1. 1 © 2013 B. Ettinger MD/MPH “… It’s Quality, not Quantity” Bruce B. Ettinger, MD, MPH Certified Federal Medicare Surveyor (Ret) Consultant for Regulatory & Accreditation Compliance Making the Case for Why…

2. 2 © 2013 B. Ettinger MD/MPH Proposals:  Harm (risk of) in ASCs - a function of rapid growth and development of the ASC industry related activities within individual ASCs.  QAPI - the most critical Condition for Coverage operational effectiveness and efficiency safety and quality of care

3. 3 © 2013 B. Ettinger MD/MPH Presentation Objectives  Understand and apply the Regulations to operations and clinical practices, to create and maintain a “safe, sanitary, and functional environment” of care.  Employ the regulations as guidelines and checklists as a method of “quality control” for all clinical, operational, and administrative services.  Incorporate the concepts of “systems' approach” and “minimum necessary standard,” when developing and implementing facility policies and procedures.

4. 4 © 2013 B. Ettinger MD/MPH Session Overview Risk of harm in the ASC Regulatory Focus for Quality Assessment/ Performance Improvement Survey Experience (Selected Issues) Summary and Conclusions

5. 5 © 2013 B. Ettinger MD/MPH PLEASE NOTE that the purpose of this discussion is to promote awareness of heath care regulations as guidelines for safe practices and quality of care in Ambulatory Surgery Centers. The opinions, suggestions, and conclusions are those of the presenter, as based on experience with surveys and the regulations, but they are not intended to replace more specifically directed consultations, including legal advice, to address the needs of specific facilities, issues, or providers. Nevertheless, inquiries are welcome, but thereafter we recommend follow-up discussions with your ASC consultants and appropriate health care attorneys to confirm compliance with all applicable laws and regulations, and their application and relationship to the federal Conditions for Coverage and related Accreditation requirements. PLEASE NOTE that the purpose of this discussion is to promote awareness of heath care regulations as guidelines for safe practices and quality of care in Ambulatory Surgery Centers. The opinions, suggestions, and conclusions are those of the presenter, as based on experience with surveys and the regulations, but they are not intended to replace more specifically directed consultations, including legal advice, to address the needs of specific facilities, issues, or providers. Nevertheless, inquiries are welcome, but thereafter we recommend follow-up discussions with your ASC consultants and appropriate health care attorneys to confirm compliance with all applicable laws and regulations, and their application and relationship to the federal Conditions for Coverage and related Accreditation requirements.

6. 6 © 2013 B. Ettinger MD/MPH Request: This work includes intellectual property that is in copyrighted, and in preparation for publication. Please do not distribute or otherwise use at this time. Thank you.

7. 7 © 2013 B. Ettinger MD/MPH But don’t despair… MURPHY'S LESSER-KNOWN LAW The things that come to those who wait, will be the things that were left behind by those who got there first !

8. © 2013 B. Ettinger MD/MPH 8 Charles Barsotti, New Yorker Magazine, July 8 & 15, 2013, p 28 “Listen carefully, I don’t have much time.”

9. © 2013 B. Ettinger MD/MPH 9 ISSUES “Little is known about ASC quality…. The immaturity of the ASC quality measurement literature [and] the lack of controls for patient risk factors, points to the need for more research.” RAND Health, 2009. California Ambulatory Surgery Centers: A Comparative Statistical and Regulatory Description “Far too many surgery centers tend to allow shortcuts in surgeon's H&Ps, anesthesia supervision, infection control, safety, peer review and quality improvement.” Herzog G. Outpatient Surgery Magazine Online, 11/5/12 “

10. 10 © 2013 B. Ettinger MD/MPH Rapid Growth of the ASC Industry  Increasing number of ASCs - 67%, 1997 - 2004 (1)  Increasing volume of patients 3.3 million Medicare beneficiaries (2010) (2) older; coexisting medical problems  Increasing number, type & complexity of procedures ~ 23 million surgeries annually (1) advances in technology and skills longer procedure time longer and deeper levels of anesthesia stacking multiple procedures at one time (1) American Hospital Association, 2011 (2) MEDPAC Report to Congress: Medicare Payment Policy, 2012

11. © 2013 B. Ettinger MD/MPH 11 Number of Medicare-Certified ASCs Source: MedPAC, Data Book, June 2006 in Ambulatory Surgery Centers: A Positive Trend in Health Care http://www.leg.state.nv.us/74th/Interim_Agendas_Minutes_Exhibits/Exhibits/HealthCare/E042108L-2.pdf 4/21/08 5260 in 2013 Amer Hosp Assoc 5175 in 2008 Rpt to Congress 2010: Medicare ASC Value-Based Purchasing Plan 1000 in 1988 1 in 1970

