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Critical Access Hospital CoPs Part 2 of 3


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Title: Critical Access Hospital CoPs Part 2 of 3

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

  • 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)

new website at
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  • And all outdated, mislabeled, or otherwise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,

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

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

ISMP Institute for Safe Medication Practices
American Society of Health System Pharmacists or
Infusion Nurses Society INS
National Coordinating Council
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USP U.S. Pharmacopeial
Institute for Healthcare Improvement IHI
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

Drug Rules Must Include 276 2015
  • Proper environmental conditions
  • Follow manufacturers recommendation such as keep
    refrigerated, room temperature, out of light,
  • 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

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
  • 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

Medications in the OR ASA Position
ASA Guidelines and Statements
Recommendation on Medications in the OR
Drugs Rules Must Include 276 2015
  • Must have PP on security and monitoring of all
  • 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

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

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.

Blue Box Advisory USP 797
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

FDAs Compounding Website
Use a Company that is Registered
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

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

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.

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Do Not Use Abbreviations ISMP
TJCs Do Not Use Abbreviation List
ISMP List of High Alert Medications
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
  • 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

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

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
  • Must have system to report ADEs and medication
  • Pharmacy needs to assess to see if problems in
    pharmacy caused or contribute to these

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

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

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

Definition of Medication Error
Definition of Adverse Drug Event ADR
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
  • Documentation of the error and notification of
    the practitioner must be made in the MR

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
  • Can do RCA, FMEA, or QAPI review

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

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
  • Change the environment or culture-called system
  • 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,

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
ISMP Medication Error Reporting Program
List of High Alert Medications
High Alert How to Guide IHI
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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

Medication Resources
  • National Patient Safety Foundation at
  • Governmental agencies may include
  • Food and Drug Administration (FDA) at
  • Med Watch Program at
  • Agency for Health Care Research and Quality
    (AHRQ) at

  • The Institute for Safe Medication Practices-
  • U.S. Pharmacopoeia (USP)
  • Institute for Healthcare Improvement-,
  • AHRQ-,
  • Sentinel event alerts at,

Additional Resources
  • American Pharmaceutical Association-
  • American Society of Heath-System
  • Enhancing Patient Safety and Errors in
  • National Coordinating Council for Medication
    Error Reporting and,
  • FDA's Recalls, Market Withdrawals and Safety
    Alerts Page http//

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
  • HAI or healthcare-associated infection is one
    that patient develops while in the hospital or
    other healthcare facility

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

Final Worksheet Infection Control
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

Infection Preventionist or IP
APIC Competency Infection Prevention
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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

APIC Website
SHEA Website
AORN Guidelines for Perioperative Practice
OSHA Website
OSHA Worker Safety in Hospitals
CDC Website
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

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//

CDC Module on C-Diff
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//

APIC C-Diff Guide
SHEA C-Diff Guidelines
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
  • This is a highly dangerous, antibiotic-resistant
  • Will help hospitals implement the CDC guidelines
    and is 56 page toolkit
  • available at

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Free Toolkit for Hospitals
CDC National Healthcare Safety Network
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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
  • Infectious patients may not be recognized
  • Immuno-compromised patients can receive treatment
    in rooms with other patients who pose a risk of

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)
  • 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

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.

APIC Resources Ambulatory Care
CDC Norovirus Guidelines
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

CDC Guide Infection Control Outpatients
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

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

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Cover Your Cough Posters
  • 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
  • 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
  • For a comprehensive list go to website1
  • 1http//

CDC Emergency Preparedness
CDC Emergency Preparedness
Bio-defense Solutions by the Army
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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

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//

CDC National Healthcare Safety Network
Infection Control 278 2015
  • Sanitary environment
  • Needed to avoid transmission of infection and
    communicable diseases
  • This includes all CAH units and off site
  • 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.

