Patient Safety Advisory Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 3 (Sept. 2005) Produced by ECRI & ISMP under contract to the Pennsylvania Patient Safety Authority Expecting the Unexpected: Ambulatory Surgical Facilities and Unanticipated Care T he substantial increase in the number of proce- dures performed in ambulatory surgical facilities (ASFs)1 has made it important for clinical staff in changes in the patient’s condition that necessitated aborting the procedure. Reported complications var- ied, but perforations were the most frequently re- ASFs to “expect the unexpected” and prepare for the ported cause for urgent transfer to the hospital, fol- need to provide unanticipated care to their patients. lowed by uncontrolled bleeding. Examples include: Of the 1,960 total reports submitted to PA-PSRS from ASFs, approximately 686 (35%) have involved the During colonoscopy, the colon was perfo- need to provide unanticipated patient care or to trans- rated. Patient was given Cipro IV and be- fer the patient to another provider. The majority of came hypotensive. Anesthesiologist accom- these reports describe procedure cancellations, trans- panied patient in ambulance and then to fers for emergent intraoperative care, or emergent OR. postoperative follow-up care. Following removal of hardware, bleeding Is there a way to reduce the incidence of cancella- continued. Dorsalis pedis artery was lacer- tions or transfers? The necessity to provide unantici- ated. Vascular surgeon called. Artery re- pated care while at the surgical center places the pa- paired. Patient transferred to hospital. tient, other patients, and the ASF staff at risk. A re- view of reports to PA-PSRS and the clinical literature Reasons for postoperative transfers are diverse. suggests the following opportunities for risk analysis Post-op transfers account for 19 (54%) of the 35 and improvement: cases. Of those 19 cases, 16 (84%) required direct hospital transfers for services ranging from immediate • Patient selection, with a focus on procedure, surgical intervention to observation, and three cases patient medical condition, and location. (16%) required transfers to emergency departments for observation or follow-up care. The following is an • Ability to provide prompt and competent unan- example of a typical report in this category: ticipated care. Post procedure patient received in PACU in • Timely, efficient, and safe transfers to hospi- respiratory distress, pulse ox 85-90% on tals, when necessary. room air. O2 supplemented with non-re- breather mask. Anesthesia and surgeon Reports to PA-PSRS agreed to ACLS transfer via local medic unit. A random sample of 100 ASF reports filed in PA- PSRS were reviewed, with 35 reports (35%) related Patient Screening for Risk of Transfer or Unantici- to unanticipated care. Thirty-one percent (11 cases) pated Hospital Admission of the 35 cases involved preoperative procedure can- Three studies support the importance of appropriate cellations, nearly all of which were secondary to car- patient selection for services at an ASF.2-4 An analy- diac-related symptoms. In each case, the patient was sis of Medicare claims found that the strongest pre- transferred or referred to another facility for follow-up dictor of post-procedure admission was hospitaliza- care. Most patients were transferred by ambulance to tion within the previous six months, with “a 2-fold in- the emergency department of a local hospital. The following report narrative is characteristic of this cate- gory: This article is reprinted from the PA-PSRS Patient Safety Advisory, Vol. 2, No. 3—Sept. 2005. The Advisory is a publication of the Pennsylvania Patient Cardiac monitoring preprocedure showed Safety Authority, produced by ECRI & ISMP under contract to the Authority as sinus bradycardia. Stat EKG performed. Si- part of the Pennsylvania Patient Safety Reporting System (PA-PSRS). nus bradycardia with first-degree block and Copyright 2005 by the Patient Safety Authority. This publication may be re- frequent PVCs in a pattern of bigeminy. printed and distributed without restriction, provided it is printed or distributed in Transported to ED. its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration provided the source is clearly attributed. Fourteen percent (5 cases) of the 35 “unanticipated To see other articles or issues of the Advisory, visit our web site at care” reports were categorized as intraoperative www.psa.state.pa.us. Click on “Advisories” in the left-hand menu bar. ©2005 Pennsylvania Patient Safety Authority Page 1 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 3 (Sept.2005) Expecting the Unexpected: Ambulatory Surgical Facilities and Unanticipated Care (Continued) creased risk associated with multiple prior inpatient and cough, and SpO2 89% on room air. hospital admissions.”3 The oldest age cohort (85 Patient stated that after his scope proce- years and older) also had a nearly 2-fold increased dure last month, he had to be admitted. risk relative to the 65- to 69-year-old cohort.3 Canceling this case probably saved the patient from A study of New York State surgery data searched for an emergent transfer and hospitalization. Though predictors of hospitalization or death in 783,483 pro- everyone wants to avoid a cancellation, it is frequently cedures, 40,000 of which were done in ambulatory better to interrupt the surgical schedule and inconven- settings. The