12. © 2013 B. Ettinger MD/MPH 12 FORECASTED DEMAND GROWTH IN THE NUMBER OF ASC PROCEDURES BY SPECIALTY Source: Etzioni DA, et al. Ann Surg. 2003 Aug;238(2):170-7, The aging population and its impact on the surgery workforce, in Ambulatory Surgery Centers: A Positive Trend in Health Care ( http://www.leg.state.nv.us/74th/Interim_Agendas_Minutes_Exhibits/Exhibits/HealthCare/E042108L-2.pdf 4/21/08)

13. 13 © 2013 B. Ettinger MD/MPH Rapid Growth of ASC industry  Volume + Complexities creates risk for Injury  Problems include (CMS) inappropriate use of technology (overuse, under-use, misuse) inappropriate cost containment policies & practices short cuts - “Time is money” “The cost of poor quality… doing things badly”  Need - increased Governing Body oversight to keep pace with rapid increases in volume, technology, internal facility growth, etc.

14. 14 © 2013 B. Ettinger MD/MPH Why does harm occur?  Uncertainty for the patient randomness of disease (occurrence; severity) relative lack of knowledge  Uncertainty for the physician diagnosis – best educated guess effect of interventions - failure to keep pace with science and technology. other  Variation in processes and outcomes of care  Unclear lines of accountability provider; facility

15. 15 © 2013 B. Ettinger MD/MPH Why does harm occur?  Health Care variation, uncertainty, randomness - lead to entropy  Entropy disorder or unpredictability uncertainty associated with a random variable entropy + lack of accountability = risk of harm “Left unattended, things can go wrong.”

16. © 2013 B. Ettinger, MD/MPH 16 Institute of Medicine Medical Error Active Errors  unsafe acts commission omission (lack of action)  committed by an individual  immediate potential for harm  uncommon - sporadic - unpredictable “ To Err is Human,” National Academy Press, 2000;

17. © 2013 B. Ettinger MD/MPH 17 Institute of Medicine Medical Error Active Errors  unsafe acts commission omission (lack of action)  committed by an individual  immediate potential for harm  uncommon - sporadic - unpredictable Latent Errors  system deficiencies  dormant – hidden within system’s infrastructure  potential for harm  sequence of events - not a single cause  activated by triggering event  not incompetence or negligence “aligning the holes in Swiss cheese” Includes all support services and other operational and administrative services “ To Err is Human,” National Academy Press, 2000

18. © 2013 B. Ettinger MD/MPH 18 Adverse Event Clinical Concern OUCH ! Clinical Course Active Error X X

19. © 2013 B. Ettinger MD/MPH 19 Latent (Systems) Factors (Layers of Defense) Policies & Procedures Credentialing; Competency Infection Control QAPI; etc. Adverse Event Clinical Concern Management & Administration Clinical Providers Lab, X-Ray, Blood Bank, etc. OUCH ! Triggering Event X X Adapted from Reason J. Managing the Risks of Organizational Accidents, 1997 Facility Infrastructure, etc.

20. 20 © 2013 B. Ettinger MD/MPH Institute of Medicine; Joint Commission Preventable Medical Error, Adverse Event  unplanned, unanticipated, unexpected event unrelated to the underlying condition  use of wrong plan, or failed or unexecuted plan  resulting in harm … death, or serious physical or psychological harm with or without permanent effect  … or the risk of harm

21. © 2013 B. Ettinger MD/MPH 21 Technical Failure Human Failure Organization Failure Dangerous Situation Adequate Defenses Return to Normal Developing incident Adequate Recovery NEAR MISS ADVERSE EVENT Adapted from Patient Safety: Achieving a new standard for care. National Academies Press, 2004, p228 YES NO Incident Causation Model PROCESSES OF CARE

22. 22 © 2013 B. Ettinger MD/MPH - Regulatory Focus - Safer Practices, Patient Safety and Quality of Care “Safe, sanitary, and functional” environment of care”

23. © 2013 B. Ettinger MD/MPH 23 Quality Defined The Quality of Health Care in the United States: Shuster MA, in Crossing the Quality Chasm, pp 231-249  “The degree to which health services… increase the likelihood of desired health outcomes, and are consistent with current professional knowledge.”  “Providing patients with appropriate services, in a technically competent manner, with good communication, shared decision making, and cultural sensitivity.”

