Critical Access Hospital CoPs Part 2 of 3

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
• Board Member Emergency Medicine Patient
  Safety Foundation
• 614 791-1468 (Call with Questions, No emails)
• sdill1_at_columbus.rr.com

2
2
3
new website at www.cms.hhs.gov/manuals/downloads
/som107_Appendixtoc.pdf
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• And all outdated, mislabeled, or otherwise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 PP to govern pharmacy services
• PP must address storage, handling, dispensing,
  and administration
• Must follow acceptable standards of care

6
Drugs and Biologicals 276 2015

• CAH rules and PP 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 PP 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

7
ISMP Institute for Safe Medication Practices
www.ismp.org
8
American Society of Health System Pharmacists or
ASHP
www.ashp.org/
9
Infusion Nurses Society INS
www.ins1.org
10
National Coordinating Council
www.nccmerp.org
11
(No Transcript)
12
USP U.S. Pharmacopeial
www.usp.org
13
Institute for Healthcare Improvement IHI
www.ihi.org
14
Drug Rules Must Include 276 2015

• Rules (PP) 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 PP
• Note can cite as reference in PPs
• Storage including location of storage areas,
  medication carts, and dispensing machines

15
Drug Rules Must Include 276 2015

• Proper environmental conditions
• Follow manufacturers recommendation such as keep
  refrigerated, room temperature, out of light,
  etc.
• Security
• PP 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

16
Drug Rules Must Include 276 2015

• Area restricted to personnel only are generally
  considered secure
• Given flexibility in non-controlled drugs such as
  dont 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

17
Medications in the OR ASA Position
www.asahq.org/For-Members/Standards-Guidelines-and
-Statements.aspx
18
ASA Guidelines and Statements
http//asahq.org/For-Healthcare-Professionals/Stan
dards-Guidelines-and-Statements.aspx
19
Recommendation on Medications in the OR
www.apsf.org/newsletters/html/2010/spring/01_confe
rence.htm
20
Drugs Rules Must Include 276 2015

• Must have PP 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

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 products
  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

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.

23
Blue Box Advisory USP 797
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 FDAs
  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

25
FDAs Compounding Website
www.fda.gov/Drugs/GuidanceComplianceRegulatoryInfo
rmation/PharmacyCompounding/default.htm
26
Use a Company that is Registered
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

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 available when needed by the patient
• Concerns or questions should be clarified with
  prescriber before dispensing

29
Drugs and Biologicals 276 2015

• Can use unit dose or floor stock system
• Automated dispensing cabinets are secure option
• Need PP for who can access medications after
  hours (night cabinet standard)
• Suggest PP 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.

30
(No Transcript)
31
Do Not Use Abbreviations ISMP
32
TJCs Do Not Use Abbreviation List
33
ISMP List of High Alert Medications
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

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
• PP to determine BUD date if not marked

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

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 using
• 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

38
Survey Procedure276 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 PP
• Long survey procedure for this tag number

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
41
Definition of Adverse Drug Event ADR
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

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

44
Reporting ADR and Errors 277 2015

• Encourages a non-punitive approach that focuses
  on system issues
• Cant 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

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
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
(No Transcript)
48
(No Transcript)
49
FDA MedWatch Form
50
ISMP Medication Error Reporting Program
www.ismp.org
51
List of High Alert Medications
52
High Alert How to Guide IHI
www.ihi.org/NR/rdonlyres/8B2475CD-56C7-4D9B-B359-8
01F3CC3A8D5/0/HighAlertMedicationsHowToGuide.doc
53
(No Transcript)
54
(No Transcript)
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

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
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
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.htm
  l

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
  PP
• 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

61
Final Worksheet Infection Control
www.cms.gov/SurveyCertificationGenInfo/PMSR/list.a
spTopOfPage
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

63
Infection Preventionist or IP
64
APIC Competency Infection Prevention
www.ajicjournal.org/article/S0196-6553(12)00165-4/
fulltext
65
(No Transcript)
66
Infection Control 278 2015

• 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

67
APIC Website
www.apic.org
68
SHEA Website
/www.shea-online.org
69
AORN
www.aorn.org
70
AORN Guidelines for Perioperative Practice
71
OSHA Website
www.osha.gov
72
OSHA Worker Safety in Hospitals
73
CDC Website
www.cdc.gov/
74
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

75
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, 20061
• 1http//www.cdc.gov/ncidod/dhqp/pdf/ar/mdroGuideli
  ne2006.pdf

76
CDC Module on C-Diff
77
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
• Have systems in place to identify and prevent
  transmission of these organisms.
• The CDC has a special publication on Management
  of Multidrug-Resistant Organisms in Healthcare
  Settings, 20061
• 1http//www.cdc.gov/ncidod/dhqp/pdf/ar/mdroGuideli
  ne2006.pdf

