Readiness for Malignant Hyperthermia Can Be Survey Stumbling Block

The inability of hospitals to meet expectations for responding to malignant hyperthermia (MH) is an occasional but persistent problem, recently released data from the Centers for Medicare and Medicaid Services (CMS) show.

From 2011 through 2015, inspection findings at eight hospitals and health systems revealed "deficiencies" related to MH preparedness, according to CMS.

Most of the problems cited by inspectors involved having an inadequate supply of dantrolene or failing to train staff to obtain and administer the drug in time to avert a potentially deadly outcome in a patient with MH.

I.V. dantrolene is the only FDA-approved drug indicated for the treatment of MH, a life-threatening rise in body temperature that can be triggered by exposure to succinylcholine or certain other drugs. In MH-susceptible patients, the condition results from a cascade of biochemical events that first affect skeletal muscles and can progress to cardiovascular collapse and death.

The Malignant Hyperthermia Association of the United States (MHAUS), an advocacy and education group that provides evidence-based advice for preventing and managing MH, recommends that dantrolene be accessible within 10 minutes after a decision is made to treat a patient for MH.

Rita Shane, chief pharmacy officer at Cedars-Sinai Medical Center in Los Angeles, recalled that surveyors have long taken that recommendation seriously.

During a 2008 California Department of Public Health survey, she stated, a surveyor surprised the staff by actually timing whether a mock MH case could be treated in the time frame recommended by MHAUS. More recently, a Joint Commission Resources mock survey recommended that all healthcare providers involved in the care of patients exposed to anesthetizing agents conduct drills to ensure the institution can meet MHAUS guidelines.

The lesson learned from these visits, she said, is that it's necessary to have "an ongoing process for MH readiness, which includes periodic review of the MHAUS guidelines."

She said this is necessary "to ensure that necessary medications are readily available in the potential areas where we could see an MH case—and that staff, including nurses, have a working knowledge and can respond per guidelines."

Kathy Doub, senior director of pharmacy operations for Novant Health, an integrated health system serving patients in Georgia, North Carolina, South Carolina, and Virginia, said she's unaware of state inspectors using a timer during a survey. But she said inspectors have paced out the distance between an MH cart and an area where succinylcholine is administered to ensure that they weren't too far apart.

"It's not a written rule—it's surveyor specific," Daub said of the expectation regarding the proximity of MH carts to areas where MH may occur.

About 1 in 2,000 people are genetically predisposed to MH, and the condition is thought to occur during about 1 in 100,000 surgical procedures in adults and 1 in 30,000 surgical procedures in children, according to MHAUS.

During 2014, 2015, and the first three months of this year, the MHAUS hotline fielded 164 calls from healthcare providers responding to a presumed MH crisis, according to a spokesperson for the organization.

Doub said she's seen perhaps two or three cases of MH during her career. She said healthcare providers must be regularly trained to recognize and respond to MH, in part because they may be unfamiliar with the illness but need to act quickly if they encounter it.

"Know what drugs can trigger malignant hyperthermia," Doub advised pharmacists. "If you have those drugs in an area, then you have to make sure that you have the MH cart. And people need to be educated on MH and know where the closest cart is."

36 Vials of Dantrolene

MHAUS recommends that at least 700 mg of dantrolene sodium—enough to treat a 70-kg patient—be available in or near operating rooms and other areas where an MH-triggering event may occur; according to MHAUS, that means keeping 36 20-mg vials or 3 250-mg vials of dantrolene close at hand.

CMS doesn't have a detailed policy on how surveyors should assess a facility's preparedness to manage MH. But the agency has stated that it expects facilities to follow "current accepted standards of practice" for MH preparedness.

In practice, that appears to mean that CMS and state surveyors expect healthcare facilities to follow MHAUS recommendations.

Hospitals must also comply with their own written policies and procedures for MH preparedness as well as applicable state rules and regulations, and inspectors can cite facilities that fail to do so.

Inspection Findings

The CMS data describe problems in California and Virginia hospitals that were cited for inadequacies in their ability to respond to MH.

Among other things, the inspectors found mismatches between the quantities of dantrolene and associated supplies stocked in MH carts and the quantities stated in policies and procedures. In some cases, MH carts or kits contained quantities different from those stated in cart or kit inventories. Also common were inadequacies in staff training and the failure of staff to find dantrolene in a reasonable amount of time.

One medical center was also out of compliance with a state law related to the storage of emergency drugs.

The Virginia Department of Health in 2013 released a memo calling the failure to have dantrolene on hand for use as a reversal agent "a growing problem" in the commonwealth.

According to the memo, which was directed to hospital administrators, if inspectors find that dantrolene is needed but the drug is unavailable or has expired, they will cite the facility for an "Immediate Jeopardy" situation and inform CMS of the citation.

CMS defines immediate jeopardy as a situation "in which the provider's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death" to a patient. A finding of immediate jeopardy can occur during any survey or investigation of any certified Medicare or Medicaid entity other than a clinical laboratory.

Doub said any finding of immediate jeopardy by any regulatory agency is a serious situation.

"In any immediate jeopardy situation, you have to have a plan, you have to have a timeline, and you have to have education and training. And you have to be able to document and demonstrate that to the regulatory agency," Doub said.

Not all identified problems reflected in the CMS data constituted immediate jeopardy. As CMS reported, one of Novant Health's freestanding emergency departments was cited in 2013 for having succinylcholine in an automated storage cabinet but not stocking an MH kit.

Doub said the succinylcholine had been stocked in the dispensing cabinet, which didn't have patient-profile capabilities and thus wasn't subject to real-time review by a pharmacist. Since succinylcholine had not been used at the facility, it was removed.

"We had no patient harm from it. It was a good learning experience and an opportunity for us," she said.

[This news story appears in the June 15, 2016, issue of AJHP.]