HospitalInspections.org

I. Based on review of the Quality Plan, Quality activities, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to evaluate the quality of 2 of 3 Radiology patient care services (Diagnostic, Ultrasound) and 4 of 7 contracted patient care services (Nuclear Medicine, Magnetic Resonance Imaging (MRI), Bone Density, and Echocardiogram). Failure to monitor and evaluate all patient care services for quality of care could potentially expose patients to inappropriate and/or substantial care.

The CAH administrative staff identified the CAH staff provided care to patients for 12 months for FY 2020 as follows:

- Diagnostic - 4926 procedures
- Ultrasound - 30 procedures

Contracted patient care services 12 months for FY 2020 as follows:
- Nuclear Medicine - 7755 studies
- MRI - 325 studies
- Echocardiogram - 30 procedures

Findings include:

1. Review of the "Quality Assurance and Performance Improvement Plan," dated 12/2020, revealed in part, "Each department or service will report monitoring data and quality improvement activities on a regular basis to the Director of Quality. Reports will include quality monitoring data and evaluation activities ...."

2. Review of the Quality Council Meeting Minutes, dated 1/29/2020 through 2/24/2021, revealed the reports lacked quality information from the Radiology department on the Diagnostic Radiology and Ultrasound procedures. The reports also lacked quality information on the contracted patient care services: Nuclear Medicine; Magnetic Resonance Imaging (MRI); Bone Density; and Echocardiogram.

3. During an interview on 3/30/2021 at 3:00 PM, the Director of Ancillary Services acknowledged the radiology department provides patient services including diagnostic x-rays, ultrasound, and CT as well as mobile services of Nuclear Medicine, MRI, Bone Density, and Echocardiogram. The Director of Ancillary Services confirmed the only evaluation of patient services for the imaging department included CT and not the rest of the services provided by the imaging department.

During an interview on 4/1/2021 at 9:35 AM, the Quality Specialist acknowledged the Radiology quality reports lacked information on the diagnostic radiology and ultrasound, and lacked quality information for the contracted patient care services of Nuclear Medicine; MRI; Bone Density; and Echocardiogram.





II. Based on review of the Quality Plan, Board of Trustees Meeting Minutes, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to provide the governing body (Board of Trustees - BOT) information for the BOT to evaluate the effectiveness of the hospital-wide quality improvement program. Failure to monitor and evaluate all patient care services for quality of care could potentially expose patients to inappropriate and/or substantial care. The CAH administrative staff identified a census of 9 patients at the beginning of the survey.

Findings include:

1. Review of the "Quality Assurance and Performance Improvement Plan," dated 12/2020, revealed in part, "The Board of Trustees at Monroe County Hospital & Clinics ensures that there is an effective, organization wide quality program to evaluate clinical care and services ...."

2. Review of the Board of Trustees Meeting Minutes, dated 11/20/2019 through 2/24/2021, revealed the lack of quality reports presented for the governing body to review.

3. During an interview on 4/1/2021 at 9:35 AM, the Director of Quality acknowledged the BOT did not receive information regarding the individual departmental quality reports for the BOT to review. Instead, the BOT received a 1 page quality pillar report. The quality pillar report lacked documentation of problems identified by the departments, recommendations for correction, and any actions taken to correct identified problems.

Based on document review, policy review, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure 1 of 1 Emergency Medicine physician, 1 of 1 Radiologist and 1 of 1 Teleradiologist selected for review received outside entity peer review by the Network Hospital, 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. (Emergency Medicine Physician B, Teleradiologist C and Radiologist D).

The CAH administrative staff identified the identified physicians provided care to patients from 1/1/21 to 3/31/21 as follows:

Emergency Medicine Physician B provided care to 84 emergency room patients.
Teleradiologist C provided imaging studies for 109 patients.
Radiologist D provided imaging studies for 788 patients.