78
www.cdc.gov/ncidod/dhqp/pdf/ar/mdroGuideline2006.p
df
79
APIC C-Diff Guide
www.apic.org/Professional-Practice/Implementation-
guides
80
SHEA C-Diff Guidelines
www.shea-online.org/GuidelinesResources/Guidelines
/Guideline/ArticleId/11/Clinical-Practice-Guidelin
es-for-Clostridium-difficile-Infection-in-Adults-2
010.aspx
81
AHRQ Toolkit on KPC 2014

• 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

82
(No Transcript)
83
Free Toolkit for Hospitals
84
CDC National Healthcare Safety Network
www.cdc.gov/nhsn/
85
www.cdc.gov/nhsn/training/
86
www.cdc.gov/hicpac/pdf/guidelines/bsi-guidelines-
2011.pdf
87
(No Transcript)
88
Infection Control Ambulatory Care

• 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

89
Infection Control Ambulatory Care

• Place in room and dont leave in lobby if can be
  contagious and implement cough etiquette protocol
• Guidelines have been developed by the CDCs
  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

90
Infection Control Ambulatory Care

• CDCs 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.

91
APIC Resources Ambulatory Care
92
CDC Norovirus Guidelines
www.cdc.gov/hicpac/norovirus/002_norovirus-toc.htm
l
93
CDC HICPAC
94
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/o
  utpatient/outpatient-settings.html?sourcegovdeliv
  ery

95
CDC Guide Infection Control Outpatients
www.cdc.gov/HAI/settings/outpatient/outpatient-car
e-guidelines.html
96
Communicable Disease Outbreaks

• Community-wide outbreaks of communicable diseases
  present many of the same types of issues as
  hospital infection disease threats
• Such as measles, 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

97
Communicable Disease Outbreaks

• 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)

98
(No Transcript)
99
Cover Your Cough Posters
www.cdc.gov/flu/protect/covercough.htm
100
Bioterrorism

• 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 website1
• 1http//www.emergency.cdc.gov/agent/agentlist.asp

101
CDC Emergency Preparedness
www.bt.cdc.gov
102
CDC Emergency Preparedness
www.bt.cdc.gov/bioterrorism/index.asp
103
Bio-defense Solutions by the Army
www.usamriid.army.mil
104
(No Transcript)
105
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

106
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 resources1
• 1http//www.cdc.gov/ncidod/dhqp/nhsn.html

107
CDC National Healthcare Safety Network
www.cdc.gov/nhsn/
108
www.cdc.gov/nhsn/training/
109
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.

110
Infection Control 278 2015

• Mitigation of risks
• Need PP 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

111
Standard Precautions CDC
www.cdc.gov/hicpac/2007IP/2007ip_part3.html
112
PPE Section in IC Worksheet
113
OSHA Bloodborne Pathogen Standard
www.osha.gov/SLTC/bloodbornepathogens/index.htm
114
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

115
IP Tools www.infectionpreventiontools.co
m/
116
Isolation Contact Precautions
117
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
• 15 second and let dry

118
Safe Medication 278 2015

• Safe medication preparation and administration
  includes
• Always using aseptic technique when preparing and
  administering injections
• Never entering 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

119
10 CDC Safe Injection Practices Standards
www.cdc.gov/hicpac/2007IP/2007isolationPrecautions
.html
120
Safe Injection Practices and Sharps Safety in IC
Worksheet
121
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
• 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

122
Wear a Mask Epidural Spinal or LP
www.cdc.gov/injectionsafety/SpinalInjection-Mening
itis.html
123
(No Transcript)
124
(No Transcript)
125
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 be done then clean after every use as
  recommended by manufacturer
• PP to make sure reusable patient care equipment
  is cleaned and reprocessed

126
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 patients
  name

127
Insulin Pens
www.cms.gov/Medicare/Provider-Enrollment-and-Certi
fication/SurveyCertificationGenInfo/Policy-and-Mem
os-to-States-and-Regions.html
128
CDC Reminder on Insulin Pens
www.cdc.gov/injectionsafety/clinical-reminders/ins
ulin-pens.html
129
Insulin Pen Posters and Brochures
www.oneandonlycampaign.org/content/insulin-pen-saf
ety
130
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

131
Single Dose Memo
132
Fingerstick Devices
133
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)

134
Safe Injection Practices Memo
www.empsf.org
135
CDC One and Only Campaign
http//oneandonlycampaign.org/
136
Not All Vials Are Created Equal
137
http//ascquality.org/advancing_asc_quality.cfm
138
Safe Medication 278 2015

• Safe medication preparation and administration
  includes
• Must train staff on infection control PP
• 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

