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Based on observations, interviews, and review of documents and records it was determined that the CAH failed to ensure that the physical environment was arranged and maintained in a safe and orderly manner for patients and staff:
* The treatment, storage and operational spaces for a non-CAH provider clinic located in the East Wing of the CAH were not separate and distinct from the CAH's treatment, storage and operations spaces.

Findings include:

1. The East Wing of the CAH was formerly the "old hospital." During observation on 04/22/2019 the provision of patient care and other CAH operations was observed on the East Wing. Patient care services provided on the East Wing included nuclear medicine and provider-based outpatient clinic services.

2. On 04/22/2019 at 1615 in the East Wing former nurses station, Room E102, and the medication room, Room E102A, the following observations were made:
* Entry to the former nurses station was open and the door to the medication room was unlocked and open.
* The medication refrigerator was unlocked and was observed to contain two large plastic bags in which each had approximately 15 to 20 unlabeled, pre-filled syringes of a clear solution. The refrigerator also contained three multi-dose vials of injectable medication and specimen collection containers that included one labeled as "Universal Viral Transport for Viruses, Chlamydia ... and Ureaplasmas."

3. During interview with the CNO at the time of the observation on 04/22/2019 he/she stated that the spaces that included the East Wing former nurses station and medication room were operated as a private dermatology clinic by an independent physician who was not associated with the CAH and that the drugs belonged to that clinic. Observations at that time revealed no markings, signage or other evidence that the space was not CAH space to ensure all patients and staff knew the clinic and its operations were not part of the CAH.

4. These findings were reviewed with the CEO on 04/24/2019 at approximately 1600 and no additional information was provided.

Based on observation, interview, review of medical records for 8 of 20 patients (Patients 16, 17, 20, 21, 22, 23, 24 and 25), review of complaint/grievance documentation for 10 of 10 patients (Patients 1 through 10), review of incident documentation, review of policies and procedures and program evaluation documentation it was determined that the CAH failed to provide for an organizational structure governing its total operation that ensured care and services were clearly organized and in accordance with written policies.

This Condition-level deficiency reflects the CAH's limited capacity to provide safe and appropriate care and services.

Findings include:

1. Refer to the deficiency cited at Tag C241, CFR 485.627(a), Standard: Governing Body or Responsible Individual.

2. Refer to the deficiency cited at Tag C270, CFR 485.635, Condition of Participation: Provision of Services. Those findings reflect the CAH's failures to ensure care and services were in accordance with written policies and procedures.

3. Refer to the deficiency cited at Tag C320, CFR 485.639, Condition of Participation: Surgical Services. Those findings reflect the CAH's failures to provide safe and appropriate surgical and anesthesia services in accordance with written policies and procedures.

4. Refer to the deficiency cited at Tag C330, CFR 485.641, Condition of Participation: Periodic Evaluation and QA Review. Those findings reflect the CAH's failure to ensure it evaluated the care and services it provided to determine whether those were in conformance with written policies and procedures and were safe and appropriate.

Based on observation, interview, review of medical records for 8 of 20 patients (Patients 16, 17, 20, 21, 22, 23, 24 and 25), review of complaint/grievance documentation for 10 of 10 patients (Patients 1 through 10), review of incident documentation, review of policies and procedures and program evaluation documentation it was determined that the CAH's governing body failed to ensure that its total operations, and safe and appropriate care and services, were clearly organized and in accordance with written policies.

Findings include:

1. Refer to the deficiency cited at Tag C221, CFR 485.623(a), Standard: Construction. Those findings reflect that non-hospital spaces and operations were not physically and visually separate and distinct from hospital spaces and operations.

2. Refer to the deficiency cited at Tag C270, CFR 485.635, Condition of Participation: Provision of Services. Those findings reflect the CAH's failures to ensure care and services were in accordance with written policies and procedures.

3. Refer to the deficiency cited at Tag C320, CFR 485.639, Condition of Participation: Surgical Services. Those findings reflect the CAH's failures to provide safe and appropriate surgical and anesthesia services in accordance with written policies and procedures.

4. Refer to the deficiency cited at Tag C330, CFR 485.641, Condition of Participation: Periodic Evaluation and QA Review. Those findings reflect the CAH's failure to ensure it evaluated the care and services it provided to determine whether those were in conformance with written policies and procedures and were safe and appropriate.

Based on observation, interview, review of medical records for 8 of 20 patients (Patients 16, 17, 20, 21, 22, 23, 24 and 25), review of complaint/grievance documentation for 10 of 10 patients (Patients 1 through 10), review of incident documentation and review of policies and procedures it was determined that the CAH failed to ensure that safe and appropriate care and services were provided in accordance with written patient care policies.

This Condition-level deficiency reflects the CAH's limited capacity to provide safe and appropriate care and services.

Findings include:

1. Refer to the Standard-level deficiencies cited at Tags C271, C276, C278 and C297 under this Condition of Participation that reflects the CAH's failures to ensure that it's care and services were provided in accordance with written patient care policies and procedures.

2. Refer to the deficiency cited at Tag C320, CFR 485.639, Condition of Participation: Surgical Services. Those findings reflect the CAH's failures to provide safe and appropriate surgical and anesthesia services in accordance with written policies and procedures.

Based on observation, interview, review of medical records for 8 of 20 patients (Patients 16, 17, 20, 21, 22, 23, 24 and 25), review of complaint/grievance documentation for 10 of 10 patients (Patients 1 through 10), review of incident documentation and review of policies and procedures it was determined that the CAH failed to ensure that safe and appropriate care and services were provided in accordance with written patient care policies in the following areas:
* Drug Storage
* Infection Control and Prevention
* Blood Transfusions
* Surgical and Anesthesia Services
* Patient incident/occurrence response and investigation
* Patient complaint/grievance response and investigation

Findings include:

1. Refer to the Standard-level deficiencies cited at Tags C276, C278 and C297 under this Condition of Participation that reflects that practices and procedures related to drug storage, infection control and prevention, and blood transfusions were not in accordance with written policies and procedures.

2. Refer to the deficiency cited at Tag C320, CFR 485.639, Condition of Participation: Surgical Services. Those findings reflect the CAH's failures to provide safe and appropriate surgical and anesthesia services in accordance with written policies and procedures.

3. a. The P&P titled "Occurrence Reporting" dated as revised 05/26/2017 reflected the following:
* "Purpose: To ensure prompt assessment and response to all incidents that occur with patients, employees, or visitors. To accurately document events and to identify staff response to the events. To identify contributing factors/conditions that led to the incident and to identify steps taken to prevent the recurrence of a similar incident. To provide accurate, timely information for an ongoing incident report database."
* "An incident is any event, which is not consistent with the routine operation of the hospital. Following are a few examples of situations that a reports should filed: Medication errors, Patient injury ... Adverse medication reaction ... Equipment/supplies issues ... Complaints by patients, visitor or staff ... Breach in security ... Skin tears and wounds occurred in hospital stay, Abnormal incidences in surgery (i.e. unplanned return to OR, incorrect count delayed surgery, wrong site) ... unexpected occurrence involving death, serious physical or psychological injury or the risk there of ... hospital acquired infections, wrong site surgeries, etc."
* "Employees who witness or are aware of an incident are responsible for completing an Incident report in Quality Data Check at the time they become aware of the incident. All Incident reports must be filled out completely. Managers will be notified of incidence (sic) email through Quality Data Check ... Managers need to document their investigations and corrective actions within two weeks of the incident report."

3. b. Review of the Incident Quality Data Check log revealed that investigations of incidents were not complete, clear or timely. Examples include, but are not limited to the following:

* An incident dated as having occurred on 02/20/2019 was described as "Medication ordered, not given due to time proximity to another beta-2 agonist." The "Investigation Findings" section reflected only "Not an issue I would address" and the "Conclusions," "Action Taken" and "Follow-up" sections were blank. There was no other documentation.

* An incident dated as having occurred on 02/14/2019 was described as "medication not verified before being given" by respiratory therapy. The "Investigation Findings" section reflected only "???" and the "Conclusions," "Action Taken" and "Follow-up" sections were blank. There was no other documentation.

* An incident dated as having occurred on 01/09/2019 reflected that during a surgical procedure the patient exhibited signs that anesthesia was not adequate or effective. The physician continued with the procedure in spite of continued signs that anesthesia was not adequate and increased sedation was administered to the point the CRNA "stated [he/she] could not safely give the pt any more anesthesia and was waking the pt up." The "Investigation Findings" and "Action Taken" sections reflected that the case was "discussed," there were "several conversations" about the incident, and "... have developed a process to help reduce the potential for further incidences." However there was no documentation of an investigation and no indication that the unidentified "process" planned to prevent recurrence was appropriate.

* An incident dated as having occurred on 11/15/2018 was described as "...RN, removed [controlled pain medication] ... for pt ... It was not documented. I emailed [RN] about it. [RN] does not remember and did not include information about it in [his/her] nurse's note. At this point, it is unaccounted for." The "Investigation Findings" reflected only "It was resolved by pharmacy." The "Action Taken" reflected "No actions at this time." The "Conclusions" and "Follow-up" sections were blank. There was no investigation that involved the RN responsible and clearly identified the causes for the controlled medication discrepancy.

* An incident dated as having occurred on 10/30/2018 reflected that a diabetic patient's great toe was found to be "bleeding at the nail, nail bed seemed loose" at the end of a outpatient radiology procedure. The "Investigation Findings" reflected "During the process of moving the patient around on the table for the procedure, the patients (sic) toe nail might have caught under the foot board. This caused the toe nail to pull back." The "Actions Taken" included "Call patient to see how [his/her] toe is doing." There was no documentation to reflect that the patient had been called and no status of the injury after that entry. The documentation lacked any corrective actions planned in relation to positioning patients on the procedure table and management of the foot board to prevent recurrence for that patient and for other patients.

