HospitalInspections.org

Based on observation and staff interview, the Critical Access Hospital (CAH) Administrative staff failed to post a notice in a place likely to be noticed by all individuals entering the dedicated Emergency Department that the CAH does not have a physician present in the hospital 24 hours a day, 7 days a week, and indicate how the CAH staff will meet the medical needs of any patient with an emergency medical condition. Failure to post a notice in a noticeable place in the Emergency Department that the CAH lacks 24/7 physician coverage interferes with a patient's ability to make an informed decision if the patient wants to receive care at the CAH. The Administrative Staff identified 2,831 patients presented to the emergency department for FY 2020 who sought emergency medical treatment.

Findings Include:

1. Observations on 3/23/22 at 8:15 AM, during a tour of the Emergency Department, revealed the CAH lacked a posted notice that the CAH did not have a physician present in the hospital 24 hours a day, 7 days a week.

2. During an interview on 3/23/22 at the time of the tour, the Emergency Department Manager verified the CAH did not have a physician present in the hospital 24 hours a day, 7 days a week and that the CAH staff failed to display a notice in a clearly visible area to ED patients that the CAH did not have a physician present in the hospital 24 hours a day, 7 days a week.

3. During an interview on 3/23/22 at 4:30 PM, the Chief Clinical Officer acknowledged the facility did not have a physician present in the hospital 24 hours a day, 7 days a week and that the CAH staff failed to display a notice in a clearly visible are to ED patients that the CAH did not have a physician present in the hospital 24 hours a day, 7 days a week.

Based on observation, document review, and staff interview, the Critical Access Hospital's (CAH) administrative staff failed to ensure the staff removed outdated supplies from the Surgery Service area. Failure to remove outdated supplies from the CAH's supplies, available for patient use, could potentially result in the staff using expired supplies for patient use after the manufacturer's expiration date, potentially resulting in the staff using the supplies on a patient after the date which the manufacturer guaranteed the sterility and efficacy of the supplies. The CAH administrative staff identified a total average of 829 surgeries/procedures in Fiscal Year 2021.

Findings include:

1. Observations during a tour of the Surgery Department on 3/23/22 at 11:00 AM revealed the following outdated supplies:

a. In the Operating Room emergency crash cart:

Drawer 2- 1 of 1 blue top BD vacutainer (blood tube) expired 2/28/2020, 1 of 1 yellow top BD vacutainer expired 11/30/2021, 1 of 1 light green top BD vacutainer expired 2/28/2022, and 1 of 1 gray top BD vacutainer expired 10/31/2021.

Drawer 3- contained 1 of 1 Endotracheal tube, 4.0 cuffed, expired 8/2021 and 1 of 1 Endotracheal tube 6.5 cuffed, expired 2/2022.


b. In the IV supply area adjacent to the Surgery Department nurses' station:

IV start tray #1- 2 of 3 18G BD Insyte IV needles expired 9/30/2020 and 1 of 3 expired 12/31/2021

IV start tray #2- 2 of 2 18G BD Insyte IV needles expired 9/30/2021


c. In the IV supply cupboard: 3 of 3 18G Insyte IV needles expired 12/31/2021


2. Review of document titled "SDS Cleaning Schedule" revealed in part, "Quarterly cleaning, date & initial, Group 2, Feb, May, Aug, Nov [Feb was circled] Crash cart check- 2/4/22 [no initials]".


3. During an interview on 3/23/22, at the time of the observation, the Surgery Manager verified each of the items were outdated. The Surgery Manager acknowledged the department did not have a policy on checking for outdated supplies and equipment, and that the quarterly cleaning and checking of supplies was not adequate to ensure no outdated supplies were available for patient use.

4. During an interview on 3/24/22 at 1:05 PM the Chief Clinical Officer verified the critical access hospital did not have a policy to manage outdated supplies.

Based on observation, document review, and interviews, the Critical Access Hospital (CAH)
Administrative staff failed to ensure the Therapy Department staff properly clean and maintain the Rolyan splint pan equipment each week, in accordance with the manufacturer's directions. Failure to change the water and clean the equipment weekly could potentially result in an increase in bacteria or the transmission of pathogens causing an infection in the next patient. The CAH Administrative staff reported the therapy staff performed approximately 6 splints per month from January 2021 to January 2022.

Findings include:

1. Observations during a tour of the therapy department on 03/23/2022 at approximately 8:40 AM revealed 1 of 1 Rolyan Splint Pan (the pan is used to properly use heating temperature used in hospitals, clinics, and OT & PT facilities, to heat and softens thermoplastic material to be used in the customization of splints and orthoses), had a log for cleaning and displayed a last date of cleaning on 9/2021. The device has been in service since 10/17/2019.

2. Review of the manufacturer's instructions for the Rolyan Splint Pan indicated in part ... "pan water should be changed once a week, and whenever the water looks cloudy." "Clean using soap or a mild detergent and warm water."

3. During an interview on 3/24/2022 at approximately 10:45 AM, the Director of Rehab, Stroke and Chronic Disease Management revealed that the therapy staff was to log each time they cleaned the Rolyan Splint Pan, which was to be cleaned weekly. The Director of Rehab Stroke and Chronic Disease Management, acknowledged the splint pan had not been cleaned since 9/2021 and was only being wiped out with a cloth once the water was drained from the pan.

4. Review of the CAH's policy, "Routine Cleaning and Infection Control in Health and Rehabilitation Services," effective 6/2021, revealed in part ... "Rehab equipment including toys will be cleaned with hospital approved disinfectant after each direct patient contact."

5. During an interview on 03/24/2022 at approximately 10:45 AM, the Director of Rehab, Stroke and Chronic Disease Management acknowledged there was no policy on the maintenance of the Rolyan Splint Pan nor direct oversight.

Based on document review, policy review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure a physician periodically reviewed the care provided for CAH Emergency Department (ED) patients, in conjunction with mid-level providers, for 2 of 2 applicable mid-level providers selected for review (Advanced Registered Nurse Practitioner A and Physician Assistant B). Failure to ensure a physician periodically reviewed mid-level provider's patient medical records, in conjunction with the mid-level provider, could potentially result in misdiagnosing patient and/or providing inappropriate or substandard patient care. The CAH administrative staff identified Advanced Registered Nurse Practitioner (ARNP) A and Physician Assistant (PA) B treated the following number of emergency room patients in 2021:

Advanced Registered Nurse Practitioner A - 293 patients
Physician Assistant B - 209 patients

Findings include:

1. Review of the CAH policy titled "Mid-level Practitioner", approved 11/2021, revealed in part, "... The mid-level provider review will be in conjunction with a physician in a periodic review of the patient's health records at [CAH] ... ".
2. Review of documentation revealed the CAH lacked evidence to show the identified ED mid-level providers participated with a physician in a periodic review of the patient's health records.

3. During an interview on 3/23/22 at 11:40 AM, the Emergency Department (ED) Manager reported that the ED Medical Director reviewed approximately 10 percent of the medical records for patients seen my the ED's mid-level providers. The ED Manager maintains documentation of the patients reviewed and physician comments, and if there are any concerns, the ED Medical Director contacts the provider and discusses the patient care. The ED Manager acknowledged the CAH lacked a process to document any medical record review the ED Medical Director completes in conjunction with the mid-level provider. The ED Manager confirmed the CAH failed to ensure documented evidence to support a physician periodically reviewed the care of CAH ED patients in conjunction with the mid-level practitioners.

