The Joint Commission © Copyright, The Joint Commission The Joint Commission & the Pharmacy Buyer: Update for 2009 Darryl S. Rich, Pharm.D., M.B.A., FASHP

The Joint Commission ©

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The Joint Commission & the Pharmacy Buyer: Update for 2009

Darryl S. Rich, Pharm.D., M.B.A., FASHPSurveyor, The Joint Commission

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The Joint Commission

Objectives Brief overview of the current Joint

Commission Accreditation and Survey Process.

Discuss major standards and national patient safety goals of relevance to purchasing managers.

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Accreditation and Certification

Triennial (3 yr) on-site survey– Ad hoc off-cycle surveys

Annual Periodic Performance Reviews (PPR)

Continuous performance measurement requirements (Core Measures)

Sentinel Event Reporting/Review.

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Core Measures Must collect data on each measure

in 4 selected core measure sets and report them to the Joint Commission quarterly

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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Sample Report

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Core Measures

• 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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Accreditation ProgramsHospitals and critical access hospitalsHome care services

– Pharmacies (home infusion, mail-order)– DMEPOS suppliers

Long term care servicesBehavioral health care servicesFreestanding ambulatory organizations Freestanding laboratories

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Certification Programs

Disease Specific Care– Primary Stroke Center– Chronic Kidney Disease – COPD – Diabetes (Inpatient) – Transplant Center

CMS-programs– Lung Volume

Reduction Surgery– Ventricular Assist

Device

Healthcare Staffing


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The Survey Process

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Some Important Points Accreditation evaluates if the appropriate

systems are in place to provide safe and effective healthcare.– Accreditation DOES NOT evaluate clinical practice

or medical care decisions. 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.* Do survey applicable law and regulation.

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Surveys

Unannounced Full Survey (18-39 months)Special Unannounced Survey for CauseRandom Validation SurveyExtension SurveyConditional Follow-up Survey

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SurveyorsHospitals

– Physician, Nurse, Administrator– Engineer– Ambulatory Surveyor– As appropriate:

Home Care, Behavioral, Long Term Care

– CALS Survey

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Survey Process Unannounced Tracer Methodology System Tracers

– Medication Management– Infection Control– Data Use – Environment of Care/Disaster Planning– Competence/Credentialing– Leadership

Priority Focus Process

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Priority Focus Process

Clinical Service Groups– Selection of Tracer Patients

Priority Focus Areas– Selection of Priority Processes to

Review

– Identification of Relevant Standards

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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

– Documentation & written policy/process identified

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Medicare Deemed Status

Implications of the Medicare Improvements for Patients and Providers Act of 2008– 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

COPEffective July 1, 2009

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Manual Chapters– 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)

– 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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Standards

Standard Number (e.g. MM.04.01.02)

Standards Statement (not scored)

Rationale (not scored)

Elements of Performance (scored)

– Categories A (yes/no), C (frequency)– Direct Impact/Indirect Impact

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ScoringRequirement for Improvement (RFI)

– Any Standard with an EP scored non-compliant or partially compliant.

– Direct vs. Indirect Impact

Surveyor only present report of findingsCentral Office determines accreditation

status based on findings– Minimum number of direct impact standard

scored required for central office review.

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Normal Follow-up

Evidence of standards compliance (ESC) – 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). Six months after survey:

– Submit data on MOS over past 4 months.

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Publicly Disclosed Decisions

AccreditationProvisional AccreditationConditional AccreditationPreliminary Denial of AccreditationDenial of AccreditationNot Accredited (never applied)


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Standardsand

National Patient Safety Goals

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Top MM Standards ScoredNon-Compliant in 2008

MM.2.20 Medication Storage 37% MM.3.20 Medication Orders 16% MM.4.10 Pharmacist Review 5% MM.7.10 High Alert Medications 3% MM.4.30 Medication Labeling 3% MM.2.30 Emergency Meds 2%

all others 1% or less.

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Top Med-related NPSG ScoredNon-Compliant in 2008

3D Med Labeling in Procedures25%

8A Admission Med Reconciliation 19% 8B Transfer/DC Med Reconciliation 12% 2B Unapproved Abbreviations 15% 3C: Look-Alike, Sound-Alike Drugs 4% 1A: Two patient identifiers

2%

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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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MM.02.01.01 (cont.)

Elements of Performance6. Standardize/limit number of available drug

concentrations7. Process for non-formulary medications 8. -- Implement this process 9. Formulary medications reviewed annually 10.Process to communicate medication

shortages to LIP/staff11.-- Implements this process

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MM.02.01.01 (cont.)


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.03.01.01 Safe Storage

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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Medication Security

Revised Medicare Conditions of Participation – Federal Register 11/27/06, 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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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.

