LUNCH AND LEARN. June 9, CE Activity Information & Accreditation

Similar documents
2017 Pharmacy Education Series

A Game Plan to Surviving a Joint Commission Survey. May Adra, BS Pharm, PharmD, BCPS

2018 Pharmacy Education Series

The Joint Commission Update: 2018

2017 Pharmacy Education Series

The Joint Commission Medication Management Update for 2010

Joint Commission Update for Ambulatory Clinics

MEDCOM Medication Management Discussion

The Joint Commission Medication Management Update for 2010

The Joint Commission 2017 Medical Staff Standards Update

2016 Pharmacy Education Series

University of Mississippi Medical Center University of Mississippi Health Care. Pharmacy and Therapeutics Committee Medication Use Evaluation

Medication Storage and Security: The #1 Non- Complaint Medication Management Standard

2017 Hospital Breakfast Briefings Medication Management

June 2018 Phc newsletter

Survey Readiness: Balancing Joint Commission and. and CMS requirements

CHAPTER 8 Hospital Accreditation

JCAHO Med Management

Accreditation Program: Long Term Care

11/1/2016. Hospital Breakfast Briefing: Provision of Care, Treatment & Services. Publications and Record Restrictions.

Understanding Antimicrobial Stewardship: Is Your Organization Ready? A S H LEIGH MOUSER, PHARM D, BCPS

Bar Code Medication Administration and MAR Resource Manual

Critical Access Hospitals Site Visit Summary Tom Johns, PharmD, BCPS Director, Pharmacy Services UF Health Shands Hospital

Definitions: In this chapter, unless the context or subject matter otherwise requires:

Joint Commission Update

PROCESS FOR HANDLING ELASTOMERIC PAIN RELIEF BALLS (ON-Q PAINBUSTER AND OTHERS)

Considerations for Sterile Compounding of Parenteral Products for Pediatric Use: Part 2 PharMEDium Lunch and Learn Series LUNCH AND LEARN

Accreditation Program: Office-Based Surgery

Arizona Department of Health Services Licensing and CMS Deficient Practices

Leadership Engagement in Antimicrobial Stewardship

Pharmaceutical Services Instructor s Guide CFR , (a)(b)(1) F425

Survey Analysis for Evaluating Risk (SAFER ) Insights July 13, 2017

Drug Events. Adverse R EDUCING MEDICATION ERRORS. Survey Adapted from Information Developed by HealthInsight, 2000.

MEDICATION USE EFFECTIVE DATE: 06/2003 REVISED: 2/2005, 04/2008, 06/2014

National Association of Rural Health Clinics

Compliance Made Simple: 24/7/365

National Patient Safety Goals Effective January 1, 2016

APPLICATION. Thank you for your interest in applying for the APIC Program of Distinction.

POLICIES AND PROCEDURES. Pharmacy Services for Nursing Facilities

AREAS OF RESPONSIBILITY

PREPARATION AND ADMINISTRATION

Overview. Diane Cousins, R.Ph U.S. Pharmacopeia. 1 Pharmacy Labeling with Color

INFECTION CONTROL SURVEYOR WORKSHEET

Ambulatory Surgical Center (ASC) INFECTION CONTROL SURVEYOR WORKSHEET

The Joint Commission Standards and the Patients

TJC Corrective Actions. Nursing Education January, 2015

PHARMACY SERVICES / MEDICATION USE

Medication Control and Distribution. Minor/technical revision of existing policy. ± Major revision of existing policy Reaffirmation of existing policy

Patient Safety Course Descriptions

CRAIG HOSPITAL POLICY/PROCEDURE

Monitoring Medication Storage & Administration

Medication Management and Use System. 6 th Edition

THE HEALTHCARE ENVIRONMENT

Compounded Sterile Preparations Pharmacy Content Outline May 2018

SECTION HOSPITALS: OTHER HEALTH FACILITIES

Medication Reconciliation

Today s webinar will begin in a few minutes.

Objectives Top Ten Cited Deficiencies for Acute Care Facilities April 21, 2015

HRSA/Bureau of Primary Health Care (BPHC) Presentation

11/16/17. Annual Survey Watch Report. Surveyors. Keeping you in the know in the ASC industry CMS. Accreditation

Optimizing Medication Safety in Maryland Assisted Living Facilities. Panel Discussion Moderated by: Nicole Brandt, PharmD

REVISED FIP BASEL STATEMENTS ON THE FUTURE OF HOSPITAL PHARMACY

Policy Statement Medication Order Legibility Medication orders will be written in a manner that provides a clearly legible prescription.

