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Quality in the ambulatory endoscopy center
Techniques in Gastrointestinal Endoscopy (2011) 13, 224-228
Techniques in GASTROINTESTINAL ENDOSCOPY www.techgiendoscopy.com
Quality in the ambulatory endoscopy center Bret T. Petersen, MD Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota. KEYWORDS: Outcomes; Quality measures; Lean method; Six sigma; Benchmarking
Quality improvement (QI) activities are now key pursuits for clinicians and managers in all medical environments. Demonstration of QI effort is required for accreditation of facilities and board recertification of most medical professionals. Every facility has opportunities for improvement and the most pressing issues are often unique to the local facility. Nevertheless, to limit risks both for the health of the practice and for patients, all endoscopy facilities should ensure satisfactory performance in regard to procedural quality, infection control, equipment reprocessing, sedation and analgesia, and management of pre- and postprocedure medications, including anticoagulants and antibiotics. Because efforts are usually constrained by staff, time, and financial considerations, improvement needs must be prioritized to identify those with the greatest urgency and impact. For units new to QI endeavors, it is useful to focus on single issues at first. Improvement methods are widely varied; many are commonly applied systematically, whereas others are particularly suitable for ad hoc application. This article reviews principles pertaining to defining and selecting improvement goals and the various methodologies often employed in pursuing them. Further reading is encouraged in regard to specific methods for use by improvement teams. © 2011 Elsevier Inc. All rights reserved.
Quality improvement (QI) is now a mainstream endeavor in American medicine,1 in part stimulated by several reports from the Institute of Medicine2-4 that identified 3 elements of quality in health care: (1) safety, or freedom from accidental injury; (2) practice consistent with present medical knowledge (use of evidence-based medicine); and (3) customization, or meeting customer-specific values and expectations. This emphasis on QI has been embraced by accrediting organizations, specialty boards, regulators, and all specialties, including the major gastroenterology organizations.5,6 Quality indicators and guidelines have been developed for overall endoscopic care and for those issues pertinent to upper endoscopy, colonoscopy, endoscopic retrograde cholangiopancreatography, and endoscopic ultrasonography.7-12
sustained leadership, and effective communication. Administration of quality initiatives in an ambulatory endoscopy center (AEC) will generally fall to both a physician leader and a nonphysician staff member or manager. The owners, partners, and management staff must all be conversant in, and supportive of, quality endeavors. Meaningful QI efforts require the following: (a) identification of gaps in care and areas in need of improvement, (b) leadership and motivation to address the identified needs, (c) careful definition of the current state and contributing factors, (d) availability of appropriate representative data, (e) a plan for improvement, and (f) transparency and accountability within the unit. Improvement efforts may be mandated by the regulatory or business climate or they may be highly altruistic.
Management for QI Managing the quality of an endoscopy unit is a multifaceted task, dependent on an informed vision, strong and
Address reprint requests to Bret T. Petersen, MD, Charlton 8, GI Endoscopy, Mayo Clinic, Rochester, MN 55902. E-mail: petersen.bret@ mayo.edu 1096-2883/11/$-see front matter © 2011 Elsevier Inc. All rights reserved. doi:10.1016/j.tgie.2011.07.002
Quality measure design and use The indicators used to evaluate performance are referred to as quality “measures,” defined by a numerator representing the frequency of a given occurrence, practice, or outcome and a denominator representing the number of opportunities for that occurrence in the population of interest.
Petersen
Quality Improvement in Endoscopy
Clinically relevant quality measures are evidence based, reproducible, valid, and feasible.13 Structural measures, which are usually assessed during accreditation surveys, define characteristics of the health care environment, such as the policies and procedures in effect and the facilities, equipment, and staffing in use. Examples might include data pertaining to the outcome of sentinel event assessments, reprocessing practices, equipment records, and availability of appropriate resuscitative equipment. Process measures deal with optimal performance based upon best practices and accepted standards. Examples include the proportions of cirrhotic patients who receive antibiotics prior to urgent endoscopy for gastrointestinal bleeding and the proportion of patients who undergo surveillance endoscopy at appropriate intervals following a prior procedure.14 Outcome measures are defined by patient results, typically following an episode of care delivered over an interval of time for an illness with a defined time frame. They are indirect measures of quality because they are influenced by factors beyond the control of the caregivers. Examples include the proportion of patients with colorectal cancer or high-risk neoplastic lesions within a given time interval after screening endoscopy or computed tomography scanning and the proportion of patients with resolution of abdominal pain after endoscopic therapies for chronic pancreatitis. Formal and informal quality measures developed locally or by national organizations can be used serially or in ad hoc fashion, depending on the needs of the business. Many organizations follow run charts of their performance on important overarching measures in the form of a “scorecard” or “dashboard” to stay abreast of highly varied activities and to provide notice of emerging problems prior to the occurrence of adverse events or recognition by patients or staff.15,16 Although some measures of efficiency or quality document performance on a per-individual basis, most important department-wide improvements result from process improvements developed for all staff rather than enhanced work habits of an individual. Although measures of individual performance may be useful for counseling of personnel, some variation between individuals is normal and should be accepted. In all cases, performance appraisals should be based on measures that reflect activity under the direct control of the staff member or group being assessed.
