Countdown to success: a fresh approach to quality in the laboratory.

Amendments to CLIA '88 require laboratories to implement programs that monitor the overall quality of the lab's testing processes. The author's lab used a step-by-step approach to launch a successful quality control program.

Everyone who enters our laboratory comments on the "new look" we've given it - the freshly painted walls and new prints in their shining frames. What they don't see is far more important than the decor - it is our new approach to quality assurance.

The changes implemented in the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) demanded a rethinking of our existing quality control protocol and taking a new direction in total quality management, forcing us to become creative laboratorians in our search for new QA activities. As supervisor of an independent clinical laboratory, I have the luxury of an ever-present director, and together with our technical and secretarial staffs, we have created a QA program that we consider the optimal blend of our past policies and our future hopes for quality medical service.

The sometimes laborious task of setting up such a program is accomplished best by following a carefully devised plan of action that requires the laboratory to "establish and follow written policies and procedures to monitor and evaluate the overall quality of the total testing process."[1] We used the headings in Subpart P of the CLIA regulations to organize our own QA manuals (see Table 1).

While researching material for our QA program, I decided to include information about other relevant topics, such as technical procedure manuals, preventive maintenance, and safety; I even created a new procedure manual. After all the information was obtained, we began the countdown to success - our new approach to overall quality in the laboratory.

10 Write procedure manuals

Our laboratory, which has been in operation for more than 40 years, has had its share of unique procedure manuals - from ear-marked textbooks and index cards to computer print-outs. The standard operating procedure manual (SOPM) mandated by Sub-part K of CLIA '88 became several manuals.

I created the general operating procedure manual (GOPM) (see Table 2), which defines the many procedures, kit tests, and activities that are a part of the daily operation of the laboratory. Our GOPM is the master manual that clearly explains the requirements of CLIA '88.[1]

Information from respected texts such as Henry, Tietz, Kapff, and Strasinger,[2-5] or organizations such as the National Committee for Clinical Laboratory Standards,[6] were invaluable in the writing of the manual. Each topic, from patient preparation to timing of testing and personnel requirements, was revised with input from all of the staff.

For example, in Section G, employees were asked to detail their job descriptions. It was instructive to learn how employees defined their responsibilities and duties, and we all benefited from the experience.

Section H on test procedures, the most extensive section in the manual, explains protocol for all the procedures performed in the laboratory by area of specialization. Each automated instrument has its own SOPM, with necessary references made to the GOPM. This eliminates the repetition of information about topics such as patient management, testing information, or standard policies. Individual SOPMs, which are kept next to the appropriate instruments, contain easily accessed information on procedures and protocols unique to each lab instrument.

9 Protect laboratorians

The safety of our personnel always has been a major concern. Standards for handling bloodborne pathogens and hazardous chemicals[7,8] already have been implemented in our facility.

A separate Occupational Safety and Health Administration (OSHA) manual contains copies of the Federal standards, including a complete Chemical Hygiene Plan, an Exposure Control Plan, information on hepatitis B virus vaccination, and declination statements - all following the Federal standards format.

Our new approach included a review of universal precautions and engineering controls (which are listed on a poster that hangs in the laboratory). We added colorful new labeling and signage where needed, and each employee can find Material Safety Data Sheets (MSDS) located in a separate red binder. Our annual training program (TP) includes the most current information possible.

Employee questions about OSHA are welcomed, and an OSHA topic is included each year in our continuing education program. The local OSHA office is an invaluable source of information and guidance.

8 Educate and assess personnel

People excel when they are well educated, and the education of our personnel is of utmost importance. Our continuing education program (see Table 3) contains a different area of specialization or topic of importance each month. It can be amended so that by year-end, at least one area of each specialty has been covered.

Each year we have a different focus. Last year's theme, for example, was "the disease of the month," where a particular disease associated with the area of specialization is presented. In this way our staff is reminded of the effects our test results have on people with particular diseases. We also keep a separate training program running throughout the year that covers practical issues of procedure and practice.

