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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.618 Condition of Participation: Emergency Services, was out of compliance.

C-0886 Drugs and biologicals commonly used in life-saving procedures, including analgesics, local anesthetics, antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids, antiarrhythmics, cardiac glycosides, antihypertensives, diuretics, and electrolytes and replacement solutions. Based on observation and interviews, the facility failed to stock commonly used drugs used in life-saving procedures. Specifically, the facility stocked succinylcholine but failed to stock Dantrolene, the reversal agent for malignant hyperthermia, in one of one observation of the medication room.

Based on observations and interviews, the facility failed to stock the appropriate amount of commonly used drugs used in life-saving procedures. Specifically, the facility stocked succinylcholine (a medication used during surgical procedures which paralyze muscles) but failed to stock the appropriate amount (36 vials) of Dantrolene, the reversal agent for malignant hyperthermia (MH) (a potentially fatal condition characterized by generalized muscle spasms, fever, fast heart rate, fast breathing, and increased demand for oxygen), in one of one observation of the medication room.

Findings include:

Reference:

The Malignant Hyperthermia Association of the United States (MHAUS) Guidelines 2018, retrieved from https://www.mhaus.org/healthcare-professionals/be-prepared/what-should-be-on-an-mh-cart/, read, in a small percentage of cases malignant hyperthermia (MH) appears to be triggered by succinylcholine alone in the absence of a volatile agent. Dantrolene (Dantrium) must be available for all anesthetizing locations where MH trigger agents are used. MHAUS recommends centers stock a minimum of 36 20-mg vials of Dantrium or Revonto (total dose 720 mg) or three 250 mg vials of Ryanodex (total dose 750 mg). These amounts of Dantrolene were originally determined by the analysis of MH event data showing some cases of acute MH required up to or more than 10 mg/kg body weight, and therefore these total dose amounts would suffice for the majority of average-sized patients who develop MH.

The consensus of our experts was the incidence of MH induced by succinylcholine alone is not rare enough to justify the absence of Dantrolene wherever succinylcholine may potentially be administered. Facilities who stock and have the potential to administer any triggering agent, including succinylcholine without volatile agents, should have Dantrolene immediately available in the event a patient in the facility develops MH.

According to the Dantrolene/Revonto package insert, Dantrolene/Revonto is indicated along with appropriate supportive measures for the management of fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crisis in patients of all ages. Dantrolene/Revonto should be administered by a continuous rapid intravenous push as soon as the malignant hyperthermia reaction is recognized.

1. The facility failed to stock the appropriate amount (36 vials) of Dantrolene, a medication used to mitigate the effects of malignant hyperthermia (MH), a possible side effect from the administration of succinylcholine.

a. Observations

i. On 8/14/23 at 2:20 p.m., an observation of the medication room was conducted. The observation revealed multiple vials of Succinylcholine in the Omnicell (an automated medication dispensing cabinet).

ii. On 8/14/23 at 2:35 p.m., an observation of the medication room was conducted. The observation revealed 18 vials of Dantrolene were present in the Omnicell.

b. Interviews

i. On 8/14/23 at 2:46 p.m., an interview was conducted with the charge nurse (Charge RN) #1. Charge RN #1 explained succinylcholine was used during intubation (insertion of a tube into a patient's airway) procedures in the emergency room. Charge RN #1 stated she was unaware of the required amount of Dantrolene needed to treat malignant hyperthermia. When asked where the facility stored Dantrolene, Charge RN#1 pulled out 3 boxes of Dantrolene from the Omnicell which contained 6 vials each of Dantrolene 20 mg, totaling 18 vials. Charge RN #1 stated she thought 18 vials of Dantrolene were enough to treat malignant hyperthermia.

ii. On 8/14/23 at 2:35 p.m., an interview was conducted with chief nursing officer (CNO) #2. CNO #2 stated succinylcholine was used for emergent intubation in the emergency room. CNO #2 further stated the facility followed MHAUS guidelines. CNO #2 explained she was unsure of the required amount of medication (Dantrolene) needed to treat an episode of malignant hyperthermia. CNO #2 explained patients were at risk of death if they were to experience malignant hyperthermia without enough medication to treat the condition.