Implementing a QI project Focused attention to a quality problem using a defined sequence of activities, established techniques, and a timeline constitutes a “QI project.” The essential elements in a successful project are noted in Table 1.17 The key first step is recognizing the need for improvement. Every facility has opportunities for improvement that are often readily apparent and known to patients and staff members alike. Improvement needs can be identified by patient questionnaires or by thoughtful assessment of the sequential steps in de-
225 Table 1
Steps for evaluating practice improvement options1,5
1. 2. 3. 4.
Identify potential improvement opportunity Gather information about optimal practices Gather information about current local practices Identify gaps and reasons for gaps between local and optimal practice 5. Develop an improvement strategy 6. Perform a trial of the proposed strategy and assess its effectiveness and cost-effectiveness 7. Consider further improvements in proposed strategy and decide whether tested changes should be implemented permanently
livery of endoscopic services. Areas needing attention may also be recognized during consideration of the mandates from regulators, payers, and accrediting organizations or upon review of the following: (a) National Quality Measures promulgated by the Centers for Medicare and Medicaid Services (CMS)18 and several quality advocacy organizations, (b) guidelines from the Centers for Disease Control and the national gastroenterology societies,8-12 and (c) the National Patient Safety Goals from the Joint Commission.19 QI needs must be prioritized to identify those with the greatest urgency and impact because local improvement efforts are usually constrained by staff, time, and financial considerations. The most pressing issues for improvement are usually unique to the local facility. All units, however, should address issues vital to their practice, such as procedural quality, infection control, equipment reprocessing, sedation and analgesia, and management of pre- and postprocedure medications, including anticoagulants and antibiotics. Adequate attention to these issues limits their significant risk to both the patients and the health of the business. Quality measures that are often tracked as part of colonoscopy benchmarking efforts are listed in Table 2, along with reference to their supporting references. For units new to QI endeavors, it is useful to focus on single issues at first. Attempting to resolve multiple complex issues at once may lead to disheartening challenges and lack of resolution of any single problem. Once an issue is identified, a representative group of staff (and perhaps patients) is assembled to undertake the improvement project, beginning with the definition and understanding of both current and optimal practices, definition of gaps in performance, design of plans for improvement, and assessment of the effectiveness of new systems or practices. This process need not be complex, expensive, or unduly time consuming. Most problems can be expressed in simple terms and solutions can be proposed and tried efficiently. A variety of tools can be employed to depict and better understand the current state of affairs and to identify gaps in care, points of risk, and waste. They include mapping of the current state using flow charts, cause-and-effect diagrams, histograms, and other relationship tools.
226 Table 2
Techniques in Gastrointestinal Endoscopy, Vol 13, No 4, October 2011 Quality measures commonly employed for colonoscopy benchmarking
1. Completeness of procedure documentation is evaluated, including patient demographics, assessment of procedural risk (ASA score), procedure indication(s), procedural technical description (medications, extent of exam, adequacy of preparation, ease and tolerance, retroflexion, other maneuvers), colonoscopic findings (with location, morphology, sampling, therapies), diagnosis and assessment, unplanned events or interventions, and follow-up plan, including medication management.7,26,27 2. Quality of colonoscopy preparation is tracked, with the goal of “adequate for detection of all polyps ⬎ 5 mm” in ⬎ 90% of patients.7,10 3. Patient satisfaction surveys are used to methodically identify service problems. 4. Screening and surveillance intervals are monitored to avoid over- and underuse relative to national guidelines. Three such measures are now approved by the National Quality Forum and one (c) is in use by the CMS Physician’s Quality Reporting Initiative (PQRI).28-31 a. Follow-up after initial diagnosis and treatment of colorectal cancer to ensure that all patients with newly diagnosed and resected colorectal cancer undergo follow-up colonoscopy within 15 months of resection. b. Appropriate follow-up interval after normal colonoscopy in average risk patients: percentage of patients 50 years old and older receiving a screening colonoscopy without biopsy or polypectomy who have a colonoscopy follow-up interval of at least 10 years recommended in their colonoscopy report. c. Colonoscopy interval for patients with a history of adenomatous polyps: percentage of patients 18 years old and older undergoing a surveillance colonoscopy for a history of a prior colonic polyp at colonoscopy who have a follow-up interval of 3 or more years since their last colonoscopy documented in the colonoscopy report (2011 PQRI No. 185). 5. Depth of intubation is documented in text and by endoscopic photos. Cecal intubation rates should exceed 95% for screening and surveillance procedures and 90% for all indications.7,10 6. Adenoma detection rate is monitored; among patients undergoing first-time screening colonoscopy it should exceed 25% for men and 15% for women.7,10,32 7. Adverse events are systematically identified and tracked throughout the unit.8,30
Several QI methodologies are commonly employed in improvement projects (Table 3). They all use preliminary testing of potential improvements followed by reassessment, redesign, and further testing. However, each utilizes slightly different tools and seeks different sorts of problem resolution; hence, their applicability varies with the problem. Central to any QI effort is the availability of accurate and timely data. The practice of gastrointestinal endoscopy is highly amenable to data collection via manual or automated formats. Manual collection often suffices for short-term ad hoc quality projects, but automated collection via computerized endoscopic report generators and medical records is useful for incorporating ongoing tracking of common items into the workflow of the practice. Appropriate skill sets for collation and manipulation of data are also important.
