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LAFAYETTE, LA null

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on record review and interview the hospital failed to ensure the right of the patient to receive care in a safe setting as evidenced by not having available surgical services at night (after scheduled surgeries were completed), on the weekends, or holidays. The hospital, which provided primarily surgical services, reported a process in which an admitted patient, needing emergent surgical interventions during times the surgery department was closed, would be transferred to Hospital A.
Findings:

Review of the Operating Agreement (provided as the Governing Body Bylaws), Medical Staff Bylaws, (Medical Staff) Organization and Function Policy, and (Medical Staff) Rules and Regulations revealed no reference to Surgical services not provided during certain times/days/dates or transfer of admitted patients needing surgical intervention during the night, weekends, or holidays.

Review of an overnight hospital census from October 1, 2013 through April 22, 2014 revealed three (3) days in which there was an overnight patient in the hospital on the weekend. Further review revealed no overnight census on the following days:
November 27 and 28, 2013 (Thanksgiving Day-November 28)
December 24 and 25, 2013 (Christmas Eve and Christmas Day)
December 31, 2013 and January 1, 2014 (New Year ' s Eve and New Year ' s Day)
March 3, 2014 and March 4, 2014 (Lundi Gras and Mardi Gras, traditionally celebrated in south Louisiana)
April 18, 19, or 20, 2014 (Good Friday and Easter weekend).

Review of Nurse Staffing Forms for 4/13/14 through 4/22/14, completed by hospital administration, revealed that the Pre-/Post-Operative Unit was closed 4/18/14, 4/19/14, and 4/20/14. Further review of the OR (Operating Room) and PACU staffing forms revealed "Closed" was written in for 4/18, 19, and 20/14. The number of staff on the OR and the PACU units on 4/18, 19, and 20/14 days were blank or marked "Closed".

In an interview 4/24/14 at 10:30 a.m. S8RNSurgeryManager reported that surgery was closed on weekends, holidays, and weekdays after surgeries were completed and staff went home. When asked about the procedure should a patient in the hospital developed an emergency or complication that required emergent surgery, S8RNSurgeryManager responded that the patient would be transferred to Hospital A. S8RNSurgeryManager confirmed that surgery staff were not on call during the "closed" hours.

In an interview 4/23/14 at 9:10 a.m. S2DON reported that no staff for surgery services was on call at night (after the scheduled surgeries were completed for the day), on the weekends, or on holidays. S2DON verified that almost all of the hospital's patients were surgical patients. When asked what the hospital's process was for treating patients that encountered a complication or emergency that would require immediate surgery, she reported that the patient would be transferred to Hospital A.

OPERATING ROOM POLICIES

Tag No.: A0951

Based on observation, record review, and interview the hospital failed to ensure surgical services were provided, consistent with needs and resources, when a policy for management of Malignant Hypertension (MH) (a potentially fatal, inherited disorder usually associated with the administration of certain general anesthetics and/or the drug succinylcholine) wasn't written, implemented, and enforced in accordance with acceptable standards of practice as outlined by Malignant Hyperthermia Association of the United States (M.H.A.U.S.). This failed practice was evidenced by only 12 vials of Dantrolene on hand, in the facility, as opposed to the recommended minimum 36 vials. This failed practice had the potential to affect all patients receiving general anesthetics and/or the drug succinylcholine.
Findings:

Review of a website for M.H.A.U.S. (www.mhaus.org/ ) revealed, in part, that Dantrolene should be kept in or very close to the operating room, so that it would be available immediately if MH occurs. A supply of sterile water for injection USP (without a bacteriostatic agent) should be kept nearby to mix with Dantrolene before injection. The recommended number of vials of Dantrolene is 36 vials. An explanation is provided for the rationale of 36 vials as opposed to 12 or 24 with regards to amount needed for initial stabilization and treatment while more vials were being acquired to continue treatment, if needed. The recommendations noted that 36 vials of Dantrolene must be available for all anesthetizing locations within 10 minutes of the decision to treat for MH, and must be available in all locations where MH trigger agents are used.

Review of hospital policy VII-A.14, titled Malignant Hyperthermia, provided by S2DON as current, revealed, in part the following:
I. Statement of Purpose: To provide a well-coordinated, rapid effective response by the surgical al team when a hypermetabolic crises occurs
II. General Information:
...D. Dantrolene sodium and patient cooling are used to reverse the hypermetabolic process of malignant hyperthermia.
III. Procedure:
...D. Dantrolene sodium is stocked on the MH Cart. 10 vials of Dantrolene Sodium will be kept on the cart.
E....An MH Cart checklist hangs on the side of the MH Cart....
" L. The Proposed Protocol for Management of Malignant Hyperthermia prepared by Malignant Hyperthermia Association of the United States ..., on top of the MH Cart, and the AORN [Association of Operating Room Nurses] Malignant Hyperthermia Guidelines, hanging on the side of the MH cart, will be available for referral in the therapeutic treatment of a patient with a malignant hyperthermia episode..."

Review of a hospital Malignant Hyperthermia Cart Checklist revealed, in part, under "3rd Drawer" Dantrium 20 mg (milligrams) # 6, and under "5th Drawer" Dantrolene (box) # 5.

During a tour of the surgical areas 3/22/14 at 1:30 p.m. an observation of a Malignant Hyperthermia Cart located between PACU (Post Anesthesia Care Unit) and the surgical suites revealed it contained 12 vials (2 boxes) of Dantrolene Sodium. The observation was verified by S2DON and S10QualityCoordinator. Further observation revealed copies of M.H.A.U.S. recommendations in a folder on the cart, which included, in part, 36 vials of Dantrolene should be available in each institution where MH could occur. S10QualityCoordinator reported, after looking further, that there were no extra vials in the medication dispensing machine, or in the surgical suites. S2DON verified that the hospital did not have 36 vials on hand in the hospital, as recommended by M.H.A.U.S.

In an interview 4/24/14 at 10:30 a.m. S8RNSurgeryManager reported the hospital only kept 12 vials of Dantrolene in the facility. She further reported that if more was needed the hospital staff would get them, already mixed, from the contracted pharmacy. After review of the M.H.A.U.S. documentation located on the MH cart, S8RNSurgeryManager verified that the hospital did not have the recommended 36 vials in the facility for immediate use.