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Based on interview, observation and record review that the Critical Access Hospital (CAH) failed to ensure necessary emergency medication was available in the event of a life threatening situation. This failure placed all patients at risk of harm or serious complications when the medication is not available.

Refer to Tag 202

Based on interview, observation and record review the Critical Access Hospital (CAH) failed to ensure necessary emergency medication was readily available for use in the event of a life threatening situation. This failure placed all patients at risk of harm, serious complications or death when the medication is not available.

Findings Include:

During interview on 9/27/2016 at 10:35 a.m. with Pharmacist Staff G, it was discovered that Succinylcholine (a medication used to paralyze a patient to allow intubation in an emergent situation) was on the hospital's list of available medications. Succinylcholine could potentially cause Malignant Hyperthermia (a life threatening emergent situation). When asked if the CAH had Dantrolene (an emergency drug used to treat malignant hyperthermia) and sterile water to reconstitute the medication, the answer was "no", they did not have any Dantrolene in the CAH.

Pharmacist staff G interviewed on 9/27/2016 at 1:15 PM. S/he said that the need to have Dantrolene was researched and s/he agreed that the CAH needed to have it available. Pharmacist Staff G informed Administrative staff C of the need to order the Dantrolene. S/he had contacted their supplier and the Dantrolene would probably be there by Thursday 9/29/2016.

- On 9/27/2016 at 5:15 PM, Pharmacist Staff G and Administrative Staff C presented a plan of action to remove the life threatening situation. The hospital pharmacy quarantined all succinylcholine and removed it from use. An alternative medication was available for use for rapid sequence intubation. The Chief of staff, all providers and nursing staff were notified of the quarantined Succinylcholine. The CAH has ordered 36 vials Dantrolene and sterile water for reconstitution, which is now due to arrive on 9/28/2016. The succinylcholine will remain quarantined until Dantrolene arrives.

- On 9/28/2016 at 1:00 PM Pharmacist Staff G and Administrative Staff C presented 36 vials of Dantrolene 20mg that had just arrived and the sterile water for dilution.

- Document titled Plan of Action reviewed on 9/28/2016 at 1:05 PM directed: ...1:00 PM UPS delivered the drop ship order with 36 vials of Revonto (dantrolene) 20mg vials. Revonto was added into the formulary and will be handled and tracked according to our outdated medication policy. Malignant Hyperthermia kit was assembled with diluent, dantrolene, and 60 ml syringes plus instructions for using med, managing situation, and where the other necessary supplies are located. This was then loaded into the Emergency Room (ER) Pyxis (an automated machine for storing and distributing medications) where the succinylcholine is stored. This is the only place the succinylcholine will be used.

- Pharmacist staff G presented document dated 9/28/2015 at 2:45 PM directed: This issue will be placed on pharmacy's QA (Quality Assurance) calendar to monitor and ensure dantrolene will always be stocked and available if succinylcholine is on the formulary and in the building. The pharmacy director will be responsible for creating and monitoring this QA project.

Policy titled GUIDELINES FOR MANAGEMENT OF PATIENT WITH MALIGNANT HYPERTHERMIA, EFFECTIVE 4/13/2007 reviewed on 9/28/2016 at 12:20 PM directed ...if malignant hyperthermia is suspected ... ...Notify the Pharmacy of the clinical diagnosis and picture. Administer Dantrium (dantrolene sodium) IV as soon as possible. The recommended dosage is from 1-10mg per kg of body weight. As a large quantity may be necessary, a sufficient supply must be available ...

Based on observation, policy review, and staff interview the CAH failed to remove outdated sterile medical supplies from patient care areas in two of three Emergency Department (ED) rooms, and in two of two adult crash carts and one of one pediatric crash cart. This deficient practice had the potential for staff to use outdated or non-sterile medical supplies for direct patient care.

Findings include:

- Observation in Emergency room #1 crash cart on 9/27/2016 at 9:00 AM revealed thirteen outdated blunt fill needles (a needle that reduces needle stick injury through their blunt-bevel design), one outdated CO2 (carbon dioxide) detector, one outdated intravenous start kit and one outdated 18 gauge intravenous needle.

- Observation of storage drawers in emergency room #1 on 9/27/2016 at 9:15 AM revealed two outdated culture tubes and two packages of Lemon Glycerin swabs outdated.

- Observation of Emergency Room #2 Pediatric crash cart 9/27/2016 at 9:30 AM revealed: one outdated Infant manual resuscitator.

- Observation of Emergency Room #2 on 9/27/2016 at 9:40 AM revealed the white Broselow bag (color coded pediatric emergency treatment system) contained one outdated intravenous start kit.

- Observation of Emergency Room #2 medical supply cabinet on 9/27/2015 at 9:50 revealed one outdated Kings tube, (a device used as an alternative to endotracheal intubation for advanced airway management) outdated suture kits and one outdated vial of Mastisol (a non-water soluble liquid adhesive that has been clinically proven to keep your tapes, dressings and devices secure for an extended period of time.)

Interview with RN staff R on 9/27/2016 at 10:10 AM verified and removed outdated emergency room and crash cart supplies. S/he reported the nurse's check for outdated supplies monthly and they have a check list to follow. Check list had items listed and the date the supplies outdate.

- Observation of Crash Cart located in patient room #3 on 9/28/2016 at 9:25 AM revealed one outdated Infant manual resuscitator and two packages of Pediatric Zoll monitor pads (pad placed on a child's chest that has a wire attached to a heart monitor) outdated.

Interview with Administrative staff C on 9/28/2016 at 9:45 verified outdated supplies on crash care and supplies removed. S/he reported the Pediatric Zoll monitor have been on back order from the supplier.

Review of policy titled Supply/Stock Rotation on 9/28/2016 at 2:00 PM directed ...Any supply/stock items discovered that have reached or are near expiration will be pulled and processed according to policy ...