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600 9TH AVENUE NORTH

SIBLEY, IA 51249

COMPLIANCE STATE AND LOCAL LAWS AND REGS

Tag No.: C0814

Based on personnel file review, document review, policy review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure 2 of 5 new employees selected for review, with a criminal background, received an Iowa Department of Human Services (DHS) clearance to work, according to State law. (Radiology Technologist H and Medical Laboratory Technologist G).

Iowa Administrative Code 481 - 51.41(3) A person who has committed a crime or has a record of founded child or dependent adult abuse shall not be employed in a hospital unless an evaluation has been performed by the department of human services.

Failure to ensure the Department of Human Services reviewed and cleared new employees with a history of criminal convictions could potentially result in the CAH staff placing patients at risk for becoming victims of criminal activity from the new employee.

Findings include:

1. Review of Radiology Technologist H's personnel file revealed the CAH staff hired Radiology Technologist H on 8/28/2020. A document "Single Contact License and Background Check (SING)," dated 8/6/2020, revealed the Iowa Division of Criminal Investigation (DCI) needed to perform additional investigation on Radiology Technologist H's criminal background check. A document "Iowa Record Check Request" revealed the DCI identified a criminal record for Radiology Technologist H on 8/7/2020 and provided a report which contained further details on the criminal conviction. The personnel file lacked evidence the DHS staff evaluated and cleared Radiology Technologist H to work at the CAH.

2. Review of Medical Laboratory Technologist G 's personnel file revealed the CAH staff hired Medical Laboratory Technologist G on 9/28/2020. The "Single Contact License and Background Check (SING)," dated 9/23/2020, revealed the Iowa Division of Criminal Investigation needed to perform additional investigation on Supervisor of Medical Laboratory Technologist G's criminal background check. The "Iowa Record Check Request" revealed the DCI identified a criminal record for Medical Laboratory Technologist G on 9/24/2020 and provided a report which contained further details on the criminal conviction. The personnel file lacked evidence the DHS staff evaluated and cleared Medical Laboratory Technologist G to work at the CAH.

3. Review of a CAH policy titled "Background Investigations," effective January 2018, revealed in part " ...Felony and misdemeanor background investigations and any applicable state-conducted background investigations as required by law will be conducted on all new hires for all positions within [CAH]... Employment is contingent on completion of the background investigation process. Applicants offered employment may not begin working until the background investigation process is completed...No applicant shall begin working for [CAH] until a successful background investigation has been completed ...If a person being considered for employment has been convicted of a crime under a law of any state, appropriate documentation will be sent to the department of human services for employment approval ...".

4. Review of a CAH procedure titled "IA [Iowa] SING Further Research Process" outlined the process and forms to use for a DHS clearance to work, when a SING background check comes back with any possible hit.

5. During an interview on 6/9/2021, at 4:40 PM, Human Resources Director acknowledged Radiology Technologist H and Medical Laboratory Technologist G's personnel files showed a criminal background and the files lacked evidence the DHS staff performed an evaluation and determined if Radiology Technologist H and Medical Laboratory Technologist G could work at the CAH. She reported the DHS clearance should have been obtained prior to Radiology Technologist H and Medical Laboratory Technologist G beginning work but had been missed.

The Human Resources Director confirmed the CAH did not obtain a DHS clearance to work when the background check for Radiology Technologist H and Medical Laboratory Technologist showed a criminal history and they currently provided services to patients.

AGREEMENTS FOR CREDENTIALING AND QLTY ASSURAN

Tag No.: C0870

Based on document review and staff interview, the Critical Access Hospital (CAH) failed to ensure the Network Hospital staff semi-annually reviewed the CAH's quality assurance plan and provided input into areas which could be improved upon in accordance with 1 of 1 Network Agreements for Quality Assurance. The CAH administrative staff identified a census of 2 patients at the beginning of the survey. Failure to ensure the Network Hospital staff annually reviewed the CAH's quality assurance plan and provided input into areas which could be improved upon in accordance with the Network Agreement for Quality Assurance could potentially result in the quality staff of the CAH failing to identify and act on patient care related issues, potentially cause adverse patient outcomes.
Findings include:

1. Review of the Network Agreement, dated June 12, 2002, revealed in part ". . . The parties agree that [Network Hospital], through participating members of its medical staff or other personnel designate by [Network Hospital], shall meet with the OHC's QA (Quality Assurance) representatives no less than on a semi-annual basis to provide objective oversight and assistance to the OHC in reviewing the quality and appropriateness of the diagnosis and treatment furnished by OHC's doctors of medicine or osteopathy and to assist OHC to implement its QA Plan, to review findings under the OHC's QA Plan, and to propose improvement plans and/or recommend corrective action...."

2. Review of CAH documentation revealed the lack of evidence showing the Network Hospital staff semi-annually reviewed the CAH's quality assurance plan and provided input into areas which could be improved upon per the Network Agreement.

3. During an interview on 6/10/2021 at 7:45 AM and 9:03 AM, the Director of Ancillary Services & Quality Initiatives confirmed the Network Hospital does not review the CAH's quality assurance plan or provide input into into areas which could be improved upon per the Network Agreement and the last meeting with the Network Hospital was 6/20/2019.

MAINTENANCE

Tag No.: C0914

Based on observation, document review and staff interviews the Critical Access Hospital's (CAH) staff failed to follow the manufacturer's instructions for the NOVA Biomedical StatStrip Glucose Meter when it failed to label the newly opened Control Solution bottles with the expiration date on the bottles. Failure to follow the NOVA Biomedical StatStrip Glucose Meter manufacturer's instructions for use may result in inaccurate blood glucose readings which may lead to inappropriate patient care. The CAH administration staff reported the hospital staff performed approximately 850 blood glucose tests in the 2020 fiscal year (June 30-July 1).

Findings include:

1. Observation on 06/07/2021 at 3:05 PM, during a tour of the Medical/Surgical Unit (Med/Surg), revealed an NOVA Biomedical StatStrip Glucose Meter and its case held 1 bottle of NOVA StatStripControl Solution Level 1 SAP and 1 bottle of NOVA StatStrip Control Solution Level 3 SAP. The bottles were not labeled with the date that the bottles were to expire.

2. Review of policy/procedure "Osceola Comunity Hospital Laboratory" reviewed 10/26/2020 and the NOVA Biomedical StatStrip Glucose Meter manufacturer's information, dated May 25, 2011 revealed in part, "Note: When opening a new vial of Control solution, check manufacturer's expiration date and write either a 3 month expiration date or manufacturer's expiration date on each vial. Use whichever come first."Write the date the bottle was opened on the bottle label. Control solution is stable for 3 months from that date or until the Use By date on the bottle label, whichever comes first...Sources of error:.. Were the...control solutions expired?.."