Based on document review, policy review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure mid-level providers periodically participated in a review of the care provided for CAH Emergency Department (ED) patients, in conjunction with a physician, for 2 of 2 applicable mid-level providers selected for review (Advanced Registered Nurse Practitioner A and Physician Assistant B). Failure to ensure a mid-level provider participated with a physician in periodic review of the mid-level provider's patient medical records, could potentially result in misdiagnosing patient and/or providing inappropriate or substandard patient care. The CAH administrative staff identified Advanced Registered Nurse Practitioner (ARNP) A and Physician Assistant (PA) B treated the following number of emergency room patients in 2021:

Advanced Registered Nurse Practitioner A - 293 patients
Physician Assistant B - 209 patients

Findings include:

1. Review of the CAH policy titled "Mid-level Practitioner", approved 11/2021, revealed in part, "... The mid-level provider review will be in conjunction with a physician in a periodic review of the patient's health records at [CAH] ... ".

2. Review of documentation lacked evidence to show the mid-level provider participated with a physician in a periodic review of the patient's health records.

3. During an interview on 3/23/22 at 11:40 AM, the Emergency Department (ED) Manager reported a selection of 10% of ED mid-level providers patient records selected monthly are reviewed by the ED Medical Director. The ED Manager maintains documentation of the patients reviewed and physician comments, and if there are any concerns, the ED Medical Director contacts the provider and discusses the patient care. The Emergency Department Manager acknowledged the CAH lacked a process to document any medical record review the ED Medical Director completes in conjunction with the mid-level provider. The ED Manager confirmed the CAH failed to ensure documented evidence to support a physician periodically reviewed the care of CAH ED patients in conjunction with the mid-level practitioners.

Based on observation, document review, and staff interviews, the critical access hospital (CAH) failed to maintain appropriate temperature and humidity control in the OR (Operating Room) as directed by the CAH's own policy. Failure to maintain the OR temperature and humidity in the appropriate range may increase the risk of infection, discomfort, and is a potential safety risk for the surgical patient. The CAH administrative staff identified approximately 325 procedures were performed on patients in the OR in Fiscal year 2021.

Findings include:


1. Review of the CAH policy "Temperature and Humidity", last approved 7/2021, revealed in part, "...Purpose: To maintain appropriate temperature and humidity control in the OR to reduce infections and provide patient safety and comfort....Humidity and Temperatures are monitored daily by SDS (Same Day Surgical) staff...Humidity is kept 20% to 60%...Temperatures between 68-72 degrees..." The policy lacked guidance on what steps to take if the values fell out of the acceptable ranges identified.

2. Observations on 3/23/2022 at approximately 11:00 AM, during a tour of the OR, revealed wall control panels registered a temperature of 66.5 degrees Fahrenheit and Humidity gauge 67%.

3. During an interview at the time of the observation, the Surgery Manager verified the OR wall control panels registered 66.5 degrees Fahrenheit and Humidity 67%.

4. Review of facility documents "DAILY TEMPERATURE AND HUMIDITY RECORDS" dated 4-7-21 through 3-24-22 revealed temperatures on 12-15-21 at 59.8 degrees Fahrenheit and on 7-1-21 at 59.7 degrees Fahrenheit. No daily temperatures documented during the time range reached 68 degrees Fahrenheit, the lowest acceptable temperature in the identified appropriate range.. The highest temperature recorded was 67.1 degrees on 3/24/22.

Review of recorded daily humidity levels from 4-7-21 through 3-24-22 revealed humidity above the 20% to 60% range in all but 5 days from 7-2-21 to 3-24-22. The out of acceptable parameters humidity values ranged from 60.1% to 67%.

The "DAILY TEMPERATURE AND HUMIDITY RECORDS" form lacked identification of the acceptable temperature and humidity ranges that the OR needed to maintain and what steps to take if the observed values were out of the acceptable range.

The "Comments" section, located beside each daily logged entry for the OR temperature and humidity, remained blank except for reviewers initials. No follow up action or explanation for the out of range temperatures or humidity was documented for nearly 11 months.

5. During an interview on 3/23/2022, at the time of the tour, when the "DAILY TEMPERATURE AND HUMIDITY RECORDS" were reviewed, the Surgery Manager was unable to identify the acceptable temperature and humidity range for the OR. The Surgery Manager acknowledged the form lacked identification of the acceptable temperature and humidity ranges and guidance for steps to take when the values observed were out of the acceptable range.

6. During an interview on 3/24/22 at 12:15 PM, the Surgery Manager reported the OR's temperature and humidity control panel was changed out to a new panel in April 2021. The humidity value was now a small number in the lower right corner of the screen and the temperature was a larger number in the center of the screen. The OR staff had actually documented the temperature on that screen, not the humidity. The humidity had not been documented in nearly a year. The error had not been discovered by the Surgery Manager until today. The Surgery Manager acknowledged the documented temperatures of the OR had been out of the identified acceptable range, 68 degrees - 72 degrees and humidity, 20% - 60% for approximately 1 year without any intervention, such as the notification of maintenance, to correct the problem.

Based on document review, medical record review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure physician notification of a medication error was documented in a patients medical record for 8 of 9 medication errors reviewed. (Patient #1, Patient #2, Patient #3, Patient #4, Patient #6, Patient #7, Patient #8, and Patient #9). Failure to notify and document physician of medication errors, in the medical record, could potentially result in a practitioner not knowing about the medication error and either failing to take steps to address the consequences of the medication error, or the practitioner 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 identified a census of 6 patients at the beginning of the survey.

Findings include:

1. Review of the CAH policy, "Medication Variance Report," approved 10/20201, revealed in part, "... A completed medication variance includes prescriber notification with time and date. Document all pertinent facts as needed in the clinical record with notation of item and date prescriber noted ... All completed medication variance reports must be forwarded to the Pharmacist in charge for review of completeness ...".


2. Review of medication errors from August 24, 2021 to February 11, 2021 revealed the following:

a. The nursing staff made a medication error (wrong administration time) on 2/11/22 at 9:00 AM which involved Patient #1. Patient #1's medical record lacked documentation to show 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 (wrong drug and wrong administration time) on 2/2/22 at 8:52 PM which involved Patient #2. Patient #2's medical record lacked documentation to show 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 omission and wrong administration time) on 12/16/21 at 9:00 PM which involved Patient #3. Patient #3's medical record lacked documentation to show the nursing staff notified the practitioner responsible for Patient #3's medical care of the medication error.

d. The nursing staff made medication errors (unordered drug and wrong dose) on 12/2/21 at 9:14 PM and 12/3/21 at 8:52 AM which involved Patient #4. Patient #4's medical record lacked documentation that the nursing staff notified the practitioner responsible for Patient #4's medical care of the medication error.

e. The nursing staff made a medication error (wrong dose) on 11/14/21 at 8:39 PM which involved Patient #5. Patient #5's medical record lacked documentation to show the nursing staff notified the practitioner responsible for Patient #5's medical care of the medication error.

f. The nursing staff made a medication error (wrong dose) on 9/4/21 at 6:19 AM which involved Patient #6. Patient #6's medical record lacked documentation to show the nursing staff notified the practitioner responsible for Patient #6's medical care of the medication error.

g. The nursing staff made a medication error (wrong drug and wrong dosage form) on 8/29/21 at 9:32 PM which involved Patient #7. Patient #7's medical record lacked documentation to show the nursing staff notified the practitioner responsible for Patient #7's medical care of the medication error.

h. The nursing staff made a medication error (order guidelines were not followed) on 8/24/21 at 10:00 PM which involved Patient #8. Nursing Patient #8's medical record lacked documentation to show the nursing staff notified the practitioner responsible for Patient #8's medical care of the medication error.


