1. Critical Access Hospital CoPs Part 2 of 3 What every CAH needs to know about the Conditions of Participation (CoPs)

2. Speaker  Sue Dill Calloway RN, Esq. CPHRM, CCMSCP  AD, BA, BSN, MSN, JD  President  5447 Fawnbrook Lane  Dublin, Ohio 43017  614 791-1468 (Call with questions, No emails)  sdill1@columbus.rr.com 2

3. Location of CMS CoP Manual 3 www.cms.hhs.gov/manuals/downloads/som107_Appendixtoc.pdf Questions to CAHscg@cms.hhs.gov

4. 4 Drugs and Biologicals 276 2015  Rules for the storage, handling, dispensing, and administration of drugs and biologicals,  Need to store drugs in accordance with acceptable standards of practice,  Keep accurate records of the receipt and disposition of all scheduled drugs,  And all outdated, mislabeled, or otherwise unusable drugs are not available for patient use,

5. Drugs and Biologicals 276 2015  Long section that pharmacy and nursing need to read and rewritten in 2015  Must make sure are managed in manner that is safe and appropriate  Must have an order for the medication  Must have written P&P to govern pharmacy services  P&P must address storage, handling, dispensing, and administration  Must follow acceptable standards of care 5

6. Drugs and Biologicals 276 2015  CAH rules and P&P must be consistent with standards or guidelines for pharmaceutical services and medication administration  Such as USP, ASHP, ISMP, Infusion Nurses Society, IHI, and National Coordinating Council  The written P&P must also be consistent with state and federal law  Others include:  ASHP Foundation (American Society of Healthcare System Pharmacist Foundation), American Nurses Association (ANA), American Pharmacy Association (APA), APIC, CDC, etc 6

7. ISMP Institute for Safe Medication Practices 7 www.ismp.org

8. American Society of Health System Pharmacists or ASHP 8 www.ashp.org/

9. Infusion Nurses Society INS 9 www.ins1.org

10. National Coordinating Council 10 www.nccmerp.org

11. 11

12. USP U.S. Pharmacopeial 12 www.usp.org

13. Institute for Healthcare Improvement IHI 13 www.ihi.org

14. Drug Rules Must Include 276 2015  Rules (P&P) must identify qualification of pharmacy director  Person must make sure state laws are followed including who can perform pharmacy services  Including supervision of the pharmacy staff  Must be able to identify standards used in developing P&P  Note can cite as reference in P&Ps  Storage including location of storage areas, medication carts, and dispensing machines 14

15. Drug Rules Must Include 276 2015  Proper environmental conditions  Follow manufacturer’s recommendation such as keep refrigerated, room temperature, out of light, etc.  Security  P&P must be consistent with state and federal law as who can access pharmacy or drug storage areas –Housekeeping, security or maintenance are usually not given unsupervised access  If kept in private office then patients and visitors are not allowed without supervision 15

16. Drug Rules Must Include 276 2015  Area restricted to personnel only are generally considered secure  Given flexibility in non-controlled drugs such as don’t have to be locked up when setting up for a procedure  Example would be the OR  Would lock up when area not staffed  Medication carts, anesthesia carts, epidural carts and non-automated medication carts with medications must be secure when not in use 16

17. Medications in the OR ASA Position 17 www.asahq.org/For-Members/Standards- Guidelines-and-Statements.aspx

18. ASA Guidelines and Statements 18 http://asahq.org/For-Healthcare-Professionals/Standards-Guidelines-and-Statements.aspx

19. Recommendation on Medications in the OR 19 www.apsf.org/newsletters/html/2010/spring/01_conference.htm

20. Drugs Rules Must Include 276 2015  Must have P&P on security and monitoring of all carts  Whether locked or unlocked  If unlocked staff must be close by and directly monitoring the cart as when passing medications  Handling medications which includes mixing or reconstituting according to mfg recommendation  Includes compounding or admixing of sterile IVs or other drugs 20

21. Drugs Rules Must Include 276 2015  Only pharmacy can reconstitute, mix, or compound a drug  Except in an emergency  Except if not feasible such as product’s stability is short  Compounding used or dispensed must be consistent with acceptable principles such as those described in USP/NF chapter  Which including adding an ingredient to a commercial product  Includes reconstitution of drug 21

22. Drugs and Biologicals 276 2015  Pharmacy must demonstrate how it assures that all sterile and non-sterile compounded preparations are pursuant to SOC  Minimal standards include compliance with USP 797 and USP 795  Include preparation, storing, and transporting  Very detailed so staff need to read this section  Can it meet low, medium or high risk levels ?  All compounded forms must be sterile including wound irrigation, eye drops and ointments, injections, infusions, nasal inhalation, etc. 22

23. Blue Box Advisory USP 797 23

24. Drugs Rules Must Include 276 2015  Drug Quality and Security Act (DQSA) has sections related to compounding  Outsourcing facilities who compound drugs register and must comply with section 503B of the FDCA and other requirements such as the FDA’s current good manufacturing practice (CGMP)  Will be inspected by the FDA according to risk based schedule  Must meet certain other conditions including reporting adverse drug events to the FDA 24

25. FDA’s Compounding Website 25 www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Pharmacy Compounding/default.htm