3. During an interview on 06/08/2021, while on tour of the CAH laboratory, the Laboratory Manager verified the NOVA StatStrip Control Solution bottles had not been labeled with the expiration dates when opened.

ORGANIZATIONAL STRUCTURE

Tag No.: C0960

Based on review of Board of Trustees meeting minutes and staff interviews, the Board of Trustees (governing body) failed to ensure the Board of Trustees administered policies to determine and maintain quality health care at the Critical Access Hospital.

1. The Board of Trustees failed to ensure the CAH had 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. Refer to C-962 and 1313.

2. The Board of Trustees failed to ensure all physicians received outside entity peer review by a qualified peer to evaluate the appropriateness of diagnosis and treatment furnished to patients at the Critical Access Hospital, prior to reappointment to the medical staff. Refer to C-999.

3. The Board of Trustees failed to ensure all mid-level practitioners were evaluated by a physician from the CAH medical staff to evaluate the quality and appropriateness of the diagnosis and treatment furnished by the mid-level practitioners. Refer to C-999.

4. The Board of Trustees failed to ensure all policies and procedures were developed and reviewed annually by the required group of professionals that included a physician and a midlevel provider. Refer to C-1008.

5. The Board of Trustees failed to ensure the privileges of all Teleradiologists and Certified Registered Nurse Anesthetists were renewed prior to the expiration of the two year reappointment date to the Medical Staff. Refer to C-1142.

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

GOVERNING BODY OR RESPONSIBLE INDIVIDUAL

Tag No.: C0962

Based on review of documentation, governing board meeting minutes, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to present or document information regarding the Quality Improvement activities at the Board of Trustees meetings so board members could exercise oversight of the quality for all patient care services, including contracted services, offered at the CAH for 13 of 25 departments (Radiology, Housekeeping, Surgery, IV Infusion, Chemotherapy, Health Information Management, Nuclear Medicine, Magnetic Resonance Imaging [MRI], Cardiovascular/Echo, Urology, Occupational Therapy, Speech, and Anesthesia). The administrative staff identified a current census of 2 inpatients at the beginning of the survey. Failure of the CAH Board of Trustees to review and evaluate Quality Improvement information could potentially result in the Board of Trustees 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 CAH "FY 2020 - 2021 Quality Plan," dated 6/2020, revealed in part, "...The Quality Plan provides a systematic, coordinated, multi-disciplinary and continuous approach to improving performance focusing upon the processes and systems that affect delivery of service and patient outcomes...The Board maintains the ultimate responsibility for assuring the public that optimal quality care is delivered through Osceola Regional Health Center's services...The Osceola Regional Health Center Quality Program uses a systematic, data driven approach to identify, analyze and improve existing care processes in order to meet goal we have identified...."

2. Review of the Board of Trustees Meeting minutes from June 1, 2020 to April 26, 2021 revealed the meeting minutes lacked documentation the Board of Trustee members reviewed and evaluated the CAH's Quality Improvement activities for Radiology, Housekeeping, Surgery, IV Infusion, Chemotherapy, Health Information Management, Nuclear Medicine, Magnetic Resonance Imaging [MRI], Cardiovascular/Echo, Urology, Occupational Therapy, Speech, and Anesthesia.

3. During an interview on 6/9/2021 at 12:20 PM, the Director of Ancillary Services & Quality Initiatives verified the lack of documented evidence of evaluation of services for IV Infusion, Chemotherapy, Health Information Management, and Urology. The Director of Ancillary Services & Quality Initiatives also verified the services for Radiology, Housekeeping, Surgery, Nuclear Medicine, Magnetic Resonance Imaging [MRI], Cardiovascular/Echo, Occupational Therapy, Speech, and Anesthesia evidence concerning problem prevention, identification, corrective action taken, and the outcomes of effective action. The Director of Ancillary Services & Quality Initiatives acknowledged Radiology - Ultrasound and Dexa Bone Density, Nuclear Medicine, MRI, and Cardiovascular/Echo monitored patient satisfaction surveys for wait time and did not evaluate the service provided. The Director of Ancillary Services acknowledged patient satisfaction surveys was all about patient perception and not an evaluation of the services provided.

PATIENT SERVICES

Tag No.: C0984

Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure a physician periodically reviewed the care provided for CAH patients, in conjunction with mid-level providers, for 2 of 2 applicable mid-level providers selected for review (Advanced Registered Nurse Practitioner E and Physician Assistant F). 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) E and Physician Assistant (PA) F treated the following number of emergency room patients from 3/1/2021 through 6/8/2021:

Advanced Registered Nurse Practitioner E - 30 patients
Physician Assistant F - 18 patients

Findings include:

1. During an interview on 6/9/2021, at 12:05 PM, the Health Information Supervisor, reported the Emergency Room medical director signed 100% of PA emergency room charts but is not aware that she conducts any medical record review in conjunction with the mid-level practitioners.

2. During an interview on 6/9/2021, at 12:30 PM, the Chief Nursing Officer (CNO) reported she is not aware of any physician review of patient care, conducted in conjunction with mid-level practitioners, but if it occurred, the Chief Executive Officer (CEO) would have the documentation. The CNO reported the CAH does not have a policy regarding requirements related to physician/mid-level medical record review.

3. During an interview on 6/9/2021, at 2:30 PM, the CEO acknowledged the CAH lacked a formal documentation process to demonstrate a physician periodically reviewed the care provided for CAH emergency room patients in conjunction with mid-level practitioners. He reported the emergency room mid-levels communicate with a physician regarding patient management but the communication is not necessarily documented.

The Chief Executive Officer confirmed the CAH failed to ensure a physician periodically reviewed the care of CAH patients in conjunction with the mid-level practitioners.

PA, NP, & CLINICAL SPEC RESPONSIBILITIES

Tag No.: C0993

Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure a mid-level provider periodically participated in a review of the care provided for CAH patients, in conjunction with a physician, for 2 of 2 applicable mid-level providers selected for review (Advanced Registered Nurse Practitioner E and Physician Assistant F). 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) E and Physician Assistant (PA) F treated the following number of emergency room patients from 3/1/2021 through 6/8/2021:

Advanced Registered Nurse Practitioner E - 30 patients
Physician Assistant F - 18 patients

Findings include:

1. During an interview on 6/9/2021, at 12:05 AM, the Health Information Supervisor, reported the Emergency Room medical director signed 100% of PA emergency room charts but is not aware that she conducts any medical record review in conjunction with the mid-level practitioners.

2. During an interview on 6/9/2021, at 12:30 PM, the Chief Nursing Officer (CNO) reported she is not aware of any physician review of patient care, conducted in conjunction with mid-level providers, but if it occurred, the Chief Executive Officer (CEO) would have the documentation. The CNO reported the CAH does not have a policy regarding requirements related to physician/mid-level medical record review.

