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Based on review of documentation and staff interview, the Critical Access Hospital (CAH) administrative staff failed to develop, evaluate, and implement, an effective Quality Improvement Program to evaluate and improve the quality and appropriateness of patient care and to improve quality on a continuous basis regarding the problem identified that the nursing staff failed to properly dispose of and waste narcotics in a timely manner per CAH policy. The administrative staff identified an average daily census of 1 patient. Failure to create and implement an effective quality improvement program that included involvement of all of the CAH's departments to improve quality and patient safety on a continuous basis and properly dispose or store narcotics away in a timely manner could potentially result in the CAH staff's failure to identify, monitor, address, and improve patient care, and could potentially result in the misuse of narcotics by the CAH staff.

Findings include:

1. Review of the CAH "Loring Hospital Quality Assessment/Performance Improvement Plan" revealed in part, "The Quality Plan of Loring Hospital will develop, implement, and maintain an effective, ongoing, hospital-wide data drive quality assessment and performance improvement program. This plan will reflect the complexity of the hospital's organization and include all hospital patient care services and other services affecting patient health and safety ... Focus on ... problem prone areas ... that clear expectations for safety are established ...."


2. Review of medication errors revealed:

a. On 02/17/2020 at 1:20 AM, Dilaudid (hydromorphone-narcotic for treating pain) 0.5mg, removed, not charted, not wasted.

b. On 02/17/2020 at 4:23 AM, Dilaudid 0.5mg, removed, not charted, not wasted

c. On 05/19/2020 at 10:17 PM, Fentanyl (narcotic for treating severe pain) 100mcg removed, 75mcg wasted documentation, 25mcg not charted, not wasted.

d. On 10/17/2019 at 3:04 PM, Roxanol (Morphine Sulfate-narcotic for the treatment of pain) removed at 3:04 PM and returned to Pyxus at 5:19, unsecured narcotic for over 2 hours.

e. On 10/05/2019 at 7:34 PM, Klonopin (clonazepam--anti-anxiety) removed, not charted, not wasted

f. On 09/17/2019 at 1:12 PM, Dilaudid 2mg removed, 1mg not given, not charted, not wasted.

g. On 09/22/2019 at 7:30 AM Fentanyl 100mcg removed, 100mcg documented wasted, 50mcg documented given, unsure if dose was given

h. On 09/17/2019 at 07:13 AM Dilaudid removed, not given until 08:52 AM, controlled substance not under double lock until given

i. On 12/15/2019 at 09:40 AM, Hydromorphone (narcotic for treating pain) 0.5mg removed, waste documented, dose given documented. Unsure if waste documented was correct.

j. On 12/15/2019 at 11:47 AM, Hydromorphone 0.5mg removed, waste documented, dose given documented. Unsure if waste documented was correct.

k. On 12/15/2019 at 1:51 PM, Hydromorphone 0.5mg removed, waste documented, dose given documented. Unsure if waste documented was correct.

l. On 12/15/2019 at 4:13 PM, Hydromorphone 0.5mg removed, waste documented, dose given documented. Unsure if waste documented was correct.

m. On 01/28/2020 at 8:16 AM, Diazepam (controlled substance-given for anxiety)10mg removed, 5mg documented given at 8:25 AM, waste documented at 3:25 PM. Nurse staff carried medication in pocket for 7 hours.

n. On 01/03/2020 at 12:06 PM, Lorazepam 1mg removed, waste documented at 12:06 PM, dose given documented at 12:06 PM, waste documented at 4:26 PM. Unsure if waste/dose given was accurate.

o. On 01/01/2020 at 06:59 AM, Fentanyl 100mcg removed, 25mcg dose given documented at 07:08 AM, 75 mcg dose wasted documented at 08:40 AM. Waste documentation greater than 1 hour after removed, concerns with double lock/security of narcotic.

