Darryl S. Rich, Pharm.D., M.B.A., FASHP
Surveyor, The Joint Commission
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The Joint Commission
& the Pharmacy Buyer:
Update for 2009
Objectives
 Brief overview of the current Joint
Commission Accreditation and Survey
Process.
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 Discuss major standards and national
patient safety goals of relevance to
purchasing managers.
Accreditation and Certification
Triennial (3 yr) on-site survey
Annual Periodic Performance Reviews
(PPR)
Continuous performance measurement
requirements (Core Measures)
Sentinel Event Reporting/Review.
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– Ad hoc off-cycle surveys
Core Measures
Must generate run or control charts on each
measure quarterly and must analyze and
improve if over three or more consecutive
quarters for the same measure, identify the
hospital as a negative outlier.
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Must collect data on each measure
in 4 selected core measure sets and
report them to the Joint Commission
quarterly
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Sample Report
• Heart Attack Care (AMI)
• Heart Failure (CHF)
• Pneumonia
• Critical Care
• Children’s Asthma
• Inpatient Psychiatric Services
• Surgical Care (SCIP)
• Venous Thromboembolism (VTE)
• Stroke
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Core Measures
Accreditation Programs
Hospitals and critical access hospitals
Home care services
Long term care services
Behavioral health care services
Freestanding ambulatory organizations
Freestanding laboratories
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– Pharmacies (home infusion, mail-order)
– DMEPOS suppliers
Certification Programs
–
–
–
–
–
Primary Stroke Center
Chronic Kidney Disease
COPD
Diabetes (Inpatient)
Transplant Center
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CMS-programs
– Lung Volume
Reduction Surgery
– Ventricular Assist
Device
Healthcare Staffing
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Disease Specific Care
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The Survey Process
Some Important Points
 Accreditation evaluates if the appropriate
systems are in place to provide safe and effective
healthcare.
 Only TJC standards surveyed – not others*.
 TJC standards specify what – not how.
 Focus is on patient safety and performance
improvement (CQI)
 Standards are optimal achievable – not minimum
or best practices.
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* Do survey applicable law and regulation.
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– Accreditation DOES NOT evaluate clinical practice
or medical care decisions.
Surveys
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Unannounced Full Survey (18-39 months)
Special Unannounced Survey for Cause
Random Validation Survey
Extension Survey
Conditional Follow-up Survey
Surveyors
Hospitals
– Physician, Nurse, Administrator
– Engineer
– Ambulatory Surveyor
– As appropriate:
– CALS Survey
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Home Care, Behavioral, Long Term Care
Survey Process
–
–
–
–
–
–
Medication Management
Infection Control
Data Use
Environment of Care/Disaster Planning
Competence/Credentialing
Leadership
Priority Focus Process
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Unannounced
Tracer Methodology
System Tracers
Priority Focus Process
Clinical Service Groups
– Selection of Tracer Patients
– Selection of Priority Processes to
Review
– Identification of Relevant Standards
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Priority Focus Areas
2009 SII: Standard
Improvement Initiative
New numbering system (MM.01.02.04)
Chapters reorganized alphabetically
– Some new chapters – EM, TS, WT, RC
Some requirements eliminated/moved
EP’s rewritten for clarity but nothing new
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– Documentation & written policy/process identified
Medicare Deemed Status
– TJC standards more closely aligned with
Medicare Conditions of Participation
– TJC interpretation based on CMS interpretation
– CMS input into survey process changes
– New EP’s based on language specificity in COP
Effective July 1, 2009
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Implications of the Medicare
Improvements for Patients and Providers
Act of 2008
– Accred. Participation
Requirements (APR)
– Environment of Care (EC)
– Emergency Management (EM)
– Human Resources (HR)
– Infection Prevention and Control
(IC)
– Information Management (IM)
– Leadership (LD)
– Life Safety (LS)
– Medication Management (MM)
– Medical Staff (MS)
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– National Patient Safety Goals
(NPSG)
– Nursing (NR)
– Provision of Care, Treatment &
Services (PC)
– Performance Improvement (PI)
– Record of Care, Treatment and
Service (RC)
– Rights and Responsibilities of
the Individual (RI)
– Transplant Safety (TS)
– Waived Testing (WT)
Not Department Specific!
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Manual Chapters
Standards
Standard Number (e.g. MM.04.01.02)
Standards Statement (not scored)
Rationale (not scored)
Elements of Performance (scored)
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– Categories A (yes/no), C (frequency)
– Direct Impact/Indirect Impact
Scoring
Requirement for Improvement (RFI)
Surveyor only present report of findings
Central Office determines accreditation
status based on findings
– Minimum number of direct impact standard
scored required for central office review.