* An incident dated as having occurred on 10/03/2018 was described as "... discrepancy for [controlled anti-anxiety medication] - only 19 were in pocket ... refilled on 10/10/2018 and reported putting in 25 - there was one unopened box of 10 and a box of 9 ..." The "Investigation Findings" reflected only "Placed box of ten not twenty five in fridge ... Will inform [first name of a person]." The "Conclusions" reflected only "Pay attention to details." The "Action Taken" and "Follow-up" sections were blank. There was no investigation that clearly identified the causes for the controlled medication discrepancy.

* An incident dated as having occurred on 09/17/2018 reflected that a patient who came to the hospital in a wheelchair for outpatient respiratory therapy had a room air O2 sat of 96% and a HR of 100. The patient was instructed to ambulate and was assisted by an aide. "After approximately 75 feet, patient appeared to be short of breath, SpO2 95, heart rate 102. We turned around to return to lobby patient suddenly fell forward to ground, [he/she] moved [his/her] hands in front of [him/her], I attempted to break fall, due to patients (sic) size I was unable to break [his/her] fall." A "Rapid Response" was called and the patient was transferred to the ED for evaluation. The "Investigation Findings" included "... Physician not sure what is causing the patient to fall. Patient states [he/she] has a history of falling. [He/she] uses a wheelchair on occasion. [Staff] acted appropriately when the fall occurred." The "Conclusions" reflected "Patient with history of falls, fell during an outpatient procedure." The "Action Taken" reflected "No actions. Team acted appropriately." The "Follow-up" section was blank.

"Action Taken" was limited to an evaluation of the response to the fall by the "team." There was no documentation of any evaluation of actions to be planned and taken to prevent such a fall incident from recurring for that patient, who was in a wheelchair and who had an elevated HR prior to ambulation, and for other patients. For example, there was no consideration of a fall prevention plan that might include that a staff person follow behind the ambulating patient with a wheelchair in the event the patient weakens and begins to fall so that the patient can be guided into the chair instead of falling to the ground.

* An incident of patient elopement from "observation" was dated as having occurred on 03/19/2019. The "Investigation Findings," "Conclusions," "Action Taken" and "Follow-up" sections of the log were blank. There was no other documentation.

* An incident dated as having occurred on 08/25/2018 was described as "Patient refused [medication] in morning and med was not disposed on. (sic) Day shift found med on bedside table in medicine cup." The "Investigation Findings," "Conclusions" and "Follow-up" sections of the log were blank. The only documentation was under the "Action Taken" section that reflected "Will remind nurses to dispose of meds that are refused." There was no other documentation.

There was no investigation that included, for example: when was the dose ordered, when was it found, how was it determined that the patient had refused it, was the physician notified of a missed dose, who was the nurse responsible for the administration and what medication administration practices by that nurse had led to the medication being found on the bedside table if the patient had refused it.

* An incident that described "[Physician] is posting inappropriate patient information on Facebook" was dated as having occurred on 07/25/2018. The "Investigation Findings," "Conclusions," "Action Taken" and "Follow-up" sections of the log were blank. There was no other documentation.

* An incident that described alleged verbal and physical abuse of a patient in the ED by a physician was dated as having occurred on 07/03/2018. The "Investigation Findings," "Conclusions" and "Follow-up" sections of the log were blank. The only documentation recorded under "Action Taken" was "Sent for Peer Review." There was no other documentation.

* An incident dated as having occurred on 06/11/2018 described "small white tablet found in patient's bed." The "Investigation Findings" reflected "N/A to pharmacy. Follow through with nurses to ensure witnessing of patient consuming oral medications." The "Conclusions" reflected "Education on witnessing patient swallowing oral medication." The "Action Taken" and "Follow-up" sections were blank.

There was no investigation that included, for example: an attempt to identify the medication that the patient did not receive, notification of the patient's physician of a missed medication, the identity of the nurse who documented the medication as given, and what medication administration practices by that nurse had led to the medication being found in the patient's bed.

* An incident dated as having occurred on 05/10/2018 described "patient received into Pacu from OR 2, attached to monitor found to have O2 sats in 70's, oral airway in place, on o2 (sic) per simple mask at 5lpm. Chin lift done by CRNA, RN retrieved narcan, Dose of narcan given, patient immediately started breathing deeper breaths, sats rebounded to 100%, patient roused and oral airway was removed ..." The "Investigation Findings" reflected "Chart notes - patient given propofol and fentanyl during a colonoscopy by the CRNA. Patient given narcan for over-sedation. Patient recovered and was discharged a few hours later." The "Conclusions" section was blank. The "Action Taken" reflected "no actions at this time." The "Follow-up" reflected "A part of a quality metric being followed."

There was no investigation that included, for example: the reasons the patient was over sedated, how much propofol and fentanyl had been given, why the patient was transferred to PACU in that condition, where the physician was that performed the colonoscopy and what his/her actions had been, and why narcan had not been given earlier. There was no documentation of appropriate corrective actions to prevent recurrence.

* An incident that reflected the wrong dose of a medication was dated as having occurred on 03/05/2018. The "Investigation Findings" reflected "Will email nurse." The "Conclusions," "Action Taken" and "Follow-up" sections of the log were blank. There was no investigation that included the reasons the wrong dose was given and appropriate corrective actions to prevent recurrence

* An incident that reflected a medication was not administered timely and was late was dated as having occurred on 03/03/2018. The "Investigation Findings" reflected "will email nurse." The "Conclusions," "Action Taken" and "Follow-up" sections of the log were blank. There was no investigation that included the reasons the medication was not administered timely and appropriate corrective actions to prevent recurrence.

3. c. During interview with the DQRM on 04/24/2019 at 1410 he/she confirmed that there were not individual records for each incident entered on the log and that there was no other incident/occurrence documentation. That information was additionally confirmed during interview with the CEO on 04/24/2019 at approximately 1600.











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4. a. Review of the P&P titled "Patient Complaints and Grievance (sic)," dated effective 06/19/2018 reflected the following:
* "Objectives...To establish...A process for prompt resolution of patients concerns or grievances and a method for informing each patient whom to contact to file a grievance."
* "All complaints and grievance (sic) will be logged in the Quality Data check to assure tracking and appropriate follow up..."
* "A patient grievance will be referred to the Director of Quality and Risk and will also be reported to the CNO. Grievances involving significant issues in the quality or timeliness of care will be reported and reviewed monthly through the Hospital's Quality and Peer Review Committee/Quality Improvement process, and ultimately reported to the Board..."
* "The hospital will review, investigate, and resolve each patient's grievance within a reasonable time frame. The time frame is dependent on the seriousness of the grievances. Situations that endanger the patient, such as neglect or abuse, should be reviewed immediately, given the seriousness of the allegations and the potential harm to the patient(s). However, regardless of the nature of the grievance, the hospital should make sure that it is responding to the substance of each grievance while identifying, investigating, and resolving deeper, systematic problems indicated by the grievance."
* "The patient will be contacted as soon as the Risk Manager becomes aware of the grievance. On average, CVH allows 7 days or less for (sic) grievance to be investigated and resolved. Occasionally for more complicated grievances that may require an extensive investigation, or if the investigation is not or will not be completed within 7 days, the hospital will inform the patient or the patient's representative that the hospital is still working to resolve the grievance and that the hospital will follow-up with a written response to the patient or patient's representative every 10 days. The hospital will attempt to resolve all grievances as soon as possible."
* "The hospital's written notice to the patient of its decision regarding the grievance will contain at minimum...The name of the hospital contact person...The steps taken on behalf of the patient to investigate the grievance...The results of the grievance process; and...The date of completion."

4. b. Review of complaint and grievance documentation reflected that all complaints were not logged in the complaint tracking system, investigations of patient grievances were not conducted, and written responses to patient grievances were not submitted to patients or patient representatives. Examples include, but are not limited to:

* Regarding Patient 1: Review of the Quality Data tracking system reflected the patient submitted a grievance to the CAH on 04/26/2018. The "Comments:" section on the log reflected "Patient presented to admitting for labs...Patient complained about [physician's] receptionist stating [he/she] was extremely rude and condescending speaking to the patient as if [he/she] did not understand [him/her]..."

There was no documentation of an investigation of the patient's grievance. There was no documentation of a written response to the patient/patient representative that included the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion. There was no documentation that reflected the hospital informed the patient/patient's representative that the hospital was still working to resolve the grievance.

* Regarding Patient 2: Review of the Quality Data tracking system reflected the patient submitted a grievance to the CAH on 08/09/2018. The "Comments:" section on the log reflected "Patient called today and states [he/she] just got home...does not have [his/her] Dilaudid prescription...[name], RN - Took care of patient while in ER...[RN] said that pt left with [his/her] meds...Safe at CVH checked no meds for this patient noted..."

There was no documentation of a written response to the patient/patient representative that included the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion. There was no documentation that reflected the hospital informed the patient/patient's representative that the hospital was still working to resolve the grievance.

* Regarding Patient 3: Review of the Quality Data tracking system reflected the patient submitted a grievance to the CAH on 08/27/2018. The "Comments:" section on the log reflected "patient called on Friday, 8/24/2018 complaining that [his/her] physician has not received the results of the echocardiogram that was done 8/20/2018. [He/she] feels that is unacceptable and the hospital has let [him/her] down multiple times...when [he/she] was in the ED complaining of face numbness, thought [he/she] was having a stroke and the ED did nothing...seen in the ED May of last year for double vision, the ED did nothing..."