p. On 04/07/2020 at 2:06 PM, Fentanyl 100 mcg removed, 50 mcg dose given documented at 2:14 PM, 50 mcg dose wasted documented at 5:29 PM. Narcotic unsecured for 3.5 hours and not wasted immediately.

q. On 10/21/2019 at 11:54 AM, Lorazepam 2mg removed, 1mg waste documented at 11:54 AM, waste documented at 11:55 AM, 1 mg dose given documented at 12:00 PM. Dose given and dose wasted do not equal to the 2 mg removed.

r. On 10/21/2019 at 08:28 AM, two narcotics, Oxycodone (narcotic for the treatment of pain) and Tramadol (narcotic for the treatment of pain) removed, not given for 1 hour, medication unsecured for 1 hour and not under double lock.

s. On 10/19/2019 at 10:30 AM, Morphine (narcotic for the treatment of pain) 2mg removed x3, Morphine 2mg dose given documented x4. 1 dose removed on over-ride on wrong patient.

t. On 06/25/2020 at 2:07 PM, Fentanyl 100 mcg removed, 50 mcg dose given documented at 2:09 PM, 50 mcg dose wasted at 4:24 PM, medication unsecured for 2.5 hours.

u. On 02/16/2020 at 11:47 AM, Ativan (sedative-controlled substance) 0.5 mg removed, 0.25 mg dose given documented at 11:56 AM, 0.25 mg dose wasted at 1:41 PM. Medication unsecured for over 2 hours.

v. On 02/01/2020 at 7:30 PM, Fentanyl 100 mcg removed, 50 mcg dose given documented at 7:34 PM, 50 mcg dose wasted documented on 02/02/2020 at 12:51 AM. Narcotic medication unsecured for over 5 hours.



3. Review of the CAH's quality improvement documentation revealed the CAH lacked any evidence of quality improvement activities to perform any corrective actions regarding the waste, disposal, or storage of narcotics after they have been removed from locked storage.

4. Review of the CAH's documents revealed the CAH staff lacked evidence concerning problem prevention, identification, corrective action taken, and the outcomes of effective action from the Pharmacy and Nursing Services.

5. During an interview on 09/10/2020, at 08:18 AM, the Director of Pharmacy confirmed she was aware of the problem with the proper removal and wasting of narcotics/controlled substances and acknowledged that it is a concern. The Director of Pharmacy also acknowledged the CAH lacked documented evidence that the CAH staff performed any quality improvement activities regarding corrective actions for the problem of narcotic wasting and/or storage after removal from locked storage.

6. During an interview on 09/10/2020 at 08:18 AM, the Clinical Nursing Officer (CNO) acknowledged the CAH staff had identified an issue with the improper narcotic removal and the nursing staff's failure to follow the CAH's policies regarding wasting narcotics. Despite the CAH staff identifying the problem, the CAH staff had not implemented any corrective actions to attempt to prevent the issues from occurring again.

7. During an interview on 09/10/2020 at 09:07 AM, the Director of Quality revealed that the CAH staff had identified the issue of improper narcotic removal and the nursing staff failing to follow the CAH's policies regarding wasting narcotics, but the CAH had not implemented any corrective actions regarding the issue of improper narcotic removal and the nursing staff's failure to follow the CAH's policies regarding wasting narcotics.

Based on observation, document review, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure the hospital had a preventative maintenance program to ensure all equipment is tested for performance and safety before initial use and to ensure all equipment is inspected, tested, and maintained to ensure their safety, availability, and reliability. Failure to have an effective preventative maintenance program could result in equipment failure or unsafe electrical equipment used by staff on patients and potentially culminate in patient harm and/or death. The CAH administrative staff identified 295 Inpatients and 21,991 Outpatients utilized its services in Fiscal year 2019.

Findings include:

1. Observations during a tour of the Emergency Department (ED) on 9/8/2020 at 2:00 PM revealed, 1 of 1 Nihon Kohden Lifescope bedside monitor with a date due to be inspected 5/20 in an ED storeroom.