24. 24 © 2013 B. Ettinger MD/MPH The Why of QAPI and Regulations Patient Safety: Achieving a new standard of care. Institute of Medicine: National Academy Press, 2004 “Safety - freedom from accidental injury, … a preeminent feature of health care quality.” “Quality Chasm” - The gap between what health care should be, and what it is - what people should receive, and what they actually receive. “If we cannot measure outcomes, we cannot begin to manage them.” Gee, R, et al. Obstet/Gynecol 2013:121;507

25. 25 © 2013 B. Ettinger MD/MPH The “How” of QAPI and Regulations “… fundamentally designed as guidelines to preemptively protect patients.” IOM 2004, Patient Safety: Achieving a New Standard of Care Guidelines for structures and processes of care what must be in place (not how to accomplish) broad terms - each facility adapts the regulations to its mission and community of service bylaws, rules, regulations, policies and procedures required facility documents - must be implemented “Minimum necessary standards”

26. 26 © 2013 B. Ettinger MD/MPH Critical Purpose of the Regulations  Reduce the occurrence of active/latent errors, adverse events, and near misses (potential or risk for AEs).  In QAPI terms - minimize the “SCOPE, SEVERITY, and FREQUENCY” of errors, adverse events and near misses.  Provide tools and directives in the Regulations, Interpretive Guidelines, and Survey Procedures.

27. 27 © 2013 B. Ettinger MD/MPH Technical Failure Human Failure Organization Failure Dangerous Situation Adequate Defenses Return to Normal Developing incident Adequate Recovery NEAR MISS ADVERSE EVENT YES NO Regulatory Oversight and Compliance PROCESSES OF CARE

28. 28 © 2013 B. Ettinger MD/MPH QAPI - The Linch-Pin for Quality in ASCs  Specific Program/Plan is not required but strongly recommended (ASC mission, vision, values)  Program and Process musts (no choice) comprehensive (facility-wide) – ongoing - systems approach identify opportunities to improve patient care data-driven to demonstrate improvements use quality indicators &/or performance measures identify problems - implement remedial actions monitor effectiveness – evaluate corrective actions

29. 29 © 2013 B. Ettinger MD/MPH Summary of Quality Assessment/Performance Improvement Regulations (Q 80 - 84)  Focus high risk/volume, problem prone procedures (low volume) adverse events, near miss (active/latent errors, w/o injury) all other areas for latent factors (operational, administrative, e.g., credentialing, RN staffing, etc. Patient-centered – surveys  Measurable = ability to compare benchmark - before/after “track and trend” incidence (prevalence, severity) improvements = PDCA

30. 30 © 2013 B. Ettinger MD/MPH Quality Indicators - Processes and Outcomes  Known, validated indicators consistent with national professional societies, and/or accepted standards of care  Internal indicators high risk, high volume problem-prone areas adverse events & near misses low volume procedures infection control (refer to Q 240) every other aspect of care and services in the ASC New Technology New Skills, Co-Morbidities, etc.

31. 31 © 2013 B. Ettinger MD/MPH IG Examples of Quality Indicators (Q82) ( b a s e d o n N a t i o n a l Q u a l i t y F o r u m ( N Q F ) s t a n d a r d s f o r A S C s ) Burn - % of ASC patients experiencing burn before discharge Prophylactic intravenous antibiotic timing - % of ASC patients receiving appropriate antibiotics, on tim e Hospital transfer/admission - % of ASC patients transferred, prior to formal discharge Fall - % of ASC patients experiencing a fall Wrong site, side, patient, procedure, implant, [medication] - % of ASC admissions experiencing any “wrong”

32. © 2013 B. Ettinger MD/MPH 32 IG Examples of Quality Indicators (Q82) (based on National Quality Forum (NQF) standards for ASCs) Burn - % of ASC patients experiencing burn before discharge Prophylactic intravenous antibiotic timing - % of ASC patients receiving appropriate antibiotics, on tim e Hospital transfer/admission - % of ASC patients transferred, prior to formal discharge Fall - % of ASC patients experiencing a fall Wrong site, side, patient, procedure, implant, [medication] - % of ASC admissions experiencing any “wrong” These are the same as current ASC Quality Reporting requirements!

