserved.

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Title Annotation:Clinical Laboratory Improvement Amendments of 1988; includes sidebars
Author:Passey, Richard B.
Publication:Medical Laboratory Observer
Date:Mar 1, 1993
Previous Article:Using critical limits to improve patient outcome.
Next Article:A tool to evaluate equipment purchases.

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