Findings include:

1. Review of the CAH's network agreement, effective 7/1/16, revealed in part " ... Medical records review as part of the quality and medical necessity of medical care at CAH ... shall be included in the services provided by [Network Hospital] to CAH under this agreement ...".

2. Review of the Peer Review Services Agreement, effective 2/20/15, revealed in part "... The CAH is a critical access hospital participating the Medicare and Medicaid programs and required ... to have the quality and appropriateness of the diagnosis and treatment furnished by physicians at the CAH ... evaluated periodically by an outside entity ... The CAH desires for [Network Hospital] to provide such evaluation and [Network Hospital] agrees to provide evaluation services pursuant to the terms and conditions outlined herein ... [Network Hospital] shall upon the request of CAH, evaluate the diagnosis and treatment provided by physicians at CAH ... Peer reviews will be completed within 60 days of the request...".

3. Review of a CAH agreement titled "Professional Radiology Services Agreement", effective 7/1/17, revealed in part "... This Professional Radiology Services Agreement is made and entered into ... between [Radiology Entity A], an Iowa professional corporation and [CAH] ...".

4. Review of a CAH policy titled "Peer Review," approved 2/2021, revealed in part "... [CAH] maintains an agreement with an external organization, [Network Hospital] to objectively and systematically monitor and evaluate the appropriateness of diagnosis and treatment, quality of patient care and clinical outcomes of medical care provided at [CAH]. All medical providers will have at least one chart reviewed externally for each 2-year credentialing period ...".

5. Review of external peer review for the selected physicians revealed the medical staff approved Emergency Medicine Physician B for reappointment to the Medical Staff on 1/14/20. The Board of Trustees approved Emergency Medicine Physician B for reappointment to the Medical Staff on 1/29/20. Emergency Medicine Physician B's external peer review results, completed by the Network Hospital, showed a completion date of 1/20/21.

6. Review of external peer review for the selected physicians revealed the medical staff approved Teleradiologist C for reappointment to the Medical Staff on 1/12/20. The Board of Trustees approved Teleradiologist C for reappointment to the Medical Staff on 1/29/20. Teleradiologist C lacked results of any external peer review conducted by the Network Hospital, prior to reappointment to the Medical Staff.

7. Review of external peer review for the selected physicians revealed the medical staff approved Radiologist D for reappointment to the Medical Staff on 1/14/20. The Board of Trustees approved Radiologist D for reappointment to the Medical Staff on 1/29/20. Radiologist D's external peer review results, completed by the Network Hospital, showed a completion date of 4/22/20.

8. During an interview on 4/1/21, at 9:15 AM and 11:50 AM, the Director of Quality reported they send 1 record for each physician, prior to reappointment, and their Network Hospital conducts the required external peer review, but the CAH is experiencing problems with receiving the external peer review results back from their Network Hospital in a timely manner. The Director of Quality confirmed the external peer review results for Emergency Medicine Physician B and Radiologist D had not been completed and returned for review by both the Medical Staff and Board of Trustees, prior to reappointment to the CAH Medical Staff. The Director of Quality reported the teleradiologists peer review is completed by Radiology Entity A and confirmed they did not have any external peer review completed by their Network Hospital for Teleradiologist C prior to reappointment to medical staff.

Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the CAH's Medical Staff approved the updated blood bank agreement. The Laboratory administrative staff reported the laboratory had 18 units of blood products available to CAH patients at the beginning of the survey. Failure to ensure a current, approved blood bank agreement was in place could potentially interrupt the availability of blood products needed for emergencies resulting in patient harm and/or death.

Findings include:

1. Review of the "Blood and Blood Product Fullservice Agreement," commencing 10/1/19, revealed the CAH's administrator signed the agreement on 12/9/19. The agreement lacked documentation the CAH's Medical Staff approved the agreement.

2. Review of the CAH's Medical Staff Meeting minutes for 1/14/00 through 3/9/21 revealed the meeting minutes lacked documentation the CAH's Medical Staff approved the Blood Product Supply Agreement.