Selected QI techniques and tools A number of techniques are commonly used for assessment of clinical practice and outcomes of care (Table 4). Their purposes and applications vary. Several are mandated by external bodies or hospital policies, whereas others are for ad hoc use when events dictate. Some are most applicable to large groups of physician staff, as in a hospital or health system, whereas others may be more appropriate for smaller groups. Additional comments on several of the techniques follow.
Benchmarking Benchmarking involves comparison of performance against a group of similar practices or institutions or against aggregate data from many groups. Risk adjustment enhances the validity of benchmark comparisons. Internal benchmarking is sometimes referred to as audit–feedback. Many academic medical centers benchmark against others in the University HealthSystem Consortium.20 Smaller and independent practices now have the opportunity to benchmark against nationally aggregated data via the GI Quality Improvement Consortium (GIQuIC), a recently established collaboration between the American Society for Gastrointestinal Endoscopy (ASGE) and the American College of Gastroenterology.21 This program receives electronically submitted data pertaining to endoscopic measures from participating endoscopy centers. The program will ultimately facilitate data submission to the Physicians Consortium for Performance Improvement (PQRI) and various other pay-for-performance programs. A similar pilot project has applied benchmarking principles to endoscopic retrograde cholangiopancreatography (Dr Peter Cotton, Olympus).
Accreditation Accreditation is a process by which an independent third party reviews and attests to the competency and performance of another organization to ensure that they abide by a wide variety of standards relating to facility, staffing, policies, safety measures, infection control practices, QI
Petersen
Quality Improvement in Endoscopy
Table 3 Methodologies employed in health care quality improvement projects Plan–Do–Study–Act (P–D–S–A)33 Employs cycles of planning (P), small-scale pilot testing (D), and analysis of test results and lessons learned (S), followed by incorporation and maintenance of new processes into practice (A) Useful when resources and time are limited and rapid stepwise improvement is desired Lean method34 Seeks to increase efficiency and reduce waste by excluding all processes, steps, or inputs that fail to contribute value to the end product Useful when existing practices are deemed to be inefficient and cumbersome and with bottlenecks and excessive rework Employs collaborative team input and process revision through value stream mapping Popularized in writings about methods of the Toyota Corporation Six Sigma method Intensively data-driven approach to minimizing variation and thereby reducing defects or errors to improve quality Uses a cyclic approach referred to as the Define–Measure– Analyze–Improve–Control method Employs more rigorous analytical tools and process control charting under the guidance of local “black belt” or “green belt” experts Especially appropriate for repetitive, high-frequency processes
efforts, etc. Accreditation is required of all AECs and hospital-based endoscopy units to gain “deemed” status for billing and reimbursement of facility fees by CMS. Many other payers follow suit; hence, accreditation is essentially a mandate for realistic business plans of an AEC. In some states accreditation is also required for outpatient performance of all procedures employing sedation or anesthesia, including office-based units. Billing and reimbursement of facility fees by accredited office-based practices varies and remains contentious. Three major organizations accredit ambulatory surgical or endoscopy facilities, including the Accreditation Association for Ambulatory Health Care,22 the Joint Commission,23 and the American Association for Accreditation of Ambulatory Surgery Facilities, Inc.24 All have programs specific to ambulatory procedural facilities; however, they vary in their accreditation requirements, processes, and costs.
Endoscopy Unit Recognition Program The ASGE’s Endoscopy Unit Recognition Program recognizes those units that employ best practices for infection control, credentialing, and other aspects of quality care. This program distinguishes recognized facilities from less qualified units in many environments.25 Recognition requires
227 continuous accreditation by a national accrediting body; practice in accord with ASGE guidelines on infection control, endoscope reprocessing, and credentialing of staff; physician or administrator attendance at the ASGE course on enhancing unit quality; and ASGE membership of at least 50% of the practicing endoscopists of the center. The program benefits include the guidance and training provided regarding quality assurance and infection control and receipt of the Endoscopy Unit Recognition Award, including use of the award in marketing via printed and electronic media. Recognition can reassure patients regarding the use of optimal practices within a given facility.