There was no documentation of an investigation of the patient's grievances. There was no documentation of a written response to the patient/patient representative that included the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion. There was no documentation that reflected the hospital informed the patient/patient's representative that the hospital was still working to resolve the grievance.

* Regarding Patient 4: Handwritten grievance documentation on a spiral note pad provided by the QRPS regarding the patient was reviewed. The documentation reflected the patient submitted a grievance to the CAH on 03/25/2019 related to "migraines," elevated blood pressures, and blood pressure medications.

There was no documentation of an investigation of the patient's grievance. There was no documentation of a written response to the patient/patient representative that included the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion. There was no documentation that reflected the hospital informed the patient/patient's representative that the hospital was still working to resolve the grievance.

Review of the Quality Data tracking system reflected no documentation that the patient's grievance was logged in the Quality Data tracking system in accordance with hospital policy.

* Regarding Patient 5: During an interview with QRPS on 04/23/2019 at the time of the grievance documentation review, the QRPS stated the patient's representative submitted a verbal complaint to the CAH on or around 03/28/2019. The QRPS stated the complaint was related to a physician who approached the patient's representative in the CAH's cafeteria and discussed confidential information about the patient's psychiatric history in the presence of other CAH staff.

There was no documentation of the patient's verbal complaint. There was no documentation of an investigation of the patient's complaint. There was no documentation of a written response to the patient/patient representative that included the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion. There was no documentation that reflected the hospital informed the patient/patient's representative that the hospital was still working to resolve the grievance.

Review of the Quality Data tracking system reflected no documentation that the patient's grievance was logged in the Quality Data tracking system in accordance with hospital policy.

* Regarding Patient 6: Handwritten grievance documentation on a spiral note pad provided by the QRPS regarding the patient was reviewed. The documentation reflected the patient submitted a grievance to the CAH on 03/26/2019 related to a CAH physician and that "no abdominal check" had been done. The documentation also included other handwritten notes that were illegible. During an interview with the QRPS on 04/23/2019 at the time of the grievance documentation review, the QRPS stated the patient submitted a grievance related to ED services and "a missed diagnosis of acute appendicitis."

There was no documentation of an investigation of the patient's grievance. There was no documentation of a written response to the patient/patient representative that included the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion. There was no documentation that reflected the hospital informed the patient/patient's representative that the hospital was still working to resolve the grievance.

* Regarding Patient 7: Handwritten grievance documentation on a spiral note pad provided by the QRPS regarding the patient was reviewed. The documentation reflected the patient submitted a grievance to the CAH on 04/03/2019 at 1620 related to a CAH physician. The documentation reflected "Does not want to go back to [physician]...treated like a dog..." The documentation included additional handwritten notes that were illegible.

There was no documentation of an investigation of the patient's grievance. There was no documentation of a written response to the patient/patient representative that included the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion. There was no documentation that reflected the hospital informed the patient/patient's representative that the hospital was still working to resolve the grievance.

* Regarding Patient 8: Handwritten grievance documentation on a spiral note pad provided by the QRPS regarding the patient was reviewed and reflected the patient submitted a grievance to the CAH on 04/17/2019. The documentation reflected "2 months ago a CT scan was done [physician] 95% sure it is cancer. Scheduled [with] [physician] to do Bx - Too Risky Referred to Bay Area - too Risky - [illegible] is high risk Now what...[He/she] lives in the Boonies, can't drive on Interstate..." During an interview with the QRPS on 04/23/2019 at the time of the grievance documentation review, the QRPS stated the patient submitted a grievance related to his/her plan of care following a diagnosis of lung cancer at the CAH.

Review of the Quality Data tracking system reflected no documentation that the patient's grievance was logged in the Quality Data tracking system in accordance with hospital policy.

* Regarding Patient 9: Handwritten grievance documentation on a spiral note pad provided by the QRPS regarding the patient was reviewed and reflected the patient submitted a grievance to the CAH on 04/19/2019. The documentation reflected "...admitted as obs Coquille Hospital - 3 days gall stone...missed in surgery..." During an interview with the QRPS on 04/23/2019 at the time of the grievance documentation review, the QRPS stated the patient submitted a grievance related to "having a gallstone after undergoing a gallbladder stone surgery."

Review of the Quality Data tracking system reflected no documentation that the patient's grievance was logged in the Quality Data tracking system in accordance with hospital policy.

* Regarding Patient 10: Review of the Quality Data tracking system reflected the patient submitted a grievance to the CAH on 04/19/2018. The "Comments:" section on the log reflected "Patient expressed concern to...[LPN] over [his/her] wound care not being done on 4/18/2018..."

There was no documentation of an investigation of the patient's grievance. There was no documentation of a written response to the patient/patient representative that included the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion. There was no documentation that reflected the hospital informed the patient/patient's representative that the hospital was still working to resolve the grievance.

4. c. During an interview and review of the grievance documentation with the QRPS on 04/23/2019 at 1500, the QRPS confirmed findings 2-11. The QRPS stated the CAH had no system for tracking grievance resolutions. The QRPS stated "There is no follow up."

Based on observations and interview it was determined that the CAH failed to ensure appropriate storage, handling, and control of drugs:
* Outdated and otherwise unusable drugs were available for patient use, including expired drugs.
* Drugs were not appropriately managed and stored to prevent cross contamination.

Findings include:

1. During tour of the ED on 04/22/2019 beginning at 1615 with the M/S ED NM, observations in the ED med room revealed:
* Two expired 50-mL bags IV 0.9% Sodium Chloride solution were observed with expiration date 01/01/2019.
* Three 100mL bags of IV 5% dextrose solution were observed on the counter at the edge of the hand washing sink. This created the risk of cross contamination as a result of water splashing from the sink.

These observations were confirmed with the M/S ED NM on 04/22/2019 at the time of the observations.

Based on observations, interview, review of policies and procedures and other documentation, it was determined that the hospital failed to ensure that infection prevention policies and procedures had been fully developed and implemented. Procedures and processes to prevent cross-contamination and to ensure infection prevention had not been developed and enforced in the following areas:
* Endoscope reprocessing and storage policies and procedures had not been developed and implemented in accordance with manufacturer's guidelines.
* Sterile processing policies and procedures had not been developed.
* All environmental surfaces were not clean and/or cleanable in SSU and endoscope storage.
* The soiled utility room was disorganized and cluttered, supplies and equipment were not readily accessible, and clean and dirty patient supplies and equipment were not stored separately.
* Hand hygiene supplies were not accessible and were not appropriate for use.
* Outdated, expired or otherwise unusable supplies and drugs were available for use and their sterility and integrity could not be assured.
* A water-borne pathogens program had not been developed and implemented.

Findings include:

1. Endoscope reprocessing and storage.

a. Refer to the findings cited under Tag C320, CFR 485.639 - CoP: Surgical Services. Those findings reflect the hospital's failure to ensure endoscope reprocessing P&Ps were developed and implemented and were in accordance with manufacturer's recommendations and nationally recognized IC practices or guidelines.

2. Sterile processing of surgical instruments.

a. Refer to the findings cited under Tag C320, CFR 485.639 - CoP: Surgical Services. Those findings reflect the hospital's failure to ensure P&Ps were fully developed related to disinfection and sterilization of surgical instruments/devices and were in accordance with manufacturer's instructions and nationally recognized IC practices or guidelines.

b. On 04/22/2019 at 1615, observations in the M/S soiled utility room with the M/S ED NM revealed a blue tote on the counter near the sink. The tote had a label on the outside of it that reflected "Cidex." The inside of the tote contained a pair of surgical scissors that were in the closed position. The inside of the tote and the scissors appeared dry. Two spray bottles of Sklar Spray-Zyme Surgical Instrument Pre-Cleaner were observed next to the tote. Observation of a sign attached to the wall above the tote reflected "All instruments placed in this blue tote MUST be sprayed thoroughly with the Prepzyme spray before placing them in this tote. Thank you! [name]." There was no information that reflected how long the scissors had been in the tote or if they were sprayed with Prepzyme as indicated on the sign.

These observations were confirmed with the M/S ED NM on 04/22/2019 at the time of the observations. The M/S ED NM stated the blue tote was used to hold instruments that had been used in the ED and M/S until staff transported them to SPD for processing. The M/S ED NM stated he/she did not know how often staff were supposed to pick up the contaminated instruments and transport them to SPD.

c. During an interview with the CNO on 04/24/2019 at 1430, the CNO stated the CAH had no P&Ps for management of contaminated instruments stored in the M/S soiled utility room.

3. Environmental surfaces.

a. Refer to the findings cited under Tag C320, CFR 485.639 - CoP: Surgical Services. Those findings reflect the hospital's failure to ensure environmental surfaces were clean and/or cleanable in SSU and endoscope storage areas.

