CMS 2016 New Pharmacy and Medication Hospital CoP Standards

Event Information
Product Format
Prerecorded Event
Sue Dill Calloway, RN, MSN, JD
120 minutes
Product Description

Decoding the CMS 2016 New Pharmacy and Medication Hospital CoPs


Did you know that CMS issued a 45 page memo announcing in advance many changes to the hospital CoP pharmacy standards in 2016? This includes changes to ten tag numbers or sections and these are now final. This include changes regarding compounding of medication and beyond use date (BUD) and to bring them into alignment with acceptable standards of practice. Language was included so that the surveyor would be able to cite the hospitals at either condition or standard level.

The most common medical error today in hospitals is medication error? According to CMS, around 1.9 million inpatients have to suffer from drug related adverse outcomes, which accounts for almost 5% of all admissions. Around 838,000 outpatients have drug related adverse events. Hospitals that spend more resources on medication issues generally have lower rates.

Just about every hospital in America accepts Medicare and Medicaid reimbursement and as such must follow the Center for Medicare and Medicaid Services (CMS) hospital interpretive guidelines. All patients in the hospital must follow these regulations as well the interpretive guidelines. There have been many recent changes in the nursing section that address medication usage also. This includes changes to timing of medication, self-administered medication, compounding, blood, and safe opioid use. There are three time frames that medications must be administered along with the QAPI requirements.

Information will be provided on the top problematic pharmacy standards by CMS. CMS is now issuing a deficiency report showing when the pharmacy is cited for being out of compliance.

It is important for the nursing to understand the medication and pharmacy standards since many of them apply to nursing. For the first time, CMS mentions that nursing needs to be aware of some of the pharmacy standards and vice versa. This includes medication errors, adverse events, and drug incompatibilities, self-administered medication and required medication policies. If a medication error or ADE occurs there must be notification of the physician, documentation in the medical record and it must be included in the PI data.

The timing of medication requires policies and procedures and training by hospitals. This section requires notification of the physicians and discusses when this must occur. Hospitals should have a non-punitive approach and the definition of medication error should be broad enough to include near misses.

The CMS interpretive guidelines address medication management and pharmacy related standards. These can be looked at when CMS conducts a complaint or validation survey. Medication management is not only a big issue with CMS but also with the Joint Commission. Medication errors are the largest number of medical errors in healthcare today. They are also the most common reason for unnecessary readmissions to the hospital.

It is essential that hospitals work together to implement and follow these regulations. Problematic standards include verbal orders for medication, order for medications, NS standing orders.

Join this session by expert speaker Sue Dill Calloway to recall that all hospitals receiving Medicare/Medicaid reimbursement need to follow the medication guidelines for all patients. You will know the CMS requirements for BUD and compounding and recall the number of pharmacy policies and procedures required by CMS. The session will help you understand the policy required by CMS for high risk drugs like dose limits or double checks.

Session Highlights:

  • Pharmaceutical Services requirements
  • How to locate the CMS manual
  • CMS final infection control worksheet: safe injection practices, microbial stewardship, and MDRO
  • Ten final tag number changes in 2016
  • Common problematic pharmacy standards
  • Standards of care
    • ISMP, USP, ASHP, APA, FDCA, etc.
  • Recent CMS Memos: safe injection practices, infection control breaches, luer misconnections, insulin pens
  • CMS 45 page memo regarding pharmacy and medication changes and changes final now
  • Nursing tag 405 and additional resource
    • Compounded medications and BUD
    • Safe injection practices
    • Compounded sterile preparations(CSP)
    • Immediate-use CSP and one hour rule
  • Meeting the needs of patients
    • What is included in pharmaceutical services?
    • Medications must be available timely
  • Condition or standard level deficiencies
  • Medications timing changes
  • MS role in developing P&P including to minimize drug errors
  • Functions of pharmacist
  • Required P&P
  • Flag new types of medication errors
  • High alert medication
  • Limiting number of medication related devices
  • Pharmacist on call if not open 24 hours
  • Standardization of prescribing and communication practices
  • Weight based dosing
  • Availability of patient specific information
  • Abbreviations, look alike-sound alike drugs
  • Pre-printed order sheets
  • Voluntary non-punitive reporting system
  • Weight based dosing for pediatric population
  • Incorporation external alerts
  • P&P required by hospitals
  • Policy to minimize drug errors
  • Storage of drugs
  • Pharmacy director role in P&P
  • Drug storage of medications and biologicals
  • Dispensing and administration of medications
  • Pharmacist job description
  • Pharmacy personnel requirements
  • First review of new medications by pharmacy
  • Policy to address medications brought in
  • Monitoring effects of medications
  • Investigation drug policy
  • Recalled or discontinued drugs
  • Compounding of drugs
    • The Drug Quality and Security Act (DQSA)
    • Outsourcing facilities
    • Use of compounding pharmacies
    • Medications compounded by hospital pharmacy
    • Compounding practices and quality control
    • BUD, packaging, and labeling of medications
  • Locked storage areas
  • OR anesthesia carts and ASA guideline
  • Medication and crash carts
  • Patient self-administration of drugs regulation
  • Outdated or mislabeled drugs
  • When pharmacist not on duty
  • Night cabinet standard
  • Automated stop orders and policy
  • Medication error and near misses
  • Proactively identify medication errors
  • Indicator or trigger drug review
  • Drug interaction information
  • Formulary

Who should attend?

This program is for anyone involved in the medication process especially pharmacists, chief pharmacy officer, physicians, all nurses, patient safety officer, nursing supervisors, nurse managers and others. Risk managers, hospital attorneys, compliance officers, Joint Commission coordinators and quality and performance improvement staff, chief nursing officer, chief medical officer, chief operation officer, policy and procedure committee members, case managers, nurse educators, nurse managers, compliance officer, director of regulations, Joint Commission director and others who participate in the medication process should attend.

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Sue Dill Calloway - Hospital Coding Expert

Sue Dill Calloway, RN, MSN, JD, is the president of Patient Safety and Healthcare Consulting and Education company with a focus on medical-legal education especially Joint Commission and the CMS hospital CoPs regulatory compliance. She also lectures on legal, risk management and patient safety issues. She was a director for risk management and patient safety for five years for the Doctors Company. She was the past VP of...   More Info
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