Table 4
Commonly employed quality improvement practices
Credentialing, privileging, and reprivileging Mandated by the accreditation process Reprivileging is required every 2 years Engenders liability to the organization Important opportunity for organizations to assess/reassess staff Physician peer review Monitors the appropriateness of the quality and quantity of routine care provided by individual clinicians Routine and periodic, as in the biannual reprivileging process, or ad hoc for concerns about a provider’s practice Typically standardized review of sample encounters by noncompeting clinicians from the same discipline Subject physician comments in a fair hearing process Audit–feedback method Provision of comparative summary statistics pertaining to any useful indicator of practice When provided with anonymous data of other colleagues, functions as internal benchmarking system Often drives performance improvement without further specific counseling Lower thresholds can be employed as an early warning of the need for remedial intervention Tissue log review Review of all malignant pathology for adequate follow-up and a subset of other pathology for consistency in practice Ensures consistency among procedure indications, procedure performed, and tissue acquired Helps prevent lapses in response to significant pathology Review of adverse events, incidents, and complaints Review of all undesirable outcomes that meet a predetermined threshold of severity/risk At a minimum, all sentinel events,35 serious adverse events, and significant grievances or complaints from patients or employees Definitions and nomenclature for gastrointestinal endoscopy recently proposed36 Benchmarking Self-comparison against the highest performers among similar practitioners or institutions Measures must be quantifiable and attainable Results should be risk adjusted Internal versus own group, facility, or hospital staff or external versus aggregate data from many groups
228
Techniques in Gastrointestinal Endoscopy, Vol 13, No 4, October 2011
PQRI Pay-for-performance programs offer incentives to health care providers for achieving predetermined outcomes in the provision of care. The PQRI is a CMS program that currently provides incentive payments for satisfactory reporting of quality data pertaining to services to Medicare beneficiaries.26-36 Few measures that have been incorporated into the PQRI program are specific to gastrointestinal endoscopy. Participation requires attention to arcane billing mechanisms. The evolution of electronic record systems and of non-claimsbased measures should facilitate participation. In due time the PQRI program will evolve to penalties for nonparticipation as measures are increasingly employed. PQRI qualified benchmarking registries will greatly enhance the ease of participation in the program. Details regarding quality measures specific to gastroenterology and GI endoscopy are available on the CMS18 and ASGE37 Web sites.
Conclusions The principles of QI and quality assurance are important to administrators and practitioners alike. Active QI experience is now required for board certification, unit accreditation, and payer reimbursement. All health care units should include staff capable of guiding local QI efforts. Ultimately, our patients and our professional activities both benefit from these efforts.
References 1. Gustafson DH, Hundt AS: Findings of innovation research applied to quality management principles for health care. Health Care Manage Rev 20:16-33, 1995 2. Chassin MR, Galvin RW: The urgent need to improve health care quality. Institute of Medicine National Roundtable on Health Care Quality. JAMA 280:1000-1005, 1998 3. Committee on Quality of Health Care in America, Institute of Medicine: Kohn LT, Corrigan JM, Donaldson MS (eds): To Err Is Human: Building a Safer Health System. Washington, DC, National Academies Press, 2000 4. Committee on Quality of Health Care in America, Institute of Medicine: Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC, National Academies Press, 2001 5. Johanson JF: Continuous quality improvement in the ambulatory endoscopy center. Gastrointest Endosc Clin N Am 12:351-365, 2002 6. Johansson JF, Schmitt C, Deas TM, et al: Quality and outcomes assessment in gastrointestinal endoscopy. Gastrointest Endosc 52:827830, 2000 7. Rex DK, Bond JH, Winawer S, et al: Quality in the technical performance of colonoscopy and the continuous quality improvement process for colonoscopy: recommendations of the U.S. Multi-Society Task Force on colorectal cancer. Am J Gastroenterol 97:1296-1308, 2002 8. Faigel DO, Pike IM, ASGE/ACG Taskforce on Quality in Endoscopy: Quality indicators for gastrointestinal endoscopic procedures: an introduction. Gastrointest Endosc 63 (suppl):S3-S9, 2006 9. Cohen J, Safdi MA, Deal SE: Quality indicators for esophagogastroduodenoscopy. Gastrointest Endosc 63 (suppl):S10-S15, 2006
10. Rex DK, Petrini JL, Baron TH, ASGE/ACG Taskforce on Quality in Endoscopy: Quality indicators for colonoscopy. Gastrointest Endosc 63 (suppl):S16-S28, 2006 11. Baron TH, Petersen BT, Mergener K, ASGE/ACG Taskforce on Quality in Endoscopy: Quality indicators for endoscopic retrograde cholangiopancreatography. Gastrointest Endosc 63 (suppl):S29-S34, 2006 12. Jacobson BC, Chak A, Hoffman B, ASGE/ACG Taskforce on Quality in Endoscopy: Quality indicators for endoscopic ultrasonography. Gastrointest Endosc 63 (suppl):S35-S38, 2006 13. Harrington L, Pigman H: Quality Measurement, in Varkey P (ed): Medical Quality Management: Theory and Practice. Sudbury, MA, Jones and Bartlett Publishers, 2010 14. Sanaka MR, Super DM, Feldman ES, et al: Improving compliance with postpolypectomy surveillance guidelines: an interventional study using a continuous quality improvement initiative. Gastrointest Endosc 