Pennsylvania Patient Safety Advisory Quarterly Update on the Preventing Wrong-Site Surgery Project: Digging Deeper Don’t you love it when you find a cache of old Figure 1. Pennsylvania Patient Safety Authority things in your drawers . . . and it is overdue bills! Wrong-Site Surgery Reports by Quarter Pennsylvania Patient Safety Authority analysts noted a wrong-site surgery report that was not captured by NUMBER the reporting system identification algorithm and OF REPORTS followed the thread to discover four missed reports 30 going back to the second quarter of 2008. This article includes these past reports. On the other hand, five 25 25 24 tube thoracostomies, previously in the database, were 21 identified as having not been done in the operating 20 19 19 19 19 room (OR) or ambulatory surgical venues. Although 17 16 wrong-site events in other parts of the healthcare sys- 15 14 14 15 14 14 14 15 tem are a problem in their own right, the focus—and 13 13 13 metrics—of this project has been on events in OR 11 11 10 and surgical procedure room venues; therefore, those 7 reports have been deleted from this operating team project. The latest figures incorporate these adjust- 5 MS10041 ments, among other updates and corrections (see Figure 1). The good results in the second quarter 0 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 of 2009 now stand uniquely luring to the potential 2004 2005 2006 2007 2008 2009 for improvement. REPORTS BY QUARTER Is Pennsylvania making progress? Possibly, although not as fast as theoretically possible. Perhaps, compar- ing the downward trend in Pennsylvania to other I asked the patient again which side we were doing, publicly available trends for wrong-site surgery (see and the patient pointed to the right. The patient then Figure 2). Although the downward trend in Pennsyl- underwent a right popliteal block. vania is not statistically significant, it is at least in the The patient, prior to left knee surgery, was given right direction. Although the trends may be informa- a right sciatic nerve block by the anesthesiologist. tive, the numbers of events reported from each source During the block time-out, the patient told the anes- should not be compared, because the populations thesiologist that the operative side was the right side. which they cover, the exact time periods for each year, A right-sided sciatic block was performed. The anes- and the exact criteria for reporting are not the same thesiologist then performed a left sciatic block. among the entities (see the caption for Figure 2 for A femoral nerve block was performed on the wrong qualifications about each source). The downward leg prior to surgery. An alternative method of pain trend in Pennsylvania is notably volatile, suggesting management was implemented postoperatively. inconsistent compliance with known best practices or wide variation in compliance with known best prac- At the time of time-out, the staff discovered the sur- tices among facilities. geon had begun to inject local anesthesia around the right ear. The surgery was consented and scheduled Unfortunately, the successive shutouts of wrong-site for the left ear. surgery by the Health Care Improvement Founda- tion’s regional collaborative to prevent wrong-site The patient was prepped, and a femoral nerve cath- surgery have come to an end with wrong-site blocks. eter was inserted on the wrong side; the right side procedure was then completed without complication. Local and Regional Anesthesia Blocks The left knee site was marked for arthroscopy accord- Wrong-site local and regional anesthesia blocks rep- ing to the surgical consent and patient’s verbal resent a major portion of wrong-site OR procedures response. In the OR, the doctor injected the right in the recent past. This quarter, 7 of the 14 reports knee with 15 ml of lidocaine. The site discrepancy (50%) were wrong-site local or regional anesthetic was discovered by staff. The procedure on the left blocks, as follows:* knee was confirmed by time-out, and the left knee I asked the patient which side the procedure was on; arthroscopy was performed. the left leg was raised. A left femoral nerve block was A femoral block [was performed] on the left leg in performed with the patient awake. Upon turning prone error. The time-out was completed with the correct leg for the popliteal block, I discovered the wrong-side error. identified. [It was an] anesthesiologist error. Notable in all seven reports is the limited use of * All reports have been edited to remove identifying information information to confirm the side. The Authority has or have not been reported if that could not be done. shown that it is necessary to validate the side against Page 26 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Vol. 7, No. 1—March 2010 Pennsylvania Patient Safety Advisory Figure 2. Comparison