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Based on observation, record review, policy review, document review and interview the Critical Access Hospital (CAH) failed to have available necessary medications used for life-saving measures and failed to have blood available for transfusion to meet the needs of patients in emergency situations.

The cumulative effects of this deficient practice resulted in two Immediate Jeopardy (IJ) (a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment or death) situations under 42 CFR 485.618, Emergency Services, 1. C0884, 485.618(b) Standard: Equipment, Supplies, and Medication; and 2. C0890, 42 CFR 485.618(c) Blood and Blood Products, The facility provides, either directly or under arrangements, the following-- (1) Services for the procurement, safekeeping, and transfusion of blood, including the availability of blood products needed for emergencies on a 24-hours a day basis.


Findings Include:

1. The Critical Access Hospital (CAH) failed to ensure it maintained a supply of medication to reverse the potential life-threatening side effect, malignant hyperthermia (MH) (dangerously high body temperature, rigid muscles or spasms, and a rapid heart rate) resulting from the use of succinylcholine (a medication used to provide muscle relaxation while inserting a breathing tube) during emergencies.

On 06/28/22 at 10:45 AM, an Immediate Jeopardy (IJ) (a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment or death) was identified following review of the CAH's drug formulary and interviews with Staff A, DON/Co-CEO, and G, RN, Pharmacy Tech and Staff H, CRNA. It was determined that the medication, succinylcholine chloride, (a paralytic agent) was stocked in the CAH for use in the Pain Management Clinic. It was further determined that the CAH failed to stock any of the required reversal agents for succinylcholine chloride i.e., dantrolene, Dantrium/Revonto, or Ryanodex, which is used to treat Malignant Hyperthermia (MH), a potentially fatal condition that can occur from the use of succinylcholine chloride.

On 06/28/22 at 12:10 PM, Staff A, DON/Co-CEO and Staff B, Chief Financial Officer (CFO)/Co-CEO were notified that an IJ existed at C0884, 485.618(b) Standard: Equipment, Supplies, and Medication, under 42 CFR 485.618, Emergency Services, and advised of the need for a Plan of Removal of the IJ.

A Plan of Removal was submitted by Staff A, DON/Co-CEO and Staff B, CFO/Co-CEO on 06/28/22 at 2:45 PM that included:

Due to the inaccessibility of Dantrolene, Dantrium, Revonto, or Ryanodex to include on our formulary to treat Malignant Hyperthermia, Succinylcholine will be removed from Lane County Hospital Pharmacy immediately. The drug will be immediately removed from the building and returned to our consulting pharmacist so no providers or staff will have access to the medication.

1. Patients that could have been in jeopardy are people that have been referred to [Name] Pain Management for evaluation and treatment of chronic pain. There have been 23 procedures performed in this fiscal year that could have been in jeopardy. [Name] Pain Management is a contracted service that supplied us with the formulary that they wanted us to carry.

2. Along with the removal of the drug Succinylcholine, Administration contacted [Name] Pain Management and [Name], Consulting Pharmacist to discuss the removal of the drug and to replace with a different medication that does not cause malignant hyperthermia. At this time we are just removing the drug and will discuss other options for the future.

3. Administration will review with the consulting pharmacist the procedures to approve and present to Medical Staff the addition or discontinuations of medications on Lane County Hospital formulary.

4. [Name] Pain Management staff have been educated and handed information about the serious side effects of using the drug Succinylcholine. Documentation has been given to [Name] Pain Management, Lane County Hospital RN that assists [Name] Pain Management, LCH's Pharmacy RN. and [Staff D], Chief of Staff have been informed of the IJ and has been given documentation for removing the drug as well as education on the drug.

5. Medical staff, administration, and Supervising Pharmacist and Pharmacy RN will do a complete review of the hospital formulary and follow up on a monthly basis of any drugs going on or coming off the formulary at our monthly Medical Staff meetings.

In conclusion since placing Succinylcholine on our formulary we have never used the drug to date. Removal of the drug took place on June 28, 2022 at 13:30 p.m. The likelihood for serious harm to any patient no longer exists.