During an interview on 9/8/2020, at the time of the tour, the ED Nurse Manager acknowledged the monitor was available for patient care and was past due to be inspected. The ED Nurse Manager reported she believed the biomedical technician came once a month but was not aware why this piece of equipment had not been checked for preventative maintenance.

2. Observations during a tour of the Surgery Department on 9/9/2020 at approximately 9:00 AM revealed the following equipment available for patient care use:

a. Same Day Surgery Rooms #3 and #4, each held 1 Nihon Kohden Lifescope bedside monitor, each had a biomedical engineering sticker with date due to be inspected 1/20.

b. Post Anesthesia Care Unit (PACU) Bay 2 contained a Valleylab Electrosurgical/Cautery machine (used to make precise surgical incisions with minimal blood loss) with a due to be inspected date of 5/20.

c. Central Supply (CS) held a Flosteady Arthroscopy Pump with a Biomedical Equipment sticker that stated Approved for Use, Date Due: In the area that was to contain the missing date due sticker, was the statement "Not valid unless dated".

During an interview on 9/9/2020, at the time of the tour, the Nurse Director of Outpatient and Surgery, acknowledged the above listed equipment was available and used for patient care. The Nurse Director verbalized the CAH had a "new" biomedical technician and thought he came once a month, was not aware the equipment was past inspection due dates and had not been contacted by the biomed technician to assist in location of equipment.

3. Observations during a tour of the Physical Therapy Department on 9/9/202 at approximately 12:45 PM revealed 3 electric beds used in patient care. All 3 beds lacked preventative maintenance stickers.

During an interview on 9/9/2020, at the time of the tour, the Physical Therapy Director reported the beds were not being assessed by the Biomedical technician or the CAH maintenance staff. The Physical Therapy Director revealed 1 of the 3 beds was new and had not been checked by maintenance prior to use.

4. Observations during a tour of the Medical Surgical Department on 9/8/2020 at approximately 11:00 AM revealed 25 patient beds without Preventative Maintenance stickers.

During an interview on 9/8/202, at the time of the tour, the Nurse Manager of Acute Care reported the patient beds are audited by nursing for functionality, mattress condition, and frame condition. The electrical cord is checked for cracks, no other electrical check is done by nursing, maintenance, or biomed. The Acute Care Manager reported the CAH had a service contract with Hillrom and they had been here in May to check the beds.

Review of Nurse Manager's Bed Audit spread sheet revealed 21 Beds were Hillrom, 2 Stryker beds and 1 Linak bed.

Review of Hillrom "Original Service Contract Invoice" dated 4/30/2020, revealed in part, "...for north wing beds...6 Versa3 beds.." serviced of the 25 patient care beds.

5. Review of CAH's "Preventative Maintenance Program" policy, last reviewed on 8/2020, revealed in part, "Purpose ... ensure all electrically operated equipment will be safety inspected ... all electrical equipment in ... patient ... areas must be electrically checked by Maintenance or contracted Bio-medical Company prior to being place in service ... electrical equipment ... will be re-inspected at the prescribed interval for that particular item ... Maintenance Manager to monitor compliance and to keep a log of safety equipment checks."

6. During an interview on 9/9/2020 at 2:45 PM, the Facilities Director revealed he was new to this position and had been hired less than 5 months ago. The Facilities Director confirmed the Biomedical Preventative Maintenance Program was a contracted service with Outside Maintenace Company A and under his supervision. The Facilities Director stated he had not had any orientation or education since hired related to the Outside Maintenace Company A Maintenance Program nor did he have a copy of the contract outlining the services under contract. The Facilities Director did not know how often the biomedical technician came to the CAH, how long the biomedical technician was on site, nor received any documented reports from the biomedical technician. The Facilities Director acknowledged the maintenance department did not provide preventative maintenance to the patient care beds on the medical surgical unit of within the Physical Therapy Department.