Table 3

Continuing education protocol

Month             Topic

January           OSHA
February          Quality assurance
March             Diagnostic immunology
April             Clinical chemistry
May               Endocrinology
June              Therapeutic substance monitoring
July              Hematology
August            CLIA compliance
September         Diagnostic immunohematology
October           Urinalysis, semen analysis, occult blood testing
November          Patient management
December          Year-end activities

Employees are assessed as being proficient in the performance of their duties if they are trained and educated properly. Employees also are evaluated for their success in testing unknowns, performing Stat tests, success on proficiency tests, and correlation of test results with the patient's clinical profile.

7 Assess proficiency testing 

HCFA and CLIA '88 require successful participation in a proficiency testing (PT) program. Having been inspected by the New York City Health Department for many years, we revamped and became a New York State approved and licensed laboratory, and began participation in the state PT program.

A separate manual was a practical way to keep our PT records. In this manual we record the date of the testing event, the grade received, and any corrective action taken. A recent addition to the manual is a year-end summary of testing events, including the grade for the year, as well as the grade for each analyst performing the test. This is an excellent tool for assessing and proving proficiency appreciated by personnel who excel, and by inspectors who can easily find PT information.

6 Manage patients with care

Patient management includes proper preparation of the patient, specimen collection, test requisition completeness, and accuracy and timing of test results.

When one truly cares about the patient, it makes all the difference. I demand the staff be concerned about the patient (respecting patient rights was one of our continuing education topics), as well as the quality of the work performed. This is stated in our GOPM and is exemplified in the implementation of our QA program.

5 Evaluate patient test information

Managing patients with care means investigating test results that are inconsistent with patient information regarding age, gender, or disease conditions. Our policy always has been to monitor results carefully and repeat any tests with results outside of the normal range, but our vigilance goes further. Both secretarial and technical staffs monitor results - the technician when performing the test, and the secretary when reporting or recording results. They are trained to question test results if they suspect a discrepancy between results and clinical data.

Technical vigilance paid off for us when a patient came to us because her mother told her she didn't like the way she looked. Due to the unfortunate interaction of several medications, the patient's liver enzymes were extraordinarily high. The experienced technician did not accept the first set of test results, which were out of the linearity of the automated equipment. Through proper dilution protocol, the technician produced valid, accurate test results that confirmed the patient's condition. This is not an exception, but business as usual for our staff.

4 Record QC activity

Before the concepts of Total Quality Management (TQM) and continuous quality improvement (CQI) became popular, our laboratory ran controls to confirm the reliability and accuracy of the testing process. When necessary, we perform linearity checks; run calibration, accuracy, and precision verification; verify reference ranges; and document remedial action.

Each test, from a waived urine dipstick to a complex tumor marker assay, is monitored by control material. For kit tests, we added a QC column to our workbook, and the controls are noted with each run. At the end of the day, the controls can be entered into the QC manual. A universal header - which is copied onto blank, lined paper that can be inserted into the QC manual - includes the name of the test, date, reagent, source, expiration dates, control results, and comments. QC data for automated equipment is plotted on standard graphs as each test is run and put into the QC section of the SOPM for each machine.

3 Monitor test reliability

Reliability of the testing process is accomplished through careful monitoring of test variations and use of control studies (see Table 4).

2 Handle communications and complaints efficiently

A laboratory that prides itself on achieving high quality certainly will want to answer questions, satisfy needs, and rectify complaints. To keep QA documented, we use a generic QA form (see box, "Quality assurance and assessment form"). These forms are kept in our QA manual to be reviewed with the staff annually and serve as a well-organized form of documentation. A QA form also is kept in the office near telephones so any conversation regarding these matters can be recorded immediately and added to our QA manual after final evaluation.