26. Use a Company that is Registered 26

27. Drug Rules Must Include 276 2015  If CAH obtains compounded medications from compounding pharmacy rather than a manufacturer or a registered outsourcing facility then must demonstrate that medicine received have been prepared in accordance with acceptable principles  Contract with the vendor would want to ensure CAH access to their quality data verifying their compliance with USP standards  Should document you obtain and review this data 27

28. Drugs and Biologicals 276 2015  Dispensing medications  Dispensed timely  Follow all state laws  Enough staff to provide accurate and timely medication delivery  System so medications orders get to pharmacy promptly and are available when needed by the patient  Concerns or questions should be clarified with prescriber before dispensing 28

29. Drugs and Biologicals 276 2015  Can use unit dose or floor stock system  Automated dispensing cabinets are secure option  Need P&P for who can access medications after hours (night cabinet standard)  Suggest P&P on do not use abbreviations, high alert drug list, safety recommendation for high alert medications, quantities of medications dispensed to minimize diversion, limit overrides, return all meds in secure one- way return bin, etc. 29

30. 30

31. Do Not Use Abbreviations ISMP 31

32. TJC’s Do Not Use Abbreviation List 32

33. ISMP List of High Alert Medications 33 www.ismp.org

34. Drugs and Biologicals 276 2015  Administer meds by qualified staff in accordance with state law  So in one state LPN can not push certain IV medications  Must follow acceptable standards of practice for medication administration  Follow record keeping for receipt and disposition of scheduled drugs  DEA has five from schedule I to V substances  Schedule IV includes certain narcotics so must track them 34

35. Drugs and Biologicals 276 2015  Want locked storage of scheduled drugs when not in use  Keep accurate counts to show use  Reconcile any discrepancies in the counts  Ensure outdated, mislabeled, or unusable medication is not used  Must have pharmacy labeling, inspection, and inventory management  Do not use past the BUD or beyond use date  P&P to determine BUD date if not marked 35

36. Drugs and Biologicals 276 2015  Each individual drug must be labeled with name, strength of drug, lot and control number and expiration date  If multidose vial open must have expiration date of 28 days until otherwise specified by the manufacturer  Must have system to report ADEs and medication errors  Pharmacy needs to assess to see if problems in pharmacy caused or contribute to these 36

37. Drugs and Biologicals 276 2015  Surveyor is to ask nursing if medications dispensed in a timely manner  If late medications surveyor is to investigate  Surveyor is to ask what professional pharmacy principles pharmacy is usin g  Surveyor to make sure drugs are secure  Will verify only pharmacist or authorized person compounds, labels, and dispenses  Some state laws state can not be done by pharmacy tech 37

38. Survey Procedure 276 2015  Surveyor to make sure has a process to follow up on ADE and medication errors  Surveyor to determine if CAH obtains compounded drugs from external source that is not FDA registered then does it evaluate and monitor adherence to safe principles  Will ask for example of when BUD had to be determined for a compounded sterile medication based on P&P  Long survey procedure for this tag number 38

39. 39 Reporting ADR and Errors 277 2015  Standard: Procedures for reporting adverse drug reactions (ADR) and medication errors  Staff must report these  Take care of patient and report for QAPI  Need a definition for both  CMS mention National Coordinating Definition of Medication Error (NCCMER)  Mentions ASHP definition of adverse event

40. Definition of Medication Error 40

41. Definition of Adverse Drug Event ADR 41

42. Reporting ADR and Errors 277 2015  ADR and medication errors that reach the patient must be reported to the practitioner  The report must be made immediately if it causes harm to the patient such as a phone call  If harm is not known then must report immediately  If no harm then can inform practitioner in the morning  Documentation of the error and notification of the practitioner must be made in the MR 42

43. Reporting ADR and Errors 277 2015  Must educate staff on medication errors and ADEs to facilitate reporting  Must include reporting of near misses  Must educate how and whom they are to be reported  For example, on a medication incident report which is sent to pharmacy, nursing and then into the QAPI program  To help assess vulnerabilities and implement reoccurrences  Can do RCA, FMEA, or QAPI review 43

44. Reporting ADR and Errors 277 2015  Encourages a non-punitive approach that focuses on system issues  Can’t just rely on incident reports  Must take other steps to identify errors and ADRs  Trigger drug analysis, observe medication passes, concurrent and retrospective reviews, medication usage evaluations for high alert drugs etc.  Encourage reporting to FDA MedWatch Program and ISMP 44

45. 45 Non-Punitive Environment  Studies showed that if you have punitive environment errors will not be reported,  Most of serious errors are made by long term employee with unblemished records,  It was the system that actually lead to the error,  Change the environment or culture-called system analysis,  Important to have a non-punitive environment,  We need to move beyond the culture of blame so we can find out what errors are occurring,  Balance this with Just Culture,

46. 46 Indicator Drugs (Trigger Drugs)  Monitor Digibind usage and develop protocol for appropriate use,  Monitor use of reversals agents such as Romazicon and Narcan to look for unreported cases of adverse events,  Narcan, antihistamines, Vitamin K,  IV glucose, glucagon,  Epinephrine, topical calamine,  Phentolamine, digibind, protamine, hyaluronidase,  Kayexalate, anti-emetics and anti-diarrheas,

47. 47

48. 48

49. FDA MedWatch Form 49

50. ISMP Medication Error Reporting Program 50 www.ismp.org

51. 51 List of High Alert Medications

52. 52 High Alert How to Guide IHI www.ihi.org/NR/rdonlyres/8B2475CD-56C7-4D9B-B359-801F3CC3A8D5/0/HighAlertMedicationsHowToGuide.doc

