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Accreditation Tips

Risk Management

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Who is our Pharmacy's Compliance Officer?

Chief Ethics & Compliance Officer: Loretta Sticknane-Harris

How do you report a suspected fraud, waste or abuse issue?

  • Notify your supervisor, Institutional Compliance Anonymous Hotline, or Chief Ethics & Compliance Officer
  • Institutional Compliance Anonymous Hotline: (315) 464-6444

Does the Outpatient Pharmacy have a business continuity/emergency management plan?

  • Refer to the Standard Operating Policy (SOP):  Business Continuity and Emergency Management 
  • All essential electronics, med fridges, freezers etc. on red power outlets (connected to backup generators)
  • SOP outlines full Business Impact Analysis with how to handle potential interruptions with phone system, facility power, access to water, refrigerators, freezers, medication storage (room / humidity), ScriptPro, EPIC, Point of sale registers
  • Backup servers in place and the ability to internally pull / transfer prescription from one dispensing location to the other (example UCH Pharmacy prescriptions will be transferred to Downtown Pharmacy or vice versa)

Patient Safety

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What do you do if a patient is on the phone and threatening to harm themselves or others?

  • Keep the caller on the line and signal to another employee for assistance in calling 911.
  • Do not hang-up, transfer the call, or put the caller on hold; remain on the line until emergency personnel are on the scene. The SUNY Outpatient Pharmacy team member will use the code word “Ketchup” to notify staff of this immediate emergency.  The number for the suicide prevention hotline is 1-800-273-8255.

How can a patient reach a Pharmacist after hours?

  • Patients can reach pharmacists 24/7/365, even when the Outpatient Pharmacy is closed.
  • On-Call Pharmacist, patient still dials 315-464-3784 option #1. Pharmacist will return all voice messages within 30 minutes.

Quality Management/Performance Improvement

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What is the purpose of the Quality Management Committee (QMC)?

Promote objective and systematic measurement, monitoring, and evaluation of specialty pharmacy services and to implement quality improvement activities within the specialty pharmacy program

What does the Performance Improvement (PI) Committee do?

  • Establish measurable goals for quality improvement
  • Design and implement strategies to improve performance Establish projected time frames for meeting goals
  • Re-measure level of performance at least annually
  • Document changes or improvements relative to the baseline measurement
  • Conduct an analysis if the performance goals are not met
  • Evaluate the Patient Management Program and Quality Management Program

How often does the Quality Management Committee (QMC) meet?

  • Meetings at least quarterly
  • Minutes are located on the shared drive
  • Charter, membership and goals approved annually

Who oversees the Quality Management Committee (QMC)?

Co-Chairs:

  • Eric Balotin, Director of Specialty / Retail Pharmacy is responsible for the overall operation and services of the Pharmacies 
  • Eamonn Murphy, Associate Director Specialty Pharmacist, Senior Clinical Staff Person, oversees clinical aspects of specialty accreditation 
  • Patricia DeMasso-Anderson, Outpatient Pharmacy Quality Manager

Who is the URAC Senior Clinical Staff Person and what is that role?

  • Eamonn Murphy, PharmD, BCPS – Associate Director of Specialty Pharmacy
  • Responsible for oversight of clinical decision-making aspects of the Patient Management Program

What is the Patient Management Program (PMP) Software?

  • TherigySTM documentation of appropriateness assessments (conducted by specialty pharmacists and clinic-based pharmacists) and refill assessments (Patient Care Coordinators). Therigy, EPIC and ScriptPro all used to meet documentation requirements.

What are the active Quality Improvement Projects (QIPS)/Performance Improvement (PI) Projects?

The two active Quality Improvement Projects (QIPs) / PI projects in the department:
  • Telephone Metrics – Improving call answering speed (Patient access to services – telephone metric quality improvement project based off of URAC 4.0 standards and 2022 Pharmacy Measures Reporting results)
  • Hepatitis C Treatment Outcomes – Goal virus to no longer be detectable post treatment: Sustained virologic response (SVR) in patients who filled hepatitis C treatment at the SUNY Outpatient Pharmacy

What are the PMP Outcomes REporting Goals?

Tracked using TherigySTM, ScriptPro, and Epic:

  • Clinical Benefit Outcomes: Adherence measured through the Proportion of Days Covered (PDC) and Medication Possession Ratio (MPR) calculations. Goal for each ≥ to 80% for PDC and MPR
  • Subjective measure: goal for 80% to respond yes, “participation in this PMP has helped to self-manage medication therapy”
  • Measure of quality of life: goal for at least 75% of patients in the PMP to report their quality of life being fair or better during clinical assessment
  • Financial Benefits: goal to save specialty patients combined total of $500,000 annually; for all patients combined $1,000,000 annually

What is measured on the Outpatient Pharmacy Scorecard?