1 Review and document QA

Our ongoing commitment to TQM involves the entire staff. All employees were made aware of CLIA '88 and were asked for input about ways to improve our QA program.

Success!

Our new approach to quality in the laboratory can be summarized by the following formula: (QC + QA) TQM = CQI. In other words, QC plus excellent QA activities multiplied by a vigilant TQM approach yields CQI, which benefits patient care, satisfies physicians, and creates a high quality laboratory staff with a sense of pride in its success.

Table 1

CLIA '88 Subpart P - Quality assurance 493.1701

493.1703 Patient test management 493.1705 Quality control assessment 493.1707 Proficiency testing 493.1709 Comparison of test results 493.1711 Relationship of patient information to patient test results 493.1713 Personnel assessment 493.1715 Communications 493.1717 Complaint investigations 493.1719 Quality assurance review with staff 493.1721 Quality assurance records

Table 2

Outline of general operating procedure manual

A. Patient test management (Subpart J 493.1101) B. Testing (Subpart J 493.1105) C. Quality control (Subpart K 493.1201) D. Personnel requirements (Subpart M 493.1401) E. Proficiency testing (Subpart H 493.801) F. Training (Subpart M 493.1401) G. General discussions unique to the facility H. Test procedures (Subpart K 493.1211) I. Verification of following records maintained in other manuals:

i. Patient log book (or computer record) ii. SOPM for each automated instrument iii. OSHA manual iv. Quality control manual v. Proficiency testing manual vi. Equipment manual

Table 4

Protocol for low control study

1. Establish linearity of the testing method from manufacturer's inserts (e.g., glucose, 10 mg/dL-700 mg/dL).

2. Establish normal range from laboratory protocol and manufacturer's inserts (e.g., glucose, 70 mg/dL-106 mg/dL).

3. Establish control ranges from assayed material (e.g., normal glucose, 76 mg/dL-92 mg/dL; abnormal glucose, 279 mg/dL-341 mg/dL).

4. Determine what dilution of known control will be within an acceptable linear low range (e.g., the 44 mg/dL-54 mg/dL low range for glucose is accomplished by a 1:4 dilution of a mix of normal (N) plus abnormal (A) control in equal volumes (N - A = 197 mg/dL; 1:4 dilution = 49 mg/dL).

5. Run low controls to check reliability and accuracy of testing process.

Quality assurance and assessment form

Date: _____ Physician's name: _____ Patient's name: _____ Test requisition description: ______ Problem/Indicator/Monitor/Threshold alarm/Complaint: _____ Corrective action description: _____ Taken by: _____ Follow-up procedures or final evaluation: _____ Taken by: _____ Date: _____ Director/Supervisor review: _____ Date: _____

References

1. Clinical Laboratory Improvements of 1988: Final Rule. 42 CFR Part 405. Subpart P, 493.1701; 1992.

2. Henry JB. Clinical Diagnosis and Management by Laboratory Methods. 18th ed. Philadelphia, Pa: W.B. Saunders Co.; 1991.

3. Tietz NW. Clinical Guide to Laboratory Tests. Philadelphia, Pa: W.B. Saunders Co.; 1990.

4. Kapff CT, Jandl JH. Blood: Atlas and Sourcebook of Hematology. 2nd ed. Boston, Mass: Little, Brown and Co.; 1991.

5. Strasinger SK. Urinalysis and Body Fluids. 2nd ed. Philadelphia: F.A. Davis Co.; 1989.

6. National Committee for Clinical Laboratory Standards. Publication Catalog. Villanova, Pa: NCCLS; 1995.

7. Occupational Exposure to Bloodborne Pathogens: Final Rule. 29 CFR Part 1910.1030. 1991.

8. Standard for Exposure to Hazardous Chemicals in Laboratories. 29 CFR. Subpart Z, 1910.1450; 1990.

Judith A. O'Brien is a consultant in clinical laboratory medicine specializing in OSHA and CLIA compliance in Bayshore, N.Y.