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– Any Standard with an EP scored noncompliant or partially compliant.
– Direct vs. Indirect Impact
Normal Follow-up
Evidence of standards compliance (ESC)
Six months after survey:
– Submit data on MOS over past 4 months.
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– 45 days after survey for each standard with direct
impact EP’s scored.
– 60 days after survey for standards with only indirect
impact EP’s scored.
– “Measure(s) of success” (MOS) for some.
Results posted on website (Quality Check).
Accreditation
Provisional Accreditation
Conditional Accreditation
Preliminary Denial of Accreditation
Denial of Accreditation
Not Accredited (never applied)
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Publicly Disclosed Decisions
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Standards
and
National Patient Safety Goals
MM.2.20 Medication Storage
MM.3.20 Medication Orders
MM.4.10 Pharmacist Review
MM.7.10 High Alert Medications
MM.4.30 Medication Labeling
MM.2.30 Emergency Meds
all others 1% or less.
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37%
16%
5%
3%
3%
2%
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Top MM Standards Scored
Non-Compliant in 2008
Top Med-related NPSG Scored
Non-Compliant in 2008
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25%
19%
12%
15%
4%
2%
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3D Med Labeling in Procedures
8A Admission Med Reconciliation
8B Transfer/DC Med Reconciliation
2B Unapproved Abbreviations
3C: Look-Alike, Sound-Alike Drugs
1A: Two patient identifiers
MM.02.01.01 Medication
Selection and Procurement
2008 Non-Compliance = <0.5%
Elements of Performance
1. Written criteria for formulary additions
2. Criteria, at minimum includes:
Effectiveness, drug interactions, potential for errors/abuse,
ADE, sentinel event advisories, other risks, costs.
3. Process to monitor pt. response to new drugs
4. Maintain formulary (incl. strength & dosage)
5. Formulary list is readily available
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–
Elements of Performance
6. Standardize/limit number of available drug
concentrations
7. Process for non-formulary medications
8. -- Implement this process
9. Formulary medications reviewed annually
10.Process to communicate medication
shortages to LIP/staff
11.-- Implements this process
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MM.02.01.01 (cont.)
Elements of Performance
12. Develops/approves medication
substitution protocols for
shortages/outages
13. -- Implement these substitution protocols
14. Communication process for substitution
protocols to LIP/staff
15. -- Implements this communication process
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MM.02.01.01 (cont.)
2008 Non-compliance = 34.0%
#1 MM Non-compliance Issue - #4 among all
standards.
EP 6. The hospital prevents unauthorized
individuals from obtaining medications in
accordance with its policy and law and
regulation.
– Medication Security
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MM.03.01.01 Safe Storage
Medication Security
effective 1/28/07
– All drugs and biologicals be kept in a secure
area, and locked when appropriate.
– Schedules II, III, IV, and V drugs must be
kept locked within a secure area.
– Only authorized personnel may have access
to locked areas, as defined in policy.
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Revised Medicare Conditions of
Participation – Federal Register 11/27/06,
Medication Security
 L&D and ICUs considered secure if entry and exit
are limited to appropriate staff, patients & visitors
 OR Suite is secure only if active and staffed
 Due to mobility, mobile carts must be in a locked
room or under constant surveillance.
 Janitors, maintenance and other staff may have
access ONLY if in organization policy
Revised Interpretive Guidelines for Hospital COP.
CMS Memo S&C-08-12, February 8, 2008
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 Medications at bedside only if self-administered
MM.03.01.01 (cont.)
No EP 1
EP 2. The hospital stores medications
according to the manufacturer’s
recommendations or, if none, according to a
pharmacist's instructions.
EP 3. The hospital stores controlled
(scheduled) medications to prevent
diversion, in accordance with law and
regulation (DEA, state).
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– Refrigerator Temperatures
MM.03.01.01 (cont.)
EP 4. Written policy addressing the
control of medication between receipt
(removal from storage) by individual HCP
(MD, RRT, RN ) and medication
administration
EP 5. The policy is implemented
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– including safe storage, handling, security,
disposition, and return to storage.
MM.03.01.01 (cont.)
Elements of Performance
7. Stored drugs and components of drugs are
labeled with contents, expiration date and
appropriate warnings.
Expiration date, not date opened
8. Removal & separate storage of expired,
damaged, outdated medications
9. Storage and precautions for concentrated
electrolytes
18. Periodic inspection of drug storage areas
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
Most Ready-to-Administer
MM.03.01.01, EP 10 – Floor stock medications
MM.05.01.11, EP 4 – Medications dispensed
– must be in the most ready-to administer form
available from a manufacturer (unit dose,
pre-filled syringes, premixed bags) either:
Using the drug in that form repackaged by a
licensed repackager.