53. 53

54. 54

55. Survey Procedure 277 2015  Will make sure nursing staff knows what to do if there is a medication error (ME) or ADE  Will ask nursing to provide an example of what they would do if ME or ADE  Surveyor will review records of ME and ADE to make sure immediately reported and documented in the medical record  Will ensure hospital has system for reporting into QAPI  Will make sure staff trained in reporting expectations 55

56. 56 Medication Resources  National Patient Safety Foundation at www.npsf.org  Governmental agencies may include ;  Food and Drug Administration (FDA) at www.fda.gov  Med Watch Program at www.fda.gov/medwatch  Agency for Health Care Research and Quality (AHRQ) at www.ahrq.gov

57. 57 Websites  The Institute for Safe Medication Practices- www.ismp.org  U.S. Pharmacopoeia (USP) www.usp.org  Institute for Healthcare Improvement- www.ihi.org,  AHRQ- www.ahrq.gov,  Sentinel event alerts at www.jointcommission.org,

58. 58 Additional Resources  American Pharmaceutical Association- www.aphanet.org  American Society of Heath-System Pharmacists- www.ashp.org  Enhancing Patient Safety and Errors in Healthcare- www.mederrors.com  National Coordinating Council for Medication Error Reporting and Prevention-www.nccmerp.org,  FDA's Recalls, Market Withdrawals and Safety Alerts Page: http://www.fda.gov/opacom/7alerts.html

59. 59 Infection Control 278 2015  Standard: Need a system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel  Must be facility wide  Provides definitions of infectious diseases and communicable disease that hospital can put in its P&P  HAI or healthcare-associated infection is one that patient develops while in the hospital or other healthcare facility

60. CMS Infection Control Worksheet  Final infection control worksheet issued November 26, 2014  Not being used at this time for CAH  However, highly recommend CAH take a look at the infection control worksheet  Great tool to help understand how to comply with the infection control standards  Available free off the CMS survey memo website  Also one published on discharge planning and QAPI 60

61. Final Worksheet Infection Control 61 www.cms.gov/SurveyCertificationG enInfo/PMSR/list.asp#TopOfPage

62. Infection Control 278 2015  CDC found 1 in 25 hospital patients has a HAI  This is 772,000 every year  75,000 patients will die from HAI every year  Must have sanitary environment  No dried blood on side rails or floor  Need infection preventionist who is qualified by education and experience  APIC has competency document 62

63. 63 Infection Preventionist or IP

64. APIC Competency Infection Prevention 64 www.ajicjournal.org/article/S0196-6553(12)00165-4/fulltext

65. 65

66. Infection Control 278 2015  Standard: Must follow nationally recognized infection control practices or guidelines  Examples include: CDC, APIC, SHEA, AORN and OSHA  CDC is Center for Disease Control  AORN is the Association for periOperative Nurses  APIC is the Association for Professionals in Infection Control and Epidemiology  SHEA is the Society for Healthcare Epidemiology of America 66

67. APIC Website 67 www.apic.org

68. SHEA Website 68 /www.shea-online.org

69. AORN 69 www.aorn.org

70. AORN Guidelines for Perioperative Practice 70

71. OSHA Website 71 www.osha.go v

72. OSHA Worker Safety in Hospitals 72

73. CDC Website 73 www.cdc.gov/

74. / 40 4 Challenges in Infection Control  CMS said there are four special challenges in infection control (just four?)  Challenge 1: Multidrug-Resistant Organisms  Challenge 2: Infection Control in Ambulatory Care  Challenge 3: Communicable Disease Outbreaks  Challenge 4: Bioterrorism 74

75. / 40 Multidrug-Resistant Organisms  Multidrug-resistant organisms (MDROs) are resistant to one or more antimicrobial agents  Treatment is more difficult  These bad bugs are more dangerous such as C-diff, VRE, MRSA, CRE (E. coli, Enterobacter, Klebsiella) etc.  National priority  Have systems in place to identify early and prevent transmission of these organisms.  The CDC has a special publication on “Management of Multidrug-Resistant Organisms in Healthcare Settings, 2006” 1 1 http://www.cdc.gov/ncidod/dhqp/pdf/ar/mdroGuideline2006.pdf 75

76. CDC Module on C-Diff 76

77. 77 www.cdc.gov/ncidod/dhqp/pdf/ar/mdroGuideline20 06.pdf

78. APIC C-Diff Guide 78 www.apic.org/Professional- Practice/Implementation-guides

79. SHEA C-Diff Guidelines 79 www.shea- online.org/GuidelinesResources/Guidelines/Guid eline/ArticleId/11/Clinical-Practice-Guidelines-for- Clostridium-difficile-Infection-in-Adults-2010.aspx

80. AHRQ Toolkit on KPC  AHRQ has a free toolkit for hospitals to help control and prevent Klebsiella pneumoniae carbapenemase (KPC)  Called the Carbapenem-Resistant Enterobacteriaceae (CRE) Control and Prevention Toolkit  This is a highly dangerous, antibiotic-resistant germ  Will help hospitals implement the CDC guidelines and is 56 page toolkit  available at www.ahrq.gov/cretoolkit 80