7. During an interview on 9/9.2020 at 3:15 PM, Chief Clinical Officer (CCO) revealed she received reports from Outside Maintenace Company A but reviewed the report for billing purposes only. The COO had not been aware that equipment was past due for preventative maintenance checks. The COO acknowledged she was also not sure how often the biomedical technician was on site to perform equipment inspections. The COO reported she had contacted the company to inquire what their policy was when unable to locate equipment. The COO revealed the CAH could not locate any of the contracted company's equipment management policies nor the Outside Maintenace Company A service contract.

8. During an interview on 9/10/2020 at 9:15 AM, Outside Maintenace Company A Clinical Engineering Manager revealed he was new, less than one year, to the role in this territory. He believed that The CAH has had a contract with Outside Maintenace Company A for Preventative Maintenance in excess of 7 - 10 years. He did not have a copy of the service contract. He believed the biomedical technician came monthly to the CAH to perform equipment checks based on a quick review of work documents. The Clinical Engineering Manager reported he had sent the CAH all the Standing Operating Procedures (SOP's) this morning following a phone call from the CAH.

Based on observation, document review and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure all drugs are appropriately stored (properly locked) when it maintained controlled medications (medications that can cause physical and mental dependence) in the operating room (OR) under a single lock. Failure to appropriately secure controlled medication could result in unauthorized access to the medication and drug diversion for personal use. The CAH administrative staff identified an average daily census of 1 patient.

Findings include:

1. Review of "Storage and Procurement of Medications" policy, dated last reviewed on 5/20, revealed in part, " Purpose...provide for safe storage of medications...applies to all drug storage areas...All CII controlled substance will be kept under a double lock...responsibility of the pharmacist..to see that this policy is followed...responsibility of nursing..all medications..appropriately stored."

2. Observations during a tour of the Operating Room on 9/9/2020 at approximately 2020, revealed 5 vials of a CII controlled drug, Morphine Sulfate, 10 mg/ml single dose vials, located in an anesthesia medication/equipment cart under a single key lock. The key to unlock this cart was located in an unlocked drawer in the adjacent anesthesia cart, approximately 1 foot away.

3. During an interview on 9/9/2020, at the time of the tour, Nurse Director of Outpatient and Surgery acknowledged the Controlled II drugs should have been under a double lock and that the key to the locked drawer was not secure. Multiple staff including registered nurses and surgical technician know where the key is located and may work alone in the department, unsupervised.

4. During an interview on 9/10/2020 at 9:00 AM, Director of Pharmacy reported it is the expectation and policy that all Control II medications be stored under double locks and the key is kept secure. The Director verified the key kept in an adjacent unlocked cart was not secured and that security of Control II drugs needed to be tightened in the OR.

Based on observation, document review, and staff interviews, Critical Access Hospital (CAH) administration failed to ensure 2 of 2 reviewed laboratory staff members (Lab Staff A and Lab Staff B), had color vision proficiency prior to interpreting the results of fecal occult blood (blood in stool) tests for all laboratory staff who read the results of the test. Failure to test all laboratory staff for color blindness before performing this test may result in staff misreading the results of the fecal occult blood test which could potentially adversely affect the diagnosis and treatment plan for patients. The CAH performed 57 fecal occult blood tests from September 1, 2019 to September 1, 2020.

Findings include:

1. Observation on 09/08/2020 at 2:00 PM, during a tour of the Laboratory Department revealed the Laboratory staff utilized Beckman Coulter Hemoccult slides to check stool for occult blood.

2. During an interview at the time of the laboratory tour, the Laboratory Manager reported the staff are not color blind tested upon hire to identify a positive Hemoccult test and to interpret the test would require the ability to identify the color blue.

