Laboratory Accreditation - David Novis Consulting

The College of American Pathologists (CAP) is the primary professional organization accrediting clinical medical laboratories. The CAP bases their accreditation standards on scientific evidence that links best practices to best outcomes. The following is a list of the CAP Accreditation Checklist standards that have emanated from clinical research published by Dr. Novis and his coworkers.

COMMISSION ON LABORATORY ACCREDITATION

Laboratory Accreditation Program

LABORATORY GENERAL CHECKLIST

GEN.20316 Phase II N/A YES NO

Are key indicators of quality monitored and evaluated to detect problems and opportunities for improvement?

NOTE: Key indicators are those that reflect activities critical to patient outcome, that affect a large proportion of the laboratory’s patients, or that have been problematic in the past. The laboratory must document that the selected indicators are regularly compared against a benchmark, where available and applicable. The benchmark may be a practice guideline, CAP Q-PROBES data, or the laboratory’s own experience. New programs or services should be measured to evaluate their impact on laboratory service. The number of monitored indicators should be consistent with the laboratory’s scope of care. Special function laboratories may monitor a single indicator; larger laboratories should monitor multiple aspects of the scope of care commensurate with their scope of service. (However, there is no requirement that an indicator(s) be assessed in every section of the laboratory during every calendar year.)

Examples of key indicators include, but are not limited to the following. (Indicators related to CAP patient safety goals include numbers 1, 4, 7, 8 and 9.)

1. Patient/Specimen Identification. May be any of the following: percent of patient wristbands with errors, percent of ordered tests with patient identification errors, or percent of results with identification errors.

2. Test Order Accuracy. Percent of test orders correctly entered into a laboratory computer.

3. Stat Test Turnaround Time. May be collection-to-reporting turnaround time or receipt-in-laboratory-to-reporting turnaround time of tests ordered with a stat priority. May be confined to the Emergency Department or intensive care unit if a suitable reference database is available. Laboratories may monitor mean or median turnaround time or the percent of specimens with turnaround time that falls within an established limit.

4. Critical Value Reporting. Percent of critical values with documentation that values have been reported to caregivers

5. Customer Satisfaction. Must use a standardized satisfaction survey tool with a reference database of physician or nurse respondents.

6. Specimen Acceptability. Percent of general hematology and/or chemistry specimens accepted for testing.

7. Corrected Reports General Laboratory. Percent of reports that are corrected.

8. Corrected Reports Anatomic Pathology. Percent of reports that are corrected.

9. Surgical Pathology/Cytology Specimen Labeling. Percent of requisitions or specimen containers with one or more errors of pre-defined type.

10. Blood Component Wastage. Percentage of red blood cell units or other blood components that are not transfused to patients and not returned to the blood component supplier for credit or reissue.

11. Blood Culture Contamination. Percent of blood cultures that grow bacteria that are highly likely to represent contaminants.

While there is no requirement that the specific key quality indicators listed above be monitored, these indicators have been field-tested and shown to be measurable in a consistent manner, to demonstrate variability from laboratory-to-laboratory, and to be important to clinicians and to patient care. For the above indicators, performance should be compared with multi-institutional performance surveys that have been conducted within ten years of the laboratory s most recent measurement, where such surveys are available (see references below). Action plans should be developed for any indicator in which laboratory performance falls below the 25th percentile (i.e., 75% or more of the other laboratories in the study perform better). Use of the indicators listed above does not require enrollment in any quality monitoring product.

4) Novis DA, et al. Biochemical markers of myocardial injury test turnaround time. Arch Pathol Lab Med. 2004; 128:158-164;

10) Novis DA, et al. Quality indicators of fresh frozen plasma and platelet utilization. Arch Pathol Lab Med. 2002; 126:527-532\

GEN.20348 Phase II N/A YES NO

Are preanalytic variables monitored?

NOTE: Preanalytic (i.e., pre-examination) variables include all steps in the process prior to the analytic phase of testing, starting with the physician s order. Examples include accuracy of transmission of physicians’ orders, specimen transport and preparation, requisition accuracy, quality of phlebotomy services, specimen acceptability rates, etc. This list is neither all-inclusive nor exclusive. The variables chosen should be appropriate to the laboratory’s scope of care.

13) Dale JC, Novis DA. Outpatient phlebotomy success and reasons for specimen rejection. A Q-Probes study. Arch Pathol Lab Med. 2002;126:416-419;

GEN.20364 Phase II N/A YES NO

Are postanalytic variables monitored?

NOTE: Postanalytic (i.e., post-examination) variables include all steps in the overall laboratory process between completion of the analytic phase of testing and results receipt by the requesting physician. Examples are accuracy of data transmission across electronic interfaces, reflex testing, turnaround time from test completion to chart posting (paper and/or electronic), and interpretability of reports. This list is neither all-inclusive nor exclusive, providing the variables chosen are appropriate to the laboratory’s scope of care.