3. During an interview on 6/9/2021, at 2:30 PM, the CEO acknowledged the CAH lacked a formal documentation process to demonstrate a mid-level practitioner participated in a periodic review of the care provided for CAH emergency room patients. He reported the emergency room mid-levels communicate with a physician regarding patient management but the communication is not necessarily documented.

The Chief Executive Officer confirmed the CAH failed to ensure a mid-level practitioner periodically participated in a review of the care provided for CAH patients, in conjunction with a physician.

PERIODIC REVIEW OF CLINICAL PRIVILEGES

Tag No.: C0999

I. Based on document review, policy review, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure 1 of 1 Orthopedic Surgeon and 1 of 1 Urologist, selected for review, received outside entity peer review by a qualified peer, to evaluate the appropriateness of diagnosis and treatment furnished to patients at the Critical Access Hospital, prior to reappointment to the medical staff. Failure to ensure all medical staff members received outside entity peer review, prior to reappointment, affects the CAH's ability to assure physicians provide quality care to the CAH patients. (Orthopedic Surgeon C and Urologist D).
,
The CAH administrative staff identified the identified physicians provided care to patients in fiscal year 2020 as follows:

Orthopedic Surgeon C - 3 surgical procedures
Urologist D - 64 clinic visits and 3 surgical procedures

Findings include:

1. Review of the CAH's network agreement, effective 6/12/02, revealed in part " ... The parties agree the [Network Hospital] through participating members of its medical staff or other personnel designated by [Network Hospital], shall ... provide objective oversight and assistance to [CAH] in reviewing the quality and appropriateness of the diagnosis and treatment furnished by [CAH's] doctors of medicine or osteopathy ..."

2. Review of an agreement titled "[CAH] Peer Review Agreement, dated 1/1/2012, revealed an agreement with a Family Practice physician to conduct external peer review on CAH physicians.

3. Review of the CAH Medical Staff Bylaws, approved by the Governing Board on 3/30/2020, revealed in part " ... Determination of initial privileges shall be based upon an applicant's training, experience and demonstrated competence ... Determination of extension of further privileges shall be based upon an applicant's training, experience and demonstrated competence ...".

4. Review of a CAH policy titled "Practitioner Peer Review Profile", revised in 2019, revealed in part "... To provide a mechanism for the utilization of an external peer review process in physician credentialing ... Each practitioner delivering medical care at the hospital will be evaluated based on quality improvement reviews ... retrospective review of patient records and evaluation of the practitioner's participation in the delivery of health care, including the appropriateness of length of stay, necessity of medical treatment ...".

5. Review of a CAH policy titled "Credentialing Process", reviewed in 2018, identified upon completion of the reappointment form, a multiple step verification process is initiated and includes the verification of professional reference attesting to clinical competence demonstrated by the results of performance profile for the past 2 years and 1 peer review.

6. Review of the credential file and external peer review for Orthopedic Surgeon C revealed the medical staff approved his reappointment to the Medical Staff on 2/3/2021. The Governing Board approved Orthopedic Surgeon C for reappointment to the Medical staff on 2/22/2021. Orthopedic Surgeon C had results of 2 external peer review dated 2/27/2021, which occurred after his reappointment to the Medical Staff and conducted by a Network Hospital Family Medicine Physician, rather than an Orthopedic Surgeon.

7. Review of the credential file and external peer review for Urologist D revealed the medical staff approved his reappointment to the Medical Staff on 9/4/2019. The Governing Board approved Urologist D for reappointment to the Medical staff on 9/30/2019. Urologist D had results of 2 external peer review completed prior to his reappointment to the Medical Staff but conducted by a Network Hospital Family Medicine Physician.

8. During an interview on 6/9/2021, at 2:15 PM, the Chief Executive Officer reported the CAH has an agreement with a Family Medicine physician to conduct all the external peer review completed for CAH physicians.

The Chief Executive Officer confirmed he did not have any external peer review results for Orthopedic Surgeon C completed prior to his last reappointment to the Medical Staff and confirmed a Family Medicine Physician would not necessarily have the training and expertise to evaluate the care provided to CAH patients by an Orthopedic Surgeon and Urologist.

II. Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure 2 of 2 applicable mid-level practitioners selected for review (Advanced Registered Nurse Practitioner E and Physician Assistant F), were evaluated by a physician from the CAH medical staff to evaluate the quality and appropriateness of the diagnosis and treatment furnished by the mid-level practitioners. Failure to ensure all mid-level practitioners are evaluated by a member of the CAH medical staff affects the CAH's ability to assure the mid-level practitioners provide quality care to the CAH patients.

The CAH administrative staff identified the mid-level providers provided care to patients from 3/1/2021 to 6/8/2021 as follows:

Advanced Registered Nurse Practitioner (ARNP) E - 30 patients
Physician Assistant (PA) F - 18 patients

Findings include:

1. During an interview on 6/9/2021, at 12:05 AM, the Health Information Supervisor, reported the Emergency Room medical director signed 100% of PA emergency room charts but is not aware that she conducts any medical record review of patient care by mid-level practitioners.

2. During an interview on 6/9/2021, at 12:30 PM, the Chief Nursing Officer reported she is not aware of any physician review of patient care provided mid-level practitioners, but if it occurred, the CEO would have the documentation. The Chief Nursing Officer reported the CAH does not have a policy regarding the requirement for a CAH physician to evaluate the care of patients provided by a mid-level practitioner.

3. During an interview on 6/9/2021, at 2:30 PM, the Chief Executive Officer acknowledged the CAH lacked a formal documentation process to demonstrate a physician reviewed the care provided for CAH emergency room patients by mid-level practitioners. He reported the emergency room mid-levels communicate with a physician regarding patient management but the communication is not necessarily documented.

The Chief Executive Officer confirmed the CAH failed to ensure a physician from the CAH Medical Staff evaluated the quality and appropriateness of the diagnosis and treatment furnished by the mid-level practitioners.

PATIENT CARE POLICIES

Tag No.: C1008

Based on review of policies/procedures, meeting minutes, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the required group of professionals, including a physician and a mid-level provider, reviewed all patient care policies annually, in accordance with facility policy, for 27 of 27 patient care departments (Nursing, Laboratory, Radiology, Dietary, Maintenance, Housekeeping, Physical Therapy, Occupational Therapy, Speech Therapy, Surgery, Anesthesia, Infection Control, Quality, Health Information Management, Emergency Room, Diabetic Education, IV Infusion, Chemotherapy, Cardiac Rehabilitation, Pulmonary Rehabilitation, Pharmacy, Sleep Study, Wound Care, Cardiovascular/Echo, Urology, Nuclear Medicine, and MRI). The CAH administrative staff identified a census of 2 patients at the beginning of the survey. Failure to ensure the required group of professionals reviewed all patient care policies annually could potentially result in the CAH staff failing to identify patient care needs not addressed in the CAH policies/procedures.