Supporting self-administration of medication in the care home setting

Prepublication Requirements

Implementing Antimicrobial Stewardship Programs- Suggestions for Rural and Critical Access Hospitals-a Hospital Story

Maryland Patient Safety Center s Annual MEDSAFE Conference: Taking Charge of Your Medication Safety Challenges November 3, 2011 The Conference Center

The QIS was designed to achieve several objectives:

3/9/2010. Objectives. Pharmacist Role in Medication Safety and Regulatory Compliance

2016 Medical Staff Standards Update Panel Featuring TJC, NCQA, URAC, DNV, and HFAP (Part 1) THE JOINT COMMISSION. Objectives

Profiles in CSP Insourcing: Tufts Medical Center

Objective Competency Competency Measure To Do List

Update on Pharmacy Issues in Long Term Care Lisa Nichols RPh, CGP

Structured Practical Experiential Program

Joint Commission Resources Quality & Safety Network (JCRQSN) Resource Guide. A Focus on Medication Safety Issues: Storage and Security

DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICES Medication Administration Observation

PACKAGING, STORAGE, INFECTION CONTROL AND ACCOUNTABILITY (Lesson Title) OBJECTIVES THE STUDENT WILL BE ABLE TO:

A shortage of everything except ERRORS

MHA/OHA HIIN Antibiotic Stewardship/MDRO Collaborative

U: Medication Administration

NEW LONG TERM CARE SURVEY PROCESS PHASE 2 REQUIREMENTS OF PARTICIPATION AUGUST 23, 2017

Nurse Orientation. Medication Management

A Discussion of Medication Error Reduction Strategies

JCI Overview Summary Update. Patcharin Boonyarungsun, Ph.D Director of Total Quality and Cost Improvement, Bangkok Hospital Head Quarter

THE JOINT COMMISSION RESOURCE GUIDE

Storage, Labeling, Controlled Medications Instructor s Guide CFR (b)(2)(3)(d)(e) F431

Antimicrobial Stewardship Program in the Nursing Home

US Compounding 2515 College Ave Conway, AR (800)

Consumers Union/Safe Patient Project Page 1 of 7

Licensed Pharmacy Technicians Scope of Practice

University of Wisconsin Hospital and Clinics Medication Reconciliation Education Packet

PGY1: Pediatric Infectious Diseases Riley Hospital for Children Indiana University Health

Immunizations Criminal Background check Infection Control HIPPA Health Insurance Portability and Accountability Act

The Joint Commission: Partnering for Excellence

CHAPTER 9 PERFORMANCE IMPROVEMENT HOSPITAL

TRENDING IN THE JOINT COMMISSION

POLICY. Clinician is any health care professional accepting responsibility for care of patients and their medications.

Tools & Resources for QI Success

Department Policy. Code: D: MM Entity: Fairview Pharmacy Services. Department: Fairview Home Infusion. Manual: Policy and Procedure Manual

7 th Edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration

Transcription:

LUNCH AND LEARN Joint Commission Update 2017 June 9, 2017 Featured Speaker: Kurt A. Patton, MS, RPh President Emeritus Patton Healthcare Consulting, LLC CE Activity Information & Accreditation (Pharmacist and Tech CE) 1.0 contact hour Funding: This activity is self funded through PharMEDium. It is the policy of to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Mr. Patton has served as a consultant for Patton Healthcare Consulting. 2 www.proce.com 1

Online Evaluation, Self-Assessment and CE Credit Submission of an online self assessment and evaluation is the only way to obtain CE credit for this webinar Go to www.proce.com/pharmediumrx Print your CE Statement online Live CE Deadline: July 7, 2017 CPE Monitor CE information automatically uploaded to NABP/CPE Monitor upon completion of the self assessment and evaluation (user must complete the claim credit step) Attendance Code Code will be provided at the end of today s activity Attendance Code not needed for On Demand 3 Ask a Question Submit your questions to your site manager. Questions will be answered at the end of the presentation. Your question...? 4 www.proce.com 2