4. Patient supplies, equipment and other items.

a. On 04/22/2019 at 1615, observations in the M/S soiled utility room with the M/S ED NM revealed the room was cluttered, disorganized and clean and dirty patient care supplies were not stored separately. Examples included:
* On the counter next to the sink, a blue tote with contaminated scissors inside it, two spray bottles of surgical instrument pre-cleaner, an open container of disinfectant wipes, and two large unopened boxes of patient "Comfort Personal Cleansing" supplies were observed next to each other. The boxes of "Comfort Personal Cleansing" supplies were stacked precariously, one on top of the other, and partially over the edge of the counter. There was no separation between the unopened box of patient supplies and the other items on the counter.
* A hopper was observed next to the counter and boxes of "Comfort Personal Cleansing" supplies. The hopper was not readily accessible as a result of a hamper and three BSCs and other equipment stacked awkwardly on top of each other in front of the hopper.
* A Hobart commode washer with several BSC buckets, a red hazard bag with unknown items inside it, and two bath benches were observed stacked awkwardly on top of the commode washer. Those equipment and items were not accessible as a result of numerous other items and equipment stacked in front of them.
* A multi-shelf metal rack was observed. On one shelf, Posey leather limb restraints, a large empty tote, a white cardboard box, a FWW, and other items were cluttered, disorganized and piled awkwardly on top of each other. On another shelf, a white plastic bag of patient personal belongings, two unlabeled clear plastic bags with unknown items inside them, and a box that indicated it contained a Projection Lamp were observed. On another shelf, two plastic bags of patient personal belongings, a container of Mt. Hood chemical disinfectant, and a toilet riser were observed next to each other with a folded FWW on top of them. Another shelf had approximately seven stacked BSC buckets and lids. The items, supplies and equipment on the shelving unit were co-mingled and there was no information to indicate whether they were clean or dirty.

The observations in the soiled utility room were confirmed with the M/S ED NM on 04/22/2019 at the time of the observations. The M/S ED NM stated "No patient supplies should be in the dirty utility room."

5. Hand hygiene supplies.

a. During tour of ED and M/S on 04/22/2019 at 1615, a hand washing sink and wall mounted hand activated paper towel dispenser were observed in the M/S soiled utility room and were not readily accessible as there was a dish cart with meal trays and dishes stacked on top of it and a large barrel and other items in front of the sink. Observation during activation of the paper towel dispenser reflected the paper towel dispensed directly into the sink causing the towel to become contaminated and unusable. There were no other sinks in the room and no other provisions for hand hygiene in the room such as ABHR. This was confirmed with the M/S ED NM on 04/22/2019 at the time of the observation.

b. During a tour of ED and M/S on 04/23/2019 at 1100, a hand washing sink and paper towel dispenser were observed in the hall outside room 315. Observation during activation of the paper towel dispenser reflected the paper towel dispensed directly into the sink causing the towel to become contaminated and unusable. This was confirmed with the CNO on 04/23/2019 at the time of the observation.

6. Outdated, expired or otherwise unusable supplies and drugs.

a. Refer to the findings cited under Tag C276, CFR 485.635(a)(3)(iv) - Standard: Patient Care Policies. Those findings reflect the hospital's failure to ensure expired drugs were not available for patient use and were appropriately managed and stored to prevent cross contamination.

b. On 04/22/2019 at 1615 in the M/S soiled utility room with the the M/S ED NM, a 150-count container of expired "Dispatch Hospital Cleaner Disinfectant Towels With Bleach" with expiration date 03/11/2019 was observed on the counter near the sink. This was confirmed with the M/S ED NM at the time of the observation.

c. On 04/23/2019 at 1030 in the Imaging Department, a container of expired "Super Sanicloth" wipes with expiration "11/2017" was observed.

d. On 04/23/2019 at 1215 in the Lab, a container of expired disinfectant towels with bleach with expiration "03/11/2019" was observed.

7. Water-borne pathogens program.

a. During interview with the ECM on 04/24/2019 at 1440 he/she stated that the hospital had not developed a water-borne pathogens program. He/she confirmed there were no P&Ps, no plan, no risk assessment, no water testing protocols established, and no water testing conducted. The ECM stated "I just started working on it last week. We don't do water testing related to Legionella." He/she stated that the only documentation he/she had related to a water-borne pathogens program was an untitled, undated, unapproved 1-page document. The document was provided and consisted of a diagram with eleven items/categories on it as follows:
"Coquille City water supply 2"
"5 micron filter"
"Drinking fountains"
"Ice machines"
"Humidifiers"
"Sinks, showers, toilets"
"Hot Water heater"
"Hot Water heater"
"Sinks and Showers"
"Kitchen appliances Dishwashers"
"Sanitary Sewer"
There was no further information on the document and no additional documentation or information was provided.

Based on interview, review of documentation in 2 of 2 medical records of patients who had blood transfusions (Patients 24 and 25), and review of policies and procedures, it was determined that the hospital failed to ensure that blood products were transfused in accordance with its policies and procedures in the following areas:
* Vital signs for monitoring patients' response to transfusion were not timely and complete.
* Blood was not transfused within the required timeframe.

Findings include:

1. The undated P&P titled "Blood Product Transfusion" was reviewed and included the following:
* "Blood should be administered over a period of time not to exceed four (4) hours."
* "Vital signs shall be taken prior to initiating, 15 minutes after transfusion begins, and at the completion of the transfusion (this applies for each blood product unit)."
* "Procedure: ... Two (2) licensed nurses shall positively identify the patient ... Explain the procedure to the patient ... Obtain baseline vital signs. Visually check the unit of blood ... Start the infusion ..."

2. The medical record of Patient 24 reflected that he/she received a blood transfusion on 12/02/2018. The record reflected the following timeline for transfusion and monitoring of the patient's response:
* At 2000 - Patient's temperature was recorded as "[high]" at 99.14.
* At 2132 - Patient's HR, RR and BP were taken. No temperature was recorded.
* At 2150 - Transfusion started.
* At 2203 - Patient's temperature was recorded as 98.4.
* At 2231 - Patient's HR, RR and BP were taken. No temperature was recorded.
* At 2240 - Transfusion was stopped.

The patient's baseline temperature was not taken with the other baseline vital signs shortly prior to the start of transfusion, the patient's HR, RR and BP were not taken within 15 minutes after the start of transfusion, and vital signs were not taken at the completion of the transfusion.

3. The medical record of Patient 25 reflected that he/she received a blood transfusion on 01/05/2019. The record reflected the following timeline for transfusion and monitoring of the patient's response:
* At 1305 - Transfusion started.
* At 1317 - A full set of vital signs was recorded.
* At 1322 - A full set of vital signs was recorded.
* At 1731 - A full set of vital signs was recorded.
* At 1733 - Transfusion stopped.

There were no baseline vital signs taken prior to the transfusion, no vital signs were taken at the completion of the transfusion, and the blood was transfused over a period of 28 minutes in excess of four hours.

4. During interview with the IP&CE on 04/23/2019 at 1700 he/she stated that the vital signs were not complete and timely, and the blood transfusion time was not timely, as required by the P&P for Patients 24 and 25.

Based on review of 8 of 20 medical records (Patients 16, 17, 20, 21, 22, 23, 24 and 25) and review of policies and procedures it was determined that the CAH failed to ensure that patient medical records were complete, accurately documented and clearly reflected the patient's course of hospital care and services.

Findings include:

1. Refer to the findings at Tag C320, CFR 485.639, Condition of Participation: Surgical Services, that reflects that surgical records and informed consents were not complete and accurate.

2. Refer to the findings at Tag C322, CFR 485.639(b), Standard: Anesthetic Risk and Evaluation, that reflects that anesthesia records were not complete and accurate.
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3. Refer to the findings at Tag C297, CFR 485.635(d)(3), Standard: Nursing Services, that reflect that blood transfusion records were not complete.

Based on observation, interview, review of medical records for 6 of 6 patients who underwent surgery and anesthesia (Patients 16, 17, 20, 21, 22 and 23) and review of policies and procedures it was determined that the CAH failed to fully develop and enforce policies and procedures that ensured the provision of appropriate and safe surgical services and anesthesia services:
* Surgical safety checks, safety time outs and other evaluation/assessment and safety information were not timely or accurate in accordance with the surgical timeline and were contradictory to the processes to ensure patient safety.
* Informed consents for surgery and anesthesia were not complete and not signed by the practitioners who performed the procedure or administered the anesthesia.
* Non-hospital employees and other unidentified individuals with unclear or unidentified roles participated in the surgical process.
* Policies and procedures were not developed and implemented related to management of endoscopes including but not limited to endoscope transport, reprocessing, storage, documentation of essential processing steps, staff education and competencies, quality assurance and protocols for responding to equipment failures.
* Policies and procedures were not fully developed and implemented related to processes for cleaning, disinfection and sterilization of surgical instruments and devices used in SSU and on patient units.
* All environmental surfaces were not clean and/or cleanable in SSU and endoscope storage.

This Condition-level deficiency represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

1. Refer to Tag 322 under this Condition of Participation, CFR 485.639(b) Standard: Anesthetic Risk and Evaluation, that reflects the deficiencies related to the lack of clear and complete evaluation of anesthesia for patents.