3. Review of manufacturer's recommendations from September 2009 for Beckman Coulter Hemoccult slides revealed, in part: "Because this test is visually read and requires color differentiation, it should not be interpreted by individuals with blue color deficiency (blindness)."

4. Review of personnel files revealed the following:

a. Laboratory Staff A started working at the CAH on 10/12/1998. Laboratory Staff A's personnel file lacked documentation the CAH staff tested Laboratory Staff A for blue color vision proficiency upon hire or at any time after hire.

b. Laboratory Staff B started working at the CAH on 06/11/1996. Laboratory Staff B's personnel file lacked documentation the CAH staff tested Laboratory Staff B for blue color vision proficiency upon hire or at any time after hire.

5. During an interview on 09/10/2020 at 9:20 AM, the Director of Quality Service verified the Laboratory Staff A and B were not tested for blue color deviciency (blindness) during their health examinations.

Based on review of policies/procedures, meeting minutes, documents, and staff interviews, 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 17 of 17 patient care departments (Emergency Room, Food and Nutrition, Health Information Management, Housekeeping and Environmental Services, Infection Control, Quality and Risk Management, Laboratory, Maintenance, Nursing, Outpatient Services, Pharmacy, Radiology, Rehabilitation Services, Respiratory Therapy, Sleep Study, Operating Room, and Anesthesia). The CAH administrative staff identified an average daily census of 1 inpatient. 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," last reviewed on 9/2019, revealed in part, "...The Policy Review committee will meet annually to review the manuals/O drive folders for each department...."

2. Review of "Policy Review Committee Meeting" minutes, dated 08/14/2020 lacked annual approval for all policies for Emergency Room, Food and Nutrition, Health Information Management, Housekeeping and Environmental Services, Infection Control, Quality and Risk Management, Laboratory, Maintenance, Nursing, Outpatient Services, Pharmacy, Radiology, Rehabilitation Services, Respiratory Therapy, Sleep Study, Operating Room, and Anesthesia

3. During an interview on 09/09/2020 at 8:50 AM, the Director of Health Information Management/Compliance Officer stated the Policy Review Committee met on 08/14/2020 and reviewed only new and revised policies. The Director of Health Information Management/Compliance Officer confirmed only new or revised policies were brought to the Policy Committee for review and not all existing policies for annual review.

During an interview on 09/09/2020 at 9:40 AM, Physician C stated they were involved in policy review by attending the Policy Review Committee Meeting where new and revised policies were reviewed and approved. Physician C confirmed only new or revised policies were brought to the Policy Committee for review and not all existing policies for annual review.

I. Based on observation, document review, and staff interview, the Critical Access Hospital's (CAH) administrative staff failed to ensure the staff removed outdated medications from the Physical Therapy treatment room and the Surgery Department. 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 medications on a patient after the date which the manufacturer guaranteed the sterility and efficacy of the medication. The Physical Therapy administrative staff identified an average of approximately 250 patients seen per month and the average daily census was 1 patient.

Findings included:

1. Observation on 09/09/2020, during a tour of the Physical Therapy Department, revealed outdated medications:
a. Dexamethasone 20 mg/5mL, single dose vials Exp. 03/2020, 4 of 4 vials

2. During an interview on 09/09/2020, at 12:45 PM, the Physical Therapist Manager acknowledged the therapy staff failed to remove the expired medication from the supply cabinet and no documentation was provided for task completion. Upon interview, the Physical Therapist Manager acknowledged that it was their responsibility to monitor for outdated medications and it was revealed by the Physical Therapist Manager that 7 patients had received Dexamethasone from March 2020 to September 2020.

3. Observation on 09/09/2020, during a tour of the Operating Room (OR)/Surgery Department, revealed outdated medications:
a. Morphine Sulfate 10 mg/mL, 1mL single dose vials Exp. 07/2020--5 of 5 vials

4. During an interview on 09/09/2020, at 10:30 AM, the Nurse Director Outpatient and Surgery, stated "It is my responsibility to check medication outdates."

