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Based on observation, document review, and staff interview, the Critical Access Hospital's (CAH) staff failed to remove outdated medications and supplies from the Medical Surgical emergency crash cart. Failure to remove outdated medications and supplies from the CAH's supplies, available for patient use, could potentially result in the staff using expired medications and/or supplies for patient use after the manufacturer's expiration date, potentially resulting in the staff using medication on a patient after the date which the manufacturer guaranteed the sterility and efficacy of the medication and supplies. The CAH administrative staff identified a census of 7 inpatients on the day of the survey.

Findings included:

1. Review of the policy, "Outdated Supply/Medication and Expired Medication Processing," approved on 12/2022, revealed in part, "... Each department will have a process for monitoring expiration dates of supplies and medications, as applicable, on at least a monthly basis (checklist, dashboard, etc). Outdated supplies should be returned to Material's Management for return to the manufacturer or donation."

2. Observations during a tour on 3/8/23 at 10:35 AM of the Medical Surgical Department and inspection of the crash cart with the Medical Surgical Manager and the Regulatory Specialist, revealed the following:

One of one size 7 ½ Protexis Latex sterile gloves expired on 4/2021.

One of one size 8 Protexis Latex sterile gloves expired on 1/2021.

One of one 4-0 1.5 metric Sofsilk wax coated braided silk suture expired on 8/31/2021.

Two of two 10 cm x 12 cm 3M Tegaderm film expired on 7/11/2022.

One of one 0 3.5 metric Sofsilk wax coated braided silk nonabsorbable suture expired on 11/30/2021.

One of one 18 G x 1- ½ inch Magellan Hypodermic Safety Needle expired on 09/2020.

One of One 18 G x 1 ¼ inch Smiths Medical ProtectIV Plus Safety IV Catheter expired on 12/13/2019.

One of One 16 G x 1 ¼ inch Smiths Medical ProtectIV Plus Safety IV Catheter expired on 1/14/2020.

One of One PDI Povidone-Iodine Swabstick expired on 7/2020.

One of One PDI Povidone-Iodine Swabstick expired on 1/2020.

Two of Two PDI Povidone-Iodine Swabstick expired on 8/2020.
One of One 25 G x 5/8 inch Magellan Hypodermic Safety Needle expired on 8/31/2021.

One of One 26 French (F) Teleflex Robertazzi Nasopharyngeal Airway (used to keep the airway open and can be used with patients who are conscious or semi-conscious) expired on 12/28/2022.

GreenLine Macintosh Blade Large Fiber Optic Laryngoscope (used for endotracheal tube intubation) expired on 11/30/2022

Bougie Endotracheal Tub Introducer (used for endotracheal tube intubation) expired on 6/17/2022.

Bougie Endotracheal Tub Introducer (used for endotracheal tube intubation) expired on 9/23/2021.

Rusch Flexi-Slip Stylet (used to guide endotracheal tube placement) expired on 03/2021.

3. During an interview on 3/8/23 at 10:35 AM with the Medical Surgical Manager and Regulator Specialist acknowledged outdates were only checked quarterly and these supplies were outdated.

Based on observation, document review and staff interviews, the Critical Access Hospital's (CAH) staff failed to ensure all drugs are appropriately stored (properly locked) when medications are to be wasted or removed from use per policy. Failure to appropriately secure medication could result in unauthorized access to the medication and drug diversion for personal use. The CAH administrative staff identified a census of 7 inpatients at the time of the survey.

Findings include:

1. Review of policy "Outdated Supply/Medication and Expired Medication Processing," approved 12/2022, revealed in part, "...non-controlled products will be placed in the nearest Clean Harbors black containers ...located either in the Pyxis med station or within central pharmacy."

2. During a tour on 3/14/23 at 9:00 AM with Clinic Manager, Clinic Service Officer, and Regulatory Specialist of the Sioux Center Clinic, revealed 4 vials of a 1% Xylocaine and 3 vails of 1% Lidocaine suspension, located in a bin in the clean utility closet. This room has push button access to staff. Medication vials were partially full and not disposed of per CAH's policy.

3. During an interview on 3/14/2023, at approximately 9:00 AM, the time of the tour, Clinic Manager, Clinic Service Officer, and Regulatory Specialist, acknowledged the this medication should have been disposed of per CAH's policy and not placed in a bin in the clean utility closet allowing access to a medication and creating a possible drug diversion opportunity.

Based on observations, document review, and staff interviews, the Critical Access Hospital's (CAH) administrative staff failed to create and implement an effective system to ensure staff detected when hot water temperatures exceeded the CAH's acceptable range for hot water (between 110 - 120 degrees Fahrenheit). Failure to monitor hot water temperatures could potentially cause serious scalding burns to patients. The depth of injury related directly to the temperature and duration of exposure to the hot water. Exposure to hot water at 133 degrees Fahrenheit can cause a third degree burn (destruction of the outer layer of skin and the entire layer beneath) to occur is 15 seconds, one minute at 127 degrees Fahrenheit, and 3 minutes at 124 degrees Fahrenheit. The CAH administrative staff reported a census of 7 inpatients at the beginning of the survey.

