Transcript cah-cops-2016-part-2-of-3 - Maine Society of Health System

Critical Access Hospital CoPs
Part 2 of 3
What every CAH needs to know about the
Conditions of Participation (CoPs)
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)
 [email protected]
2
Location of CMS CoP Manual
Questions to [email protected]
www.cms.hhs.gov/manuals/downloads/som107_Appendixtoc.pdf
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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And all outdated, mislabeled, or otherwise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,
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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
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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
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ISMP Institute for Safe Medication Practices
www.ismp.org
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American Society of Health System Pharmacists or ASHP
www.ashp.org/
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Infusion Nurses Society INS
www.ins1.org
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National Coordinating Council
www.nccmerp.org
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USP U.S. Pharmacopeial
www.usp.org
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Institute for Healthcare Improvement IHI
www.ihi.org
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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
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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
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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
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Medications in the OR ASA Position
www.asahq.org/For-Members/StandardsGuidelines-and-Statements.aspx
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ASA Guidelines and Statements
http://asahq.org/For-Healthcare-Professionals/Standards-Guidelines-and-Statements.aspx
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Recommendation on Medications in the OR
www.apsf.org/newsletters/html/2010/spring/01_conference.htm
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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
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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
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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.
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Blue Box Advisory USP 797
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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
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FDA’s Compounding Website
www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Pharmacy
Compounding/default.htm
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Use a Company that is Registered
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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
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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
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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 oneway return bin, etc.
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Do Not Use Abbreviations ISMP
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TJC’s Do Not Use Abbreviation List
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ISMP List of High Alert Medications
www.ismp.org
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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
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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
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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
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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
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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
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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
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Definition of Medication Error
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Definition of Adverse Drug Event ADR
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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
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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
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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
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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,
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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,
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FDA MedWatch Form
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ISMP Medication Error Reporting Program
www.ismp.org
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List of High Alert Medications
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High Alert How to Guide IHI
www.ihi.org/NR/rdonlyres/8B2475CD-56C7-4D9B-B359-801F3CC3A8D5/0/HighAlertMedicationsHowToGuide.doc
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53
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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
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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
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Websites
The Institute for Safe Medication
Practices- www.ismp.org
U.S. Pharmacopoeia (USP)
www.usp.org
Institute for Healthcare Improvementwww.ihi.org,
AHRQ- www.ahrq.gov,
Sentinel event alerts at
www.jointcommission.org,
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Additional Resources
 American Pharmaceutical Associationwww.aphanet.org
 American Society of Heath-System Pharmacistswww.ashp.org
 Enhancing Patient Safety and Errors in Healthcarewww.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
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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
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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
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Final Worksheet Infection Control
www.cms.gov/SurveyCertificationG
enInfo/PMSR/list.asp#TopOfPage
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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
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Infection Preventionist or IP
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APIC Competency Infection Prevention
www.ajicjournal.org/article/S0196-6553(12)00165-4/fulltext
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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
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APIC Website
www.apic.org
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SHEA Website
/www.shea-online.org
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AORN
www.aorn.org
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AORN Guidelines for Perioperative Practice
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OSHA Website
www.osha.go
v
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OSHA Worker Safety in Hospitals
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CDC Website
www.cdc.gov/
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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
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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
1http://www.cdc.gov/ncidod/dhqp/pdf/ar/mdroGuideline2006.pdf
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CDC Module on C-Diff
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www.cdc.gov/ncidod/dhqp/pdf/ar/mdroGuideline20
06.pdf
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APIC C-Diff Guide
www.apic.org/ProfessionalPractice/Implementation-guides
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SHEA C-Diff Guidelines
www.sheaonline.org/GuidelinesResources/Guidelines/Guid
eline/ArticleId/11/Clinical-Practice-Guidelines-forClostridium-difficile-Infection-in-Adults-2010.aspx
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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
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Free Toolkit for Hospitals
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CDC National Healthcare Safety Network
www.cdc.gov/nhsn/
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www.cdc.gov/nhsn/training/
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www.cdc.gov/hicpac/pdf/guidel
ines/bsi-guidelines-2011.pdf
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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
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87
Infection Control Ambulatory Care
 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
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Infection Control Ambulatory Care
 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.