63:97-103, 2006 15. Lim T: Statistical process control tools for monitoring clinical performance. Int J Qual Health Care 15:3-4, 2003 16. Bolsin S, Colson M: Making the case for personal performance monitoring in healthcare. Int J Qual Health Care 15:1-2, 2003 17. Matchar DB, Samsa GP: The role of evidence reports in evidencebased medicine: A mechanism for linking scientific evidence and practice improvement. Jt Comm J Qual Improv 25:522-528, 1999 18. http://www.cms.hhs.gov/PQRI. Accessed January 30, 2011 19. http://www.jointcommission.org/patientsafety/nationalpatientsafetygoals. Accessed January 30, 2011 20. https://www.uhc.edu/12443.htm. Accessed January 30, 2011 21. http://www.giquic.org. Accessed January 30, 2011 22. http://www.aaahc.org. Accessed January 30, 2011 23. http://www.jointcommission.org. Accessed January 30, 2011 24. http://www.aaaasf.org. Accessed January 30, 2011 25. Petersen BT: Advances in endoscopy: ASGE’s Endoscopy Unit Recognition Program. J Gastroenterol Hepatol 11:756-757, 2009 26. Lieberman D, Nadel M, Smith RA, et al: Standardized colonoscopy reporting and data system: report of the Quality Assurance Task Group of the National Colorectal Cancer Roundtable. Gastrointest Endosc 65:757-766, 2007 27. Lieberman DA, Faigel DO, Logan JR, et al: Assessment of the quality of colonoscopy reports: results from a multicenter consortium. Gastrointest Endosc 69:645-653, 2009 28. Krist AH, Jones RM, Woolf SH, et al: Timing of repeat colonoscopy: disparity between guidelines and endoscopists’ recommendation. Am J Prev Med 33:471-478, 2007 29. Schoen RE, Pinsky PF, Weissfeld JL, et al: Utilization of surveillance colonoscopy in community practice. Gastroenterology 138:73-81, 2010 30. http://www.qualityforum.org/Measures_List.aspx. Accessed February 1, 2011 31. http://www.cms.gov/PQRI/15_MeasuresCodes.asp#TopOfPage. Accessed February 1, 2011 32. Kaminski MF, Regula J, Kraszewska E, et al: Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med 362:17951803, 2010 33. Langley GJ, Nolan KM, Nolan TW, et al: The Improvement Guide: A Practical Approach to Enhancing Organizational Performance. San Francisco, Jossey–Bass, 1996 34. Womack J, Jones D: Lean Thinking: Banish Waste and Create Wealth in Your Corporation. New York, Simon and Schuster, 1996 35. http://www.jointcommission.org/sentinel_event.aspx. Accessed January 30, 2011 36. Cotton PB, Eisen GM, Aabakken L, et al: A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 71:446-454, 2010 37. http://www.asge.org. Accessed April 11, 2011
Techniques in GASTROINTESTINAL ENDOSCOPY www.techgiendoscopy.com
Quality in the ambulatory endoscopy center Bret T. Petersen, MD Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota. KEYWORDS: Outcomes; Quality measures; Lean method; Six sigma; Benchmarking
Quality improvement (QI) activities are now key pursuits for clinicians and managers in all medical environments. Demonstration of QI effort is required for accreditation of facilities and board recertification of most medical professionals. Every facility has opportunities for improvement and the most pressing issues are often unique to the local facility. Nevertheless, to limit risks both for the health of the practice and for patients, all endoscopy facilities should ensure satisfactory performance in regard to procedural quality, infection control, equipment reprocessing, sedation and analgesia, and management of pre- and postprocedure medications, including anticoagulants and antibiotics. Because efforts are usually constrained by staff, time, and financial considerations, improvement needs must be prioritized to identify those with the greatest urgency and impact. For units new to QI endeavors, it is useful to focus on single issues at first. Improvement methods are widely varied; many are commonly applied systematically, whereas others are particularly suitable for ad hoc application. This article reviews principles pertaining to defining and selecting improvement goals and the various methodologies often employed in pursuing them. Further reading is encouraged in regard to specific methods for use by improvement teams. © 2011 Elsevier Inc. All rights reserved.
Quality improvement (QI) is now a mainstream endeavor in American medicine,1 in part stimulated by several reports from the Institute of Medicine2-4 that identified 3 elements of quality in health care: (1) safety, or freedom from accidental injury; (2) practice consistent with present medical knowledge (use of evidence-based medicine); and (3) customization, or meeting customer-specific values and expectations. This emphasis on QI has been embraced by accrediting organizations, specialty boards, regulators, and all specialties, including the major gastroenterology organizations.5,6 Quality indicators and guidelines have been developed for overall endoscopic care and for those issues pertinent to upper endoscopy, colonoscopy, endoscopic retrograde cholangiopancreatography, and endoscopic ultrasonography.7-12
sustained leadership, and effective communication. Administration of quality initiatives in an ambulatory endoscopy center (AEC) will generally fall to both a physician leader and a nonphysician staff member or manager. The owners, partners, and management staff must all be conversant in, and supportive of, quality endeavors. Meaningful QI efforts require the following: (a) identification of gaps in care and areas in need of improvement, (b) leadership and motivation to address the identified needs, (c) careful definition of the current state and contributing factors, (d) availability of appropriate representative data, (e) a plan for improvement, and (f) transparency and accountability within the unit. Improvement efforts may be mandated by the regulatory or business climate or they may be highly altruistic.