81. 81

82. Free Toolkit for Hospitals 82

83. CDC National Healthcare Safety Network 83 www.cdc.gov/nhsn/

84. 84 www.cdc.gov/nhsn/training/

85. 85 www.cdc.gov/hicpac/pdf/guidel ines/bsi-guidelines-2011.pdf

86. 86

87. / 40  Infection control in ambulatory care presents special problems  Patients remain in common areas such as the lobby and ED waiting areas  Patients are turned around quickly with minimal cleaning  Infectious patients may not be recognized immediately  Immuno-compromised patients can receive treatment in rooms with other patients who pose a risk of infection Infection Control Ambulatory Care 87

88. / 40  Place in room and don’t leave in lobby if can be contagious and implement cough etiquette protocol  Guidelines have been developed by the CDC’s Healthcare Infection Control Practices Advisory Committee (HICPAC) hwww.cdc.gov/hicpac/pubs.html  Infection control plan for ambulatory care  Norovirus gastroenteritis outbreaks  Guidelines for Disinfection and Sterilization in Healthcare Facilities  Guidelines for Isolation Precautions  CDC Intravascular guidelines  MRDO and Influenza Vaccination of Healthcare Personnel Infection Control Ambulatory Care 88

89. / 40  CDC’s Guidelines (continued)  Guidance on Public Reporting of HAI 2005  Guidelines for Preventing Healthcare Associated Pneumonia 2004  Guidelines for Environmental Infection Control in Healthcare Facilities 2003, 2002 Hand hygiene guidelines, Prevention of Surgical Site Infections and more  HICPAC is a federal advisory committee made up of 14 external IC experts who provide guidance and advice to the CDC and HHS –Members from APIC, SHEA, AORN, CMS, FDA etc. Infection Control Ambulatory Care 89

90. APIC Resources Ambulatory Care 90

91. CDC Norovirus Guidelines 91 www.cdc.gov/hicpac/norovirus/002_no rovirus-toc.html

92. CDC HICPAC 92

93. Preventing Infections in the Outpatient Unit  CDC has a guide and checklist for preventing infections in the outpatient setting  The Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care and  The Infection Prevention Checklist for Outpatient Settings; Minimum Expectations for Safe Care  Free off the website at www.cdc.gov/hai/settings/outpatient/outpatient- settings.html?source=govdelivery 93

94. CDC Guide Infection Control Outpatients 94 www.cdc.gov/HAI/settings/outpatient/outpatient-care- guidelines.html

95. / 40  Community-wide outbreaks of communicable diseases present many of the same types of issues as hospital infection disease threats  Such as measles, mumps, SARS, or the flu  Understand the epidemiology  Know how it is transmitted and the clinical course of the disease in order to manage the outbreak Communicable Disease Outbreaks 95

96. / 40  There are at a minimum four things that must be addressed:  Preventing transmission among patients, healthcare personnel, and visitors  Identifying persons who may be infected and exposed  Providing treatment or prophylaxis to large numbers of people  Logistical issues (staff, medical supplies, resupply, continued operations, and capacity ) Communicable Disease Outbreaks 96

97. 97

98. 98 Cover Your Cough Posters www.cdc.gov/flu/protect/covercough.htm

99. / 40  Hospitals should be well versed in emergency preparedness, including bioterrorism  The response will be different based on the agent  Work with state and local agencies to develop a plan  There is a long list of bioterrorism agents  Anthrax, arenaviruses, botulism, brucellosis, cholera, Ebola virus hemorrhagic fever, E. coli, Lassa fever, plague, ricin toxin, salmonella, and cryptosporidium  For a comprehensive list go to website 1 1 http://www.emergency.cdc.gov/agent/agentlist.asp Bioterrorism 99

100. CDC Emergency Preparedness 100 www.bt.cdc.go v

101. CDC Emergency Preparedness 101 www.bt.cdc.gov/bioterrorism/index.asp

102. 102

103. Infection Control 278 2015  Surveillance and corrective actions  Need active surveillance program  Surveillance includes detection, data collection, analysis, monitoring and evaluation  Must have facility wide surveillance to monitor infections and communicable diseases in the CAH  Must be consistent with recognized surveillance activities like the CDC National Healthcare Safety Net (NHSN)  Must address interventions to address issues identified 103

104. / 40 Infection Control  NHSN replaces the CDCs National Nosocomial Infection Surveillance system (NNIS)  Was considered the gold standard for tracking HAI for more than 30 years  Designed to help hospitals better manage episodes of HAI such as MRSA and VRE  Used by the VA hospitals  Hospitals report central line infections in ICUs and NICUs and certain CaUTI  Enroll on-line for HAI surveillance and many other resources 1 http://www.cdc.gov/ncidod/dhqp/nhsn.html 104

105. CDC National Healthcare Safety Network 105 www.cdc.gov/nhsn/

106. 106 www.cdc.gov/nhsn/training/

107. Infection Control 278 2015  Sanitary environment  Needed to avoid transmission of infection and communicable diseases  This includes all CAH units and off site locations  Need to monitor housekeeping  Must monitor maintenance including repair, renovation, and construction activity  Must monitor food storage, preparation, serving and dish rooms, refrigerators, ice machines, air handlers, autoclave rooms, venting systems, inpatient rooms, treatment areas, labs, waste handling, surgical areas, supply storage, equipment cleaning, etc. 107

