1. Regulatory Updates Kimberly Smoak, MSH, QIDP And Patricia Kaczmarek, RN, BHSc., MSHL Health Quality Assurance Bureau of Field Operations

2. Objectives Discuss the Top Most Citied Federal and State Hospital Deficiencies Review recent CMS Survey & Certification Memo Update on the Patient Safety Initiative 2

3. Objectives Discuss the Adverse Incident Reporting requirements Provide an overview of the Emergency Access and EMTALA survey process Discuss the hospitals role in PASRR 3

4. Top Ten Health Deficiency Citations 4

5. Nationwide Top Ten Federal Health Deficiency Citations January 1, 2013 through December 31, 2013 RANKTAGDESCRIPTION 1 A0395RN Supervision of Nursing Care (482.23(b)(3)) 2 A0144Patient Rights-Care in Safe Setting (482.13(c)(2)) 3 A0749Infection Control Program (482.42(a) 4 A0396Nursing Care Plan (482.23(b)(4)) 5 A0115Patient Rights (482.13) CoP 6 A0385Nursing Services (482.23) CoP 7 A0405Administration of Drugs (482.23(c)) 8 A0043Governing Body (482.12) CoP 9 A0724Facilities, Supplies, Equipment Maintenance (482.41(c)(2)) 10 A2400Compliance with 489.24 (489.20(1)) Note: The entire description of each deficiency can be found at: http://ahca.myflorida.com/MCHQ/Current_Regs.shtml http://ahca.myflorida.com/MCHQ/Current_Regs.shtml

6. Nationwide Top Ten Federal Health Deficiency Citations January 1, 2014 through December 31, 2014 RANKTAGDESCRIPTION 1 A0395RN Supervision of Nursing Care (482.23(b)(3)) 2 A0144Patient Rights-Care in Safe Setting (482.13(c)(2)) 3 A0749Infection Control Program (482.42(a) 4 A0396Nursing Care Plan (482.23(b)(4)) 5 A0115Patient Rights (482.13) CoP 6 A0385Nursing Services (482.23) CoP 7 A0405Administration of Drugs (482.23(c)) 8 A2400Compliance with 489.24 (489.20(1)) 9 A2406Medical Screening Exam (489.24(r) and 489.24(c)) 10 A0724Facilities, Supplies, Equipment Maintenance (482.41(c)(2)) Note: The entire description of each deficiency can be found at: http://ahca.myflorida.com/MCHQ/Current_Regs.shtml http://ahca.myflorida.com/MCHQ/Current_Regs.shtml

7. Florida Top Ten Federal Health Deficiency Citations January 1, 2013 through December 31, 2013 RANKTAGDESCRIPTION 1 A0395RN Supervision of Nursing Care (482.23(b)(3)) 2 A0396Nursing Care Plan (482.23(b)(4)) 3 A0405Administration of Drugs (482.23(c)) 4 A2400Compliance with 489.24 (489.20(1)) 5 A0749Infection Control Program (482.42(a)) 6 A2405Emergency Room Log (489.20(r)(3) 7 A2406Medical Screening Exam (489.24(r) and 489.24(c)) 8 A0385Nursing Services (482.23) CoP 9 A0168Patient Rights: Restraint or Seclusion (482.13(e)(5) 10 A2411Recipient Hospital Responsibilities (489.24(f)) Note: The entire description of each deficiency can be found at: http://ahca.myflorida.com/MCHQ/Current_Regs.shtml http://ahca.myflorida.com/MCHQ/Current_Regs.shtml

