2017 Pharmacy Education Series

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1 2017 Pharmacy Education Series March 15, Joint Commission Update Featured Speakers: Patricia C. Kienle, RPh, MPA, FASHP Terry Baughman Kathryn E. DeSear, PharmD, BCPS, AAHIVP Online Evaluation, Self-Assessment and CE Credit Submission of an online post test and evaluation is the only way to obtain CE credit for this webinar Go to Webinar attendees will also receive an with a direct link to the web page Print your CE statement of completion online Credit for live or enduring (not both) Deadline: April 14, 2017 CPE Monitor (applicable to pharmacists and pharmacy technicians) CE credit automatically uploaded to NABP/CPE Monitor upon completion of post test and evaluation (user must complete the claim credit step) Attendance Code Code will be provided at the end of today s activity 2 1

2 How to Ask a Question Locate menu bar on your computer desktop Click orange arrow button to open menu box Type question into question box Click Send Do not close menu box This will disconnect you from the Webcast Please submit questions throughout presentation Enter question Click No! Click 3 Accessing PDF Handout No! Click the hyperlink that is located directly above the question box Do not close menu box This will disconnect you from the Webcast Click hyperlink 4 2

3 March 15, Pharmacy Education Series 2017 Joint Commission Update Featured Speakers: Patricia C. Kienle, RPh, MPA, FASHP Terry Baughman Kathryn E. DeSear, PharmD, BCPS, AAHIVP 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. Ms. Kienle is an employee of Cardinal Health and is a member of the USP Compounding Expert Committee. Dr. Baughman does not have any relevant commercial and/or financial relationships to disclose. Dr. DeSear does not have any relevant commercial and/or financial relationships to disclose. Please note: The opinions expressed in this activity should not be construed as those of the CME/CE provider. The information and views are those of the faculty through clinical practice and knowledge of the professional literature. Portions of this activity may include unlabeled indications. Use of drugs and devices outside of labeling should be considered experimental and participants are advised to consult prescribing information and professional literature. 5 CE Activity Information & Accreditation (Pharmacist and Pharmacy Technician CE) 2.0 contact hours Funding: This activity is self funded through CHSPSC

4 2017 Joint Commission Update PATRICIA C. KIENLE, RPH, MPA, FASHP 7 Disclosure Patricia Kienle is an employee of Cardinal Health She is a member of the USP Compounding Expert Committee, but this presentation is not affiliated with or endorsed by USP 8 4

5 Objectives for Pharmacists State the agencies and organizations which can enforce the CMS Conditions of Participation Identify the most-cited issues in Joint Commission surveys concerning medication use Define time-critical scheduled medications Describe the expectations for preparation of compounded sterile preparations in procedural areas 9 Objectives for Pharmacy Technicians Identify the federal document which sets regulations for medication use in hospitals Identify which functions of medication use activities receive the most citations during Joint Commission surveys Identify time-critical scheduled medications at your organization State what department needs to prepare compounded sterile preparations

6 Who Sets Regulations and Standards? Federal agencies State agencies Accreditation organizations 11 Federal Agencies Centers for Medicare and Medicaid Services (CMS) Food and Drug Administration (FDA) United States Pharmacopeia (USP) Drug Enforcement Administration (DEA) Occupational Health and Safety Administration (OSHA)

7 State Agencies State Boards of Pharmacy State Departments of Health 13 Accreditation Organizations Four hospital AOs deemed by Medicare The Joint Commission (TJC) DNV Healthcare Healthcare Facilities Accreditation Program (HFAP) Center for Improvement in Healthcare Quality (CIHQ Growing number of ambulatory AOs

8 CMS Documents Hospital Conditions of Participation (CoP) Conditions for Coverage (CfC) for other healthcare settings Available on the CMS web site Sent to states as Survey and Certification letters 15 Welcome That announcement that says Welcome to CMS, Welcome, Joint Commission surveyors or Welcome to the Department of Health Inspections vs. surveys Policies, procedures, and practice Outside business space within the hospital

9 WHAT AGENCIES AND ORGANIZATIONS VISIT YOUR SITE? 17 Accreditation Organizations Must include CoPs in their standards Must survey for those elements Some organizations will have a validation survey following a survey from an accreditation organization Some states overlap inspections with AO surveys