Findings include:

1. Review of CAH policies "Critical Access Hospital Plan," dated 6/2001, revealed in part "...Annual evaluation, review and/or revision of all health care policies by the Critical Access Policy and Procedure Committee, which will consist of the CEO/Administrator, CNO, CFO, Quality Director, a member of the ORHC Board of Directors, and a member of the ORHC Medical Staff...."

2. Review of the Quality Process Improvement Minutes dated June 23, 2020 through May 14, 2021 lacked documentation that the required group of professionals, including a physician and mid-level provider, reviewed all policies for Nursing, Laboratory, Radiology, Dietary, Maintenance, Housekeeping, Physical Therapy, Occupational Therapy, Speech Therapy, Surgery, Anesthesia, Infection Control, Quality, Health Information Management, Emergency Room, Diabetic Education, IV Infusion, Chemotherapy, Cardiac Rehabilitation, Pulmonary Rehabilitation, Pharmacy, Sleep Study, Wound Care, Cardiovascular/Echo, Urology, Nuclear Medicine, and MRI.

3. During an interview on 6/8/2021 at 2:02 PM, the Chief Executive Officer (CEO) confirmed the CAH policy addressed annual review of all health care policies by a group of professionals which included a physician and the policy lacked a requirement that a mid-level provider participated in the annual policy review process. The CEO verified the required group of professionals, including a physician and mid-level provider, only reviewed new or revised policies as they were placed in Policy Stat and failed to review all policies for Nursing, Laboratory, Radiology, Dietary, Maintenance, Housekeeping, Physical Therapy, Occupational Therapy, Speech Therapy, Surgery, Anesthesia, Infection Control, Quality, Health Information Management, Emergency Room, Diabetic Education, IV Infusion, Chemotherapy, Cardiac Rehabilitation, Pulmonary Rehabilitation, Pharmacy, Sleep Study, Wound Care, Cardiovascular/Echo, Urology, Nuclear Medicine, and MRI.

PATIENT CARE POLICIES

Tag No.: C1016

Based on observation, document review, and interviews, the Critical Access Hospital (CAH)
administrative staff failed to ensure the surgery staff changed the sterile water flush bottles after
endoscopy procedures for each patient, in accordance with the manufacturer's directions. Failure
to change the flush bottle of sterile water after each patient could potentially result in bacteria
growing in the sterile water and potentially causing an infection in the next patient. The OR Outpatient
Services Manager and Infection Control Lead identified that the surgery staff performed an average of
170 endoscopy procedures from 07/01/2020 to 06/09/2021.

Findings include:

1. Observations during a tour of the surgery department on 06/08/2021 at approximately 07:50
AM in the Endoscopy Room in the Operating Room (OR) revealed 1 of 1 bottle Baxter 1000 mL bottle of
sterile water for irrigation connected to the endoscopy equipment (a nonsurgical procedure
where a physician inserts a flexible camera into a patient's body to examine the digestive tract).

2. Review of the manufacturer's instructions indicated in part... "For single-dose only. Sterile Water for
Irrigation is available in a flexible plastic container and plastic pour bottle." The hospital staff must
discard any unused portions of the sterile water for irrigation after use on a single patient. The sterile
water for irrigation did not contain any chemicals to prevent bacteria from growing in the sterile water
once the hospital staff opened the bottles of sterile water for irrigation.

3. During an interview at the time of the tour, OR Outpatient Services Manager and Infection Control
Lead stated the surgery staff opened the bottles of sterile water for irrigation each day for endoscopy
procedures that are scheduled and connected it to the equipment. The equipment contained a one-way
valve to prevent backflow between patients to prevent contamination of the source bottle. The surgery
staff changed the flush tubing between the patient and the one-way valve after each endoscopy
procedure, but did not change the tubing between the one-way valve and the bottle of sterile water for
irrigation or replace the bottle of sterile water for irrigation between endoscopy procedures. The
surgery staff would only discard the bottles of sterile water for irrigation once they completed all of the
endoscopy procedures for the day or if the bottle ran empty.

4. During an interview on 06/09/2021 at approximately 9:15 AM, the OR Outpatient Services Manager
and Infection Control Lead stated they reviewed and confirmed the manufacturer's directions for the
Baxter 1000 mL bottles of sterile water for irrigation. The OR Outpatient Services Manager and
Infection Control Lead acknowledged the manufacturer did not support using the bottles of sterile water
for irrigation for more than one patient.

LABORATORY SERVICES

Tag No.: C1028

Based on observation, document review and staff interviews, Critical Access Hospital (CAH) administration failed to ensure 2 of 2 reviewed laboratory staff members (Medical Technologist A and Medical Technologist B) had color vision proficiency prior to interpreting the results of fecal occult blood (blood in stool) tests for all laboratory staff who read the results of the test. Failure to test all laboratory staff for color blindness before performing this test may result in staff misreading the results of the fecal occult blood test which could potentially adversely affect the diagnosis and treatment plan for patients. The CAH performed 20 fecal occult blood tests in the 2020 fiscal year (June 30-July 1).

Findings include:

1. Observation on 06/08/2021 at 9:35 PM, during a tour of the Laboratory revealed the laboratory staff utilized Beckman Coulter Hemoccult slides to check stool for occult blood.

2. During an interview at the time of the tour of the laboratory,the Laboratory Manager reported the staff identified a positive occult blood test result by identifying the slide turned the color blue. The Laboratory Manager acknowledged the laboratory staff interpreting the test would require the ability to identify the color blue.

3. Review of manufacturer's recommendations for Beckman Coulter Hemoccult slides, dated March 2015 revealed, in part: "Because the test is visually read and requires color differentiation, it should not be interpreted by individuals with blue color deficiency (blindness)."

4. Review of personnel files revealed the following:

a. Medical Technologist A started working at the CAH on 09/28/20. Medical Technologist A's personnel file lacked documentation the CAH staff tested Medical Technologist A for blue color vision proficiency upon hire or at any time after hire.

b. Medical Technologist B started working at the CAH on 06/20/2018. Medical Technologist B's personnel file lacked documentation the CAH staff tested Medical Technologist B for blue color vision proficiency upon hire or at any time after hire.

5. During an interview on 06/09/2021, at 9:05 AM, the CNO confirmed the CAH did not currently have a policy for color blind testing and competency of laboratory staff and had not performed testing for color blindness on any of the CAH laboratory staff.