1) Novis DA, Dale JC. Morning rounds inpatient test availability. A College of American Pathologists Q-Probes study of 79 860 morning complete blood cell count and electrolyte test results in 367 institutions. Arch Pathol Lab Med. 2000;124:499-503;

4) Jones BA, Novis DA. Nongynecologic cytology turnaround time. A College of American Pathologists Q-Probes study of 180 laboratories. Arch Pathol Lab Med. 2001;125:1279-1284

point-of-care testing CHECKLIST

POC.03200 Phase II N/A YES NO

Is the POCT program enrolled in the appropriate available graded CAP Surveys or a CAP approved alternative proficiency testing program for the patient testing performed?

COMMENTARY:

The POCT program must participate in a CAP Surveys or CAP approved program of graded interlaboratory comparison testing appropriate to the scope of the laboratory, if available. This must include enrollment in surveys with analytes matching those for which the laboratory performs patient testing (e.g., patient whole blood glucose testing requires enrollment in CAP survey WBG or approved equivalent). Laboratories will not be penalized if they are unable to participate in an oversubscribed program.

6) Novis DA, Jones BA. Interinstitutional comparison of bedside glucose monitoring. Characteristics, accuracy performance, and quality control documentation: a College of American Pathologists Q Probes study of bedside glucose monitoring performed in 226 small hospitals. Arch Pathol Lab Med. 1998;122:495-502

POC.03225 Phase II N/A YES NO

For tests for which CAP does not require PT, does the laboratory at least semiannually 1) participate in external PT, or 2) exercise an alternative performance assessment system for determining the reliability of analytic testing?

NOTE: Appropriate alternative performance assessment procedures may include: participation in ungraded proficiency testing programs, split sample analysis with reference or other laboratories, split samples with an established in-house method, assayed material, regional pools, clinical validation by chart review, or other suitable and documented means. It is the responsibility of the Laboratory Director to define such alternative performance assessment procedures, as applicable, in accordance with good clinical and scientific laboratory practice.

COMMENTARY:

For analytes where graded proficiency testing is not available, performance must be checked at least semi annually with appropriate procedures such as: participation in ungraded proficiency surveys, split sample analysis with reference or other laboratories, split samples with an established in house method, assayed material, regional pools, clinical validation by chart review, or other suitable and documented means. It is the responsibility of the Laboratory Director to define such procedures, as applicable, in accordance with good clinical and scientific laboratory practice.

2) Novis DA, Jones BA. Interinstitutional comparison of bedside glucose monitoring. Characteristics, accuracy performance, and quality control documentation: a College of American Pathologists Q Probes study of bedside glucose monitoring performed in 226 small hospitals. Arch Pathol Lab Med. 1998;122:495-502;

POC.03500 Phase II N/A YES NO

Does the point-of-care testing program have a written QC/QM program?

NOTE: The QM/QC program for POCT must be clearly defined and documented. The program must ensure quality throughout the preanalytic, analytic, and post-analytic (reporting) phases of testing, including patient identification and preparation; specimen collection, identification, and processing; and accurate result reporting. The program must be capable of detecting problems and identifying opportunities for system improvement. The laboratory must be able to develop plans of corrective/preventive action based on data from its QM system.

COMMENTARY:

The quality control (QC) and quality management (QM) program in POCT should be clearly defined and documented. The program must ensure quality throughout the preanalytic, analytic, and post-analytic (reporting) phases of testing, including patient identification and preparation; specimen collection, identification, and processing; and accurate result reporting. The program must be capable of detecting problems and identifying opportunities for system improvement. The POCT program must be able to develop plans of corrective/preventive action based on data from its QM system.

Before patient results are reported, QC data must be judged acceptable. The Laboratory Director or designee must review QC data at least monthly. Beyond these specific requirements, a laboratory may (optionally) perform more frequent review at intervals that it determines appropriate. Because of the many variables across laboratories, the CAP makes no specific recommendations on the frequency of any additional review of QC data.

5) Novis DA, Jones BA. Interinstitutional comparison of bedside glucose monitoring. Characteristics, accuracy performance, and quality control documentation: a College of American Pathologists Q Probes study of bedside glucose monitoring performed in 226 small hospitals. Arch Pathol Lab Med. 1998;122:495-502

POC.08800 Phase II N/A YES NO

For QUANTITATIVE tests, are control materials at more than one concentration (level) used for all tests at least daily?

NOTE: For coagulation tests under CLIA 88, 2 different levels of control material are required during each 8 hours of patient testing, and each time there is a change in reagents. For blood gas testing under CLIA-88, a minimum of 1 quality control specimen for pH, pCO2 and pO2 is required during each 8 hours of patient testing.

COMMENTARY:

For quantitative tests, an appropriate quality control (QC) system must be in place.