Findings include:

1. Observations on 3/8/23 to 3/13/23, during the surveying tour of the CAH's facilities with the Regulatory Specialist, revealed the following hot water temperatures at the hand washing sinks in several areas of the CAH:

a. Public bathroom- Cardiac Rehab/Physical Therapy Department- 135.0 degrees Fahrenheit.
b. Labor Rooms #1 - 129.7 degrees Fahrenheit.
c. Public bathroom- Emergency Room near Trauma bay- 70.3 degrees Fahrenheit.

2. Review of the policy "Hot Water," approved 7/2022 revealed in part, " ...Facility Services Department will test the water temperature on a daily basis and a log will be kept in the boiler room ...water temperature should be regulated so that it does not go below 110 degrees and not exceed 120 degrees Fahrenheit in showers, bathtubs, and handwashing facilities."

3. Review of documentation from 12/11/22- 3/15/23 of the Hospital Boiler Room checks reveled the boilers and water temperatures were recorded daily at the boiler location. However there were no logs documentation of water temperatures being tested at the various sinks, showers, tubs or handwashing stations.

4. The administrative staff failed to have a process in place to test and record the water temperatures throughout the facility, thereby allowing the maintenance staff to detect abnormal water fluctuations allowing the CAH to maintain acceptable range for hot water temperatures.

5. During an interview on 3/13/2023 at 1:10 PM with the Support Service Officer and the Grounds Keeper (former Maintenance Manager) revealed when this hospital was built the mixers (which controls the mixing of hot and cold water) where placed at the location of the sinks, tubs, showers, and handwashing stations instead of by the boilers. The Support Service Officer acknowledged the water temperatures exceeded the CAH's acceptable limit for hot water temperatures (120 degrees Fahrenheit) and the CAH lacked a process for the maintenance staff to check the temperatures daily at the facilities sink, tubs, showers and handwashing stations.

Based on document review and staff interviews, the Critical Access Hospital's (CAH) staff failed to ensure physician notification for the occurrence of a medication error for 4 of 12 medication errors reviewed. (Patient #1 and Patient #2 and Patient #3 and Patient #4). Failure to notify the physician of medication errors could potentially result in the 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, potentially resulting in inappropriate treatment or even a fatal reaction. The CAH administrative staff identified a census of 7 patients at the beginning of the survey.

Findings include:

1. Review of CAH policy, "Occurrence - Medication," approved 2/2023, revealed in part, "... report occurrence to appropriate personnel. (i.e., physician) ..."

2. Review of medication errors from January 23, 2023 to February 27, 2023 revealed, the practitioner was not notified in the following medication error records:

a. The nursing staff made a medication error (medication not given) on 2/7/23 at 7:20 PM which involved Patient #1. The medication error was discovered on 2/8/23 at 4:00 AM. Patient #1's medical record lacked documentation of the date and time that the practitioner responsible for Patient #1's medical care was notified of the medication error.

b. The nursing staff made a medication error (medication not given) on 2/22/23 at 5:30 PM which involved Patient #2. Patient #2's medical record lacked documentation that 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 not given) on 2/24/23 at 7:50 PM which involved Patient #3. Patient #3's medical record lacked documentation that 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 not given) on 2/25/23 at 10:08 PM 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.

3. During an interview on 3/15/23 at 9:00 AM, the Regulatory Specialist acknowledged that the medication errors had not been reported to the practitioner immediately upon discovery.

Based on observation, document review, and staff interviews, the Critical Access Hospital's (CAH) administrative staff failed to ensure the CAH staff kept patient medical information secure from unauthorized access in 5 CAH departments (Emergency Department, Radiology, Lab, Hull Clinic, and Hull Therapy Department). Failure to keep patient medical information confidential could potentially result in theft of a patient's information and potentially result in identity theft or unauthorized release of a patient's private medical information. The CAH's administrative staff identified an average monthly census of 1008 radiology patients, 19,539 lab patients, 306 ER patients, 470 Hull Clinic patients, and 326 Hull Clinic therapy patients from July 2021 to June 2022.

Findings include:

1. Review of the CAH policy "Safeguarding Protected Health Information (PHI)," last approved 4/2022, revealed in part, " ...all documents containing PHI should be stored appropriately to reduce the potential for incidental use or disclosure. Documents should not be easily accessible to any unauthorized staff or visitors.... Documents containing PHI will be promptly removed from the printer copier or fax machine and placed in an appropriate and secure location ..."

2. Observation on 3/8/23 at approximately 9:00 AM, during a tour of the Emergency Department (ED) with the ED Manager, revealed 1 of 1 fax machine that receives confidential patient information printed automatically that is not secure when the ED staff is not present in the department.