33. 33 © 2013 B. Ettinger MD/MPH QAPI - Quantitative, Data-Driven Methodology  Track and Analyze - incidence (prevalence, severity)  Benchmark and Gap Analysis/closure identify desired goal (benchmark) identify (root) causes for differences close gap between current activity and goal  Demonstrate sustained improvements implement preventive strategies compare before/after implementing corrective actions  Sophisticated statistical methods not expected must have appropriately qualified personnel to collect and interpret data on-line programs, consultant okay

34. 34 © 2013 B. Ettinger MD/MPH Benchmarking (goal-setting)  Purpose comparison with accepted standards uses specific indicators, and data (metrics) of performance understand differences (gaps )  Examples Internal - patient surveys; staff focus groups; incidence calculations Best Practice standard - preliminary evidence of effectiveness, w/wo expert opinion Evidence-Based standard - best available evidence from simple observations to bona fide systematic research

35. 35 © 2013 B. Ettinger MD/MPH Incidence Rate (frequency) at which a situation occurs think… “I” stands for “Interval” measured in intervals over time (day, month, year, etc. ) expressed as % (# of problems or observations) (total # of “at risk” situations over time) (# Antibiotics given on time) ( Total number of cases at risk for SSI, for a month, or year) I (ABx) = (800 ABx on time) / (1000 procedures per year) = 8/10 x 100 = 80% w appropriate ABx per year X 100 = % = I = I =

36. 36 © 2013 B. Ettinger MD/MPH  If Incidence of on-time Abx is 80%, and benchmark (local, regional, or national average) is 97% * Gap is 17% --- ASK: Why the difference ?  Implement program to reduce the gap Investigative methods, e.g. root cause analyses (case) Look for common causes, issues, events (“trend”- all cases) Implement corrective actions to close the GAP Re-measure at defined intervals (“track”) Repeat until gap is closed, or as close as possible after repeated trials. Benchmarking and Gap Analysis/Closure to Improve Processes and Outcomes of Care * Medicare Hospital Compare, 7/18/13. 10 0 Patient Safety Benchmarks, Becker's Hospital Review, 8/12/13. www.beckershospitalreview.com

37. © 2013 B. Ettinger MD/MPH 37 CAUSES EFFECT Ishikawa Fishbone Diagram

38. © 2013 B. Ettinger MD/MPH 38 Organizational Directives Benchmarking Mission Who you are. What you do. Reveals gaps (Where you are) Vision Where you want to go, from where you are. How you plan to get there. The goals for best practices and outcomes. (Actual benchmarks) Value Ethics, qualities, and processes to fulfill mission and vision. Ethics, qualities, and processes to fulfill mission and vision. Processes to close the gaps, Gap Analysis, (RCA FMEA, PDCA, etc.) Benchmarking - Key to Safer Practices Similar to Mission, Vision and Value Statements

39. 39 © 2013 B. Ettinger MD/MPH QAPI: Governing Body Responsibilities (Q 84*)  QAPI Program Defined expectations for safety ASC’s priorities - chooses indicators implemented, maintained, evaluated for effectiveness  QAPI Projects conducted on annual basis (not episodic) reflects scope and complexity of ALL services & operations specifies data collection methods, frequency, details  Allocates sufficient staff, time, information systems, and training to implement the QAPI program * Q84, with IGs & Survey Procedures, provides the outline for developing QAPI Program, from which Projects are derived and implemented.

40. 40 © 2013 B. Ettinger MD/MPH Survey Experience

41. 41 © 2013 B. Ettinger MD/MPH ASC Survey Findings LA County, June 2009 - December 2010  47 ASC surveys - 32 reports (68%) available for review  399 total violations (Conditions, Standards) average 8 - 9 per facility range 0 to 26 2 facilities with 26 violations  2/3 rds of facilities with 10 or more violations  225 of 399 violations (56.4%) were repetitive i.e., identified across facilities

42. © 2013 B. Ettinger MD/MPH 42 TABLE 1. REGULATORY DOMAIN (in order of publication in the Federal Regulations) Total # Violations in 32 ASCs Totals (% *) Condition (% *) Standard (% *) 1. General Conditions, and 2. Compliance with Laws 7 (6.40)0 (0)7 (1.6) 3. Governing Body, Management23 (21.0)19 (6.6) (10.5) 42 (10.5) 4. Surgical Services4 (3.7)8 (2.8)12 (3.0) 5. QAPI18 (16.5)69 (23.8) (21.8) 87 (21.8) 6. Environment of Care4 (3.7)23 (7.9)27 (6.8 ) 7. Medical Staff20 (18.3)43 (14.8) (15.8) 63 (15.8) 8. Nursing Services8 (7.3)13 (4.5)21 (5.3) 9. Medical Records1 (1.0)18 (6.2)19 (4.8) 10. Pharmacy Services13 (12.0)17 (5.9)30 (7.5) 11. Lab and Radiology4 (3.7)11 (3.8)15 (3.8) 12. Patient Rights1 (1.0)16 (5.5)17 (4.3) 13. Infection Control5 (4.6)27 (9.3)32 (8.0) 14. Admit, Assess, Discharge1 (1.0)26 (9.0)27 (6.8) Totals * Rounded for presentation 109 (100.2)*290 (100.1)*399 (100)

43. © 2013 B. Ettinger MD/MPH 43 Frequency of Regulatory Violations (by Domain) Number of Violations Regulatory Domains

44. © 2013 B. Ettinger MD/MPH 44 The frequency of regulatory violations changes, when the regulations are combined into functional groups of related activities and accountability. The frequency of regulatory violations changes, when the regulations are combined into functional groups of related activities and accountability.

