HospitalInspections.org

Based on observation and staff interview, it was determined the CAH failed to ensure emergency medical equipment and supplies were maintained. This had the potential for the health and safety of all patients presenting to the ED to be compromised in the event of a medical emergency. Findings include:

1. Observation and tour of the CAH's emergency department was conducted on 5/18/21, beginning at 10:45 AM. The ED RN present at that time opened emergency response carts for inspection.

a. The following emergency supplies were expired in the ED Crash cart between beds #1 and #2:

- Nasopharyngeal airway 32F expired 4/2021

- Supraglotic airway 50-90 kg expired 7/2020

- Supraglotic airway 30-60 kg expired 2/2020

- Supraglotic airway >90 kg expired 4/2020

- Pediatric CO2 detectors (3) expired 12/23/20, 10/14/20, 12/23/20

- scalpel #10 expired 10/2019

b. The following emergency supplies were expired in the supply cart:

- IV cannula 14g (3) all expired 10/31/20

- IV cannula 16g (4) all expired 9/30/20

- IV cannula 24g (2) both expired 12/31/19

- Caresite IV Y-extension set (2) both expired 11/30/20

- Sutures ethilon 6.0 (15) all expired 12/31/20

c. The following emergency supplies were expired in the ED crash cart in the hallway of the emergency department:

- infant electrodes expired 12/12/20

d. The following emergency supplies were expired in the Pediatrics intubation cart located in the ED:

- endotrachial tube 3.5 expired 8/2020

- I-gel supraglottic device 5-12kg expired 3/2021

e. The following supplies were expired in the ED supply closet:

- HemaPrompt Guaiac Blood Test Kit (6) all expired 4/31/21

- Cricothyrotomy kit expired 8/08/19

- Trocar catheter kit 28f expired 1/2021

The CNO and Clinical RN Manager were interviewed on 5/19/21, beginning at 9:00 AM. They confirmed the emergency supplies were expired and were inventoried and replaced "last night".

When asked about oversite of ED supplies, the Clinical RN Manager stated "the ER Nurse is supposed to open and go through the crash carts every other Monday". He agreed that this process was not being followed.

The CAH failed to ensure medical supplies were maintained.

Based on observation and staff interview, it was determined the CAH failed to ensure patient-care equipment was maintained. This had the potential for patient care equipment not functioning and/or being safe for use when needed. Findings include:

A tour of the CAH's offsite outpatient physical therapy treatment facility was conducted in the presence of the CNO on 5/18/21, beginning at 2:29 PM. During the tour, patient care equipment was identified without affixed biomedical inspection tags:

- Parabath unit

- 2 TENS units

Additionally, during the tour, patient care equipment was identified in disrepair:

- Schwinn AD86 stationary bike had a compromised, frayed bike seat

- A physical therapy treatment table had a compromised, frayed outer surface

The CNO was interviewed during the tour on 5/18/21, beginning at 2:29 PM. She confirmed the absence of required biomedical inspection tags and stated the items had been missed. Additionally, the CNO confirmed the identified patient care equipment in disrepair needed to be corrected.

The CAH failed to ensure patient care equipment was maintained.

Based on observation and staff interview, it was determined the CAH failed to ensure drugs were properly stored. This had the potential for access to medications by unauthorized individuals. Findings include:

A tour of the CAH's infusion room was conducted in the presence of the CNO on 5/18/21, beginning at 3:10 PM. During the tour, a multidose vial of Lidocaine (a local anesthetic) was found unsecured in the infusion cart.

The CNO was interviewed during the tour on 5/18/21, beginning at 3:10 PM. She confirmed the Lidocaine should have been secured.

The CAH failed to ensure drugs were properly stored.