3. Observation on 3/8/23 at approximately 2:45 PM, during a tour of the Laboratory Department with the Laboratory Manager, revealed the following number of patients whose information (patient name, date of birth, type of test, and test results) was unsecured in a 3-ring binder stored on the counter:

a. 587 RSS (rapid covid) test results
b. 484 Influenza test results
c. 59 RSV (respiratory syncytial virus) test results
d. 22 Mononucleosis test results
e. 16 ROM (presence of amniotic fluid) test results
f. 1 Whole Blood Ketone (break down of fat by the liver) test results
g. 88 BNP (heart failure) test results
h. 117 BNP (heart failure) Quantitative Calculation test results
i. 99 D-Dimer Quantitative Calculation (clotting disorder) test results
j. 99 ABG (arterial blood gases) test results

In an unsecured drawer in the lab contained the following number of patients whose information (patient name, date of birth, type of test, and test results):

a. 20 Covid test results
b. 37 strep test results
c. 14 influenza ATB (test for variants) test results
d. 1 RSV (respiratory virus) test result
e. 8 UA (urine analysis) test results
f. 8 HCG (pregnancy) test results

4. Observation on 3/8/23 at approximately 3:30 PM, during a tour of the Radiology Department with Imaging Manager, revealed 1 of 1 fax machines on the counter in the Tech Work Area received confidential patient information that prints automatically during and after business hours. Patient information sits in the unattended fax machine tray until staff arrive.

5. Observation on 3/13/23 at approximately 10:50 AM, during a tour of the Hull Clinic with Regulatory Specialist, Clinic Manager, and Registered Radiology Technician (RTR) G, revealed confidential patient information in the unlocked rooms of Physician E and Physician F. Staff placed patient confidential information, patient charts and test results, in a tray on the desks in the unlocked rooms.

6. Observation on 3/13/23 at approximately 11:55 AM, during a tour of the Hull Clinic Therapy Department, revealed confidential patient information in an unlocked drawer at the reception desk. Also revealed, 1 of 1 fax machines placed on the counter in the reception area that receives confidential patient information that prints automatically during and after business hours. Confidential patient information sits in the unattended fax machine tray until staff arrive.

7. During an interview on 3/8/23 at 9:00 AM, with ED Manager, it was revealed that ED staff are utilized by other departments in the hospital when there are no ED patients. The ED is unattended until a patient arrives, then ED staff return. The ED Manager verified that while the ED is unoccupied, unauthorized personnel have access to the ED and confidential patient information that has printed on the fax machine and sitting in the fax machine tray. The ED Manager and the Regulatory Specialist acknowledged this was against the CAH's policies to have Protected Health Information unsecured for easily accessible by unauthorized persons.

8. During an interview on 3/8/23 at 2:45 PM, with Laboratory Manager, it was revealed she utilized a 3-ring binder to record test results. This binder contained the patient's name and date of birth. The binder was left on top of the counter in the laboratory. Another binder was stored in an unlocked drawer. Staff is present until approximately 11:00 PM, returning at 6:00 AM. The Laboratory Manager verified that during that time, unauthorized personnel have access to the lab. The Laboratory Manager and the Regulatory Specialist acknowledged this was against the CAH's policies to have Protected Health Information unsecured for easily accessible by unauthorized persons.

9. During an interview on 3/8/23 at 3:30 PM, with the Imaging Manager, it was revealed a fax machine in the Tech Work Area receives orders from outside referrals which print automatically and remain in the fax machine tray until staff arrive the next morning. The
Imaging Manager verified that after hours, unauthorized personnel have access to the confidential patient information in the fax machine tray. The Imaging Manager and the Regulatory Specialist acknowledged this was against the CAH ' s policies to have Protected Health Information unsecured for easily accessible by unauthorized persons.

10. During an interview on 3/13/23 at 11:55 AM, with the Hull Clinic Manager and RTR G revealed that Physician E and Physician F's offices remained unlocked at all times. Patient charts and test results were placed in a tray on top of each of the desks. Hull Clinic Manager and RTR G verified that after hours, unauthorized personnel have access to confidential patient information in the Physician offices. The Clinic Manager and the Regulatory Specialist acknowledged these rooms should be locked when the clinic is closed.

11. During an interview on 3/13/23 at approximately 1:00 PM, with Physical Therapy Scheduler H, revealed the fax machine in the reception area receives orders and referrals which print automatically during and after business hours. The confidential information remains in the fax machine tray until therapy staff arrive the next day. The Physical Therapy Scheduler H verified that unauthorized personnel have access to the confidential patient information in the fax machine tray after hours. Regulatory Specialist and Physical Therapy Scheduler H acknowledged this was against the CAH's policies to have Protected Health Information unsecured for easily accessible by unauthorized persons.

12. During an interview on 3/14/23 at approximately 4:12 PM, the Regulatory Specialist acknowledged the triage area of the Sioux Center Clinic had a fax machine that was not staffed at all times. This fax machine prints confidential patient information automatically during and after business hours. The confidential information remains in the fax machine tray until the triage clinic staff arrive.

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 150 surgical procedures performed in Fiscal Year 2022.

Findings include:

1. Review of the CAH documents, including Medical Staff Bylaws, Rules and Regulations, Board Bylaws, administrative and surgical policies revealed Physician Assistants are granted the privilege to render services to patients in the hospital in accordance with their scope of practice and the listing of specific tasks as delineated in their privileges with their supervising physician.

