Welch Community Hospital

“SECURE STORAGE CFR(s): 482.25(b)(2)(i) §482.25(b)(2)(i) - All drugs and biologicals must be kept in a secure area, and locked when appropriate. This Standard is not met as evidenced by: 38282 Based on observation, document review, and staff interview, it was determined that the hospital failed to store all medications in a secure locked area in the emergency room (ER) and intensive care unit (ICU). This failure has the potential to affect all patients receiving treatment in the ICU and ER. Findings are as follows: An observation was conducted on 03/04/24, starting at 3:20 p.m. of the emergency room (ER), accompanied by Employee #1 and Employee #2. The ER’s medication room was located behind a keypad locked door in the main hallway; and the door was easily accessible to all staff, patients, and visitors. At the time of the observation, the door to the medication room was standing open and the room was left unattended. There were no staff inside or near the medication room. The Schedule II, III, IV, and V narcotics were located inside a locked box on the wall inside the medication room; and the key to the box was hanging on a hook attached to the left side of the box. The other medication was stored in individual labeled plastic drawers with red plastic zip tie closures, some of which were missing. An observation was conducted on 03/04/24 starting at 11:05 a.m. of the intensive care unit (ICU), accompanied by Employee #1 and Employee #3. There was no locked medication room. The ICU’s medication was being stored on open shelves on the right-side wall of the unit, visible to all staff, visitors, and patients. The medication was stored on the shelves in individual labeled plastic drawers with red plastic zip tie closures. The current patients’ oral medications were kept in labeled plastic drawers that had no plastic zip tie closures. There were two (2) bags of intravenous antibiotics labeled with patient names lying on top of a separate cart in front of the shelves. The Schedule II, III, IV, and V narcotics were located inside a locked box on the wall to the left of the medication shelves; and the key to the box was with a nurse. The patient area, separated by curtains, was located on the left side of the nurses station. There was one (1) private patient room located between the open medication shelves and the nurses station. A policy titled: “Medication Management - Storage;” review date: 02/2023; stated, in part: “All drugs and biologicals must be secure; controlled substances must be locked within a secure area ... Generally, all drugs should be kept in a locked room or container ... All drugs and biologicals must be stored in a manner to prevent access by non-authorized individuals ... If unauthorized personnel could gain access to the drugs or biologicals stored in an area, the hospital is not in compliance with the requirement to store all drugs and biologicals in a locked storage area.” An interview was conducted on 03/04/24 at 3:25 p.m. with Employee #2 regarding the open medication room door. Employee #2 stated, “The ER medication room should always be locked, and the nurses have the code to the keypad lock on the door. We keep the key to the narcotics box hanging on the box, so the staff have easy access to the narcotics. When we need a medication, we break the red zip tie and get it. The pharmacy replaces the medication in the drawers with broken red zip ties.” Employee #2 then concurred that if the door is left open and the room unattended, anyone in the ER would have access to the medications. An interview was conducted on 03/05/24, at 11:12 a.m. with Employee #3 regarding medication storage in ICU. Employee #3 stated, “We don’t have a locked medication room. We have always stored our medication on the open shelves. The narcotics are locked and secure. We have never had a problem.” An interview was conducted on 03/05/24, at 11:15 a.m. with Employee #1 regarding the medication storage in ICU. Employee #1 stated, “The medication storage in ICU is not ideal, as it is visible and accessible to everyone entering the unit. We have never addressed it because it has always been done this way.” An interview was conducted on 03/05/24, at 1:45 p.m. with Employee #4. Regarding the ER, Employee #4 stated: “When the ER uses a medication, the red zip tie is broken, and the medication is removed from the drawer. The pharmacy checks the drawers for the broken zip ties, counts the remaining medications, and replaces them. The ER is not good with compliance. The door is often found open, and sometimes there are discrepancies in the narcotics documentation that we have to track down and account for. It’s not that staff are taking them; I think sometimes they are just really busy and forget to document. We have to do a lot of education and retraining with ER staff. An electronic dispensing system would force them to be in compliance.” Regarding the ICU, Employee #4 stated, “I realize the medication storage area is not ideal, but we’ve always done it that way. There is no locked medication area on the unit, and medication is out in the open. We do have the red zip ties on the standard stock, but the patient medicines are not locked up. The narcotics are in a locked box, and the ICU staff are good with compliance of documenting narcotics.””

