Finding Description
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, interview, and record review the facility failed to ensure safe practices on storage and handling of the hazardous medications (or HD, Drugs that pose short- or long-term harm upon exposure to human via skin or inhalation) in three out of six medication carts with resident census of 106 based on CDC's (Centers for Disease Control and Prevention, a federal agency leading the science-based, data-driven, service organization that protects the public's health) National Institute for Occupational Safety and Health (NIOSH a federal agency that is part of the CDC; NIOSH conducts research and makes recommendations for the prevention of work-related hazards, injury and illness) guidelines.
The unsafe storage and handling of hazardous medications could pose health risk to staff and residents.
Findings:
1. During a concurrent observation and interview with Licensed Nurse 2 (LN 2), on 8/19/24, at 10:40 AM, in the facility's B2 unit, the Medication Cart 2 stored multiple medications labeled by pharmacy as Hazardous Material with a black and white strip as part of prescription label. Further observation indicated a bottle of drug called megestrol tablet (or Megace, a type of hormone used to treat cancer or stimulate appetite) was stored inside an individual zip lock plastic bag with a large yellow [NAME] to handle safely Observe safety precautions for handling and administration. The medication cart additionally stored other labeled hazardous material drugs including finasteride (a hormone used to treat enlarged prostate) and tofacitinib (a drug belong to class of drugs called tumor necrosis factor blockers, suppressed immune system, and used to treat sever arthritis) that were not contained inside a zip lock bag to prevent the accidental exposure during medication storage and handling. LN 2 stated she was not sure why some bottles were in a hazard bag, and some were not.
2. During a concurrent observation and interview with Licensed Nurse 3 (LN 3), on 8/19/24, at 11 AM, in facility's B2 unit, the Medication Cart 1 stored multiple medications labeled by pharmacy as Hazardous Material on the body of the prescription label. Further observation indicated a bottle of drug called methotrexate in tablet form (a drug used to treat cancer and severe arthritis) was stored inside an individual zip lock plastic bag with a large yellow warning to handle safely Observe safety precautions for handling and administration. The medication cart additionally stored other labeled hazardous material drugs including colchicine tablet (drug used to treat pain associated with [NAME] arthritis), Dilantin (or Phenytoin, used to treat or prevent seizure in the brain; Seizure a disease that caused temporary burst of uncontrolled electrical activity in the brain leading to loss of conscious and body movement) in capsule form, and Liquid bottles of megestrol. LN 3 stated the yellow hazard bag alerted the nurse to use gloves when handling the drug.
3. During an inspection of the facility's Medication Cart 2, at Unit B3, on 8/19/23, at 2:54 PM, accompanied by Licensed Nurse 7 (LN 7), the cart stored a bottle of drug called megestrol tablet stored inside an individual zip lock plastic bag with a large yellow warning to handle safely Observe safety precautions for handling and administration. Further observation indicated storage of hazardous drugs without protective covering including oxcarbazepine bottle of pills (drug used to treat Seizure), Divalproex bottle of pills (or Depakote, a seizure drug also used for treating mood swings) which was not labeled as Hazardous in the body of the label, and Dilantin (or phenytoin drug used to treat seizure) liquid bottles with yellow color spills on the outer surface of the bottle.
In an interview with Director of Nursing (DON), on 8/22/24, at 12:49PM, the DON stated the inconsistent storage of hazardous drugs for safe handling could be pose safety to staff who used the medication cart every day. The DON stated the facility relied on pharmacy to provide consistent method of highlighting the risks and safe containment. The DON stated pharmacy should put all of the hazardous drugs in a protective bag for safe use and handling. The DON stated the nurses should use gloves and whatever needed per policy. The DON stated having hazardous med in the hazard bag helped the nurses to recognize them for safer handling in addition to use of protective gloves.