On 06/28/22 at 4:20 PM, Staff A, DON/Co-CEO and Staff B, Chief Financial Officer (CFO)/Co-CEO were notified that the IJ plan of removal was accepted. Implementation of the IJ removal plan was verified by onsite surveyors prior to survey exit. Refer to tag C0884



2. The Critical Access Hospital (CAH) failed to have blood products needed for emergencies on a 24-hours a day basis either directly or under arrangement for procurement and transfusion of blood for two (Patient 3 & 20) of 20 emergency department records reviewed.


On 06/29/22 at 9:30 AM, Staff A, DON/Co-CEO and Staff B, Chief Financial Officer (CFO)/Co-CEO were notified that an IJ existed at C0890 - 485.618(c) Standard: Blood and Blood Products The facility provides, either directly or under arrangements, the following-- (1) Services for the procurement, safekeeping, and transfusion of blood, including the availability of blood products needed for emergencies on a 24-hours a day basis and advised of the need for a Plan of Removal of the IJ.

A Plan of Removal was submitted by Staff A, DON/Co-CEO and Staff B, CFO/Co-CEO on 06/30/22 at 3:30 PM that included:

1. Patients that could have been in jeopardy are patients presenting to the ER.

2. Administration has secured a Memorandum of Agreement with [Facility D] County Hospital, to have access to O-negative packed blood cells (the universal donor type). Lane County Hospital will meet the services for procurement, safekeeping, and transfusion of blood, including the availability of blood products for emergency services. Effective Date is June 30, 2022. [Facility D] City is 30 miles from our facility and both CEO's live in [Facility D] County and would be the first contacts to obtain the blood product since they are in the community. They both are on call in case of emergency. If either one were not available lab personnel would be responsible to secure the product.

3. We are also going to maintain the memorandum with [Facility E] as a backup plan to obtain the services for procurement, safekeeping, and transfusion of blood, including the availability of blood products for emergency services.

4. If there are unforeseen circumstances to obtain the blood from either facility the best practice would be to transport the patient to the source of a blood supply rather than bring the blood to the patient at this CAH.

5. Medical providers and Lab Director and staff have been given a copy of Regulation #C0890 and will be a given a copy of the Memorandum agreement between the two facilities.

6. Education and policy and procedures will be given to the Providers and to the Lab and Nursing staff that is on duty today. The DON will give Education and policies and procedures to each nurse prior to their next shift. It will also be presented again at the monthly nursing meeting to be held on July 13, 2022.

On 06/30/22 at 3:44 PM, Staff A, DON/Co-CEO and Staff B, Chief Financial Officer (CFO)/Co-CEO were notified that the IJ plan of removal was accepted. Implementation of the IJ removal plan was verified by onsite surveyors prior to survey exit. Refer to tag C0890

Based on observation, document review, and interview, the Critical Access Hospital (CAH) failed to ensure it maintained a supply of medication to reverse the potential life-threatening side effect, malignant hyperthermia (MH) (dangerously high body temperature, rigid muscles or spasms, and a rapid heart rate) resulting from the use of succinylcholine (a medication used to provide muscle relaxation while inserting a breathing tube) during emergencies. Failure to maintain a supply of medication to reverse the potential life-threatening side effect of succinylcholine places all patients at risk for harm or death.


Findings Include:


Review of the Malignant Hyperthermia Association of the United States (MHAUS) showed, All facilities, including ambulatory surgery centers and offices, where MH triggering anesthetics (isoflurane, desflurane, and sevoflurane) and depolarizing muscle relaxants (succinylcholine) are administered, should stock dantrolene as indicated below, along with the other drugs and devices necessary to treat an MH reaction. If none of these agents are ever in use in the facility, then dantrolene need not be kept on hand ...

... To treat an MH episode, an initial dose of dantrolene at 2.5 mg/kg is recommended, with a suggested upper limit of 10 mg/kg. If a patient of average weight (approximately 70 kg) were to require dantrolene at the upper dosing limit, then at least 700 mg of dantrolene would be needed.

DANTRIUM®/REVONTO® - stock a minimum of 36 - 20 mg vials
RYANODEX®- stock a minimum of 3 - 250 mg vials

In addition, a review of cases has shown that in a "worse case" scenario of a very large person (i.e., about 100-110 kg or 220 - 250 pounds) having an acute MH incident, as much as 8-10 mg/kg will be needed for treatment; higher doses may be required on rare occasions. This regimen of dantrolene will allow for initial stabilization and treatment while more vials are being acquired to continue treatment, as needed.


