F761 Label/Store Drugs and Biologicals is currently the 8th most frequently cited deficiency throughout the nation thus far in FY2021.
Source: CASPER 08/08/2021
REGULATION
The F761 regulation includes three requirements:
Labeling – (1) Drugs and biologicals used in the facility must be labeled in accordance with currently accepted professional principles, and include the appropriate accessory and cautionary instructions, and the expiration date when applicable.
Storage – (2) In accordance with State and Federal laws, the facility must store all drugs and biologicals in locked compartments under proper temperature controls, and permit only authorized personnel to have access to the keys. (3) The facility must provide separately locked, permanently affixed compartments for storage of controlled drugs listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse, except when the facility uses single unit package drug distribution systems in which the quantity stored is minimal and a missing dose can be readily detected.
Source: SOM Appendix PP
SURVEY PROCESS
The Medication Storage and Labeling is a mandatory task that surveyors will complete during each annual recertification survey. Surveyors will use the Survey Pathway ‘Medication Storage and Labeling’ to determine compliance with F761. Surveyors will review half of the med storage rooms, covering different units and review half of the med carts on units where the storage room was not observed. Areas surveyors will focus on during the review include:
- Medications/biologicals are maintained within secured locations accessible on to designated staff; clean and sanitary conditions; and maintain proper temperatures.
- Schedule II controlled medications (excluding single-unit packaging in minimal quantities that can readily be detected if missing) are maintained within a separately locked permanently affixed compartment.
- Sufficiently detailed records of receipt and disposition of controlled medications are maintained to enable an accurate reconciliation.
- All medication records are in order and an account of all controlled medications was maintained and periodically reconciled.
- Medications/biologicals are labeled in accordance with currently accepted professional principles, and include appropriate cautionary instructions and expiration date, when applicable.
- Multi-dose vials to be used for more than one resident are kept in a centralized medication area and do not enter the immediate resident treatment area (e.g., resident room). If multi-dose vials enter the immediate resident treatment area they should be dedicated for single-resident use only.
- Multi-dose vials which have been opened or accessed (e.g., needle-punctured) should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial.
- Multi-dose vials which have not been opened or accessed (e.g., needle-punctured) should be discarded according to the manufacturer’s expiration date.
- Insulin pens containing multiple doses of insulin are meant for single-resident use only, and must never be used for more than one person, even when the needle is changed; insulin pens must be clearly labeled with the resident’s name and other identifier(s) to verify that the correct pen is used on the correct resident; insulin pens should be stored in a sanitary manner to prevent cross-contamination.
- Disposal methods for controlled medications involve a secure and safe method to prevent diversion and/or accidental exposure.
Source: FORM CMS-20089
EXAMPLES OF ACUTAL CITATIONS (FY2021)
Immediate Jeopardy
Based on observation, interview and record review, the facility failed to ensure medications were secured, allowing a resident to have access to medication that was ingested for a suicide attempt. These practices resulted in an immediate jeopardy (IJ) for resident, whom was hospitalized and then intubated as a result of the adverse effects of the medication overdose.
Camera footage showed:
- 6:07 p.m. Staff removed medication from the cart, and was interrupted by another resident. Staff set the medication down on top of the cart.
- 6:09 p.m. Staff walked away from the cart, leaving a medication card on top of the cart.
- 6:15 p.m. Resident was seen standing at the medication cart, taking a card off the medication cart, then returned to her room next to the cart.
- 6:25 p.m. Staff returned to the medication cart and continued her medication pass.
- 6:40 p.m. Resident approached the staff member and handed a medication card.
Documentation indicated the resident ingested the medication and that she wanted to die.
Actual Harm (Level G)
Based on observation, interview and record review, the facility failed to ensure that medications were secure and inaccessible to residents. One resident with a history of self harm, accessed and ingested an unknown amount of acetaminophen that was left in an unlocked isolation cart.
- The facility staff became aware that the resident had ingested medication he/she took from an unsecured cart. The resident received immediate medical attention and the facility initiated an investigation.
- Staff were interviewed with no staff member admitting to leaving the Tylenol on the isolation cart. Unable to determine how the Tylenol was placed there. Staff members admitted they were aware of the Tylenol being in the drawer yet did not remove it.
No Actual Harm (Level E)
Based on facility policy review, observation, and interview the facility failed to ensure medications were
stored in a locked medication cart on 2 of 4 resident hallways observed.
The findings include:
- Observation on the hall showed the medication cart with the medication drawers closed, unlocked, and unattended.
- During an interview, the Registered Nurse (RN) House Supervisor confirmed the medication cart was left unlocked and unattended.
- A subsequent observation on the hall showed License Practical Nurse (LPN) unlocked the medication cart then walk away from the cart leaving the cart with the medication drawers closed, unlocked, and out of line of site.
No Actual Harm (Level D)
Based on observation, interview, and facility policy review, it was determined the facility failed to ensure that all drugs and biologicals used in the facility were labeled in accordance with professional standards,
including expiration dates and with appropriate accessory and cautionary instructions.
Observation of two (2) of four (4) medication carts revealed one (1) cart had 2 boxes of expired medications.
Source: CMS Care Compare
COMPLIANCE WITH F761
Facilities should take advantage of access to the survey pathway to conduct internal monitoring to address identify and correct any potential areas of non-compliance.
Findings should be presented to the QAPI team and proper actions taken to achieve and maintain compliance.
Checklist for Compliance:
- Review your policies to determine that they reflect the requirements in this regulation.
- Review the orientation program for nurses and medication aides/techs to determine that education on policies/procedures for medication storage and labeling is completed prior to performance of this job duty.
- Review Pharmacy contract to determine their involvement with F761 compliance. Are they providing all services outlined in the contract to maintain compliance (e.g. medication room/cart checks, monitoring emergency kit medications for expiration dates, providing education, etc.)
- Ensure that annual and prn competency skills review of nurses and medication aides/techs include Labeling/Storage of Drugs and Biologicals.
- Establish a process for routine monitoring of compliance using quality assurance tools.
