John Karwoski, RPh, MBA President and Founder JDJ Consulting, LLC
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