Quality Assurance in Health Care, Vol. 3, No. 3, pp. 167-177, 1991 Printed in Great Britain.
1040-6166/91 $3.00 + 0.00 © 1991 Pergamon Press pic
USING Q-PROBES TO IMPROVE THE QUALITY OF LABORATORY MEDICINE: A QUALITY IMPROVEMENT PROGRAM OF THE COLLEGE OF AMERICAN PATHOLOGISTS Paul Bachner* and Peter J. Howanitzf 'Chairman, QAS-Qua]ity Assurance Committee College of American Pathologists and Chairman, Pathology and Laboratory Medicine United Hospital Medical Center Port Chester New York, USA tVice-Chairman, QAS-Quality Assurance Committee College of American Pathologists Director of Clinical Laboratories and Professor of Pathology UCLA Los Angeles California, USA (First submitted 31 May 1991; accepted 20 June 1991)
Key words: Clinical pathology, turnaround times, quality probes, phlebotomy.
First presented to the 8th Congress of ISQA, Washington, 29-31 May 1991. Reprint requests should be sent to: Paul Bachner, MD, Department of Pathology and Laboratory Medicine, United Hospital Medical Center, Port Chester, NY 10573, USA.
767
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This paper will review the reasons for the increasing emphasis on quality assurance in American healthcare and laboratory medicine. This emphasis is driven in part by economic, social and regulatory concerns as well as the traditional commitment to the search for excellence in services provided to patients. The Q-Probes Program of the College of American Pathologists (CAP) represents a response to these pressures and will be described in some detail. The program is based upon the historical success of interlaboratory comparison programs developed and sponsored by the CAP in achieving demonstrable improvement in laboratory performance. These programs are dependent on the gathering of data from large numbers of laboratories in order to establish provisional "benchmarks" of quality practice which serve as a baseline for systematic quality improvement efforts. The Q-Probes Program gathers peer-group specific institutional data concerning defined aspects of quality practice in pathology and laboratory medicine. These highly structured programs provide laboratories and pathology services with a format to collect data for submission to the CAP for analysis and to compare their performance against that of appropriately stratified peer groups. Several representative examples chosen from clinical laboratory medicine and pathology will be presented. We will attempt to demonstrate how individual laboratory and pathology services utilize aggregate data to effect specific changes in practice that lead to improvement in processes of patient care and better patient outcomes.
168
P. Bachner and P. J. Howanitz
INTRODUCTION "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" . . . Israel Diamond, MD [1].
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The achievements of American Medicine and the capabilities of our healthcare system are widely recognized. Despite this, critics of our healthcare system focus on high cost, excessive utilization of new and unproven technologies, impediments and limitations in access to care, and documented as well as anecdotal deficiencies in quality. Economic, social and political circumstances have led to decreased resource allocations for healthcare in general and laboratory medicine in particular and it is arguable that "quality" will suffer unless the laboratory community can address quality issues in a systematic manner. In addition, an unprecedented national legislative and regulatory initiative (CLIA'88) will result in a profound increase in the degree of regulation of hospital, independent and other laboratories. The scope and uncertain implementation of these regulations have aroused profound concerns on the part of the entire laboratory medicine community [2]. In recognition of the increased demands for accountability and the need to validate the quality of laboratory services, we will describe in this paper a new and unique program, Q-Probes, developed by members of the College of American Pathologists, that attempts to respond to the initiative for quality improvement and to provide some assistance to laboratories in implementing quality assurance and quality improvement programs. One of the implicit assumptions of this program, Q-Probes, is that laboratories and hospitals wish to participate in the move from a quality assurance to a quality improvement platform. Those responsible for the development of the Q-Probes program recognize that traditional quality assurance approaches suffer from certain limitations. These include: undue reliance upon peer review usually stimulated by complications or undesirable results; case-by-case review based on subjective criteria that are not established in advance and are performed by different reviewers with an exclusive focus on the practitioner or technologist; a "medical audit" system that relies on pre-defined but not necessarily objective criteria [3]. In support of the current emphasis of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) [3], the Q-Probes program stresses on-going monitoring, priority setting and the use of indicators. Central to our process is the collection of multi-institutional peer-validated data which identify trends and patterns, not just individual problem cases. In the attempt to avoid an excessive "department/discipline" orientation, our efforts have been directed to developing an "outcomes" perspective that concentrates at every opportunity upon the interaction of the pathology and laboratory service with patients and the hospital as a whole by studying the total analytic cycle including test selection, test interpretation, test performance, results reporting and the relationship of the elements of this cycle to patient outcomes.