Using the drug in that form prepared or
repackaged by the pharmacy.
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Using the manufacturer’s product
NPSG.03.05.01
Anticoagulation Management

–
Note: For pediatric patients, pre-filled syringe
products should only be used if specifically
designed for children.
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EP 2: To reduce compounding and labeling
errors, the hospital uses only oral unit dose
products, pre-filled syringes, or pre-mixed
infusion bags when these types of products
are available.
MM 03.01.03
Emergency Medications
2008 Non Compliance = 3.4% (#4)
Elements of Performance
1. Medical staff decide which emergency
medications and supplies will be accessible
Crash cart, Emergency Boxes/Kits
2. Emergency medications/supplies are accessible
in patient care areas
3. Unit-dose, age-specific, & most ready-toadminister form available
6. Replacement of emergency medications and
supplies as soon as possible.
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
2008 Non Compliance = <0.5%
Elements of Performance
1. Defines when medications brought in by
patient or MD can be administered
2. Prior to use, identification and visual
evaluation of integrity
3. Inform prescriber/patient if medications
brought in are not permitted
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MM.03.01.05
Medications Brought In
MM.05.01.07
Medication Preparation
2008 Non-Compliance = 2.5% (#6)
Elements of Performance
1. Pharmacy compounds/admixes all
compounded sterile preparations, except:
Urgent situations where delay could harm patient
When the product’s stability is short.




Compounded product = 2+ drugs
Admixture = addition of drug to <50ml bag/bottle.
Exception: Closed transfer system
Does not apply to reconstitution
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

Elements of Performance
2. Use of clean/sterile techniques and clean,
uncluttered, and functionally separate area for
preparation.
3. Staff visually inspect medication for particulates,
discoloration, or loss of integrity
4. Laminar airflow hood/ISO Class 5 environment in
pharmacy and where product will not be used within
24 hours.
A Word About USP 797
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MM.05.01.07 (cont.)
New COP Related EP
– EP 6: In-house preparation of
radiopharmaceuticals is done by, or
under the supervision of, an
appropriately trained registered
pharmacist or doctor of medicine or
osteopathy.
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MM.05.01.07 Medication Preparation
MM.05.01.09
Medication Labeling
–
An immediately administered medication is one
that is prepared or obtained, taken directly to a
patient, and administered to that patient without
any break in the process.
2. Label information in standardized format
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2008 Non-compliance = 2.8% (#5)
Elements of Performance
1. Medication containers are labeled whenever
medications are prepared but not
immediately administered
MM.05.01.09 (cont.)



Medication name,
•
strength, amount
Expiration date
(when used >24 hrs)
Expiration time (if
<24 hours)
For compounded IV
admixtures and TPN:

Date prepared and
diluent used
When preparing
individualized meds for
multiple patients OR
when medication is
prepared by someone
other than person
administering it:



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Patients name
Location where
medication is to be
delivered
Directions for use,
accessory and cautionary
instructions
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
Medication Labeling NPSG
NPSG 03.04.01: Label all medications and
solutions on and off the sterile field (25%)
Use of pre-labeled containers or syringes not
acceptable
Preprinted labels OK
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– All medications and solutions labeled.
– Name, strength, etc.
– Actual containers labeled.
– Must be labeled immediately before or after
transfer as part of same process.
2008 Non-compliance = <0.5%
Elements of Performance
1. Process for providing medications when
pharmacy is closed
When non-pharmacist health care professionals
obtain medications after pharmacy closed:
2. Medications limited
3. Medications stored/secured outside
pharmacy
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MM.05.01.13
Medication After Hours
Elements of Performance
4. Only designated prescribers/nurses have
access to limited supply (never to pharmacy)
5. Quality control measures are used to
prevent medication retrieval errors
6. Pharmacist available on-call or at another
location to answer questions and access
pharmacy after-hours.
7. Implements process
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MM.05.01.13 (cont.)
2008 Non-compliance = 0.6%
Elements of Performance
1. Written policy for retrieval/handling recalled
and discontinued medications by mfgr/FDA
2. Implements policy
3. When drug recalled/discontinued, notifies
those who prescribe, dispense, administer
4. Inform patients when their medications are
recalled and discontinued.
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MM.05.01.17 Recalled,
Discontinued Medications
2008 Non-compliance = <0.6%
Elements of Performance
1. Determines under what circumstances
unused, expired, or returned medication will
be managed by the pharmacy or hospital
2. Process for returning medications to
pharmacy’s control
3. When outside sources used for destruction
4. Implements process
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MM.05.01.19
Returned Medications
MM.06.01.05
Investigational Medications
2008 Non-compliance = <0.5%
Elements of Performance
Written process:
1. Use of investigational medications
review, approval, supervision, and monitoring.