Observation on 06/27/22 at 4:00 PM during a tour of the CAH emergency department rooms, showed two ED rooms, the ED had drugs, biologicals, equipment and supplies used in life-saving procedures including but not limited to the crash cart, obstetric kit and supplies, Braslow kits, suction, cardiac monitor, endotracheal tubes. All supplies and medications inspected an none were expired. There was no succinylcholine observed in the ED refrigerator.

Review of the hospitals drug formulary on 06/28/22 at 9:45 AM showed the hospital has a supply of succinylcholine 20 mg/ml 10 ml, 10 vials on hand. Further review shoed there was no Dantrolene, Dantrium, Revonto, or Ryanodex listed on the formulary to treat malignant hyperthermia should it occur.

During an interview on 06/28/22 at 10:00 AM, Staff A, DON/Co-CEO stated that the Succinylcholine is on the formulary list at the request of Pain Management. Staff A stated that she did not know what the Pain Management group was using succinylcholine for.

Observation of the pharmacy room and interview on 06/28/22 at 10:15 AM, Staff G, RN, Pharmacy tech, stated that Pain Management wanted the succinylcholine available as part of a protocol. Staff G presented a list of medication requested by and obtained for Pain Management that included Succinylcholine 100 mg/5 ml. Staff G stated that they had succinylcholine but was not able to locate or show the surveyor the succinylcholine, when Staff G was told the surveyor needed to see the succinylcholine, Staff G stated that it was probably in with Pain Management staff who was doing a procedures. Staff G was asked to let the surveyor know when it was available to view. When asked if the CAH had a malignant hyperthermia kit, that contained Dantrolene, Dantrium/Ryanodex or Revonto, Staff G stated "no, if it's not on the list then we don't have it."

During an interview on 06/28/22 at 10:45, Staff H, contracted Pain Management, Certified Registered Nurse Anesthetist (CRNA), Pain Management, stated that succinylcholine would be used in case of an emergency for a patient needing intubation. He stated that he has never used it in any facility in the realm of pain management. Staff H stated that he does not carry his own medications or have dantrolene and each hospital orders everything the Pain Management clinic needs.

The CAH failed to stock Dantrolene, Dantrium/Revonto, or Ryanodex necessary to treat an MH reaction should it occur.

Based on document review, record review, and interview the Critical Access Hospital (CAH) failed to have blood products needed for emergencies on a 24-hours a day basis either directly or under arrangement for procurement and transfusion of blood for two (Patient 3 & 20) of 20 emergency department records reviewed. Failure to have blood available for emergencies on a 24-hours a day basis places patient needing blood at risk for harm up to and including death.


Findings Include:


Review of a document provided by the hospital showed effective December 1, 2019, Facility B will no longer offer Blood Bank related testing and crossmatched blood products for client hospitals. Also provided was a document with the heading "Blood Banking." Further review of the document showed, ... To evaluate usage, I reviewed Lane County Hospital Blood Bank Logs to find we transfused 2 patients in 2016 and 1 patient in Feb 2019 for a total of 3 patients in 4 years. This was then discussed with [physician] 10/28/19. He has visited with [name], and his suggestion was to discontinue this service since we have transfused in our facility only once in four years. Met with Administration to let them know I was looking at different avenues.

...Choices available to us:

1. Discontinue Blood Bank Services
2. Contract with American Red Cross
3. Set up Blood Banking ourselves
4. Partner with any available Hospitals in our area

Conclusion as to cost effectiveness for our facility is to follow [physician] suggestion to Discontinue Blood Bank Services at this time. I will follow up on Partnering with Hospitals in our area as an option as this is an issue for all smaller facilities and new programs are being looked at.

Taken to Med Staff and Board in January- Decision was unanimous to discontinue Blood Bank Services effective 1/1/ 2020.

During an interview on 06/27/22 at 6:15 PM, Staff A, DON/Co-CEO stated that they are not currently partnered with any hospital for blood products. She stated that the Network hospital is 90 minutes away, then 90 minutes to get back and they can't get it to the patient for greater than 3 hours. She stated that they can get patients transferred out quicker than they can get the blood.