2. a. The P&P titled "Consents, Refusal to Consent" was dated as "Last Revised 4/11/2017" and "Next Review" due 04/11/2019. It was reviewed and included the following:
* "In order to obtain the informed consent of a patient, a physician shall explain the following ... In general lay terms, the procedure or treatment to be undertaken ... That there are or may be alternative procedures or methods of treatment, if any ... That there may be risks, if any, to the procedure or treatment ... After giving the explanation specified, the physician shall ask the patient if a more detailed explanation is wanted ..."
* "For the purpose of this policy, the responsible physician is defined as the physician primarily responsible for rendering the treatment or performing the procedure in question."
* "For Surgical or Medical Treatments to Adults ... A consenting person must give consent before preparative medications render him or her incompetent. A person who is irrational due to the effects of alcohol or drugs, or to their medical or surgical condition, is incapable of giving consent."
* "A written consent shall be obtained before procedures are performed ... This consent shall be obtained from all patients who are to receive medical or surgical procedures which involve some risk."
* "Non-physician hospital employees may not accept delegated responsibility for explaining the procedure, viable alternatives, and material risks of the procedure. However, hospital employees are allowed to obtain the patient's signature on the consent form in the circumstances where the physician has discussed the procedures with the patient and the patient has given informed consent. When an informed consent has not been obtained, the hospital employee shall refer the case back to the responsible physician prior to the actual procedure or preparation for that procedure."
* "The patient's informed consent is to be completed in the following instances ... For any surgical procedure involving anesthesia, whether inpatient or outpatient ... For any diagnostic procedure or medical treatment which involves significant possible risks ... For any use of drugs with a significant potential for adverse reaction ..."
* "Qualified consenters: Since a signature by a legally authorized person is crucial to a binding consent, the hospital shall take due precaution to obtain a qualified person to sign each consent."
* "Witness: When anyone other than the patient signs the informed consent statement, that signature requires a witness. Any hospital employee may witness such a signature. One witness is sufficient and the witness's signature signifies only the fact that the signature was that of the person indicated."

The "Consent for Anesthesia Services" form attached to the P&P had a revision date of "11/2018" and included reflected signature lines for the "Patient," the "Patient's Legally Authorized Representative," a "Witness" and "Person Providing Information."

The "Informed Consent for Surgery or Special Procedures" form attached to the P&P had a revision date of "5/18" and included a space for "Name and Description of the Procedure (must be completed by Practitioner)," and signature lines for the "Patient," the "Patient's Authorized Representative," the "Reason Patient Cannot Consent," a "Witness" and "Statement of Practitioner Obtaining Consent" with "Practitioner's Signature.

2. b. The P&P titled "Consents for Anesthesia" was dated as "Last Revised: 11/8/2016" and "Next Review" due 08/22/2018. It was reviewed and reflected the following in entirety:
* "To ensure that all patients undergoing a surgical or endoscopies procedure will give prior consent for anesthesia services. The consent will include the type of anesthesia planned, the type of results expected, the techniques used, and any risks involved. The attending anesthetist will obtain an anesthesia consent for all patients who will undergo any anesthesia except Conscious Sedation (that is: general anesthesia, spinal or epidural anesthesia, major or minor nerve block, intravenous regional anesthesia, or monitored anesthesia). It is the responsibility of the anesthetist to obtain this consent by interviewing the patient, providing information regarding anesthesia, and allowing questions from the patient/responsible person. The form 'Consent for Anesthesia Services' will be completed by the anesthetist and the patient/responsible person." The attending RN will obtain a consent for all patients who will undergo anesthesia by conscious sedation. It is the responsibility of the RN to obtain this consent by interviewing the patient, providing information regarding anesthesia, and allowing questions from the patient/responsible person. The form 'Consent for Anesthesia with Conscious Sedation' will be completed by the RN and the patient/responsible person."

2. c. The P&P titled "Moderate Sedation" dated as approved on 08/20/2018 was reviewed and included the following:
* "The RN who is to administer the moderate sedation shall have no other responsibilities other than monitoring the patient and delivering the ordered medication thru the recovery phase.
* "The ordering licensed independent practitioner shall review the risks, options and benefits of the selected agents with the patient, parent or guardian and document the patient, parent or guardian's informed consent in the medical record. The nurse must verify the presence of this documentation before administration of the sedative. Documentation may consist of a written note in the medical record by the LIP."
* "A ''time out' shall be performed immediately prior to the start of the procedure. 'Time out' will consist of verifying ... The 'time out' shall involve all members in the patients care, including the patient."

2. d. The P&P titled "Universal Protocol (Time Out)" dated as "Effective: 6/18/2018" was reviewed and included the following:
* "All relevant documents and related information or equipment will be available, correctly identified and labeled, and matched to the patient before the procedure starts. Surgical checklists will guide staff and providers through the verification processes and team briefings to assure that all steps are completed."
* "... applies to all patients having surgery or other procedures within the OR."
* "If discrepancies are found during the site verification process before the patient is transferred to the OR ... The patient will not be transferred to the OR suite or procedure room until the discrepancy is resolved."
* "Ask the patient or patient representative to state the procedure including the site/side when applicable ... Final confirmation of correct procedure and site/side takes place during the team briefing and time out in the operating room but confirmation that the correct site/side is marked and visible is also required throughout patient preparation, including: Before administration of local anesthesia or an anesthetic block ... Before positioning, Before prepping."
* "The surgeon will mark the procedure site/side with their initials. This will be done: After the procedure site/side has been verified with the patient but before the patient is moved to the OR ... With patient or patient representative involvement."
* "In the OR, surgical team briefings will take place before the incision is made and again at the end of the procedure, before the patient is transferred to the PACU ..."
* "The time out is a collective verbal verification by all members of the surgical team and takes place immediately before the procedure begins ..."
* "A second team briefing, or debriefing, is completed at the end of the procedure, before the patient is transferred to the PACU ... It must be completed before the surgeon has left the OR

2. e. The Perioperative Record contained three safety check and time out sections as follows:

* The "Safety Check Sign In" fields included:
- Patient has confirmed the identity, site, procedure, consent.
- Anesthesia safety check completed.
- Does patient have a known allergy?
- Site marked/Not applicable.
- Pulse oximeter on patient and functioning.
- Does patient have a difficult airway/aspiration risk?

According to the "Universal Protocol (Time Out)" P&P found under Finding 2.d. above, this safety check should occur "... before the patient is transferred to the OR ... before the patient is moved to the OR."

* The "Safety Check Time Out" fields included:
- Surgeon, anesthesia, and nurse confirm patient, site, procedure
- Anesthesia team reviews any patient-specific concerns.
- All team members have introduced themselves by name and role.
- Surgeon reviews critical or unexpected steps, operative duration, anticipated blood loss.
- Nursing team reviews sterility ... and equipment issues/concerns

According to the "Universal Protocol (Time Out)" P&P found under Finding 2.d. above, this safety check should occur "... before the incision is made ... immediately before the procedure begins."

* The "Safety Check Sign Out" fields included:
- Nurse verbally confirms with team the name of the procedure(s) recorded.
- Nurse verbally confirms with team how specimen(s) is labeled, including patient name
- Surgeon, anesthesia, nurse review key concerns for recovery and management of patient.
- Nurse verbally confirms with team that instrument, sponge, and needle counts are correct.
- Nurse verbally confirms with team any equipment problems to be addressed.

According to the "Universal Protocol (Time Out)" P&P found under Finding 2.d. above, this safety check should occur "... at the end of the procedure, before the patient is transferred to the PACU ... It must be completed before the surgeon has left the OR."

3. a. The medical record of Patient 20 reflected that he/she underwent an outpatient "colonoscopy" on 12/17/2018 under "conscious sedation." Review of the anesthesia and endoscopy procedure documentation revealed that the timeline of events was unclear and contradictory to hospital policies and procedures:

* The physician's H&P was documented as a "Clinic Note" dated 11/27/2018. A stamped statement on the "Clinic Note" reflected a statement that "The previous H&P is still valid and this patient is medically cleared for surgery." The statement was initialed and dated 12/17/2018. It was not timed to reflect it was completed prior to the procedure.

* On 12/17/2018 at 0917 - Patient arrived to "Preop."
* At 0920 - RN recorded that "Anesthesia Consent signed" and "Procedure Consent Signed" prior to the time the consent forms were signed at 0925 as indicated below.
* At 0925 - Patient signed "Consent for Surgical and/or Medical Treatment"
* At 0925 - Patient signed "Consent for Anesthesia with Conscious Sedation"
* At 0942 - A CRNA signed in as in "Preop Case Attendance."
* At 0948 - A "Local Monitoring RN" signed in as in "Case Attendance."
* At 0948 - Patient into the OR.
* At 0948 - Anesthesia started.
* At 0952 - "Safety Check Sign In" conducted after the patient was in the OR and after anesthesia started.
* At 0955 - The "Surgeon" signed in as in "Case Attendance."
* At 0956 - "Safety Check Time Out."
* At 1001 - Surgery/procedure started.
* At 1024 - Surgery/procedure stopped.
* At 1024 - The "Surgeon" signed out of the case.
* At 1026 - Anesthesia stopped.
* At 1026 - The "Local Monitoring RN" signed out of the case.
* At 1026 - Patient out of the OR.
* At 1029 - Patient transferred to PACU.
* At 1033 - "Safety Check Sign Out" conducted after the surgeon and "Local Monitoring RN" had signed out of the case and after the patient had left the OR.
* At 1110 - Patient discharged from PACU.

The "Safety Checks" and consent information were not conducted timely in accordance with the surgical timeline and were contradictory to the processes to ensure patient safety.

3. b. A "Consent for Surgical and/or Medical Treatment" form, with version date of 05/21/2012, was signed by the patient and dated on 12/17/2018 at 0925.
* The form was an outdated version of the current form attached to the "Consents, Refusal to Consent" P&P found under Finding 2.a. above and lacked the information required by that P&P and the current form, including documentation by the practitioner related to name of procedure and the practitioner's statement and signature.
* The consent lacked documentation to reflect that the physician had reviewed the consent and the risks of the procedure with the patient.
* The consent lacked the signature of the physician who was to perform the procedure

3. c. A "Consent for Anesthesia with Conscious Sedation" form, with version date 12/01/2005, was signed by the patient and dated on 12/17/2018 at 0925
* The form was an outdated version of the current form attached to the "Consents, Refusal to Consent" P&P found under Finding 2.a. above and lacked the information required by that P&P and the current form.
* The space for the name of the anesthetist who was to administer anesthesia was blank and that information was not elsewhere on the form.
* The consent reflected "I expressly desire the following considerations be observed (or write 'none'):" The space next to that statement was blank.
* The "Local Monitoring RN" who signed in on the case had not signed the form to reflect that he/she had reviewed the consent and the risks of anesthesia with the patient.