3. During an interview on 3/31/2021 at 3:15 PM, the Chief Executive Officer confirmed the Blood Product Supply Agreement, dated commencing 10/1/19, lacked approval by the CAH's Medical Staff.

I. Based on observation, policy review, and staff interviews, the Critical Access Hospital (CAH) failed to remove outdated supplies from the Operating Room area. The CAH identified 633 surgical procedures in the operating room from July 1, 2019 to June 30, 2020. Failure to remove outdated patient supplies from the Operating Room area resulted in expired supplies remaining available for use in patient care, potentially resulted in staff using the expired items for patient care after the manufacturers expiration date (the date after which the manufacturer will no longer guarantee the safety and quality of the supply).

Findings include:

1. Observations during a tour of the Operating Room 3/31/2021 at 1:00 PM, revealed the following:
- Scrub sink wall dispenser - 1 of 1 Avagaard Hand Antiseptic expired 12/22/20
- Outside of the Operating Room wall dispenser - 1 of 1 Avagaard Hand Antiseptic expired 3/11/21.

2. Review of the CAH policy "Outdated Supplies," dated last approved 12/2020, revealed in part, "Each department within the Hospital is responsible to check all supplies monthly for outdates...."

3. During an interview at the time of the tour, the Surgery Manager revealed the Surgery staff check supplies monthly. The Surgery Manager acknowledged the Surgery staff failed to remove the expired Avagaard Hand Antiseptic from the surgery area staff could potentially use the expired supplies for patient care.

During an interview on 4/1/2021 at 7:50 AM, the Surgery Manager acknowledged the CAH did not have any more Avagaard Hand Antiseptic for the wall dispensers as it was a special order item for surgery but did replace the Avagaard Hand Antiseptic wall dispenser items with Avagaard Hand Antiseptic pump bottles for use in the surgery area.



II. Based on observation, policy review, and staff interviews, the Critical Access Hospital (CAH) failed to secure 1 of 2 oxygen cylinder in the x-ray film storage room. The CAH identified 7,945 radiology procedures from July 1, 2019 to June 30, 2020. Failure to secure oxygen cylinders could potentially result in the oxygen tank being knocked over and becoming a projectile object that could result in patient and/or staff injury or death.
Findings include:

1. Observation during a tour of the Radiology area on 3/30/2021 at 2:30 PM, revealed 1 of 2 unsecured oxygen cylinders in the x-ray film storage room.

2. Review of the CAH policy "Oxygen Therapy," dated last approved 3/2017, revealed in part, "...Properly secure cylinder in transport cart...."

3. During an interview on 3/30/2021 at 2:30 PM, the Director of Ancillary Services acknowledged the unsecured oxygen cylinder in the x-ray film storage room and confirmed the cylinder should have been stored securely.

Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure timely physician notification for the occurrence of a medication error for 5 of 9 medication errors reviewed. (Patient #1, Patient #2, Patient #3, Patient #4, and Patient #5). Failure to notify the physician of medication errors could potentially result in the provider not knowing about the medication error and either failing to take steps to address the consequences of the medication error, or the provider making a medical decision without the knowledge of the medication error, either way potentially resulting in inappropriate treatment or even a fatal reaction. The CAH administrative staff reported a census of 9 patients on entrance.

Findings include:

1. Review of "Adverse Drug Events," last reviewed 11/2020, revealed in part: "Monroe County Hospital & Clinics" encourages reporting of adverse drug events (ADEs), and potential adverse medication events (PADEs) as a mean to assess and improve the medication use process and provide a safe environment for patient care. The purpose of the reporting errors is ... to make it difficult for practitioners to commit errors. Practitioners involved in medication use are required to participate in the detection and reporting of errors, the identification of the system-based causes of errors, and the facilitation of system enhancements to reduce the likelihood of errors".