Based on observation, policy review, and staff interview, it was determined the Governing Body failed to implement policies which governed the monitoring and removal of expired patient care supplies. This directly affected patient care supplies located in the CAH's inpatient and outpatient physical therapy departments and had the potential for compromised patient care supplies being used on patients. Findings include:

1. A tour of the CAH's outpatient physical therapy department was conducted in the presence of the CNO on 5/18/21, beginning at 2:29 PM. During the tour, multiple expired patient care supplies were found:

- Easy trode electrodes; expired 2014

- Duoderm; expired 2016

- Tegaderm x 2; expired 2014

- Sorbact x 4; expired 2017 and 2019

- Silvasorb x 2; expired 2018 and 2019

- Curity x 2; expired 2018

- Silver dressing x 7; expired 2018

- Non-stick strips x 2; expired 2017

- Aliginant dressing; expired 2014

- Sorbion (entire box); expired 2015

- Sodium chloride dressing (entire box); expired 2013

- Lubricant (entire box); expired 2016

- Steri-strips x 9; expired 2020

- Multiple items in first-aid kit; expired 1994

- Large ultrasound gel container used to refill smaller containers; expired 2015

2. A tour of the CAH's inpatient physical therapy department was conducted in the presence of the CNO on 5/18/21, beginning at 3:10 PM. During the tour, multiple expired patient-care supplies were found:

- Hydrofera Blue (entire box); expired 2019

- Xeroform gauze; expired 2020

The CAH's policy table-of-contents was requested by surveyors and reviewed. A policy which governed the monitoring and removal of expired patient care supplies was not found, nor provided upon request. It was unclear how the Governing Body provided oversight to ensure expired patient care items did not reach patients.

The CNO was interviewed on 5/18/21, beginning at 3:10 PM. She confirmed the expired patient care supplies should have been removed. The CNO stated she did not believe the CAH had a policy which governed the monitoring and removal of expired patient care supplies.

The Governing Body failed to implement policies which governed the monitoring and removal of expired patient care supplies.

Based on direct observation, policy review, record review, and staff interview, it was determined the CAH failed to ensure healthcare services were provided in accordance with written policies. This directly affected 1 of 2 patients ( #37) whose care was observed in the ED and whose records were reviewed. This had the potential to cause substandard outcomes. Findings include:

A facility policy titled "Chest Pain", last reviewed on 5/08/20, stated: "Nursing Actions: 1. O2 therapy for chest pain, dyspnea a. O2 by nasal cannula 2-5 lpm b. Non-rebreather @ 10-15 lpm c. Maintain O2 sats greater than 92% 2. Cardiac monitoring 3. EKG within 10 minutes of arrival". This policy was not followed. Example includes:

1. Patient #37 was an 83 year old male seen in the ED on 5/18/21, beginning at 2:30 PM, with a documented and stated chief complaint of "chest pain since this morning". Patient #37 had an EKG at 2:45 PM. ED MD was observed at patient bedside at 2:48 PM. Aspirin was ordered and given at 2:56 PM. Portable chest x-ray was at bedside at 3:03 PM. During this observation from 2:30 PM to 3:03 PM, it was observed that no oxygen therapy was administered to patient. Patient Care orders dated 5/18/21, at 2:44 PM stated "ED Chest Pain Protocol Order Set [Syringa General Hospital]"

The Clinical RN Manager was interviewed on 5/19/21, beginning at 9:00 AM. When asked if the ED staff have a chest pain protocol he replied "yes". Observations of patient #37 were reviewed with the Clinical RN Manager. When asked if patient #37 should have received oxygen he stated "yes, he should have gotten 2L immediately."

The patient record was obtained and reviewed on 5/20/21. The only documentation of oxygen therapy was "O2 placed 3L NC, sats 96%. on 5/18/2021 17:27 PDT by [RN]."

Chest pain protocol was not provided in accordance with written policy.

Based on medical record review, policy review, and staff interview, it was determined the CAH failed to ensure medical records were complete and accurately documented for 2 of 2 patients (#2 and #4) who left the hospital against medical advice (AMA), and whose records were reviewed. This resulted in missed identification of patients who left the CAH AMA. Findings include:

A CAH policy, "Leaving Against Medical Advice," reviewed 11/13/19, stated, "The patient is given a copy of the Patient Decision Against Medical Advice form for review and signature." This policy was not followed.

1. Patient #2 was a 63 year old female admitted to the CAH on 12/04/20 with a primary diagnosis of rule out COVID-19.

Patient #2's medical record included a "Discharge Documentation," dated 12/09/20, signed by her physician, which stated, "She will be discharged home at her request. I advised her that it would be recommended that she stay but this is not jail and she certainly can go if she would like...I again advised her that it would be most beneficial for her to stay but she wanted to go home." Patient #2's medical record did not include an "Against Medical Advice" form.

