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Q-Probes: a tool for enhancing your lab's QA.

The late Dr. Israel (Dick) Diamond, distinguished senior pathologist and New England commissioner of the College of American Pathologists laboratory accreditation program, summarized the goals of quality improvement programs when he stated that "in the clinical laboratory our product is dependable, timely, and economical information. Quality assurance must determine whether this is what the patient is receiving and whether the laboratory has contributed to the patient's optimum and frugal care." [1]

CAP developed Q-Probes as a response to economic, societal, and regulatory pressures for providing such care. The project builds on the success of CAP's interlaboratory comparison programs in achieving demonstrable improvement in laboratory performance. These programs depend on the gathering of data from large numbers of laboratories in order to establish provisional benchmarks of quality practice on which to base systematic quality improvement efforts.

The Q-Probes program gathers peer group data on defined aspects of quality practice in pathology and laboratory medicine. Laboratories and pathology services are provided with a format to use in collecting data, which are then submitted to CAP for analysis. Performance at the laboratory in question is compared with performance at similar labs.

* Analytical cycle. Q-Probes support the current emphasis of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) on quality improvement by emphasizing ongoing monitoring, priority setting, and the use of indicators. [2] The collection of multi-institutional, peer-validated data that identify trends and patterns, not merely problems, is central to the Q-Probes process, as is avoiding excessive focus on individual hospital departments.

Efforts have been directed at developing a perspective that concentrates on outcomes. At every opportunity, the focus is placed on the interaction of the pathology and laboratory services by studying the components of the total analytic cycle (test selection, specimen collection and transportation, test performance and interpretation, results reporting) and the relationship of the elements of this cycle to patient outcomes.

* Selecting indicators. First offered on a subscription basis in January 1989, Q-Probes were designed to provide periodic "off-the-shelf" studies of outcome, process, and structure-oriented quality assurance (QA) indicators. CAP created a series of independent snapshots of laboratory quality elements that could be used as they stood, as templates for continued monitoring, or as the foundation on which to develop other indicators. Among the indicators offered in 1989 were test turnaround time (TAT), lab report error rates, fine-needle biopsy correlation, frozen section correlations, blood transfusion utilization, cervicovaginal cytology specimen adequacy, and nosocomial infection rates.

Currently, laboratories subscribe to the program on an annual basis and may choose a combined module consisting of clinical and anatomic pathology probes or separate anatomic or clinical pathology modules. If a particular probe is deemed inappropriate, the lab may choose not to submit data but still receive the critique and aggregate data summary of results from participating labs. Laboratories are encouraged to submit data, however, both to realize the full potential of the program and to enhance the national database.

* Evolving TATs. Every year, Q-Probes modules provide new and repeat studies. The repeats permit comparisons with previous results to be made both within the individual lab and with group performance.

Some probes examine different aspects of similar problems. The 1989 TAT probe, for example, evaluated cerebrospinal fluid analysis for glucose, protein, cells, and Gram stain. It defined turnaround time as intralaboratory TAT for this group of Stat analytes (those usually requiring analysis in more than one physically separate part of the laboratory). The 1990 TAT probe studied hemoglobin and potassium TAT from phlebotomy in the emergency room to result reporting. The 1991 Q-Probe studies TAT for routine analytes performed for in-patients. Figure I lists past and future Q-Probes.

Except for anatomic pathology probes, which are mailed on a trimester basis, Q-Probe studies are mailed quarterly. They include an explanation of the reason for the probe, background information, instructions, and forms for data collection and input. The forms are used to return summarized data to the CAP Computer Center. The studies are to be limited to a certain period of time.

Data collection is done either retrospectively or prospectively, depending on the indicator. After completing the study, labs submit data to CAP, whose staff and statisticians edit the material, enter data, and analyze it. Q-Probe author(s), statisticians, and CAP quality assurance committee (QAS) staff prepare data summaries and critiques. More details are available from the Q-Probes Program, College of American Pathologists, 325 Waukegan Road, Northfield, IL 60093; (800) 323-40400 ext. 463.

* Critical results. Each laboratory receives an expert critique from the authors of the probe as well as a summary of results. Individual laboratory results for several selected key indicators are grouped into percentiles for comparison with similar labs and with participating laboratories overall.

Approximately 1,300 laboratories subscribe to Q-Probes. The largest group are in private and community hospitals (45.8% and 34%, respectively). The remainder are in Federal (6.4%), non-Federal government (8.5%), and university (5.4%) hospitals. Non-teaching hospitals comprise 63%. Approximately 80% of participating labs are accredited by CAP; 25%, by JCAHO.