10 WHAT MEDICATION MANAGEMENT CITATION HAS YOUR HOSPITAL RECEIVED? 19 Top-Cited TJC Hospital Medication Issues Standard Non- Compliant MM Medication Orders 34% MM Medication Storage 31% NPSG Labeling in Procedures 11% MM Order Review 11% MM Medication Preparation 6% NPSG Medication Reconciliation 4% MM Medication Labeling 3% First Half of

11 Your Hospital Issues Have they been corrected? Is the correction sustainable? Can you prove results? 21 Frequent Hospital Issues Orders Storage Time-critical medications Labeling Compounding in procedural areas

12 Orders Protocols and standing orders Scope of practice Texting Auto-verification Titration Range orders Therapeutic duplication 23 Protocols and Standing Orders Approved by Medical Staff Committee, with input from pharmacy and nursing Evidence-based Standing orders Set of orders from a prescriber Protocol Set of orders to treat specific condition with objective parameters Must be within scope of practice of clinician Must have a defined frequency of review

13 Protocols in Medical Records A copy of the protocol or standing order must be in the patient s medical record The protocol or standing order must be authenticated by the prescriber, including date and time 25 Texting Orders Texting orders is NOT OK 2011 policy changed in May 2016 and changed again in December 2016 Stay tuned

14 Texting Orders All healthcare organizations should have policies prohibiting the use of unsecure text messages (SMS) from a mobile device for communicating protected health information CMS and TJC agree that CPOE should be the preferred method for submitting orders If an electronic or written order cannot be issued, a verbal order is acceptable The use of secure text orders is not permitted 27 Auto-Verification of Orders Cannot replace pharmacist review of orders Where does auto-verification occur?

15 Titration Orders Medication and route Starting dose Titration amount Titration time frame Maximum dose Clinical endpoint 29 Other Order Issues Range orders Therapeutic duplication Objective parameters Medical order, not nurse s or patient s choice

16 Medication Storage Secure Safe Integrity protected In date Stored at the correct temperature 31 Reasons for Citations Single-use containers Nursing units Procedural areas Pharmacy IV room Multiple dose vials Mark with beyond-use date (BUD) Not puncture date No room temperature storage time from manufacturer

17 WITHIN WHAT TIME PERIOD MUST A Q12H MED BE ADMINISTERED? 33 The 30 Minute Rule Establish standard dosing times Identify medications not eligible for scheduled dosing times, such as stat, first time, loading, one-time, time sequenced, investigational agents, and PRNs Identify time critical scheduled medications that must be administered within 30 minutes of the scheduled time Other scheduled medications must be administered within 1 hour of the scheduled time

18 Workable Policy Short list of critical-timed medications that must be given within 30 minutes of scheduled time Other meds administered within 1 hour of scheduled time Monitor and take action on outliers 35 Procedural Areas Surgical services Anesthesia Imaging Clinics Physician Offices

19 WHAT ARE YOUR TIME- CRITICAL MEDICATIONS? 37 Monitoring Administration Times Be able to demonstrate compliance Routinely access scanning reports Patient scans Medication time scans Use this as a Performance Improvement tool Identify issues Adjust list of meds

20 Labeling Two standards apply NPSG for procedural areas MM primarily for pharmacy and nursing areas 39 Compounding Nonsterile USP <795> Sterile USP <797> Hazardous USP <800>

21 CMS and Compounding All elements of <797> have been in the CMS CoP since 2015 State Boards have focus on both nonsterile and sterile compounding Hazardous drugs are part of <797> and will be moved to <800> on July 1, Compounding Facilities Neat, clean, functionally separate Nonsterile Master Formulation Records Beyond-use dates Sterile Facilities Training Personnel and environmental monitoring

22 Pharmacy Sterile Compounding Cleanroom suite ISO 7/8 anteroom + ISO 7 buffer room Proper pressurization HEPA filtration Segregated Compounding Area Read, understand, and react to your certification report 43 Take Action Now Combined ante/buffer room Unlikely to be allowed when <797> is revised Chemo preparation outside of negative pressure Will not be allowed as of July 1, 2018 CAI outside of cleanroom Will probably be limited to 12 hour BUD when <797> is revised