3. d. In addition, the "Intraop Nursing Record Summary" reflected under "General Comments" that "[Name of a person] with [physician] as observer in room." It was unclear who the individual was and what the role of "observer" included. There was no documentation in the record to reflect that the patient had consented to a non-hospital observer being present for the procedure and that he/she had received information about the role of the "observer."

4. a. The medical record of Patient 21 reflected that he/she underwent an outpatient "bunionectomy" on 01/18/2019 under "MAC" anesthesia. Review of the anesthesia and surgical procedure documentation revealed that the timeline of events was unclear and contradictory to hospital policies and procedures:

* The physician's H&P was documented as an "Examination" dated 01/07/2019. A stamped statement on the "Examination" document reflected a statement that "The previous H&P is still valid and this patient is medically cleared for surgery." The statement was initialed and dated 01/18/2019. It was not timed to reflect it was completed prior to the procedure.

* On 01/18/2019 at 0840 - Patient arrived to "Preop."
* At 0848 - RN recorded that "Anesthesia Consent signed" and "Procedure Consent Signed" prior to the time the consent forms were signed at 0900 as indicated below.
* At 0850 - The Anesthetist competed the "Pre-Anesthetic Evaluation."
* At 0900 - Patient signed "Informed Consent for Surgery of Special Procedure."
* At 0900 - Patient signed "Consent for Anesthesia with Conscious Sedation."
* At 0923 - Patient into the OR.
* At 0923 - Anesthesia started.
* At 0923 - The "Surgeon" signed in as in "Case Attendance."
* At 0923 - The "Anesthesia Care Provider" signed in as in "Case Attendance."
* At 0935 - Surgery/procedure started.
* At 1004 - "Safety Check Sign In" conducted after the patient was in the OR and after anesthesia and surgery had started.
* At 1004 - "Safety Check Time Out" was documented after anesthesia and surgery started, and as having been conducted at 0935.
* At 1005 - "Skin Assessment ... baseline" and "Implements protective measures" documented after surgery started.
* At 1006 - "Skin Prep" and "Verifies allergies" documented after surgery started.
* At 1007 - "Cautery" and "Implements protective measures to prevent injury due to electrical sources" documented after surgery started.
* At 1007 - "Surgical Equipment" checked after surgery started.
* At 1015 - "Patient Positioning" and "Identifies baseline musculoskeletal status" documented after surgery started.
* At 1016 - "Safety Check Sign Out" conducted before anesthesia and surgery were stopped. That included "Nurse verbally confirms with team that instrument, sponge, and needle counts are correct" for which "Yes" was recorded. However, the incomplete "Counts" were not conducted until 1024 as indicated below.
* At 1024 - "Counts verification" documented before surgery stopped. In addition, the "Initial Count" and "Final Count" of "Sharps, Sponges" were not recorded. The spaces for those were blank.
* At 1047 - Surgery/procedure stopped.
* At 1050 - The "Surgeon" signed out of the case.
* At 1050 - Anesthesia stopped.
* At 1050 - The "Anesthesia Care Provider" signed out of the case.
* At 1050 - Patient out of the OR.
* At 1050 - Patient transferred to PACU I.
* At 1100 - The anesthetist signed a "Post-Anesthesia Evaluation" that was incomplete as specified below.
* At 1105 - Patient transferred to PACU II.
* At 1215 - Patient discharged from PACU II.

The "Safety Checks" and other consent, assessment and safety information were not documented timely in accordance with the surgical timeline and were contradictory to the processes to ensure patient safety.

4. b. The current "Informed Consent for Surgery of Special Procedure" form, with version date "5/18," was signed by the patient on 01/18/2019 at 0902 and by the surgeon on that date at 0900.
* It was unclear whether it was the practitioner's handwriting that completed the "Name and Description of the Procedure" as required.

4. c. An outdated "Consent for Anesthesia Services" form, with version date 10/06/2005, was signed by the patient on 01/18/2019 at 0900.
* The consent was not the current form attached to the policy that required the anesthetist's signature.
* The space for the name of the anesthetist who was to administer anesthesia reflected "CRNA" and did not contain the name of the anesthetist.
* The consent reflected "I expressly desire the following considerations be observed (or write 'none'):" The space next to that statement was blank.
* The "Anesthesia Care Provider" who signed in on the case had not signed the form to reflect that he/she had reviewed the consent and the risks of anesthesia with the patient.

5. a. The medical record of Patient 22 reflected that he/she underwent an outpatient "I&D" of a neck abscess on 02/12/2019. Review of the anesthesia and surgical procedure documentation revealed that the timeline of events was unclear and contradictory to hospital policies and procedures:

* On 02/12/2019 at 1535 - Patient arrived to "Preop."
* At 1543 - RN recorded that "Anesthesia Consent signed" and "Procedure Consent Signed" prior to the time the consent forms were signed at 1604 and 1606 as indicated below.
* At 1604 - Patient signed the "Informed Consent for Surgery of Special Procedure."
* At 1606 - Patient signed the "Consent for Anesthesia Services."
* At 1607 - The Anesthetist competed the "Anesthesia Pre-Op" evaluation.
* At 1625 - Patient into the OR.
* At 1625 - Anesthesia started.
* At 1625 - The "Surgeon" signed in as in "Case Attendance."
* At 1625 - Two "Nurse Anesthetists" signed in as in "Case Attendance."
* At 1651 - Surgery/procedure started.
* At 1720 - The "Surgeon" signed out of the case.
* At 1720 - Patient out of the OR.
* At 1725 - Two "Nurse Anesthetists" signed out of the case.
* At 1729 - Anesthesia stopped.
* At 1729 - Patient transferred to PACU I.
* At 1738 - An anesthetist signed the "CVH Anesthesia" record.
* At 1739 - An anesthetist signed a "Anesthesia Post-Op Note."
* At 1742 - "Safety Check Sign In" conducted after the patient was in the OR, after anesthesia had been started and stopped, after surgery started and after the patient was in PACU.
* At 1743 - "Safety Check Sign Out" conducted before surgery was stopped and after the two anesthetists and the surgeon had signed out of the case. The sign-out included "Nurse verbally confirms with team that instrument, sponge, and needle counts are correct" for which "Yes" was recorded. However, the incomplete "Counts" were not conducted until 1800 as indicated below.
* At 1745 - Surgery/procedure stopped.
* At 1745 - Patient transferred to PACU II.
* At 1753 - "Patient Positioning" and "Identifies baseline musculoskeletal status" documented.
* At 1754 - "Skin Assessment ... baseline" and "Implements protective measures" documented.
* At 1756 - "Skin Prep" and "Verifies allergies" documented.
* At 1757 - "Cautery" and "Implements protective measures to prevent injury due to electrical sources" documented.
* At 1800 - "Counts verification" documented after patient left the OR. In addition, the "Initial Count" and "Final Count" of "Sharps, Sponges" were not recorded. The spaces for those were blank.
* At 1824 - Patient discharged from PACU II.

* On 02/13/2019 at 1133, the day after the surgery, the "Safety Check Time Out" was documented as having been conducted the day prior, on 02/12/2019 at 1650.

The EHR system documentation reflected that entries in the surgical record were "modified" and signed by surgical staff for two days following the procedure. It was not clear what was modified and why. Those times were:
* On 02/13/2019 at 1134.
* On 02/13/2019 at 1152.
* On 02/14/2019 at 0826.

The "Safety Checks" and other consent, assessment and safety information were not documented timely in accordance with the surgical timeline and were contradictory to the processes to ensure patient safety.

5. b. The current "Informed Consent for Surgery of Special Procedure" form, with version date "5/18," was signed by the patient on 02/12/2019 at 1604.
* Although the surgeon signed and dated the form "2/12," he/she did not complete the "Time" space to reflect when he/she signed the informed consent.
* It was unclear whether it was the practitioner's handwriting that completed the "Name and Description of the Procedure" as required.

5. c. An outdated "Consent for Anesthesia Services" form, with version date 10/06/2005, was signed by the patient on 02/12/2019 at 1606.
* The consent was not the current form attached to the policy that required the anesthetist's signature.
* The space for the name of the anesthetist who was to administer anesthesia contained a first name only.
* Neither of the "Nurse Anesthetists" who signed in on the case had signed the form to reflect that the anesthetist who would be administering anesthesia had reviewed the consent and the risks of anesthesia with the patient.

5. d. In addition, the "Intraop Nursing Record Summary" reflected that two "Nurse Anesthetists" were signed into the case. It was unclear what the roles of the two were and there was no documentation in the record to reflect that the patient had been informed of that information.

6. a. The medical record of Patient 23 reflected that he/she underwent a "Right Hip Replacement" on 03/05/2019 under "General" anesthesia and was admitted as an inpatient. Review of the anesthesia and surgical procedure documentation revealed that the timeline of events was unclear and contradictory to hospital policies and procedures. For example:

* The physician's H&P was documented as an "Office/Clinic Note" dated 02/25/2019. A stamped statement on the "Examination" document reflected a statement that "The previous H&P is still valid and this patient is medically cleared for surgery." The statement was initialed and dated 03/05/2019. It was not timed to reflect it was completed prior to the procedure.