NURSING SERVICES

Tag No.: C1050

Based on document review and staff interviews, the Critical Access Hospital (CAH) staff failed to update and keep current a nursing care plan for 1 of 1 applicable open acute inpatient medical record (Patient #8) and 4 of 4 applicable closed acute inpatient medical records (Patient #9, Patient #10, Patient #11, Patient #12). Failure to develop and keep current a care plan that meets the physical and psychosocial needs of the individual patients could potentially impede the patient's progression toward attaining goals and achieving the highest level of well-being and independence possible. The CAH administrative staff identified a census of 2 patients on entrance.

Findings include:

1. Review of CAH policy "Care Plans," dated last approved 04/2021, revealed in part, "...Documentation will be on the "Problems and Goals" intervention in...EMR... Evaluation of the current interventions will be done daily by the RN...."

2. Review of the 1 open acute inpatient medical records on 6/9/2021 revealed the CAH staff admitted Patient #8 to acute inpatient status on 6/4/2021 for right lower extremity cellulitis with chronic open wounds. Patient #8's medical record lacked evidence the nursing care plan had been reviewed and/or revised since it was developed for patient #8 on 6/5/2021, 4 days prior to the record review.

3. Review of closed acute inpatient medical records revealed the following:

a. The CAH staff admitted Patient #9 to acute inpatient status from 12/1/2020 - 12/3/2020 for new onset atrial fibrillation (occurs when the heart's two upper chambers beat chaotically and irregularly-out of coordination with the two lower chambers of the heart). Patient #9's medical record lacked evidence the nursing care plan had been reviewed and/or revised since developed for Patient #9 on 12/2/2020.

b. The CAH staff admitted Patient #10 to acute inpatient status on 4/9/2021-4/11/21 for respiratory failure secondary to Covid-19. Patient #10's medical record lacked evidence the nursing care plan had been reviewed and/or revised since developed for Patient #10 on 4/10/2021.

c. The CAH staff admitted Patient #11 to acute inpatient status on 12/9/2020-12/11/20 Covid-19 pneumonia and hypoxia (low oxygen in the blood). Patient #11's medical record lacked evidence the nursing care plan had been reviewed and/or revised since developed for Patient #11 on 12/9/2020.

d. The CAH staff admitted Patient #12 to acute inpatient status on 11/14/2020-11/16/20 for respiratory failure and pneumonia secondary to Covid-19. Patient #12's medical record lacked evidence the nursing care plan had been reviewed and/or revised since developed for Patient #12 on 11/14/2020.


4. During an interview on 6/9/2021 at 2:00 PM, the Chief Nursing Officer acknowledged Patient #8's, Patient #9's, Patient #10's, Patient # 11's and Patient #12's medical records lacked evidence that the nursing care plans had been reviewed or revised on an ongoing basis to reflect the patient's current physical and psychosocial needs and progression towards identified goals during each patient's hospitalization.

PATIENT VISITATION RIGHTS

Tag No.: C1056

Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to inform each patient of their visitation rights, including any clinical restriction or limitation on such rights, and the reasons for the clinical restriction or limitation for 1 of 1 emergency departments (ED) and 15 of 15 outpatient services. Failure to inform each patient of their visitation rights could potentially result in limiting/restricting access of visitors to patients that infringed on their right to have a support person when they are provided any type of care, services, or treatment. The CAH's administrative staff identified 1,109 ED patients and the following outpatient services volumes in Fiscal Year 2020 ( July 1, 2019 - June 30, 2020) as follows:
Lab-7,480
Physical Therapy- 3,654
Radiology-2,403
Outpatient Services-!,351
IV Infusions-731
Occupational Therapy-407
Same Day Surgery-153
Wound Care-39
Chemotherapy-33
Diabetes Education-23
Cardiac Rehab-18
Pulmonary Rehab 5
Speech Therapy-3
Dietary Consult-5
Urology Clinic Visits-64
Sleep Studies 20

Findings include:

1. Review of policy "Visitation Rights", dated last revised 6/2021, revealed in part, "...applies to...outpatient setting...visitation rights disclosure shall be made in advance of furnishing patient care..."

2. Review of policy "Patient Registration", dated last revised 6/2021, revealed in part, "...All patients will be given the Privacy cy Notice.." The policy lacked direction for the registration staff to disclose a patient's visitation rights in advance of care.

3. Observations during a tour of the Emergency Department (ED) on 6/7/2021 at 2:06 PM revealed the CAH failed to post or otherwise make the patients' visitation rights information available to patients of the Emergency Department.

During an interview on 6/7/2021, at the time of the ED tour, ER RN M reported staff do not disclose or provide visitation rights information to any patients.

During an interview on 6/7/2021 at 3:10 PM, Business Office Representative L verified the Registration staff did not disclose to a patient or otherwise make the patient's rights information available to patients of the Emergency Department.

4. Observations on 6/8/2021 at 10:50 AM at the Patient Registration and Admitting desk revealed the CAH failed to post or otherwise make available the patient's visitation rights information available to the CAH's outpatients.
During a interview on 6/8/2021 at the time of the observation, Business Office Representative L reported outpatients present to the registration desk prior to receiving hospital services. Business Office Representative L repeated registration staff do not disclose verbally or otherwise make the patient's visitation rights information available to outpatients that come to the CAH for services.

5. During an interview on 6/8/21 at 11:50 PM, CNO acknowledged that Patient's Visitation Rights information was not posted, disclosed, or otherwise made available to ER and Outpatients anywhere in the CAH where these patient's received services.

RECORDS SYSTEM

Tag No.: C1102

Based on observation, policy review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the staff kept patient medical information secure from unauthorized access to 398 billing files which contained patient's medical information, 282 x-ray films with labels of patient information attached and one 4 foot barrel containing 18 inch deep of discarded x-ray films patient information found in a storage room located between Laboratory and Environmental Services Department which allowed access to unauthorized staff. Failure to keep patient medical information confidential could potentially result in unauthorized access of a patient's personal/medical information and potentially result in unauthorized release of personal information. The CAH administrative staff identified 31 swing bed admissions in Fiscal Year 2020 with an average length of stay of 3.44 days.

Findings include:

1. Review of policy, "Safeguarding PHI" dated effective 06/2021, revised 06/2021 revealed in part, " ...Any documentation of PHI shall be stored in a location that ensures, to the extent possible, that such PHI is accessible only to authorized individuals."

2. Observation on 06/09/21 at 9:35 AM, during a tour of the Radiology storage department with Radiology Tech K, revealed a box containing 398 billing files which contained patient's medical information, 282 x-ray films with labels of patient information attached and one 4 foot barrel containing 18 inch deep of discarded x-ray films patient information found in a storage room located between Laboratory and Environmental Services Department (EVS), potentially allowing unauthorized personnel access to confidential patient information.

