Next up in CMSCG’s “Ftag of the Week” Blog series is F755 – Pharmacy Services, which is part of the regulatory group with the same name. Since there are multiple parts to this regulation, the next few CMSCG Blog posts will dig into the requirements.
F755 Pharmacy Services – Regulatory Requirements Overview
Per Appendix PP of the State Operations Manual (SOM), a facility must:
- Provide routine and emergency drugs and biologicals to its residents or obtain them under an agreement.
- Have procedures for the provision of pharmaceutical services that meet the needs of each resident.
- Employ or obtain the services of a licensed pharmacist who provides consultation on the provision of pharmacy services in the facility.
- Establish a system to enable the accurate reconciliation of all controlled drugs.
- Ensure that drug records are in order and that an account of all controlled drugs is maintained and reconciled periodically.
The regulation defines pharmaceutical services, which includes all the components of the process of ordering through use or ultimate disposal of the medication/biological. Pharmaceutical service also includes the process for identifying, evaluating and addressing med-related issues, such as med errors, and the provision, monitoring and/or the use of medication-related devices. It also includes the provision of medication-related information to both healthcare professionals and residents.
First, let’s look at all the procedures that a facility should have in place for pharmaceutical services. The consultant pharmacist is expected to collaborate with the medical director and the facility to develop, implement and evaluate procedures for these services that:
- Are consistent with State and Federal requirements
- Reflect current standards of practice
- Meet the needs of residents
Pharmaceutical Services – Procedures
Facilities need to ensure their policies address:
- Administration – including authorized personnel
The process through which a facility requests and obtains medications needs to be thorough and consider things like the availability of medications, verification/clarification of orders, or what to do when delivery of a medication will be delayed or is not available. While not an exhaustive list of procedures facilities need to have in place, at a minimum, the Interpretive Guidance includes:
- Receipt, labeling, storage and administration of medications dispensed by the prescriber, if allowed by the State
- Transportation of meds from the dispensing pharmacy or vendor to the facility to prevent contamination, degradation and diversion – This should be in accordance with both State and Federal requirements and consider manufacturer’s specifications
- Contacting the pharmacy to acquire medications – Facility staff need to know who may contact the pharmacy, when, and how to they should contact the pharmacy regarding original orders, refills, and emergency med orders
- Verification/clarification of an order if it becomes necessary
- Availability of medications either in the facility’s emergency supply or obtainable from a pharmacy – The pharmacy must be reachable 2/47
- Availability of an emergency supply of medications – If permissible by State law, procedures need to include:
- Types/categories of medications
- Amounts, dosages/strengths
- Location of emergency supply
- Which staff are authorized to access the supply
- How the emergency supply is monitored for expiration dates
- Process for replacing medications that have been used
Here’s what can happen if a facility does not have strong systems in place with comprehensive procedures:
Citation 1 (S/S: D) – A facility was cited for failure to ensure that its emergency medicine kits were re-ordered on a timely basis in accordance with facility policy. During review of the medication storage rooms, a nurse opened the emergency kits to show a surveyor and it was identified that insulin vials had been removed, but there was no documentation as to when this occurred or any other information in the log.
Citation 2 (S/S: F) – A facility was cited for failure to ensure that emergency drugs were accessible for all residents in case of an emergency when it was identified that staff were unable to retrieve medication from the emergency cart due to no one having a sign on and password that worked. On interview, multiple staff members told surveyors that they had been having issues for weeks with passwords not working, and one LPN stated that although the pharmacy had come to reset the password, it was still not working.
Both of these were avoidable citations, and although there was no harm, there could have been a negative outcome in either facility. Not only that, think about the unnecessary penalty points associated with a deficiency at S/S of F.
Now that we have looked at what providers need to think about related to acquiring medications, let’s look at considerations and requirements related to receiving medications. Receipt refers the process used to ensure that medications that are accepted at the facility are accurate and how they will be reconciled. Facilities should ensure that processes are in place for reconciling received medications with the prescriber’s order and the requisition for the meds. Procedures should also define which staff are authorized to receive medications, how they will be identified, and how the medications will be controlled until they are delivered to a secure storage area. Many providers may have already made tweaks in the past year to these processes given the restrictions to accessing facilities due to COVID-19, so it is likely that their procedures already considered this.
Once the medications have been delivered to the storage area, procedures also need to define which staff are responsible for getting the medications into the appropriate storage place for each resident. While it is not part of the regulatory requirements at F755, many providers get caught at F761 Storage of Drugs & Biologicals by issues with their medication storage areas, so pay attention here.
In Part 2 of CMSCG’s Ftag of the Week for F755 Pharmacy Services, we will look at dispensing, administering and disposing of medications – all of which can present another set of compliance issues.