45. © 2013 B. Ettinger MD/MPH 45 Federal ASC Conditions for Coverage (l isted in order of publication, State Operations Manual) 1. General Conditions 2. Compliance with Federal, State, Local Laws 3. Governing Body, Management 4. Surgical Services 5. Quality Assessment/ Performance Improvement 6. Environment of Care 1. General Conditions 2. Compliance with Federal, State, Local Laws 3. Governing Body, Management 4. Surgical Services 5. Quality Assessment/ Performance Improvement 6. Environment of Care 7. Medical Staff 8. Nursing Services 9. Medical Records 10. Pharmacy Services 11. Laboratory & Radiologic Services 12. Patient Rights 13. Infection Control 14. Admission, Assessment, Discharge 7. Medical Staff 8. Nursing Services 9. Medical Records 10. Pharmacy Services 11. Laboratory & Radiologic Services 12. Patient Rights 13. Infection Control 14. Admission, Assessment, Discharge (57 “Standards” (sub-regulations); 1-14 for each Condition )

46. © 2013 B. Ettinger MD/MPH 46 Realigning the CfCs into Functional SYSTEMS of Accountability Functional GroupingDomain of Accountability 1.Governing Body; QAPI; General Requirements & Laws ● Facility oversight 2.Medical and Nursing Staffs● Verification of credentials, competency; provision of care 3.Infection Control and Environment of Care ● “Safe, sanitary, functional” environment 4.Surgical Services; Admission, Assessment and Discharge ● Clinical evaluations and procedures 5.Pharmacy, Laboratory, and Radiologic Services ● Ancillary services 6.Medical Records and Patient Rights ● Required documentation of patient care, and services

47. © 2013 B. Ettinger MD/MPH 47 REGULATIONS GROUPED BY FUNCTION Violations Conditions (n) Standards (n) Total (%) (Rounded) Governing Body; QAPI; Laws & Regs 4888 (34) 136 (34) Medical Staff; Nursing Service 2856 (21) 84 (21) Infection Control; Environment 950 (15) 59 (15) Lab, Radiology; Pharmacy 172845 (11) Surgery; Admit/ Assess/ Discharge 53439 (10) Patient Rights; Medical Records 23436 (9) Totals 109290399

48. © 2013 B. Ettinger MD/MPH 48 REGULATIONS GROUPED BY FUNCTION Violations Conditions (n) Standards (n) Total (%) (Rounded) Governing Body; QAPI; Laws & Regs 4888 (34) 136 (34) Medical Staff; Nursing Service 2856 (21) 84 (21) Infection Control; Environment 950 (15) 59 (15) Lab, Radiology; Pharmacy 172845 (11) Surgery; Admit/ Assess/ Discharge 53439 (10) Patient Rights; Medical Records 23436 (9) Totals 109290399 70% 70% 55%

49. 49 © 2013 B. Ettinger MD/MPH Field Experience – Acute Care Hospitals  Investigation of 4 maternal and 5 fetal deaths during labor and delivery, 1 each in 9 different, unrelated hospitals in LA County.  Findings of non-compliance were similar across all hospitals repetitive clustering of specific system domains failure to develop/implement policies & procedures failure to implement/enforce internal rules and regulations

50. 50 © 2013 B. Ettinger MD/MPH Multiple Errors …  Occurred at different operational levels within each hospital administrative, clinical, and support  Exposed multiple concurrent, unsafe systems (latent) and practices (active errors)  Three regulatory domains were consistently cited Governing Bodies (Administration) Medical Staffs Nursing Services

51. © 2013 B. Ettinger MD/MPH 51 REGULATIONS GROUPED BY FUNCTION Violations Conditions (n) Standards (n) Total (%) (Rounded) Governing Body; QAPI; Laws & Regs 4888 (34) 136 (34) Medical Staff; Nursing Service 2856 (21) 84 (21) Infection Control; Environment 950 (15) 59 (15) Lab, Radiology; Pharmacy 172845 (11) Surgery; Admit/ Assess/ Discharge 53439 (10) Patient Rights; Medical Records 23436 (9) Totals 109290399 55%