3. During an interview on 06/09/2021 at approximately 10:03 AM, the Medical Records Director, Director Of Nursing (DON) and Chief Financial Officer (CFO) revealed the Medical Records Director, DON and CFO were unaware this box containing 398 billing files with patient information and x-ray films were housed in this store room. The Medical Records Director, DON and CFO acknowledged the private patient information in the storage located between Laboratory and EVS was available for unauthorized personnel access since this store room housed other billing and financial records, some medical equipment and supplies. Unauthorized staff had access to this storage room potentially on a daily basis.

SURGICAL SERVICES

Tag No.: C1140

I. 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 polices must be in accordance with acceptable standards of medical practice and surgical patient care. The CAH Administrative Staff identified a total of 259 procedures performed during fiscal year July 1, 2020-May 31, 2021, which include the following procedures:

EGD (Esophagogastroduodenoscopy) procedures from July 1, 2020-June 9, 2021= 53

Colonoscopy procedures from July 1, 2020- June 8, 2021 - 117


1. The CAH Administrative staff failure to ensure a history and physical (H&P) was conducted by a qualified practitioner prior to surgical services for a CAH patient. Please refer to C-1140

2. The CAH Administrative staff failed to ensure a Pre-Anesthesia risk assessment was conducted by a qualified practitioner prior to surgical services for a CAH patient. Please refer to C-1144.

The cumulative effect of the systemic failure and deficient practices resulted in the facility's inability to ensure quality and safe health care provided to patients.


II. Based on document review and staff interview, the Critical Access Hospital's administrative staff failed to ensure the surgical services staff verified the patient had undergone a History and Physical examination prior to the start of the surgical procedure for 1 of 5 patients reviewed (Patient #3). Failure to ensure a patient underwent a History and Physical examination prior to surgery could potentially result in the hospital staff failing to detect a patient with medical risks from surgery, and potentially allowing the patient to undergo surgery, and potentially resulting in the patient's death. The CAH surgical staff performed 259 surgical procedures during the fiscal year July 1, 2020-May 31, 2021.

Findings include:

1. Review of the Medical Staff Rules and Regulations policy revealed in part, "A complete history and physical examination (H&P), in all cases ...will be completed and accepted within 30 days [prior to surgery] ..."

2. Review of the Document Requirements policy, revised 2020, revealed in part, "Surgical procedures shall be canceled if the H&P is not recorded in the records or dictated waiting for transcription ... for the procedure to be performed."

3. Review of the Patient #3's medical record revaled Patient #3 underwent surgery to remove their gallbladder on 5/24/21. Patient #3's medical record lacked evidence that Patient #3 underwent a History and Physical exam prior to undergoing surgery on 5/24/21.

4. During interview on 06/08/2021 at approximately 3:20 PM, the Medical Records Director and Outpatient Services Manager/Infection Control Lead verified that Patient #3's medical record lacked evidence that Patient #3 underwent a History and Physical examination by a qualified provider in the 30 days prior to Patient #3 undergoing surgery.

DESIGNATION OF QUALIFIED PRACTITIONERS

Tag No.: C1142

I. Based on document review and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure the privileges of 1 of 2 Teleradiologists (Teleradiologist B) and 1 of 2 Certified Registered Nurse Anesthetists (Certified Registered Nurse Anesthetist A), were renewed prior to the expiration of the two year reappointment date to the Medical Staff. Failure to ensure practitioners privileges are approved prior to the end of the appointment to the Medical Staff could potentially result in the practitioners to perform procedures they lacked competence and skill to safely perform and compromise safety of CAH patients.

The CAH administrative staff identified Teleradiologist B and Certified Registered Nurse Anesthetist (CRNA) A, performed the following volume of services from 2/1/2021 to 6/9/2021:

Teleradiologist B - 38 diagnostic imaging reports
CRNA A - 13 anesthesia procedures

Findings include:

1. Review of the CAH Medical Staff by-laws, approved 4/2020, revealed in part "... Term appointment shall be for a period of two years ...".

Review of the credential file for Teleradiologist B revealed the medical staff approved the delineation of privileges and reappointment to the Medical Staff on 12/5/2018. The Governing Board approved Teleradiologist B's delineation of privileges and reappointment to the Medical staff on 2/4/2019.

Review of the credential file for CRNA A revealed the medical staff approved the delineation of privileges and reappointment to the Medical Staff on 1/2/2019. The Governing Board approved CRNA A's delineation of privileges and reappointment to the Medical staff on 2/4/2019.

During an interview on 6/9/2021, at 8:20 AM, the Medical Staff Credentialist acknowledged Teleradiologist B's privileges expired on 2/4/2021 and the CAH is currently seeking approval of temporary privileges pending the full reappointment to the Medical Staff. She reported Teleradiologist B's reappointment had been scheduled previous to expiration but weather caused a postponement of the Governing Board meeting and did not get scheduled for the next meeting to approve the reappointment.

During an interview on 6/9/2021, at 10:30 AM, the Medical Staff Credentialist acknowledged CRNA A's privileges expired on 2/4/2021 and the CAH is currently seeking approval of temporary privileges pending the full reappointment to the Medical Staff. She reported CRNA's reappointment had been scheduled at the same time as Teleradiologist B's, but weather caused a postponement of the Governing Board meeting and did not get scheduled for the next board meeting to approve the reappointment.

The Medical Staff Credentialist confirmed the privileges for Teleradiologist B and CRNA A expired in February 2021 and both practitioners continued to provided services to CAH patients.


II. Based on document review and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure 1 of 1 Registered Nurses (Contracted RN I), who assisted Ophthalmologist J during surgical procedures, was qualified to assist. The administrative staff identified RN I assisted Ophthalmologist J on 17 surgical procedures in fiscal year 2020 and 24 surgical procedures from 1/1/2021 to 6/10/2021.

Failure to ensure the qualifications of all individuals providing assistance to surgical procedures of CAH patients could potentially result in the performance of care beyond their capabilities and placing the patient at risk for surgical complications and potential harm.

Findings include:

During an interview on 6/8/2021, at 7:50 AM, the Surgery Manager reported Ophthalmologist J provided surgical services with her own RN who performs as a scrub nurse.

During an interview on 6/8/2021, at 4:25 PM, the Surgery Manager confirmed Contracted RN I accompanies Ophthalmologist J, and performs as a scrub nurse during surgical procedures. She reported the CAH no longer credentialed scrub nurses but believed Human Resources has a file of information on her. She reported they have a process to follow for individuals accompanying a physician during procedures instead of the credential file.