Management for QI Managing the quality of an endoscopy unit is a multifaceted task, dependent on an informed vision, strong and
Address reprint requests to Bret T. Petersen, MD, Charlton 8, GI Endoscopy, Mayo Clinic, Rochester, MN 55902. E-mail: petersen.bret@ mayo.edu 1096-2883/11/$-see front matter © 2011 Elsevier Inc. All rights reserved. doi:10.1016/j.tgie.2011.07.002
Quality measure design and use The indicators used to evaluate performance are referred to as quality “measures,” defined by a numerator representing the frequency of a given occurrence, practice, or outcome and a denominator representing the number of opportunities for that occurrence in the population of interest.
Petersen
Quality Improvement in Endoscopy
Clinically relevant quality measures are evidence based, reproducible, valid, and feasible.13 Structural measures, which are usually assessed during accreditation surveys, define characteristics of the health care environment, such as the policies and procedures in effect and the facilities, equipment, and staffing in use. Examples might include data pertaining to the outcome of sentinel event assessments, reprocessing practices, equipment records, and availability of appropriate resuscitative equipment. Process measures deal with optimal performance based upon best practices and accepted standards. Examples include the proportions of cirrhotic patients who receive antibiotics prior to urgent endoscopy for gastrointestinal bleeding and the proportion of patients who undergo surveillance endoscopy at appropriate intervals following a prior procedure.14 Outcome measures are defined by patient results, typically following an episode of care delivered over an interval of time for an illness with a defined time frame. They are indirect measures of quality because they are influenced by factors beyond the control of the caregivers. Examples include the proportion of patients with colorectal cancer or high-risk neoplastic lesions within a given time interval after screening endoscopy or computed tomography scanning and the proportion of patients with resolution of abdominal pain after endoscopic therapies for chronic pancreatitis. Formal and informal quality measures developed locally or by national organizations can be used serially or in ad hoc fashion, depending on the needs of the business. Many organizations follow run charts of their performance on important overarching measures in the form of a “scorecard” or “dashboard” to stay abreast of highly varied activities and to provide notice of emerging problems prior to the occurrence of adverse events or recognition by patients or staff.15,16 Although some measures of efficiency or quality document performance on a per-individual basis, most important department-wide improvements result from process improvements developed for all staff rather than enhanced work habits of an individual. Although measures of individual performance may be useful for counseling of personnel, some variation between individuals is normal and should be accepted. In all cases, performance appraisals should be based on measures that reflect activity under the direct control of the staff member or group being assessed.
Implementing a QI project Focused attention to a quality problem using a defined sequence of activities, established techniques, and a timeline constitutes a “QI project.” The essential elements in a successful project are noted in Table 1.17 The key first step is recognizing the need for improvement. Every facility has opportunities for improvement that are often readily apparent and known to patients and staff members alike. Improvement needs can be identified by patient questionnaires or by thoughtful assessment of the sequential steps in de-
225 Table 1
Steps for evaluating practice improvement options1,5
1. 2. 3. 4.
Identify potential improvement opportunity Gather information about optimal practices Gather information about current local practices Identify gaps and reasons for gaps between local and optimal practice 5. Develop an improvement strategy 6. Perform a trial of the proposed strategy and assess its effectiveness and cost-effectiveness 7. Consider further improvements in proposed strategy and decide whether tested changes should be implemented permanently
livery of endoscopic services. Areas needing attention may also be recognized during consideration of the mandates from regulators, payers, and accrediting organizations or upon review of the following: (a) National Quality Measures promulgated by the Centers for Medicare and Medicaid Services (CMS)18 and several quality advocacy organizations, (b) guidelines from the Centers for Disease Control and the national gastroenterology societies,8-12 and (c) the National Patient Safety Goals from the Joint Commission.19 QI needs must be prioritized to identify those with the greatest urgency and impact because local improvement efforts are usually constrained by staff, time, and financial considerations. The most pressing issues for improvement are usually unique to the local facility. All units, however, should address issues vital to their practice, such as procedural quality, infection control, equipment reprocessing, sedation and analgesia, and management of pre- and postprocedure medications, including anticoagulants and antibiotics. Adequate attention to these issues limits their significant risk to both the patients and the health of the business. Quality measures that are often tracked as part of colonoscopy benchmarking efforts are listed in Table 2, along with reference to their supporting references. For units new to QI endeavors, it is useful to focus on single issues at first. Attempting to resolve multiple complex issues at once may lead to disheartening challenges and lack of resolution of any single problem. Once an issue is identified, a representative group of staff (and perhaps patients) is assembled to undertake the improvement project, beginning with the definition and understanding of both current and optimal practices, definition of gaps in performance, design of plans for improvement, and assessment of the effectiveness of new systems or practices. This process need not be complex, expensive, or unduly time consuming. Most problems can be expressed in simple terms and solutions can be proposed and tried efficiently. A variety of tools can be employed to depict and better understand the current state of affairs and to identify gaps in care, points of risk, and waste. They include mapping of the current state using flow charts, cause-and-effect diagrams, histograms, and other relationship tools.