of Pennsylvania Trend and Publicly Available Trends for Wrong-Site Surgery NUMBER OF REPORTS New York Minnesota Connecticut 150 Pennsylvania New Jersey Joint Commission 130 121 117 115 115 120 93 90 84 79 81 76 60 60 50 48 44 39 35 26 31 30 11 14 9 14 MS10067 4 5 3 6 0 2004 2005 2006 2007 2008 REPORTS BY QUARTER New York data are NYPORTS codes 911: Wrong Patient, Wrong Site – Surgical Procedure and 912: Incorrect Procedure or Treatment – In- vasive. New York data includes procedures performed in settings other than the operating room (OR). Data are for calendar years 2005 to 2008; data for calendar year 2009 (79 reports) is currently incomplete because of reporting delays. Data courtesy of NYPORTS (personal communication with John N. Morley, MD, and Ruth W. Leslie). Pennsylvania data are for wrong-site, wrong-procedure, and wrong-patient reports, restricted to OR and ambulatory surgical facility pro- cedures. Data are reported for years running from October to September to match Minnesota data. Pennsylvania’s downward slope is not statistically significant. Minnesota data are for wrong-site, wrong-procedure, and wrong-patient reports for years running from October to September Minnesota data include reports from outside of the OR. The data are from the Minnesota Department of Health’s Adverse Health Events in Minnesota Reports from 2005 through 2010. See: http://www.health.state.mn.us/patientsafety/publications/index.html. New Jersey data are for wrong-body-part, wrong-patient, and wrong-procedure reports. Data are for calendar years 2005 to 2007 only. The data are from the New Jersey Department of Health and Senior Services’ Patient Safety Initiative 2007 Summary Report. See: http:// www.state.nj.us/health/ps/documents/ps_initiative_report07.pdf. Connecticut data are for surgery performed on the wrong body part, surgery performed on the wrong patient, and wrong surgical pro- cedure performed on a patient. Data are from July to June. Data are from Connecticut Department of Health’s Legislative Report to the General Assembly on Adverse Event Reporting, October 2009. See: http://www.ct.gov/dph/lib/dph/hisr/hcqsar/healthcare/pdf/adversee- ventreportoct2009.pdf. Joint Commission data are for reviewable sentinel events involving surgery on the wrong patient or wrong body part. Data are for cal- endar years 2005 to 2008. The data can be seen graphically on the Joint Commission sentinel event trends reported by year—updated through 2008. See: http://www.jointcommission.org/NR/rdonlyres/67297896-4E16-4BB7-BF0F-5DA4A87B02F2/0/se_stats_trends_year.pdf. the patient’s understanding and all documents (the con- reverts to stating that the time-out should be done sent, the history and physical examination, and the prior to the incision.1 Based on multiple studies from schedule at a minimum) to minimize the risk for error. its Preventing Wrong-Site Surgery Project,* the Author- Wrong-site blocks represent 29% of all reports of ity strongly advises that a formal time-out be done with the wrong-site procedures in the surgical suites, the larg- anesthesia provider just before any anesthetic block and that est cohort of wrong-site procedures within a single another time-out be done with the surgeon just before the inci- specialty in the suites. Over time, wrong-site blocks sion, unless the surgeon performs the anesthetic block have increased significantly from less than 20% of all and incision in continuity after the surgical field has reports to more than 40% of all reports (see Figure 3, been prepped and draped. p < 0.05 by Pearson’s Correlation Coefficient), sug- Pain Management Procedures gesting that the implementation of best-practices to prevent wrong-site blocks lags behind other efforts to Pain management is not immune from wrong-site prevent wrong-site surgery. The proportion of wrong- problems, even though the patients are awake, as site anesthesia blocks is more notable given that only a fraction of patients who are vulnerable to wrong-site * The Pennsylvania Patient Safety Authority has a Web page surgery receive anesthesia in the form of blocks. devoted to educational tools for preventing wrong-site surgery (available at http://www.patientsafetyauthority.org/Educational The 2010 revision of the Joint Commission’s Univer- Tools/PatientSafetyTools/PWSS/Pages/home.aspx). Its resources sal Protocol will, in the analysts’ opinion, aggravate include all of the Authority’s publications on the subject, includ- ing self-assessment tools, sample forms and checklists, educational this concerning trend. The 2009 version of the Uni- posters and videos, illustrative figures and tables, and patient versal Protocol stated that the time-out should be education brochures, as well as links to information from other done before the start of anesthesia; the 2010 version Web sites. Vol. 7, No. 1—March 