2. During a tour of the surgical suite with Surgery Manager and Regulatory Specialist revealed a Practitioner's privilege list was seen electronically on each computer desktop by surgery staff. But the delineation of privileges for Physician Assistants that accompanied the Orthopedic Surgeons were not listed.
The 4 Physician's Assistants (PA) (PA A, PA B, PA C, PA, D) have seen an average monthly number of case for surgery and/or procedure:

PA A has seen 4 patients per month.
PA B has seen 8 patients per month.
PA C has seen 10 patients per month.
PA D has seen 10 patients per month.

3. During an interview on 3/9/23 at 8:30 AM, 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 desktop and can be accessed by all surgical staff. The Surgery Manager further acknowledged these PAs did not have a delineation of privileges list for surgical staff to review prior to the scheduling or performance of a procedure.

Based on review of policies and procedures, document review, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure policies and procedures implemented were enforced. Surgical services policies must be in accordance with acceptable standards of medical practice and surgical patient care. The CAH Administrative Staff identified an average monthly census of 150 procedures performed during fiscal year July 1, 2021-June 20, 2022.

Findings include:

1. Review of the CAH's Rules and Regulations policy reveals in part, " ...An updated examination of the patient, including any changes in the patient's condition, ... must be placed in the patient's medical record ..."

2. Review of 4 of 5 (Patient #5, Patient #6, Patient #7, and Patient #8) medical records revealed there was no documented updated H&P present prior to the patient(s) surgical procedures.

3. Review of 1 of 5 (Patient #9) medical records revealed the patient did not have a completed H&P present prior to the patient's surgical procedure.

4. During interview on 03/15/2023 at approximately 3:00 PM, Surgical Manager verified there was no update to the H&P of 4 of 5 charts and an incomplete H&P on 1 of 5 charts that was performed by a qualified provider found in the medical record.

Based on document review and staff interviews, the CAH's Quality Improvement and Performance Improvement staff failed to develop, implement, and maintain an effective, ongoing, CAH-wide data-driven quality assessment and performance improvement program.

1. The CAH's Quality Assurance/Improvement program (QAPI) failed to involve all department of the CAH and services provided to the CAH's patients. Please refer to C-1306.

2. The CAH's Quality Assurance/Improvement program (QAPI) failed to utilize objective measures to evaluate organizational processes and services for all services, including contracted services. Please refer to C-1309.

3. The CAH's Quality Assurance/Improvement program (QAPI) failed to address outcome indicators related to improved health outcomes and the prevention and reduction of medical errors, adverse events, CAH acquired conditions, and transitions of care, including readmissions. Please refer to C-1311.

4. The CAH failed to have an effective quality program with governing body oversight that evaluated all patient care services including contracted services and failed to ensure quality improvement information was reviewed. Please refer to C-1313.

5. The CAH's Quality Assurance/Improvement program (QAPI) failed to focus on measures related to improved health outcomes that are shown to be predictive of desired patient outcomes. Please refer to C-1315.

6. The CAH's Quality Assurance/Improvement program (QAPI) failed to use the measures to analyze and track its performance for predictive patient outcomes. Please refer to C-1319.

7. The CAH's Quality Assurance/Improvement program (QAPI) failed to set priorities for performance improvement with consideration of high volume, high -risk services or problem prone areas. Please refer to C-1321

8. The CAH's Quality Assurance/Improvement program (QAPI) failed to incorporate quality indicator data including patient care data, and other relevant data, in order to achieve the goals of the QAPI program. Please refer to C-1325

The cumulative effect of these systemic failures and deficient practices resulted in the CAH staff's inability to ensure the CAH staff provided quality health care provided to patients.

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 30 of 52 patient care services. 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. The CAH administrative staff reported a census of 7 inpatients at the beginning of the survey

Findings include:

1. Review of CAH Quality Plan Reporting and Improvement Focus, revealed, in part. "... Quality Plan provides a systematic, coordinated, multidisciplinary and continuous approach to improving performance focusing upon the processes and systems that affect delivery of service and patient outcomes."

2. Review of the CAH's quality documents revealed the lack of documentation the CAH staff evaluated all patient care services, including Anesthesia Services, Surgical Services, Respiratory Therapy [RT], Speech Therapy [ST], Radiology, Nuclear Medicine, PET Scan, Echocardiogram Scans, Teleradiology, Dexa Scan, Ultrasound, Magnetic Resonance Imaging [MRI], Voluntary Services, Dietary/Nutritional Services, Dietician, Diabetic Education, Finance, Pulmonary Rehab, Outpatient Pain, Sleep Lab, Wound Care Clinic, Plant Operations, Sioux Center Clinic, Hull Clinic, Infusion Clinic/Chemo Clinic, Environmental Services [EVS], Marketing, IT, Quality, Materials Management, and Admitting.

3. During an interview on 3/15/22, at 3:24 PM with the Chief Nursing Officer (CNO) revealed the previous employee that headed the Quality Department left last year and the CNO just assumed this role in January 2023. The CNO acknowledged not all CAH departments were reporting quality measures and data to the Quality Department. The CNO is in the process of creating a dashboard in which all departments' quarterly submitted information can be viewed throughout the year. This process will show evaluation of performance and improvement activities and detect areas of high risk. The CNO further acknowledged this system is not up and running yet, which has revealed little information is being reported, evaluated, or tracked by many departments throughout the CAH.