3. During an interview on 3/24/22, at 9:00 AM, the Pharmacist reported she does not see all of the medication error forms. She explained the forms go to the nurse managers and the Chief Clinical Officer and the ones directly involving the pharmacy are shared with her. She reported she becomes of aware of the other ones when she attends the quality meetings.

4. During an interview on 3/24/2022, at 1:00 PM, the Medical/Surgical (M/S) Nursing Manager acknowledged the CAH policy requires nursing staff to document medication error notification to the practitioner responsible for a patient's care, in the patients medical record. The M/S Nursing Manager confirmed the medical records of Patient #1, Patient #2, Patient #3, Patient #4, Patient #5, Patient #6, Patient #7 and Patient #8 lacked documentation of medication error notification to the practitioner responsible for the patient's care.

Based on observation, document review, and staff interviews, the Critical Access Hospital's administrative staff failed to ensure a current roster listing each practitioner's surgical privileges was available in the surgical suite and area/location where the scheduling of surgical procedures is done. Failure to maintain a current list of procedures in the surgical suite available for surgical staff to access and verify a provider's privileges prior to scheduling and performance of a procedure may result in a provider performing a procedure for which they are not privileged to perform due to lack of training, skills, quality, and or sufficient knowledge and may result in a poor patient outcome. The CAH administrative staff identified 829 surgical procedures performed in Fiscal Year 2021.

Findings include:

1. Review of the CAH documents, including Medical Staff Bylaws, Rules and Regulations, Board Bylaws, administrative and surgical policies revealed the lack of a policy or guidance to ensure a current roster listing each surgical practitioner's privileges was maintained and accessible in the surgery department to all surgical staff.

2. During an interview on 3/23/22 at 3:45 PM, at the time of the tour of the Surgical Department, the Surgery Manager reported a list of current surgical practitioner's privileges is maintained in a file on their computer and could only be accessed by the surgery manager. The Surgery Manager verified the list of surgical practitioner's privileges was not available at the scheduling desk or to any other surgical staff for their review prior to scheduling or performance of a procedure.

3. During an interview on 3/23/2022 at 3:48 PM, at the time of the tour, Surgery RN C, verified RN C did not have computer access to the list of surgical providers and their privileges.

Based on document review and staff interviews, the individual(s) responsible for the Critical Access Hospital's (CAHs) antibiotic stewardship and infection prevention and control programs failed to have active facility-wide programs that demonstrate adherence to nationally recognized programs. These programs failed to provide ongoing surveillance, prevention and control of hospital acquired infections (HAIs) and other infectious diseases using best practices for improving the prevention of antibiotic-resistant organisms and coordinating this data though a facility-wide quality assessment and performance improvement (QAPI) program.

1. The CAH's staff failed to ensure that the infection preventionist responsible for the infection prevention and control program had been appointed by the Governing Body and that the appointment was based on the recommendations of medical staff leadership and nursing leadership. Please refer to C-1204.

2. The CAH's staff failed to ensure that the infection preventionist employed a method for preventing and controlling the transmission of infections within the CAH and other healthcare settings. Please refer to C-1206.

3. The CAH's staff failed to ensure that the infection preventionist documented, tracked, prevented, and controlled HAIs, including the maintenance of a clean and sanitary environment, by reducing the risk in the of transmission of infection, and any identified infection control issues that are identified by public health authorities. Please refer to C-1208.

4. The CAH's staff failed to ensure that the infection prevention and control program reflected the scope and complexity of the CAH services. Please refer to C-1210.

5. The CAH's staff failed to ensure that the individual responsible for the antibiotic stewardship had been appointed by the Governing Body and that the appointment was based on the recommendations of medical staff leadership and pharmacy leadership. Please refer to C-1212.

6. The CAH's staff failed to ensure that the individual responsible for the antibiotic stewardship had been communicating and coordination with all departments that utilize antibiotics and including the infection prevention and control program, the QAPI program, the medical staff, nursing services and pharmacy services. Please refer to C-1218.

7. The CAH's staff failed to ensure that the individual responsible for the antibiotic stewardship program had demonstrated improvements in proper antibiotic use. Please refer to C-1219.

8. The CAH's staff failed to ensure that the individual responsible for the antibiotic stewardship program had ongoing documentation of sustained improvement in proper antibiotic use. Please refer to C-1220.

9. The CAH's staff failed to ensure that the individual responsible for the antibiotic stewardship adhered to the nationally recognized guidelines, as well as best practices, for improving antibiotic use. Please refer to C-1221.

10. The CAH's staff failed to ensure that the Antibiotic Stewardship program reflected the scope and complexity of the CAH services. Please refer to C-1223.

11. The CAH's staff failed to ensure that the individual responsible for the antibiotic stewardship program and infection prevention program had systems in place and operational for tracking of all infection surveillance, prevention and control, and antibiotic use activities, in order to demonstrate any intervention was able to be sustained and successful. Please refer to C-1225.

12. The CAH's staff failed to ensure that the individual responsible for the infection prevention and control and antibiotic stewardship program identified all hospital acquired infections (HAI)s, and other infectious diseases and antibiotic use issues, are addressed in collaboration with the CAH's QAPI leadership. Please refer to C-1229.

13. The CAH's staff failed to ensure that the individual responsible for the infection prevention and control program had developed and implemented a facility-wide infection surveillance, prevention, and control policy and procedure supported by nationally recognized guidelines. Please refer to C-1231.

14. The CAH's staff failed to ensure that the individual responsible for the infection prevention and control program provided all documentation, either written or electronic, on the prevention of infections through surveillance and control activities. Please refer to C-1235.

15. The CAH's staff failed to ensure that the individual responsible for the infection prevention and control program provided clear communication and collaboration with the CAH's QAPI program on infection prevention and control issues. Please refer to C-1237.

16. The CAH's staff failed to ensure that the individual responsible for the infection prevention and control program monitored all hospital acquired infections (HAI)s and other infectious diseases, including continual audits that would control the prevention of infection transmission, and allowing the introduction of policies and procedures to the CAH personnel. Please refer to C-1240.

17. The CAH's staff failed to ensure that the individual responsible for the infection prevention and control program had clear communication and collaboration with the individual responsible for the antibiotic stewardship program. Please refer to C-1242.