Using Q-Probes to Improve Quality
169
COLLEGE OF AMERICAN PATHOLOGISTS: LABORATORY IMPROVEMENT PROGRAMS
Q-PROBES
Several years ago, the Quality Assurance Services Committee (QAS) of the CAP recognized the need for a new program that would provide pathologists and clinical laboratories with a selected group of quality assurance indicators that would be applicable to a broad range of laboratory settings and would address important areas of service. The QAS Committee further believed that the positive role of other CAP programs in improving laboratory performance on a nationwide basis (Surveys, QAS interlaboratory comparisons) provided a model for the development of a natior,ally-based and peer-referenced data base of quality indicators. The program was conceptualized, developed and extensive pilot studies were performed over a period of several years. Q-Probes was offered on a subscription basis in January 1989 as a subscription program providing studies of outcome, process and structure-orientated quality assurance indicators [5]. "Off-the-shelf" periodic studies provide a laboratory with a series of independent "snapshots" of laboratory quality elements that can be used "as is" or as "templates" for continuing monitoring or to develop other related indicators. The indicators that were offered in
Downloaded from by guest on June 8, 2016
The College of American Pathologists (CAP) is a national medical specialty society representing more than 12,000 physicians who are board certified or eligible to be certified by the American Board of Pathology. CAP members practice their specialty in community hospitals, independent medical laboratories, academic medical centers, medical examiner/coroner offices, and federal and state health facilities. The CAP sponsors and provides many laboratory improvement programs which, in addition to addressing traditional quality control, continuing education and laboratory management needs, provide pathologists and laboratory professionals with the means to achieve the following goals [4]: (1) To fulfill quality assurance requirements of regulatory and accrediting agencies; (2) To develop mechanisms for measuring quality in the various disciplines of the clinical and pathology laboratory; (3) To help pathologists and other laboratory professionals assume leadership roles for quality improvement; (4) To assist pathologists in expanding their traditional commitment to excellence and quality improvement in the laboratory and the hospital; (5) To develop strategies for building public and government confidence in the quality of pathology and laboratory services. The laboratory improvement programs of the CAP include a proficiency testing (surveys) program, a Standards program, multiple programs for interlaboratory quality control (QAS-QC), a laboratory inspection program that accredits more than 4,000 hospital and independent laboratories, and performance improvement programs in cytopathology (PAP) and surgical pathology (PEP). The newest of these programs is the Q-Probes program which we will now describe in greater detail.