Based on review of documentation and staff interview, the Critical Access Hospital's (CAH) Quality Assurance/Improvement program failed to utilize objective measures to evaluate organizational processes and services for all services, including contracted services for 30 of 52 departments (Anesthesia Services, Surgical Services, Respiratory Therapy [RT], Speech Therapy [ST], Radiology, Nuclear Medicine, PET Scan, Echocardiogram Scans, Teleradiology, Dexa Scan, Ultrasound, Magnetic Resonance Imaging [MRI], Voluntary Services, Dietary/Nutritional Services, Dietician, Diabetic Education, Finance, Pulmonary Rehab, Outpatient Pain, Sleep Lab, Wound Care Clinic, Plant Operations, Sioux Center Clinic, Hull Clinic, Infusion Clinic/Chemo Clinic, Environmental Services [EVS], Marketing, IT, Quality, Materials Management, and Admitting). Failure to utilize objective measures in the CAH's quality improvement program resulted in the CAH staff failing to identify patient care concerns and potentially failed to identify trends impacting patient care, potentially resulting in the CAH staff failing to prevent negative patient outcomes such as greater lengths of hospitalization, medically acquired infections, or potentially even a patient's death. The CAH administrative staff reported a census of 7 inpatients at the beginning of the survey.

Findings include:

1. Review of CAH Quality Plan Reporting and Improvement Focus, revealed, in part. "... Quality Plan provides a systematic, coordinated, multidisciplinary and continuous approach to improving performance focusing upon the processes and systems that affect delivery of service and patient outcomes."

2. Review of the Quality Departments department reports revealed since the position of the head of the Quality Department was vacated in 2022, there has been inconsistencies in the departments reporting measures to the Quality Department. This position was vacant until January 2023.

3. During an interview on 3/16/22, at 8:36 AM with the Chief Nursing Officer (CNO) revealed many departments had not been reporting to the Quality Department as required. The CNO is aware the departments that had been reporting have not been reporting a patient center measurement, instead they are reporting subjective information such as Press Ganey results. The CNO acknowledged little information is being reported, evaluated, or tracked by many departments throughout the CAH.

Based on document review and staff interview, the Critical Access Hospital's administrative staff failed to ensure the Quality Improvement (QI) program included quality improvement measures related to improved patient care outcomes for 30 of 52 departments (Anesthesia Services, Surgical Services, Respiratory Therapy [RT], Speech Therapy [ST], Radiology, Nuclear Medicine, PET Scan, Echocardiogram Scans, Teleradiology, Dexa Scan, Ultrasound, Magnetic Resonance Imaging [MRI], Voluntary Services, Dietary/Nutritional Services, Dietician, Diabetic Education, Finance, Pulmonary Rehab, Outpatient Pain, Sleep Lab, Wound Care Clinic, Plant Operations, Sioux Center Clinic, Hull Clinic, Infusion Clinic/Chemo Clinic, Environmental Services [EVS], Marketing, IT, Quality, Materials Management, and Admitting) involved with patient care. Failure to utilize quality improvement measures related to improved patient care resulted in the CAH staff monitoring items which did not improve patient care. The CAH administrative staff identified a census of 7 inpatients at entrance.

Findings include:

1. Review of CAH Quality Plan Reporting and Improvement Focus, revealed, in part. "... Quality Plan provides a systematic, coordinated, multidisciplinary and continuous approach to improving performance focusing upon the processes and systems that affect delivery of service and patient outcomes." "Administration is responsible for the overall implementation and operation ...Quality Plan and aligned initiatives."

2. Review of the "Sioux Center Health Quality Plan Reporting and Improvement Focus July 2021-June 2023" revealed the following:

a. Several departments utilized patient satisfaction data (CAHPS survey date) as a directional tool, such as Press Ganey scores.

3. During an interview on 3/16/22, at 8:36 AM with the Chief Nursing Officer (CNO) acknowledged the departments failed to track quality improvement activities related to improved health outcomes.

Based on review of documentation, governing board meeting minutes, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed ensure the Board of Directors has sufficient information regarding the CAH's quality improvement activities to ensure the CAH's Board of Directors could exercise oversight of the quality for all patient care services, including contracted services, offered at the CAH for 30 of 52 departments (Anesthesia Services, Surgical Services, Respiratory Therapy [RT], Speech Therapy [ST], Radiology, Nuclear Medicine, PET Scan, Echocardiogram Scans, Teleradiology, Dexa Scan, Ultrasound, Magnetic Resonance Imaging [MRI], Voluntary Services, Dietary/Nutritional Services, Dietician, Diabetic Education, Finance, Pulmonary Rehab, Outpatient Pain, Sleep Lab, Wound Care Clinic, Plant Operations, Sioux Center Clinic, Hull Clinic, Infusion Clinic/Chemo Clinic, Environmental Services [EVS], Marketing, IT, Quality, Materials Management, and Admitting). The CAH administrative staff identified a census of 7 inpatients at the time of the survey. Failure of the CAH Board of Directors to review and evaluate Quality Improvement information could potentially result in the Board of Directors inability to provide effective oversight to the Quality Improvement committee and result in the CAH staff delaying actions to correct any identified deficiencies in the quality of care provided to patients at the CAH.

