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