139
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

140
Watch this Video on Preventing HAI
www.hhs.gov/ash/initiatives/hai/training/
141
Watch Award Winning Video
Safe Injection Practices - How to Do It Right
www.youtube.com/watch?v6D0stMoz80kfeatureyoutu.
b
142
CDC Guidelines on Hand Hygiene
143
(No Transcript)
144
CDC Poster Clean Hands Save Lives!
www.cdc.gov/h1n1flu/pdf/handwashing.pdf
145
This is Your Hand Unwashed Johns Hopkins
www.hopkinsmedicine.org/heic/docs/HH_hand_unwashed
.pdf
146
Safe Medication 278 2015

• Safe medication preparation and administration
  includes
• Must monitor compliance with all PP 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

147
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)
• 1www.apic.org/AM/Template.cfm?SectionEducation_Re
  sourcesTemplate/TaggedPage/TaggedPageDisplay.cfm
  TPLID91ContentID8738

148
(No Transcript)
149
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 PP
• 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

150
Risk Assessment Tools from IP Tools
www.infectionpreventiontools.com/home
151
Risk Assessment Tools
152
Risk Assessment Tools
153
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

154
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

155
Dietary Services 279 2015

• Must follow recognized dietary practices
• For example, the IOMs Food and Nutrition Boards
  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

156
Dietary Services 279 2015

• IOMs Food and Nutrition Boards 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

157
IOM DRI or Dietary Reference Intake
http//fnic.nal.usda.gov/dietary-guidance/dietary-
reference-intakes/dri-nutrient-reports
158
(No Transcript)
159
Dietary Guidelines for Americans
160
Interactive DRI Tool and Tables
161
Dietary Services 279 2015

• Therapeutic diets may help meet the patients
  nutritional needs
• Patients must be assessed to determine if they
  need a therapeutic diet for other nutritional
  deficiencies
• Include in patients care plan
• Include the need to monitor intake
• Include if need daily weights, IO, or lab values

162
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 SS 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.

163
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 CP to order diet as consistent with state law
  requirement

164
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 arent losing weight and
  maintaining protein level

165
Patient Services 280 2015

• Standard Must provide diagnostic and therapeutic
  services as those provided in doctors 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 physicians
  office
• These services include medical history, physical
  examination, specimen collection, assessment of
  health status, and treatment for a variety of
  medical conditions.

166
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

167
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

168
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.

169
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

170
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

171
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 PP for collecting, preserving,
  transport, receipt if tissue specimen results,

172
Radiology Services 283 2015

• Radiology services must be provided by qualified
  staff,
• Can be provided as a direct service or through a
  contract,
• And do not expose patients or staff to radiation
  hazards,
• Must have services to meet the needs of its
  patients at all times,

173
Radiology Services 283

• Can offer minimal set or more complex, according
  to needs of the patients including nuclear
  medicine,
• Hospital has flexibility to decide the types and
  complexities of radiologic services offered
• Interpretation can be contracted out
• Diagnostic, therapeutic, and nuclear medicine,
  must be provided in accordance with acceptable
  standards of practice and must meet
  professionally approved standards for safety

174
Radiology Services 283

• Scope or what you do has to be in PPs approved
  by board or responsible party,
• Must be consistent with state law
• If telemedicine is used must comply with
  telemedicine standards
• And by standards recommended by nationally
  recognized professions such as the AMA, Radiology
  Society of North America, Alliance for Radiation
  Safety in Pediatric Imaging, ACC, American
  College of Neurology, ACP, and ACR,
• Example would be the ACR 2013 MRI safety
  standards and 2013 contrast manual

175
Radiology Services 283

• PP on adequate radiation shielding for patients,
  personnel and facilities which includes
• Shielding built into the physical plant
• Types of personal protective shielding to use and
  under what circumstances
• Types of containers to be used for radioactive
  materials
• Clear signage identifying hazardous radiation
  area

176
Radiology Policies Required

• Labeling of all radioactive materials, including
  waste with clear identification of the material
• Transportation of radioactive materials between
  locations within the CAH
• Security of radioactive materials, including
  determining who may have access to radioactive
  materials and controlling access to radioactive
  materials
• Periodic testing of equipment for radiation
  hazards

177
Radiology Policies

• Periodic checking of staff regularly exposed to
  radiation for the level of radiation exposure,
  via exposure meters or badge tests
• Storage of radio nuclides and radio
  pharmaceuticals as well as radioactive waste and
  
• Disposal of radio nuclides, unused radio
  pharmaceuticals, and radioactive waste,
• To ensure periodic inspections of equipment,
• Make sure problems are corrected in timely manner
  and have evidence of inspections and corrective
  actions