The CNO was interviewed on 5/19/21, beginning at 9:52 AM, and Patient #2's medical record was reviewed in her presence. She confirmed Patient #2 left the CAH against her physician's medical advice, but did not sign an "Against Medical Advice" form.

Patient #2's medical record was not complete or accurate.

2. Patient #4 was a 54 year old male admitted to the CAH on 12/28/20 with a primary diagnosis of GI bleed.

Patient #4's medical record included a "Discharge Documentation," dated 12/30/20, signed by his physician, which stated, "I have advised him that given his melena as well as his low hemoglobin and need for 5 total units of PRBCs that continued hospitalization overnight with repeat H&H in the morning is advised. He is adamant that he be discharged at this time." Patient #4's medical record did not included an "Against Medical Advice" form.

The CNO was interviewed on 5/19/21, beginning at 9:19 AM, and Patient #4's medical record was reviewed in her presence. She confirmed Patient #4 left the CAH against his physician's medical advice, but did not sign an "Against Medical Advice" form.

Patient #4's medical record was not complete or accurate.

Based on medical record review and staff interview, it was determined the CAH failed to ensure informed consents were executed properly for 13 of 37 patients (#7, #11, #13, #19, #21, #23, #27, #28, #29, #31, #32, #34, and #35), whose records were reviewed. This had the potential for misunderstanding of the course of patient care and the ability for patients and their representatives to exercise their patient rights. Examples include:

1. Patient #31 was a 52 year old male admitted to the CAH on 5/05/21 with a primary diagnosis of hepatic encephalopathy.

Patient #31's medical record included a "CONSENT AND CONDITIONS OF TREATMENT" form, dated 5/05/21, signed by him. The form included a section for the time the consent was signed by Patient #31, however, this section was left blank.

The Clinical RN Manager was interviewed on 5/19/21, beginning at 10:50 AM, and Patient #31's medical record was reviewed in his presence. He confirmed Patient #31's consent was incomplete.

Patient #31's consent was not properly executed.

2. Patient #32 was a 51 year old female who presented to the ED on 1/12/21 with a chief complaint of anxiety.

Patient #32's medical record included a "CONSENT AND CONDITIONS OF TREATMENT" form, signed by her. The form included a section for the date and time the consent was signed by Patient #32, however, this section was left blank.

The Clinical RN Manager was interviewed on 5/19/21 beginning at 10:50 AM, and Patient #32's medical record was reviewed in his presence. He confirmed Patient #32's consent was incomplete.

Patient #32's consent was not properly executed.



44100

3. Patient #19 was a 3 year old male who presented to the ED on 12/24/20 with a chief complaint of halitosis x 3 months.

Patient #19's medical record included a "CONSENT AND CONDITIONS OF TREATMENT" form, signed by the patient's grandmother. The form included a section for the time the consent was signed, however, this was left blank. The consent also had a "signature of Witness" line with a "Date/time". The RN left this blank.

The CNO was interviewed on 5/19/21, beginning at 9:00 AM, and Patient #19's medical record was reviewed in her presence. She confirmed Patient #19's consent was incomplete.

Patient #19's consent was not properly executed.

4. Patient #27 was a 70 year old male who presented to the ED on 4/13/21 with a chief complaint of "burns.

Patient #19's medical record included a "CONSENT AND DISCLOSURE FOR SURGICAL AND MEDICAL PROCEDURE" form. This form was signed by the patient's wife for consent to "debridement". The section for time was left blank. This form had a physician signature line which was unsigned. An "EMTALA/TRANSFER CONSENT" form was also in the medical record. The form was signed by the sending physician. The form included a section for the date and time the consent was signed, however, this was left blank.

The CNO was interviewed on 5/19/21, beginning at 9:00 AM, and Patient #27's medical record was reviewed in her presence. She confirmed Patient #27's consents were incomplete.

Patient #27's consents was not properly executed.

5. Patient #7 was a 64 year old female who presented to the ED on 1/18/21 with a chief complaint of abdominal pain.

Patient #7's medical record included a "Medicare notice about your rights" form, signed by patient #7. The form included a section for the date and time the notice was signed, however, this was left blank. Patient #7 decided to leave AMA and signed form titled "PATIENT DECISIONS AGAINST MEDICAL ADVICE". This form had a physician signature line which was unsigned.