2010 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Page 27 Pennsylvania Patient Safety Advisory The Authority strongly advises that in constant attendance with the patient. The patient asked after the procedure why the right was injected a formal time-out be done with the rather than the left. The doctor was notified, and the anesthesia provider just before any correct side was then done. No adverse outcomes were noted from the injections. anesthetic block and that another A site marking, visible in the prepped and draped time-out be done with the surgeon field, is essential to avoid problems arising from disori- entation, right-left confusion, and confirmation bias. just before the incision. Ureteral Stenting noted in another of the most recent 14 reports, as Two of the reports this quarter involved stenting the follows: wrong ureter: The patient was admitted to the procedure room. A stent was placed in the left ureter instead of the right. The physician reviewed the medical record; then, the physician and nurse performed the time-out procedure. Following scheduled cystoscopy, with right retrograde, The physician performed the preprocedural skin prep, and placement of right ureteral stent, the x-ray tech then inserted the spinal needle into the left side of stated “stent in left ureter, not right.” Physician was the patient’s sacral (SI) epidural space rather than informed. Procedure was repeated with removal of the right side. We did not learn of the error until the left ureteral stent, . . . and the right ureteral stent spouse questioned [bandages] on the left side of the was placed in patient without any complications spine rather than the right. or problems. The 30 wrong-site procedures for pain management Overall, ureteral procedures account for 21 (6%) of represent another 8% of the wrong-site procedures all wrong-site surgery reports and 81% of wrong-site done in surgical suites. An earlier 2009 report illus- urological procedures. All but one were wrong-side trates another need to follow the Universal Protocol procedures, and all but one occurred in hospital ORs. for pain management procedures, as follows: Some of the other examples of stenting the wrong ure- The patient was scheduled for left cervical injection. ter in the Authority reporting system database include The time-out was done prior to procedure, and all the following: parties, including the patient, verified the procedure Patient with signed consent for cystoscopy and right was to be done on the left side. The doctor injected stent replacement. The final time-out was completed. the right side. He did not mark the site since he was During the cystoscopy, the surgeon stated the anatomy Figure 3. Percentage of Wrong-Site Surgery Reports that Describe Wrong-Site Anesthesia Blocks PERCENTAGE 60 55% 50% 50% 50 47% 47% 43% 43% 40% 40 36% 30 29% 31% 27% 32% 27% 20 23% 21% 15% 16% 14% 10 13% MS10045 7% 6% 0 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2004 2005 2006 2007 2008 2009 REPORTS BY QUARTER Page 28 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Vol. 7, No. 1—March 2010 Pennsylvania Patient Safety Advisory caused him to insert stent in the left side. The pro- prior to surgery, had hung the correct CT [computed cedure was not done under x-ray visualization. The tomography] films, etc. He removed the incorrect stent surgeon assumed the consent was in error. After in his office the day following the original procedure, patient was in PACU [postanesthesia care unit], the and the patient came back to the hospital two days surgeon confirmed with his office that the right side later to have the correct stent placed. was the correct side. [Staff] took the patient back to the OR; the surgeon removed the left-sided stent and The patient, with a history of bilateral kidney stones, placed the right stent. was scheduled to have a left kidney stone removed due to left-sided pain. Preoperatively, the surgeon Medical evaluation of a [patient] revealed obstruct- spoke with the patient and verbally identified with ing calculus within the range of the left ureteropelvic the patient that surgery was to be performed on the junction, producing hydronephosis. The patient was right side; the surgeon marked the right side. In the taken to the OR . . . for stenting of the left ureter. OR, the surgeon identified the patient and the fact The time-out verifying right patient, right procedure, that he was doing a right -sided ureteroscopy, which right side was performed. Upon arrival in the PACU, he performed, inserting a stent in the right ureter. The the physician reviewed x-ray films completed during surgeon then realized the surgery was to be on the the procedure and confirmed misplacement of the left side, and he proceeded to do a ureteroscopy with stent in the right ureter instead of the intended left removal