5. Review of "Medication Recall and Outdated Medication" last reviewed 08/2019, revealed "...Pharmacy will remove all outdated medication from drug storage areas. Surgery nurses will check for outdated medications in the surgery area. If an outdated medication is found it will immediately be returned to pharmacy and quarantined and labeled "Outdated/Recalled Medication--Not for Patient Use."




II. Based on observations, policy review and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure pharmacy oversight of wasting and documentation of narcotics/controlled substances. Failure of pharmacy oversight in the dispensing, wasting, and documentation, of narcotics/controlled medications could result in the potential for theft of medications or the unauthorized use of medications by unauthorized persons. The CAH reported the average daily census was 1 patient.

Findings include:

1. Review of "Narcotic and Controlled Substance Waste - Automated Dispensing System (ADS)", last reviewed on 04/2020, revealed "To define authority and accountability for the safe and effective storage and administration of controlled substances and to safeguard against the potential abuse and diversion of controlled substances ... Nursing and Pharmacy ... will adhere ... to ensure secure storage, accurate accountability and disposal of narcotic and controlled substances ... Pharmacist: oversight [and] nursing: proper administration, wasting, and documentation of narcotic and controlled substances".

2. Review of "Storage and Procurement of Medications", reviewed on 05/2020, revealed "All controlled substances outside of the pharmacy must be under a double lock...It is the responsibility of the pharmacist to see that this policy is followed".

3. Review of "Timing of Medication Administration", reviewed on 09/2019, revealed "The goals of these guidelines will be to increase patient safety by eliminating ... skipping of double checks".

4. During record and documentation review, 22 records and documentations revealed inaccuracy with removal, documentation, and wasting, of narcotics and controlled substances (drugs or chemicals that are regulated by government or law).

5. Observations during tour of the CAH nursing services on 09/08/2020 at 02:00 PM with the Clinical Nurse Officer (CNO) revealed the recommended procedure for removal and wasting of narcotics requires a witness by a second nurse.


6. Review of medication errors revealed:

a. On 02/17/2020 at 1:20 AM, Dilaudid (hydromorphone-narcotic for treating pain) 0.5mg, removed, not charted, not wasted.

b. On 02/17/2020 at 4:23 AM, Dilaudid 0.5mg, removed, not charted, not wasted

c. On 05/19/2020 at 10:17 PM, Fentanyl (narcotic for treating severe pain) 100mcg removed, 75mcg wasted documentation, 25mcg not charted, not wasted.

d. On 10/17/2019 at 3:04 PM, Roxanol (Morphine Sulfate-narcotic for the treatment of pain) removed at 3:04 PM and returned to Pyxus at 5:19, unsecured narcotic for over 2 hours.

e. On 10/05/2019 at 7:34 PM, Klonopin (clonazepam--anti-anxiety) removed, not charted, not wasted

f. On 09/17/2019 at 1:12 PM, Dilaudid 2mg removed, 1mg not given, not charted, not wasted.

g. On 09/22/2019 at 7:30 AM Fentanyl 100mcg removed, 100mcg documented wasted, 50mcg documented given, unsure if dose was given

h. On 09/17/2019 at 07:13 AM Dilaudid removed, not given until 08:52 AM, controlled substance not under double lock until given

i. On 12/15/2019 at 09:40 AM, Hydromorphone (narcotic for treating pain) 0.5mg removed, waste documented, dose given documented. Unsure if waste documented was correct.

j. On 12/15/2019 at 11:47 AM, Hydromorphone 0.5mg removed, waste documented, dose given documented. Unsure if waste documented was correct.

k. On 12/15/2019 at 1:51 PM, Hydromorphone 0.5mg removed, waste documented, dose given documented. Unsure if waste documented was correct.

l. On 12/15/2019 at 4:13 PM, Hydromorphone 0.5mg removed, waste documented, dose given documented. Unsure if waste documented was correct.

