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333 N BYRON BUTLER PKWY

PERRY, FL 32348

OPERATING ROOM POLICIES

Tag No.: A0951

Based on observations, interviews and facility record review, the facility failed to ensure policies and procedures to reflect current surgical service practices, not limited to, but included the use of Immediate-Use Steam Sterilization (IUSS) and the facility's process for ensuring the monitoring and tracking of the endoscope reprocessing process for each patient.

The findings included:

On 03/19/2019 at approximately 2:00pm, the facility's endoscopy suite was toured, along with the scope reprocessing room, accompanied by the Director of Surgical Services. The facility utilizes an automated endoscope reprocessor using Rapicide, a high level disinfectant solution. Per interview with Staff Member M, a Surgical Technician/Endoscopy Technician, indicated that the Rapicide is checked for efficacy after the used endoscope had been run through the automated scope reprocessor. The facility does not document the efficacy once completed. There is, however, patient information that is logged into the automated reprocessor when the scope is placed in the bin for high level disinfection, but the facility is not currently able to demonstrate any measures implemented to track and/or trace the use of the endoscope used for patients that might have had a potentially infectious outcome. The facility was not able to provide a current policy and procedure describing the current process for ensuring the proper cleaning and disinfections of endoscopes and of those procedures/measures used to track the use of the endoscope from patient to patient following high level disinfection.

On 03/20/2019 at approximately 10:00am, a tour of the facility's central reprocessing area was conducted with the assistance of the Director of Surgical Services. The facility's process for sterilization of surgical instruments was reviewed with Staff Member N, a Surgical Technician. Staff Member N, stated that occassionally the facility performs flash sterilization - and that IUSS is, from her understanding, the same thing. Staff Member N, stated that flash sterilization is occasionally performed at the facility. After some discussion and explanation of the difference between flash sterilization and IUSS, it was determined that IUSS is seldom performed in the surgery department. However, the facility has no policy that clearly defines IUSS, or the difference/uses between flash sterilization and IUSS. A review of the random central reprocessing documents identified the use of 'Flash Sterilization' infrequently - unable to determine any IUSS at this time.

REQUIRED OPERATING ROOM EQUIPMENT

Tag No.: A0956

Based on observations, interviews and facility record review, the facility failed to ensure that emergency equipment was in date and readily available for emergencies occurring in the Surgical Services Department - for 2 of 3 emergency carts inspected in the Surgical Services Department.

The findings included:

On 03/19/2019 at approximately 1:45pm, a tour of the facility Surgical Services Department was conducted with the assistance of the Director of Surgical Services. During the tour an inspection of the facility Emergency Crash Cart was conducted. The Surgical Services Director (SSD) stated the crash cart is checked every day the facility has surgery cases. The SSD presented a log book with an "Emergency Crash Cart Checklist" for each month. A review of the March 2019 checklist indicated that daily checks included: "Cart locked, O2 cyclinder >500 psi (O2 wrench), backboard, CPR Resuscitation Forms, Lead patches, Defib Load Test, External Pacer Functioning, Pacer Pad, if applicable (check exp. date), pacer cable, if applicable, and Manual Blood pressure cuff (adult)" - should be checked daily. An inspection of the cart revealed expired electrode pads with expiration date of 01/2019. There was no oxygen on the crash cart. The SSD stated that part of the daily check was to ensure the electrode pads were 'in date,' and stated that they don't keep portable oxygen on the cart any longer because the rooms are each equipped with wall oxygen She stated if they need a portable oxygen tank, one could be obtained from the bay directly across from the crash cart. The bay directly across from the crash cart, revealed oxygen tanks stored back behind stretchers and other equipment and was not readily accessible.