52. 52 © 2013 B. Ettinger MD/MPH Key Points for QAPI from Surveys and Investigations  Every activity in the ASC should be reviewed/included in the QAPI program clinical, operations, administration  Governing Body (GB) has absolute responsibility, especially for the QAPI program (Regulation)  Most GBs do not fully appreciate the QAPI concepts or methodology (interviews and GB meeting minutes) therefore not properly implemented labor & time intensive (time is $$$) critical violation

53. 53 © 2013 B. Ettinger MD/MPH Governing Body; QAPI; Laws and Definitions  Domain facility oversight facility oversight includes Life/Safety (Building Codes) includes Life/Safety (Building Codes)  Accountability (  Accountability (quality indicators; framework for systems of care) Legal responsibility and accountability Legal responsibility and accountability Transfers Transfers Contracts Contracts Disaster preparation Disaster preparation Everything Else Everything Else

54. 54 © 2013 B. Ettinger MD/MPH Medical and Nursing Staffs  Domain verification of credentials and competency verification of credentials and competency provision of care provision of care  Accountability (  Accountability (quality indicators; framework for systems of care) MD - How to credential; initial proctor; peer review for re-credential; vs. GACH medical staff letter (why every 2 years for ASC) MD - How to credential; initial proctor; peer review for re-credential; vs. GACH medical staff letter (why every 2 years for ASC) RN, others – annual competency & skills assessment RN, others – annual competency & skills assessment Staff – licenses; scope of practice vs. assignment of duties Staff – licenses; scope of practice vs. assignment of duties

55. 55 © 2013 B. Ettinger MD/MPH Infection Control & Environment of Care  Domain “safe, sanitary, functional” effective environment “safe, sanitary, functional” effective environment  Accountability (  Accountability (quality indicators; framework for systems of care) Survey w/in survey Survey w/in survey Qualified (training, experience) in-house designated person for day to day (IC consultant – recommended) Qualified (training, experience) in-house designated person for day to day (IC consultant – recommended) Includes elements of life/safety for environment (e.g. HVAC, etc.) Includes elements of life/safety for environment (e.g. HVAC, etc.) Adverse events related to unsafe environment Adverse events related to unsafe environment Cross refer to Pts’ Rights to receive care in safe setting (Q232) Cross refer to Pts’ Rights to receive care in safe setting (Q232)

56. 56 © 2013 B. Ettinger MD/MPH Surgical Services; Admission, Assessment, and Discharge  Domain clinical evaluations and procedures clinical evaluations and procedures  Accountability (  Accountability (quality indicators; framework for systems of care) 3 patient assessments – who performs 3 patient assessments – who performs surgical checklists/time out surgical checklists/time out provision of anesthesia and monitoring vital signs (scope of practice) vs. assignment of duties provision of anesthesia and monitoring vital signs (scope of practice) vs. assignment of duties emergency equipment, supplies emergency equipment, supplies clinical assessments at discharge clinical assessments at discharge specific discharge instructions specific discharge instructions discharge to responsible adult (unless waived by MD) discharge to responsible adult (unless waived by MD)

57. 57 © 2013 B. Ettinger MD/MPH Pharmacy, Laboratory, and Radiology  Domain ancillary services ancillary services  Accountability (  Accountability (quality indicators; framework for systems of care) Dedicated oversight for these services in accordance with laws and regulations Dedicated oversight for these services in accordance with laws and regulations Includes individual &/or facility licenses & permits Includes individual &/or facility licenses & permits Lab – defined policies for indicated lab studies before procedures and emergencies Lab – defined policies for indicated lab studies before procedures and emergencies Radiology - GACH requirements Radiology - GACH requirements

58. 58 © 2013 B. Ettinger MD/MPH Patient Rights & Medical Records  Domain Protect patients Protect patients Ensure adequate care through required actions Ensure adequate care through required actions Required documentation Required documentation  Accountability (  Accountability (quality indicators; framework for systems of care) DO NOT MINIMIZE IMPORTANCE - 26 pages in SOM DO NOT MINIMIZE IMPORTANCE - 26 pages in SOM Provision and Posting of Rights Provision and Posting of Rights Informed Consent & Advance Directives Informed Consent & Advance Directives Grievances; Privacy & Safety Grievances; Privacy & Safety Confidentiality of clinical records (HIPAA) Confidentiality of clinical records (HIPAA) Protection of medical records – secure storage to protect confidentiality, integrity, and availability Protection of medical records – secure storage to protect confidentiality, integrity, and availability other other