108. Infection Control 278 2015  Mitigation of risks  Need P&P to mitigate risks associated with HAI  Must implement IC techniques and standard precautions  Must include but not be limited to:  Hand hygiene, cough etiquette, use of contact, droplet, and airborne precautions –See Infection Control Worksheet  Use of PPE such as gloves, masks, and gowns  Safe work practices to prevent bloodborne pathogen 108

109. Standard Precautions CDC 109 www.cdc.gov/hicpac/2007IP/2007ip_part3.html

110. PPE Section in IC Worksheet 110

111. OSHA Bloodborne Pathogen Standard 111 www.osha.gov/SLTC/bloodbornepathogens/index.htm

112. OSHA Blood borne Pathogen Standard Must implement UNIVERSAL PRECAUTIONS to prevent contact with blood such as:  Hand washing (see CDC hand hygiene document at www.cdc.gov or WHO 2009 hand hygiene)  No recapping needles  Sharp containers in close proximity to use  Not eating or drinking in work station  No apply lip balm in work areas, if reasonable likelihood of occupational exposure)  Not handling contact lens in work area  Must wash your hands after gloves removed 112

113. IP Tools www.infectionpreventiontools.com / 113

114. Isolation Contact Precautions 114

115. Safe Medication 278 2015  Safe medication preparation and administration includes:  Prepare injectables in designated clean medication area not adjacent to contaminated areas –Such as medication room  Proper hand hygiene before handling medications  Always disinfect a rubber septum with alcohol before piercing it –10 or 15 second and let dry 115

116. Safe Medication 278 2015  Safe medication preparation and administration includes:  Always using aseptic technique when preparing and administering injections  Never enter a vial or IV with a used syringe or needle  Never administering medications from the same syringe to more than one patient, even if the needle is changed  Single dose vials can be used on only one patient –Unless prepared in pharmacy under USP 797 guidelines 116

117. 10 CDC Safe Injection Practices Standards 117 www.cdc.gov/hicpac/2007IP/2007isolationPrecautions.html

118. Safe Injection Practices and Sharps Safety in IC Worksheet 118

119. Safe Medication 278 2015  Safe medication preparation and administration includes:  IV bags can be used on one patient  If multi-dose vial try and use for one patient only and do not take into patient room or into the OR  Mark multi-dose vial expires in 28 days unless sooner by manufacturer  Wear a mask when placing a catheter or injecting into epidural, spinal or subdural area –Like ED physician doing LP or anesthesiologist who puts in epidural for pain relief 119

120. Wear a Mask Epidural Spinal or LP 120 www.cdc.gov/injectionsafety/SpinalInjection-Meningitis.html

121. 121

122. 122

123. Safe Medication 278 2015  Safe medication preparation and administration includes:  Never use same finger stick device for more than one patient  Never use insulin pens on more than one patient and CMS issues memo on this  Avoid sharing glucose meters  If must share then clean after every use as recommended by manufacturer  P&P to make sure reusable patient care equipment is cleaned and reprocessed 123

124. CMS Memo on Insulin Pens  CMS issues memo on insulin pens on May 18, 2012  Insulin pens are intended to be used on one patient only  CMS notes that some healthcare providers are not aware of this  Insulin pens were used on more than one patient which is like sharing needles  Every patient must have their own insulin pen  Insulin pens must be marked with the patient’s name 124

125. Insulin Pens 125 www.cms.gov/Medicare/Provider-Enrollment- and- Certification/SurveyCertificationGenInfo/Polic y-and-Memos-to-States-and-Regions.html

126. CDC Reminder on Insulin Pens 126 www.cdc.gov/injectionsafety/clinical-reminders/insulin- pens.html

127. Insulin Pen Posters and Brochures 127 www.oneandonlycampaign.org /content/insulin-pen-safety

128. CMS Memo on Safe Injection Practices  June 15, 2012 CMS issues a 7 page memo on safe injection practices  Discusses the safe use of single dose medication to prevent healthcare associated infections (HAI)  Notes new exception which is important especially in medications shortages  General rule is that single dose vial (SDV)can only be used on one patient  Will allow SDV to be used on multiple patients if prepared by pharmacist under laminar hood following USP 797 guidelines 128

129. Single Dose Memo 129

130. Fingerstick Devices 130

131. Fingerstick Devices  Anyone performing fingerstick procedures should ensure that a device is not used on more than one patient  Use auto-disabling single-use disposable fingerstick devices  Pen like devices should not be used on multiple patients due to difficulty with cleaning and disinfection (one patient use) 131

132. Safe Injection Practices Memo 132 www.empsf.org

133. CDC One and Only Campaign 133 http://oneandonlycampaign.org/

134. Not All Vials Are Created Equal 134

135. 135 http://ascquality.org/advancing_asc_quality.cfm

136. Safe Medication 278 2015  Safe medication preparation and administration includes:  Must train staff on infection control P&P  Expected to provide role specific education on: –Proper hand hygiene, standard and transmission-based precautions, asepsis, sterilization, disinfection, food sanitation, housekeeping, linen care, medical and infectious waste disposal, injection safety, separation of clean from dirty, as well as other means for limiting the spread of infections 136

137. Infection Control Video  HHS has published a training video that every nurse, physician, infection preventionist and healthcare staff should see  This includes risk managers  It is an interactive video  Called Partnering to Heal: Teaming Up Against Healthcare-Associated Infections  Go to http://www.hhs.gov/partneringtoheal 137