18. The CAH's staff failed to ensure that the individual responsible for the antibiotic stewardship program developed, implemented, monitored, and reported improvements in a facility-wide program based on nationally recognized guidelines for the use of antibiotics. Please refer to C-1244.

19. The CAH's staff failed to ensure that the individual responsible for the antibiotic stewardship program provided all documentation, written or electronic, of the antibiotic stewardship program's activities. Please refer to C-1246.

20. The CAH's staff failed to ensure that the individual responsible for the antibiotic stewardship program communicated and collaborated with the CAH's medical staff, nursing staff, pharmacy leadership, individual in charge of infection prevention and control program, and QAPI program leadership about antibiotic use issues. Please refer to C-1248.

21. The CAH's staff failed to ensure that the antibiotic stewardship professional responsible for the antibiotic stewardship program provided competency-based training and education to CAH personnel and staff (including medical staff and contracted staff), on the application of infection control policies from the nationally recognized guidelines, policies, and procedures. Please refer to C-1250.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that the infection preventionist responsible for the infection prevention and control program had been appointed by the Governing Body, and that the appointment was based on the recommendations of medical staff leadership and nursing leadership for 1 of 1 infection preventionist. Failure to comply with regulations could potentially hinder the infection prevention and control program including surveillance, prevention, and control of hospital-acquired infections (HAI)s, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and address any infection control issues, potentially causing harm or death to patients and their safety. The CAH administrative staff identified an inpatient census of 6 patients upon entrance.

Findings include:

1. Review of the CAH's Policies and Procedures revealed that no policy existed regarding an appointment for the Infection Preventionist by the Governing Board.

2. Review of the Governing Board Meeting Minutes, from 2/1/21 to 2/1/22, revealed that an appointment had not been made by the Governing Board for the position of Infection Preventionist.

3. During an interview on 3/24/22 at 11:33 PM, with the Quality Improvement and Medical Surgical Manager, revealed she had been the interim Infection Preventionist since 4/2021 and handling the Antibiotic Stewardship documentation. The Quality Improvement and Medical Surgical Manager acknowledged she did not know if the new Infection Preventionist had been appointed as the CAH Infection Preventionist by the Governing Board.

4. During an interview on 3/24/22 at approximately 12:45 AM, Chief Clinical Officer (CCO) confirmed the CAH did not provide recommendations to the P&T Committee (Medical Staff) for approval as needed

5. During an interview on 3/24/22 at approximately 12:45 AM, Chief Clinical Officer (CCO) confirmed the CAH was unable to find documentation that the Infection Preventionist was approved by the Governing Board.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that the infection preventionist responsible for the infection prevention and control program employed a method for preventing and controlling the transmission of infections within the CAH and other healthcare settings for 1 of 1 infection prevention program. Failure to employ a method for preventing and controlling infection in the CAH could potentially result in the infection preventionist failing to identify a hospital wide infection which could cause can increased risk to patient safety, harm or death. The CAH administrative staff identified an inpatient census of 6 patients upon entrance.

Findings include:

1. Review of the CAH's policy, "Infection Control Program," effective 7/2021, revealed in part ... "the programs and processes in place for the surveillance and specific measures for the prevention, early detection, control, education and the investigation of infections and communicable diseases in the health care system. Including a mechanism to evaluate the effectiveness of the program and corrective actions taken."

2. During an interview on 3/24/2022 at approximately 11:33 PM, the Infection Preventionist revealed she had just taken this position on 4/2021 and was only given information collected by Registered Nurse (RN) House Supervisor/Case Manager about hand hygiene and terminal clean audits that are placed in an Excel spreadsheet once a month and documented on the National Healthcare Safety Network (NHSN). Any issues are directly communicated to that department via email by the Infection Preventionist.

The Infection Preventionist, further revealed, there are no other audits, surveillance, or tracking performed on any other potential areas of infection throughout the CAH.


3. During an interview on 3/24/2022 at approximately 12:08 PM, the Quality Improvement and Medical Surgical Manager acknowledged there has been little activity in regards to infection prevention position since the retirement of the previous Infection Preventionist.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that the infection preventionist document, track, prevent, and control Healthcare Associated Infections (HAIs), including the maintenance of a clean and sanitary environment by reducing the risk in the of transmission of infection, and any identified infection control issues that are identified by public health authorities. Failure to document, track, prevent and control HAIs may result in the CAH staff failing to address potential infection outbreaks in the CAH, which could potentially result in the CAH patients developing a life-threatening infection or death. The CAH administrative staff identified an inpatient census of 6 patients upon entrance.

Findings include:

1. Review of the CAH's policy, "Infection Control Program," effective 7/2021, revealed in part ... "the programs and processes in place for the surveillance and specific measures for the prevention, early detection, control, education and the investigation of infections and communicable diseases in the health care system. Including a mechanism to evaluate the effectiveness of the program and corrective actions taken."

2. During an interview on 3/24/2022 at approximately 11:33 PM with Infection Preventionist, revealed she had just taken this position on 4/2021 and was only given information collected by Registered Nurse (RN) House Supervisor/Case Manager about hand hygiene and terminal clean audits that are placed in an excel spreadsheet once a month and documented on the National Healthcare Safety Network (NHSN). Any issues are directly communicated to that department via email by the Infection Preventionist.

The Infection Preventionist, further revealed, she follows the Center of Disease Control (CDC) and Iowa Department of Public Health (IP) guidelines, but does not regularly communicate any updated information to the CAH's Administrative staff.


3. During an interview on 3/24/2022 at approximately 12:08 PM with the Quality Improvement and Medical Surgical Manager acknowledged there has been little activity in regards to infection prevention position since the retirement of the previous Infection Preventionist.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that the infection prevention and control program reflect the scope and complexity of the CAH services. Failure to ensure the CAH's infection prevention program reflected the complexity of the CAH's services could potentially result in the CAH staff failing to identify all infection prevention problems in the CAH, potentially resulting in the CAH staff failing to identify and prevent the spread of infections in parts of the CAH, potentially resulting in patients developing a life-threatening infection or dying. The CAH administrative staff identified an inpatient census of 6 patients upon entrance.

Findings include:

1. Review of the CAH's policy, "Infection Control Program," effective 7/2021, revealed in part ... "Policy: ...uses guidelines recommended by organizations such as the Centers for Disease Control and Prevention guidelines for Prevention and Control of Nosocomial Infections, the Facilities, the Occupational Health and Safety Administration Regulations, and the Association for Professionals in Infection Control and Epidemiology infection control guidelines to guide and direct actions for prevention and control of disease. The surveillance program will include patient and staff measure."

2. During an interview on 3/24/2022 at approximately 11:33 PM, the Infection Preventionist, revealed the Infection Control Program is to follow the set out guidelines by the program identified in the CAH's policy, but does not exhibit a robust surveillance practice.

3. During an interview on 3/24/2022 at approximately 12:08 PM with the Quality Improvement and Medical Surgical Manager acknowledged the Infection Preventionist only follows hand hygiene and terminal cleaning at this time.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that the individual(s) responsible for the antibiotic stewardship had been appointed by the Governing Body, and that the appointment was based on the recommendations of medical staff leadership and pharmacy leadership. Failure to comply with regulations could potentially hinder the antibiotic stewardship program and potentially risk patient safety, causing harm or death. The CAH administrative staff identified an inpatient census of 6 patients upon entrance.