23 WHERE ARE STERILE PREPARATIONS MIXED OUTSIDE OF PHARMACY? 45 Compounding in Procedural Areas Minimize Use premixed products or compounded ready-to-use preparations Immediate Use is not intended for convenience or scheduled cases Document competency of personnel

24 Action Plan Read the regulations and standards Identify prior citations Provide evidence of sustained correction Prioritize potential risk points 47 CHS TJC Survey Summation for

25 CHS TJC Survey Summation 2016 Learning Objective: List frequent Medication Management standard findings and how to avoid them in future surveys

26

27 53 Community Health System, Inc. Strengths Implementation of daily safety huddles Patients complimentary of care received Increased empowerment of staff to make patient care improvements working toward sustainability Increased focused senior leadership rounding acknowledged by staff Increased medical staff involvement in high reliability efforts

28 CHS Medication Management Opportunities Documentation of actions related to titration drips Following current orders or obtaining new orders specifically related to medication administration Following medication policies related to potential therapeutic duplication of medications. 55 Potential Documentation for Tirtration Drip Solutions Consider education of staff regarding need to assess and document the measurement of the stated outcome or end point goal for titration each time it is changed Document re-assessment measurements to ensure action achieves desired goal Perhaps standardization of documentation process and form

29 Potential Solutions for Following Current Orders Consider education of staff regarding need to obtain a new order and document if varying from existing order or patient refuses and requests alternative; e.g. do not give a medication listed for pain of 1-3 if patient has pain of 7 without order from physician 57 Potential Solutions for Prevention of Therapeutic Duplication in Medication Management Policies Consider adoption of standardized order sets and if more than one medication is selected have priority established Encourage Pharmacy to not accept orders and clarify those containing more than one medication without priority established

30 Project Refresh Health Systems Corporate Liaisons May 12 th, What is Project Refresh? A series of 11 inter-related and/or interdependent process improvement initiatives underway at The Joint Commission Guiding principles: Simplification, Relevancy, Innovation, Transparency REFRESH projects will be implemented in a phased and coordinated approach, beginning in June 2016 and extending through

31 Outcomes of REFRESH Projects Real-time information gathering between surveyors and Standards Interpretation Group during survey Enhanced mobile technology Fewer standards Revised criticality models for standards Easier & less complex decision process Streamlined post-survey process Higher consistency in interpretation of standards 61 Survey Analysis for Evaluating Risk (SAFER) Matrix & Post-Survey Follow-up

32 Future Vision Develop one single, comprehensive method of categorizing the risk associated with standards 63 A New SAFER Concept Likelihood to Harm a Patient Scope

33 Prioritized Follow-up Action 65 How is Risk Determined? Operational definitions and anchors Surveyor experience and expertise will provide the support to determine the scope and likelihood to harm for the finding Based on the context of the finding Discussion amongst the survey team

34 Example #1 It was observed that there was an entry in the record which had not been authenticated and/or dated and timed. The Intake assessment had been signed by the author but the entry was not dated and timed. 67 A picture is worth 1,000 words

35 Benefits of SAFER Matrix Focus on patient safety/risk to patients Critical thinking Visual representation of survey More clearly identifies the highest risks Aggregate data for standards refinement, improving consistency, etc. 69 Customer Impacts: No more Direct and Indirect EP designations Consolidated ESC into one 60-day timeframe No more A or C categories No more Opportunities for Improvement (OFIs) No more Measures of Success (MOS)

36 Medication Management Standards Binder 71 Medication Management Standards Binder

37 Medication Management Binder Goals: To assure all required policies/ documents are in place. To enable surveyors to answer questions about hospital policies. To create an impression that the hospital is well prepared for survey. 73 Medication Management Hot Buttons: Medication Room Temperature put a temperature gauge in each medication room. Succinylcholine in ED, ICU does staff know how to respond if patient develops malignant hyperthermia? Warmed Baxter IV Bags/Irrigation Bottles can be used until marked expiration date if not kept warmed more than 14 days

38 THE JOINT COMMISSION S NEW ANTIMICROBIAL STEWARDSHIP STANDARD KATE DESEAR, PHARMD, BCPS, AAHIVP ANTIMICROBIAL STEWARDSHIP MANAGER 75 OBJECTIVE Relate TJC Antimicrobial Stewardship Standard to Facility to assess readiness and compliance Not Ready Ready