of the stone on the left side. The patient did ureter. The . . . patient was returned to the OR for well postoperatively and was discharged home. removal of the right urethral stent and placement of a left urethral stent. The procedure occurred without The patient was scheduled for a left ureteroscopy and further complication. Complete disclosure was [done]. left retrograde with removal of stone. The patient [A patient was] admitted for insertion of a ureteral went back to the OR and underwent a right ureteros- stent. [The patient] had stones bilaterally. One side copy. The procedure was completed; no stone was was worse than the other. Per radiology interpreta- found. In the PACU, the surgeon said he was to do tion, insertion of stent was planned and completed for the left, and he did the right. The patient was taken the left side. [Staff] determined following procedure back to the OR to undergo the left ureteroscopy and [that] the stones in the right side were actually more removal of stone. problematic. The patient returned to the OR. Left- Procedure was consented for right ureteroscopy. No side stent was removed; right-side stent was inserted. stone [was] seen in right ureter. A stone was seen in Office incorrectly scheduled case. Schedule read the left ureter. A left ureterosopy was performed. The ureteroscopy with possible insertion of stent. Consent surgeon called the office to review [imaging] results, read right ureteroscopy with possible insertion of which reported a large stone in the patient’s left stent. The OR nurse confirmed with patient, at the ureter. time of preoperative checklist completion, and the patient confirmed above. A time-out was completed Patient had a cystoscopy and right retrograde for in the room, and staff confirmed with consent and ureteral calculus. When the radiologist was review- surgeon the right ureteroscopy and stent. After com- ing intraoperative films the next day, she recognized pleting the procedure, the surgeon reviewed his office discrepancy between the preoperative CT [film] and record and noted that the procedure should have been the intraoperative films. The preoperative CT [film] completed on the left side. indicated left ureteral calculus. A cystoscopy and left retrograde were performed the next day. Patient underwent left ureter stent placement [instead of] right. Consent, preoperative interview, and hold- The physician originally told office staff to schedule ing area confirmed with patient for right cystoscopy patient for a left ureteroscopic stone removal. After with stone retrieval from right ureter. A time-out was review of a subsequent CT scan, the patient was completed prior to procedure. The surgeon completed consented for a right ureteroscopic stone extraction. In procedure. The patient was taken to PACU. The sur- the OR, the patient confirmed left side, and the left geon was documenting and noted that the stent was side was done. When no stone was found, the right placed in the wrong side. The patient was returned to side was then done. surgery for right side ureter stone retrieval. Preoperatively, patient, surgeon, and nurse identi- The physician inserted the stent into the wrong ureter fied right side for procedure, and the right side was even after discussion with staff and the time-out pro- marked. In room before procedure began, a time-out cess. The patient was taken from the recovery room was performed stating the right side was the correct back into the OR where the stent was removed and site. Near the end of the case, the anesthesia provider placed in the right kidney. asked the surgeon to state the procedure. The surgeon A physician reported to the patient safety officer stated that he had done a left retrograde and stent that he had placed a right ureteral stent in a patient insertion. The nurse then stated that the permit, when he should have placed the stent on the left. The history and physical, and markings all stated right. physician was clear that the hospital OR staff had Surgeon then removed the left stent and did a right correctly followed the Universal Protocol on time-out retrograde and stent insertion. Vol. 7, No. 1—March 2010 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Page 29 Pennsylvania Patient Safety Advisory A patient was scheduled and consented for a right in mid-procedure, and one of the recent confusions ureteroscopy and placement of a right ureteral stent. was detected by the radiography technician. These During procedure, a renal stone was identified to be experiences suggest that the urologists should follow on left side by the doctor and verified by in-room fluo- the same principles as vertebral surgeons by obtaining roscopy. [Staff] scheduled a procedure to be performed an intraoperative imaging study to confirm proper on left side. stent placement, with the interpretation