The Clinical RN Manager was interviewed on 5/19/21, beginning at 9:00 AM. Patient #7's medical record was reviewed in his presence. He confirmed Patient #7's Medicare form and AMA form were incomplete.

Patient #7's Medicare form and AMA form were not properly executed.

6. Patient #13 was a 68 year old male who presented to the ED on 1/13/21 with a chief complaint of abdominal issues.

Patient #13's medical record included a "CONSENT AND CONDITIONS OF TREATMENT" form which was signed by Patient #13. The form included a section for the date and time the consent was signed, however, this was left blank. The patient decided that he could not stay for the recommended labs and radiology ordered. Patient #13 signed the form titled "PATIENT DECISIONS AGAINST MEDICAL ADVICE". This form had a physician signature line which was unsigned.

The Clinical RN Manager was interviewed on 5/19/21, beginning at 9:00 AM. Patient #13's medical record was reviewed in his presence. He confirmed Patient #13's consent and AMA forms were incomplete.

Patient #13's consent and AMA forms were not properly executed.



37262

7. Patient #34 was a 64 year old male admitted to the CAH on 5/06/21 with a primary diagnosis of SOB.

Patient #34's medical record included a "CONSENT AND CONDITIONS OF TREATMENT" form, dated 5/06/21, signed by him. The form included a section for the time the consent was signed by Patient #34, however, this section was left blank.

The CNO was interviewed on 5/19/21, beginning at 10:19 AM, and Patient #34's medical record was reviewed in her presence. She confirmed Patient #34's consent was incomplete.

Patient #34's consent was not properly executed.

8. Patient #23 was a 29 year old female who presented to the ED on 1/24/21 with a chief complaint of sexual assault.

Patient #23's medical record included a "CONSENT AND CONDITIONS OF TREATMENT" form, dated 1/24/21, signed by her. The form included a section for the time the consent was signed by Patient #23, however, this section was left blank.

The CNO was interviewed on 5/19/21, beginning at 10:07 AM, and Patient #23's medical record was reviewed in her presence. She confirmed Patient #23's consent was incomplete.

Patient #23's consent was not properly executed.

9. Patient #29 was a 48 year old male admitted to the CAH on 4/19/21 with a primary diagnosis of pneumonia.

Patient #29's medical record included a "CONSENT AND CONDITIONS OF TREATMENT" form, dated 4/19/21, signed by him. The form included a section for the time the consent was signed by Patient #29, however, this section was left blank.

The CNO was interviewed on 5/19/21, beginning at 10:13 AM, and Patient #29's medical record was reviewed in her presence. She confirmed Patient #29's consent was incomplete.

Patient #29's consent was not properly executed.

10. Patient #21 was a 20 year old female who presented to the ED on 1/20/21 with a chief complaint of psychiatric issues.

Patient #21's medical record included a "CONSENT AND CONDITIONS OF TREATMENT" form, dated 1/20/21, signed by him. The form included a section for the time the consent was signed by Patient #21, however, this section was left blank.

The CNO was interviewed on 5/19/21, beginning at 9:19 AM, and Patient #21's medical record was reviewed in her presence. She confirmed Patient #21's consent was incomplete.

Patient #21's consent was not properly executed.

11. Patient #28 was a 56 year old female who presented to the ED on 4/18/21 with a chief complaint of psychiatric issues.

Patient #28's medical record included a "CONSENT AND CONDITIONS OF TREATMENT" form, dated 4/18/21, signed by her. The form included a section for the time the consent was signed by Patient #28, however, this section was left blank.

The CNO was interviewed on 5/19/21, beginning at 10:03 AM, and Patient #28's medical record was reviewed in her presence. She confirmed Patient #28's consent was incomplete.

Patient #28's consent was not properly executed.

12. Patient #35 was a 77 year old male who presented to the ED on 5/16/21 with a chief complaint of a fall.

Patient #35's medical record included a "CONSENT AND CONDITIONS OF TREATMENT" form, dated 5/16/21, signed by him. The form included a section for the time the consent was signed by Patient #35, however, this section was left blank.