2. Specifies pharmacy controls storage,
dispensing, labeling, and distribution
3. Accommodates continued participation
4. Processes implemented
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–
EC.02.02.01 Hazardous Material
2008 Non-compliance = 1%
Elements of Performance
1. The hospital maintains a written, current
inventory of hazardous materials and waste that
it uses, stores, or generates.
3. Has written procedures (including precautions,
PPE) to follow in response to hazardous material
and waste spills or exposures.
4. Procedures are implemented
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The only materials that need to be included on the
inventory are those whose handling, use, and storage
are addressed by law and regulation.
Hazardous Medications
EC.02.02.01
MM.01.01.03
4. Minimizes risks associated with managing
hazardous medications.
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8. Minimizes risks associated with disposing
hazardous medications.
11. Has all hazardous material and waste permits,
licenses, manifests, and MSDS required by law
and regulation.
Emergency Management
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EM.01.01.01
– The hospital keeps a documented
inventory of the resources and assets it
has on site that may be needed during an
emergency, including… medicationrelated resources and assets.
EM.02.01.01
– Addresses preparedness, mitigation,
response and recovery.
– Identifies the hospital’s capabilities and
establishes response procedures for
when the hospital cannot be supported by
the local community for at least 96 hours.
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Emergency Operations Plan
Emergency Operations Plan
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EM.02.02.01
Emergency Operations Plan addresses
– How the hospital will communicate with
purveyors of essential supplies, services,
and equipment during an emergency.
Emergency Operations Plan
EM.02.02.03
Emergency Operations Plan addresses
–
Including access to and distribution of caches that may
be stockpiled by the hospital, its affiliates, or local,
state, or federal sources.
2. Medical Supplies
3. Non-medical Supplies
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1. How the hospital will obtain and replenish
medications and related supplies required
throughout the emergency & recovery from it.
EM.02.02.03 (con’t)
4. How it will share resources and assets with other
health care organizations within the community,
if necessary.
5. -- and outside the community in the event of a
regional or prolonged disaster.
6. How it will monitor quantities of its resources and
assets during an emergency.
9. Arrangements for transporting some or all
patients, their medications, supplies, equipment,
and staff to an alternative care site, if necessary.
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Emergency Operations Plan addresses
EOP Implementation
EM.02.02.03
EM.03.01.01 Documented annual review of its
inventory list.
EM.03.01.03 Implements its EOP (real or drill)
twice a year (not table-top).
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12. The hospital implements the components of its
Emergency Operations Plan that require
advance preparation to provide for resources
and assets during an emergency.
NPSG 02.02.01
Do Not Use Abbreviations
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2008 Non-compliance = 18.3%
QD, QOD, U, IU, MS, MgSO4, MS04,
Leading decimal, trailing zero
Computer entries, preprinted forms.
NPSG 03.03.01
LASA Drugs
 The hospital identifies a list of look-alike/sound-alike
medications used by the hospital.
 The hospital reviews the list of look-alike/sound-alike
medications at least annually.
 The hospital takes action to prevent errors involving
the interchange of the medications on the list of lookalike/sound-alike medication list.
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2008 Noncompliance = 5% (#9 tied)
Elements of Performance
NPSG 03.03.01 (cont.)
Top Compliance Issue
– Not following own policy
e.g. insulin not segregated in unit refrigerators
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– Most organizations not implementing
effective actions – most errors in past
year have been related to LASA issues.
Other Standards
IM.03.01.01
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– Knowledge based information are up-todate and available.
For Further Information
Sentinel Event Alert
Joint Commission Online
– Pre-publication Standards
Current Standards (CAMH) and Perspectives must
be obtained from hospital TJC coordinator
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www.jointcommission.org
– FAQ for current standards
– FAQ for current NPSG
– Copy of 2009 NPSG
– Current and Past Copies of:
Questions
– Calling the Standards Interpretation Unit at 630792-5900
– Submitting the question in writing by using the
following on-line form:
http://www.jointcommission.org/Standards/Online
QuestionForm/
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For questions about the interpretation of Joint
Commission standards, organizations (or the
public) can submit their questions by either:
Disclaimer
These slides are only meant to be cue points, which
were expounded upon verbally by the original
presenter and are not meant to be comprehensive
statements of standards interpretation or represent
all the content of the presentation. Thus, care
should be exercised in interpreting Joint
Commission requirements based solely on the
content of these slides.
These slides are copyrighted and may not be further
used, shared or distributed without permission of
the original presenter or the Joint Commission
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This presentation is current as of June 21, 2009. The
Joint Commission reserves the right to change the
content of the information, as appropriate.