Findings include:

1. Review of the Bylaws of Sioux Center Health Board of Directors 2022, revealed in part, " ...the Board of Directors, which may delegate ordinary operating affairs of the Hospital to the Executive Board."

2. Review of the CAH's "Sioux Center Health Quality Plan Reporting and Improvement Focus July 2021-June 2023," revealed in part, "The governing body assures adequate resources exit to conduct Quality Assessment and Performance Improvement (QAPI) efforts. The object, scope, organizational structure and effectiveness of the organization's quality plan will be evaluated annually and revised as necessary."

3. Review of the Executive Board Meeting minutes, from 3/17/2022-1/19/2023, revealed the CAH's quality staff provided the Executive Board with quality presentations that addressed topics including the CAH's initiative to get ready for a survey, meeting with each department and leaders to discuss the importance of dashboards; meeting with different departments on a monthly basis; and the CAH's patient satisfaction scores. The meeting minutes lacked information on the CAH's Quality Improvement activities for Anesthesia Services, Surgical Services, Respiratory Therapy [RT], Speech Therapy [ST], Radiology, Nuclear Medicine, PET Scan, Echocardiogram Scans, Teleradiology, Dexa Scan, Ultrasound, Magnetic Resonance Imaging [MRI], Voluntary Services, Dietary/Nutritional Services, Dietician, Diabetic Education, Finance, Pulmonary Rehab, Outpatient Pain, Sleep Lab, Wound Care Clinic, Plant Operations, Sioux Center Clinic, Hull Clinic, Infusion Clinic/Chemo Clinic, Environmental Services [EVS], Marketing, IT, Quality, Materials Management, and Admitting

4. During an interview on 3/16/22, at 8:36 AM with the Chief Nursing Officer (CNO) revealed acknowledged they failed to present the Executive Board at least quarterly with information on the CAH staff's quality improvement efforts to prevent problems, create measurable goals, corrective actions taken for identified problems, and outcomes of the corrective actions for Anesthesia Services, Surgical Services, Respiratory Therapy [RT], Speech Therapy [ST], Radiology, Nuclear Medicine, PET Scan, Echocardiogram Scans, Teleradiology, Dexa Scan, Ultrasound, Magnetic Resonance Imaging [MRI], Voluntary Services, Dietary/Nutritional Services, Dietician, Diabetic Education, Finance, Pulmonary Rehab, Outpatient Pain, Sleep Lab, Wound Care Clinic, Plant Operations, Sioux Center Clinic, Hull Clinic, Infusion Clinic/Chemo Clinic, Environmental Services [EVS], Marketing, IT, Quality, Materials Management, and Admitting.

Based on review of documentation and staff interview, the Critical Access Hospital's (CAH) administrative staff failed to ensure all contracted services reported on quality measures related to improved health outcomes that are shown to be predictive of desired patient outcomes for 2 of 3 contracted services (PET Scan and Sleep Lab) The CAH administrative staff identified a census of 7 patients at the beginning of the survey. Failure to focus on measures related to improved health outcomes that are shown to be predictive of desired patient outcomes to include involvement of all of the CAH's departments on a continuous basis could potentially result in the CAH quality staff failing to identify potentially significant patient care concerns while monitoring items not related to patient care, thus missing potentially life-threatening patient care concerns.

Findings include:

1. Review of the CAH's "Sioux Center Health Quality Plan Reporting and Improvement Focus July 2021-June 2023," revealed in part, "...data systems in place to monitor the care and services provided. Feedback systems actively incorporate input from staff, patients, families, and others as appropriate. This process includes: Using performance indicators to monitor a wide range of care processes and outcomes. Reviewing findings against benchmarks and/or targets the system has established for performance. Tracking, investigating, and monitoring adverse events and implementing action plans to prevent recurrences."

2. Review of the CAH's quality documentation from 1/2022 to 1/2023 revealed the following:

a. No quality indicators were identified for PET Scan

b. No quality indicators were identified for Medbridge for the Sleep Study Program.

3. During an interview on 3/16/22, at 8:36 AM with the Chief Nursing Officer (CNO), verified the CAH staff failed to ensure all contracted services reported on quality measures related to improved health outcomes that are shown to be predictive of desired patient outcomes.

Based on review of documentation and staff interview, the Critical Access Hospital's (CAH) failed to use the quality measures to analyze and track performance for predictive patient outcomes for all services, including contracted services for 30 of 52 departments (Anesthesia Services, Surgical Services, Respiratory Therapy [RT], Speech Therapy [ST], Radiology, Nuclear Medicine, PET Scan, Echocardiogram Scans, Teleradiology, Dexa Scan, Ultrasound, Magnetic Resonance Imaging [MRI], Voluntary Services, Dietary/Nutritional Services, Dietician, Diabetic Education, Finance, Pulmonary Rehab, Outpatient Pain, Sleep Lab, Wound Care Clinic, Plant Operations, Sioux Center Clinic, Hull Clinic, Infusion Clinic/Chemo Clinic, Environmental Services [EVS], Marketing, IT, Quality, Materials Management, and Admitting). The CAH administrative staff identified a census of 7 patients at the beginning of the survey. Failure to use the quality measures to analyze and track performance for predictive patient outcomes for all services to include involvement of all of the CAH's departments on a continuous basis could potentially result in the CAH quality staff failing to identify potentially significant patient care concerns while monitoring items not related to patient care, thus missing potentially life-threatening patient care concerns.