(QMC and PI Metrics Monitored) - all errors, near misses and complaints reported in LicenseTrak and reviewed at quarterly Quality Management Committee meetings

Telephone Access Reports

  • Average speed of answer as a percentage (URAC Goal: > 80% of calls within 30 secs; Organizational Quality Improvement Project Goal: > 90% of calls within 30 secs)
  • Call abandonment rate as a percentage (URAC Goal is < 5% abandoned calls; Organizational Quality Improvement Project Goal < 2.5%)
  • Call blockage rate as a percentage (URAC Goal is < 5%) – Calls cannot be blocked with current phone system
Complaint turnaround time: Goal 90% resolved within 30 calendar days (non-Medicare patients); Goal 90% resolved within 14 calendar days (Medicare patients). Pharmacy has a MUCH faster turnaround time then that though.  Complaints are addressed immediately upon discovery. Average less than 2 business days for resolution.
  • Near Misses: Goal <1% near misses reported per quarter
  • Distribution (mailing) accuracy: Goal for > 99% distribution accuracy
  • Dispensing accuracy: Goal for > 99% dispensing accuracy
  • Billing and coding errors: Goal > 99% accuracy
  • Patient satisfaction (twice yearly survey cards): Goal > 70% patient satisfaction
  • Provider Satisfaction (annual survey): Goal > 80% prescriber satisfaction
  • Employee Satisfaction (annual survey): Goal > 70% employee satisfaction
  • Clinical Interventions and Adverse Events: documented in Therigy and EPIC and analyzed/reviewed at QMC

What takes place if the department is not meeting a goal?

  • Corrective Action Plans (CAPs), Quality Improvement Projects (QIPs),
  • Performance Improvement Projects (PI Projects), and
  • Quality Improvement Activities (QIAs) are created and monitored through the Quality Management Committee (QMC)

What were a few corrective actions plans/performance improvement projects in the past:

  • Distribution errors – focusing on re-training staff and updating shipping procedures
  • Increasing access for patients, by making specialty medication line option #1 and working with telecom for additional information on phone system reports

Consumer Protection & Empowerment

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What do you do if a patient/caregiver has or places a complaint?

  • Staff can notify their direct supervisor and document all errors, near misses and complaints to be in LicenseTrak. Reviewed daily by Quality Manager, then discussed at quarterly Quality Management Committee (QMC) meetings
  • New Patient Welcome Packet lists additional places patients can place complaint including our pharmacy, Upstate Patient Relations, accreditation bodies, boards of pharmacy, department of health.
  • Refer to SOP Measuring Complaints

What controls does your Pharmacy have in place to assure unauthorized personnel cannot access your patient’s data?

  • Authorized individuals have access to the SUNY Outpatient Pharmacies via their SUNY Upstate Medical University ID Badge (Refer to SOP Facility Security)
  • SUNY Outpatient Pharmacies identify persons/positions authorized to access protected health information (PHI) collected by the organization. Password protected, unique log ins and annual confidentiality, ethics, code of conduct and cyber security training (Refer to SOP Confidentiality of Individually Identifiable Health Information and Information Management)
  • Annual Information Security Risk Assessments conducted by Upstate’s Information Security Officer

 

Summarize some of the safe guards your Pharmacy has in place for Consumer Protection and protection of PHI?

  • HIPAA - ALL staff are responsible for maintaining patient privacy in both paper and electronic format
  • All patients receive Rights and Responsibilities in the New Patient Welcome Packet
  • All of patient PHI is protected. Pharmacist always present when pharmacy open. Cameras, locked doors, security badge access only to PHI stored areas. Password protected programs and passwords never shared. Information Security Officer conducts annual risk assessment of potential vulnerabilities.

Operations & Infrastructure and Staff Training

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What is the Outpatient Pharmacy’s procedure to allow a caregiver access to the patient’s PHI?

  • In EPIC, in patient Demographics – listed patient contacts, relation to patient, if emergency contact and permission to discuss
  • If full records are requested, can contact Upstate Medical Records Request: Health Information Management/Clinical Data Services–Release of Information Services.

What are some of the annual competencies that you must complete?

This is done via BrightSpace (formerly Blackboard).