Findings include:

1. Review of the CAH's policy, "Antimicrobial Stewardship Policy," effective 7/2021, revealed in part ... "ASP shall be physician-directed or supervised with support provided by a multidisciplinary inter-professional team. The antimicrobial stewardship team should include 1 or more members that have training in antimicrobial stewardship."

2. Review of the Governing Board Meeting Minutes, from 2/1/21 to 2/1/22, revealed that an appointment had not been made by the Governing Board, nor pharmacy leadership, for the position of antibiotic stewardship.

3. During an interview on 3/24/22 at 11:33 PM, the Quality Improvement and Medical Surgical Manager revealed she did not know if the Antibiotic Stewardship position had been appointed by the Governing Board or pharmacy leadership.

4. During an email on 3/31/22 at approximately 8:41 AM, the Quality Improvement and Medical Surgical Manager revealed the Chief Clinical Officer (CCO) confirmed the CAH was unable to find documentation that the Antibiotic Stewardship position was approved by the Governing Board.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that the individual responsible for the antibiotic stewardship had been communicating and coordination with all departments that utilize antibiotics and the resistance of including the infection prevention and control program, the QAPI program, the medical staff, nursing services and pharmacy services. Failure to include all departments could potentially result in the CAH staff failing to utilize the information from the antibiotic stewardship program, potentially resulting in the CAH staff allowing bacteria to develop increased antibiotic resistance, potentially resulting in the CAH's patients developing antibiotic resistant infections, potentially resulting in the CAH's patients developing a life threatening infection that the CAH staff could not treat with antibiotics, potentially resulting in a fatal infection. The CAH administrative staff identified an inpatient census of 6 patients upon entrance.

Findings include:

1. Review of the CAH's policy, "Antimicrobial Stewardship Policy," effective 7/2021, revealed in part ... "ASP shall develop, implement, and update evidence-based practice protocols and guidelines that incorporate local microbiology and resistance patterns ..." "Recommendations shall be presented to the P&T Committee (Medical Staff) for approval as needed. Physicians should utilize available protocols to ensure patients are receiving antimicrobial therapy that is appropriate, as per evidence-based guidelines or best practice."

2. During an interview on 3/24/22 at 12:08 PM, the Quality Improvement and Medical Surgical Manager revealed she had never been included in the P&T Committee (Medical Staff) nor requested approval for the CAH's antibiotic stewardship program. She also acknowledged there was no hospital wide policy for antibiotic stewardship. The Antibiotic Stewardship meeting was last held on 3/30/21.

4. During an interview on 3/24/22 at approximately 12:45 AM, Chief Clinical Officer (CCO) confirmed the CAH staff did not provide recommendations to the P&T Committee (Medical Staff) for approval as needed.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that the individual(s) responsible for the antibiotic stewardship had demonstrated improvements in proper antibiotic use in all departments and services of the CAH. Failure to demonstrate improvements could potentially result in the CAH staff utilizing ineffective antibiotics for patients, potentially resulting in the antibiotics not treating the patient's infection, potentially resulting in the patient's death. The CAH administrative staff identified an inpatient census of 6 patients upon entrance.

Findings include:

1. Review of the CAH's policy, "Antimicrobial Stewardship Policy," effective 7/2021, revealed in part ... "The ASP shall review antimicrobial regimens on selected patients for: Appropriate indication, local resistance patterns, dose optimization, and preferred route of administration, duration of therapy, duplication of therapy, drug interactions, and potential for toxicity ...."

2. Review of the Antibiotic Stewardship Meeting minutes, dated 3/30/2021, revealed that the antibiotic stewardship program retrospectively monitored the antibiotic use in the CAH and failed to concurrently monitor the antibiotic use in the CAH, allowing the CAH staff to ensure they used the correct antibiotic for the patient while the patient was receiving the antibiotic.

3. During an interview on 3/24/22 at 12:08 PM, the Quality Improvement and Medical Surgical Manager acknowledged the CAH's electronic medical record had an alert built into the system to ensure the physicians reviewed the antibiotic used, but the physicians did not understand the intent of the alert. Only half of the physicians acknowledged the alert in the medical record system and utilized the recommendations for the appropriate antibiotic therapy regimen.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) staff failed to ensure that the individual responsible for the antibiotic stewardship had ongoing documentation of sustained improvement in proper antibiotic use. Failure to document ongoing improvement, whether sustained or not, could potentially result in the CAH staff failing to utilize appropriate antibiotics to treat patients with infections at the CAH, potentially resulting in the infection failing to get better, potentially resulting in the patient's death. The CAH administrative staff identified an inpatient census of 6 patients upon entrance.

Findings include:

1. Review of the CAH's policy, "Antimicrobial Stewardship Policy," effective 7/2021, revealed in part ... "Pharmacist shall document any interventions and outcomes (accepted vs. rejected recommendation) in the Electronic Medical Record (EMR)."

2. During an email exchange on 3/31/22 at 1:08 PM, with the Quality Improvement and Medical Surgical Manager revealed a Pharmacist did attend the Antibiotic Stewardship meeting.


3. Review of the Antibiotic Stewardship Meeting minutes, dated 11/24/2020 and 3/30/2021, revealed the minutes did not reflect interventions or patient outcomes. The Pharmacist indicated in the 3/30/2021 minutes they had a concern regarding the individuals prescribing antibiotic therapy in the CAH failed to address the antibiotic alerts in the patient's electronic medical record.

Failure to provide surveillance can cause antimicrobial resistance results from inappropriate use of antibiotics and makes common or life-threatening infections more difficult or sometimes impossible to treat. Proper adherence to antibiotic therapy is one among several measures required to prevent antimicrobial resistance.


4. During an interview on 3/24/22 at 12:08 PM, the Quality Improvement and Medical Surgical Manager revealed the Antibiotic Stewardship meeting was last held on March 30, 2021.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that the individual responsible for the antibiotic stewardship adhered to the nationally recognized guidelines, as well as best practices, for improving antibiotic use. Failure to adhere to nationally recognized guidelines could potentially result inappropriate treatment risking patient safety, causing harm or death. The CAH administrative staff identified an inpatient census of 6 patients upon entrance.

Findings include:

1. Review of the CAH's policy, "Antimicrobial Stewardship Policy," effective 7/2021, revealed in part ... "The program assessment and strategic plan is based on the IDSA/SHEA guidelines for Antimicrobial Stewardship. In addition, the team will establish projects and goals designed upon the recommendations of the CDC for an ASP."

2. During an interview on 3/24/22 at 12:08 PM, the Quality Improvement and Medical Surgical Manager revealed the Antibiotic Stewardship meeting was last held on March 30, 2021. Per the CAH's policy for Antimicrobial Stewardship, the administrative staff failed to ensure new projects or goals were designed for recommendation as set forth by the guidelines of the nationally recognized bodies.

3. Review of the CAH's policy, "Antimicrobial Stewardship Policy," effective 7/2021, revealed in part ... "The outcomes and impact of the program shall be tracked and reported to the Medical Staff ..."