researchers identified the following fac- ience the patient than to risk an emergent situation. tors for predicting hospital admission or death follow- ing outpatient surgery and concluded that patients Emergency Preparedness with four or more of these risk factors would fare best Of the 35 reports reviewed, 69% involved patients if treated in a center connected to a hospital:4 who required intraoperative or postoperative hospital- level care, with transfers for direct admission, immedi- • Patient age greater than 85 years. ate surgical intervention, or emergency department • Peripheral vascular disease. care in which patient observation or follow-up ser- • Operating room time greater than one hour. vices were provided. Both regulatory and accrediting • Malignancy. bodies address the issue of ASF preparation for • Positive HIV status. emergencies. • Heart disease. Emergency preparedness procedures may include • A requirement for general anesthesia. designating which practitioner from the ASF will es- cort the patient during transfer, determining when to All ambulatory surgical patients require some level of activate the 911 system, and deciding where the pa- care and support postoperatively. This need may be tient will go.7 The following case demonstrates the substantial for medically complex patients. Adequate necessity for activation of an emergency medical sys- support at home is needed to provide for treatment tem and determination of accompaniment: and monitoring related to both the surgical interven- tion and their preoperative state. Therefore, attention Following a cervical epidural injection, the to preoperative medical needs, the expected postop- patient became unresponsive to verbal erative care, and the level of home support is taken and tactile stimulation. Patient had a into consideration when deciding on a location for pulse and blood pressure but was not surgery. Additional criteria mentioned in the literature breathing. Manual respirations applied for consideration when screening patients for appro- via ambu bag. Physician intubated pa- priateness of surgery location are baseline medica- tient, deemed patient stable for transfer tions, general mental health,5 functional limitations, via emergency services (911). Physician and social support.6 accompanied patient. Examining the patient’s history of recent hospitaliza- As long as a patient is on-site, staff certified in ACLS tion and reviewing identified risk factors may provide (and/or PALS, depending on patient age) are avail- insight into the potential for transfer or admission able.7 In addition, Pennsylvania regulations require an postprocedure as well as the likelihood of case can- anesthetist to remain until the last patient is dis- cellation. The routine preoperative assessment com- charged when general anesthesia, regional anesthe- pleted upon patient admission to the ASF frequently sia, or sedation is administered.8 captures critical information necessary to decide whether to abort the case. Changes in the patient’s A written plan or policy typically addresses the issue condition, complex medical histories, noncompliance of readiness for the unexpected when patients are in with preoperative instructions, or other unexpected the facility. Staff educated in activation of the emer- issues may necessitate a case cancellation, as the gency plan will perform with confidence and efficiency following case indicates: in responding to changes in a patient’s condition. Re- view of this plan, including individual responsibilities Upon pre-op assessment for a TURP according to the various roles delineated in the plan, [transurethral resection of the prostate] is important to ensure readiness for urgent or emer- scheduled under general anesthesia, it gent situations. Routine drills may be added to the was detected the 80-year-old patient had review process to further ensure that emergency a history of severe COPD [chronic ob- readiness is maintained. structive pulmonary disease], recent cold Page 2 ©2005 Pennsylvania Patient Safety Authority Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 3 (Sept. 2005) Expecting the Unexpected: Ambulatory Surgical Facilities and Unanticipated Care (Continued) Readiness for transferring a patient is required by the tions. As resources are extended to meet the pro- Pennsylvania Department of Health rules and regula- jected rising demand, anticipate scrutiny of case can- tions, as follows: cellations and tightly managed transfers. Expect fo- cused attention on maintaining quality care, helping to • “An ASF shall be prepared to initiate immedi- ensure that ASFs provide competent and consistent ate on-site resuscitation or other appropriate surgical care of the highest standard, with apprecia- response to an emergency which may be tion for the strain that unanticipated care places on associated with procedures performed there. the patient and caregiver, the staff, and the schedule, not to mention the inherent risk to all involved. Readi- • “The ASF shall have an effective procedure ness for unexpected patient transfers and attention to for the immediate transfer to a hospital of pa- patient selection provides for optimal patient out- tients requiring emergency medical care be- comes, staff satisfaction, and best use of resources in yond the capabilities of the ASF. delivering high-quality care. • “The ASF shall have a written transfer agree- ment with a hospital which has emergency Notes and surgical services available or physicians 1. Rehnquist, J. Quality oversight of ambulatory surgical centers performing surgery in the ASF shall have ad- the role of certification and accreditation supplemental report 1 Department of Health and Human Services Office of Inspector mitting privileges at a hospital in close prox- General. [online] http://oig.hhs.gov/oei/reports/oei-01-00-00451.pdf. imity to the ASF, to which patients may be 2. Winter A. Comparing the mix of patients in various outpatient transferred. surgery settings. Health Affairs. 