* On 02/27/2019 at 0929 - Patient signed "Informed Consent for Surgery of Special Procedure."

* On 03/05/2019 at 0650 - Patient arrived to the hospital for registration
* At 0712 - RN recorded that "Anesthesia Consent signed" and "Procedure Consent Signed" prior to the time the consent forms were signed at 0805 and 0830 as indicated below.
* At 0733- The Anesthetist competed the "Anesthesia Pre-Op" evaluation.
* At 0805 - Patient signed the outdated form "Consent for Anesthesia Services."
* At 0830 - Physician signed "Informed Consent for Surgery of Special Procedure" that the patient had signed and dated on 02/27/2019.
* At 0853 - Patient into the OR.
* At 0853 - The "Anesthesiologist of Record" signed in as in "Case Attendance."
* At 0853 - Anesthesia started.
* At 0853 - The "Surgeon" signed in as in "Case Attendance."
* At 0956 - Surgery/procedure started.
* At 1013 - "Safety Check Sign In" conducted after the patient was in the OR and after anesthesia and surgery had been started.
* At 1015 - "Safety Check Time Out" documented as having been conducted at 0955.
* At 1017 - "Patient Positioning" and "Identifies baseline musculoskeletal status" documented.
* At 1021 - "Skin Assessment ... baseline" and "Implements protective measures" documented.
* At 1024 - "Skin Prep" and "Verifies allergies" documented.
* At 1025 - "Cautery" and "Implements protective measures to prevent injury due to electrical sources" documented.
* At 1030 - "Surgical Equipment" checked after surgery started.
* At 1311 - Surgery/procedure stopped.
* At 1321 - Patient out of the OR.
* At 1321 - Patient transferred to PACU I.
* At 1321 - The "Surgeon" signed out of the case.
* At 1321 - The "Anesthesiologist of Record" signed out of the case.
* At 1322 - Anesthesia stopped.
* At 1544 - Patient discharged from PACU I.
* At 1910 - The anesthetist signed a "Anesthesia Post-Op Note" that reflected the anesthesia was "General."

The day after the surgery, on 03/06/2020, the following documentation was recorded:
* At 1447 - "Safety Check Sign Out" conducted the following day, after the patient was discharged from PACU.
* At 1449 - "Counts verification" and the "Initial Count" and "Final Count" of "Sharps, Sponges" were not recorded. The spaces for those were blank.
* At 1452 - "Dressing and Packing" documented.
* At 1503 - Implant 2 documented in "Implant Log" and "Verifies operative procedure, surgical site, and laterality ... Records implants inserted ..."
* At 1505 - Implant 1 and 3 as above.
* At 1507 - Implant 4 as above.
* At 1534 - Implant 5 as above.
* At 1728 - The surgeon electronically signed the "Operative Report." There was no documentation in the record to reflect that the surgeon had written a note immediately after the surgery on 03/05/2019.

The EHR system documentation reflected that entries in the surgical record were "modified" and signed by surgical staff on days following the procedure. It was not clear what was modified and why. Those times were:
* On 03/07/2019 at 1614.
* On 03/13/2019 at 1535.

The "Safety Checks" and other consent, assessment and safety information were not documented timely in accordance with the surgical timeline and were contradictory to the processes to ensure patient safety.

6. b. The current "Informed Consent for Surgery of Special Procedure" form, with version date "5/18," was signed by the patient on 02/27/2019 at 0929 and the surgeon on 03/05/2019 at 0830.
* It was unclear whether it was the practitioner's handwriting that completed the "Name and Description of the Procedure" as required.

6. c. An outdated "Consent for Anesthesia Services" form, with version date 10/06/2005, was signed by the patient on 03/05/2019 at 0805.
* The consent was not the current form attached to the policy that required the anesthetist's signature.
* The "Anesthesiologist of Record" who signed in on the case had not signed the form to reflect that he/she had reviewed the consent and the risks of anesthesia with the patient.

6. d. In addition, the "Intraop Nursing Record Summary" reflected that at 0940 an individual identified by name and by position as "Industry" had signed into the case and signed out at 1321. It was unclear who the individual was and what the role of "Industry" included. There was no documentation in the record to reflect that the patient had consented to a "Industry" person being present for the procedure and that he/she had received information about the role of that person.

7. During interview with the HIM and other staff present at the time of the surgical record review on 04/24/2019 between 1030 and 1240 findings for Patients 20, 21, 22 and 23 were confirmed and no additional information was provided.



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8. a. Patient 16's medical record was reviewed with RN 11 on 04/23/2019 at 1145. The record reflected the patient was admitted for a GI bleed. RN 11 stated the patient was currently undergoing an exploratory laparatomy surgical procedure on 04/23/2019 at the time of the medical record review.

8. b. The "Consent For Anesthesia Services" reflected general anesthesia would be used during the procedure. The consent was signed by the patient and dated 04/23/2019 at 1003 and revealed the following information:
* "I hereby consent to the anesthesia service..and authorize that it be administered by the Certified Registered Nurse Anesthetist (CRNA)..." The informed consent form did not include the name of the CAH staff who would administer the anesthesia.
* The spaces for "Signature of Person Providing Information" and "Date and Time" were blank. The informed consent did not include the name/signature of the person who explained the anesthesia services to the patient.

9. a. Review of Patient 17's medical record reflected the patient was admitted for an OP colonoscopy procedure on 04/24/2019.

9. b. The "Consent For Anesthesia With Conscious Sedation" signed by the patient and dated 04/24/2019 at 0638 revealed the following information:
- "I, [blank line] acknowledge that my doctor has explained to me that I will have an operation, diagnostic, or treatment procedure...I also understand that anesthesia services are needed so that my doctor can perform the operation or procedure." The informed consent was incomplete as it did not include the name of the patient for whom the consent applied.
- "I hereby consent to the anesthesia service...and authorize that it be administered by [blank line] or his/her associates, or a Coquille Valley Hospital employed Registered Nurse..." The informed consent did not include the name of the CAH staff who would administer the anesthesia.
- "I also consent to an alternative type of anesthesia or anesthesia provider, if necessary, as deemed appropriate by them. I expressly desire the following considerations be observed (or write 'none'):" This was followed by a blank line. The informed consent did not include the alternative "considerations to be observed" or reflect that there were none.
- The space for recording "Substitute's Signature" unclearly reflected "4/24/19 [at] 0631."
- The space for "Witness" was signed by a student nurse.

9. c. The "Consent For Surgical And/Or Medical Treatment" signed by the patient and dated 04/24/2019 at 0638 revealed the following information:
- "I authorize...[physician name]...to perform "Esophago Gastro Duodenoscopy With Possible Biopsies/Colonoscopy With Possible Biopsies And/or Polyectomies...Th

Based on interview, review of medical records for 4 of 4 patients who underwent surgery and anesthesia and were reviewed for anesthesia evaluations (Patients 20, 21, 22 and 23) and review of policies and procedures it was determined that the CAH failed to fully develop and enforce policies and procedures that ensured the provision of appropriate and safe anesthesia services:
* Pre-anesthesia evaluations were not conducted or were incomplete and unclear.
* Post-anesthesia evaluations were not conducted or were incomplete and unclear.
* Information about the types and methods of anesthesia used was not clear and accurate.

Findings include:

1. a. The P&P titled "Pre-op anesthetic risk evaluation" was dated as "Last Revised: 8/31/2017 and "Next Review" due 08/31/2018. It was reviewed and reflected the following in entirety: "The pre-anesthesia evaluation must be performed prior to inpatient or outpatient surgery/procedure. The pre-anesthesia evaluation must be performed by an individual qualified to administer anesthesia. The pre-operative anesthetic evaluation should include: Notation of anesthesia risk, Anesthesia, drug and allergy history, Any potential anesthesia problems identified, Patients condition prior to induction to anesthesia."

1. b. The undated P&P titled "Postoperative Anesthesia Care" was reviewed and included the following:
* "The anesthetist shall be responsible for post anesthesia care of all patients who have received anesthesia (general, spinal, regional, local anesthesia with standby.). This shall include documentation of all post anesthesia visits."
* "Any individual who is qualified to administer anesthesia, and is privileged to administer anesthesia by the hospital, may conduct the post anesthesia evaluation."
* "The patient shall be transferred from the operating room at the completion of the procedure when the anesthetist feels that the patient is stable."
* "The patient shall be accompanied to the PACU by the anesthetist and the OR Circulating RN."
* The anesthetist shall remain with the patient as long as necessary to ensure the patient's safety and post procedure status is assessed on admission to PACU.
* "A licensed independent practitioner shall document in the medical record the discharge of the patient from the PACU, when the patient's condition is stable and the patient meets the PACU discharge criteria (Modified Aldrete Scoring System)."
* "When the post anesthesia visit and documentation cannot be completed by the attending anesthetist because of early patient discharge, the attending physician who discharges the patient shall be responsible for meeting the same requirements."