4. During an interview on 3/24/22 at 12:08 PM, with the Chief Clinical Officer, acknowledged the Medical Staff has never been included in the outcomes and impact of the Antimicrobial Stewardship Program to ensure patients are receiving the appropriate antimicrobial therapy per any updated evidence-based guidelines of these nationally recognized organizations.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) staff failed to ensure that the Antibiotic Stewardship program reflected the scope and complexity of the CAH services. Failure to ensure the antibiotic stewardship program reflected the scope and complexity of the CAH services could potentially result in the antibiotic stewardship program failing to identify areas needing to participate in the antibiotic stewardship program, and potentially resulting in providers failing to prescribe the appropriate antibiotic for a patient, potentially resulting in the patient developing a life-threatening infection or death. The CAH administrative staff identified an inpatient census of 6 patients upon entrance.

Findings include:

1. Review of the CAH's policy, "Antimicrobial Stewardship Policy," effective 7/2021, revealed in part ... "The policy encompasses Madison County Health Care System's emergency department, hospital, and clinics."

2. Review of the Antibiotic Stewardship Meeting Minutes, from 11/24/2020 and 3/30/2021, revealed no comprehensive data involving all the CAH's departments that utilized antibiotics which showed any effective or ineffective treatment, tracking, or monitoring of antibiotic use.

4. During an interview on 3/24/22 with the Chief Clinical Officer and the Quality Improvement and Medical Surgical Manager revealed since there has not been a meeting of the Antibiotic Stewardship Meeting since 3/30/2021, there has been little communication, education or follow up on antibiotic use throughout the CAH's departments or administrative staff.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that the individual responsible for the antibiotic stewardship and infection preventionist had systems in place and operational for tracking of all infection surveillance, prevention and control, and antibiotic use activities, in or to demonstrate any implementation was able to be sustained and successful. Failure to have systems in place with continued surveillance of both programs could potentially risk patient safety, causing harm or death. The CAH administrative staff identified an inpatient census of 6 patients upon entrance.

Findings include:

1. Review of the CAH's policy, "Board Communication," effective 10/2021, revealed in part ... "The purpose of a Board Communication policy is to insure ...keeps the Board of Trustees informed, knowledgeable, and involved in the general day-today operations of the system." " ...as a part of each board of trustee meeting, members will receive updates from medical staff committees and administration."

2. During an interview on 3/24/22 with the Infection Preventionist and Quality Improvement/Medical Surgical Manager revealed the Infection Preventionist only provides audits for hand hygiene and terminal cleaning of patient rooms. They both acknowledged that the Infection Preventionist has not been able to expand into other areas and there has not been a meeting in a year for either infection prevention and control or antibiotic stewardship.

3. Review of the CAH's policy, "Infection Control Nurse," effective 7/2021, revealed in part ... "the Infection Preventionist is responsible for coordination the system wide infection control efforts ... Policy and clinical decisions shall be made with consultation from the Medical Staff. All policies shall be review and updated on a regular basis."

4. Review of the CAH's policy, "Antimicrobial Stewardship Policy," effective 7/2021, revealed in part ... "ASP shall develop, implement, and update evidence-based practice protocols and guidelines ...recommendations shall be presented to the P&T Committee (Medical Staff)."

5. During an interview on 3/24/22, Quality Improvement/Medical Surgical Manager and CCO acknowledged Medical Staff had not been included in the information shared at the Antibiotic Stewardship Program nor any information gathered about infection prevention or control.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that the individual responsible for the infection prevention and control and antibiotic stewardship program identified all hospital acquired infections (HAI)s and other infectious diseases and antibiotic use issues are addressed in collaboration with the CAH's QAPI leadership. Failure to address these issues could potentially result in inaccurate reporting of infections risking patient safety, causing harm or even death. The CAH administrative staff identified an inpatient census of 6 patients upon entrance.

Findings include:

1. Review of the CAH's policy, "Infection Control Nurse," effective 7/2021, revealed in part ... "The Chief Executive Officer, medical staff and Chief Clinical Officer shall ensure the system-wide QI program and staff in-service training programs address problems identified through the infection control program."

2. During an interview on 3/24/22 at approximately 12:43 PM with the Chief Clinical Officer (CCO), acknowledged no communication has been reported to Quality Assurance Performance Improvement (QAPI) Program, due to the fact that the Antibiotic Stewardship program had not held a meeting since 3/30/21 (over a year prior).

Therefore, by not providing information to the QAPI program on a regular basis about HAIs, other infection diseases, and antibiotic use issues, the infection prevention program and antibiotic stewardship program had not incorporated their information into the CAH's QAPI program. This resulted in the CAH's QAPI program not providing quality improvement assistance and collaboration to the Infection Preventionist for areas in the CAH needing additional assistance with infection prevention or antibiotic stewardship.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that the individual responsible for the infection prevention and control had developed and implemented a facility-wide infection surveillance, prevention, and control policy and procedure supported by nationally recognized guidelines. Failure to have facility-wide infection policies and procedures could potentially risk patient safety, causing harm or even death. The CAH administrative staff identified an inpatient census of 6 patients upon entrance.

Findings include:

1. Review of the CAH's policy, "Infection Control Program," effective 7/2021, revealed in part ... "Policy: ...uses guidelines recommended by organizations such as the Centers for Disease Control and Prevention guidelines for Prevention and Control of Nosocomial Infections, the Facilities, the Occupational Health and Safety Administration Regulations, and the Association for Professionals in Infection Control and Epidemiology infection control guidelines to guide and direct actions for prevention and control of disease. The surveillance program will include patient and staff measure."

2. During an interview on 3/24/22 at approximately 11:33 AM, the Infection Preventionist revealed the infection prevention and control program policy identified nationally recognized guidelines but failed to implement a facility-wide infection surveillance and prevention. The infection prevention and control program only captures data on hand hygiene and terminal cleaning of patient rooms. The Quality Improvement/Medical Surgical Manger and COO acknowledged the lack of a facility-wide infection surveillance and prevention program.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that the individual responsible for the infection prevention and control provided all documentation, either written or electronic, on the prevention of infection through surveillance and control activities. Failure provider documentation of infection prevention and control could potentially result in inaccurate reporting of infections risking patient safety, causing harm or even death. The CAH administrative staff identified an inpatient census of 6 patients upon entrance.

Findings include:

1. Review of the CAH's policy, "Infection Control Program," effective 7/2021, revealed in part ... "Providing continuous collection and analytical review of pertinent data with recommendations for follow up action ... Identifying, investigating and reporting infections and outbreaks of communicable diseases among patients and hospital personnel, including contract staff and volunteers, especially those occurring in clusters."

2. During an interview on 3/24/22 at approximately 11:33 AM, the Infection Preventionist revealed the Case Manager/House Supervisor is currently gathering all information on hand hygiene and terminal cleaning of patient rooms, putting it in an Excel spreadsheet, and enters it into the National Healthcare Safety Network (NHSN) program. The Infection Preventionist will communicate any outstanding information that needed to be addressed to the CAH's department manager(s), based on area through an email. The Infection Preventionist further acknowledged there was no other areas under surveillance, such as but not limited to, personal protective equipment use, respiratory hygiene, sharp safety, sterile instrument and device cleaning, etc.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that the individual responsible for the infection prevention and control provided clear communication and collaboration with the CAH's QAPI program on infection and prevention and control issues. Failure to communicate could potentially result in inaccurate reporting of infections risking patient safety, causing harm or even death. The CAH administrative staff identified an inpatient census of 6 patients upon entrance.