2003 Nov-Dec;22(6):68-75. • “There shall be a written agreement in effect 3. Fleisher LA, Pasternak LR, Herbert R et al. Inpatient hospital with an ambulance service staffed by certified admission and death after outpatient surgery in elderly patients: importance of patient and system characteristics and location of EMT personnel, for the safe transfer of a pa- care. Archives of Surgery. 2004 Jan; 139(1):67-72. tient to a hospital in an emergency situation, 4. Fleisher LA Pasternak LR, Lyles A. A novel index of elevated or as the need arises.”8 risk for hospital admission or death immediately following outpa- tient surgery,” American society of Anesthesiologists 2002 Meeting In addition to the state regulations, the American Col- Abstracts, [online] http://www.hopkinsmedicine.org/press/2002/ lege of Surgeons Guidelines for Optimal Ambulatory October.021014.htm. Surgical Care and Office-based Surgery and federal 5. Reiling R. McKellar D. Outpatient surgery. ACS Surgery. Med- regulations describe the need for emergency equip- scape [online] 2004 [cited 2005 June 17]. Available from Internet: http://www.medscape.com/viewarticle/505418_print. ment and transfer agreements.9,10 The federal regula- tions, similar to the state regulations, require that sur- 6. Smith I. Screening and selection of ambulatory surgery patients. European Society of Anaesthesiologists [online] 2003 May 31 [cited geons performing procedures at an ASF have privi- 2005 June 17]. Available from Internet: http:// leges at the receiving hospital or that the facility have www.euroanesthesia.org/education/rc2003glasgow/2rc1.pdf. transfer agreements with the hospital(s), if war- 7. Ambulatory surgery: principles and practice: standards and rec- ranted.10 ommended practices for ambulatory surgery, Vinson, NJ, ed. Asso- ciation of Perioperative Registered Nurses. Denver, CO: AORN, Since 1999, the Association of periOperative Regis- 2003. tered Nurses (AORN) has annually updated or re- 8. Pennsylvania Bulletin Issue: Volume 29, Number 43 Issue Date: vised its comprehensive publication Standards and Saturday, October 23, 1999, Part II, Subject: Rules and Regulation, Agency: Department of Health 29 Pa. Bull. 5583 Title 28 Health Recommended Practices for Ambulatory Surgery, and Safety Department of Health (28 PA. Code CHS. 555.22) Am- which provides detailed information specific to any bulatory Surgical Facilities ambulatory surgical setting. This text includes AORN 9. Guidelines for Optimal Ambulatory Surgical Care and Office- practice standards specific to ambulatory settings, based Surgery, Developed by the Board of Governors Committee providing pre-, post-, and intraoperative nursing care on Ambulatory Surgical Care, third edition, May 2000. considerations, as well as guidance related to issues 10. Electronic Code of Federal regulations (e-CFR) Title 42: Public specific to the ambulatory setting.7 Health, Part 416 Ambulatory Surgical Services, Subpart C Specific Conditions for Coverage, 416.41 condition for coverage-Governing Conclusions body and management. [47 FR 34094. Aug. 5. 1982, as amended at 51 FR 22041, June 17, 1986] [online] at http:// As the shift to outpatient surgery is fueled by techno- www.gpoaccess.gov. logical advances, the current proportion of all surgical 11. Marley R, Swanson J, Patient care after discharge from the procedures that occur on an outpatient basis (60%) is ambulatory surgical center. Journal of PeriAnesthesia Nursing. likely to increase.11 This expected industry growth 2001 Dec;16(6):399-417. increases the need for vigilance in early identification of patients at risk of intra- or postoperative complica- ©2005 Pennsylvania Patient Safety Authority Page 3 Reprinted from the PA-PSRS Patient Safety Advisory—Vol. 2, No. 3 (Sept.2005) An Independent Agency of the Commonwealth of Pennsylvania The Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI, as contractor for the PA-PSRS program, is issuing this newsletter to advise medical facilities of immediate changes that can be instituted to reduce serious events and incidents. For more information about the PA- PSRS program or the Patient Safety Authority, see the Authority’s website at www.psa.state.pa.us. ECRI is an independent, nonprofit health services research agency dedicated to improving the safety, efficacy and cost-effectiveness of healthcare. ECRI’s focus is healthcare technology, healthcare risk and quality management and healthcare environmental management. ECRI provides information services and technical assistance to more than 5,000 hospitals, healthcare organizations, ministries of health, government and planning agencies, and other organizations worldwide. 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 non-punitive approach and systems-based solutions. Page 4 ©2005 Pennsylvania Patient Safety Authority