  • URAC Specialty 4.0 Training and ACHC Specialty and DME training
  • Institutional compliance (ethics, code of conduct, fraud waste and abuse, confidentiality)
  • Sexual harassment prevention
  • Privacy and security awareness, cyber security training
  • Right to Know (hazardous communication training)
  • Safety at Work (Fire safety, disaster training, hazardous drugs, hazardous waste, diversity training)
  • Outpatient Pharmacy disaster plans
  • Risk Evaluation and Mitigation Strategies (REMS) drugs training

Summarize the Outpatient Pharmacy code of conduct?

Follow the law, act professional, treat patients and staff with respect, do not discriminate, adhere to Upstate’s policies and procedures, report any concerns regarding patient care or ethical issues, communicate with supervisor, Hospital Compliance, and contact Compliance Hot Line if any concerns

Do you receive training on sexual harassment?

  • Yes, Sexual Harassment Prevention and Title IX Training annually

Do you receive training on and conduct annual fire and disaster drills?

  • Yes, refer to DDP A-144 - Departmental Disaster Plan-Outpatient Pharmacy/Pharmacy Enterprise, non-hospital based locations
    • This policy can be found by going to the iPage and selecting Policies & Forms\MCN Policy Management system.

Outpatient Pharmacy Dispensing

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What is the Outpatient Pharmacy’s process for shipping medications and monitoring temperature once the prescription leaves the Outpatient Pharmacy until it is delivered to the patient?

  • Diagrams and step by step instructions for proper shipping materials selection and packing are displayed in the shipping areas of both outpatient pharmacies and reviewed at least annually
  • For non-refrigerated medications use only validated Controlled Room Temperature packouts
  • For refrigerated medications use only validated Refrigeration / Cold Chain packouts
  • Sensor is placed in all refrigerated packouts to notify patient if temperature may be out of range

How are packages tracked to ensure they arrive as expected?

  • Patient is contacted to verify address prior to medications being shipped
  • Primarily using UPS for shipping - shipping labels and tracking information generated, and tracking # goes back into ScriptPro Rx batch
  • Tracking logs for all packages are reviewed to ensure the package was delivered
  • Mobilus for couriers - signed patient delivery from courier kept by pharmacy (electronically in Mobilus reports)

Hazardous Medications & Employee Safety

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•What is the process for receiving hazardous medications?

Staff involved in receiving MUST refer to the SOP: Safe Handling of Hazardous Drugs and Materials, pages 5-7

  • Space will be dedicated in the receiving areas for NIOSH Group (Table) 1 Hazardous Medications (HDs) that the distributor has separated into containers labeled with orange chemo tags or has identified HDs in another distinguishing fashion.
  • Staff receiving HDs must wear chemotherapy gloves that have been tested to the ASTM standard 6978 donned over the cuff of a back-closing, coated chemotherapy gown.

How would a staff member in the pharmacy know that a medication is a Hazardous Drugs (NIOSH Drug)?

  • ScriptPro identifies all hazardous meds in orange with “hazard”; the Pharmacy list is re-ran quarterly
  • Hazardous Risk Assessment of each medication and dosage form conducted annually – Based off of NIOSH 2016 list and NIOSH 2020 draft with NIOSH updates
    • Category A: Red Bin - High Risk/Full USP 800 to be followed (would be stored in hazardous non-sterile compounding room)
    • Category B: Yellow Label/Sticker – stored with other inventory
    • Category C: Green Label/Sticker – stored with other inventory
  • No hazardous medications are stored in the automated dispensing machines

Does non-sterile compounding of a hazardous medication take place in the outpatient pharmacy?

  • Manipulation / compounding of hazardous medications at UCH Pharmacy only, following USP 800; non-sterile hazardous compounding room (externally vented, negative-pressure room) with appropriate garbing. PHARMACISTS ONLY – SOP: Medication Compounding

How would you count out 30 tacrolimus capsules from a bulk bottle?

  • Use Hazardous Med Counting Trays: labeled and located at both pharmacies. To be used when counting any hazardous medication and cleaned between use
  • Wear gloves when counting for employee protection and no automated counting or dispensing machines

Where are Safety Data Sheets located?

  • On iPage in Policies & Forms then Safety Data Sheets (SDS)
    • Call Environmental Health and Safety at ext. 4-5782 for additional guidance

Do the outpatient pharmacies have Medication Spill Kits?

  • Located in both outpatient pharmacies
    • (all new and current staff to be signed off on training at hire and annually)
  • Call University Environmental Health and Safety department for them to clean up a spill (#4-5782)
  • Follow Hazardous Materials Spill DIS M-45 and Hazardous Drug Spills Proc CH H-26A (located on iPage in Policies & Forms within the MCN Policy Management System)

Do the outpatient pharmacies have Eye Wash Stations?

  • Located at both outpatient pharmacies
  • Tested weekly; training at hire and annually thereafter
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