Joint Commission Update 2017 PharMEDium Lunch and Learn Series

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

ProCE, Inc. (Pharmacist and Tech CE) 1.0 contact hour

Funding: This activity is self‐funded through PharMEDium.

It is the policy of ProCE, Inc. 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

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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

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. Questions will be answered at the end of the presentation.

Your question. . . ?

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Resources

. Visit www.ProCE.com/PharMEDiumRx to access: – Handouts – Activity information – Upcoming live webinar dates – Links to receive CE credit

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Joint Commission Update 2017 - PharMEDium

Kurt A. Patton MS, R.Ph. President Emeritus Patton Healthcare Consulting, Inc. Former Executive Director Accreditation The Joint Commission.

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+ Pressures on the 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

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+ 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.

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+ Joint Commission Survey Teams

 Physicians

 Nurses

 Behavioral healthcare specialists

 Ambulatory specialists

 Some pharmacists at larger teaching and for cause events

 Home infusion pharmacists

 Life safety code specialists

 All clinical surveyors conduct tracers and report to each other their observations

 One surveyor will conduct a MM System tracer in depth.

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+ 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.

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+ 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/

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+ 12 New TJC Scoring System

 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

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+ Project Refresh Onsite SAFER Matrix

 Survey Analysis for Evaluating Risk (SAFER) Matrix  Help you prioritize  Visual – on report  Can sort & filter

13 Scope

+ 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.

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+ 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.

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+ 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 pre- sedation assessment.  TJC does not perform peer review.

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Most Frequently Scored Medication Management Standards

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+ Joint Commission Standards Structure

 Standard xx.xx.xx – a high level concept that is not directly evaluated by the surveyors

 There are also National 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.

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+ 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.

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+ 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.

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+ 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.

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+ 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 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.

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+ 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.

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+ 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.

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+ 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.

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+ 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.

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+ 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

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+ 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.

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+ 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.

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+ 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.

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+ 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.

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+ 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

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+ 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

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+ 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

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+ 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.

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+ 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

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+ 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

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+ 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

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+ 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”.

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+ ASP EP 3

 The hospital educates 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.

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+ 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.

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+ 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.

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+ 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

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+ 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.

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+ 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.

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+ 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.

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+ 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.

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+ 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

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+ 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

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+ 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.

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+ 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

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+ 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.

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+ Questions?

[email protected]

 To review past monthly newsletters, or to subscribe go to:

 www.Pattonhc.com

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