Review of facility's undated policy, titled Policies and Procedures for Safe handling of Hazardous Drugs, the policy under purpose indicated The policies and procedures within this document are designed to establish safe handling of hazardous drugs (HD's) for the healthcare worker at this facility and to provide guidance to create a safe, consistent method for receipt, storage, preparation, administration and disposal of hazardous drug. The policy on objective section indicated To ensure that the staff at this LTC (Long Term Care) nursing facility handle all hazardous drug according to procedures in this document or to state or federal regulation, whichever is stricter. The policy on receiving section indicated Yellow HD Caution: Hazardous Drug auxiliary labels should be affixed by pharmacy personnel receiving medication to manufacturers packaging prior to transportation to storage. The policy on storage section indicated HDs shall be stored in a manner that prevents spillage .
Review of the Center for Disease Control's National Institute for Occupational Safety and Health (CDC, and NIOSH, a federal agency sets standard of safety in health care) document, titled Managing Hazardous Drug Exposures: Information for Healthcare Settings, dated 4/2023, last accessed on 8/27/24 via https://www.cdc.gov/niosh/docs/2023-130/default.html, the document indicated Workplace exposure to hazardous drugs can result in negative acute and chronic health effects in healthcare workers including adverse reproductive outcomes. Efforts should be made to reduce all worker exposures to hazardous drugs. Occupational exposure to hazardous drugs merits serious consideration, as workers may be exposed daily to multiple hazardous drugs over many years.
Review of the clinical guidelines from American Society of Health-System Pharmacists (ASHP serves as a collective voice on issues related to medication use and public health), titled ASHP Guidelines on Handling Hazardous Drugs, last accessed on 8/24/24 via https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/handling-hazardous-drugs.ashx , the guideline indicated Drugs that have been identified as requiring safe handling precautions should be clearly labeled at all times during their transport, storage, and use . The document indicated NIOSH categorized hazard level to three groups: Group 1 hazard level included antineoplastic drugs (cancer drugs) and Group 2, and Group 3 were non-antineoplastic hazardous drugs including reproductive risks (ability to have healthy children).
Review of the facility provided NIOSH list of hazardous drug, and comparative review of the drug information website called UpToDate Lexidrug, last accessed on 8/27/24, the documents indicated Megace (or megestrol) was on Group 1 of hazardous drugs while tofacitinib, Dilantin, and oxcarbazepine were listed in the Group 2 of hazardous drugs and finasteride and colchicine were listed in the Table 3 of the NIOSH hazardous drug with recommendation Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal.
The unsafe storage and handling of hazardous medications could pose health risk to staff and residents.
Findings:
1. During a concurrent observation and interview with Licensed Nurse 2 (LN 2), on 8/19/24, at 10:40 AM, in the facility's B2 unit, the Medication Cart 2 stored multiple medications labeled by pharmacy as Hazardous Material with a black and white strip as part of prescription label. Further observation indicated a bottle of drug called megestrol tablet (or Megace, a type of hormone used to treat cancer or stimulate appetite) was stored inside an individual zip lock plastic bag with a large yellow [NAME] to handle safely Observe safety precautions for handling and administration. The medication cart additionally stored other labeled hazardous material drugs including finasteride (a hormone used to treat enlarged prostate) and tofacitinib (a drug belong to class of drugs called tumor necrosis factor blockers, suppressed immune system, and used to treat sever arthritis) that were not contained inside a zip lock bag to prevent the accidental exposure during medication storage and handling. LN 2 stated she was not sure why some bottles were in a hazard bag, and some were not.
2. During a concurrent observation and interview with Licensed Nurse 3 (LN 3), on 8/19/24, at 11 AM, in facility's B2 unit, the Medication Cart 1 stored multiple medications labeled by pharmacy as Hazardous Material on the body of the prescription label. Further observation indicated a bottle of drug called methotrexate in tablet form (a drug used to treat cancer and severe arthritis) was stored inside an individual zip lock plastic bag with a large yellow warning to handle safely Observe safety precautions for handling and administration. The medication cart additionally stored other labeled hazardous material drugs including colchicine tablet (drug used to treat pain associated with [NAME] arthritis), Dilantin (or Phenytoin, used to treat or prevent seizure in the brain; Seizure a disease that caused temporary burst of uncontrolled electrical activity in the brain leading to loss of conscious and body movement) in capsule form, and Liquid bottles of megestrol. LN 3 stated the yellow hazard bag alerted the nurse to use gloves when handling the drug.