170
P. Bachner and P. J. Howanitz
COMPLICATIONS OF PHLEBOTOMY: AN EXAMPLE OF A Q-PROBE
In the spring of 1990, we studied complications of phlebotomy in 630 institutions [7]. Phlebotomy probably is the most common medical procedure performed on
Downloaded from by guest on June 8, 2016
1989 included test turnaround-time, laboratory report error rates, fine needle biopsy correlation, frozen section correlations, blood transfusion utilization, cervicovaginal cytology specimen adequacy and nosocomial infection rates. Laboratories subscribe to the program on an annual basis and may subscribe to a combined module consisting of eight clinical and three anatomic pathology probes or separate anatomic or clinical pathology modules. If a particular probe is felt to be inappropriate, the lab does not need to submit data but will still receive the critique and overall data summary from participating laboratories. Laboratories are encouraged to submit data so that they will realize the full potential of the program and to maximize the participant data base. Each year, Q-Probes modules provide new studies as well as some "repeats" from previous years to allow for individual laboratory and group performance comparisons with previous results. Some probes are designed to examine different aspects of similar problems. For example, the 1989 "turnaround time" (TAT) probe evaluated cerebrospinal fluid analysis for glucose, protein, cells and Gram stain and defined TAT as intra-laboratory TAT for this group of stat analytes usually requiring analysis in more than one physically separate part of the laboratory; in 1990, the TAT probe studied hemoglobin and potassium as TAT from phlebotomy in the emergence room to result reporting. The 1991 Q-Probe will study TAT for routine analytes performed for inpatients. Q-Probes studies are mailed quarterly (on a trimester basis for anatomic pathology probes) and consist of a package that includes "front-end" explanations of the reasons for the probe and background information, descriptive literature, instructions, data collection forms and input forms to be used to return summated data to the CAP central offices in Northfield, TL. The studies are time-limited and data collection is retrospective or prospective depending on the indicator. Following completion of the study (over a fixed period of time and finite data set), laboratories submit their data to the College where data editing, entry and analysis is performed by CAP staff and statisticians. The Q-Probe author(s), statisticians and QAS staff then proceed with the preparation and printing of the critique. Each laboratory receives an "expert" critique written by the probe authors in addition to a laboratory-specific summary of their results. Individual laboratory results for several selected "key" indicators are grouped into percentiles for comparison with the corresponding demographic peer group and all participants aggregated data. At the present time, approximately 1,300 laboratories subscribe to Q-Probes. The largest group of laboratories are in private (45.8%) and community (34%) hospitals with the remainder in federal (6.4%), non-federal government (8.5%) and university (5.4%) hospitals. Sixty-three per cent of labs are in non-teaching hospitals. Approximately 80% of the labs are CAP accredited and 25% of the labs report that they are JCAHO accredited. In addition, participating laboratories are located in the United States (including Guam and overseas armed forces facilities), Canada, Australia and Ireland [6].
171
Using Q-Probes to Improve Quality
This section (o be completed by patient: I expected the discomfort to be: • m o r e •less Were you satisfied with the procedure? • yes • no Commentsj
•same.
Was there an outstanding employee you met? Name:_
This section to be completed by laboratory: Time registered: Number of needle sticks: Phlebotomist Initials:
Date:.
Time blood collected:. Time since last phlebotomy: • more than 3 months • less than 3 months
FIGURE 1. Pre-printed postcard used by patients to measure ecchymoses diameters, and to record their assessments of the procedure.
Downloaded from by guest on June 8, 2016
patients and one of only a few procedures performed directly on patients by laboratorians. Only a few scientific reports had been published on its performance and complications. Some reports had documented anemia from repetitive phlebotomies in hospitalized patients [8,9]; one report has described patient hemoglobin levels so low as to necessitate blood transfusions [10] and in the third, syncopal rate was described as 0.49% [11]. Frequently, phJebotomists are the only representatives of the clinical laboratory that patients meet, and a patient's perception of the quality of the laboratory services and the institution may be influenced by the activities of phlebotomists. Subscribers were given an instruction package which included directions for participation, five worksheets, a sample letter, 80 pre-printed postcards, and a questionnaire about the study which began on 1 February 1990, and continued until 31 March 1990, or until the 80 postcards were distributed to consecutive participating patients, whichever occurred first. Ostensibly healthy outpatients were selected and given a letter signed by the laboratory director describing the study and seeking their participation as a means of monitoring and improving laboratory phlebotomy practices. The registration and procedure completion time were recorded on a pre-printed, return-postage-guaranteed postcard for patients who agreed to participate (Fig. 1). On the side of the card was a millimeter scale for measurement of any ecchymoses present 24 hours after phlebotomy. After phlebotomy, the measurement procedure was demonstrated to the patient by the phlebotomist. Prior to the patient leaving the outpatient blood collection area, the phlebotomist recorded the number of phlebotomy attempts on the card. At home, patients measured any ecchymosis and checked the appropriate boxes, or wrote answers to questions on the card: (1) I expected the discomfort to be more, less, the same? (2) Were you satisfied with the procedure?