138. Watch this Video on Preventing HAI 138 www.hhs.gov/ash/initiatives/hai/training/

139. Watch Award Winning Video 139 Safe Injection Practices - How to Do It Right www.youtube.com/watch?v=6D0stMoz80k&feature=youtu.b

140. CDC Guidelines on Hand Hygiene 140

141. 141

142. CDC Poster Clean Hands Save Lives ! 142 www.cdc.gov/h1n1flu/pd f/handwashing.pdf

143. This is Your Hand Unwashed Johns Hopkins 143 www.hopkinsmedicine.org/heic/docs/HH_hand_unwashed.pdf

144. Safe Medication 278 2015  Safe medication preparation and administration includes :  Must monitor compliance with all P&P and IC program requirements  Must do a program evaluation and make revisions when indicated  Need to provide education to patients and visitors about precautions to prevent infections –CDC and APIC have many free resources 144

145. 145 APIC Brochures  APIC has a number of educational brochures that hospitals can download and provide to staff and patient 1  Includes 10 tips to prevent the spread of infection and hand hygiene for patients and one for healthcare workers  Information to patients is on standard precautions (hand hygiene) and transmission precautions for patients with certain diseases (contact precautions )  1 www.apic.org/AM/Template.cfm?Section=Education_Resources&Template=/TaggedPage/TaggedPag eDisplay.cfm&TPLID=91&ContentID=8738

146. 146

147. Survey Procedure 278  Surveyor to make sure there is a qualified IP  CAH must show how program follows national guidelines and standards  Recommend citing sources in P&P  Will look to make sure hospital is sanitary and hospital performs active surveillance  Will make sure staff follow standard precautions and have IC education  Will make sure medications are prepared safely 147

148. Risk Assessment Tools from IP Tools 148 www.infectionpreventiontools.com/home

149. Risk Assessment Tools 149

150. Risk Assessment Tools 150

151. 151 Dietary 279 2015  Standard: If the CAH furnishes inpatient services, including swing bed patients  Procedures must be in place that ensure that the nutritional needs of inpatients are met in accordance with recognized dietary practice  And the orders of a practitioner  A CAH is not required to prepare meals itself.  Can obtain meals under contract,  Infection control issues in dietary hit hard

152. Dietary Services 279 2015  Must be staffed to ensure that the nutritional needs of the patients are met  Must have a qualified director  Based on education, experience, specialized training and license, certified, or registered if required by the state  If swing beds must comply with following:  Make sure resident maintains acceptable parameters of nutritional status such as body weight and proteins  Receives a therapeutic diet 152

153. Dietary Services 279 2015  Must follow recognized dietary practices  For example, the IOM’s Food and Nutrition Board’s DRI or Dietary Reference Intake 4 reference values  RDA or the recommended dietary allowance is average dietary intake of a nutrition sufficient of healthy people  Adequate Intake (AI) for a nutrient is similar to the ESADDI and is only determine when an RDA cannot be determined –Estimated Safe and Adequate Daily Intake (ESADDI) –AI is based on observed intakes of the nutrient by a group of healthy persons 153

154. Dietary Services 279 2015  IOM’s Food and Nutrition Board’s DRI or Dietary Reference Intake 4 reference values (continued)  Tolerable Upper Intake Level (UL) is highest daily intake of a nutrient that is likely to pose no risks of toxicity for most people –As the UL increase, risk increases  Estimated Average Requirement (EAR) is the amount of the nutrient that is estimated to meet the requirement of half of the health people 154

155. IOM DRI or Dietary Reference Intake 155 http://fnic.nal.usda.gov/dietary-guidance/dietary-reference-intakes/dri-nutrient-reports

156. 156

157. Interactive DRI Tool and Tables 157

158. Dietary Services 279 2015  Therapeutic diets may help meet the patient’s nutritional needs  Patients must be assessed to determine if they need a therapeutic diet for other nutritional deficiencies  Include in patient’s care plan  Include the need to monitor intake  Include if need daily weights, I&O, or lab values 158

159. Nutritional Assessment Includes  Patient May Need Comprehensive Assessment if:  Medical or surgical conditions or physical status interferes with their ability to digest or absorb nutrients  Patient has S&S indicating risk for malnutrition –Anorexia, bulimia, electrolyte imbalance, dysphagia, ESRD or certain medications  Patient medical condition adversely affected by intake and so need a special diet –CHF, renal disease, diabetes, etc. 159

160. Dietary 279 2015  Patient May Need Comprehensive Assessment if (continued):  Patient receiving artificial nutrition  Tube feeding, TPN, or peripheral parenteral nutrition  Need an order for diets, including therapeutic diet, from practitioner responsible for care  Dietician or qualified nutritional specialist can be C&P to order diet as consistent with state law requirement 160

161. Survey Procedure 279 2015  Surveyor will verify dietician is qualified  Will ask how CAH uses DRIs in its menus to meet the nutritional needs of patients  Will identify to make sure patients were screened and assessed  Will make sure all diets are ordered  Will make sure dietary intake and nutritional status are being monitored as appropriate and swing beds patients aren’t losing weight and maintaining protein level 161

162. 162 Patient Services 280 2015  Standard: Must provide diagnostic and therapeutic services as those provided in doctor’s office or at entry of healthcare organization like an outpatient department or ED,  Changed from Direct Services to Patient Services  Can provide directly or under contract  Must have supplies as that typically found in an ambulatory healthcare setting and a physician’s office  These services include medical history, physical examination, specimen collection, assessment of health status, and treatment for a variety of medical conditions.