Findings include:

1. Review of the CAH's "Sioux Center Health Quality Plan Reporting and Improvement Focus July 2021-June 2023," revealed in part, "...framework which identifies the highest priorities for quality measurement and improvement. It involves only assessing those core issues that are the most critical to providing high-quality care and improving individual outcomes. The Meaningful Measure Areas serve as the connectors between CMS strategic goals and individuals measures/initiatives that demonstrate how high quality outcomes for are being achieved."

2. Review of the "Sioux Center Health Quality Plan Reporting" documentation revealed the following:

a. Review of the July 2021-June 2023 Focus Quality presentation revealed the facilities focused objective goal to continue NHSH Surveillance: NSHN enrollment and reporting with more active focus on performance improvement of healthcare acquired infections including root cause analysis. The CAH will have an infection count less than NHSN predicted count for the following infections: (C-diff [is a germ (bacterium) that causes an inflammation of the colon], CAUTI [is an infection involving any part of the urinary system], CLABSI [Central Line-associated Bloodstream Infection. The document lacked evidence that the CAH's quality staff focused on measures to analyze and track the quality program's performance.

b. Review of the July 2021-June 2023 Focus Quality presentation revealed the CAH objective focused on leveraging innovative strategies across the healthcare system to prevent unnecessary readmissions by reviewing and adopting a Utilization Review Plan. The clinics will have means to measure % of patients attributed to clinic that had an appointment with primary care physician (PCP) within 30 days following an inpatient discharge. Reduce admissions to hospital for attributed Accountable Care Organization (ACO) populations by relative 10%. The document lacked evidence that the CAH's quality staff focused on measures to analyze and track the quality program's performance.

c. Review of the July 2021-June 2023 Focus Quality presentation revealed the CAH objective focused on the utilize performance improvement methodologies to reduce excess readmission. The CAH will be at or below the system benchmark for 30 day all cause readmission rate as evidenced by the CAH Quarterly Insights. The document lacked evidence that the CAH's quality staff focused on measures to analyze and track the quality program's performance.

3. During an interview on 3/16/22, at 8:36 AM with the Chief Nursing Officer (CNO), acknowledged the CAH staff failed to ensure each service offered at the CAH identified quality projects that focused on measures to analyze and track the quality program's performance.

Based on review of documentation and staff interview, the Critical Access Hospital's (CAH) failed to set priorities for performance improvement with consideration of high volume, high -risk services or problem prone areas for predictive patient outcomes for all services, including contracted services for 30 of 52 departments (Anesthesia Services, Surgical Services, Respiratory Therapy [RT], Speech Therapy [ST], Radiology, Nuclear Medicine, PET Scan, Echocardiogram Scans, Teleradiology, Dexa Scan, Ultrasound, Magnetic Resonance Imaging [MRI], Voluntary Services, Dietary/Nutritional Services, Dietician, Diabetic Education, Finance, Pulmonary Rehab, Outpatient Pain, Sleep Lab, Wound Care Clinic, Plant Operations, Sioux Center Clinic, Hull Clinic, Infusion Clinic/Chemo Clinic, Environmental Services [EVS], Marketing, IT, Quality, Materials Management, and Admitting). The CAH administrative staff identified a census of 7 patients at the beginning of the survey. Failure to set priorities for performance improvement with consideration of high volume, high -risk services or problem prone areas for predictive patient outcomes for all services to include involvement of all of the CAH's departments on a continuous basis could potentially result in the CAH quality staff failing to identify potentially significant patient care concerns while monitoring items not related to patient care, thus missing potentially life-threatening patient care concerns.

Findings include:

1. Review of the CAH's "Sioux Center Health Quality Plan Reporting and Improvement Focus July 2021-June 2023," revealed in part, " ...Purpose: Better Care: Improve the overall quality by making healthcare more person-centered, reliable, accessible and safe. Healthier People/Healthier Community: Improve the health ...by supporting proven interventions to address behavior, social and environmental determinants of health in addition to delivering high-quality care. Affordable Care: Reduce cost of quality healthcare for individuals, families..."

