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Based on observation, record review, policy review, and interview, the Critical Access Hospital (CAH) failed to ensure arrangements or referral to a higher level of care was obtained for one of four Patients reviewed (Patient 1). The CAH's failure to arrange or refer a patient to a higher level of care has the potential for continued patient decline, loss of function, harm, and death.


Findings Include:


Review of the facilities Documented titled "Medical Staff By-Laws," revised 04/2006, showed the Physician responsibility included: ...25. The hospital shall admit all patients requiring care, with the exception of those for whom adequate facilities and care are not available.


Review of Patient 1's emergency department (ED) Visit Note showed he arrived at the CAH emergency department (ED) on 10/09/21 at 6:05 AM, by private car, accompanied by his wife, Family 4 (F4), with complaint of dizziness, left sided weakness, and "walking funny." The note included a neurology consultant's recommendations to obtain a computerized tomography scan (CT- computerized image of the brain) of the head and neck. "If normal, keep locally and start ASA 325 milligram (mg) by mouth (PO) daily, MRI brain, fasting lipids, HgA1c, and echocardiogram."


The CT scan was obtained on 10/09/21 at 6:47 AM, and showed, "1. Chronic encephalomalacia (softening of brain tissue) involving the posterior parietal occipital region (an area at the back of the brain) on the right side. 2. Generalized atrophy (wasting away or deterioration) and some deep white matter changes. 3. No acute findings such as hemorrhage (bleeding), midline shift or mass effect."


Review of the Tele-neurology consult note dated 10/09/21 at 7:54 AM, showed a phone consult with Staff LL, Neurology, Doctor of Osteopathic (branch of medical practice that emphasizes the treatment of medical disorders through the manipulation and massage of the bones, joints, and muscles.) Medicine (DO). The note showed "Impression, ischemic stroke, acute" (a stroke caused by a blood clot blocking blood flow in the brain), with recommendations to admit, consult on-site neurology service for full work-up and evaluation recommendations. "If patient has any neurological deterioration, please call me back immediately" ... "I have discussed my recommendations with the referring provider" ...

The ED Visit Note showed Patient 1 was admitted to acute care in stable condition.

Review of Patient 1's inpatient medical record, Nurses Note dated 10/10/21 at 8:30 AM, showed Staff V, Registered Nurse, (RN), documented Patient 1 had an increase in generalized weakness in both upper and lower extremities and was requiring two to three people to assist him out of bed.

Review of Progress Note dated 10/10/21 at 9:54 AM, by Staff P, PA, showed increase weakness in left arm, Patient 1 unable to move left leg, leaning to the left side. Needing more assistance to ambulate. Plan of care was to repeat the head CT scan.

A repeat CT scan was obtained on 10/10/21 at 9:53 AM, that showed "slightly more low density involving the right parietal region which suggests an ischemic insult ..."

Patient 1's Nurses Note dated 10/10/21 at 6:00 PM, showed Staff T, RN, called Staff P about Patient 1's conditions. "Very difficult to transfer from bed to chair, assist x 3. Patient unable to stand up straight. Leans all body weight to the left." A nurse reported to Staff T that Patient 1 has been losing the ability to ambulate and move his left side today. Staff T's documentation showed Staff P "said she reviewed the CT results and talked with a neurologist who said he is to take an aspirin a day for treatment. No new orders."

Patient 1's medical record showed no documented evidence that Staff P made a phone call for consultation with a neurologist following Staff T's report of Patient 1's change in condition on 10/10/21 and there was no documented evidence a neurologist completed a consultation on 10/10/21.

Patient 1's medical record showed he was transferred to a rehabilitation hospital on 10/15/21 to maximize potential for return to independent living.


During an interview on 12/09/21 at 10:00 AM, Patient 1's daughter, F1, stated that Patient 1 had walked into the facility upon arrival on 10/09/21. He began to decline over the next 24 hours. Family stated that the patient was asleep when they were at the facility 10/10/21. F1 stated that the family did not receive an update on the decline of Patient 1, or that a repeat CT scan had been performed. F1 stated that they were not aware until 10/11/21, of the significant decline, he was unable to use left side of his body, he was unable to transfer without assistance of three staff members, and he unable to safely swallow food.


