Wiregrass Medical Center

“PATIENT CARE POLICIES CFR(s): [The policies include the following:] (iv) Rules for the storage, handling, dispensation, and administration of drugs and biologicals. These rules must provide that there is a drug storage area that is administered in accordance with accepted professional principles, that current and accurate records are kept of the receipt and disposition of all scheduled drugs, and that outdated, mislabeled, or otherwise unusable drugs are not available for patient use. This Standard is not met as evidenced by: 41623 Based on observations, facility policy and procedure, Ryanodex Tools and Resources for Malignant Hyperthermia, Association of Perioperative Registered Nurses (AORN) article, and interviews, it was determined the facility failed to ensure medications were stocked at recommended levels and anesthesia medications were stored properly. This deficient practice did affect one of one observation of surgery including Patient Identifier # 34, and had the potential to affect all patients receiving surgery at this facility. Findings include: Facility Policy: Malignant Hyperthermia Policy Number: Not Listed Revised: 11/20/24 ...Purpose: To provide a well coordinated, rapid, effective response by the surgical team when a hypermetabolic crisis occurs... I. Malignant Hyperthermia is a life threatening complication of the surgical patient that may be triggered by drugs commonly used in anesthesia (i.e., ... succinylcholine). .. IV. Ryanodex and patient cooling are used to reverse the hypermetabolic process... Pharmacy: I. Will provide adequate supply of Ryanodex for Malignant Hyperthermia crisis. Web Article: Ryanodex Tools and Resources for Malignant Hyperthermia Copyright: 2025 Eagle Pharmaceuticals, Inc. ...6. How much Ryanodex should we stock? MHAUS (Malignant Hyperthermia Association of the United States) recommends stocking a minimum of 700 mg (milligrams) dantrolene sodium, which is supplied in only 3 (three) vials of Ryanodex (dantrolene sodium) for injectable suspension (in contrast to the 36 vials required to obtain 700 mg with other dantrolene sodium IV (intravenous) products)... AORN Article: Patient Safety Published: 12/3/2013 ...3. In and Out: Succinylcholine and Rocuronium are to be refrigerated, but once removed, they can be stored at room temperature for specific periods of time (14 days for Succinylcholine; 60 days for Rocuronium, 28 days for opened Rocuronium)... Once they’re removed from refrigeration, they should be clearly marked with either the manufacturer’s expiration date, or the appropriate date based on when they were removed, whichever comes first. They shouldn’t be re-refrigerated... 1. A tour of the Surgery Department was conducted on 2/18/25 at 2:00 PM with Employee Identifier # 12, Emergency Department Director. Two Ryanodex 250 mg vials were observed stored in the Pyxis medication storage unit. EI # 12 stated the hospital currently stocks Ryanodex for the treatment of malignant hyperthermia and there were no other vials available in the hospital. An interview was conducted on 2/21/25 at 9:00 am with EI # 14, Pharmacist, who confirmed the facility failed to stock the recommended amount of medication for the treatment of Malignant Hypertention. 2. PI # 34 presented to the Surgery Department on 2/19/25 for an Esophagogastroduodenoscopy with Dilation. An observation of the surgical procedure was conducted on 2/19/25 at 8:00 AM. At 8:05 AM, EI # 17, Registered Nurse removed a tray containing Anesthesia medications including two 10 milliliter (ml) vials of Succinylcholine 200 mg/ml and two 5 ml vials of Rocuronium Bromide 50 mg/ml from the refrigerated medication storage unit and handed the medications to PI # 11, Certified Registered Nurse Anesthetist. Review of PI # 34’s Anesthesia Record dated 2/19/25 revealed Anectine (Succinylcholine) 160 mg was given at 8:15 AM. At 9:30 AM, the medication tray containing one vial of Succinylcholine and two vials of Rocuronium Bromide was returned to the refrigerated medication storage unit per EI # 17. An interview was conducted on 2/21/25 at 9:00 AM with EI # 14, who confirmed the Succinylcholine and Rocuronium were not labeled with the date they were removed from refrigeration and confirmed the vials were not to be re-refrigerated.”

