HospitalInspections.org

Based on observation, policy and procedure review, review of annual competencies and staff interviews; the hospital failed to provide surgical services in accordance with acceptable standards of practice by failing to ensure 36 vials of Dantrolene Sodium were available in immediate operating room areas to meet the potential emergent need of a patient in a Malignant Hyperthermia crisis.

These findings presented a serious and immediate threat to the health and safety of all patients susceptible to Malignant Hyperthermia (MH). The Malignant Hyperthermia Association of the United States (MHAUS) stated "High incidence areas in the United States include Wisconsin, Nebraska, West Virginia and Michigan. However, the prevalence of genetic change that predisposes to MH is much higher. About one in 2,000 patients harbor a genetic change that makes them susceptible to MH."Review of the surgery schedule dated 11/20/15 revealed a patient scheduled at 0730 in OR 6 received general anesthesia with a family history of MH.
Hospital Administration was notified of the Immediate Jeopardy (IJ) deficient practice on 11/20/15 at 12:00 noon.
The IJ was determined to be abated on 11/20/15 at 4:00 PM based on the Hospital obtaining an additional 36 vials of Dantrolene Sodium. This additional amount allowed the hospital to have 36 vials of Dantrolene in the immediate OR area and also on the 4th floor OB (obstetrics) surgery suite.
The Condition Of Participation for Surgical Services is out of compliance due to the seriousness of the deficiency cited at A-0951.
The average number of surgeries performed at the hospital on a monthly basis is 263.

Based on observation, policy and procedure review, review of annual competencies and staff interviews; the hospital failed to provide surgical services in accordance with acceptable standards of practice by failing to ensure 36 vials of Dantrolene Sodium were available in immediate operating room (OR) areas to meet the emergent need of a patient in a Malignant Hyperthermia (MH) crisis. This failed practice had the potential to affect all surgical patients using inhaled general anesthetics and Succinycholine Chloride (A short-acting depolarizing skeletal muscle relaxant). The average number of surgical procedures performed at the hospital on a monthly basis is 263.

Findings are:

A. Interview with the Perianesthesia Manager on 11/20/15 at 10:35 AM revealed the facility stored 12 vials of Dantrolene in the OR in the MH cart, 12 vials in pharmacy (approximately 240 feet from the OR) and 12 vials on 4th floor in OB (obstetrics) for c-sections (cesarean sections). Observation on 11/20/15 at 11:30 AM of the MH cart located in the OR corridor between OR suites 3 and 4 confirmed 12 vials of Dantrolene Sodium expiration date 10/16. The Perianesthesia Manager felt confident that if there was a MH crisis by the time the first 12 vials were mixed the other 12 vials from the other areas would be in the OR.

Interview on 11/20/15 at 11:40 AM with CRNA (Certified Registered Nurse Anesthetist) revealed that the CRNA knew that there were to be 36 vials of Dantrolene "did not know there were only 12 vials" in the MH cart. "I have heard of places sharing due to costs but didn't know they were [sharing] here."

B. Review of the Malignant Hyperthermia annual competency training (no date) stated "Because treatment of MH may require a dose of as much as 10 mg/kg (milligram/kilogram) and since each vial of Dantrolene IV (intravenous) contains 20 mg of Dantrolene sodium, experts recommend that 36 vials of Dantrolene be kept available to the OR area at all times." Interview on 11/20/15 at 10:35 AM with the Perianesthesia Manager revealed the hospital had scheduled a 429 lb (pound) patient for surgery. Interview with the OutPatient Surgery Administrator stated they have done surgery on a 400 lb patient.

-Review of the 2015 Malignant Hyperthermia annual competency tests revealed the staff needed to know the following:
-Additional vials of Dantrolene are kept in OB and pharmacy
-It is recommended that 36 vials be available in the hospital setting

C. Review of policy and procedure titled Malignant Hyperthermia Protocol (revised 2/14) stated "The plan includes the ability to recognize the signs and symptoms of MH, the development of an appropriately stocked and readily available MH crash cart, and an annual review of the nationally recognized standard of care provided by MHAUS (Malignant Hyperthermia Association of the United States). The policy stated MH drug kit per MHAUS. MHAUS stated drug kits should contain "Dantrium (Dantrolene) - stock a minimum of 36 - 20 mg vials [or] Ryanodex-stock a minimum of 3 - 250 mg vials". MHAUS recommended "Dantrolene should be kept in or very close to the operating room, so that it is available immediately if MH occurs."
D. Review of the surgery schedule dated 11/20/15 revealed a patient scheduled at 0730 in OR 6 received general anesthesia with a family history of MH. Review of American Society of Perianesthesia Nurses Chapter 13 titled Malignant Hyperthermia revealed that for appropriate management of MH susceptible patients "Assure that adequate amounts of unexpired Dantrolene (36 vials) and 2500 ml of sterile preservative free water to reconstitute are available."
E. Observations between 3:30-4:00 PM confirmed placement of 36 vials of Dantrolene in OB and the additional 24 vials of Dantrolene placed in the OR MH cart.