* Phlebotomy probe. In the spring of 1990, the authors studied complications of phlebotomy in 630 institutions. [3] Because venipuncture may be the most common medical procedure that is performed on patients and is one of the few procedures performed directly on patients by laboratorians, its proper performance is of particular importance to a laboratory's quality improvement program. Frequently, the phlebotomist is the only representative of the clinical laboratory whom patients meet. Patients' perception of the quality of laboratory service and the institution is influenced by the experience.

Q-Probes subscribers were sent an instruction package that included directions for participation, five worksheets, a sample letter, 80 printed postcards, and a questionnaire about the study. Staff members at participating labs selected ostensibly healthy outpatients and gave them a letter, signed by the laboratory director, describing the study and seeking their participation.

* Postcard response. Requested information on the postpaid cards had been designed to elicit information on registration and procedure completion times, number of needlesticks, time since last venipuncture, amount of discomfort, degree of satisfaction, name of phlebotomist, and whether an outstanding employee was encountered. On the side of the card was printed a scale, in millimeters, with which to measure any ecchymosis present 24 hours after the needlestick.

Patients mailed the cards to the appropriate laboratory, where staff members then transferred the information to forms that were then mailed to CAP. Names of outstanding employees remained


with the participating lab. The percentage of times an outstanding employee was identified was tabulated by each institution and a percentile ranking determined.

The postcards were returned by 22,884 patients in 630 institutions for an impressive return rate of 80.1%. A specimen had been obtained on the first phlebotomy attempt for 97.3% of respondents, indicating good venipuncture skills. Nevertheless, patients' perceptions of waiting time between registration and completion did not always jibe with those of their institutions (Figure II).

* Waiting time. The mean time of 16.8 minutes was much longer than the median time of 6.0 minutes. In 25% of cases, phlebotomy required 5 minutes or less; in 10% of cases, more than 19 minutes. For 21% of patients, one hour or more was required. When the length of time was expressed in terms of the institutional mean patient values, the mean was 11.9 minutes, the 25th percentile, 5.0; the median, 6.0; and the 75th percentile, 9. Undoubtedly some of these patients registered, anticipated a long wait, and left, returning to have venipuncture performed at a less busy time. In these instances, the time calculated from registration to completion was exceedingly long and responsible for the large differences between the mean and median time. In some circumstances the total phlebotomy time required may have been extended as the study was being explained to patients.

* European practice. We were surprised that 25% of all patients had venipuncture performed in five minutes or less, and half in six minutes or less. Practices in Europe commonly require a 15-minute wait before specimen collection. [4,5] A wait of this length of time is supported by scientific studies for some analytes; with a change from sitting to standing, values of alanine aminotransferase, aspartate aminotransferase, and creatine kinase increase by 10%, for example, and lactate dehydrogenase and uric acid decrease by 15%. [6] For such laboratory procedures as cholesterol determination, patients should remain seated for 5 to 15 minutes before specimens are collected.

Of the 24,343 punctures, 4,048 (16%) resulted in ecchymosis (Figure III). The mean and median size where 15.1 mm and 10 mm in diameter, respectively. At the ends of the scale, 10% of ecchymoses were 5.0 mm or less in diameter and another 10% were 30.0 mm or more in diameter. (When data were determined for each lab, the distribution was less broad). This aspect of the phlebotomists' skill is substantiated in that only 16.1% of the punctures created ecchymoses; 90% of these were less than 30 mm in diameter.

* Pain. Patients experienced more pain than they had expected in 35.3% of all reported phlebotomy procedures, whereas 6.9% felt less pain than expected. Because patients tend to be satisfied when their perceptions are fulfilled and dissatisfied otherwise, the outcome measure of discomfort from the venipuncture may be very important in determining their response to the procedure.

Over one-third (35.3%) of patients had more discomfort than expected and 57.7% experienced the amount of pain anticipated. These findings suggest opportunities for improvement. Since specimen taking was successful on the first attempt in nearly all cases (more than 97%), repetitive attempts to obtain a specimen appear only rarely to be the reason for the reporting of more pain than expected.

* Satisfaction. An overwhelming proportion (98.6%) of the 23,039 patients who revealed their level of satisfaction reported feeling satisfied, while only 1.4% said they were not. We recommended that institutions with more than one dissatisfied patient consider opportunities for improvement.

A large amount of other kinds of data was collected, some relating to the training and tenure of phlebotomists. We concluded that care provided by clinical laboratory venipuncture services for outpatients is well received by patients. We recommended that studies of patient satisfaction be written for other procedures involving laboratory medicine.

One caution: Recruitment of ostensibly healthy individuals for the study provided data that are obtained under the best circumstances. If sick as well as healthy individuals were studied, the likely result would be higher complication rates and less satisfaction. A postcard response rate of over 80% is remarkable and may indicate that patients are truly interested in helping the laboratory improve its services. The high return may also show that the additional personal attentionl shown by participation in the study strengthens the bond between phlebotomist and patient.

* Learning and improving. The Q-Probes program is nearing the end of its third yeard. An emerging database of quality assurance practices is helping many laboratories develop practice patterns. Table I, which displays highlights of this database, demonstrates the scope and breadth of Q-Probes.

We believe that Q-Probes is on the cutting edge of quality improvement. Its potential to expand quality assurance and improvement efforts is not yet well defined. Laboratories are in the process of evaluating options and adapting external programs, including Q-Probes, to their internal ones. Perhaps the most satisfying aspect of the Q-Probes program is the way participants use its data to repeat studies internally toward improving performance (Figure IV). As the process evolves, we anticipate a growing need for additional Q-Probe modules that focus on specific disciplines and functions.

The QAS committee has been asked to consider establishing separate modules on such topics as transfusion medicine, laboratory management, pediatric pathology, and small laboratories. A module for small laboratories is expected to be available by 1993. We believe that Q-Probes will evolve in an analogous manner to the CAP Surveys program. New models and ordering options will be offered in response to the needs of the pathology and laboratory community.

* Pitfalls. We are aware of potential pitfalls of the program. The development of standards of care, norms, and practice guidelines could impede innovation and freeze performance at the lowest common denominator. Such an unfortunate circumstance might occur among individuals and organizations driven less by the desire to set high standards and to improve performance than by the impulse to contain costs.

CAP hopes to avoid these pitfalls by presenting the results of Q-Probes studies as snapshots of evolving performance. We hope not only to define the state of the art in various individual respects but also to elucidate goals for improvement.

* Benefits. The Q-Probes program represents a significant new opportunity for quality improvement by clinical labs and pathology services. We believe the essential benefits are fivefold:

1. Provision of convenient, structured, ready-to-use packages of short-term quality assurance indicators that can be adapted and modified for local and long-term implementation.

2. Establishment of indicators of individual laboratory performance that can be compared with that of a nationally based peer group.

3. Creation of a national database characterizing and describing performance levels in pathology and laboratory medicine.

4. Presentation of authoritative critiques to assist in interpreting data and implementing initiatives for continuous improvement.

5. Documentation of laboratory participation in ongoing QA monitoring activities.

Q-Probes has been developed under CAP's traditional precept of performance improvement by education and peer review. The philosophy of the program, following Berwick, [7] supports continual incremental improvement that is based not on a fault-finding inspection process but on proper system design driven by data and by the traditional commitment of pathologists and laboratory professionals to excellence and to the welfare of patients.

[1] Diamond, I. Quality assurance and/or quality control. Arch. Pathol. Lab. Med. 110: 875, 1986.

[2] Bachner, P. College of American Pathologists Conference XVII on quality assurance in pathology and laboratory medicine: Summary. Arch. Pathol. Lab. Med. 114: 1175, 1990.

[3] Howanitz, P.R., and Cembrowski, G.S. "Complications of Phlebotomy: Data Analysis and Critique" (Q-Probe 90-10A). Northfield, Ill., College of American Pathologists, 1990.

[4] Grasbeck, R. Reference values: Relevant controls for clinical decision-making. Eur. J. Haematol. 40: 1, 1988.

[5] Grasbeck, R. Terminology and biological aspects of reference intervals. In: Benson, E.S., and Rubin, M., eds. "Logic and Economics of Clinical Laboratory Use," pp. 77-90. New York, Elsevier, 1978.

[6] Statland, B.E., and Winkel, P. Effects of preanalytical factors on the intraindividual variaton of analytes in the blood of healthy subjects: Consideration of preparation of the subject and time of venipuncture. CRC Critical Review. Clin. Lab. Sci. 8: 105, 1977.

[7] Berwick, D.M. Measuring health care quality. Pediatr. Rev. 10: 11, 1988.

Dr. Bachner is chairman of pathology and laboratory medicine at United Hospital Medical Center, Port Chester, N.Y. Dr. Howanitz is director of clinical laboratories at UCLA Medical Center and professor of pathology and laboratory medicine at the UCLA School of Medicine, Los Angeles. The authors are immediate past chair and current chair, respectively, of the QAS-Quality Assurance Committee of the College of American Pathologists.
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Title Annotation:College of American Pathologists' laboratory quality assurance program
Author:Bachner, Paul; Howanitz, Peter J.
Publication:Medical Laboratory Observer
Date:Nov 1, 1991
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