226 Table 2
Techniques in Gastrointestinal Endoscopy, Vol 13, No 4, October 2011 Quality measures commonly employed for colonoscopy benchmarking
1. Completeness of procedure documentation is evaluated, including patient demographics, assessment of procedural risk (ASA score), procedure indication(s), procedural technical description (medications, extent of exam, adequacy of preparation, ease and tolerance, retroflexion, other maneuvers), colonoscopic findings (with location, morphology, sampling, therapies), diagnosis and assessment, unplanned events or interventions, and follow-up plan, including medication management.7,26,27 2. Quality of colonoscopy preparation is tracked, with the goal of “adequate for detection of all polyps ⬎ 5 mm” in ⬎ 90% of patients.7,10 3. Patient satisfaction surveys are used to methodically identify service problems. 4. Screening and surveillance intervals are monitored to avoid over- and underuse relative to national guidelines. Three such measures are now approved by the National Quality Forum and one (c) is in use by the CMS Physician’s Quality Reporting Initiative (PQRI).28-31 a. Follow-up after initial diagnosis and treatment of colorectal cancer to ensure that all patients with newly diagnosed and resected colorectal cancer undergo follow-up colonoscopy within 15 months of resection. b. Appropriate follow-up interval after normal colonoscopy in average risk patients: percentage of patients 50 years old and older receiving a screening colonoscopy without biopsy or polypectomy who have a colonoscopy follow-up interval of at least 10 years recommended in their colonoscopy report. c. Colonoscopy interval for patients with a history of adenomatous polyps: percentage of patients 18 years old and older undergoing a surveillance colonoscopy for a history of a prior colonic polyp at colonoscopy who have a follow-up interval of 3 or more years since their last colonoscopy documented in the colonoscopy report (2011 PQRI No. 185). 5. Depth of intubation is documented in text and by endoscopic photos. Cecal intubation rates should exceed 95% for screening and surveillance procedures and 90% for all indications.7,10 6. Adenoma detection rate is monitored; among patients undergoing first-time screening colonoscopy it should exceed 25% for men and 15% for women.7,10,32 7. Adverse events are systematically identified and tracked throughout the unit.8,30
Several QI methodologies are commonly employed in improvement projects (Table 3). They all use preliminary testing of potential improvements followed by reassessment, redesign, and further testing. However, each utilizes slightly different tools and seeks different sorts of problem resolution; hence, their applicability varies with the problem. Central to any QI effort is the availability of accurate and timely data. The practice of gastrointestinal endoscopy is highly amenable to data collection via manual or automated formats. Manual collection often suffices for short-term ad hoc quality projects, but automated collection via computerized endoscopic report generators and medical records is useful for incorporating ongoing tracking of common items into the workflow of the practice. Appropriate skill sets for collation and manipulation of data are also important.
Selected QI techniques and tools A number of techniques are commonly used for assessment of clinical practice and outcomes of care (Table 4). Their purposes and applications vary. Several are mandated by external bodies or hospital policies, whereas others are for ad hoc use when events dictate. Some are most applicable to large groups of physician staff, as in a hospital or health system, whereas others may be more appropriate for smaller groups. Additional comments on several of the techniques follow.
Benchmarking Benchmarking involves comparison of performance against a group of similar practices or institutions or against aggregate data from many groups. Risk adjustment enhances the validity of benchmark comparisons. Internal benchmarking is sometimes referred to as audit–feedback. Many academic medical centers benchmark against others in the University HealthSystem Consortium.20 Smaller and independent practices now have the opportunity to benchmark against nationally aggregated data via the GI Quality Improvement Consortium (GIQuIC), a recently established collaboration between the American Society for Gastrointestinal Endoscopy (ASGE) and the American College of Gastroenterology.21 This program receives electronically submitted data pertaining to endoscopic measures from participating endoscopy centers. The program will ultimately facilitate data submission to the Physicians Consortium for Performance Improvement (PQRI) and various other pay-for-performance programs. A similar pilot project has applied benchmarking principles to endoscopic retrograde cholangiopancreatography (Dr Peter Cotton, Olympus).