During an interview on 12/14/21 at 8:38 AM, Staff O, APRN, stated that during a routine stroke protocol, the practitioner does an evaluation, a CT scan of the head is obtained, baseline laboratory panels are obtained, a neurological function test is performed, and a neurologist consult is done by telemedicine once a radiologist reads the CT scan. The neurologist will make recommendations of care and collaborate. If there are any neurological changes in the patient later during the admission, the entire process is repeated, and treated as a new event. Staff O stated that he does recall Patient 1. Staff O stated that on 10/11/21, he initiated a therapy evaluation, an magnetic resonance imaging (MRI, imaging that provides precise details of your body parts), swallow studies, and looked at facilities near that could accept a transfer.


During an interview on 12/14/21 at 11:30 AM, Staff T, RN, stated that prior to COVID-19, all stroke patients were sent to a higher level of care immediately. Now maybe they treat stroke patients for three to four hours, but they are usually then transferred to another facility. She stated that she was the Charge RN on 10/10/21, and that she called Staff P, PA, herself at 6:00 PM. Staff P informed her "she called a neurologist and was told to give the patient an aspirin" as documented in her note on 10/10/21 at 6:00 PM.


During an interview on 12/14/21 at 2:00 PM, Staff V, RN, stated that she notified Staff P, PA, on 10/10/21 at around 9:00 AM of Patient 1's deterioration from the previous shift before. Staff P ordered a repeat of the head CT scan. She stated that she was told by Staff P that the neurologist just suggested to give the patient an aspirin for treatment. She stated that she believed the patient should have been transferred to a stroke center then.


During an interview on 12/14/21 at 4:15 PM, Staff P, PA, stated that she remembered Patient 1. She stated that after Staff LL, neurologist, was consulted and instructed to admit for observation, she notified Staff X, Physician. There was no other treatment that could be provided since the patient was out of the treatment window (intervention that can be done within a three to four-hour window of last time known well). On 10/10/21, she stated she was notified by nursing staff that Patient 1 had a neurological decline, so she reordered a head CT scan. She stated that she then contacted Staff X, who said to continue the current course. She can't recall if she spoke with Staff LL, since it is not documented in her notes.


During an interview on 12/15/21 at 8:00 AM, Staff A, Chief Executive Officer, (CEO), stated that he is still an active Physical Therapist on staff, and he did the evaluation of Patient 1 on 10/11/21 and his recommendations were to transfer to a stroke center for intensive rehabilitation therapy.


During an interview on 12/15/21 at 11:00 AM, Staff X, Physician, stated that he does not recall talking to Staff P, PA on 10/10/21. He stated that he was contacted by Staff P on 10/09/21 and notified of Patient 1's admission. He stated that he was not contacted again by Staff P and verified this by his phone call log. He was contacted by Staff L, RN, on 10/11/21, and notified of Patient 1's decline since admission and asked Staff L to notify Staff O, APRN, to see the patient, as he was not available to.


During an interview on 12/15/21 at 5:36 PM, a representative from the telemedicine neurology consultants stated that there was no documented evidence a physician talked to a provider at the CAH from the morning of 10/09/21 to 10/14/21 and there was no documented evidence of a call reporting neurological changes of any patient in the CAH during that period of time.

Based on observation, document review, policy review, record review, and interview the Critical Access Hospital (CAH) failed to ensure provision of services by failing to ensure written policies were compliant with state law, and failed to ensure staff followed hospital policy and procedure.

The cumulative effects of this deficient practice have the potential to affect all patients by causing harm, adverse outcomes, including death and immediate jeopardy.


Findings Include:


1. The Critical Access Hospital (CAH) failed to ensure patient rights were provided in accordance with applicable state law (Refer to C1006).

2. The CAH failed to ensure expired medication were removed from the automatic medication dispensing system, crash cart, or the pharmacy. (Refer to C1016).

3. The CAH failed to ensure dietary staff provided an appropriate diet, that did not contradict documented allergies, served to one of four patients reviewed (Patient 4). (Refer to C1020).

4. The CAH failed to ensure nursing services met the needs of patients use of Thrombo-Embolic-Deterrent (TED Hose-compression stockings to prevent blood clots) or Sequential Compression Device (SCD- sleeves that wrap around the legs and inflate with air one at a time. This imitates walking and helps prevent blood clots) and repositioning of patients (Refer to C1046).

5. The CAH failed to ensure medication allergies were documented on the Medication Administration Summary, failed to ensure medications allergies were reviewed and updated in the medical record and failed to ensure a documented allergy to a medication was not given to one of four patients reviewed (Patient 1). (Refer to C1049).

Based on document review, policy review, and interview, the Critical Access Hospital (CAH) failed to ensure patient rights were provided in accordance with applicable state law for four of four patients (Patient 1, 2, 3, and 4) identified. This deficient practice has the potential to affect all patients by not providing patients with all Kansas required patient rights and may lead to harm or other adverse outcomes.

Findings Include:

Review of Kansas Administrative Regulations (KAR) showed, 28-34-3b. Patient rights. (a) Policies and procedures. The governing body shall ensure that the facility establishes policies and procedures which support the rights of all inpatients and outpatients. At a minimum, each facility shall ensure that:
(1) Each patient has the right to respectful care given by competent personnel;
(2) each patient has the right, upon request, to be given the name of his attending physician, the names of all other practitioners directly participating in his care and the names and functions of other health care persons having direct contact with the patient;
(3) each patient has the right to make health care decisions. Each patient has the right to the information necessary to make treatment decisions reflecting the patient's wishes and to request a change in his physician or transfer to another health facility due to religious or other reasons;
(4) each patient has the right to accept medical care, to refuse treatment to the extent permitted by state law and to be informed of the medical consequences of refusing treatment;
(5) each patient has the right to formulate advance directives and appoint a surrogate to make health care decisions on the patient's behalf to the extent permitted by law;
(6) each patient has the right to assistance in obtaining consultation with another physician or practitioner at the patient's request and own expense;
(7) each patient has the right to hospital services without discrimination based upon his race, color, religion, sex, national origin or source of payment;
(8) each patient or patient's legally designated representative has access to the information contained in the patient's medical records within the limits of state law;
(9) each patient has the right to examine and receive a detailed explanation of the patient's bill; and
(10) each patient is informed of the facility's policies regarding patient rights during the admission process.
(b) Grievances. The facility's policies and procedures shall establish a mechanism for responding to patient complaints. (Authorized by and implementing K.S.A. 1991 Supp. 65-431; effective June 28, 1993.)


Review of the CAH's document titled, "Subject: Patient Rights, Policy," last revised 01/29/08, showed, "The governing board . . . has established this statement in recognition of the hospitals responsibility to adhere to patient's right and to recognize the patient's responsibilities in the effort to offer the highest quality of care possible."


Review of the CAH's document titled, "Statement of Patient Rights," undated, failed to include the following rights in accordance with applicable state law:

1. The right to care given by competent personnel; the right, upon request, to be given the name of his attending physician, the names of all other practitioners directly participating in his care and the names and functions of other health care persons having direct contact with the patient.
2. The right to transfer to another health facility due to religious or other reasons; the right to be informed of the facility's policies regarding patient rights during the admission process.
3. The right to each patient or patient's legally designated representative to have access to the information contained in the patient's medical records within the limits of state law.
4. The right to be informed of the medical consequences of refusing treatment; and
5. The right to assistance in obtaining consultation with another physician or practitioner at the patient's request and own expense.


Review of Patient 1's medical record showed Patient 1 received and signed the Patient Rights on 10/09/21, that did not include all of the Kansas required patient rights.

Review of Patient 2's medical record showed Patient 2 received and signed the Patient Rights on 07/16/21, that did not include all of the Kansas required patient rights.

Review of Patient 3's medical record showed Patient 3 received and signed the Patient Rights on 08/18/21, that did not include all of the Kansas required patient rights.

Review of Patient 4's medical record showed Patient 4 received and signed the Patient Rights on 11/21/21, that did not include all of the Kansas required patient rights.


During an interview on 12/15/21 at 11:07 AM Staff B, Quality Risk Manager (QRM) was given an opportunity to review the CAH's patient rights and acknowledged the missing state requirements.

Based on observation, document review, policy review, and interview, the Critical Access Hospital (CAH) failed to ensure expired medication were removed from the automatic medication dispensing system, crash cart, or the pharmacy. This deficient practice has the potential to cause harm, illness, or ineffective treatment for all patients.

Findings Include:

Review of the CAH's policy titled, "Medication Administration," dated 07/20/16, showed "To promote safety, drugs and biologicals will be ordered, prepared and administered in accordance with Federal and State laws and accepted standards of practice . . . Staff will demonstrate competency . . . knowledge of indications, side effects, drug interactions, compatibility, and dose limits."


Review of the CAH's grievance log showed an unidentified patient received an outdated tetanus-diphtheria (Td) vaccination (a combination of vaccination that protects against two potentially life-threatening bacterial diseases tetanus (bacterial infection that causes painful muscle spasm and can lead to death) and diphtheria (a highly contagious bacterial infection that causes inflammation of the mucous membranes, formation of a false membrane in the throat that hinders breathing and swallowing, and potentially fatal heart and nerve damage) on 05/04/21.


Observation on 12/08/21 at 2:25 PM showed a crash cart (a set of trays or drawers on wheels used in hospitals to transport, and dispense emergency medication and/or equipment, at the site of a medical and/or surgical emergency, for life support protocols, to potentially save someone's life) located at the north end of the hospital, had the following expired medications:

Epinephrine (a vasoconstrictor and blood pressure support used along with emergency medical treatment and to treat life-threatening allergic reactions) Injection vial 1 milligram (mg)/1 milliliter (ml) vial expired 10/2021.

Furosemide (a diuretic used to treat fluid retention and swelling caused by congestive heart failure, liver disease, kidney disease, and other medical conditions) 40 mg/3 ml in 3 ml vial expired 11/2021.

During an interview at the time of the observations, Staff D, Chief Nursing Officer (CNO) verified the expired medications.


Observation on 12/08/21 at 12:25 PM showed an automatic medication dispensing system (a machine that provides computer-controlled storage, dispensing and tracking of medications) at the nurse's station had the following expired medications in it:

Enoxaparin (an anticoagulant used to treat and prevent deep vein thrombosis (clots) and pulmonary embolism (clots in the lungs)) 300 mg/3 ml in 3 ml vial expired 11/2021.

Two bags of Levofloxacin (an antibiotic used to treat bacterial infections) in 5 % dextrose 750 mg/150 ml bag expired 11/2021.

During an interview at the time of the observation, Staff H, Registered Nurse (RN), verified the expired medication found.


Observation on 12/08/21 at 1:13 PM showed the pharmacy had expired medications:

Two vials of Rocuronium (a paralytic that relaxes muscles during surgery and medical procedures) 50 mg/5 ml vials expired on 12/06/21.

Nine tablets of Etodolac (treats pain and arthritis) 500 mg expired 04/2021.

Five vials of Lidocaine HCL injection (a local anesthetic to reduce pain or discomfort) 200 mg/5 ml in 5 ml vials expired 11/2021.

One bottle of Prednisone oral solution (a steroid used to treat inflammation) 5 mg/5 ml expired 11/2021.

One bottle, approximately 2/3 full of an eight-ounce bottle, of Senna Syrup (treats constipation) extract 176 mg/5 ml expired on 03/31/21.

One bottle, 100 tablets per bottle, approximately 2/3 full, of Butalbital Acetaminophen and Caffeine (treats headaches) expired 06/2021.

Two tablets of Rivastigmine (treats dementia) 3 mg caplets expired on 02/18/21.

100 tablets of Enalapril Maleate (treats high blood pressure) 20 mg expired 11/2021.

10 tablets of Ezetimibe (treats high cholesterol) 10 mg expired 11/2021.

One vial of Physostigmine Salicylate (treats glaucoma) 1 mg/ml expired 04/2021.

Four bottles of Albumin (preparation of human plasma) 5% expired on 06/21/21.

One tablet of Amitiza (treats constipation) 24 micrograms (mcg) expired 08/2021.

Partial box of 100 tablets of Topiramate (anticonvulsant and nerve pain medication) 25 mg expired 10/2021.

During an interview at the time of the observation, Staff G, Registered Pharmacist (RPh), acknowledged the expired medications and stated that if they [CAH] have someone with a reaction and if she had to choose between the use of an outdated drug or death, the outdated drug will be used.

Based on record review and interview the Critical Access Hospital failed to ensure dietary staff provided an appropriate diet, that did not contradict documented allergies, served to one of four patients reviewed (Patient 4). This deficient practice had the potential to cause harm, illness, or other adverse outcomes.

Findings Include:

Review of Patient 4's current medical record showed that she had allergies to codeine and red dye. Further review showed Staff Z, Licensed Practical Nurse (LPN), documented on 11/26/21 at 6:38 PM, "Patient . . . reports she is severely allergic to red dye, causing throat swelling. Patient did receive red Jell-O yesterday but did not eat it."

During an interview on 12/15/21 at 12:26 Staff D, Chief Nursing Officer (CNO) stated that a report is automatically generated several times a day that includes a list of inpatients, their diet orders, and their allergies. The kitchen gets this automated report to refer to while preparing trays.

Based on record review and interview the Critical Access Hospital (CAH) failed to ensure nursing services met the needs of patients for the use of Thrombo-Embolic-Deterrent hose (TED -compression stockings to prevent blood clots in the legs), sequential compression devices (SCD- device used to prevent blood clots in the legs) for two of four patients reviewed (Patient 1 and 4), and repositioning for one of four patients reviewed (Patient 1). This deficient practice has the potential to cause harm or other adverse outcomes.


Findings Include:


Patient 1

Review of Patient 1's discharged medical record showed a document titled, "Deep Vein Thrombosis (DVT) (a condition that occurs when a blood clot forms in one or more of the deep veins in your body, usually in your legs) Risk Factor Assessment and Order Form," completed on 10/09/21 that scored Patient 1 as "Very High Risk, Score of three (5) [sic] or greater." The box for Sequential Compression Device (SCD) (sleeves that wrap around the legs and inflate with air one at a time. This imitates walking and helps prevent blood clots), is checked and the "calf" is circled, and "WITH (sic) elastic stockings (TED hose -compression stockings designed to help prevent the occurrence of and guard against further progression of venous disorders such as edema [swelling], phlebitis [inflammation of a vein with or without a blood clot], and thrombosis [blood clot] . . . "

Patient 1's discharged medical record showed that staff must document on the written TED hose Order twice a day with the question "TED hose on?" All documentation for the order were marked "N" for "no" during Patient 1's stay at the CAH.

Patient 1's hourly checks completed by the nursing staff and certified nurse aides (CNA) showed that at each hourly check made, "no" was selected for the prompts of TED hose and SCDs. Patient 1's hourly checks that were documented in in the medical record showed the comment sections were left blank.

The medical record lacked documented evidence that TED hose or SCDs were used as ordered.

During an interview on 12/14/21 at 10:30 AM, Staff L, RN stated that there is a DVT risk sheet that is completed and that TED hose and SCDs are usually checked off. Staff L stated that TED hose is usually worn when the patient is out of bed and the SCDs while the patient is in bed. Staff L stated that if a patient refuses the TED hose or SCDs there is a comment box in the hourly check where the nursing staff can document the reasons why they are not being used or refused.


Patient 1 Repositioning:

Review of Patient 1's discharged medical record, physical therapy note dated 10/11/21 at 4:01 PM showed Patient 1 required moderate assistance from staff with rolling and moderate assistance to complete laying on his back and to sit.

Review of Patient 1's hourly checks documented by nurses and CNAs showed the following:

1. 10/09/21 11:47 AM through 10/09/21 5:08 PM Staff AA, Certified Nursing Aide (CNA) documented that Patient 1 was in a semi-fowler (a position in which a patient is on their back and the head of the bed is between 30- and 45-degree angle) sitting position at each of her hourly checks.
2. 10/09/21 7:23 PM through 10/10/21 6:00 AM Staff S, CNA, documented that Patient 1 was in a semi-fowler position at each of her hourly checks.
3. 10/10/21 7:55 AM through 6:02 PM Staff AA, CNA documented that Patient 1 was in a semi-fowler position other than sitting in a chair for lunch and dinner at each of her hourly checks.
4. 10/10/21 10:03 PM through 10/11/21 6:00 AM Staff S, CNA, documented that Patient 1 was in a semi-fowler position at each of her hourly checks.
5. 10/11/21 1:09 PM through 10/11/21 5:06 PM Staff EE, CNA, documented that Patient 1 was in a semi-fowler position at each of her hourly checks except time spent in a chair for dinner.
6. 10/11/21 7:47 PM through 10/12/21 6:15 AM Staff AA, CNA, documented that Patient 1 was in a semi-fowler position at each of her hourly checks.
7. 10/12/21 7:39 AM through 10/12/21 4:17 PM Staff L, Registered Nurse (RN), documented that Patient 1 was in a semi-fowler or high-fowler position in bed during her hourly checks.
8. 10/12/21 7:52 PM through 5:29 AM Staff S, CNA, documented that Patient 1 was in a semi-fowler position at each of her hourly checks.
9. 10/13/21 8:02 AM through 1:25 PM Staff AA, CNA, documented that Patient 1 remained in a high-fowlers position in bed or chair at each of her hourly checks and then semi fowlers 3:27 PM through 5:26 PM.
10. 10/13/21 9:12 PM through 10/14/21 9:57 AM, Staff Q, RN, Staff FF, CNA, and Staff Q, RN documented that Patient 1 was in a semi-fowler position at each of their hourly checks.
11. 10/14/21 9:57 AM through 6:10 PM Staff GG, CNA, documented that Patient 1 was sitting in the chair at each of her hourly checks.
12. 10/14/21 7:35 AM through 10/15/21 2:22 AM Staff FF, CNA, documented that Patient 1 was semi-fowlers at each of her hourly checks.
13. 10/15/21 at 3:01 AM was the first documentation that the patient was supported to a position that was off his bottom. There was no documented evidence that Patient 1 was repositioned every two hours.


Patient 4

Review of Patient 4's discharged medical record showed that Patient 4 arrived to the Emergency Department (ED) for a cerebrovascular accident (CVA, a stroke) on 11/21/21 and admitted to acute care for further care and treatment. On 11/22/21 at 10:04 PM, was the first documentation that TED hose and SCD's were not in use. There was no further documented evidence of use of TED hose or SCD's during Patient 4's acute stay until admitted to Swing-bed on 11/24/21



During an interview on 12/08/21 at 2:43 PM, Staff D, Chief Nursing Officer, (CNO), stated that the standard of care is that all nursing staff round a minimum of every two hours, and the certified nursing assistants round hourly on patients. Patients are to be turned every two hours, unless there is a physician order stating otherwise. There is no policy on turning, it is a hard stop in the electronic record, that turns the screen "pink" when it is time to document turning.


During an interview on 12/14/21 at 10:07 AM, Staff S, Certified Nurse Assistant, (CNA), stated that the CNA's and RN's are expected to round on their patients hourly. Staff S stated that the TED hose is to be worn during the day, off at night. The SCD's are to be worn at bedtime. The staff does have an area in the charting that they can document why the SCD's or TED hose are off, such as a patient request.


During an interview on 2/14/21 at 12:39 PM, Staff AA, CNA, stated that staff round hourly to address bathroom, repositioning, and feeding. Ted hose are to be worn during the day, and SCD at night when patients are in bed. Staff AA stated that she could not recall if Patient 1 wore his TED hose as ordered but does recall one time placing them on the patient.

Based on record review, policy and procedure review, and interview the Critical Access Hospital (CAH) failed to ensure medication allergies were documented on the Medication Administration Summary, failed to ensure medications allergies were reviewed and updated in the medical record and failed to ensure a documented allergy to a medication was not given to one of four patients reviewed (Patient 1). This deficient practice has the potential to cause illness, serious adverse outcomes, or death.

Findings Include:

Review of the CAH's document titled, "Medication Administration," dated 07/20/16, showed "To promote safety, drugs and biologicals will be ordered, prepared and administered in accordance with Federal and State laws and accepted standards of practice . . . The medication administration process will include components to assure the 5 [five] rights are confirmed with each administration . . . Right Medication - medications will be scanned before administration. Pharmacy will maintain the barcodes on each medication. Allergy information must be added to the patient's profile in the Electronic Medication Charting system before medications are added to the patient's profile."


Patient 1

During an interview on 12/15/21 at 10:41 AM, F1 (family member and durable power of attorney for Patient 1) stated that Patient 1 had developed an allergy to penicillin (an antibiotic used to treat bacterial infections) five or six years ago.

Review of Patient 1's discharged medical record showed a form titled, "Magnetic Resonance Procedure Screening form for Patients," completed by Patient 1 on 10/11/21. Patient 1 marked that he had allergies and wrote in Penicillin. Further review of the medical record showed notes pulled into Patient 1's medical record from the CAH's clinic that showed Patient 1 had an allergy to Penicillin. Review of documentation from the patient's primary care physician dated 09/13/21 and added 10/13/21 to the patient's record showed that Patient 1 has an allergy to Penicillin. Review of the Kardex in the medical record showed that an employee had hand written that Penicillin was a patient allergy.

Review of Patient 1's "Medication Administration Summary" showed, "No known allergies."

Review of an order entered by Staff G, Registered Pharmacist (RPh), on 10/12/21 at 11:17 AM showed Zosyn (an antibiotic to treat a bacterial infection), 4.5 milligrams (mg). The Comment showed: "Zosyn is a penicillin. Double check allergies." Further review of the medical record showed there was no documentation that allergies were checked prior to the administration of Zosyn.

Patient 1's medical record showed an order was written on 10/13/21 for hydrocortisone (a topical steroid medication used to treat redness, swelling, itching, and discomfort of various skin conditions) 1% apply to back rash every eight hours as needed (PRN) for rash. Cetirizine (medication used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives and itching) 10 mg and Fluticasone (nasal steroid used to treat the symptoms of allergic and non-allergic nasal symptoms) were started on 10/15/21 by Staff O, Advanced Registered Nurse Practitioner (ARNP).

During an interview on 10/14/21 at 8:37 AM Staff O, ARNP, stated that he was not aware of Patient 1's allergy to penicillin and that he missed it, that the error "was on him and that the rash was most likely because of the patient's allergy to penicillin" than his original thought of contact dermatitis.


Patient 4

Review of Patient 4's current medical record showed that she had allergies to codeine and red dye. Further review of Patient 4's discharged acute care medical record showed a document titled "Magnetic Resonance (MR) Procedure Screening Form for Patients." completed by F5, Patient 4's niece, on 11/22/21. The form showed "Are you allergic to any medication?" and provides space to write in the allergies. The question remained unanswered and nothing was written into the comments. Staff JJ, Radiology Technician (RT), signed the form as reviewed and failed to document the patient's allergies.

During an interview on 12/14/21 at 9:09 AM Staff Q, Registered Nurse (RN), stated that nurses should be documenting the patient's allergies upon admission unless the doctor documented them during their history and physical. Staff Q stated that she did recall that the patient complained of itching, he had a rash on his back, and medication was provided to treat the rash. Any allergies that are written on the Kardex, are placed there by the initial RN, or Charge RN, and are to be placed in the computer system.

During an interview on 12/14/21 at 2:01 PM, Staff V, RN stated that if they are pulling the information from the patient's history, they should still be double checking with the patient by asking the patient directly.

During an interview on 12/15/21 at 8:39 AM, Staff B, Quality Risk Manager (QRM) stated that if you are a first-time patient that there are hard stops in the computer system that forces you to enter allergies before you can enter any medication orders. If it is a subsequent visit, there is no spot or button to push stating that you had verified the allergies this visit.

During an interview on 12/15/21 at 12:25 PM, Staff D, Chief Nursing Officer, stated that if a patient has never been to the facility before, the allergies must be placed in the computer system by a Registered Nurse. No medications can be given until allergies have been addressed. If the patient has been here before, there is a "glitch", and medication can be provided without addressing any new allergies. She stated that it is her practice to ask patients each time before medication administration, what their allergies are. She stated that she does monitor if allergies were put in the system as part of her monthly audits. The computer system at the clinic is different than that of the CAH, so any allergies that were listed in the clinic system, would have to place into the computer manually by an RN.

Based on observation, document review, and interview, the Critical Access Hospital (CAH) failed to ensure medication to treat malignant hyperthermia (a life-threatening reaction that occurs on administration of general anesthesia, characterized by hyper metabolism causing high body temperatures that may exceed 110 degrees Fahrenheit, rigid muscles or spasms, and a rapid heart rate. Severe complications include cardiac arrest, brain damage, internal bleeding or failure of other body systems) was available during surgical procedures in which general anesthesia was being used.

The cumulative effects of this deficient practice resulted in 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) situation.

On 12/09/21 at 11:35 AM the surveyor notified the Critical Access Hospital that 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) situation existed related to 42 CFR 485.639, Surgical Services.

The hospital submitted an IJ plan of removal that was accepted and verified by the onsite surveyors on 12/09/21 at 3:18 PM, prior to survey exit. The plan of removal included the following:

1. A drop ship order was submitted for one additional vial of Ryanodex (medication used to treat malignant hyperthermia) the morning of 12/09/21. The order was expected to arrive 12/10/21. Thirteen (13) vials of Revento (medication used to treat malignant hyperthermia) were acquired at the facility on 12/09/21 at 1:17 PM.

2. On 12/09/21 the "Malignant Hyperthermia Protocol" was updated to state [CAH] will keep in stock a minimum of 720 milligrams (mg) of dantrolene (generic name for Ryanodex), which may include Ryanodex, Dantrium (medication used to treat malignant hyperthermia), or Revonto.

3. On 12/09/21 surgery personnel were educated on the changes made to the updated "Malignant Hyperthermia Protocol." The pharmacist will create reference guides for personnel on proper preparation of required medications. Reference guides for the use of the medications and Ryanodex dosage schedule to treat malignant hyperthermia with the Malignant Hyperthermia Association of the United States (MHAUS) hotline phone number, are currently attached to the automatic medication dispenser anesthesia workstations and on all crash carts. Surgery, anesthesia and nursing personnel will be re-educated on the location for the reference guides. The Certified Registered Nurse Anesthetist (CRNA) on call received written and verbal education on the use of the reversal agents for malignant hyperthermia by her supervisor on 12/09/21. An in-person competency check-off for malignant hyperthermia will be held on or before 12/20/21 for surgery, anesthesia, and nursing personnel.

4. The Chief Executive Officer (CEO) will ensure the training for the CRNA on 12/09/21 and the in-person competency check-off are completed by all necessary personnel. The pharmacy and surgery departments, through Quality Assurance and Performance Improvement (QAPI), will monitor the inventory of malignant hyperthermia medications to ensure the proper quantity is available. [CAH] will continue to include malignant hyperthermia in the annual competency fair for all nursing and anesthesia personnel.


Findings Include:


Review of the Malignant Hyperthermia Association of the United States (MHAUS) recommendations showed there are two formulations of dantrolene to treat malignant hyperthermia (MH): 1. DANTRIUM®/REVONTO® (a medication which is a skeletal muscle relaxant and the only currently accepted specific treatment for malignant hyperthermia) - 36 vials should be available in each institution where MH can occur, each vial to be diluted at the time of use with 60 ml sterile water, or, 2. RYANODEX® (a medication which is a skeletal muscle relaxant and the only currently accepted specific treatment for malignant hyperthermia) - stock a minimum of 3 - 250 milligrams (mg) vials (total of 750 mg). Dantrolene must be available for all anesthetizing locations within 10 minutes of the decision to treat for malignant hyperthermia.


Review of the CAH's document titled, "Malignant Hyperthermia Protocol" dated 12/19/18 showed that the CAH will keep a minimum of 2 vials of 250 mg of Ryanodex (a total of 500 mg).

Review of the CAH's drug formulary showed they use the following anesthetic agents which are known triggers for a Malignant Hyperthermia Crisis (the malignant hyperthermia crisis is "triggered" by commonly used general anesthetics and the paralyzing agent succinylcholine (a neuromuscular blocker), within the skeletal muscles of susceptible individuals): Succinylcholine, Sevoflurane, and Desflurane.


Observation on 10/08/21 at 11:34 AM during a tour showed the CAH had two operating rooms and one procedural room.

Review of the Hospital/CAH Database Worksheet updated on 10/08/21 by Staff C, Executive Assistant, showed the CAH provided anesthesia services; emergency services; nuclear medicine services; inpatient and outpatient surgery services to include orthopedic surgeries to include shoulder, hip, knee, hand, and elbow; general abdominal laparoscopic surgery; dental surgery; scopes; cesarean sections; plastic surgery; hardware removal; and trauma care.


Review of the operating room schedule showed that the CAH had two umbilical hernia repairs scheduled for 12/08/21, four colonoscopies (a procedure in which a flexible fiber-optic instrument is inserted into the anus to examine the colon) and four esophagogastroduodenoscopies (an examination of the lining of the throat, stomach and first part of the small intestine using a camera held on to a flexible tube called an endoscope) were scheduled for 12/09/21.


The CAH failed to have the recommended amount of Ryanodex or Dantrium available for use to treat an episode of MH and the Malignant Hyperthermia Protocol does not reflect the MHAUS recommendation to have a stock of a minimum of 3 vials of Ryanodex or 36 vials of Dantrium.


During an interview on 12/08/21 at 1:13 PM, Staff G, Registered Pharmacist (RPh), verified that the hospital only has two vials of Ryanodex on hand. Staff G stated that two vials were more than enough to treat a case.


During an interview 12/09/21 at 7:57 AM, Staff K, Certified Registered Nurse Anesthetists (CRNA), stated that she has been a CRNA for three years, and has never had a Malignant Hypothermia (MH) patient. Staff K stated that once she recognized the signs of MH, she would stop the surgery, administer the reversal mediation to treat MH and call the MH Hotline to ask for guidance. She stated that the medication the facility uses is Ryanodex, but does not know the concentration of the bottle in her Anesthesia cart. She stated that it is to be mixed with Sterile Water but does not know how much is needed to reconstitute the medication. Staff K stated that she is unsure how many bottles of the medication are on her cart, or how many bottles are recommended by MHAUS are to be stocked of Ryanodex.