163. 163 Outpatient Department 280 2015  Must provide adequate services, equipment, staff, and facilities adequate to provide the outpatient services,  Must follow acceptable standards of practices such as ACR, AMA, ACOS, etc.,  OP Dept must be integrated with inpatient services such as MR, lab, radiology, anesthesia or other diagnostic services,  CAH physician or non-physician practitioner must be available to treat patients at the CAH when such outpatient services are provided  For those outpatient services that fall only within the scope of practice of a physician or non-physician practitioner

164. Patient Services 281 2015  Standard: The CAH furnishes acute care inpatient services  Average LOS is 96 hours  CAH provide less complicated inpatient services to meet the LOS requirement  Will look at data to make sure patients who need inpatient care are admitted  Must certify that Medicare patients may be expected to be discharged or admitted to a hospital within 96 hours  Does not believe in best interest to transfer a patient that can be cared for locally 164

165. Patient Services 281 2015  CMS notes that CAH may have seasonal variations  CAH is not required to maintain a minimum average daily census of inpatients  Nor are they required to maintain a minimum number of inpatient beds  Will look at volume of ED and outpatient services, number of certified beds and dedicated observation beds, average annual occupancy, average inpatient beds quarterly and annually, % of ED patients admitted, etc. 165

166. Patient Services 281 2015  Wants to be sure not an excess number of observation beds  Wants to be sure not transferring patients from the ED to another hospital when the CAH could care for them  Data shows about ½ the number of patients who visit a rural hospital are admitted then in a non-rural hospital (8.3 % vs. 16%)  If admits 8% of its ED patients annually CAH is compliant with inpatient services and surveyors do not need to investigate further 166

167. 167 Lab Services 282 2015  Must provide basic lab services to include,  Urine dipstick or tablet including urine ketones,  Hemoglobin or hematocrit,  Blood glucose,  Stool for occult blood,  Pregnancy tests,  Primary culturing for transmittal to certified lab,  Will need written policy to make sure all labs tests are recorded in the MR,  Lab and radiology dept do not have to be a direct service

168. 168 Lab 282  Must have these basic lab services,  Must provide emergency services 24 hours/7 days a week,  Must have current CLIA certificate and if contracted out make sure they have a CLIA certificate  Scope of services and complexity must be adequate to meet the needs of the patients,  Can be employed or contract services,  Patient lab results are medical records and must comply with the MR chapter  Must have written P&P for collecting, preserving, transport, receipt if tissue specimen results,

169. 169 Nursing Care 294 2015  Standard: Nursing service must met the needs of patients  RN must provide nursing care to each patient or assign  Nursing service must be well organized  Need chief nursing officer (CNO) who is responsible for development of nursing P&P  Staff must be aware of all P&P  CNO responsible to supervise nursing staff  Must have ongoing review and analysis of nursing care

170. Nursing Care 294 2015  All agency nurses must be oriented and supervised  Surveyor will interview RN and ask how nursing needs of patients are determined  How are staff assigned to provide care?  How are staff trained and oriented?  Will look at written staffing schedules to make sure adhere to P&Ps  Will review personnel files to make sure nurses are licensed 170

171. Nursing Care 294 2015  Must have RN, LPN, or CNS on duty whenever the CAH has 1 or more patients  Must ensure appropriate staffing for outpatient nursing services  Must have sufficient numbers of supervisory and non-supervisory personnel to meet patient needs  Must be competent, educated, trained, oriented, and licensed  Need procedure for assigning and coordinating nursing care  RN make assignments 171

172. 172 RN 295  RN must provide the care for each patient or assign care to other personnel,  Including SNF and swing be patients,  Care must be provided in accordance with patient needs,  RN must make all patient care assignments,  Assignments must take into consideration complexity of patient’s care,  Will look at written staffing plans,  Staff must be competent,  Make sure if temporary nurses used they are oriented and supervised,

173. 173 RN Supervising Care 296 2015  A RN must supervise and evaluate the nursing care for each patient (or if state law allows a PA)  Includes SNF level is a swing bed  Must evaluate the care of each patient upon admission including swing beds  Nursing care plans do not have to be developed for outpatients  But follow acceptable standards for medication administration

174. 174 Drugs and IVs 297 2015  Standard: All drugs and IVs are administered under the supervision of RN, MD/DO, or a PA if allowed by state law  Need a signed order  Be sure there is signature and date and TIME on all orders  Orders must be written with the acceptable standard of care  Must be consistent with both state and federal laws

175. Drugs and IVs 297 2015  Drugs must be administered and prepared in accordance with the standard of care  Mentions NCCMERP, IHI, USP, ISMP, CDC, and Infusion Nurses Society  Discussed previously  P&P must specify who can administer meds  Need signed order by one authorized by P&P  Need P&P for verbal and standing orders  Need minimum content of medication orders  Name, dose, route, frequency, etc. 175

176. 176

177. Drugs and IVs 297 2015  Ensure compliance with acceptable practices  Self administration of medications  Training  Basic safe practices  Timing of medication  IV medication  Documentation  Assessment of patients receiving medications 177

178. Drugs and IVs 297 2015  Verbal and standing orders  Practitioner must authenticate order ASAP  Need P&P for both  Standing orders must include how it is developed, approved, monitored and updated  Must include when staff can initiate a standing order  Must include that standing order is signed off  List of things that must be in the verbal order 178