“CONTROLLED DRUGS KEPT LOCKED CFR(s): 482.25(b)(2)(ii) Drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 must be kept locked within a secure area. This Standard is not met as evidenced by: 38282 Based on observation, document review, and staff interview, the hospital failed to ensure that all Schedules II, III, IV, and V narcotics were locked within a secure area in the ER. This failure has the potential to affect all patients receiving treatment in the ER. Findings are as follows: An observation was conducted on 03/04/24 starting at 3:20 p.m. in the emergency room (ER), accompanied by Employee #1 and Employee #2. The ER’s medication room was located behind a keypad locked door in the main hallway; and the door was easily accessible to all staff, patients, and visitors. At the time of the observation, the door to the medication room was standing open and the room was left unattended. There were no staff inside or near the medication room. The Schedule II, III, IV, and V narcotics were located inside a locked box on the wall inside the medication room; and the key to the box was hanging on a hook attached to the left side of the box. The other medication was stored in individual labeled plastic drawers with red plastic zip tie closures, some of which were missing. A review of the policy, titled “Medication Management - Storage” dated 02/2023, stated, in part, “All drugs and biologicals must be secure; controlled substances must be locked within a secure area ... Generally, all drugs should be kept in a locked room or container ... All drugs and biologicals must be stored in a manner to prevent access by non-authorized individuals ... If unauthorized personnel could gain access to the drugs or biologicals stored in an area, the hospital is not in compliance with the requirement to store all drugs and biologicals in a locked storage area.” An interview was conducted on 03/04/24, at 3:25 p.m. with Employee #2 regarding the open medication room door. Employee #2 stated, “The ER medication room should always be locked, and the nurses have the code to the keypad lock on the door. We keep the key to the narcotics box hanging on the box, so the staff have easy access to the narcotics. When we need a medication, we break the red zip tie and get it. The pharmacy replaces the medication in the drawers with broken red zip ties.” Employee #2 then concurred that if the door is left open and the room unattended, anyone in the ER would have access to the medications, including the narcotics. An interview was conducted on 03/05/24, at 1:45 p.m. with Employee #4. Regarding the ER, Employee #4 stated, “When the ER uses a medication, the red zip tie is broken, and the medication is removed from the drawer. The pharmacy checks the drawers for the broken zip ties, counts the remaining medications, and replaces them. The ER is not good with compliance. The door is often found open, and sometimes there are discrepancies in the narcotics documentation that we have to track down and account for. It’s not that staff are taking them; I think sometimes they are just really busy and forget to document. We have to do a lot of education and retraining with ER staff. An electronic dispensing system would force them to be in compliance.””

“FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE CFR(s): 482.41(c)(2) Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. This Standard is not met as evidenced by: 40165 Based on observation, and staff interview it was determined the facility failed to maintain the equipment was maintained to ensure an acceptable level of safety and quality. Findings include: a) Observation on 3/5/24 revealed a large piece of equipment (sterilizer) in the Sterilization room, missing protective panels around the machine. b) During an exit interview on 3/5/24 at 3:30 p.m. with the Maintenance Director and The CEO the above findings were verified.”

“Building Services - Other CFR(s): NFPA 101 Building Services - Other List in the REMARKS section any LSC Section 18.5 and 19.5 Building Services requirements that are not addressed by the provided K-tags, but are deficient. This information, along with the applicable Life Safety Code or NFPA standard citation, should be included on Form CMS-2567. This Standard is not met as evidenced by: 40165 Based on observation, and staff interview it was determined the facility failed to maintain large building equipment within the facility. Facility census 5. Findings include: a) Observation on 3/5/24 revealed a large piece of equipment (sterilizer) in the Sterilization room, missing protective panels around the machine. b) During an exit interview on 3/5/24 at 3:30 p.m. with the Maintenance Director and The CEO the above findings were verified.”