8. Florida Top Ten Federal Health Deficiency Citations January 1, 2014 through December 31, 2014 RANKTAGDESCRIPTION 1 A0395RN Supervision of Nursing Care (482.23(b)(3)) 2 A0396Nursing Care Plan (482.23(b)(4)) 3 A2400Compliance with 489.24 (489.20(1)) 4 A2406Medical Screening Exam (489.24(r) and 489.24(c)) 5 A0405Administration of Drugs (482.23(c)) 6 A0392Staffing and Delivery of Care (482.23(b)) 7 A2405Emergency Room Log (489.20(r)(3) 8 A0385Nursing Services (482.23) CoP 9 A2409Appropriate Transfer (489.24(e)(1)-(2)) 10 A1104Emergency Services Policies (482.55(a)(3)) Note: The entire description of each deficiency can be found at: http://ahca.myflorida.com/MCHQ/Current_Regs.shtml http://ahca.myflorida.com/MCHQ/Current_Regs.shtml

9. Florida Top Ten State Health Deficiency Citations January 1, 2013 through December 31, 2013 RANKTAGDESCRIPTION 1 H0120Nursing Service - Care Process (59A-3.2085(5)(E)1-3., F.A.C.) 2 H0119Nursing Service-Std Of Practice & Policy/Procedure (59A-3.2085(5)(D), F.A.C. 3 H0029Patient Rights & Care - Add'L Policy/Procedure (59A-3.254(4)(C)-(H) And (5), F.A.C.) 4 H0020Patient Rights & Care - Reassessment (59A-3.254(1)(C)-(D), F.A.C.) 5 H0190Health Information Mgmt - Medical Records (59A-3.270(3)(A)-(X), F.A.C.) 6 H0022Patient Rights & Care - Coord Of Care (59A-3.254(2)(A)-(D), F.A.C.) 7 H0094Pharmacy - Administration Of Drugs (59A-3.2085(2)(M), F.A.C) 8 H0199Surveil/Preven/Control Of Infection- Program (59A-3.250(1)(A)-(D), F.A.C) 9 H0024Patient Rights & Care - Discharge Instruction (59A-3.254(3)(B)3. F.A.C) 10 H0116Nursing Service - Management (59A-3.2085(5)(A)1-5, F.A.C) Note: The entire description of each deficiency can be found at: http://ahca.myflorida.com/MCHQ/Current_Regs.shtml http://ahca.myflorida.com/MCHQ/Current_Regs.shtml

10. Florida Top Ten State Health Deficiency Citations January 1, 2014 through December 31, 2014 RANKTAGDESCRIPTION 1 H0120Nursing Service - Care Process (59A-3.2085(5)(E)1-3., F.A.C.) 2 H0412Incident Reporting System - Reports (59A-10.0055(2)(C)-(E), F.A.C.) 3 H0426Patient Safety Officer And Committee (395.1012(2), F.S.) 4 H0119Nursing Service-Std Of Practice & Policy/Procedure (59A-3.2085(5)(D), F.A.C.) 5 H0020Patient Rights & Care - Reassessment (59A-3.254(1)(C)-(D), F.A.C.) 6 H0410Rm Prog - Incident Reporting System (395.0197(1)(E), F.S.) 7 H0411Incident Reporting System-Procedures/Training (59A-10.0055(1), F.A.C.) 8 H0190Health Information Mgmt - Medical Records (59A-3.270(3)(A)-(X), F.A.C.) 9 H0029Patient Rights & Care - Add'L Policy/Procedure (59A-3.254(4)(C)-(H) And (5), F.A.C.) 10 H0022Patient Rights & Care - Coord Of Care (59A-3.254(2)(A)-(D), F.A.C.) Note: The entire description of each deficiency can be found at: http://ahca.myflorida.com/MCHQ/Current_Regs.shtml http://ahca.myflorida.com/MCHQ/Current_Regs.shtml

11. Federal Survey & Certification Memos 11

12. S&C: 14-31-Hospitals/CAH’s Provision of Electronic Health Record (EHR) Navigators during surveys –Surveyors may request experienced EHR users with appropriate system permissions to be assigned as navigators to assist surveyors with medical record information. 12