178
Radiology Policies 283 6-7-2013

• There must be written policies developed and
  approved by the medical staff to designate which
  radiological tests must be interpreted by a
  radiologist,
• MR chapter standards apply
• Make sure patient shielding aprons are maintained
  properly and inspected
• Surveyor will review equipment maintenance
  reports (PM)
• Make sure staff know PPs

179
Radiology Policies 283

• Supervision must include that all files, scans,
  and images are kept in a secure place and are
  retrievable,
• Written policy, consistent with state law on
  which personnel can operate radiology equipment
  and do procedures,
• Need copies of all reports and printouts,
• Written policy to ensure integrity of
  authentication,
• See tag 283 for required signage on hazardous
  radiation areas and more

180
Tag 283 Blue Box Advisory
181
Emergency Procedures 284 2015

• Must provide medical emergency services as a
  first response to common life threatening
  injuries and acute illness,
• Emergency services can be done directly or
  through contracted services
• Individuals providing the services must to be
  able to recognize a patient need for emergency
  care
• Must provide medically appropropriate initial
  interventions, treatment, and stabilization of
  any patient who requires emergency services

182
Agreements 285

• CAH has to have agreements with one or more
  providers or suppliers participating under
  Medicare to furnish services to patients
• CMS made an exception since distant-site
  telemedicine entity (DSTE) is not required to be
  a Medicare provider
• Agreements such as for obtaining outside lab tests

183
Contracted Services 287 2015

• Must have agreement or arrangement with one or
  more providers or supplies participating under
  Medicare to provide services to patients
• Arrangement or agreement with 1 or more doctors
  to provide care
• If referral agreement is not in writing then can
  show that doctors are accepting patients when
  referred (given appointments and seen)
• Need PP for referring patients it discharges who
  need additional care

184
Lab Diagnostic Services 288 2015

• Lab or diagnostic services that are not available
  at the CAH
• Want to have an agreement with 1 or more other
  providers
• Want to be sure referred patients are accepted
  and treated
• Need to make sure basic lab services are
  available to ensure an immediate diagnosis and
  treatment
• Staff can provide or contracted services can
  provide at the hospital

185
Contracted Services 286-289

• Need to have agreement with a lab that can
  provide additional or specialized lab tests
• CAH draws and sends tests out
• Required to have PP on this
• If labs that provide additional diagnosis and
  clinical lab services must be in compliance with
  CLIA and lab will be surveyed separately for
  compliance,
• CAH needs evidence that the outside lab has a
  CLIA certificate or waiver
• Same is true of radiology services and if done
  outside make sure CAH gets copy of report

186
Contracted Services Food 289 2015

• CAH can provide food and other services to meet
  inpatients nutritional needs
• Or CAH can contract out this service
• Must still make sure patient nutritional needs
  are met
• Dietary services must be provided as per the PP
• Exception is grandfathered co-located CAH but
  surveyor will assess it

187
Contracted Services 291 2015

• Need to keep list of all services provided under
  contract or agreement
• Must include service offered, individual or
  entity that is providing it, and whether on or
  off-site
• Must include if any limit on the volume of
  frequency of the services provided
• Must include when the services are available
• Update list each time services added or removed

188
Contracted Services 292 2015

• CEO is responsible for operation of all patient
  services furnished in the CAH
• This includes those performed directly or by
  contract
• Must take action to ensure this
• It includes not only care provided directly to
  patient but also services related to patient care
• Housekeeping, instrument cleaning and
  sterilization, laundry, pharmacy services, lab

189
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 PP
• Staff must be aware of all PP
• CNO responsible to supervise nursing staff
• Must have ongoing review and analysis of nursing
  care

190
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 PPs
• Will review personnel files to make sure nurses
  are licensed

191
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

192
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 patients care,
• Will look at written staffing plans,
• Staff must be competent,
• Make sure if temporary nurses used they are
  oriented and supervised,
  
  

193
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

194
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

195
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
• PP must specify who can administer meds
• Need signed order by one authorized by PP
• Need PP for verbal and standing orders
• Need minimum content of medication orders
• Name, dose, route, frequency, etc.

196
(No Transcript)
197
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

198
Drugs and IVs 297 2015

• Verbal and standing orders
• Practitioner must authenticate order ASAP
• Need PP 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

199
Verbal Order PP
200
Blue Box Advisory Verbal Standing
201
Drugs and IVs 297 2015

• Self administered meds
• Need an order
• Can include meds brought from home
• Must have PP
• 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 PP

202
Drugs and IVs 297 2015

• Basic safe practices
• Five rights
• Culture of safety where staff feel free to ask
  questions
• Timing of medications
• PP specify time frames
• PP must include those medications not eligible
  for scheduled dosing times
• Such as stat, PRN, on call for surgery, loading
  dose
• Evaluation of timing policies

203
3 Time Frames for Administering Medication
204
Timing of Medication PP

• 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
• PP 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