The CNO was interviewed on 5/19/21, beginning at 10:20 AM, and Patient #35's medical record was reviewed in her presence. She confirmed Patient #35's consent was incomplete.

Patient #35's consent was not properly executed.

13. Patient #11 was a 94 year old female admitted to the CAH on 12/10/20 with a primary diagnosis of cellulitis.

Patient #11's medical record included a "CONSENT AND CONDITIONS OF TREATMENT" form, dated 12/10/20, signed by her. The form included a section for the time the consent was signed by Patient #11, however, this section was left blank.

The CNO was interviewed on 5/19/21, beginning at 9:35 AM, and Patient #11's medical record was reviewed in her presence. She confirmed Patient #11's consent was incomplete.

Patient #11's consent was not properly executed.

Based on medical record review and staff interview, it was determined the CAH failed to ensure anesthesia records were complete for 4 of 4 patients (#1, #3, #12, and #27), whose records were reviewed and included anesthesia services. This resulted in a lack of complete CRNA oversight. Findings include:

1. Patient #1 was a 25 year old female admitted to the CAH on 2/02/21, for a cesarean section.

Patient #1's medical record included a "PREANESTHESIA EVALUATION" form, dated 2/02/21, signed by her CRNA. The form included 5 sections to document a systems assessment which included "RESPIRATORY", "CARDIOVASCULAR", " HEPATO/GASTROINTESTINAL", "NEURO/MUSCULOSKELETAL", and "RENAL/ENDOCRINE". These 5 sections were not completed. It could not be determined if the CRNA performed a pre-anesthesia evaluation of Patient #1 prior to her surgical procedure.

The CRNA was interviewed on 5/19/21, beginning at 2:10 PM. Patient #1's medical record was reviewed in his presence. He stated a pre-anesthesia systems assessment was performed, but confirmed he did not document as such.

Patient #1's pre-anesthesia evaluation was incomplete.

2. Patient #27 was a 70 year old male who presented to the ED on 4/13/21 with burns requiring debridement.

Patient #27's medical record included a "PREANESTHESIA EVALUATION" form, dated 4/13/21, signed by his CRNA. The form included 5 sections to document a systems assessment which included "RESPIRATORY", "CARDIOVASCULAR", "HEPATO/GASTROINTESTINAL", "NEURO/MUSCULOSKELETAL", and "RENAL/ENDOCRINE". These 5 sections were not completed. It could not be determined if the CRNA performed a pre-anesthesia evaluation of Patient #27 prior to his procedure. The anesthesia consent was signed by the CRNA but on the line for patient signature, CRNA wrote "pt unable to sign". In the "REMARKS" section, it was documented: "2334 Pt interviewed in ER1. Reviewed hx and addressed concerns. Pt appears to understand anesthetic plan."

The CRNA was interviewed on 5/19/21,beginning at 2:10 PM. Patient #27's medical record was reviewed in his presence. He stated a pre-anesthesia assessment was performed, but confirmed he did not document as such. He was unable to clarify why the patient was unable to sign his anesthesia consent.

Patient #27's pre-anesthesia evaluation and consent was incomplete.


37262

3. Patient #3 was a 19 year old female admitted to the CAH on 4/23/21 with a primary diagnosis of induction of labor.

Patient #3's medical record included a "PREANESTHESIA EVALUATION" form, dated 4/24/21, signed by her CRNA. The form included 5 sections to document a systems assessment such as "RESPIRATORY," "CARDIOVASCULAR," "HEPATO/GASTROINTESTINAL," "NEURO/MUSCULOSKELETAL," and "RENAL/ENDOCRINE." These 5 sections were not completed. It could not be determined if the CRNA performed a pre-anesthesia evaluation of Patient #3 prior to her surgical procedure.

Patient #3's CRNA was interviewed on 5/19/21, beginning at 2:10 PM, and Patient #3's medical record was reviewed in his presence. He stated a pre-anesthesia systems assessment was performed, but confirmed he did not document as such.

Patient #3's pre-anesthesia evaluation was incomplete.