172
P. Bachner and P. J. Howanitz TABLE 1.
Demographics of participants
Variable
Number
Participating institutions Patients registered Patients responding % Of patients responding Institutions with
1040-6166/91 $3.00 + 0.00 © 1991 Pergamon Press pic
USING Q-PROBES TO IMPROVE THE QUALITY OF LABORATORY MEDICINE: A QUALITY IMPROVEMENT PROGRAM OF THE COLLEGE OF AMERICAN PATHOLOGISTS Paul Bachner* and Peter J. Howanitzf 'Chairman, QAS-Qua]ity Assurance Committee College of American Pathologists and Chairman, Pathology and Laboratory Medicine United Hospital Medical Center Port Chester New York, USA tVice-Chairman, QAS-Quality Assurance Committee College of American Pathologists Director of Clinical Laboratories and Professor of Pathology UCLA Los Angeles California, USA (First submitted 31 May 1991; accepted 20 June 1991)
Key words: Clinical pathology, turnaround times, quality probes, phlebotomy.
First presented to the 8th Congress of ISQA, Washington, 29-31 May 1991. Reprint requests should be sent to: Paul Bachner, MD, Department of Pathology and Laboratory Medicine, United Hospital Medical Center, Port Chester, NY 10573, USA.
767
Downloaded from by guest on June 8, 2016
This paper will review the reasons for the increasing emphasis on quality assurance in American healthcare and laboratory medicine. This emphasis is driven in part by economic, social and regulatory concerns as well as the traditional commitment to the search for excellence in services provided to patients. The Q-Probes Program of the College of American Pathologists (CAP) represents a response to these pressures and will be described in some detail. The program is based upon the historical success of interlaboratory comparison programs developed and sponsored by the CAP in achieving demonstrable improvement in laboratory performance. These programs are dependent on the gathering of data from large numbers of laboratories in order to establish provisional "benchmarks" of quality practice which serve as a baseline for systematic quality improvement efforts. The Q-Probes Program gathers peer-group specific institutional data concerning defined aspects of quality practice in pathology and laboratory medicine. These highly structured programs provide laboratories and pathology services with a format to collect data for submission to the CAP for analysis and to compare their performance against that of appropriately stratified peer groups. Several representative examples chosen from clinical laboratory medicine and pathology will be presented. We will attempt to demonstrate how individual laboratory and pathology services utilize aggregate data to effect specific changes in practice that lead to improvement in processes of patient care and better patient outcomes.
168
P. Bachner and P. J. Howanitz
INTRODUCTION "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" . . . Israel Diamond, MD [1].
Downloaded from by guest on June 8, 2016
The achievements of American Medicine and the capabilities of our healthcare system are widely recognized. Despite this, critics of our healthcare system focus on high cost, excessive utilization of new and unproven technologies, impediments and limitations in access to care, and documented as well as anecdotal deficiencies in quality. Economic, social and political circumstances have led to decreased resource allocations for healthcare in general and laboratory medicine in particular and it is arguable that "quality" will suffer unless the laboratory community can address quality issues in a systematic manner. In addition, an unprecedented national legislative and regulatory initiative (CLIA'88) will result in a profound increase in the degree of regulation of hospital, independent and other laboratories. The scope and uncertain implementation of these regulations have aroused profound concerns on the part of the entire laboratory medicine community [2]. In recognition of the increased demands for accountability and the need to validate the quality of laboratory services, we will describe in this paper a new and unique program, Q-Probes, developed by members of the College of American Pathologists, that attempts to respond to the initiative for quality improvement and to provide some assistance to laboratories in implementing quality assurance and quality improvement programs. One of the implicit assumptions of this program, Q-Probes, is that laboratories and hospitals wish to participate in the move from a quality assurance to a quality improvement platform. Those responsible for the development of the Q-Probes program recognize that traditional quality assurance approaches suffer from certain limitations. These include: undue reliance upon peer review usually stimulated by complications or undesirable results; case-by-case review based on subjective criteria that are not established in advance and are performed by different reviewers with an exclusive focus on the practitioner or technologist; a "medical audit" system that relies on pre-defined but not necessarily objective criteria [3]. In support of the current emphasis of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) [3], the Q-Probes program stresses on-going monitoring, priority setting and the use of indicators. Central to our process is the collection of multi-institutional peer-validated data which identify trends and patterns, not just individual problem cases. In the attempt to avoid an excessive "department/discipline" orientation, our efforts have been directed to developing an "outcomes" perspective that concentrates at every opportunity upon the interaction of the pathology and laboratory service with patients and the hospital as a whole by studying the total analytic cycle including test selection, test interpretation, test performance, results reporting and the relationship of the elements of this cycle to patient outcomes.