Resources Visit www.proce.com/pharmediumrx to access: Handouts Activity information Upcoming live webinar dates Links to receive CE credit 5 + Joint Commission Update 2017 - PharMEDium Kurt A. Patton MS, R.Ph. President Emeritus Patton Healthcare Consulting, Inc. Former Executive Director Hospital Accreditation The Joint Commission. 6 www.proce.com 3

+ Pressures on the Hospital Pharmacy Director Workload New service requests Staffing Drug budget Budget impact of healthcare reforms Quality Anticipated survey by Joint Commission Adverse outcome Potential survey by CMS/state surveyors Corrective actions and follow up for either survey 7 + Who is the Joint Commission? Private, not for profit accrediting body with a Board of Directors from AHA, AMA, ACS, ACP, ADA, 6 public members and 4 at large specialty members, RN, BHC, HC, LTC. Standards are developed using a PTAC (Professional Technical Advisory Committee) an advisory group with 50 different professional associations represented including ASHP. TJC has deemed status with CMS, previously in law, now a periodic approval process. TJC actually comes around regularly, full survey at least every 3 years and when they receive significant complaints or media reports. 8 www.proce.com 4

+ Joint Commission Survey Teams Physicians Nurses Behavioral healthcare specialists Ambulatory specialists Some pharmacists at larger teaching hospitals and for cause events Home infusion pharmacists Life safety code specialists All clinical surveyors conduct patient tracers and report to each other their observations One surveyor will conduct a MM System tracer in depth. 9 + Joint Commission and USP Chapter <797> The physician and nurse surveyors know a little about USP 797 and to a limited extent apply the requirements if your state has adopted USP 797 as state regulations. The physician, nurse and life safety code specialist all understand air pressure relationships. TJC has just started a medication compounding certification program. Surveyors usually either perform accreditation or certification surveys, but not both. The now published medication compounding standards are a good learning tool for hospital surveyors however. 10 www.proce.com 5

+ Joint Commission and USP Chapter <800> Nothing definitive on the horizon at this time from TJC or CMS. However: The life safety code specialists will probably be spending more time looking at environmental safety issues relative to hazardous medications The consulting arm JCR (firewall between) has done an excellent web-based hospital self assessment tool, which has the potential to also be an excellent marketing tool to those who need the most help in preparing. http://www.jcrinc.com/safe-handling-of-hazardous-drugs/ 11 + New TJC Scoring System 12 All surveys beginning 1/1/17 now use a new risk assessment methodology to score standards. No A or C elements, no direct or indirect 1 observation of noncompliance = Requirement For Improvement (RFI) You must respond on how you fixed the noncompliance Two variables will be considered. How wide spread is the defect? How critical, how important is the defect? Examples: 1 expired oral medication in one location. Multiple expired sterile medications in multiple locations 12 www.proce.com 6

+ Project Refresh Onsite SAFER Matrix Survey Analysis for Evaluating Risk (SAFER) Matrix Help you prioritize Visual on report Can sort & filter Scope 13 + How Will Surveyors Assign Risk? Surveyor experience and expertise based on scope and likelihood to harm Talking amongst the team Impact of risk assignment: Guldens mustard color and red require additional content on leadership involvement and sustainability in evidence of standards compliance (ESC). As of 3/20/17, 26% of findings are red or dark mustard color. 14 www.proce.com 7

+ What Might Be Red in Medication Management? The most difficult and complex medication issue on surveys today - improper medication titration in the ICU setting. Nurses practicing outside the scope of licensure Protocols not in the chart or not referenced Incremental dose missing from titration orders Assessment criteria missing from the order Failure to assess How and where this gets scored is very diverse so this does not show in stats published by TJC. 15 + Why Do Surveyors Like to Score the Medication Management Chapter? Its objective: you did it or you did not. TJC shares lots of medication safety information with surveyors including the ISMP newsletter. Compare with the more subjective PC standards regarding the quality of a history and physical or the accuracy of a presedation assessment. TJC does not perform peer review. 16 www.proce.com 8

+ Most Frequently Scored Medication Management Standards 17 + Joint Commission Standards Structure Standard xx.xx.xx a high level concept that is not directly evaluated by the surveyors There are also National Patient Safety Goals which are just like standards developed using a different process Elements of performance (EP)1, 2, 3, etc. More finite and specific requirements each of which must be in place for the standard to be scored as compliant. Some elements of performance have a D icon, meaning documentation is mandatory. A failure on any one element of performance causes the standard to be scored non compliant. This results in a requirement for improvement and you must tell TJC how you fixed the issue. Too many standards scored noncompliant is a problem. 18 www.proce.com 9