The observation and interviews were in contrast to the MHAUS guidelines which read, facilities that stocked and had the potential to administer any triggering agent, including succinylcholine without volatile agents, should have had Dantrolene immediately available in the event a patient in the facility developed MH. MHAUS further recommended centers stocked a minimum of 36 20-mg vials of Dantrolene (dantrium) or Revonto (total dose 720 mg), or three 250 mg vials of Ryanodex (total dose 750 mg).

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.635 Condition of Participation: Provision of Services was out of compliance.

C-1006 The CAH's health care services are furnished in accordance with appropriate written policies that are consistent with applicable State law. Based on observations and interviews, the facility failed to ensure patient care equipment was not expired. Specifically, the facility's glucometer (a device used to measure blood sugar levels) test strips and control solutions were both expired in one of one observation of the facility's glucometer. In addition, the facility failed to ensure expired medical supplies were not readily available for patient use and were discarded in accordance with facility policy. The failure was observed in two of four medical supply storage areas.

Based on observations and interviews, the facility failed to ensure patient care equipment was not expired. Specifically, the facility failed to ensure the glucometer (a device used to measure blood sugar levels) test strips and control solutions were not expired in one of one observation of the facility's glucometers. In addition, the facility failed to ensure expired medical supplies were not readily available for patient use and were discarded in accordance with facility policy. The failure was observed in two of four medical supply storage areas.

Findings include:

Facility policies:

The Glucosemeter-StatStrip Xpress2 Quality Control policy read, to keep the Nova StatStrip Glucose Control Solution vial tightly closed when not in use, check the expiration date on the control solution vial, and not to use expired controls. The policy further read, once opened, solutions stored as indicated are only stable for up to three months after opening or until the expiration date, whichever comes first. The policy also read to write the expiration date on the label of the control vial when it is opened.

The Glucosemeter-StatStrip Xpress2 (Testing Strips) policy read, not to use the test strips if the expiration date had passed, for this may cause inaccurate results.

The Guidelines for Stocking and Rotating Nursing Supplies policy read, stock will be checked monthly for expired items. Expired items will be removed, logged as outdates, and re-ordered.

References:

The EvenCare Glucose Control Solutions Instructions for Use, provided by the facility, read, the purpose of the control solution test was to validate the performance of the EvenCare G2 Blood Glucose Monitoring System using a testing solution with a known range of glucose. A control test that falls within the acceptable range indicates the user's technique was appropriate and the test strip and meter were functioning properly. The policy further read, newly opened bottles of control solutions must be marked on the space provided on the control solutions label with the date it was opened, check the expiration date of the control solutions to make sure they have not expired, and discard any unused control solutions 90 days after opening or after the expiration date.

The StatStrip Glucose Hospital Meter Test Strips Instruction for Use, provided by the facility read, the
expiration date was printed on the vial of test strips. Once opened, the StatStrip glucose hospital meter test strips were stable when stored as indicated for up to six months or until the expiration date, whichever came first. The instructions further read, not to use the test strip if the expiration date had passed, for this may cause inaccurate results.

1. The facility failed to date patient glucometer test strips and control solution bottles for glucometer testing in the medication room with the date they opened or expired to ensure accurate glucose results.

a. Observations

i. On 8/14/23 at 2:35 p.m., an observation of the facility's two glucometers in the medication room was conducted. During the observation, the test strips showed no indication of when they had been opened or when they expired. According to the strip IFUs, the strips were stable for six months after opening. There was no date written to show when the strips were opened to indicate their stability.

In addition, there was no date indicating when the control solution bottles were opened or when they expired.