Accreditation Accreditation is a process by which an independent third party reviews and attests to the competency and performance of another organization to ensure that they abide by a wide variety of standards relating to facility, staffing, policies, safety measures, infection control practices, QI
Petersen
Quality Improvement in Endoscopy
Table 3 Methodologies employed in health care quality improvement projects Plan–Do–Study–Act (P–D–S–A)33 Employs cycles of planning (P), small-scale pilot testing (D), and analysis of test results and lessons learned (S), followed by incorporation and maintenance of new processes into practice (A) Useful when resources and time are limited and rapid stepwise improvement is desired Lean method34 Seeks to increase efficiency and reduce waste by excluding all processes, steps, or inputs that fail to contribute value to the end product Useful when existing practices are deemed to be inefficient and cumbersome and with bottlenecks and excessive rework Employs collaborative team input and process revision through value stream mapping Popularized in writings about methods of the Toyota Corporation Six Sigma method Intensively data-driven approach to minimizing variation and thereby reducing defects or errors to improve quality Uses a cyclic approach referred to as the Define–Measure– Analyze–Improve–Control method Employs more rigorous analytical tools and process control charting under the guidance of local “black belt” or “green belt” experts Especially appropriate for repetitive, high-frequency processes
efforts, etc. Accreditation is required of all AECs and hospital-based endoscopy units to gain “deemed” status for billing and reimbursement of facility fees by CMS. Many other payers follow suit; hence, accreditation is essentially a mandate for realistic business plans of an AEC. In some states accreditation is also required for outpatient performance of all procedures employing sedation or anesthesia, including office-based units. Billing and reimbursement of facility fees by accredited office-based practices varies and remains contentious. Three major organizations accredit ambulatory surgical or endoscopy facilities, including the Accreditation Association for Ambulatory Health Care,22 the Joint Commission,23 and the American Association for Accreditation of Ambulatory Surgery Facilities, Inc.24 All have programs specific to ambulatory procedural facilities; however, they vary in their accreditation requirements, processes, and costs.
Endoscopy Unit Recognition Program The ASGE’s Endoscopy Unit Recognition Program recognizes those units that employ best practices for infection control, credentialing, and other aspects of quality care. This program distinguishes recognized facilities from less qualified units in many environments.25 Recognition requires
227 continuous accreditation by a national accrediting body; practice in accord with ASGE guidelines on infection control, endoscope reprocessing, and credentialing of staff; physician or administrator attendance at the ASGE course on enhancing unit quality; and ASGE membership of at least 50% of the practicing endoscopists of the center. The program benefits include the guidance and training provided regarding quality assurance and infection control and receipt of the Endoscopy Unit Recognition Award, including use of the award in marketing via printed and electronic media. Recognition can reassure patients regarding the use of optimal practices within a given facility.
Table 4
Commonly employed quality improvement practices
Credentialing, privileging, and reprivileging Mandated by the accreditation process Reprivileging is required every 2 years Engenders liability to the organization Important opportunity for organizations to assess/reassess staff Physician peer review Monitors the appropriateness of the quality and quantity of routine care provided by individual clinicians Routine and periodic, as in the biannual reprivileging process, or ad hoc for concerns about a provider’s practice Typically standardized review of sample encounters by noncompeting clinicians from the same discipline Subject physician comments in a fair hearing process Audit–feedback method Provision of comparative summary statistics pertaining to any useful indicator of practice When provided with anonymous data of other colleagues, functions as internal benchmarking system Often drives performance improvement without further specific counseling Lower thresholds can be employed as an early warning of the need for remedial intervention Tissue log review Review of all malignant pathology for adequate follow-up and a subset of other pathology for consistency in practice Ensures consistency among procedure indications, procedure performed, and tissue acquired Helps prevent lapses in response to significant pathology Review of adverse events, incidents, and complaints Review of all undesirable outcomes that meet a predetermined threshold of severity/risk At a minimum, all sentinel events,35 serious adverse events, and significant grievances or complaints from patients or employees Definitions and nomenclature for gastrointestinal endoscopy recently proposed36 Benchmarking Self-comparison against the highest performers among similar practitioners or institutions Measures must be quantifiable and attainable Results should be risk adjusted Internal versus own group, facility, or hospital staff or external versus aggregate data from many groups
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PQRI Pay-for-performance programs offer incentives to health care providers for achieving predetermined outcomes in the provision of care. The PQRI is a CMS program that currently provides incentive payments for satisfactory reporting of quality data pertaining to services to Medicare beneficiaries.26-36 Few measures that have been incorporated into the PQRI program are specific to gastrointestinal endoscopy. Participation requires attention to arcane billing mechanisms. The evolution of electronic record systems and of non-claimsbased measures should facilitate participation. In due time the PQRI program will evolve to penalties for nonparticipation as measures are increasingly employed. PQRI qualified benchmarking registries will greatly enhance the ease of participation in the program. Details regarding quality measures specific to gastroenterology and GI endoscopy are available on the CMS18 and ASGE37 Web sites.
Conclusions The principles of QI and quality assurance are important to administrators and practitioners alike. Active QI experience is now required for board certification, unit accreditation, and payer reimbursement. All health care units should include staff capable of guiding local QI efforts. Ultimately, our patients and our professional activities both benefit from these efforts.
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