Findings include:

1. Review of the CAH's policy, "Infection Control Nurse," effective 7/2021, revealed in part ... "The Chief Executive Officer, medical staff and Chief Clinical Officer shall ensure the system-wide QI program and staff in-service training programs address problems identified through the infection control program."

2. Review of the CAH's policy, "Quality Improvement Plan," effective 7/2021, revealed in part ... "QI Committee is a coordinating advisory body for all plans and programs that relate to the monitoring and evaluating the quality and appropriateness of patient care. The committee will communicate information regarding problems and opportunities to improve care with the departments and services involved."

3. During an interview on 3/24/22 at approximately 12:43 PM , the Chief Clinical Officer (CCO) acknowledged no communication has been reported to Quality Assurance Performance Improvement (QAPI) Program, since there has not been an infection prevention committee meeting since 3/30/21 (a year prior). Therefore, by not providing communication as to what area(s) needed improvement and what people/disciplines are affected by the process, it is impossible to fix or improve the identifiable problems.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that the individual responsible for the infection prevention and control addresses the prevention and control of Healthcare Associated Infections (HAI) by auditing the CAH staff to ensure the CAH staff adhered to infection control and prevention policies. Failure to audit the CAH staff's infection control and prevention policy adherence could potentially result in the CAH's infection prevention staff failing to identify that the CAH staff engaged in practices potentially leading to the spread of infections between patients, potentially resulting in the CAH's patients developing life-threatening infections or a patient's death. The CAH administrative staff identified an inpatient census of 6 patients upon entrance.

Findings include:

1. Review of the CAH's policy, "Infection Control Nurse," effective 7/2021, revealed in part ... "The Infection Preventionist is responsible for a collaborative review of the hospital policy including clarity around which policies are to be followed for all infection control practices. Infection control includes the following but not limited to universal precautions, needle techniques handling/disposal, exposure precautions, hand washing, isolation, cleaning of rooms, equipment and instruments."

2. During an email exchange on 4/05/22 at approximately 7:57 AM, the Quality Improvement/Medical Surgical Manager revealed she notified the Infection Preventionist the patients that are on the medical surgical unit that are on isolation, the reason for isolation, those that have catheters and those that have peripherally inserted central catheter (PICC) lines.

3. During an interview on 3/24/2022 at approximately 11:33 PM, the Infection Preventionist revealed the Infection Control Program should follow the guidelines in the CAH's policies. However, the CAH's infection prevention program did not engage in any auditing of the CAH staff's infection prevention practices, except for auditing the staff's compliance with hand hygiene and terminal cleaning of patient rooms. The Infection Preventionist did not perform any auditing related to the areas of potential infection prevention issues identified by the Quality Improvement/Medical Surgical Manager.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that the individual responsible for the infection prevention and control has clear communication and collaboration with the individual responsible for antibiotic stewardship. Failure of understanding each individual's role in communication and collaboration could potentially result in an inaccurate reporting of infections, lack of follow through and monitoring creating a risking for patient safety, which could causing harm or even death. The CAH administrative staff identified an inpatient census of 6 patients upon entrance.

Findings include:

1. Review of the CAH's policy, "Infection Control Nurse," effective 7/2021, revealed in part ... "The Infection Preventionist is responsible for a collaborative review of the hospital policy including clarity around which policies are to be followed for all infection control practices. Infection control includes the following but not limited to universal precautions, needle techniques handling/disposal, exposure precautions, hand washing, isolation, cleaning of rooms, equipment and instruments." " ...Identifying, investigating and reporting infections and outbreaks of communicable diseases among patients and hospital personnel, including contract staff and volunteers, especially those occurring in clusters."

According to the policy for the Infection Control Nurse, all possible infectious threats and prevention information should be identified, investigated and reported by the Infection Control Nurse and communicated to other staff members. The Infection Control Nurse is to collaborate with the Antibiotic Stewardship Program by providing surveillance techniques for the Antibiotic Stewardship program to track.

2. During an interview on 3/24/2022 at approximately 11:33 PM, the Infection Preventionist revealed all information collected on possible infection is gathered and given to the Infection Preventionist by the Case Manager/House Supervisor or Quality Improvement/Medical Surgical Manager through email. The Infection Preventionist did not provide the information to the individual responsible for the antibiotic stewardship program.

3. During an email exchange on 4/05/22 at approximately 9:28 AM, the the Quality Improvement/Medical Surgical Manager acknowledged she notifies the Infection Preventionist the patients that are on the medical surgical unit that are on isolation, the reason, those that have catheters and those that have peripherally inserted central catheter (PICC) lines. This information is placed in a worksheet and tracked by the Infection Preventionist.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that the individual responsible for the antibiotic stewardship developed, implemented, monitored, and reported improvements in a facility-wide program based on nationally recognized guidelines for the use of antibiotics. Failure could potentially result in poor staff education, ineffective treatment, and incomplete data risking patient safety, causing harm or death. The CAH administrative staff identified an inpatient census of 6 patients upon entrance.

Findings include:

1. Review of the CAH's policy, "Antimicrobial Stewardship Policy," effective 7/2021, revealed in part ... "The program assessment and strategic plan is based on the IDSA/SHEA guidelines for Antimicrobial Stewardship. In addition, the team will establish projects and goals designed upon the recommendations of the CDC for an ASP."

2. Review of the CAH's policy, "Antimicrobial Stewardship Policy," effective 7/2021, revealed in part ... "Recommendations shall be presented to the P&T Committee (Medical Staff) for approval as needed. Physicians should utilize available protocols to ensure patients are receiving antimicrobial therapy that is appropriate, as per evidence-based guidelines or best practices."

3. During an interview on 3/24/22 at 12:08 PM, with the Quality Improvement and Medical Surgical Manager, acknowledged the Antibiotic Stewardship meeting was last held on March 30, 2021. Medical Staff has not been included in the Antibiotic Stewardship meeting minutes, nor have the Medical Staff received recommendations from the Antibiotic Stewardship meeting.

4. Review of the CAH's policy, "Antimicrobial Stewardship Policy," effective 7/2021, revealed in part ... "The outcomes and impact of the program shall be tracked and reported to the Medical Staff ..."

5. During an interview on 3/24/22 at 12:08 PM, with the Chief Clinical Officer, acknowledged the Medical Staff has never been included in the outcomes and impact of the Antimicrobial Stewardship Program to ensure patients are receiving the appropriate antimicrobial therapy per any updated evidence-based guidelines of these nationally recognized organizations.

6. Review of the Antibiotic Stewardship Meeting Minutes of 3/30/21, revealed the Case Manager/House Supervisor reviewed the culture reports for appropriate antibiotic use for the Emergency Room and Clinics and providers reviewed their own on the inpatient floor.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that the individual responsible for the antibiotic stewardship provide all documentation (written or electronic) of the antibiotic stewardship program activities. Failure to follow such regulations could potentially ineffective treatment, poor education, ineffective alerts, and incomplete data risking patient safety, causing harm or death. The CAH administrative staff identified an inpatient census of 6 patients upon entrance.