4. Patient #12 was a 53 year old male admitted to the CAH on 12/20/20 with a primary diagnosis of throat foreign body.

Patient #12's medical record included a "PREANESTHESIA EVALUATION" form, dated 12/19/20 [sic], signed by his CRNA. The form included 5 sections to document a systems assessment such as "RESPIRATORY," "CARDIOVASCULAR," "HEPATO/GASTROINTESTINAL," "NEURO/MUSCULOSKELETAL," and "RENAL/ENDOCRINE." These 5 sections were not completed. It could not be determined if the CRNA performed a pre-anesthesia evaluation of Patient #12 prior to his surgical procedure.

Patient #12's CRNA was interviewed on 5/19/21, beginning at 2:10 PM, and Patient #12's medical record was reviewed in his presence. He stated a pre-anesthesia systems assessment was performed, but confirmed he did not document as such.

Patient #12's pre-anesthesia evaluation was incomplete.

Based on observation, CDC guidelines review, policy review, and staff interview, it was determined the CAH failed to ensure its infection prevention and control included prevention and control of COVID-19 in inpatient and outpatient settings observed. This had the potential for unidentified transmission of COVID-19 in these settings and increased risk for adverse patient outcomes. Findings include:

A CAH policy, "CoVid-19 [sic] Screening Guidelines," undated, stated:

- "Until Further Notice: Incident command has deemed that during COVID-19 pandemic the public entrances of the hospital will station a door screener with the purpose to help reduce the risk of spreading COVID-19 in the facility by redirecting those who may be at risk for COVID-19 to appropriate locations."

- "Screeners: The door screeners take a temperature and ask COVID screening questions for those entering the facility."

- "Temperature: All persons entering Syringa Hospital and Clinics shall have a daily temperature taken."

- "Screening Questions: All persons entering Syringa Hospital and Clinics shall review and answer door screening questions daily."

- "Face Coverings: All persons entering any of Syringa Hospital and Clinics shall have a face covering."

This policy was not followed. Additionally, the policy did not specify how door-screeners would function in CAH outpatient settings or if outpatient staff would perform the above duties. It was unclear how patients were screened for COVID-19 in CAH outpatient settings. Examples include:

1. Surveyors entered the facility on 5/17/21 at 12:00 PM. Upon entrance, surveyors' temperatures were taken, however, they were not asked to review and answer questions regarding COVID-19 symptoms or exposure.

The Director of Quality and the COVID-19 Coordinator were interviewed together on 5/19/21, beginning at 1:10 PM. They confirmed surveyors were not screened according to the CAH policy.

COVID-19 screening was not performed according to the CAH policy for persons entering the inpatient facility.

2. Potential transmission of COVID-19 was not controlled in the CAH's outpatient physical therapy department.

A tour of the CAH's outpatient physical therapy department was conducted in the presence of the CNO on 5/18/21, beginning at 2:29 PM. Upon entering the outpatient physical therapy department, 2 patients were seated in the lobby area, not socially distanced, and not wearing face coverings. Two other patients were observed on the treatment floor; neither were wearing face coverings. A COVID-19 door-screener was not present.

The Therapy Services Coordinator, who was seated near the front door of the outpatient physical therapy department, was interviewed on 5/18/21, beginning at 2:29 PM. When asked if patients were screened for COVID-19 in the CAH prior to presenting to the outpatient physical therapy department, she stated, "no." When asked if patients were screened for COVID-19 upon arrival to the outpatient physical therapy department, the Therapy Services Coordinator stated, "no." Additionally, she stated staff did not have a thermometer available to take patient temperatures in the outpatient physical therapy department. When asked if the CAH utilized door-screeners in the outpatient physical therapy department, the Therapy Services Coordinator stated, "no."

The CNO was interviewed during the tour on 5/18/21, beginning at 2:29 PM. She confirmed all patients and visitors inside the outpatient physical therapy department should be socially distanced and wear a face covering.

Potential transmission of COVID-19 was not controlled in the CAH's outpatient physical therapy department.

3. Potential transmission of COVID-19 was not controlled in the CAH's outpatient radiology department (dexascan).

A tour of the CAH's outpatient radiology department, was conducted in the presence of the Radiology Manager on 5/19/21, beginning at 8:21 AM. The outpatient radiology department was located in a separate part of the outpatient physical therapy department building. The outpatient radiology department was utilized for the sole purpose of patient dexascans. Upon entering the outpatient radiology department, a screening station, door-screener, or staff were not observed. It was unclear how patients arriving to the outpatient radiology department were screened for COVID-19.