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APIC Resources Ambulatory Care
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CDC Norovirus Guidelines
www.cdc.gov/hicpac/norovirus/002_no
rovirus-toc.html
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CDC HICPAC
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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/outpatientsettings.html?source=govdelivery
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CDC Guide Infection Control Outpatients
www.cdc.gov/HAI/settings/outpatient/outpatient-careguidelines.html
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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, 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
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95
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)
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96
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Cover Your Cough Posters
www.cdc.gov/flu/protect/covercough.htm
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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
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CDC Emergency Preparedness
www.bt.cdc.go
v
100
CDC Emergency Preparedness
www.bt.cdc.gov/bioterrorism/index.asp
101
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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
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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 http://www.cdc.gov/ncidod/dhqp/nhsn.html
/104
40
CDC National Healthcare Safety Network
www.cdc.gov/nhsn/
105
www.cdc.gov/nhsn/training/
106
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
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
Standard Precautions CDC
www.cdc.gov/hicpac/2007IP/2007ip_part3.html
109
PPE Section in IC Worksheet
110
OSHA Bloodborne Pathogen Standard
www.osha.gov/SLTC/bloodbornepathogens/index.htm
111
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
IP Tools
www.infectionpreventiontools.com/
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Isolation Contact Precautions
114
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
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
10 CDC Safe Injection Practices Standards
www.cdc.gov/hicpac/2007IP/2007isolationPrecautions.html
117
Safe Injection Practices and Sharps Safety in IC Worksheet
118
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
Wear a Mask Epidural Spinal or LP
www.cdc.gov/injectionsafety/SpinalInjection-Meningitis.html
120
121
122
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
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
Insulin Pens
www.cms.gov/Medicare/Provider-EnrollmentandCertification/SurveyCertificationGenInfo/Polic
y-and-Memos-to-States-and-Regions.html
125
CDC Reminder on Insulin Pens
www.cdc.gov/injectionsafety/clinical-reminders/insulinpens.html
126
Insulin Pen Posters and Brochures
www.oneandonlycampaign.org
/content/insulin-pen-safety
127
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
Single Dose Memo
129
Fingerstick Devices
130
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
Safe Injection Practices Memo
www.empsf.org
132
CDC One and Only Campaign
http://oneandonlycampaign.org/
133
Not All Vials Are Created Equal
134
http://ascquality.org/advancing_asc_quality.cfm
135
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
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
Watch this Video on Preventing HAI
www.hhs.gov/ash/initiatives/hai/training/
138
Watch Award Winning Video
Safe Injection Practices - How to Do It Right
www.youtube.com/watch?v=6D0stMoz80k&feature=youtu.b
139
CDC Guidelines on Hand Hygiene
140
141
CDC Poster Clean Hands Save Lives!
www.cdc.gov/h1n1flu/pd
f/handwashing.pdf
142
This is Your Hand Unwashed Johns Hopkins
www.hopkinsmedicine.org/heic/docs/HH_hand_unwashed.pdf
143
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
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)

145
1www.apic.org/AM/Template.cfm?Section=Education_Resources&Template=/TaggedPage/TaggedPag
eDisplay.cfm&TPLID=91&ContentID=8738
146
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
Risk Assessment Tools from IP Tools
www.infectionpreventiontools.com/home
148
Risk Assessment Tools
149
Risk Assessment Tools
150
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
151
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
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
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
IOM DRI or Dietary Reference Intake
http://fnic.nal.usda.gov/dietary-guidance/dietary-reference-intakes/dri-nutrient-reports
155
156
Interactive DRI Tool and Tables
157
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
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
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
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
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.
162
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
163
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
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
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
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
167
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,
168
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
169
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
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
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,
172
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
173
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
174
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
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
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
Verbal Order P&P
179
Blue Box Advisory Verbal & Standing
180
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
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
3 Time Frames for Administering Medication
183
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
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
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
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
ISMP List of High Alert Medication
188
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
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
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
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
Pasero Opioid‐induced Sedation Scale POSS
https://secure.tha.com/surveys/files/p
asero-opioid-induced-sedation-scaleposs.pdf
193
Richmond Agitation Sedation Scale RASS
www.icudelirium.org/docs/RASS.pdf
194
Comparison of Sedation Scales Medscape
www.medscape.com/vi
ewarticle/708387_3
195
ISMP Use a Standard Sedation Scale
196
197
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
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
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
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)
 [email protected]
201