2. Review of medication errors from March 2020 to March 2021 revealed:

a. The nursing staff made a medication error (wrong dose) on 07/28/2020 at 10:40 AM which involved Patient #1. Patient #1's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #1's medical care of the medication error.

b. The nursing staff made a medication error (medication administered too close to last dose) on 09/30/2020 at 10:43 PM which involved Patient #2. Patient #2's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #2's medical care of the medication error.

c. The nursing staff made a medication error (missed dose-medication not given) on 03/17/2020 at 9:00 PM which involved Patient #3. Patient #3's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #3's medical care of the medication error.

d. The nursing staff made a medication error (missed dose-medication not give) on 07/22/2020 at 8:17 PM which involved Patient #3. Patient #3's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #3's medical care of the medication error.

e. The nursing staff made a medication error (wrong dose-wrong rate) on 12/21/2020 at 5:46 PM which involved Patient #4. Patient #4's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #4's medical care of the medication error.

3. During an interview on 03/30/2021 at approximately 2:00 PM, the Chief Nurse Officer acknowledged the medication error paperwork for Patient #1, Patient #2, Patient #3, Patient #4, and Patient #5 lacked documentation that the nursing staff notified the patient's provider of the medication error.

4. During an interview on 03/31/2021 at approximately 9:00 AM, the ED Manager reported that it is the expectation for all practitioners to report medication errors to the Provider immediately and acknowledged the medication error paperwork for Patient #1, Patient #2, Patient #3, Patient #4, and Patient #5 lacked documentation that the nursing staff notified the patient's provider of the medication error.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) x-ray staff failed to ensure staff secured 1 of 1 radiation exposure cords to not allow staff access into general x-ray room 1 during completion of radiological tests of patients. The CAH x-ray staff reported completing 2,000 radiology x-rays per year in general x-ray room 1. Failure to secure radiation exposure cords could allow staff access to the x-ray room while performing an x-ray procedure and exposing staff to unnecessary radiation.

Findings include:

1. Observations during tour of the radiology department on 3/30/2021 at 1:45 PM, with the Director of Ancillary Services, revealed 1 of 1 unsecured exposure cord in general x-ray room 1 which allowed a staff member to enter approximately 6 feet into the x-ray room and still activate the x-ray machine.

2. Review of the CAH policy "Radiation Protection - Personnel & Patients," last approved 11/2020, revealed in part, "...Staff should position themselves 6 feet or more from the x-ray tube when producing a radiograph...."

3. During an interview on 3/30/2021 at 1:45 PM, the Director of Ancillary Services confirmed the staff failed to secure the radiation exposure cord and would allow staff to access into general x-ray room 1 during x-ray procedures.

I. Based on observation, document review, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to inform each patient or support person of their visitation rights, including any clinical restriction or limitation on such rights, and the reasons for the clinical restriction or limitation for the inpatient unit and outpatient services at 1 of 1 front registration desk. The CAH's administrative staff identified a census of 9 patients at the beginning of the survey. The CAH's administrative staff also identified 258 patients (Inpatients, swing bed, observation, Laboratory, Radiology, Infusion, and Surgery patients) registered at the front registration desk from 3/15/20 through 3/30/21. 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 were provided any type of care, services, or treatment.

Findings include:

1. Observation during a tour of the front registration desk on 3/30/21 at 1:25 PM revealed the CAH staff displayed a form for "Consent to Treat" and the "Notice of Privacy Practices" brochure at the front registration desk.

2. Review of the form for "Consent to Treat" and the "Notice of Privacy Practices" brochure at the front registration desk revealed the form and brochure lacked information to inform patients and/or their support person of the reasons the CAH staff could place clinical restrictions or limitations on the patient's right to receive visitors.

3. Review of CAH policy, "Visitation/Access to Patients," dated last approved 6/2017, revealed in part, "Each patient or support person ... shall be informed of any clinical restriction or limitations on such rights. This notifications shall be provided in advance of furnishing patient care whenever possible to all inpatients and outpatients ... by the person registering the patient...."