Infection Control 278 2015
  • Mitigation of risks
  • Need PP to mitigate risks associated with HAI
  • Must implement IC techniques and standard
  • 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

Standard Precautions CDC
PPE Section in IC Worksheet
OSHA Bloodborne Pathogen Standard
OSHA Blood borne Pathogen Standard
  • Must implement UNIVERSAL PRECAUTIONS to prevent
    contact with blood such as
  • Hand washing (see CDC hand hygiene document at 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

IP Tools
Isolation Contact Precautions
Safe Medication 278 2015
  • Safe medication preparation and administration
  • Prepare injectables in designated clean
    medication area not adjacent to contaminated
  • 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

Safe Medication 278 2015
  • Safe medication preparation and administration
  • 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

10 CDC Safe Injection Practices Standards
Safe Injection Practices and Sharps Safety in IC
Safe Medication 278 2015
  • Safe medication preparation and administration
  • 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

Wear a Mask Epidural Spinal or LP
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Safe Medication 278 2015
  • Safe medication preparation and administration
  • 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

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

Insulin Pens
CDC Reminder on Insulin Pens
Insulin Pen Posters and Brochures
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

Single Dose Memo
Fingerstick Devices
Fingerstick Devices
  • Anyone performing fingerstick procedures should
    ensure that a device is not used on more than one
  • 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)

Safe Injection Practices Memo
CDC One and Only Campaign
Not All Vials Are Created Equal
Safe Medication 278 2015
  • Safe medication preparation and administration
  • 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

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//

Watch this Video on Preventing HAI
Watch Award Winning Video
Safe Injection Practices - How to Do It Right
CDC Guidelines on Hand Hygiene
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CDC Poster Clean Hands Save Lives!
This is Your Hand Unwashed Johns Hopkins
Safe Medication 278 2015
  • Safe medication preparation and administration
  • 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

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)

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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

Risk Assessment Tools from IP Tools
Risk Assessment Tools
Risk Assessment Tools
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

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

Dietary Services 279 2015
  • Must follow recognized dietary practices
  • For example, the IOMs Food and Nutrition Boards
    DRI or Dietary Reference Intake 4 reference
  • 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

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

IOM DRI or Dietary Reference Intake
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Dietary Guidelines for Americans
Interactive DRI Tool and Tables
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
  • Include in patients care plan
  • Include the need to monitor intake
  • Include if need daily weights, IO, or lab values

Nutritional Assessment Includes
  • Patient May Need Comprehensive Assessment if
  • Medical or surgical conditions or physical status
    interferes with their ability to digest or absorb
  • 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.

Dietary 279 2015
  • Patient May Need Comprehensive Assessment if
  • Patient receiving artificial nutrition
  • Tube feeding, TPN, or peripheral parenteral
  • 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

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

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
  • These services include medical history, physical
    examination, specimen collection, assessment of
    health status, and treatment for a variety of
    medical conditions.

Outpatient Department 280 2015
  • Must provide adequate services, equipment, staff,
    and facilities adequate to provide the outpatient
  • 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

Patient Services 281 2015
  • Standard The CAH furnishes acute care inpatient
  • 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

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.

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

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
  • 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

Lab 282
  • Must have these basic lab services,
  • Must provide emergency services 24 hours/7 days a
  • Must have current CLIA certificate and if
    contracted out make sure they have a CLIA
  • 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,

Radiology Services 283 2015
  • Radiology services must be provided by qualified
  • Can be provided as a direct service or through a
  • And do not expose patients or staff to radiation
  • Must have services to meet the needs of its
    patients at all times,

Radiology Services 283
  • Can offer minimal set or more complex, according
    to needs of the patients including nuclear
  • 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

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

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
  • Clear signage identifying hazardous radiation

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
  • Periodic testing of equipment for radiation

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

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
  • 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

Radiology Policies 283
  • Supervision must include that all files, scans,
    and images are kept in a secure place and are
  • 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
  • See tag 283 for required signage on hazardous
    radiation areas and more

Tag 283 Blue Box Advisory
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
  • Must provide medically appropropriate initial
    interventions, treatment, and stabilization of
    any patient who requires emergency services

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

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

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
  • 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
  • Staff can provide or contracted services can
    provide at the hospital

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
  • 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

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

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
  • 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

Contracted Services 292 2015
  • CEO is responsible for operation of all patient
    services furnished in the CAH
  • This includes those performed directly or by
  • 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

Nursing Care 294 2015
  • Standard Nursing service must met the needs of
  • RN must provide nursing care to each patient or
  • 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

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

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

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
  • 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,

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

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

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.

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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

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
  • Must include that standing order is signed off
  • List of things that must be in the verbal order

Verbal Order PP
Blue Box Advisory Verbal Standing
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

Drugs and IVs 297 2015
  • Basic safe practices
  • Five rights
  • Culture of safety where staff feel free to ask
  • 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
  • Evaluation of timing policies

3 Time Frames for Administering Medication
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
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