Using Q-Probes to Improve Quality
169
COLLEGE OF AMERICAN PATHOLOGISTS: LABORATORY IMPROVEMENT PROGRAMS
Q-PROBES
Several years ago, the Quality Assurance Services Committee (QAS) of the CAP recognized the need for a new program that would provide pathologists and clinical laboratories with a selected group of quality assurance indicators that would be applicable to a broad range of laboratory settings and would address important areas of service. The QAS Committee further believed that the positive role of other CAP programs in improving laboratory performance on a nationwide basis (Surveys, QAS interlaboratory comparisons) provided a model for the development of a natior,ally-based and peer-referenced data base of quality indicators. The program was conceptualized, developed and extensive pilot studies were performed over a period of several years. Q-Probes was offered on a subscription basis in January 1989 as a subscription program providing studies of outcome, process and structure-orientated quality assurance indicators [5]. "Off-the-shelf" periodic studies provide a laboratory with a series of independent "snapshots" of laboratory quality elements that can be used "as is" or as "templates" for continuing monitoring or to develop other related indicators. The indicators that were offered in
Downloaded from by guest on June 8, 2016
The College of American Pathologists (CAP) is a national medical specialty society representing more than 12,000 physicians who are board certified or eligible to be certified by the American Board of Pathology. CAP members practice their specialty in community hospitals, independent medical laboratories, academic medical centers, medical examiner/coroner offices, and federal and state health facilities. The CAP sponsors and provides many laboratory improvement programs which, in addition to addressing traditional quality control, continuing education and laboratory management needs, provide pathologists and laboratory professionals with the means to achieve the following goals [4]: (1) To fulfill quality assurance requirements of regulatory and accrediting agencies; (2) To develop mechanisms for measuring quality in the various disciplines of the clinical and pathology laboratory; (3) To help pathologists and other laboratory professionals assume leadership roles for quality improvement; (4) To assist pathologists in expanding their traditional commitment to excellence and quality improvement in the laboratory and the hospital; (5) To develop strategies for building public and government confidence in the quality of pathology and laboratory services. The laboratory improvement programs of the CAP include a proficiency testing (surveys) program, a Standards program, multiple programs for interlaboratory quality control (QAS-QC), a laboratory inspection program that accredits more than 4,000 hospital and independent laboratories, and performance improvement programs in cytopathology (PAP) and surgical pathology (PEP). The newest of these programs is the Q-Probes program which we will now describe in greater detail.