“K3 Building: 0101 K6 Plan Approval:1954/1963/1973/1995 K7 Survey Under: 2012 Existing K8 HOSP Generators: Two Generac Diesel: one 175 kW and one 275 kW (both installed 2023) FACP: Harrington HS3200 (installed 2015) Locking Devices: None Beds: 25 Census: 9 Type of Structure: 1954 original building one story unprotected wood frame, Type V(000). 1963 single story addition (500 Hall) protected noncombustible, Type II(111). 1973 single story addition (600 Hall) protected noncombustible, Type II(222). 1995 single story addition protected noncombustible, Type II(222). The facility has a complete automatic sprinkler system. During an initial conversion survey conducted on this date, the requirements of 42 CFR, Subpart 482.41 were not met as evidenced by the following deficiencies of the 2012 NFPA 101 Life Safety Code (LSC), the 2012 NFPA 99 Health Care Facilities Code and the standards referenced by these codes, as observed by the LS Surveyors while accompanied by the facility maintenance personnel.”

“Sprinkler System - Maintenance and Testing CFR(s): NFPA 101 Sprinkler System - Maintenance and Testing Automatic sprinkler and standpipe systems are inspected, tested, and maintained in accordance with NFPA 25, Standard for the Inspection, Testing, and Maintaining of Water-based Fire Protection Systems. Records of system design, maintenance, inspection and testing are maintained in a secure location and readily available. a) Date sprinkler system last checked _____________________ b) Who provided system test ____________________________ c) Water system supply source __________________________ Provide in REMARKS information on coverage for any non-required or partial automatic sprinkler system. 9.7.5, 9.7.7, 9.7.8, and NFPA 25 This Standard is not met as evidenced by: 42853 Based on observation and review of documentation, the facility failed to maintain the automatic dry sprinklers per the requirements of: 2012 NFPA 101, 19.3.5.1, and 9.7.5 2011 NFPA 25, 5.3.1.1.1.6 This deficiency affects 4 of 4 dry sprinklers. Findings include: During a tour of the facility, the facility failed to provide documentation that the 4 dry sprinklers installed in 2003, located in the kitchen walk-in cooler (2) and freezer (2) had been replaced within 10 years of installation. A member of the maintenance staff and the administrator were present when this deficiency was identified.”

“Electrical Systems - Essential Electric Syste CFR(s): NFPA 101 Electrical Systems - Essential Electric System Maintenance and Testing The generator or other alternate power source and associated equipment is capable of supplying service within 10 seconds. If the 10-second criterion is not met during the monthly test, a process shall be provided to annually confirm this capability for the life safety and critical branches. Maintenance and testing of the generator and transfer switches are performed in accordance with NFPA 110. Generator sets are inspected weekly, exercised under load 30 minutes 12 times a year in 20-40 day intervals, and exercised once every 36 months for 4 continuous hours. Scheduled test under load conditions include a complete simulated cold start and automatic or manual transfer of all EES loads, and are conducted by competent personnel. Maintenance and testing of stored energy power sources (Type 3 EES) are in accordance with NFPA 111. Main and feeder circuit breakers are inspected annually, and a program for periodically exercising the components is established according to manufacturer requirements. Written records of maintenance and testing are maintained and readily available. EES electrical panels and circuits are marked, readily identifiable, and separate from normal power circuits. Minimizing the possibility of damage of the emergency power source is a design consideration for new installations. 6.4.4, 6.5.4, 6.6.4 (NFPA 99), NFPA 110, NFPA 111, 700.10 (NFPA 70) This Standard is not met as evidenced by: 42853 Based on review of documentation, the facility failed to maintain the diesel generator’s fuel per the requirements of: 2012 NFPA 99, 6.5.1, 6.4.4.1.1.3, and 6.5.4.2 2010 NFPA 110, 1.3, and 8.3.8 This deficiency affects 2 of 2 generators. Findings include: During a tour of the facility, the facility failed to provide documentation that a fuel quality test was performed within the past twelve months using tests approved by ASTM standards. A member of the maintenance staff was present when this deficiency was identified.”