179. Verbal Order P&P 179

180. Blue Box Advisory Verbal & Standing 180

181. Drugs and IVs 297 2015  Self administered meds  Need an order  Can include meds brought from home  Must have P&P  Training  Medication administration training and education during orientation and CNE to include: –Safe handling and preparation of drugs –Knowledge of side effects, ADE, dose limits –How to use equipment and need P&P 181

182. Drugs and IVs 297 2015  Basic safe practices  Five rights  Culture of safety where staff feel free to ask questions  Timing of medications  P&P specify time frames  P&P must include those medications not eligible for scheduled dosing times –Such as stat, PRN, on call for surgery, loading dose  Evaluation of timing policies 182

183. 3 Time Frames for Administering Medication 183

184. Timing of Medication P&P  Time-critical scheduled medications (30 minute or 1 hour total window)  These are ones in which an early or late administration of greater than thirty minutes might cause harm or have significant, negative impact on the intended therapeutic or pharmacological effect  P&P must include whether these drugs are always time critical –Examples include: Antibiotic given within one hour of incision time in the OR, fast acting insulin with 15 minutes of lunch 184

185. Timing of Medication P&P  Non-time-critical scheduled medications  Greater flexibility is given  Medications scheduled more frequently than daily but less than every 4 hours (such as bid or tid) can be given 1 hour before or after for window not to exceed 2 hours  Medications given once daily, weekly, or monthly may be given within 2 hours before or after but can not exceed a total window of 4 hours (such as Allegra once a day) 185

186. Timing of Medication P&P  Missed or late administration of medications  Policy must include what action to take if missed or not given in permitted window of time  Missed dose may be due from patient who is out of the department, patient refusal, problems related to medication being available or other reasons  Policy needs to include parameters of when nursing staff are allowed to use their own judgment on the rescheduling of late or missed dosed  Missed or late doses must be reported to the attending physician 186

187. Medication Assessment 297 2015  Assessment of Patients on Medications  Very concerned about patient having respiratory depression or ADR from opioids  Must carefully monitor  May include respiratory status, BP, pulse ox and ETCO2  Evaluate for confusion, agitation, unsteady gait, itching, lethargy, etc.  Opioids are considered high risk medications 187

188. ISMP List of High Alert Medication 188

189. Medication Assessment 297 2015  Assessment of Patients on Medications  Factors that put patients at greater risk for adverse events and respiratory depression  Liver or kidney failure  History of sleep apnea or snoring  Age, thoracic or other surgical incisions  History of smoking, pulmonary or cardiac disease  First time medication use, receiving benzodiazepines, antihistamines  Asthma, Patient weight 189

190. Medication Assessment 297 2015  Need to communicate in report and hand offs  High alert medications would want to assess sedation level  Staff are expected to include patient reports of their experience of medication’s effects  Educate the patient and family to notify nurse if any difficulty breathing or ADEs  P&P must discuss manner and how frequent to monitor patient 190

191. IV Medication & Blood 297 2015  Need correct choice of vascular access devise to deliver blood and medications  Peripheral catheters, PICC, midlines, central lines, implanted ports and other types of devices  Need P&P to address which ones can be given IV and via what type of access  Trace lines and tubes for correct connections and prior to giving meds  Verify IV pump is properly programmed 191

192. IV Medication & Blood 297 2015  P&P expected to address:  Monitoring for fluid and electrolyte imbalance –Electrolyte imbalance can occur with IV meds or blood  Monitoring of patients receiving high alert medication including opioids –How often and what devices such as pulse ox or ETCO2, and document pain level, VS, respiratory status and sedation level  Monitoring for over-sedation and respiratory depression related to opioid in post-op patients 192

193. Pasero Opioid ‐ induced Sedation Scale POSS 193 https://secure.tha.com/surveys/files/p asero-opioid-induced-sedation-scale- poss.pdf

194. Richmond Agitation Sedation Scale RASS 194 www.icudelirium.org/docs/RASS.pdf

195. Comparison of Sedation Scales Medscape 195 www.medscape.com/vi ewarticle/708387_3

196. ISMP Use a Standard Sedation Scale 196

197. 197

198. Blood Transfusions 297 2015  Confirm correct patient  Verify correct blood product  Standard calls for two qualified persons, one who is administering the transfusion  TJC NPSG allows one person hanging blood if use bar coding  Document monitoring  P&P include how frequent you monitor the patient and do vital signs  How to identify and treat and report any adverse transfusion reaction 198

199. Nursing Care Plan 298 2015  Must keep a current nursing care plan (POC) for each inpatient  Starts upon admission and need to keep current  Includes planning for patient’s care while in hospital  Includes planning for transfer  Considers treatment goals, physiological and psychosocial factors and discharge planning 199

200. Nursing Care Plan 298 2015  POC develops appropriate nursing interventions based on identified needs  Must be part of the permanent medical record  Nursing can do it as part of the interdisciplinary POC  Must still do a nursing POC  Surveyor will check to make sure POC started soon after admission  Will also make sure it is revised as necessary 200

201. The End! Questions??  Sue Dill Calloway RN, Esq. CPHRM, CCMSCP  AD, BA, BSN, MSN, JD  President  5447 Fawnbrook Lane  Dublin, Ohio 43017  614 791-1468 (Call with questions, No emails)  sdill1@columbus.rr.com 201