59. 59 © 2013 B. Ettinger MD/MPH Joint Commission Perspectives, 2013;33(4);1 Top 10 ASC Compliance Domains & Issues, 2012  Medical Staff - Physician Credentialing Granting initial, renewed, or revised clinical privileges  Pharmacy and Medication Control Unsafe…storage of medications; use of look- alike/sound-alike medications; management of high- alert and hazardous medications  Infection Control / Environment Risk from… medical equipment, devices, supplies; acquiring/ transmitting infections; CDC/WHO hand hygiene guidelines; hazardous materials & waste; conditions in the environment  Universal Protocols Time-out before the procedure

60. Selected Issues Just Culture Patient-Centered Care Systems of Care

61. 61 © 2013 B. Ettinger MD/MPH “Patient Safety and ‘Just Culture:’ A Primer For Health Care Executives” Marx D, 2001 www.ahrq.gov  Competent professionals make mistakes “To Err is Human” - inadvertent, unplanned, unintentional  At-risk behavior - competent professionals develop unhealthy “norms“ convincing oneself that corners can be cut choosing shortcuts that lead to increased risk – (entropy) "routine rule violations”  Reckless behavior - choosing to put others in harm's way knowingly performing tasks /procedures beyond the scope of one’s licensing and training ContinuumContinuum

62. 62 © 2013 B. Ettinger MD/MPH Culture of Safety - Human Factor Engineering “Righting Wrong Site Surgery” Carayon et al. Jt Comm J Qual Saf 2004:30(7)  Interactions of humans and a “work system” tasks, tools, technologies, physical environment, organizational conditions human strengths, capabilities, limitations  How systems work in actual practice the "fit" between user, and the work system  Minimize - risk of error in complex environments  Optimize - system performance, quality, safety  For QAPI - how change (benchmarking) affects the processes of care

63. 63 © 2013 B. Ettinger MD/MPH Establishing a “Just Culture” for Safety Adapted from Dana-Farber Cancer Institute, Principles of a Fair and Just Culture (www.dana-farber.org/.../principles-of-a-fair-and-just-culture.pdf‎)  open interdisciplinary discussion of untoward events ( include patient, family) respect, compassion, support for all staff individuals accountable to job responsibilities, not system flaws  improve the workplace best fit – between worker, job duties, scope of practice, skills and competencies environment, actions, attitudes - monitored for effectiveness to reduce errors (QAPI) ongoing education, interventions, safety-based leadership (QAPI)

64. 64 © 2013 B. Ettinger MD/MPH Just Culture of Care / Employee Satisfaction  Employee satisfaction - translates to patient satisfaction patients recognize when staff members are not happy significant association with staff attitudes, body language, and cross talk  Employee assessment - ASC safety & quality of care would you recommend family, friend? if not, why not?  Leadership Issue for QAPI !

65. 65 © 2013 B. Ettinger MD/MPH Patient Surveys  Older surveys - factors unrelated to care e.g., fulfillment of desires no correlation with processes and outcomes  New CMS hospital survey - focus on patient-centered experiences (1) strongly correlated with better outcomes (2)  CMS developing ASC survey on patient-reported experiences and outcomes (3) pain; nausea & vomiting; infection deep vein thrombosis; pneumonia; urinary retention  Consider revised patient survey now – include in QAPI ! (1) Manary NEJM 2013; 368:201; (2) www.cms.gov/Medicare/Quality-Initiatives- Patient-Assessment -Instruments; (3) Federal Register, 1/25/13, p 5459

66. 66 © 2013 B. Ettinger MD/MPH “Shadowing patients and families during the Care Experience” DiGioia AM, 2013. Univ. Pittsburg Med Ctr. Patient & Family Centered Care (www.pfcc.org/shadowing-resources)  For Internal QAPI (CMS “Tracer” Observations) how care givers interact among themselves and patients/families flow of care - how long each process takes comments and concerns raised by care givers comments, questions, and concerns raised by patient & family how helpful are discharge instructions to patient & family

67. 67 © 2013 B. Ettinger MD/MPH AHRQ - Project R E D Re-Engineered Discharge - for Hospitals  Reduce preventable readmission patient-centered, standardized approach to discharge planning prepare for self care education and post-hospital follow-up  Align organizational values with patient demands care coordination patient centeredness organizational culture transparency and organizational learning