+ MM.04.01.01 Seems Easy, But it is Not and it may be Red The most problematic standard today. The hospital has a written policy that identifies the specific types of medication orders that it deems acceptable for use. This includes, PRN, standing orders, titration orders, taper orders, range orders, etc. Hospitals did not specify enough order details so TJC has posted an FAQ with the minimum requirements. 19 + Titration Order Minimum Elements Medication name Medication route Initial or starting rate of infusion Incremental rate the infusion can be increased or decreased Frequency of rate adjustments Maximum rate of infusion Objective clinical endpoint, Richmond Agitation Sedation Scale (RASS), blood pressure (BP), etc. 20 www.proce.com 10

+ Sedation Titration Example Propofol 5-50 mcg/kg/min, start at 5 mcg and increase by 5 mcg every 5 minutes to a maximum dose of 50 mcg/kg/min to achieve a RASS of -3. If this is in a structured order set in an EMR or a paper order form, practitioners don t need to remember all the required order details. If you allow ad hoc EMR or paper orders you are likely to have many gaps requiring clarification. 21 + Sedation Titration Survey Follow up Simple RFI, document in ESC how you fixed it and sound convincing, easy. If survey outcome is Accreditation with follow up survey (AFS), preliminary denial of accreditation (PDA) or Pharmaceutical Service Medicare condition out, document in ESC how you fixed it and sound convincing, but TJC surveyors are coming back to validate and you must be 100% compliant, all titrations all charts - and this is hugely different. MM Condition out less than 45 days PDA you have about 60 days AFS you have about 4 months to make it perfect. 22 www.proce.com 11

+ Sedation Titration, Real Example of Survey Disaster Full survey, hospital cited for improperly written and documented sedation titrations. Survey outcome AFS ESC submitted said a titration protocol was prepared for nursing staff with instructions on how to titrate sedating agents. AFS follow up survey conducted, nursing staff interviewed and replied: we just use our clinical judgment. Accreditation status changed to PDA, hospital now decides to develop detailed order sets in EMR. 23 + MM.01.01.03 High Alert/Hazardous Medications EP 1: The hospital identifies in writing its high alert and hazardous medications. The hazardous list is often missing. TJC does not mean dangerous, they mean hazardous just like NIOSH. This was moved from EC to MM a decade ago and still often missing. 24 www.proce.com 12

+ MM.01.02.01 LASA EP 3: The hospital annually reviews its list of LASA medications. Date the list? You incentivize the surveyor to drill down if your list is undated. Need to find reauthorization in minutes. You get no credit if its 2 years old. Staff on the units need to be able to find the list. Write your enhanced safety strategies describing what you do and where you do it. If hospital practices vary, mention it, e.g. these strategies occur in the pharmacy itself, while these are required for nursing, etc. 25 + Frequently Scored, but Much Easier to Manage MM.03.01.01 Medication storage temperatures Paper logs gaps and failure to act on out of range conditions is the problem Automated data loggers failure to document actions taken is the problem Failure to document what happened over the weekend in a 5 day/week clinic Failure to document vaccine storage per CDC Data loggers required, no dorm refrigerators. Failure to track or document fluid and contrast warmer storage conditions and shortened expiration dating. 26 www.proce.com 13

+ MM.03.01.01 Medication Security A very confusing issue for surveyors and hospital pharmacists. Do what you say you do. Don t let the surveyors assume your policy. Non controlled drugs can be secured by supervision or locking Your hospital sets the standard for non-controlled drug security. You identify those authorized. If you say licensed professionals only, TJC holds you to that. No materials management or central sterile supply delivery of IV fluids No unlocked storage in a clean utility room on the floor 27 + MM.03.01.01 Medication Security If you say the area is secure, but the surveyor walks in and there are no staff around If you say the OR is secure, but the surveyor walks in and only the housekeeper is present cleaning up after a case and there are medications present. Crash carts in areas not open 24/7 and supervised must be placed in locked storage when closed. 28 www.proce.com 14