documented The provider inserted a stent into left ureter and at the time. Pregnant patients could have ultrasound then discovered after viewing CT and images that he imaging. placed the stent in the wrong side. The review of wrong-side stents suggests that they The patient consented to cystoscopy with left ureteral could be prevented by mentioning the correct side stent insertion. The RN [registered nurse] confirmed when scheduling; verifying and reconciling the side operative consent verbally with patient, and a brace- on the schedule, the consent, the history and physi- let was applied confirming left side. Intraoperatively, cal examination and/or the office notes, and the it was discovered that it should have been right ureter. preoperative imaging studies, rather than relying on The procedure was stopped, and physician spoke [with memory; and properly marking the side before enter- the] patient and family and then did the right side. ing the OR. During the time-out, the surgeon should be engaged, the side should be mentioned, and, as The patient was diagnosed with bilateral renal stones with all time-outs, the OR staff should be explicitly with left urethral obstruction. The patient inadver- empowered by the surgeon to speak up if concerned. tently consented to have urethral stent placed on the right side instead of the left side that was obstructed. It may be helpful to “call out” the placement of the The patient underwent the right-side stent place- stent, including the side, when it is placed intraop- ment. It was discovered, while the patient was in the eratively and have the circulating nurse verify this PACU, that the incorrect side was stented. Consent information mid-operation against the documents. was obtained for the patient to return to the OR to Finally, it may be useful to follow an intraoperative have the left-side stent placed. The patient and family verification protocol, similar to that for spinal surgery, were informed of the error. using an intraoperative imaging study to confirm Contributing factors that were reported multiple proper stent placement, with the interpretation docu- times included bilateral pathology (four times), mented at the time. patient indicated the incorrect side (four times), schedule was incorrect (three times), consent was Hand Surgery incorrect (three times), preoperative image was not One report this quarter involved hand surgery, referenced (three times), and office notes were not ref- as follows: erenced (three times). Overall, 10 (50%) of the reports The patient was scheduled for left trigger thumb specifically mentioned some form of misinformation, release. The surgeon made the incision for carpal correctable prior to entering the OR, as a contribut- tunnel release. The surgical technician questioned the ing factor. procedure. The correct procedure was then done. Six stents were placed on the wrong side despite spe- Overall, hand surgery accounts for 21 (6%) of all the cific reference to doing a time-out. This suggests that wrong-site surgery reports. All of the wrong sites were perhaps the side is not referenced during the time- on the correct hand, but in the wrong part of the out. The reports also suggest that wrong-side ureteral hand; 11 were the wrong procedure altogether, and stenting can still occur because the intervention on the other 10 were the correct procedure but on the the wrong side occurs after the operation has begun, wrong digit. Remarkably, 7 of the 11 incorrect proce- rather than initially, and that the side of the instru- dures were carpal tunnel releases when the patients mented ureter may only be known to the surgeon were scheduled for release of “trigger fingers” (or visualizing the landmarks, not to the other members “trigger thumbs”). Of the other 10, 7 mentioned both of the OR team, who have more limited views of the the correct and incorrect locations and, in all cases, procedure, if any. These reports suggest that stenting involved adjacent digits, albeit not in any pattern. of the ureters has similarities with localization of the vertebral levels. The surgeon may be victim to right- Misinformation in the schedule and consent was only left confusion or the fact that the two ureteral orifices mentioned in one report, whereas misorientation are only about 4 cm apart, but are usually not in the was a factor in six: a loss of orientation in one, the same field of vision. absence of a proper mark in two, and starting before or without a time-out in the other three. The absence A review of the reports shows that the failure to do of a proper mark and the loss of orientation resulted intraoperative imaging was cited as a contributing in reports of mental lapses, as indicated by the follow- factor in one case and that patients were returned to ing reports in the series: the OR to correct errors