John Karwoski, RPh, MBA June 11th... · John Karwoski, RPh, MBA President and Founder JDJ...
Transcript of John Karwoski, RPh, MBA June 11th... · John Karwoski, RPh, MBA President and Founder JDJ...
John Karwoski, RPh, MBA President and Founder
JDJ Consulting, LLC
JDJ Consulting, LLC Since 2001 our Mission Statement remains the same:
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To provide each client with the most up-to-date, all-inclusive
and relevant information and guidance so they can achieve
the following goals:
Enhance Patient Safety
Maintain Regulatory Compliance
Reduce Cost
JDJ Consulting, LLC Providing consultant pharmacist services to Ambulatory Surgery Centers
and Surgical Specialty Hospitals in the Mid-Atlantic States
State, Federal, and Accreditation Regulatory Guidance
Policy and procedure review
Formulary management
Quality Improvement Studies
Benchmarking
Chart audits
Newsletters
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…and EDUCATION
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The Importance of Education
Medication Management and Safety
In-servicing – Malignant Hyperthermia
– Drug Diversion Prevention
– Safe Injection Practice
In-patient Hospital Physician Order Review and Verification
24/7 access to clinical pharmacists
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Drug Compounding Challenges in
the ASC Setting
Drugs remain widely compounded in the ambulatory setting
The Ambulatory Setting VS Hospitals – Outpatient surgical settings lack the resources of hospitals
– Pharmacists are rarely available 24/7
– Facilities lack pharmacies
The requirements of USP <797> are complex and risks associated with compounding are great
Few centers have facilities to meet the compounding requirements of USP Chapter <797>
Regulatory Guidance
Accreditation agencies & CMS use USP <797> as the standard for acceptable compounding practice
Regulation for syringe preparation/ safe injection preparation – AAAHC for ASCs and AAHHS for Hospitals
– Joint Commission
– AAAASF
– CMS
The One and Only Campaign
Safe Injection Practices
JCAHO Medication Management Standards Comprehensive Accreditation Manual for Ambulatory Care (CAMAC)
MM.05.01.07: The organization safely prepares medications
MM.05.01.09.A1: Medication containers are labeled whenever medications are prepared but not immediately administered.
MM.05.01.09.A2: Information on medication labels is displayed in a standardized format, in accordance with law and regulation and standards of practice.
8 CAMAC update 2, January 2016
Preparation of Compounded Drugs
Drugs should always be compounded by a licensed pharmacist – Preparation by a 503B Outsourcing Facility is preferable
– “Mixing” drugs in a non-sterile clinical setting can be dangerous
Patient Safety Risks – Sterility of the drug
– Ensuring the correct concentration is in each dose
– Ensuring the proper drug is in each dose
Discuss how to choose a compounder with your consultant pharmacist
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When compounding is done wrong…
NECC – Over 800 effected
– 64 Deaths
Poorly compounded drugs: – Could have particulate matter in the drug
– Could be non-sterile
– Pose an infection control risk
Inconsistencies in your orders of compounded drugs are a red flag!
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Medication Errors
Safe Injection Practices
– Improperly labeled syringes
– Out of date syringes
– Breach of sterility
Narcotic Control
– Infection control risk for diverted syringes
– Patients don’t receive intended meds/ doses 11
Drug Administration Error
dis
14 http://www.denverpost.com/news/ci_29470332/swedish-medical-center-patients-at-risk-hiv-hepatitis
Diversion Puts Patients at Risk
February, 2016
2,900 patients recommended for testing of HIV, Hep B, Hep C
Employee was diverting narcotics – No evidence of patient exposure
– Hospital is testing patients as a precaution
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The Infection Risk of Diversion
• 2009: Surgical technician was diverting narcotics and reusing
syringes/ vials on patients
• 5970 patients effected
• 88% submitted to testing
• 18 positive cases of Hep C linked to the surgical tech were
identified
http://www.denverpost.com/fitness/ci_14466337
Who is in charge of your infection control
policies/procedures?
Does your infection control policy comply with
accreditation and regulatory standards?
Consider This…
CMS ASC Infection Control
Worksheet (Rev: 142, Issued: 07-17-15, Effective: 07-17-15, Implementation: 07-17-15)
Part 2 Section II A-C. Observations are to be made of staff preparing and administering medications and performing injections. A. Needles are used for only 1 patient B. Syringes are used for only 1 patient C. The rubber septum on a medication vial, whether unopened or previously accessed, is disinfected with alcohol prior to piercing
CMS ASC Infection Control
Worksheet (Rev: 142, Issued: 07-17-15, Effective: 07-17-15, Implementation: 07-17-15)
Part 2 Section II J. Multi-dose medication vials used for more than one patient are stored appropriately and do not enter the immediate patient treatment area (ie., operating room, patient room, anesthesia carts).
If multi-dose vials enter the immediate patient treatment area, they must be dedicated for single patient use and discarded immediately after use.
Ensuring Medication Safety
Prefilled syringes
– Consistency
– Labeling
– Anti-diversion safety caps with breakable seal
EMR and Barcode Scanning
– Bedside medication scanning
– RFID
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“If you’re not moving forward you’re falling back”
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THANK YOU!
John Karwoski, RPh, MBA
JDJ Consulting, LLC
(609) 313-7572
www.JDJConsulting.net