Review of the information provided for Contracted RN I revealed a copy of a fax, dated 6/9/21 at 7:58 AM, which showed a current RN license and a recent tuberculosis test, but lacked any information to support the qualifications to perform as a scrub nurse or approved privileges for the role she is performing.

During an interview on 6/9/2021, at 4:40 PM, the Surgery Manager confirmed the only information the CAH has for Contracted RN I is a copy of a current RN license and a tuberculosis test. She reported she believed the contract for the Ophthalmology service requires the person be qualified . She acknowledged the CAH lacked a policy and procedure to managed individuals accompanying physicians during surgical procedures.

Review of a document titled "Clinical Lease, Services and Supplies Agreement", dated 6/10/2015, revealed the agreement outlined a standard business lease agreement and lacked any language regarding qualifications of individuals providing the services.

During an interview on 6/9/2021, at 5:05 PM, the Director of Human Resources confirmed the contract for the Ophthalmology service does not identify the expectations for qualifications of an individual accompanying the Ophthalmologist to assist during a surgical procedure and the CAH failed to confirm her qualifications and define her privileges at the CAH.

ANESTHETIC RISK AND EVALUATION

Tag No.: C1144

Based on review of policies/procedures, medical record review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the anesthesia staff performed an anesthesia risk evaluation and examination by a qualified anesthesia provider for 5 of 5 surgical records reviewed (Patient #3, Patient #4, Patient #5, Patient #6, and Patient #7). Failure to perform a pre-surgical anesthesia risk evaluation could potentially result in the anesthesia staff failing to detect a patient who is not a safe candidate for anesthesia, potentially allowing the patient to undergo surgery, and potentially die during the surgical procedure. The CAH's Administrative Staff identified a total of 259 procedures performed during fiscal year July 1, 2020-May 31, 2021, which include the following procedures:

EGD (Esophagogastroduodenoscopy) procedures from July 1, 2020-June 9, 2021= 53

Colonoscopy procedures from July 1, 2020- June 8, 2021 =117

Findings include:

1. Review of closed surgical records revealed the following:

a. Patient #3 underwent gallbladder removal surgery on 5/24/21. Patient #3's medical record lacked evidence that an anesthesia provider examined Patient #3 prior to surgery to ensure Patient #3 could safely undergo anesthesia.

b. Patient #4 underwent left knee replacement surgery on 2/12/21. Patient #4's medical record lacked evidence that an anesthesia provider examined Patient #4 prior to surgery to ensure Patient #4 could safely undergo anesthesia.

c. Patient #5 underwent cataract surgery on their right eye on 4/7/21. Patient #5's medical record lacked evidence that an anesthesia provider examined Patient #5 prior to surgery to ensure Patient #5 could safely undergo anesthesia.

d. Patient #6 underwent a surgical procedure to remove food stuck in their throat on 5/26/21. Patient #6's medical record lacked evidence that an anesthesia provider examined Patient #6 prior to surgery to ensure Patient #6 could safely undergo anesthesia.

e. Patient #7 underwent surgical removal of their gallbladder on 5/3/21. Patient #7's medical record lacked evidence that an anesthesia provider examined Patient #7 prior to the surgical procedure to ensure Patient #7 could safely undergo anesthesia.


2. During an interview on 6/08/2021 at approximately 3:20 PM, the Medical Records Director and the OR Outpatient Services Manager/Infection Control Lead acknowledged the closed medical records lacked documentation of an anesthetic risk evaluation examination by a qualified provider immediately before surgery to evaluate the risks prior to the performance of the procedure.

3. During an interview on 06/08/2021 at approximately 4:00 PM, OR Outpatient Services Manager/Infection Control Lead contacted a CRNA (Certified Registered Nurse Anesthetist) to see if they performed an anesthetic risk evaluation examination on patients prior to surgery and documented their findings. The CRNA told the OR Outpatient Services Manager/Infection Control Lead that the CRNAs at the CAH did not perform a pre-anesthesia assessment prior to surgery.

INFECTION PREVENT & CONTROL POLICIES

Tag No.: C1206

Based on document review and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to develop and implement a water management plan which included a facility risk assessment and implementation of policies and procedures developed to mitigate the risk of Legionella infections and other waterborne pathogens. The CAH administrative staff identified at census of 2 inpatients at the time of the survey and an average daily census of 4 patients. Failure to develop and implement a water management plan could potentially result in the CAH staff failing to identify and implement a program which reduces the risk of Legionella infections, which could potentially result in patients developing a life threatening infection.

Findings include:

1. Review of the CAH's policies/procedures revealed the CAH lacked a policy/procedure which included a facility risk assessment and identified procedures implemented to mitigate the risk of Legionella infections and other waterborne pathogens.

2. During an interview on 6/8/2021, at 4:25 PM, the Infection Control Lead acknowledged she knew of the requirement for a water management plan. She reported she has been the infection preventionist for a short time and discovered the CAH lacked such a plan. She has talked to the Facility Services Manager regarding the need to create a water management plan, and he indicated he recalled conversations with the previous Infection Control Lead and would look for documentation of the plan and any associated policies.

3. During an interview on 6/9/2021, at 11:40 AM, the Facility Services Manager confirmed he had conversations with the previous Infection Control Lead about the development of a water management plan but acknowledged a complete risk assessment plan had not been developed and unable to identify and current practices conducted to mitigate the risk for waterborne illness. He acknowledged he and the current Infection Control Lead met on 6/7/2021 to discuss the development of a water management plan and reviewed some material from the Centers For Disease Control.

The Facility Services Manager confirmed the CAH failed to develop and implement a water management plan to mitigate the risk for Legionella infection and other waterborne illnesses.

QAPI

Tag No.: C1300

The CAH failed to develop and implement an effective quality assurance program.

1. The CAH's Quality Assurance/Improvement program lacked problem prevention, identification, identification of corrective actions, implementation of corrective actions, evaluation of corrective actions, and measures to improve quality on a continuous basis including contracted services. Please refer to C-1306.

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

3. 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. Refer to C-962 and C-1313.

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

QAPI

Tag No.: C1306

Based on review of documentation and staff interview, the Critical Access Hospital (CAH) administrative staff failed to develop, evaluate, and implement an effective Quality Improvement Program to evaluate and improve the quality and appropriateness of patient care and to improve quality on a continuous basis including all services, including contracted services, offered at the CAH for 13 of 25 departments (Radiology, Housekeeping, Surgery, IV Infusion, Chemotherapy, Health Information Management, Nuclear Medicine, Magnetic Resonance Imaging [MRI], Cardiovascular/Echo, Urology, Occupational Therapy, Speech, and Anesthesia). The administrative staff identified a current census of 2 inpatients at the beginning of the survey. Failure to create and implement an effective quality improvement program that included involvement of all of the CAH's departments to improve quality on a continuous basis 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 departments.