13. S&C: 14-44-Hospital/CAH/ASC Change in Terminology regarding Immediate Use Steam Sterilization (IUSS) in Surgical Settings –Recommendations from nationally recognized organizations with expertise in infection prevention and control to abandon the use of the term “flash” sterilization, and replace with the term “Immediate Use Steam Sterilization” (IUSS) 13

14. S&C: 14-45-Hospital Revised Guidance Related to Governing Body and Medical Staff Regulations –Permits medical staff of a hospital that is part of a hospital system to participate in a unified, integrated medical staff which the system utilizes for two or more of its separately certified hospitals, in accordance with State law. 14

15. S&C: 15-12-Hospital CMS finalized and released the three surveyor worksheets for assessing compliance with Quality Assessment and Performance Improvement, Infection Control, and Discharge Planning. –These worksheets are used by federal and state surveyors on all hospital survey activity in which compliance with any or all of the three CoPs are assessed –Hospitals are encouraged to use these worksheets as part of their self-assessment tools to promote quality and patient safety 15

16. S&C: 15-22-Hospital/ASC/RHC/FQHC Revised Guidance and Update to Appendix A- Hospitals –Updates to the following CoP’s Food and Dietetic Services, 482.28 Nuclear Medicine Services, 482.53 Outpatient Services, 482.54 Swing-Bed Services, 482.58 Utilization Review, 482.30 16

17. Hospital Compare Star Ratings April 16, 2015-CMS introduced Star Ratings on Hospital Compare –The Hospital Compare star ratings relate to patients experience of care at almost 3,500 Medicare-certified acute care hospitals 17

18. Reportable Disease Rule: http://www.floridahealth.gov/disease s-and-conditions/disease-reporting- and-management/index.html http://www.floridahealth.gov/disease s-and-conditions/disease-reporting- and-management/index.html 18

19. 19

20. Reporting to Department of Health Call your local health department anytime you have an outbreak or cluster of infections –All outbreaks and clusters of any disease are reportable to the Department of Health by law per Section 381.0031, Florida Statutes 20

21. Examples: When To Call Two or more epidemiologically linked cases or suspected cases: confirmed illness not required –Influenza-like illness (ILI) –Gastro-intestinal illness Especially of unknown cause –Scabies Not sure? Call the local health department 21

22. Reportable Disease Rule Changes: Effective June 4, 2014 Electronic Laboratory Reporting Antimicrobial Resistance –Acinetobacter baumannii –Citrobacter species –Enterococcus species –Enterobacter species –Escherichia coli species –Klebsiella species –Pseudomonas aeruginosa –Serratia species 22

23. Pre-Admission Screening and Resident Review (PASRR) 59G-1.040, F.A.C. 23

24. PASRR Authorities The Pre-Admission Screening and Resident Review (PASRR) is a federal requirement mandated by the Social Security Act, Title 42, Subpart C, and 42 Code of Federal Regulations sections 483.100 through 483.138 (CFR). AHCA’s PASRR Rule, 59G-1.040, Florida Administrative Code, became effective on December 31, 2013. 24

25. PASRR Purpose The purpose of PASRR is to ensure individuals who are being considered for placement in a Medicaid-certified Nursing Facility (NF), regardless of payor, are: 1.Evaluated for a serious mental illness (SMI), and/or an intellectual disability or related conditions (ID) as defined in 59G-1.040, F.A.C. 25

26. PASRR Purpose, cont. 2.Offered the most integrated setting appropriate for their long- term care needs (including determining whether an NF is appropriate). 3.Able to receive the services they need in those settings. Includes Specialized Services: –Services that are not covered in the NF per diem and are required for appropriate placement in the NF setting for individuals with ID or SMI whose needs are such that continuous supervision, treatment, and training by qualified mental health or intellectual disability personnel is necessary. 26

