Quality in the Clinical Microbiology Laboratory

Published on 08/02/2015 by admin

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Quality in the Clinical Microbiology Laboratory

Objectives

1. Distinguish between the terms total quality management (TQM), continuous quality improvement (CQI), performance improvement (PI), quality assurance (QA), LEAN, and Six Sigma.

2. Describe the quality program associated with the microbiology laboratory.

3. Identify acceptable guidelines for specimen collection and transport, and give examples of unacceptable specimens.

4. State the purpose of the Standard Operating Procedure Manual.

5. Explain the requirements for laboratory personnel, use of reference laboratories, and elements of patient reports.

6. Define proficiency testing (PT), and outline the necessary steps to achieve successful results.

7. Design a log to check performance for instruments and media used in the microbiology laboratory.

8. Explain the requirements for Antimicrobial Susceptibility Tests (AST).

9. Compare the maintenance of reference quality control stocks in bacteriology, mycology, mycobacteriology, virology, and parasitology.

10. Outline a QA program for the microbiology laboratory to include all phases of infectious disease diagnosis, and differentiate between external and in-house QA audit programs.

11. Describe daily monitoring activities by microbiologists and supervisors that result in providing quality care to the patient population.

Since the publication of the report “To Err is Human” by the Institute of Medicine, the endeavor for a safer and a more efficient health care delivery system has been in full force. The issue of quality in the medical laboratory has evolved over more than four decades following the publication of the recommendations for quality control (QC) in 1965. Just as microbial taxonomy has changed over the years, the approach to quality has evolved as well. QC is now seen as only one part of the total laboratory quality program. Quality also includes total quality management (TQM), continuous quality improvement (CQI) or performance improvement (PI), and quality assurance (QA). TQM, CQI, and PI are umbrella terms, encompassing the entire institution’s quality program. TQM evolved as an activity to improve patient care by having the laboratory monitor its work to detect deficiencies and subsequently correct them. CQI and PI went a step further by seeking to improve patient care by placing the emphasis on preventing mistakes; CQI and PI advocate continuous training to guard against having to correct deficiencies.

The LEAN methodology concentrates on eliminating redundant motion, recognizing waste, and identifying what creates value from the client’s perspective. The main objective for the medical laboratory is to deliver quality patient results at the lowest cost, within the shortest time frame, while maintaining client satisfaction. It involves five principles: value, value stream, flow, pull, and continuous improvement. The first principle is to define the value in the process from the client’s perspective, which is what the patient knowingly pays for the attributes of service. Next, identify the value stream for each process providing that value, challenge the wasted steps, and eliminate all of the waste. Then make sure the service flows continuously through the remaining value-added step. Now it is time to pull it all together by introducing a continuous flow of events between all steps of the process where continuous flow is possible. The last principle is continuous improvement by management working toward perfection on an ongoing basis so the number of steps and time is constantly under scrutiny. The scope of resources and the information needed to provide the service to the client needs to be monitored also. These principles can increase quality, throughput, capacity, and efficiency while decreasing cost, inventory, space, and lead time. Ultimately it would provide better patient care within the clinical laboratory.

Six Sigma is a relatively new concept as compared to TQM. Six Sigma originated in 1986 from Motorola’s drive to reduce defects by minimizing variation in processes through metrics measurement. The process focuses on continuous quality improvements for achieving near perfection by restricting the number of possible defects to fewer than 3.4 defects per million. Six Sigma is based on DMAIC (define, measure, analyze, improve, control), which helps in making precise measurements, identifying exact problems, and providing measurable solutions. When implemented correctly, Six Sigma can help organizations reduce operational costs by focusing on reducing defects, minimizing turnaround time, and trimming costs. The main difference between TQM and Six Sigma is the approach. TQM tries to improve quality by ensuring conformance to internal requirements, whereas Six Sigma focuses on improving quality by reducing the number of defects and impurities. Six Sigma is also fact-based, data-driven, and results-oriented, providing quantifiable and measurable bottom-line results, linked to strategy and related to customer requirements.

QC is associated with the internal activities that ensure diagnostic test accuracy. QA is associated with the external activities that ensure positive patient outcomes. Positive patient outcomes in the microbiology laboratory are as follows:

CQI and PI, through well-thought-out programs of QC and QA, are part of the requirements for laboratory accreditation under Clinical Laboratory Improvement Amendments (CLIA, 1988).

Specimen Collection and Transport

The laboratory is responsible for providing written policies and procedures that ensure positive identification and optimum integrity of a patient’s specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results.