Findings include:

1. Review of the CAH "FY 2020 - 2021 Quality Plan," dated 6/2020, revealed in part, "...The Quality Plan provides a systematic, coordinated, multi-disciplinary and continuous approach to improving performance focusing upon the processes and systems that affect delivery of service and patient outcomes...The Board maintains the ultimate responsibility for assuring the public that optimal quality care is delivered through Osceola Regional Health Center's services...The Osceola Regional Health Center Quality Program uses a systematic, data driven approach to identify, analyze and improve existing care processes in order to meet goal we have identified...."

2. Review of the CAH's documents revealed the CAH staff lacked evidence concerning problem prevention, identification, corrective action taken, and the outcomes of effective action from the following departments: Radiology, Housekeeping, Surgery, IV Infusion, Chemotherapy, Health Information Management, Nuclear Medicine, Magnetic Resonance Imaging [MRI], Cardiovascular/Echo, Urology, Occupational Therapy, Speech, and Anesthesia.

3. During an interview on 6/9/2021 at 12:20 PM, the Director of Ancillary Services & Quality Initiatives verified the lack of documented evidence of evaluation of services for IV Infusion, Chemotherapy, Health Information Management, and Urology. The Director of Ancillary Services & Quality Initiatives also verified the services for Radiology, Housekeeping, Surgery, Nuclear Medicine, Magnetic Resonance Imaging [MRI], Cardiovascular/Echo, Occupational Therapy, Speech, and Anesthesia evidence concerning problem prevention, identification, corrective action taken, and the outcomes of effective action. The Director of Ancillary Services & Quality Initiatives acknowledged Radiology - Ultrasound and Dexa Bone Density, Nuclear Medicine, MRI, and Cardiovascular/Echo monitored patient satisfaction surveys for wait time and did not evaluate the service provided. The Director of Ancillary Services acknowledged patient satisfaction surveys was all about patient perception and not an evaluation of the services provided.

QAPI

Tag No.: C1309

Based on review of documentation and staff interview, the Critical Access Hospital (CAH) administrative staff failed to utilize objective measures to evaluate organizational processes and services for all services, including contracted services, offered at the CAH for 13 of 25 departments (Radiology, Housekeeping, Surgery, IV Infusion, Chemotherapy, Health Information Management, Nuclear Medicine, Magnetic Resonance Imaging [MRI], Cardiovascular/Echo, Urology, Occupational Therapy, Speech, and Anesthesia). The administrative staff identified a current census of 2 inpatients at the beginning of the survey. Failure to create and implement an effective quality improvement program that included involvement of all of the CAH's departments to improve quality on a continuous basis 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 departments.

Findings include:

1. Review of the CAH "FY 2020 - 2021 Quality Plan," dated 6/2020, revealed in part, "...The Quality Plan provides a systematic, coordinated, multi-disciplinary and continuous approach to improving performance focusing upon the processes and systems that affect delivery of service and patient outcomes...The Board maintains the ultimate responsibility for assuring the public that optimal quality care is delivered through Osceola Regional Health Center's services...The Osceola Regional Health Center Quality Program uses a systematic, data driven approach to identify, analyze and improve existing care processes in order to meet goal we have identified...."

2. Review of the CAH's documents revealed the CAH staff lacked evidence the quality program utilized objective measures to evaluate organizational processes and services for all services including Radiology, Housekeeping, Surgery, IV Infusion, Chemotherapy, Health Information Management, Nuclear Medicine, Magnetic Resonance Imaging [MRI], Cardiovascular/Echo, Urology, Occupational Therapy, Speech, and Anesthesia.

3. During an interview on 6/9/2021 at 12:20 PM, the Director of Ancillary Services & Quality Initiatives verified the lack of documented evidence of utilize objective measures to evaluate organizational processes and services for all services including Radiology, Housekeeping, Surgery, IV Infusion, Chemotherapy, Health Information Management, Nuclear Medicine, Magnetic Resonance Imaging [MRI], Cardiovascular/Echo, Urology, Occupational Therapy, Speech, and Anesthesia.

QAPI

Tag No.: C1313

Based on review of documentation, governing board meeting minutes, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to present or document information regarding the Quality Improvement activities at the Board of Trustees meetings so board members could exercise oversight of the quality for all patient care services, including contracted services, offered at the CAH for 13 of 25 departments (Radiology, Housekeeping, Surgery, IV Infusion, Chemotherapy, Health Information Management, Nuclear Medicine, Magnetic Resonance Imaging [MRI], Cardiovascular/Echo, Urology, Occupational Therapy, Speech, and Anesthesia). The administrative staff identified a current census of 2 inpatients at the beginning of the survey. Failure of the CAH Board of Trustees to review and evaluate Quality Improvement information could potentially result in the Board of Trustees 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 CAH "FY 2020 - 2021 Quality Plan," dated 6/2020, revealed in part, "...The Quality Plan provides a systematic, coordinated, multi-disciplinary and continuous approach to improving performance focusing upon the processes and systems that affect delivery of service and patient outcomes...The Board maintains the ultimate responsibility for assuring the public that optimal quality care is delivered through Osceola Regional Health Center's services...The Osceola Regional Health Center Quality Program uses a systematic, data driven approach to identify, analyze and improve existing care processes in order to meet goal we have identified...."

2. Review of the Board of Trustees Meeting minutes from June 1, 2020 to April 26, 2021 revealed the meeting minutes lacked documentation the Board of Trustee members reviewed and evaluated the CAH's Quality Improvement activities for Radiology, Housekeeping, Surgery, IV Infusion, Chemotherapy, Health Information Management, Nuclear Medicine, Magnetic Resonance Imaging [MRI], Cardiovascular/Echo, Urology, Occupational Therapy, Speech, and Anesthesia.

3. During an interview on 6/9/2021 at 12:20 PM, the Director of Ancillary Services & Quality Initiatives verified the lack of documented evidence of evaluation of services for IV Infusion, Chemotherapy, Health Information Management, and Urology. The Director of Ancillary Services & Quality Initiatives also verified the services for Radiology, Housekeeping, Surgery, Nuclear Medicine, Magnetic Resonance Imaging [MRI], Cardiovascular/Echo, Occupational Therapy, Speech, and Anesthesia evidence concerning problem prevention, identification, corrective action taken, and the outcomes of effective action. The Director of Ancillary Services & Quality Initiatives acknowledged Radiology - Ultrasound and Dexa Bone Density, Nuclear Medicine, MRI, and Cardiovascular/Echo monitored patient satisfaction surveys for wait time and did not evaluate the service provided. The Director of Ancillary Services acknowledged patient satisfaction surveys was all about patient perception and not an evaluation of the services provided.