The Radiology Manager was interviewed during the tour on 5/19/21, beginning at 8:21 AM. He stated dexascan patients would check-in with the Therapy Services Coordinator next door in the outpatient physical therapy department. When asked if patients were screened for COVID-19 in the CAH prior to presenting to the outpatient radiology department, the Radiology Manager stated, "no." When asked if patients were screened for COVID-19 upon arrival to the outpatient radiology department, he stated, "no."

Potential transmission of COVID-19 was not controlled in the CAH's outpatient radiology department.

Based on CAH policy review, OPO agreement review, and staff interview, it was determined the CAH failed to ensure written protocols were developed and implemented to address organ, tissue and eye procurement. This had the potential to result in a lack of identification of suitable organ, tissue, and eye donors. Findings include:

1. Refer to C-1503 as it relates to the CAH's failure to incorporate a valid agreement with an OPO.

2. Refer to C-1507 as it relates to the CAH's failure to ensure potential donor families would be approached by an individual trained in the methodology for approaching potential donor families and requesting organ, tissue or eye donation.

5. Refer to C-1511 as it relates to the CAH's failure to work cooperatively with the designated OPO, tissue bank, and eye bank in educating staff on donation issues and reviewing death records to improve identification of potential donors.

The cumulative effect of these deficient practices created the potential for suitable organ, tissue, and eye donors to not be identified.

Based on OPO agreement review and staff interview, it was determined the CAH failed to ensure a valid agreement with an OPO. This had the potential to interfere with patient and family donor options regarding organ donation for all CAH patients. Findings include:

The CAH's OPO "TISSUE RECOVERY AGREEMENT," dated 1/11/16, was reviewed. The agreement was written for, and referenced, CMS Conditions of Participation for Hospitals at 42 CFR 482, not CMS Conditions for Participation for Critical Access Hospitals at 42 CFR 485.643. The OPO agreement did not address the correct regulatory requirements for a Critical Access Hospital.

The CNO was interviewed on 5/20/21, beginning at 8:40 AM, and the OPO agreement was reviewed in her presence. She confirmed the OPO agreement referenced the wrong CMS regulatory set.

The CAH failed to incorporate a valid agreement with an OPO.

Based on the CAH's OPO agreement review and staff interview, it was determined the hospital failed to ensure the individual who initiated a request for organ, tissue, or eye donation to the family of a deceased patient was an organ procurement representative or a designated requestor. This had the potential to affect possible organ, tissue, and eye donation for all patients who expired at the hospital. Findings include:

The CAH's OPO "TISSUE RECOVERY AGREEMENT," dated 1/11/16, was reviewed. It stated, "Ensure that the family of any potential donor is advised of donor designation or donation option only by either a [OPO] representative, or a designated requestor."

The CMO was interviewed on 5/20/21 at 9:35 AM. He stated the CAH staff initiated requests for tissue donation to the families of deceased patients. He confirmed the CAH did not have staff trained as designated requestors.

The hospital failed to ensure requests for organ/tissue/eye donations were made only by an OPO representative or a trained designated requester.

Based on CAH policy review and staff interview, it was determined the CAH failed to work cooperatively with the designated OPO, tissue bank, and eye bank in educating staff on donation proceedings and reviewing death records to improve identification of potential donors. This had the potential to result in failure of the facility employees to identify potential organ, tissue and eye donors, as well as failure to inform potential donor families of their donation options. Findings include:

A CAH policy "Donation of Organ and Tissue," dated 3/29/21, was reviewed. The policy did not include the process for staff education in regards to donation issues. Additionaly, it did not include a death record review process to improve identification of potential donors.

The CNO was interviewed on 5/20/21, beginning at 8:40 AM. When asked what training CAH staff received in regards to the OPO program and donation proceedings, she stated she did not know. The CNO was unable to provide staff education materials regarding the OPO program and donation proceedings.

The CMO was interviewed on 5/20/21, beginning at 9:35 AM. When asked if the CAH reviewed death records to improve identification of potiential donors, he stated, "no."

The CAH failed to work cooperatively with the designated OPO, tissue bank, and eye bank in educating staff on donation proceedings and reviewing death records to improve identification of potential donors.