Patient 3

Review of an emergency medical service (EMS) trip report dated 06/18/22 at 5:58 PM, showed EMS received a call for a reported fall. On arrival Patient 3 complained of blood in his stool. Patient 3's blood pressure (BP) was 65/54, (normal range 90-120/60-80) Pulse (P) 134 (normal range for healthy adult 60-100), respirations (R) 20 (normal range 12-20) and oxygen saturation (Ox) 88% (normal range 95% - 100%). Patient 3 was place on oxygen and transport to the CAH.

Review of Patient 3's ED medical record showed he presented to the ED on 06/18/22 at 6:21 PM, for fall and weakness. A Complete Blood Count (CBC), Comprehensive Metabolic Profile (CMP), and Fecal Occult Blood Screen were ordered. Patient 3's red blood cell count (RBC) was 2.89 (3.80-5.80); his hemoglobin (Hgb) (the protein in red blood cells that carries oxygen) was 8.8 (11.0-16.6); and hematocrit (Hct) (a test that measures the proportion of red blood cells in your blood) was 26 (35-50).

The medical record showed Patient 3's first BP in the ED was 97/55 and ranged from 105/63 at 7:45 PM to a low of 81/49 at 9:00 PM prior to the time of transfer.

The Assessment/Plan showed: 1. Hemorrhagic Shock (a medical emergency where the body begins to shut down due to heavy blood loss); 2. Melena (black stools that occur as a result of gastrointestinal bleeding); 3. Syncope (fainting). Hgb 8.8 at 7:11 PM.

Patient 3 was accepted for transfer to Facility A and transferred by emergency medical services (EMS), advanced life support (ALS) ground transport at 9:17 PM.

During an interview on 06/29/22 at 1:15 PM, Staff D, Doctor of Osteopathy (DO) stated that Patient 3 had syncope, he was dizzy, had black stools and a history of bleeding ulcers. He stated that they did not have blood and Patient 3 needed packed red blood cells (PRBC). He stated that he called Facility A and presented the case to the physician assistant (PA) who said that they had blood available, a gastrointestinal (GI) physician that would be there Monday or Tuesday and surgical services. He stated that Patient 3 was transferred by ground ambulance to Facility A for blood transfusion.


Patient 20

Review of Patient 20's ED medical record showed he presented on 01/06/22 at 2:41 PM after a syncopal (fainting) episode. Patient 20's past medical history showed, history of prostate cancer, Metastatic melanoma, and Pneumothorax of right lung after biopsy. A Complete Blood Count (CBC) showed Patient 20's was Hgb 8.7, Hct. was 24, and RBC were 2.66.

The medical record showed Patient 20's first BP in the ED was 100/53 with the lowest documented BP of 77/54 at 7:18 PM, the last recorded BP prior to transfer showed 90/54.

Review of the provider note showed: Patient needs immediate transfer to HLOC (higher level of care) for surgical management of hemorrhagic liver lesion.

The assessment/plan showed: 1. hemorrhagic shock, fluid resuscitation currently maintaining BP, 2. Hemoperitoneum (bleeding into the abdominal cavity), 3. Hypotension (low blood pressure), 4. Anemia (a condition in which you lack enough healthy red blood cells to carry adequate oxygen to your body's tissues) 5. Pneumothorax (collapsed lung) of right lung after biopsy. Hgb 8.7 at 2:47 PM.

The medical record showed calls made to 19 other hospitals in an ascending radius were unsuccessful. Patient 20 was eventually accepted at Facility C.

Review of an EMS run report dated 01/06/22 at 7:10 PM, showed EMS responded to the call and was on scene and at Patient 20 at 7:34 PM and departed the CAH at 7:51 PM. Patient 20 was transported to a neighboring town's airport to meet emergency medical fixed wing flight crew to transfer to Facility C. Ground EMS arrived at the destination at 8:16 PM.

During an interview on 06/30/22 at 10:45 AM, Staff D, DO, stated that Patient 3 and Patient 20 were both acutely anemic and it was clinically indicated to give blood. Staff D stated that he would have definitely given blood to both of these patients if the blood had been available.