documented by intraopera- tive radiographs on two occasions and, most certainly, Scheduled, consented, and marked for release of trig- by a postoperative CT scan on a third occasion. ger; area prepped [with] alcohol; during prep site, The error identified by fluoroscopy was corrected mark washed off [with] alcohol; time-out done; Page 30 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Vol. 7, No. 1—March 2010 Pennsylvania Patient Safety Advisory surgeon proceeded to do carpal tunnel . . . surgeon of this help came from members of the staff, reinforc- told staff he was thinking about a patient he had ing the importance of specifically empowering the OR done the previous day. staff to speak up if concerned during the time-out. Verification of procedure was performed with all OR The review of hand surgery reports suggests that errors staff for the procedure to be done on the left ring fin- would best be prevented if the surgeon made the mark ger. The surgeon turned from field to consult records, as close as possible to mimicking the incision and turned back to field, picked up long finger, and pro- by doing the time-out as close as possible to actually ceeded with surgery. making the incision. The surgeon should be engaged The errors were reported to have been detected and in the time-out by actively stating the procedure to corrected during 17 of the procedures. Seven were be done and by pointing to the marks in the areas of realized by the surgeon, four were brought to the the planned incisions. The surgeon should explicitly attention of the surgeon by members of the OR staff empower the OR staff to speak up if concerned. (as in the example above), and three by the patients; The Wrong-Site Surgery Consultation Program the remaining three did not mention how the error was detected. The Authority has begun an on-site consultation pro- gram for Pennsylvania facilities that wish to analyze It appears that wrong-site hand surgery is almost their vulnerability for wrong-site surgery, particularly always the wrong procedure or in the wrong location following a wrong-site event (or a close call) in a of the correct hand documentation. Five reports surgical suite. Requests can be made through the mentioned that an appropriate time-out was done. Authority office or the regional Patient Safety Liaison. As illustrated in the examples, the reports suggest The Authority clinical specialists will assist facilities that the errors resulting in wrong-site hand surgery in assessing policies and procedures, measuring staff frequently begin with confusion in the mind of the compliance, and doing a thorough analysis of any surgeon between the pause for a time-out and the events, using resources developed by the Authority incision. This confusion at the start of the operation (see footnote on page 27). is in contrast to heart surgeons and upper abdominal surgeons. No reports have been submitted to the The Pennsylvania Patient Safety Authority is com- Authority of a surgeon intending to do a coronary mitted to having no patient experience wrong-site artery bypass and doing a valve replacement instead surgery. Are you? (or vice versa) or of a surgeon intending to remove Note one upper abdominal organ and removing another instead. And, hand surgeons even have the advantage 1. Joint Commission. Revised Universal Protocol; some of being able to mark different, specific incision loca- changes are effective immediately. Joint Commission Online 2009 Sep 9 [cited 2010 Jan 25]. Available tions unique to the correct procedures. from Internet: http://www.jointcommission.org/ Errors were brought to the surgeons’ attention by oth- NR/rdonlyres/25D5EC4D-F17C-4DCB-B0D2- ers as often as self-correction occurred. The majority 8967EE48D5F1/0/jconlineSept909.pdf. Vol. 7, No. 1—March 2010 REPRINTED ARTICLE - ©2010 Pennsylvania Patient Safety Authority Page 31 PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 7, No. 1—March 2010. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority. Copyright 2010 by the Pennsylvania Patient Safety Authority. 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Consistent with Act 13, ECRI Institute, as contractor for the Authority, is issuing this publication to advise medical facilities of immediate changes that can be instituted to reduce Serious Events and Incidents. For more information about the Pennsylvania Patient Safety Authority, see the Authority’s Web An Independent Agency of the Commonwealth of Pennsylvania site at http://www.patientsafetyauthority.org. ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for nearly 40 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, and healthcare processes, devices, procedures and drug technology. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP’s efforts are built on a nonpunitive approach and systems-based solutions.