m. On 01/28/2020 at 8:16 AM, Diazepam (controlled substance-given for anxiety)10mg removed, 5mg documented given at 8:25 AM, waste documented at 3:25 PM. Nurse staff carried medication in pocket for 7 hours.

n. On 01/03/2020 at 12:06 PM, Lorazepam 1mg removed, waste documented at 12:06 PM, dose given documented at 12:06 PM, waste documented at 4:26 PM. Unsure if waste/dose given was accurate.

o. On 01/01/2020 at 06:59 AM, Fentanyl 100mcg removed, 25mcg dose given documented at 07:08 AM, 75 mcg dose wasted documented at 08:40 AM. Waste documentation greater than 1 hour after removed, concerns with double lock/security of narcotic.

p. On 04/07/2020 at 2:06 PM, Fentanyl 100 mcg removed, 50 mcg dose given documented at 2:14 PM, 50 mcg dose wasted documented at 5:29 PM. Narcotic unsecured for 3.5 hours and not wasted immediately.

q. On 10/21/2019 at 11:54 AM, Lorazepam 2mg removed, 1mg waste documented at 11:54 AM, waste documented at 11:55 AM, 1 mg dose given documented at 12:00 PM. Dose given and dose wasted do not equal to the 2 mg removed.

r. On 10/21/2019 at 08:28 AM, two narcotics, Oxycodone (narcotic for the treatment of pain) and Tramadol (narcotic for the treatment of pain) removed, not given for 1 hour, medication unsecured for 1 hour and not under double lock.

s. On 10/19/2019 at 10:30 AM, Morphine (narcotic for the treatment of pain) 2mg removed x3, Morphine 2mg dose given documented x4. 1 dose removed on over-ride on wrong patient.

t. On 06/25/2020 at 2:07 PM, Fentanyl 100 mcg removed, 50 mcg dose given documented at 2:09 PM, 50 mcg dose wasted at 4:24 PM, medication unsecured for 2.5 hours.

u. On 02/16/2020 at 11:47 AM, Ativan (sedative-controlled substance) 0.5 mg removed, 0.25 mg dose given documented at 11:56 AM, 0.25 mg dose wasted at 1:41 PM. Medication unsecured for over 2 hours.

v. On 02/01/2020 at 7:30 PM, Fentanyl 100 mcg removed, 50 mcg dose given documented at 7:34 PM, 50 mcg dose wasted documented on 02/02/2020 at 12:51 AM. Narcotic medication unsecured for over 5 hours.


7. During an interview on 09/10/2020 at 08:38 AM, the CNO reported when the medications are removed from the locked storage (the Pyxus machine), the nursing staff is not always in compliance with the policies and procedures to ensure that accurate documentation, wasting, and administration is being safely completed. The CNO reported that the medication should be wasted upon removal from the Pyxus, (if a partial dose is being administered). The CNO acknowledged that there is a problem with proper disposal, wasting, and documentation of narcotics/controlled substances among the nursing staff, that has not been properly addressed.

8. During an interview on 09/10/2020, at 08:18 AM, the Director of Pharmacy confirmed she was aware of the problem with the proper removal and wasting of narcotics/controlled substances and acknowledged that it is a concern.

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 7 of 21 medication errors reviewed. (Patient #1, Patient #2, Patient #3, Patient #4, Patient #5, and Patient #6). 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 0 patients on entrance, and an average daily census of 1 patient per day.

Findings include:

1. Review of "Medication Errors" last reviewed 02/2020, revealed in part: "Any medication not given according to the physicians order will be reported as a medication error...Immediate reporting applies to drug administration errors, adverse drug reactions or incompatibilities that have harmed or have the potential to harm the patient. If the outcome of a drug administration is unknown, the physician must be notified without delay. When a medication error is discovered, the patient's physician will immediately be notified if there is harm to the patient...For medication errors that have no change in patient condition or harm, the physician will be notified within 24 hours of when the error was discovered."