The daily use of 2 levels of instrument and/or electronic controls as the only QC system is acceptable only for unmodified test systems cleared by the FDA and classified under CLIA 88 as “waived” or “moderate complexity.” The laboratory is expected to provide documentation of its validation of all instrument reagent systems for which daily controls are limited to instrument and/or electronic controls. This documentation must include the federal complexity classification of the testing system and data showing that calibration status is monitored.

TRANSFUSION MEDICINE CHECKLIST

TRM.20000 Phase II N/A YES NO

Does the transfusion medicine section have a written quality management/quality control (QM/QC) program?

NOTE: The QM/QC program in the transfusion medicine section must be clearly defined and documented. The program must ensure quality throughout the preanalytic, analytic, and post-analytic (reporting) phases of testing, including patient identification and preparation; specimen collection, identification, preservation, transportation, and processing; and accurate, timely result reporting. The program must be capable of detecting problems in the laboratory s systems, and identifying opportunities for system improvement. The laboratory must be able to develop plans of corrective/preventive action based on data from its QM system.

All QM questions in the Laboratory General Checklist pertain to the transfusion medicine section.

9) Novis DA, et al. Quality indicators of blood utilization. Three College of American Pathologists Q-probes studies of 12, 288, 404 red blood cell units in 1639 hospitals. Arch Pathol Lab Med. 2002;126:150-156;

10) Novis DA, et al. Quality indicators of fresh frozen plasma and platelet utilization. Three College of American Pathologists Q-probes studies of 8 981 796 units of fresh frozen plasma and platelets in 1639 hospitals. Arch Pathol Lab Med. 2002;126:527-532;

11) Novis DA, et al. Operating room blood delivery turnaround time. A College of American Pathologists Q-Probes study of 12 647 units of blood components in 466 institutions. Arch Pathol Lab Med. 2002;126:909-914.

CYTOPATHOLOGY CHECKLIST

CYP.00800 Phase II N/A YES NO

Is there a clearly defined and documented quality management program in cytopathology?

NOTE: Laboratories should consistently review activities and monitor their effectiveness in improving performance. Each laboratory should design a program that meets its needs and conforms to appropriate regulatory and accreditation standards.

6) Jones BA, Novis DA. Cervical biopsy-cytology correlation. A College of American Pathologists Q-Probes study of 22439 correlations in 348 laboratories. Arch Pathol Lab Med. 1996;120:523-531;

CYP.07569 Phase II N/A YES NO

Is an effort made to correlate gynecologic cytopathology findings with available clinical information?

NOTE: Methods of clinical correlation should be documented in the laboratory procedure manual, and selected reports can be reviewed to confirm practice. Possible mechanisms may include: focused rescreening of cases based on clinical history, history of bleeding, or previous abnormality; correlation of glandular cells with hysterectomy status, age of patient, and last menstrual period; review of previous or current biopsy material. Documentation of clinical correlation may include policies, problem logs with resolution, or notes in reports.

COMMENTARY:

An effort must be made to correlate gynecologic cytopathology findings with available clinical information.

3) Jones BA, Novis DA. Follow-up of abnormal gynecologic cytology. A College of American Pathologists Q-Probes study of 16 132 cases from 306 laboratories. Arch Pathol Lab Med. 2000;124:665-671; .

CYP.07690 Phase I N/A YES NO

Are 90% of reports on routine non-gynecologic cytology cases completed within 2 working days of receipt by the laboratory performing the evaluation?

NOTE: This question is primarily concerned with the majority of routine specimens, and applies to all laboratories. Longer reporting times may be allowed for specimens requiring special processing or staining (e.g., immunohistochemistry or other molecular analysis), or for screening (as opposed to diagnostic) specimens (for example, urines). If the laboratory has certain classes of specimens, patient types, etc., for which longer turnaround times are clinically acceptable, these must be identified, together with reasonable target reporting times, for Inspector review. Documentation may consist of continuous monitoring of data or periodic auditing of reports by the laboratory. In lieu of this documentation, the Inspector may audit sufficient reports to confirm turn around time.

Jones BA, Novis DA. Nongynecologic cytology turnaround time. A College of American Pathologists Q-Probes study of 180 laboratories. Arch Pathol Lab Med. 2001;125:1279-1284.

LIMITED SERVICE LABORATORY CHECKLIST

LSV.37050 Phase II N/A YES NO

Are routine and STAT results available within a reasonable time?

NOTE: A reasonable time for routine daily service, assuming receipt or collection of specimen in the morning is 4 to 8 hours. Emergency or STAT results that do not require additional verification procedures should be reported within 1 hour after specimen receipt in the laboratory.

COMMENTARY:

Routine and stat results must be available within a reasonable time. A reasonable time for routine daily service, assuming receipt or collection of specimen in the morning, is 4 to 8 hours. Emergency or stat results that do not require additional verification procedures should be reported within 1 hour after specimen receipt in the laboratory.

2) Steindel SJ, Novis DA. Using outlier events to monitor test turnaround time. A College of American Pathologists Q-Probes study in 496 laboratories. Arch Pathol Lab Med. 1999;123:607-614.