+ MM.03.01.01 Medication Security New Spin 2017 Pharmaceutical waste and sharps bins in non secure locations like a dirty utility room, or in a pick up cart in the hallway, or on the back loading dock, and even in the OR with the housekeeper. 29 + MM.03.01.01 Medication Expiration EP 7: All meds are labeled with contents and an expiration date. Multi dose vial (MDV) not a date opened, an expiration date Short stability meds like propofol need a time of expiration even from anesthesia Warmers not a date placed, an expiration date Remember the One and Only campaign: If a MDV has been brought into a procedure room it becomes an single dose vial (SDV) and any residual is discarded after the procedure. 30 www.proce.com 15

+ MM.03.01.03 Emergency Medications EP 3: Whenever possible, emergency medications are available in unit-dose, age specific, and ready to administer form. Magnesium sulfate is often stocked 1G/2 ml Broselow tape for 3-4 Kg infants calls for doses 150mg, 225 mg Can staff in a crisis situation easily calculate the volume of magnesium sulfate to administer? Test your own ED staff, but consider a volume table as an aid. 31 + MM.04.01.01 Medication Orders EP 13: The hospital implements its policies for medication orders. A PRN without indication An unclear order not clarified A range order not adherent to your policy TJC does not prohibit range orders, but it would be easier if they did. Consistency in application is the problem. Go and interview 10 nurses and check the documentation in the record 32 www.proce.com 16

+ MM.05.01.01 Pharmacist Review of Orders EP 1: Pharmacist reviews the new order prior to administration, unless LIP control. (licensed independent practitioner) Exemptions: ED, radiology if radiologist is present to intervene and urgent situations anywhere in the hospital. What do you do in PACU and outpatient clinics? EP 8: Pharmacist reviews for therapeutic duplication. *** Duplicative PRN analgesics, antiemetics Advice: stratify your order sets Analyze your interventions; ID root cause and fix 33 + MM.05.01.01 EP 8 Complication The order is written well with all the details such as Tylenol for mild pain, Percocet for moderate pain and Dilaudid for severe pain. The patient with a pain of 9 requests Percocet instead of Dilaudid because they don t want. New FAQ, you can do it if approved in policy The patient with a pain of 3 requests Dilaudid because they just saw the physical therapist walk down the hallway and they know their pain will spike during therapy. You can t do it 34 www.proce.com 17

+ MM.05.01.07 IV Preparation TJC hospital surveyors are not experts in all things relative to USP 797. Over time they may gain knowledge from their colleagues performing the new Medication Compounding certification or these standards. They are very familiar with specialized air pressures and may carry a vaneometer. If you have wall meters, be ready and able to discuss what those meters are measuring. 35 + MM.05.01.07 IV Preparation EP 2: Staff use clean or sterile techniques and maintain clean, uncluttered, and functionally separate areas for product preparation to avoid contamination. Surveyors readily ID filth, clutter and too close a proximity to sinks in medication rooms. Sometimes pill crushers and tablet splitters are the problem. Make these patient specific with patient labels 36 www.proce.com 18

+ MM.09.01.01 Antibiotic Stewardship Nicely written new set of requirements, 1 standard, 8 elements of performance. Consistent with CDC and National Quality Forum (NQF) guidance Survey process design is about the best seen for any new requirements. Antibiotic stewardship program (ASP) designed to be explored in 6 different survey sessions. Patient tracers, competence assessment session, medical staff, data management system tracer, MM system tracer, leadership 37 + ASP EP 1 Leadership has identified ASP as an organizational priority. Accountability documents Budget plans Infection Control plans Performance Improvement plans Strategic plans EMR used to collect ASP data 38 www.proce.com 19

+ ASP EP 2 The hospital educates staff, and LIP s involved in ordering, dispensing, administration and monitoring about antimicrobial resistance and ASP practices. Upon hire and periodically. You are going to want some evidence this was done, even though this is not a mandatory documentation element of performance. (D) Because during interview with the surveyor it is too easy for staff to get nervous and say: they didn t tell me anything about ASP when I started. 39 + ASP EP 3 The hospital educates patients and their families as needed, regarding appropriate use of antimicrobials. TJC suggests CDC document: http:www.cdc.gov/getsmart/healthcare/index.html Suggest using EMR patient teaching logs even though there is no D. Surveyors may interview patients or families of patients being discharged on antibiotics. 40 www.proce.com 20