39 INTRODUCTION TJC released MM in 2016 Live: January 1 st, 2017 Several documents must be available within 1 st hour Components necessary during tracers and sessions Survey activity guide uploaded on intranets: Legacy and CHS14 Stewardship Score Progress Report released February 28 th, BACKGROUND: REGULATORY INTERVENTION The CLABSI Approach Clearly defined goals ALL hospitals engaged in CLABSI prevention CLABSI bundles/checklists made it easy Strong national measurement system (NHSN) C-suite involvement National policies Nation-wide education Research Applying CLABSI Success to ASP Education Measurement Guidelines National Goals National Policies Research CLABSI = Central line-associated bloodstream infections

40 GUIDELINES FOR ANTIMICROBIAL STEWARDSHIP How do we measure our efforts? 79 TJC MM

41 = Documentation Required Stewardship Score Progress Report Goal is to provide means of continually assessing status and progress of ASP Gaps should be assessed Discussion with ASP Prioritized action plan Short and long term goals Engage key stakeholders 81 AT RISK* FACILITIES Description # At Risk Facilities 2016Q3 # At Risk Facilities 2016Q4 EP1: Leadership Support EP2: Education for Staff EP3: Patient Education EP4: Key Support for the Antibiotic 5 2 Stewardship Program EP5: Antibiotic Stewardship Program Includes CDC Core Elements 6 2 EP6: Policies, Protocols, Procedures 2 1 EP7: Tracking 3 3 EP8: The Antimicrobial Stewardship Program Takes Action At least one failure point *At risk = < 10% on Element of Performance

42 CDC CORE ELEMENTS OF ANTIBIOTIC STEWARDSHIP 83 STEWARDSHIP SCORE CALCULATION 2016Q4 Stewardship Score P o 5 i 3 n 1 t 0 s 84 0% 20% 40% 60% 80%

43 STEWARDSHIP SCORE PROGRESS REPORT 85 TJC 1 ST HOUR DOCUMENTS 1. List of patients receiving antimicrobials as follows: Emergency department patients who are prescribed antimicrobials. Ambulatory and clinic patients surveyed under the hospital program who are prescribed antimicrobials Hospitalized patients who will be discharged on antimicrobials 2. Documents demonstrating leadership support for the organization antimicrobial stewardship program 3. Document describing how the organization is using the CDC s Core Elements of Hospital Antibiotic Stewardship Programs 4. Organization approved antimicrobial stewardship protocols (e.g. policies, procedures, or order sets) 5. Antimicrobial stewardship data 6. Antimicrobial stewardship reports documenting improvement

44 OTHER FIRST HOUR DOCUMENTS Requirement Documents demonstrating leadership support for the organization antimicrobial stewardship program Document describing how the organization is using the CDC s Core Elements of Hospital Antibiotic Stewardship Programs Organization approved antimicrobial stewardship protocols (e.g. policies, procedures, or order sets) Antimicrobial stewardship data Antimicrobial stewardship reports documenting improvement Solution Signed AS Charter or leadership support statement AS Progress Report Facility order sets and any pertinent pharmacy policies (IV to PO, PK dosing, therapeutic interchange) Antimicrobial Spend per APD & DDD/APD reports from corporate Sentri-7 reports or Stewardship Score 87 TRACERS AND OTHER SESSIONS Individual tracer Patient education on antimicrobials Staff education on antimicrobial resistance and facility ASP Competence assessment Staff education on antimicrobial resistance and facility ASP Data management tracer & Medication management tracer 1 st hour binder will be helpful here TJC transcript Policies, procedures, order sets Documented improvement Leadership session Discussing leadership s support of ASP; organizational priority Medical staff credentialing Staff education on antimicrobial resistance and facility ASP

45 SUMMARY A binder should be assembled for TJC surveyors prior to arrival AS charter or statement of leadership support Stewardship Score Progress Report Policies, procedures, order sets Upon surveyor arrival, other documentation should be produced Sentri-7 reports DDD/APD or antibiotic spend/apd reports Make sure staff are aware of tracer requirements Preparedness is KEY to successful survey!

46 Update on Current Pharmacy Initiatives and Strategies Jerry H. Reed, MS, RPh, FASCP, FASHP Senior Director, Pharmacy Services Community Health Systems

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