These guidelines and instructions should be available to health care providers for use when specimens are collected. The written collection instructions should be in detail and include the following:

The collection instructions should include information on how a requisition should be filled out electronically or by hand, and the laboratory must include a statement indicating that the requisition must be filled out entirely. In addition to standard information, such as patient name, hospital or laboratory number, and ordering physician, other critical information includes (1) whether the patient is receiving antimicrobial therapy, (2) the suspect agent or syndrome, (3) immunization history (if applicable), and (4) travel history when certain microorganisms or parasites are suspected. The laboratory should also establish criteria for unacceptable specimens. Examples of unacceptable specimens include the following:

Sometimes, even though the specimen is not acceptable, the physician may ask that it be processed anyway. If this happens, a disclaimer should be put on the final report, indicating that the specimen was not collected properly and the results should be interpreted with caution.

Standard Operating Procedure Manual

The requirement for a Standard Operating Procedure Manual (SOPM) is considered part of the QC program. The SOPM should define test performance, tolerance limits, reagent preparation, required quality control, result reporting, and references. The SOPM should be written in the format of Clinical and Laboratory Standards Institute (CLSI), and must be reviewed and signed annually or bi-annually by the laboratory director who appears on the CLIA certificate; in addition, all changes must be approved and dated by the laboratory director. The SOPM should be available in the work areas. It is the definitive laboratory reference and is used often for questions relating to individual tests. Any obsolete procedure should be dated when removed from the SOPM and retained for at least 2 years.

Personnel

It is the laboratory director’s responsibility to employ sufficient qualified personnel for the volume and complexity of the work performed. For example, published studies regarding staffing of virology laboratories suggest one technologist per 500 to 1000 specimens per year. Technical on-the-job training must be documented, and the employee’s competency must be assessed twice in the first year and annually thereafter. Continuing education programs should be provided, and verification of attendance should be maintained in the employee’s personnel file. CLIA has improved the regulations associated with personnel competency (CLIA subpart K:493.1235). Laboratory employee competency assessment must include the following: (1) Direct observation of test performance, to include patient preparation (if applicable), specimen handling, processing, and testing; (2) monitoring the recording and reporting of test results; (3) review of intermediate test results or work sheets, QC results, patient results, and preventative maintenance records; (4) direct observation of performance or instrument maintenance and function checks; (5) assessment of test performance through testing previously analyzed specimens, internal blind testing of samples or external patients samples, and; (6) assessment of problem-solving skills. These competency assessments must be documented and completed by qualified personnel.

Patient Reports

There should be an established system for supervisory review of all laboratory reports. This review involves checking the specimen workup to verify that the correct conclusions were drawn and no clerical errors were made in reporting results. Reports should be released only to individuals authorized by law to receive them (physicians and various midlevel practitioners). Clinicians should be notified about “panic values” immediately. Panic values are potential life-threatening results, for example, positive Gram stain for cerebrospinal fluid (CSF) or a positive blood culture. Reference ranges must be included on the report where appropriate. All patient records should be maintained for at least 2 years. In reality, records should be maintained for at least 10 years because they may be needed to support medical necessity in the event of a postpayment billing audit by the Centers for Medicare and Medicaid Services.

Proficiency Testing (PT)

Proficiency testing (PT) is a quality assurance measure used to monitor the laboratory’s analytic performance in comparison to its peers and reference standards. It provides an external validation tool and objective evidence of the laboratory competence for patients and accrediting and oversight agencies. Laboratories are required to participate in a PT program for each analyte (test) for which a program is available; the laboratory must maintain an average score of 80% to maintain licensure in any subspecialty area. The federal government no longer maintains a PT program, but some states, such as New York, as well as several private accrediting agencies, such as the College of American Pathologists (CAP), send out “blind unknowns.” These unknowns are to be treated exactly as patient specimens, from accessioning into the laboratory computer or manual logbook through workup and reporting of results. The testing personnel and laboratory director are required to sign a statement when the PT is completed attesting to the fact that the specimen was handled exactly like a patient specimen. In this way, PT specimens establish the accuracy and reproducibility of a laboratory’s day-to-day performance. The laboratory’s procedures, reagents, equipment, and personnel are all checked in the process. Furthermore, errors on PT help point out deficiencies, and the subsequent education of the staff can lead to overall improvements in laboratory quality. When grades (evaluations) come back, critiques (summaries) accompanying them should be discussed with the entire technical staff. Evidence of corrective action in the event of problems should be documented, including changes in procedures, retraining of personnel, or the purchase of alternative media and reagents.

Some laboratories have a system of internal PT in addition to those received from external agencies. When external audit is not available for a particular test method, laboratories are required by law to set up an internal program to revalidate the test at least semiannually. Internal PT samples can be set up by (1) seeding a simulated specimen and labeling it as an autopsy specimen so that no one panics if a pathogen is recovered, (2) splitting a routine specimen for workup by two different technologists, or (3) sending part of a specimen to a reference laboratory to compare and confirm the laboratory’s result.

Performance Checks

Instruments

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