4. During an interview on 3/30/2021 at 1:25 PM, Patient Access Specialist A reported when they register patients at the front registration desk, the patients were offered a brochure titled "Notice of Privacy Practices."

During an interview on 3/30/2021 at 1:35 PM, the Compliance & Privacy Officer acknowledged the brochure titled "Notice of Privacy Practices" lacked information to inform patients and/or their support person of the reasons the CAH staff could place clinical restrictions or limitations on the patient's right to receive visitors.



II. Based on review of policies and patient medical records, and staff interview, the Critical Access Hospital (CAH) administrative staff failed document each patient or support person were informed of their visitation rights, including any clinical restriction or limitation on such rights, and the reasons for the clinical restriction or limitation for the inpatient unit and outpatient services at 3 of 3 registration desks. The CAH's administrative staff identified a census of 9 patients at the beginning of the survey. The CAH's administrative staff also identified 258 patients (Inpatients, swing bed, observation, Laboratory, Radiology, Infusion, and Surgery patients) registered at the front registration desk from March 15, 2021 through March 30, 2021. The CAH's administrative staff also identified from July 1, 2019 to June 30, 2020 patient visits for Cardiac Rehabilitation 1379, Physical Therapy - 13116, Occupational Therapy - 2055, Speech Therapy - 65, Emergency Department - 3172, and Outpatient Clinic 4388 (Patients #6 through 38). Failure to document each patient were informed 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 were provided any type of care, services, or treatment.

Findings inlcude:

1. Review of CAH policy, "Visitation/Access to Patients," dated last approved 6/2017, revealed in part, "Each patient or support person...shall be informed of any clinical restriction or limitations on such rights. This notifications shall be provided in advance of furnishing patient care whenever possible to all inpatients and outpatients...by the person registering the patient...."

2. Review of inpatient and outpatient medical records on 3/30/2021, 3/31/2020 and 4/1/2020 for Patients #6 through #38 revealed the records lacked documentation that the required notice of the patient's visitation rights was provided to the patient or, if appropriate, the patient's support person.

3. During an interview on 3/30/2021, 3/31/2020 and 4/1/2020, at the time of record review, the Physical Therapy Manager and Director of Ancillary Services acknowledged all patient medical records lacked documentation that the required visitation rights notice was provided to the patient or the patient's support person.

7. During an interview on 1/13/21 at 11:30 AM, the Chief Nursing Officer confirmed the CAH staff provide the brochure "Patient Rights and Responsibilities" to all patients at registration or admission. The Chief Nursing Officer acknowledged the CAH staff failed to document in the patient's medical record the the required visitation rights notice was provided to the patient or the patient's support person.

Based on observation, document review, and staff interview, the Critical Access Hospital's (CAH) administrative staff failed to ensure the CAH staff kept patient medical information secure from unauthorized access in 1 of 1 x-ray film storage room. The Radiology Manager identified approximately 1650 x-ray films stored in 1 of 1 x-ray film storage room. Failure to keep patient medical information confidential could potentially result in theft of a patient's information and potentially result in identify theft.

Findings include:

1. Review of CAH policy "Handling of Records," dated last approved 12/2020, revealed in part, "Security and confidentiality of patient records should be maintained at all times ...."

2. Observation on 3/30/2021 at approximately 2:30 PM during a tour of the x-ray film storage room with the Director of Ancillary Services revealed 1 of 1 x-ray film storage area in 1 of 1 x-ray film storage room. The Director of Ancillary Services identified approximately 1650 x-ray films stored on 4 open shelving units in the x-ray film storage room.

3. During an interview on 3/30/2021 at 2:30 PM, the Director of Ancillary Services acknowledged the x-ray films contained patient information and materials management staff restock supplies in the x-ray film storage room while unattended by radiology staff.