170
P. Bachner and P. J. Howanitz
COMPLICATIONS OF PHLEBOTOMY: AN EXAMPLE OF A Q-PROBE
In the spring of 1990, we studied complications of phlebotomy in 630 institutions [7]. Phlebotomy probably is the most common medical procedure performed on
Downloaded from by guest on June 8, 2016
1989 included test turnaround-time, laboratory report error rates, fine needle biopsy correlation, frozen section correlations, blood transfusion utilization, cervicovaginal cytology specimen adequacy and nosocomial infection rates. Laboratories subscribe to the program on an annual basis and may subscribe to a combined module consisting of eight clinical and three anatomic pathology probes or separate anatomic or clinical pathology modules. If a particular probe is felt to be inappropriate, the lab does not need to submit data but will still receive the critique and overall data summary from participating laboratories. Laboratories are encouraged to submit data so that they will realize the full potential of the program and to maximize the participant data base. Each year, Q-Probes modules provide new studies as well as some "repeats" from previous years to allow for individual laboratory and group performance comparisons with previous results. Some probes are designed to examine different aspects of similar problems. For example, the 1989 "turnaround time" (TAT) probe evaluated cerebrospinal fluid analysis for glucose, protein, cells and Gram stain and defined TAT as intra-laboratory TAT for this group of stat analytes usually requiring analysis in more than one physically separate part of the laboratory; in 1990, the TAT probe studied hemoglobin and potassium as TAT from phlebotomy in the emergence room to result reporting. The 1991 Q-Probe will study TAT for routine analytes performed for inpatients. Q-Probes studies are mailed quarterly (on a trimester basis for anatomic pathology probes) and consist of a package that includes "front-end" explanations of the reasons for the probe and background information, descriptive literature, instructions, data collection forms and input forms to be used to return summated data to the CAP central offices in Northfield, TL. The studies are time-limited and data collection is retrospective or prospective depending on the indicator. Following completion of the study (over a fixed period of time and finite data set), laboratories submit their data to the College where data editing, entry and analysis is performed by CAP staff and statisticians. The Q-Probe author(s), statisticians and QAS staff then proceed with the preparation and printing of the critique. Each laboratory receives an "expert" critique written by the probe authors in addition to a laboratory-specific summary of their results. Individual laboratory results for several selected "key" indicators are grouped into percentiles for comparison with the corresponding demographic peer group and all participants aggregated data. At the present time, approximately 1,300 laboratories subscribe to Q-Probes. The largest group of laboratories are in private (45.8%) and community (34%) hospitals with the remainder in federal (6.4%), non-federal government (8.5%) and university (5.4%) hospitals. Sixty-three per cent of labs are in non-teaching hospitals. Approximately 80% of the labs are CAP accredited and 25% of the labs report that they are JCAHO accredited. In addition, participating laboratories are located in the United States (including Guam and overseas armed forces facilities), Canada, Australia and Ireland [6].
171
Using Q-Probes to Improve Quality
This section (o be completed by patient: I expected the discomfort to be: • m o r e •less Were you satisfied with the procedure? • yes • no Commentsj
•same.
Was there an outstanding employee you met? Name:_
This section to be completed by laboratory: Time registered: Number of needle sticks: Phlebotomist Initials:
Date:.
Time blood collected:. Time since last phlebotomy: • more than 3 months • less than 3 months
FIGURE 1. Pre-printed postcard used by patients to measure ecchymoses diameters, and to record their assessments of the procedure.
Downloaded from by guest on June 8, 2016
patients and one of only a few procedures performed directly on patients by laboratorians. Only a few scientific reports had been published on its performance and complications. Some reports had documented anemia from repetitive phlebotomies in hospitalized patients [8,9]; one report has described patient hemoglobin levels so low as to necessitate blood transfusions [10] and in the third, syncopal rate was described as 0.49% [11]. Frequently, phJebotomists are the only representatives of the clinical laboratory that patients meet, and a patient's perception of the quality of the laboratory services and the institution may be influenced by the activities of phlebotomists. Subscribers were given an instruction package which included directions for participation, five worksheets, a sample letter, 80 pre-printed postcards, and a questionnaire about the study which began on 1 February 1990, and continued until 31 March 1990, or until the 80 postcards were distributed to consecutive participating patients, whichever occurred first. Ostensibly healthy outpatients were selected and given a letter signed by the laboratory director describing the study and seeking their participation as a means of monitoring and improving laboratory phlebotomy practices. The registration and procedure completion time were recorded on a pre-printed, return-postage-guaranteed postcard for patients who agreed to participate (Fig. 1). On the side of the card was a millimeter scale for measurement of any ecchymoses present 24 hours after phlebotomy. After phlebotomy, the measurement procedure was demonstrated to the patient by the phlebotomist. Prior to the patient leaving the outpatient blood collection area, the phlebotomist recorded the number of phlebotomy attempts on the card. At home, patients measured any ecchymosis and checked the appropriate boxes, or wrote answers to questions on the card: (1) I expected the discomfort to be more, less, the same? (2) Were you satisfied with the procedure?
172
P. Bachner and P. J. Howanitz TABLE 1.
Demographics of participants
Variable
Number
Participating institutions Patients registered Patients responding % Of patients responding Institutions with