27. Elements of PASRR PAS – Pre-Admission Screening –Level I A Level I PASRR screen determines whether an individual referred for admission into an NF has or is suspected of having an SMI and/or an ID diagnosis. –Level II The Level II PASRR is an individualized, in-depth evaluation of the individual, including confirming or ruling out the suspected diagnosis and determining the need for NF services. If an NF is the most integrated setting appropriate to meet the individual’s long- term care needs, the Level II PASRR must also evaluate what specialized services, if any, are needed for the individual. See Rule 59G-1.040, F.A.C. 27

28. Level I - Screeners The following are designated as Level I screeners: –The Agency for Health Care Administration (AHCA) or its delegate for children under the age of 21. –Comprehensive Assessment and Review for Long- Term Care Services (CARES) for adults aged 21 and older. 28

29. Level I – Screeners, cont. Level I screeners may delegate these responsibilities as follows: –AHCA: Florida Department of Health (DOH) –Level I Screenings may not be further delegated by DOH –CARES: Hospital or NF Staff (physician, RN, MSW, LCSW) 29

30. PASRR Level I Screeners 30

31. Exemptions The following exemptions to the PASRR process apply: –Individuals who are discharged from a hospital into an NF after receiving acute inpatient care, and require NF services for the condition for which they received the inpatient care, may be admitted to the NF if a physician certifies on the AHCA MedServ-3008 form before admission that the individual is likely to require less than 30 days of NF services. 31

32. When is a Level I Screen Required? The Level I PASRR screen must be completed prior to admission to an NF. The Level I PASRR screen does not need to be completed when an: –Individual is returning to the NF after being in a hospital for 90 days or less; or –NF resident is transferred to another NF. 32

33. Provisional Admission, cont. The following are the relevant time limits for completion of the Level II's for individuals admitted to an NF under a provisional admission or hospital discharge exemption: –1. In cases of delirium, within 7 days after the delirium clears; –2. For emergency admissions requiring protective services, within 7 days of admission; –3. If an individual is admitted to an NF for a caregiver’s respite, in advance of the expiration of 14 days; and –4. If an individual is admitted under the hospital discharge exemption and stays longer than 30 days, in advance of the expiration of 40 days (notify CARES or DOH by the 25 th day of stay if possible). 33

34. Purpose of the Level I Screen Determine whether there is a suspicion of SMI or ID Request a Level II evaluation, if appropriate Document and request additional Level II evaluations (Resident Review) for nursing facility residents and readmissions when necessary 34

35. Level I Screen Findings Did the Level I screen indicate a suspicion or diagnosis of SMI and/or ID? –YES: Standard Admission: Individual may not be admitted to the NF and must be referred for a Level II evaluation within two days of completion of the Level I. The referral must include all required documentation Provisional Admission: Individual may be admitted to the NF and must be referred for a Level II evaluation within the specified timeframe based on the reason for provisional admission. –NO: PASRR process ends and the individual may be admitted to the NF. 35

36. Level II - Initiation To initiate a Level II evaluation, CARES or DOH must submit the following to the Level II evaluator: –Completed Level I PASRR form. –Documented informed consent. –Medical certification for NF/home and community-based services (AHCA MEDSERV-3008 form) –Other medical documentation including relevant case notes or records of treatment/medication administration record. –Psychiatric or psychological evaluation, if available. –A CARES assessment (adults) –CMAT assessment (child) –Minimum Data Set, as appropriate 36

37. Level II Evaluation and Determinations – Findings, cont. Completed Level II PASRR evaluation/determination is to be sent to the: PASRR Level I Screener (CARES and DOH); evaluated individual or, if appropriate, legal guardian; admitting or retaining NF, if applicable; evaluated individual’s attending physician; and discharging hospital, if applicable. 37

38. Other PASRR Process Highlights There are no categorical determinations. Children of all ages must have a Level I and a Level II (if needed) PASRR. There are no age exemptions. 38

39. AHCA PASRR FORMS PASRR information and the new PASRR Level I forms are available on the AHCA PASRR website with instructions to assist in their completion. These forms will be required once rule-making is complete. http://ahca.myflorida.com/Medicaid/PASRR/index.s htmlhttp://ahca.myflorida.com/Medicaid/PASRR/index.s html. 39