2. Review of the "Sioux Center Health Quality Plan Reporting" documentation revealed the following:

a. Review of the July 2021-June 2023 Focus Quality presentation revealed the facilities focused objective goal to continue NHSH Surveillance: NSHN enrollment and reporting with more active focus on performance improvement of healthcare acquired infections including root cause analysis. The CAH will have an infection count less than NHSN predicted count for the following infections: (C-diff [is a germ (bacterium) that causes an inflammation of the colon], CAUTI [is an infection involving any part of the urinary system], CLABSI [Central Line-associated Bloodstream Infection. The document lacked evidence that the CAH's quality staff focused on priorities that considered high volume, high-risk services, or problem prone areas.

b. Review of the July 2021-June 2023 Focus Quality presentation revealed the CAH objective focused on leveraging innovative strategies across the healthcare system to prevent unnecessary readmissions by reviewing and adopting a Utilization Review Plan. The clinics will have means to measure % of patients attributed to clinic that had an appointment with primary care physician (PCP) within 30 days following an inpatient discharge. Reduce admissions to hospital for attributed Accountable Care Organization (ACO) populations by relative 10%. The document lacked evidence that the CAH's quality staff focused on priorities that considered high volume, high-risk services, or problem prone areas.

c. Review of the July 2021-June 2023 Focus Quality presentation revealed the CAH objective focused on the utilize performance improvement methodologies to reduce excess readmission. The CAH will be at or below the system benchmark for 30 day all cause readmission rate as evidenced by the CAH Quarterly Insights. The document lacked evidence that the CAH's quality staff focused on priorities that considered high volume, high-risk services, or problem prone areas.

3. During an interview on 3/16/22, at 8:36 AM with the Chief Nursing Officer (CNO), acknowledged the CAH staff failed to ensure each service offered at the CAH identified quality projects that focused on measures that considered high volume, high-risk services, or problem prone areas.

Based on review of documentation and staff interview, the Critical Access Hospital's (CAH) Quality Assurance/Improvement program (QAPI) failed to incorporate quality indicator data including patient care data, and other relevant data, in order to achieve the goals of the QAPI program predictive patient outcomes for all services, including contracted services for 30 of 52 departments (Anesthesia Services, Surgical Services, Respiratory Therapy [RT], Speech Therapy [ST], Radiology, Nuclear Medicine, PET Scan, Echocardiogram Scans, Teleradiology, Dexa Scan, Ultrasound, Magnetic Resonance Imaging [MRI], Voluntary Services, Dietary/Nutritional Services, Dietician, Diabetic Education, Finance, Pulmonary Rehab, Outpatient Pain, Sleep Lab, Wound Care Clinic, Plant Operations, Sioux Center Clinic, Hull Clinic, Infusion Clinic/Chemo Clinic, Environmental Services [EVS], Marketing, IT, Quality, Materials Management, and Admitting). The CAH administrative staff identified a census of 7 patients at the beginning of the survey. Failure to incorporate quality indicator data including patient care data, and other relevant data, in order to achieve the goals of the QAPI program for predictive patient outcomes for all services to include involvement of all of the CAH's departments on a continuous basis could potentially result in the CAH quality staff failing to identify potentially significant patient care concerns while monitoring items not related to patient care, thus missing potentially life-threatening patient care concerns.

Findings include:

1. Review of the CAH's "Sioux Center Health Quality Plan Reporting and Improvement Focus July 2021-June 2023," revealed in part, " ...Process: Using performance indicators to monitor a wide range of care processes and outcomes. Reviewing findings against benchmarks and/or targets the system has established for performance. Tracking, investigating, and monitoring adverse events and implementing action plans to prevent recurrences ..."

2. Review of the "Sioux Center Health Quality Plan Reporting" documentation revealed the following:

a. Review of the July 2021-June 2023 Focus Quality presentation revealed the facility discussed goals to continue NHSH Surveillance: NSHN enrollment and reporting with more active focus on performance improvement of healthcare acquired infections including root cause analysis. The CAH will have an infection count less than NHSN predicted count for the following infections: (C-diff [is a germ (bacterium) that causes an inflammation of the colon], CAUTI [is an infection involving any part of the urinary system], CLABSI [Central Line-associated Bloodstream Infection. The document lacked evidence that the CAH's quality staff incorporated quality indicator data, including patient care data, to achieve the goals of the QAPI program.

b. Review of the July 2021-June 2023 Focus Quality presentation revealed the facility discussed goals leveraging innovative strategies across the healthcare system to prevent unnecessary readmissions by reviewing and adopting a Utilization Review Plan. The clinics will have means to measure % of patients attributed to clinic that had an appointment with primary care physician (PCP) within 30 days following an inpatient discharge. Reduce admissions to hospital for attributed Accountable Care Organization (ACO) populations by relative 10%. The document lacked evidence that the CAH's quality staff incorporated quality indicator data, including patient care data, to achieve the goals of the QAPI program.

c. Review of the July 2021-June 2023 Focus Quality presentation revealed the facility discussed goals on the utilize performance improvement methodologies to reduce excess readmission. The CAH will be at or below the system benchmark for 30 day all cause readmission rate as evidenced by the CAH Quarterly Insights. The document lacked evidence that the CAH's quality staff incorporated quality indicator data, including patient care data, to achieve the goals of the QAPI program.

3. During an interview on 3/16/22, at 8:36 AM with the Chief Nursing Officer (CNO), acknowledged the CAH staff failed to ensure each service offered at the CAH incorporated quality indicator data, including patient care data, to achieve the goals of the QAPI program.