Medications at bedside only if self-administered

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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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.– Refrigerator Temperatures

EP 3. The hospital stores controlled (scheduled) medications to prevent diversion, in accordance with law and regulation (DEA, state).

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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 – including safe storage, handling, security,

disposition, and return to storage.

EP 5. The policy is implemented

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MM.03.01.01 (cont.)

Elements of Performance7. 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 manufacturer’s product

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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NPSG.03.05.01 Anticoagulation Management

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.

– Note: For pediatric patients, pre-filled syringe products should only be used if specifically designed for children.

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MM 03.01.03 Emergency Medications2008 Non Compliance = 3.4% (#4)Elements of Performance1. 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-to-administer form available

6. Replacement of emergency medications and supplies as soon as possible.

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MM.03.01.05 Medications Brought In

2008 Non Compliance = <0.5%


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.05.01.07 Medication Preparation

2008 Non-Compliance = 2.5% (#6)


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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MM.05.01.07 (cont.)


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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New COP Related EP

MM.05.01.07 Medication Preparation– 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.05.01.09 Medication Labeling

2008 Non-compliance = 2.8% (#5)Elements of Performance 1. Medication containers are labeled whenever

medications are prepared but not immediately administered

– 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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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: 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%)– All medications and solutions labeled.– Name, strength, etc.– Actual containers labeled.– Must be labeled immediately before or

after transfer as part of same process.Use of pre-labeled containers or syringes

not acceptablePreprinted labels OK

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MM.05.01.13 Medication After Hours

2008 Non-compliance = <0.5%Elements of Performance1. Process for providing medications when

pharmacy is closedWhen non-pharmacist health care professionals

obtain medications after pharmacy closed:2. Medications limited3. Medications stored/secured outside

pharmacy

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MM.05.01.13 (cont.)

Elements of Performance4. Only designated prescribers/nurses have

access to limited supply (never to pharmacy)5. Quality control measures are used to

prevent medication retrieval errors6. Pharmacist available on-call or at another

location to answer questions and access pharmacy after-hours.

7. Implements process

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MM.05.01.17 Recalled, Discontinued Medications

2008 Non-compliance = 0.6%


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.05.01.19 Returned Medications

2008 Non-compliance = <0.6%


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.06.01.05 Investigational Medications

2008 Non-compliance = <0.5%


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 Performance1. The hospital maintains a written, current inventory of

hazardous materials and waste that it uses, stores, or generates.

The only materials that need to be included on the inventory are those whose handling, use, and storage are addressed by law and regulation.

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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Hazardous Medications

EC.02.02.01 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.

MM.01.01.034. Minimizes risks associated with managing

hazardous medications.

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Emergency Management

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… medication-related resources and assets.

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Emergency Operations Plan

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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EM.02.02.01

Emergency Operations Plan addresses– How the hospital will communicate with

purveyors of essential supplies, services, and equipment during an emergency.

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EM.02.02.03

Emergency Operations Plan addresses1. How the hospital will obtain and replenish

medications and related supplies required throughout the emergency & recovery from it.

– 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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EM.02.02.03 (con’t)

Emergency Operations Plan addresses4. 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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EOP Implementation

EM.02.02.0312. The hospital implements the components of its

Emergency Operations Plan that require advance preparation to provide for resources and assets during an emergency.

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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NPSG 02.02.01 Do Not Use Abbreviations 2008 Non-compliance = 18.3% QD, QOD, U, IU, MS, MgSO4, MS04, Leading decimal, trailing zero Computer entries, preprinted forms.

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NPSG 03.03.01 LASA Drugs

2008 Noncompliance = 5% (#9 tied)

Elements of Performance 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 look-alike/sound-alike medication list.

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NPSG 03.03.01 (cont.)Top Compliance Issue

– Not following own policye.g. insulin not segregated in unit refrigerators

– Most organizations not implementing effective actions – most errors in past year have been related to LASA issues.

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Other StandardsIM.03.01.01

– Knowledge based information are up-to-date and available.

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For Further Information

www.jointcommission.org– FAQ for current standards– FAQ for current NPSG– Copy of 2009 NPSG – Current and Past Copies of:

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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Questions

For questions about the interpretation of Joint Commission standards, organizations (or the public) can submit their questions by either: – Calling the Standards Interpretation Unit at 630-

792-5900– Submitting the question in writing by using the

following on-line form: http://www.jointcommission.org/Standards/OnlineQuestionForm/

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DisclaimerThis presentation is current as of June 21, 2009. The

Joint Commission reserves the right to change the content of the information, as appropriate.

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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Documents

The Joint Commission © Copyright, The Joint Commission The Joint Commission & the Pharmacy Buyer: Update for 2009 Darryl S. Rich, Pharm.D., M.B.A., FASHP