68. © 2013 B. Ettinger MD/MPH 68 PATIENT SAFETY CARE COORDINATION PATIENT CENTEREDNESS ORGANIZATIONAL CULTURE TRANSPARENCY & ORGANIZATIONAL LEARNING Reliability Foundational Elements Overview of Safety,Harm Human Factors & Cognitive Psychology Culture Just Culture Teamwork & Communication Leadership & Facilitation Adapted from Patient Safety Leadership Fellowship Brochure, 2013-2014. © 2011 American Hospital Association. American Hospital Association/National Patient Safety Foundation. (PSLF 2013-2014 Brochure- FINAL.pdf) AHRQ Project RED

69. 69 © 2013 B. Ettinger MD/MPH AHRQ - Safety Program for Ambulatory Surgery http://ascsafetyprogram.org  Support CMS’ Conditions for Coverage especially QAPI, infection control Quality Reporting Program.  Improve quality, teamwork and communication within ambulatory settings, nationally  Benchmarking  Expected outcomes improve patient safety culture enhance teamwork and communication improve patient, provider, and staff satisfaction reduce SSIs and complications

70. © 2013 B. Ettinger MD/MPH 70 PATIENT SAFETY CARE COORDINATION PATIENT CENTEREDNESS ORGANIZATIONAL CULTURE TRANSPARENCY & ORGANIZATIONAL LEARNING Reliability Foundational Elements Overview of Safety,Harm Human Factors & Cognitive Psychology Culture Just Culture Teamwork & Communication Leadership & Facilitation Quality Assessment/ Performance Improvement is integral to an ASC’s organizational value systems

71. 71 © 2013 B. Ettinger MD/MPH System of Care  Integration and coordination of factors to address clinical problems and situations individual skills, competency, and performance processes of care technology administrative oversight other unique factors to the system under evaluation

72. 72 © 2013 B. Ettinger MD/MPH Systems Approach Agency for Healthcare Research and Quality  prospectively identify situations or factors with potential for error  implement changes to reduce the likelihood of occurrence and/or severity of impact error analysis - predictable human failings in the context of poorly designed systems  focus on human factors when designing protocols, schedules, etc. more likely to be effective than efforts to create flawless providers avoids individual blame, reprimand, corrective efforts, etc.

73. 73 © 2013 B. Ettinger MD/MPH Robert Wachter (ACOG ACM 2009) Old Model of Patient Safety  Culture of low expectations “Perfection is not possible.” complexities, technology machinery vs. human factors medication similarities and numbers  “Unless I’m sure it’s wrong – it must be right.”  Culture of blame – individual’s accountability

74. 74 © 2013 B. Ettinger MD/MPH Robert Wachter (ACOG ACM, 2009) New Model of Patient Safety  Use of Checklists (Regulations) simplify standardize performance expectations accountable  Science of Safety analyze and learn from mistakes  “Unless I’m sure it’s right – it must be wrong.”

75. 75 © 2013 B. Ettinger MD/MPH Conclusions  “Left to their own devices – things can go wrong.”  Risks to patient safety increase when staff are unprepared to manage complications adverse events are not anticipated “routine” practices not regularly evaluated on ongoing basis.  Compliance (with regulations and accreditation standards ) = risk management

76. 76 © 2013 B. Ettinger MD/MPH Increased Governing Body oversight for … ongoing internal review of all processes and procedures pre-emptive planning standardizing systems and process of care implementing and enforcing minimum standards to eliminate substandard/ unsafe care implement strategies for safer environments and responses to unexpected events monitoring compliance Consider “the cost of poor quality” “You can pay me now, or you can pay me later!”

77. 77 © 2013 B. Ettinger MD/MPH Why it’s Quality …  Regulations and Interpretive Guidelines can be confusing convoluted redundancies multiple cross references  Advantage of the Guidelines and Survey Procedures text-book for safe systems and practices constant updating (vs. static text that is updated every few years, but outdated at time of re-publication) supplemented by AFLs, S&C Letters, feed-back from CMS & CDPH  Implement as a functional and integrated clinical, operational, and administrative system.

78. © 2013 B. Ettinger MD/MPH 78 The holes in Havarti cheese are smaller than in Swiss cheese. “The bigger the holes, the weaker the defenses against system failures.” Getting to Havarti. Veltman Obst Gynecol 2007;110:1147 Systems Defenses Systems Failures

79. © 2013 B. Ettinger MD/MPH 79 Getting to Havarti. Veltman Obst Gynecol 2007;110:1147 Systems Defenses Systems Failures ”Make the holes smaller. Lessen the risk for adverse outcomes at every level of care and service.” Minimize the risk of harm.

80. © 2013 B. Ettinger MD/MPH 80 “The obstacles lie in beliefs, intention, cultures, and choices. All of these can change.” Donald Berwick Donald Berwick Former CMS Administrator