+ ASP EP 4 The hospital has an ASP team that includes: Infectious Disease physician Infection Control Practitioner (ICP) Pharmacist Practitioner Part time, consultants and telehealth are all acceptable. 41 + ASP EP 5 The ASP includes core elements:(same as CDC) Leadership commitment Accountability (single leader) Drug expertise Action Tracking Reporting Education What are you going to show to TJC to convince them you have all these elements? D for documentation This document is requirement #49 in Day one document list. 42 www.proce.com 21

+ ASP EP 6 The hospitals ASP uses organization approved multidisciplinary protocols. Examples: Formulary restrictions Community acquired pneumonia Skin and soft tissue infections UTI infections C difficile care Appropriate use in pediatrics Parenteral to oral conversion Preauthorization Use of prophylaxis D for documentation be ready to discuss and show at MM system tracer session 43 + ASP EP 7 The hospital collects, analyzes and reports data on its ASP. D for documentation Be prepared to discuss and show at the data use system tracer and potentially MM system tracer. 44 www.proce.com 22

+ ASP EP 8 The hospital takes action on improvement opportunities identified in its ASP. Be careful how you word minutes of meetings, don t point fingers. Get it done, don t whine Be ready to discuss accomplishments in MM system tracer. Provide leadership some bullet points in the event this is asked at the leadership session. 45 + ASP Conclusion Meticulously written requirements, consistent with other expert groups. Superb survey process written for surveyors for these new standards. So far in 2017, not seeing scoring on this issue. May be due to surveyor training, may be due to newness Be prepared to pro-actively discuss if you have accomplishments at MM, Data. 46 www.proce.com 23

+ National Patient Safety Goal.03.04.01(NPSG) Label medications in procedural settings. The OR usually does this well Surveyors look in outpatient procedural settings, bedside procedures and ED procedures. No one can be compliant if you don t give them the tools to be compliant sterile labels in procedure kits. Try to convince anesthesia that even propofol needs a label. Try to convince radiology that contrast agents and saline in a power injector needs a label. PS the saline is single dose; the contrast agent if manufactured, labeled and used appropriately may be MDV. This safety goal is scored way too often and it will be red. 47 + NPSG.03 Anticoagulation safety goal, seldom scored today. Sometimes EP 2: Use approved protocols for the initiation and maintenance of anticoagulants. You want to be able to say: yes we have protocols and here they are If the protocol is used by an LIP to aide in decision making the protocol does not need to be in the chart. PC.02.01.03 Top 10, 46% of hospitals getting hit for failure to include the protocol used by a dependent practitioner in the EMR. If the protocol is used by a dependent practitioner, a copy of the protocol must be in the chart. Not easy to do with most EMR s 48 www.proce.com 24

+ NPSG.03 Medication reconciliation: Seldom scored today. Sometimes EP 3: Compare the medication information the patient brought to the hospital with the medications ordered for the patient by the hospital in order to identify and resolve discrepancies. Many times staff during a tracer are unable to display the end result of med reconciliation drug by drug. I reconciled button is a problem Errors of omission are a problem User security and viewing is a problem 49 + Leadership Standards and Clinical Contracting CMS wants hospitals to evaluate all contracted services so they can believe their money is being well spent. TJC wants hospitals to critically evaluate all clinical contractors to verify they are meeting professional standards, hospital expectations for service and TJC standards. Who/what are clinical contractors? Speech pathologist who is not an employee Orthotist performing a custom fitting Nurse contractor who does PICC line insertion Commonality: these are licensed professionals who are touching patients and impacting care at the hospital. 50 www.proce.com 25

+ Clinical Contracting and Pharmacy Merck is not a clinical contractor manufacturer Cardinal is not a clinical contractor wholesaler CAPS can be a clinical contractor for 503A work PharMEDium, if only doing 503B work would not be subject to clinical contractor evaluation under the TJC leadership standards Regional health systems performing compounding may be subject to clinical contractor evaluation if performing 503A work. Cardinal radiopharmacy is a clinical contractor 51 + Implications for Clinical Contractors The hospital must supply the surveyors with a complete list of clinical contractors The hospital must establish performance expectations A contract manager must evaluate performance against those known performance expectations. TJC/ASHP/FDA webinar has advised hospital pharmacists to conduct site validations at offsite compounding pharmacies. TJC Home care surveyors are piloting evaluation tools Leadership must review the performance evaluation done by the contract manager and authorize continuation. 52 www.proce.com 26

+ Questions? Kurt@Pattonhc.com To review past monthly newsletters, or to subscribe go to: www.pattonhc.com 53 www.proce.com 27