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

a. The nursing staff made a medication error (medication ordered-not administered) on 01/24/2020 at 09:30 AM 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 01/10/2020 at 08:32 AM 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 (wrong medication) on 02/14/2020 at 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.

d. The nursing staff made a medication error (medication pulled-not charted-not wasted) on 02/17/2020 at 01:20 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.

e. The nursing staff made a medication error (wrong dose) on 02/21/2020 at 2:05 PM which involved Patient #4. Patient #4's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #4's medical care of the medication error.

f. The nursing staff made a medication error (medication ordered-not administered) on 07/30/2020 at 4:30 PM which involved Patient #5. Patient #5's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #5's medical care of the medication error.

g. The nursing staff made a medication error (wrong route) on 10/22/2019 at 02:58 AM which involved Patient #6. Patient #6's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #6's medical care of the medication error.


3. During an interview on 09/10/2020 at 03:30 PM, the Clinical Nurse Officer acknowledged the medication error paperwork for Patient #1, Patient #2, Patient #3, Patient #4, Patient #5, and Patient #6, lacked documentation that the nursing staff notified the patient's provider of the medication error.

Based on observation, document review, and staff interviews the Critical Access Hospital (CAH) staff failed to ensure it maintained a clean and sanitary environment to avoid sources and transmission of infection when it failed to remove items from patient rooms that could not be properly disinfected and could be used by multiple patients in 4 of 4 patient rooms observed ( rooms 107, 111, 114, 117.) Failure to remove sources of infection could result in the transmission of the infectious organism(s) to the next patient that handled the contaminated item leading to illness or potentially death. The CAH administrative staff identified approximately 242 inpatients utilized its services in Fiscal year 2019.

Findings include:

1. Review of "Environmental Services Cleaning Guidebook-Med/Surg" revealed in part, "Cross-contamination is the transfer of harmful germs from one person, place, or object ... Isolation Precautions..used to reduce risk of transmission of germs to patients... Terminal cleaning ... thorough cleaning of a patient room following discharge in order to remove germs that might be transferred to the next patient in the room ... Hot Zone ... area closest to the patient ... most contaminated... Bedside tables ... high touch area ..."

2. Observations during a tour of the medical surgical unit on 9/8/2020 at approximately 11:00 AM, revealed the following:

a. Patient Room #111, top drawer of bedside stand contained a Gideon's Holy Bible and a telephone book
b. Patient Room #117, top drawer of bedside stand contained regional phone book and a telephone book
c. Negative Pressure Room (room designed to prevent the spread of harmful pathogens and viruses) #114, bedside stand contained a Gideon's Holy Bible, regional phone book, and telephone book.
d. Covid-19 wing room #107, top drawer of bedside stand contained Gideon's New Testament Psalms, regional phonebook and a telephone book.

3. During an interview on 9/8/2020, at the time of the tour, the Nurse Manager of Acute Care acknowledged these books were left in the drawer, from patient to patient, to use and believed housekeeping wiped the cardboard type covers between patients. The Nurse Manager acknowledged that the negative pressure room and Covid-19 rooms were used for patients with infectious illnesses.

4. During an interview on 9/10/2020 at 8:25 AM, Lead Housekeeper verified the books were left in the patient rooms after a patient was discharged. All items that can not be properly disinfected between use is removed from the room except for these books. The Lead Housekeeper stated they attempt to wipe off the books with the cleaning product, oxide, which is required to stay wet for 5 minutes to be effective in killing harmful organisms and that does not happen. The Lead Housekeeper acknowledged the books are an infection risk and shouldn't be there.

5. During an interview on 9/9/2020 at 2:30 PM, Director of Quality and Infection Control acknowledged the books are left in the patient bedside stands and cannot be properly disinfected. The Director reported they had discussed this concern in the past but had not acted on it.