Findings include:

1. Review of the CAH's policy, "Antimicrobial Stewardship Policy," effective 7/2021, revealed in part ... "The ASP team activities shall meet the core elements for inpatient and outpatient antimicrobial stewardship ...accountability, drug expertise/action, tracking, education ...reporting ..."

2. Review of the CAH's policy, "Antimicrobial Stewardship Policy," effective 7/2021, revealed in part ... "Recommendations shall be presented to the P&T Committee (Medical Staff) for approval as needed. Physicians should utilize available protocols to ensure patients are receiving antimicrobial therapy that is appropriate, as per evidence-based guidelines or best practices."

3. During a review of the Antibiotic Stewardship Meeting Minutes 11/24/20, revealed the staff indicated they would provide a report at the next Antibiotic Stewardship meeting from the CAH's electronic medical record that indicated the frequency of providers prescribing different antibiotics. The next meeting, held on 3/30/21, revealed the lack of the information on antibiotic prescription frequency was not provided to the CAH's providers. The meeting minutes also indicated that the House Supervisor would remind providers to address any antibiotic alerts and acknowledge the alert in the patient's medical record.


4. During an interview on 3/24/22 at 12:08 PM, the Quality Improvement and Medical Surgical Manager acknowledged this report showed the providers responding to the antibiotic alert in the EMR only 50% of the time. She believes they do not understand this alert and bypass it.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that the individual responsible for the antibiotic stewardship communicate and collaborate with medical staff, nursing, pharmacy leadership, individual in charge of infection prevention and control and QAPI program about antibiotic use issues. Failure could potentially result in ineffective treatment, poor education, ineffective alerts, and incomplete data risking patient safety, causing harm or death. The CAH administrative staff identified an inpatient census of 6 patients upon entrance.

Findings include:

1. Review of the CAH's policy, "Antimicrobial Stewardship Policy," effective 7/2021, revealed in part ... "Communicate pertinent antimicrobial therapy recommendations to providers based on prospective audit of patients' medical records." "Pharmacist shall document any interventions and outcomes ..."

2. During an interview on 3/24/22 at approximately 12:43 PM, the Chief Clinical Officer (CCO) acknowledged no communication has been reported to Quality Assurance Performance Improvement (QAPI) Program since the Antibiotic Stewardship Program has not had a meeting since 3/30/21 (almost a year prior).

3. Review of the CAH's policy, "Antimicrobial Stewardship Policy," effective 7/2021, revealed in part ... "Recommendations shall be presented to the P&T Committee (Medical Staff) for approval as needed. Physicians should utilize available protocols to ensure patients are receiving antimicrobial therapy that is appropriate, as per evidence-based guidelines or best practices."

4. During an interview on 3/24/22 at 12:08 PM, the Quality Improvement and Medical Surgical Manager acknowledged medical staff is not included in or given the minutes from the Antibiotic Stewardship meeting.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that the antibiotic stewardship professional responsible for the antibiotic stewardship program provide competency-based training and education to CAH personnel and staff (including medical staff and contracted staff), on the application from the nationally recognized guidelines, policies and procedures. Failure could potentially result in inappropriate antibiotic therapy levels, inaccurate reporting of scope and complexity of infectious disease, and facility-specific treatment recommendations, based on national guidelines and local susceptibilities potentially causing harm or death to patients and their safety. The CAH administrative staff identified an inpatient census of 6 patients upon entrance.

Findings include:

1. Review of the CAH's policy, "Antimicrobial Stewardship Policy," effective 7/2021, revealed in part ... "The ASP team will receive education related to antimicrobial stewardship ...team will educate the medical staff ..."

2. Review of the Antibiotic Stewardship Meeting Minutes dated 11/24/20 revealed the 48 hour antibiotic timeout (An antibiotic time out (ATO) at 48-72 hours is a critical component of antimicrobial stewardship programs to improve judicious antibiotic use. It is a strategy to prompt clinicians to re-evaluate antibiotic appropriateness, including the need for de-escalation and discontinuation) alerts were noted to only have 30% compliance in August 2020; 19% compliance in September 2020; 50% compliance in October 2020. The meeting minutes lacked evidence the CAH staff educated the CAH's providers about the importance of the 48-hour antibiotic timeout.

3. Review of the Antibiotic Stewardship Meeting Minutes, dated 3/30/21 ,revealed the 48 hour antibiotic timeout alerts were noted to only have 20.45% compliance in November 2020; 30.77% compliance in 2020; 9.09% compliance in January 2021; 35.71% compliance February 2021. "Unsure of reasons ...will try to do some additional education with the providers and try to address the ones that are least likely to address the alerts on a lone on one basis." "...ask ...how [Network Hospital's name] does antibiotic stewardship and antibiotic alerts."

4. During an email exchange on 3/30/22 at 5:22 PM, the Quality Improvement and Medical Surgical Manager revealed she had not officially been appointed as the Antibiotic Stewardship leader by the Governing Board and felt since she took a few courses and her experience she was willing to spearhead this program. She acknowledged there has been no Antibiotic Stewardship Meeting or follow up since 3/30/21. She also acknowledged that when they held the Antibiotic Stewardship Meeting, the medical staff was not given the meeting minutes nor included in Antibiotic Stewardship Program's request for recommendations.

Based on review of the Quality Improvement Plan, Quality Improvement activities, and staff interviews, the Critical Access Hospital (CAH) quality improvement staff failed to evaluate all patient care services provided for 3 of 24 patient care services. (Anesthesia Services, Outpatient Infusion Services, and Environmental Services) The CAH administrative staff reported a census of 6 inpatients at the beginning of the survey. Failure to evaluate all patient care services could potentially result in the CAH staff's failure to identify, monitor, address, and improve patient care problems in each patient care area through the efforts of all involved patient care services.

Findings include:

1. Review of CAH policy titled "Quality Improvement Plan", approved 7/20217, revealed, in part. "... Goals of Performance Improvement: To plan, prioritize, develop and implement a comprehensive quality improvement program through continual systematic measurement, assessment and improvement of performance by all [CAH] staff and support services ... All hospital departments and committees will participate directly or indirectly in the QI [Quality Improvement] program ...".

2. Review of the CAH's quality documents revealed the lack of documentation the CAH staff evaluated all patient care services, including Anesthesia Services, Outpatient Infusion Services and Environmental Services.

3. During an interview on 3/24/22, at 11:40 AM, the Medical/Surgical (M/S) Nursing Manager reported all CAH departments are required to enter quality measures and data into share drive spread sheets and submit a quarterly quality report. The M/S Nursing Manager acknowledged CAH quality documentation does not show evaluation of performance improvement activities for Anesthesia and Outpatient Infusion Services and Environmental Services failed to consistently evaluate performance improvement activities, as the department only provided data for one month since the start of Fiscal Year 2022 (7/1/22). The M/S Nursing Manager confirmed Anesthesia, Outpatient Infusion and Environmental Services failed to evaluate and participate in performance improvement activities at the CAH.