40. Patricia Cobb E-mail: Patricia.Cobb@AHCA.myflorida.com 40 PASRR Contact

41. Requirements for Adverse Incident Reporting 41

42. Adverse Incident Reporting Section 408.813, Florida Statutes, authorizes the Agency to impose fines for facilities that fail to submit timely adverse incident reports as required by the following statutes: –Section 395.0197: Hospitals and Ambulatory Surgical Centers must report within 15 days after the occurrence –Section 641.55: Clinic Model HMOs must report within 3 working days after the occurrence, with a more detailed follow-up report within 10 days after the first report –Section 429.23: Assisted Living Facilities must report within 1 business and 15 day after the occurrence –Section 400.147: Nursing Homes must report within 15 days after the occurrence 42

43. Contact for Adverse Incident Reporting to the Agency Florida Center for Health Information and Policy Analysis, Office of Risk Management and Patient Safety (850) 412-3731 43

44. Overview of EMTALA and Emergency Access Survey Process 44

45. Federal EMTALA 45 Emergency Medical Treatment and Active Labor Act EMTALA –Section 1864 of the Social Security Act –Regulations: 42 CFR §489.24 42CFR §489.20(l)(m)(q) and (r)

46. General Information EMTALA Appendix V EMTALA – Must provide a Medical Screening Exam - Applies to ALL Individuals - Includes Critical Access Hospital 46

47. General Information EMTALA Appendix V Dedicated Emergency Department CRITERIA: Licensed by the State Is held out to the public During the preceding calendar year. Provided at least one third of all visits the treatment of an Emergency Medical Condition 47

48. General Information EMTALA- Appendix V EMTALA – Complaint Regional Office State Agency Field Office Survey Team 48

49. Investigation Procedures P&P Comply with 42 CFR §489.24 Signs Posted Transfer Records On Call Practitioners / Physicians Central Log Requesting Treatment Medical Screening Exam Appropriate Stabilization Capability and Capacity Transfer Stabilized 49

50. Task 1 Entrance to Facility Request CEO/President or Designee Entrance Conference- Document Requests 50

51. Task 2 Sample Selection Evaluation of- Dedicated Emergency Department Document and file Requests 51

52. Task 3 Record Review Emergency Department and QAPI Appropriate Transfers, ED Logs, Pregnancy, Psychiatric Treatments- Diagnostics 52

53. Task 4 Interviews Various Staff: Including those involved in Incidents- Nurses, Physicians, Department Staff 53

54. Task 5 Exit Conference Decision-making – A review findings to determine compliance. Review data gathered for any additional information needs Exit Conference-Discuss findings-Explain the RO will determine final compliance status 54

55. Task 6 Post Survey Tasks Review data gathered for any additional information needs Team coordinator works with Field Office Administration Complete Survey 55

56. Regional Office Post Survey Tasks Survey to Regional Office for Review and Determinations 56

57. Emergency Access Survey 57

58. Survey Comparisons Emergency Access Pre-survey Activities Task 1 Task 2 Task 3 Task 4 Task 5 Post-survey Activities Federal EMTALA Pre-survey Activities Task 1 Task 2 Task 3 Task 4 Task 5 Post-survey Activities 58

59. REFERENCES http://cms.gov/emtala http://oig.hhs.gov/fraud/enforcement/cmp/patient_dumping.asp http://ecfr.gpoaccess.gov http://ahca.myflorida.com/mchq/Health_Facility_Regulation/Hospit al_Outpatient/hospital.shtmlhttp://ahca.myflorida.com/mchq/Health_Facility_Regulation/Hospit al_Outpatient/hospital.shtml 59

60. QUESTIONS 60

61. Contact Information Kimberly Smoak Kimberly.Smoak@ahca.myflorida.com (850) 412-4516 And Patricia.Kaczmarek@ahca.myflorida.com (239) 464-4671 61