The SSD stated that the facility does perform general anesthesia and has a Malignant Hyperthermia cart. An inspection of the Malignant Hyperthermia cart, stored in the room for surgical central supply, revealed a log containing a "Malignant Hyperthermia Cart Checklist." The checklist indicated it had been checked last on 03/01/2019. The same sheet had notations of 'checks occurring' from 11/15/2018 to current. Under the heading of "Drugs" - "Need" indicated Dantrolene (a muscle relaxant used in a rare, life-threatening disorder triggered by general anesthesia) - "36" [Hospitals are recommended to keep a minimum stock of 36 Dantrolene vials totaling 720mg, sufficient for a 70-kg person.] Under the heading of "Here" was noted to either be 34, 35 or 36, the writing was illegible [photo documentation obtained.] With the assistance of the SSD, the Malignant Hyperthermia cart was inspected. The emergency cart contained a total of only 24 vials of Dantrolene, not the 34-35-36 as noted on the checklist. The SSD did not know why there was a discrepancy, where the remaining 12 were located and thought maybe pharmacy had the remaining vials. The SSD stated she would check into it. There were no surgical cases performed on 03/19/2019.

On 03/20/2019 at approximately 09:00am, an interview was conducted with the SSD regarding the Dantrolene discrepancy. She stated she was able to locate the remaining vials of Dantrolene. She said, that 6 vials were stored in the Intensive Care Unit and 6 vials were stored in the Emergency Department. All of her staff have now been informed as to the location of all the vials, in the event a Malignant Hyperthermia crisis occurs. She confirmed that her staff, along with the CRNAs (Certified Registered Nurse Anesthetists) were not aware of where the other 12 vials of Dantrolene were stored [other than what was in the Malignant Hyperthermia cart.] "They are now though," she stated

A review of the facility's policy and procedure entitled "Code/Crash Cart: Location and Checks", last reviewed 08/28/2018, indicates "a. Code cart shall be checked at a minimum of every 24 hours and after each code when they have been restocked by either Pharmacy or Central processing. Checks must be documented by daily signature when drawer(s) are replaced after use, expiration or broken seal. b. A licensed staff member/Charge nurse must review the external contents, expiration dates and placement of items without breaking the lock seal on the drawer. All trays shall be marked with an expiration date. The drawers/trays shall not be used beyond the expiration date. All medication/supplies in the drawers shall have an expiration date that is equal to or greater than the drawer/tray expiration date. c. The Charge Nurse and or designee will be responsible for performing the check. Team members may be assigned to take turns performing the check. D. The check includes the crash cart, oxygen cylinder levels, defibrillator, and documenting compliance of crash cart checklist. f. Defibrillator load checks will be performed every shift per manufacturer's guidelines. Guidelines: a. The cart is inspected for the following External contents: i. portable monitor/defibrillator unit with charged batteries, multi-function cable, multifunction pads (Ped, adult or both as appropriate), pacer cable (if pacer capable machine), EKG electrodes, appropriate sized paddles (adult, pediatric), monitor paper, blood pressure cuff (adult carts), SpO2 prober, Resuscitation records; Emergency Crash Cart Check Sheet; List of Cart Contents; Cardiopulmonary Resuscitation PI form, Cardiac Board, Numbered lock is intact."

A review of the facility's policy and procedure entitled "Management of Patient with Malignant Hyperthermia" to outline the proper procedure for the management of a patient with malignant hyperthermia. The P&P indicates to "administer Dantrium IV as soon as possible .... A large quantity may be necessary, sufficient supply must be available. Vials are available in the Surgical Services Department, in the Malignant Hyperthermia cart. Additional vials will be obtained by Pharmacy from outside sources, if needed.
Malignant hyperthermia, although rare, does exist and prompt recognition and intervention are crucial Dantrium is kept on the Malignant Hyperthermia cart. Large quantities of sterile water for reconstitution will be kept near the Dantrium in the Malignant Hyperthermia cart. Other necessary drugs will be found in the Malignant Hyperthermia cart.

A review of the facility's policy and procedure regarding Malignant Hyperthermia, failed to identify the location of where all 36 vials were located/stored.