3. During an inspection of the facility's Medication Cart 2, at Unit B3, on 8/19/23, at 2:54 PM, accompanied by Licensed Nurse 7 (LN 7), the cart stored a bottle of drug called megestrol tablet stored inside an individual zip lock plastic bag with a large yellow warning to handle safely Observe safety precautions for handling and administration. Further observation indicated storage of hazardous drugs without protective covering including oxcarbazepine bottle of pills (drug used to treat Seizure), Divalproex bottle of pills (or Depakote, a seizure drug also used for treating mood swings) which was not labeled as Hazardous in the body of the label, and Dilantin (or phenytoin drug used to treat seizure) liquid bottles with yellow color spills on the outer surface of the bottle.
In an interview with Director of Nursing (DON), on 8/22/24, at 12:49PM, the DON stated the inconsistent storage of hazardous drugs for safe handling could be pose safety to staff who used the medication cart every day. The DON stated the facility relied on pharmacy to provide consistent method of highlighting the risks and safe containment. The DON stated pharmacy should put all of the hazardous drugs in a protective bag for safe use and handling. The DON stated the nurses should use gloves and whatever needed per policy. The DON stated having hazardous med in the hazard bag helped the nurses to recognize them for safer handling in addition to use of protective gloves.
Review of facility's undated policy, titled Policies and Procedures for Safe handling of Hazardous Drugs, the policy under purpose indicated The policies and procedures within this document are designed to establish safe handling of hazardous drugs (HD's) for the healthcare worker at this facility and to provide guidance to create a safe, consistent method for receipt, storage, preparation, administration and disposal of hazardous drug. The policy on objective section indicated To ensure that the staff at this LTC (Long Term Care) nursing facility handle all hazardous drug according to procedures in this document or to state or federal regulation, whichever is stricter. The policy on receiving section indicated Yellow HD Caution: Hazardous Drug auxiliary labels should be affixed by pharmacy personnel receiving medication to manufacturers packaging prior to transportation to storage. The policy on storage section indicated HDs shall be stored in a manner that prevents spillage .
Review of the Center for Disease Control's National Institute for Occupational Safety and Health (CDC, and NIOSH, a federal agency sets standard of safety in health care) document, titled Managing Hazardous Drug Exposures: Information for Healthcare Settings, dated 4/2023, last accessed on 8/27/24 via https://www.cdc.gov/niosh/docs/2023-130/default.html, the document indicated Workplace exposure to hazardous drugs can result in negative acute and chronic health effects in healthcare workers including adverse reproductive outcomes. Efforts should be made to reduce all worker exposures to hazardous drugs. Occupational exposure to hazardous drugs merits serious consideration, as workers may be exposed daily to multiple hazardous drugs over many years.
Review of the clinical guidelines from American Society of Health-System Pharmacists (ASHP serves as a collective voice on issues related to medication use and public health), titled ASHP Guidelines on Handling Hazardous Drugs, last accessed on 8/24/24 via https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/handling-hazardous-drugs.ashx , the guideline indicated Drugs that have been identified as requiring safe handling precautions should be clearly labeled at all times during their transport, storage, and use . The document indicated NIOSH categorized hazard level to three groups: Group 1 hazard level included antineoplastic drugs (cancer drugs) and Group 2, and Group 3 were non-antineoplastic hazardous drugs including reproductive risks (ability to have healthy children).
Review of the facility provided NIOSH list of hazardous drug, and comparative review of the drug information website called UpToDate Lexidrug, last accessed on 8/27/24, the documents indicated Megace (or megestrol) was on Group 1 of hazardous drugs while tofacitinib, Dilantin, and oxcarbazepine were listed in the Group 2 of hazardous drugs and finasteride and colchicine were listed in the Table 3 of the NIOSH hazardous drug with recommendation Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal.