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Based on observation, document review, and staff interviews, the Critical Access Hospital (CAH) staff failed to remove outdated supplies from 1 of 1 Medical/Surgical Unit, and 1 of 1 Surgery Department. The CAH administrative staff identified a census of 4 patients at the beginning of the survey and perform approximately 476 surgical procedures per year. Failure to remove outdated patient supplies from the CAH's supplies, available for use in patient care, could potentially result in staff using the expired items for patient care after the manufacturers' expiration date, indicating the staff should not use the supplies for patient care.

Findings include:

1. Observations on 10/12/2020 at 10:25 AM, during a tour of the Medical/Surgical Unit, revealed the following:

a. 1 of 2 Patterson Medical Chair Sensor Pad (pad that senses patient movement off a chair/bed triggering a
monitor) expired 09/19/2020.
b. 1 of 2 Patterson Medical Chair Sensor Pad without a date opened and not labeled with date of first use.
c. 1 of 2 Patterson Medical Bed Sensor Pad expired 09/19/2020.
b. 1 of 2 Patterson Medical Bed Sensor Pad without a date opened and not labeled with date of first use.

During an interview on 10/12/2020 at the time of the tour, the Medical/Surgical Manager confirmed the outdated supplies in the Medical Surgical supply closet and reported nursing staff should be checking the supplies monthly.

Review of manufacturer's documentation revealed in part, "...Do not use a pad that is past its warranty date...."
Warranty date for the Patterson Medical Chair Sensor Pad listed as 1 year. Warranty date for the Patterson Medical Bed Sensor Pad listed as 180 days.

During an interview on 10/14/2020 at 10:30 AM, the Chief Nursing Officer stated the CAH lacked a policy to address the use of the Medical Chair or Bed Sensor Pads.

2. Observations on 10/13/2020 at 2:15 PM, during a tour of the Surgery Department, revealed the following expired supplies in the crash cart (emergency supply and drug cart):

a. 5 of 5 Pink top vacutainer blood tubes (used to collect blood sample) expired 12/31/2019
b. 5 of 5 Green vacutainer blood tubes expired 09/30/2019
c. 5 of 5 Grey top vacutainer blood tubes expired 02/29/2020
d. 5 of 5 Purple top vacutainer blood tubes expired 02/29/2020

During an interview on 10/13/2020 at the time of the tour, the Surgery and Wound Care Manager confirmed the outdated supplies in the surgery department. The Director of Patient Care Services reported it was the responsibility of the nursing staff to monthly monitor and remove from use outdated patient care supplies from the crash cart.

Review of documentation revealed the surgery department crash cart was last checked for outdated supplies on 10/13/2020.

Review of policy "Checking Outdated Medications and Supplies," revealed in part, "...Any supplies not stocked in PAR [predetermined quantity of supply] level bins will be the responsibility of the department staff to check for outdates...."

Based on observation, document review and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure all drugs are appropriately stored (properly secured) when it maintained drugs, including controlled medications (medications that can cause physical and mental dependence) in 3 of 3 mobile carts containing medications (anesthesia medication arcart, Surgery Department crash cart, and omnicell medication cart) in an unsecured surgery department near unlocked public access doors. Failure to appropriately secure drugs, including controlled medication, could result in unauthorized access to the medication and drug diversion for personal use.

Findings include:

1. Review of policy "Security of Medications-Anesthesia Carts", dated last reviewed on 12/16//20, revealed in part, "scheduled drugs ... shall be locked within a secure area ... only authorized staff ... access to locked areas ... stored in a secure area ... where access by unauthorized staff is prohibited ... All controlled substance must be locked within a secure area ... "

Review of pharmacy policy "Medication Control Omnicell", approved 09/26/2016, revealed in part, "... to ... control and secure ... all medications, including controlled substances ... to conform with ... federal and state regulations ... All medications stocked in a patient care area are secured ..."

2. Observations during a tour of the Surgery Department on 10/12/2020 at approximately 1:45 PM, revealed 1 mobile, wheeled anesthesia medication cart in an unlocked, unsecured operating room and 2 mobile, wheeled carts (surgery department crash cart and Omnicell medication cart) located in the unsecured surgery department hallway adjacent to unlocked surgery department public access doors. The surgery public access doors, upon exit of the surgery department, lead to a public hallway, a nearby building exit, and parking lot. The wheeled, mobile medication carts are identified as follows:

a. 1 of 1 anesthesia cart, contained approximately 150 medications, including controlled drugs (medications such as morphine and fenanyl), that may be administered to a patient during a surgical procedure for sedation and pain control.

b. 1 of 1 Omnicell medication dispensing cart, containing approximately 200 medications, including controlled drugs, that may be administered to a surgical patient pre and/or post surgical procedures.

c. 1 of 1 surgery department crash cart, contained approximately 100 medications, that may be admisnistered to a surgical patient experiencing an emergency medical condition.



3. During an interview on 10/13/2020, at the time of the tour, Surgery and Wound Care Manager acknowledged the 3 carts, which contained drugs, including controlled substances, were not secured. The surgery department had at least 5 entry doors and none of the 5 doors are locked when the dpartment is not staffed. The Surgery and Wound Care Manager acknolwdged it would be possible for an individual person(s) to roll the carts through any of the 5 unlocked access doors, into a hallway and out of the building without detection.

4. During an interview on 10/14/2020 at 1:24 PM, Pharmacy Manager acknowledged the pharmacy is responsible for all medications in the hospital . The Pharmacy Manager acknowledged she knew that the Surgery Department was not a locked department after hours when the department is closed and not staffed. The Pharmacy Manager revealed they knew the carts were on wheels and the location of the carts, but had not thought about the lack of security as the carts had always been that way. The Pharmacy manager acknowledged the three medication carts, included controlled medications, and despite being locked, failed to be secured because the carts could be rolled out of the department and the hospital.

Based on review of policies/procedures, meeting minutes, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the required group of professionals, including a physician, and a mid-level provider reviewed all patient care policies annually for 7 of 23 patient care departments (Cardiac Rehabilitation/Pulmonary Rehabilitation, Respiratory Therapy, Environmental Services, Laboratory, Maintenance, and Materials Management). The CAH administrative staff identified a census of 4 patients at the beginning of the survey. Failure to ensure the required group of professionals reviewed all patient care policies annually could potentially result in failure to identify patient care needs not addressed in the CAH policies/procedures.

Findings include:

1. Review of the CAH policy "... Policy Review Committee members will include: Physician, Advanced Practice Provider ... Policy and Procedure Development and Review," last reviewed 05/27/2020, revealed in part, "... Upon completion of each Department's annual policy and procedure review by the Policy Review Committee, all information will be forwarded on to the Board of Trustees for review and approval...."

2. Review of the "Policy Review Committee," meeting minutes from August 29, 2019 through August 19, 2020 lacked annual approval for all policies for Cardiac Rehabilitation/Pulmonary Rehabilitation, Respiratory Therapy, Environmental Services, Laboratory, Maintenance, and Materials Management.

3. During an interview on 10/14/2020 at 11:20 AM, the Chief Operating Officer acknowledged lack of annual approval for all policies by the required group of professionals for Cardiac Rehabilitation/Pulmonary Rehabilitation, Respiratory Therapy, Environmental Services, Laboratory, Maintenance, and Materials Management.

Based on observation, document review, and staff interview, the Critical Access Hospital's (CAH) administrative staff failed to ensure the staff removed outdated medication from 3 of 4 Crash Carts (emergency drugs and supply carts). Failure to remove outdated medications from the CAH's supplies, available for patient use, could potentially result in the staff using expired medications for patient use after the manufacturer's expiration date, potentially resulting in the staff using medication on a patient after the date which the manufacturer guaranteed the sterility and efficacy of the medication. The administrative staff identified approximately 1,571 Cardiac Rehab patients, 476 Surgical patients, and 3500 Emergency patients received care in fiscal year July 1, 2019 to June 30, 2020.

Findings included:

1. Observations on 10/12/2020, at 1:15 PM, during a tour of the Emergency Department (ED), revealed 1 of 1 Flumazenal 0.5 mg per 5 ml vial, expired 7/2020, and 2 of 2 50% Dextrose Injection (0.5 grams/ml) 25 grams per 50 ml, Expired 9/2020, readily available for patient use, in the emergency crash cart.

Review of ER policy "Crash Carts" , approved 1/02/2020, revealed in part, "ER nurses will inspect the crash cart medications ... for outdates on the first of the month."

Review of ER policy "Checking outdated medications and supplies", approved 08/06/2018, revealed in part, "crash cart is checked for outdated medications..at the first of every month...outdated drugs are returned to pharmacy for replacement"

Review of "LCHC ER DAILY CHECKS", revealed "10/6/2020 outdates completed".

During an interview on 10/12/2020, at the time of the observation, the ER Nurse Manager acknowledged the medications were outdated and ER nursing staff failed to remove the outdated medications from the crash cart.


2. Observations on 10/13/2020 at 11:30 AM, during a tour of the Cardiac Rehab Department, revealed 1 of 1 Lidocaine Cream 2% expired 1/2020 in the crash cart (emergency drugs and supply cart).

During an interview on 10/13/2020, at the time of the observation, the Cardiac Rehab Manager acknowledged the medication was outdated and cardiac rehab staff failed to remove the outdated medication from the crash cart.


3. Observations on 10/13/2020 at 2:15 PM, during a tour of the Surgery Department, revealed the following:
a. 1 of 1 Sodium Bicarbonate Inj USP 8.4%, expired 4/2019 with a note on the box "use until Pharmacy can get in- short supply"
b. 2 of 2 Magnesium Sulfate Injection, 1 Gram per 2 ml expiration date 9/2020
c. 1 of 1 Intralipid 20% 250 ml, expiration date 9/2020

Review of Central Sterile policy "Outdated Medication & Supplies", approved 12/13/2016, revealed in part, "Medications that will outdate within the next three months will be pulled ... taken to Pharmacy ... responsibility of all surgery staff ... checking ... date of expiration."

Review of document "MONITORS/DEFIBRILLATOR TO BE CHECKED WHEN DEPT. STAFFED", revealed in part, "Check Drugs [Expiration] Dates monthly ... 9/10/2020 staff initials".

During an interview on 10/13/2020, at the time of the observation, the Surgery and Wound Care Manager acknowledged the medications were outdated and surgery staff failed to remove the outdated medication from the crash cart.


4. Review of Pharmacy policy "Checking Outdated Medications and Supplies", last reviewed 02/26/2020, revealed in part, "Other Departments Affected: All Departments ... Any medication stored ... crash cart ... responsibility of the department ... check outdates ... expired will be returned to pharmacy for disposal and replacement."

During an interview on 10/14/2020 at 9:00 AM, the Pharmacy Manager revealed that the hospitals had no drug shortages and had adequate supply of medications available for patient use, including the medications listed above.

Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure timely physician notification for the occurrence of a medication error for 3 of 12 medication errors reviewed. (Patient #1, Patient #2, and Patient #3). Failure to notify the physician of medication errors could potentially result in the provider not knowing about the medication error and either failing to take steps to address the consequences of the medication error, or the provider making a medical decision without the knowledge of the medication error, either way potentially resulting in inappropriate treatment or even a fatal reaction. The CAH administrative staff reported a census of 4 patients on entrance, and an average daily census of 3 patients per day.

Findings include:

1. Review of "Medication Administration" last reviewed 02/26/2020, revealed in part: "All medication errors (e.g. incorrect dose or solution, time, route, patient, drug) must be reported to the provider immediately and an event reporting form must be completed."

2. Review of medication errors from September 2019 to September 2020 revealed:

a. The nursing staff made a medication error (medication ordered-not administered) on 02/21/2020 at 19:00 PM which involved Patient #1. Patient #1's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #1's medical care of the medication error.

b. The nursing staff made a medication error (medication administered too close to last dose) on 10/28/2019 at 16:01 PM which involved Patient #2. Patient #2's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #2's medical care of the medication error.

c. The nursing staff made a medication error (medication administered late, needed to be given on schedule for required laboratory blood collection) on 03/05/2020 at approximately 11:00 AM which involved Patient #3. Patient #3's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #3's medical care of the medication error.


3. During an interview on 10/13/2020 at 01:30 PM, the Clinical Operations Officer acknowledged the medication error paperwork for Patient #1, Patient #2, and Patient #3, lacked documentation that the nursing staff notified the patient's provider of the medication error.

Based on observation, document review, and staff interviews, Critical Access Hospital (CAH) administration failed to ensure CAH staff tested the emergency department medical providers for color blindness so providers could correctly read results for occult blood (blood in the stool) in 20 of 20 medical providers. Failure to test medical providers for color blindness before performing this test may result in providers misreading the results of the Hemoccult slide which could potentially adversely affect the diagnosis and treatment plan for patients. The CAH identified approximately 3,500 patients presented to the emergency department for care per year, and the emergency providers performed approximately 24 occult blood tests per year.

Findings include:

1. Observation on 10/12/2020 at 1:12 PM, during a tour of the Emergency Department with the ED & Ambulance Manager and the Chief Nursing Officer (CNO), revealed the emergency department providers utilized Beckman Coulter Hemoccult Slides for testing of occult blood (blood in the stool).


2. During an interview on 10/12/2020, at the time of the observation, the Chief Nursing Officer reported the CAH staff had started color blind testing of all new hired staff and had begun the process to colorblind test all staff hired prior to the onset of testing. The emergency room providers had not been among the staff hired and tested, many of the providers were contracted staff and the CAH failed to recognize the need for the emergency providers to be tested for color blindness.

Interview on 10/15/2020 at approximately 10:30 AM, Chief Operations Officer reported the CAH had 20 emergency medical staff providers that worked the emergency department. The CAH did not have documentation in the providers credential files that any of these 20 providers had been tested for color blindness.


3. Review of manufacturer's directions for the Beckman Coulter Hemoccult Slides, copyright 2015 revealed in part, "The Hemoccult test is a rapid and qualitative method for detecting fecal occult blood (blood in the stool). Read results within 60 seconds, a blue color will appear on the slide after two drops of developer applied directly over the fecal (stool) smear if positive for blood ... Because this test is visually read and requires color differentiation, it should not be interpreted by individuals with blue color deficiency (blindness) ..."

Based on observation, review of policies/procedures, and staff interviews, the Critical Access Hospital (CAH) Rehabilitation Services Department, Cardiac Rehabilitation Department, and Surgery Department staff failed to protect all confidential patient information from unauthorized access in 2 of 2 Outpatient Clinics and 1 of 1 Surgery Department. Failure to secure medical records against unauthorized access could result in identity theft and/or unauthorized disclosure of personal medical information. The CAH clinic administrative staff identified a combined average of 7,493 out-patient Rehabilitation Service and Cardiac Rehabilitation visits, and an average of 476 OR (Operating Room) procedures (07/01/2019-06/30/2020) over the past fiscal year.

Findings include:

1. Observation on 10/12/2020 at 1:30 PM, during a tour of Rehabilitation Services Department, and on 10/13/2020 at 11:30 AM, during a tour of Cardiac Rehabilitation Department, revealed 2 of 2 FAX machines located in an unlocked area of each nursing office space. A file cabinet in the Rehabilitation Services Department containing confidential patient information located in an unlocked area of the nursing office space, revealed the file cabinet is locked after hours, however, the keys to the cabinet are left in the unlocked office space, potentially allowing unauthorized personnel access to confidential patient information.

2. During an interview on 10/12/2020 at 1:45 PM, Manager of Rehabilitation Services Department revealed the Rehabilitation Services Department areas are locked when the departments are closed, however, housekeeping staff have access to the locked departments and clean in the early morning hours when the departments have no staff present. Fax machines are not secured and private patient information is received after hours and sit on the Fax machines until staff retrieves the information. The Manager of Rehabilitation Services Department acknowledged that the private patient information on the FAX machine and in the file cabinets is available for unauthorized personnel access. The Manager of Rehabilitation Services Department acknowledged the private and confidential patient information is not secured as hospital policy requires.

During an interview on 10/14/2020 at approximately 3:15 PM, Manager of Rehabilitation Services Department revealed the Rehabilitation Services received approximately 8 Faxes per month after the clinic has closed

During an interview on 10/13/2020 at approximately 3:45 PM, RN of Cardiac Rehabilitation Services revealed the Cardiac and Pulmonary Rehabilitation received approximately 6 Faxes per month after the clinic has closed


3. During an interview on 10/13/2020 at 11:30 AM, at the time of the tour, RN of Cardiac Rehabilitation Services acknowledged that at times confidential patient information is sent by FAX after hours which could potentially be viewed by unauthorized personnel.

4. Review of policy "Locking Patient Files", reviewed 12/17/2019, revealed in part, "It will be the policy of the Rehabilitation Services Department to protect the privacy of all patients by appropriately locking patient files within our department."

5. Review of policy "Confidentiality and Security", reviewed 05/01/2020, revealed in part, "Information known or contained in the patient's medical record shall be treated as confidential".


6. Observation on 10/14/2020 at 8:49 AM, during a tour of the Surgery Department with the Surgery Nurse Manager, revealed the following in the staff break room:

a. approximately 40 medical records of patients that had received pain procedures provided by CRNA A in the past year, in an unsecured file drawer.

b. a 3 shelf tray file on top of the counter which contained confidential patient information of scheduled patients for the current week

During an interview on 10/14/2020 at the time of the tour, the Surgery Nurse Manager reported that the staff break room is locked at the end of the day to secure the records, however housekeeping had a key to the staff break room and may clean the break room after surgery staff have left for the day.