This was in contrast with the manufacturer's instructions for use which instructed users to write the open date on the label of the test strips and control solution vials.

b. Interviews

i. On 8/15/23 at 2:12 p.m., an interview with registered nurse (RN) #3 was conducted. RN #3 stated labeling glucose test strips and control solution bottles was essential to ensure expired supplies were not used on patients. RN #3 further stated using expired supplies could have resulted in incorrect results and caused harm to patients.

ii. On 8/14/23 at 2:35 p.m., an interview with the charge nurse (Charge RN) #1 was conducted. Charge RN #1 stated she was unaware the test strips and control solution bottles were not labeled with an expiration date.

iii. On 8/14/23 at 2:35 p.m., an interview with chief nursing officer (CNO) #2 was conducted. CNO #2 stated they were not aware the test strips and control solution bottles had not been labeled. When asked what the risk was to patients if expired supplies were used, CNO #2 stated that it could put patients in danger of inaccurate or inappropriate treatment.

2. The facility failed to ensure expired medical supplies were removed from inventory and not available for use in patient care.

a. Observations

i. On 8/14/23 at 2:55 p.m., observations conducted of the medication storage room revealed 73 25 gauge needles, expired 5/31/22, one 25 gauge needle expired 6/30/23, 14 27 gauge needles expired 4/1/23, and 17 spinal needles expired 2/28/23.

ii. On 8/14/23 at 2:15 p.m., observations conducted of the procedure room revealed five pairs of size seven sterile surgical gloves expired 5/2023.

This was in contrast to the Guidelines for Stocking and Rotating Nursing Supplies policy, which read, stock was checked monthly for expired items. Expired items were to be removed, logged as outdated, and reordered.

b. Interviews

i. On 8/14/23 at 3:06 p.m., an interview with registered nurse (RN #1) revealed the central supply tech was responsible for monitoring medical supplies in the medication storage room for expiration date. RN #1 stated she stocked the medical supplies in the procedure room. RN #1 stated at the conclusion of days with procedures, she visually checked each medical supply used during procedures for expiration date. RN #1 stated she had no written audit process in place to monitor medical supplies in the procedure room for expiration date. RN #1 stated it was important to avoid expired medical supplies for patient care as they were not considered sterile past the expiration date. RN #1 stated patients were at risk for infection if expired medical supplies were used in patient care.

ii. On 8/16/23 at 3:16 p.m., an interview with the certified nurse assistant (Tech #5) was conducted. Tech #5 stated she was responsible for stocking medical supplies in the medication room and the emergency department. Tech #5 stated she visually monitored medical supplies for expiration dates in the medication room. Tech #5 stated she did not track which medical supplies were in the medication room or track their expiration dates. Tech #5 stated there was no documented process in place to track medical supplies stored in the medication room and procedure room for expiration date. Tech #5 stated it was important to monitor medical supplies for expiration dates as expired medical supplies might not be sterile or work as intended. Tech #5 stated the patient was at risk if expired medical supplies were used in patient care.

iii. On 8/16/23 at 12:45 p.m., an interview with the medical director (Director #4) was conducted. Director #4 stated medical supply expiration dates were important as the expiration date indicated how long the particular supply was safe for use. Director #4 stated the patient was at risk for infection and a particular medical supply might not work as intended if expired medical supplies were used in patient care.

iv. On 8/17/23 at 11:20 a.m., an interview with chief nursing officer (CNO #2) was conducted. CNO #2 stated Tech #5 was responsible for monitoring medical supplies for expiration date in the medication room. CNO #2 stated RN #1 was responsible for monitoring medical supplies in the procedure room for expiration date. CNO #2 stated there was no tracking process for auditing and monitoring medical supplies in the medication room and procedure room for expiration date. CNO #2 stated it was important to monitor medical supplies for expiration date to ensure the sterility and the supply worked as intended. CNO #2 stated the patient was at risk for infection if expired medical supplies were used in patient care.