1. c. The P&P titled "Moderate Sedation" dated as approved on 08/20/2018 was reviewed and included the following:
* "The RN who is to administer the moderate sedation shall have no other responsibilities other than monitoring the patient and delivering the ordered medication thru the recovery phase."
* "The ordering licensed independent practitioner shall ... A pre-sedation assessment shall be performed and documented in the medical record for each patient before administering moderate sedation. The patient shall be reevaluated immediately before moderate sedation is administered."
* "Pre-sedation assessment must be completed by a LIP and include: Ensure informed consent is signed, H&P, Airway, Review of patient medications, including recreational drugs, alcohol and tobacco, Height and weight, Last time the patient's ate or drank, Results of pregnancy test, if applicable, ... If the patient reports a history of sleep apnea, the RN administering the moderate sedation shall consult with CRNA."
* "Monitoring shall include: ... Physical assessment (Must be completed prior to sedation)."
* "Patients must be screened for potential risk factors for any pharmacological agents selected. This decision on which agent to use must be based on the goals of sedation, type of procedure and condition and age of patient. Patients shall be screened by the ordering LIP for risk factors utilizing the ASA Physical Status Classification. An RN may administer moderate sedation to an adult patient with an ASA score of I, II, or III. They may not administer moderate sedation to a patient with an ASA IV or above ..."
* "Post-procedure Monitoring and Discharge Criteria: Heart rate, rhythm - cardiac monitoring, Blood pressure, Pulse oximetry, Level of consciousness, Wound and dressing assessment, Level of pain, Drains as applicable, IV line patency, as applicable, Documentation of the Modified Aldrete score shall be completed prior to patient discharge. The score must return to the baseline assessment before the patient may be released from the procedure area. The range is 10 for complete recovery to zero (0) in comatose patient. Evidence that patient has met discharge criteria must be clearly documented in the medical record. All outpatients who receive sedation for any procedure must have a Aldrete score of 8 or greater or equal to pre-procedure baseline prior to being discharged home. Vital signs ... are recorded at 15-30 minute intervals."
* "Medical staff approved discharge criteria shall include: Aldrete score of 8 or greater or equal to pre-procedure baseline. No signs of respiratory distress, able to swallow and cough or (return to baseline). Fully oriented to time, person, and place or return to baseline mentation. Tolerate fluid intake at pre-procedure."

2. a. The medical record of Patient 20 reflected that he/she underwent an outpatient "colonoscopy" on 12/17/2018 under "conscious sedation." The timeline of anesthesia related events reflected in the record included the following:
* At 0700 - Patient's last fluid intake reported at home.
* At 0942 - A CRNA signed in as in "Preop Case Attendance"
* At 0948 - A "Local Monitoring RN" signed in as in "Case Attendance."
* At 0948 - Patient into the OR.
* At 0948 - Anesthesia started.
* At 0955 - Physician signed in as in "Case Attendance."
* At 1024 - Physician signed out of the case.
* At 1026 - Anesthesia stopped.
* At 1026 - The "Local Monitoring RN" signed out of the case.
* At 1026 - Patient out of the OR.
* At 1029 - Patient transferred to PACU.
* At 1115 - Patient discharged to home.

2. b. Regarding a pre-anesthesia evaluation: The physician's H&P was documented as a "Clinic Note" dated 11/27/2018. A stamped statement on the "Clinic Note" reflected a statement that "The previous H&P is still valid and this patient is medically cleared for surgery." The statement was initialed and dated 12/17/2018. It was not timed to reflect it was completed prior to the procedure. There was no documentation by the physician or another LIP or anesthetist prior to the procedure as required by the "Pre-op anesthetic risk evaluation" and "Moderate Sedation" P&Ps found under Finding 1 above. The physician documentation prior to the procedure did not include all of the assessment information required by the P&P, including, but not limited to: airway, use of recreational drugs, alcohol and tobacco, height, current weight, last time the patient ate or drank, history of sleep apnea, screening for potential risk factors for the pharmacological agents selected, screening for risk factors utilizing the ASA Physical Status Classification.

2. c. Regarding a post-anesthesia evaluation: There was no documentation to reflect that a post-anesthesia evaluation had been conducted as required by the "Postoperative Anesthesia Care" and "Moderate Sedation" P&Ps found under Finding 1 above, including, but not limited to a Modified Aldrete score. The only documentation by the "Local Monitoring RN" was dated 12/17/2018 at 1031 and reflected in its entirety "Patient tolerated well, vitals stable. To PACU in stable condition. Fentanyl 100 mcg, Versed 5mg titrated slowly." The only documentation related to the patient's post-anesthesia condition by the physician was in the Operative Report dated 12/17/2018 at 1356, after the patient had been discharged home, and reflected "[Patient 20] tolerated the procedure well and is resting comfortably."

3. a. The medical record of Patient 21 reflected that he/she underwent an outpatient "bunionectomy" on 01/18/2019 under "MAC" anesthesia. The timeline of anesthesia related events reflected in the record included the following:
* At 0850 - The Anesthetist competed the "Pre-Anesthetic Evaluation."
* At 0923 - Patient into the OR.
* At 0923 - Anesthesia started.
* At 1050 - Anesthesia stopped.
* At 1050 - Patient out of the OR.
* At 1050 - Patient transferred to PACU I.
* At 1100 - The anesthetist signed a "Post-Anesthesia Evaluation" that was incomplete as specified below.

3. b. Regarding a pre-anesthesia evaluation: The "Pre-Anesthetic Evaluation" dated on 01/18/2019 at 0850 was incomplete. Fields and spaces on the form that were blank and not completed included:
* Weight, height, vital signs, SaO2.
* "Review of System" for the following systems: Dental Status, Respiratory, Gastro-Intestinal, Genito-Urinary, Hematology.
* The box next to "Signed consent" was not checked.
* The box next to "PARQ" was not checked and the corresponding space next to "With patient or [empty space]" was blank.

3. c. Regarding a post-anesthesia evaluation: The "Post-Anesthesia Evaluation" dated on 01/18/2019 at 1100 was incomplete. Fields and spaces on the form that were blank and not completed included:
* "Vital Signs"
* "Post-Op Hydration"
* The box next to "No Apparent Anesthesia Related Complications" was unchecked.
* The box next to "Patient Satisfied with Anesthetic" was unchecked.

In addition, there was no documentation of the post-anesthesia Modified Aldrete Score required by the P&Ps found under Finding 1 above.

4. a. The medical record of Patient 22 reflected that he/she underwent an outpatient "I&D" of a neck abscess on 02/12/2019. The timeline of anesthesia related events reflected in the record included the following:

* At 1607 - The Anesthetist competed the "Anesthesia Pre-Op" evaluation and identified the anesthesia "Plan" was for "Combined technique (TAP Block, Sciatic)."
* At 1625 - Patient into the OR.
* At 1625 - Anesthesia started.
* At 1625 - Two "Nurse Anesthetists" signed in as in "Case Attendance."
* At 1630 - An anesthetist recorded on the "CVH Anesthesia" record "General w/ ETT."
* At 1720 - Patient out of the OR.
* At 1725 - Two "Nurse Anesthetists" signed out of the case.
* At 1729 - Anesthesia stopped.
* At 1729 - Patient transferred to PACU I.
* At 1737 - The physician signed a "Postoperative" note that reflected "Anesthesia: LMA."
* At 1738 - An anesthetist signed the "CVH Anesthesia" record that reflected "Anesthesia Type: MAC."
* At 1739 - An anesthetist signed a "Anesthesia Post-Op Note" that reflected "Anesthesia utilized: General."
* At 1745 - Surgery/procedure stopped.
* At 1745 - Patient transferred to PACU II.
* At 1817 - Patient was provided with and signed and dated discharged instructions for "MAC" anesthesia.

4. b. Pre and post-anesthesia evaluations, and other anesthesia information including patient discharge instructions, did not contain clear and accurate documentation related to the type of anesthesia used. Anesthesia type was documented as "Combined technique (TAP Block, Sciatic)," "General w/ETT," "LMA," and "MAC."

In addition, there was no documentation of the post-anesthesia Modified Aldrete Score required by the P&Ps found under Finding 1 above.

5. a. The medical record of Patient 23 reflected that he/she underwent a "Right Hip Replacement" on 03/05/2019 under "General" anesthesia and was admitted as an inpatient. The anesthetist documented an "Anesthesia Post-Op Note" on 03/05/2019 at 1910. There was no documentation of the post-anesthesia Modified Aldrete Score required by the P&Ps found under Finding 1 above

6. During interview with the HIM and other staff present at the time of the surgical record review on 04/24/2019 between 1030 and 1155 findings for Patients 20, 21 and 22 were confirmed and no additional information was provided.

Based on observation, interview, review of medical records for 8 of 20 patients (Patients 16, 17, 20, 21, 22, 23, 24 and 25), review of complaint/grievance documentation for 10 of 10 patients (Patients 1 through 10), review of incident documentation, review of policies and procedures and program evaluation documentation it was determined that the CAH failed to develop and implement an effective periodic evaluation and quality assurance program that ensured the provision of safe and appropriate care and services in all areas of its operations.

This Condition-level deficiency reflects the CAH's limited capacity to provide safe and appropriate care and services.

Findings include:

1. Refer to the Standard-level deficiencies cited at Tags C333, C334, C335 and C337 under this Condition of Participation that reflect the CAH's failures to ensure it evaluated medical records, policies and procedures, and all services provided, and that evaluation determined whether policies were appropriate and followed and whether changes were needed.

2. Refer to the deficiency cited at Tag C270, CFR 485.635, Condition of Participation: Provision of Services. Those findings reflect the CAH's failures to ensure care and services were in accordance with written policies and procedures.

3. Refer to the deficiency cited at Tag C320, CFR 485.639, Condition of Participation: Surgical Services. Those findings reflect the CAH's failures to provide safe and appropriate surgical and anesthesia services in accordance with written policies and procedures.

Based on observation, interview, review of medical records for 8 of 20 patients (Patients 16, 17, 20, 21, 22, 23, 24 and 25), review of complaint/grievance documentation for 10 of 10 patients (Patients 1 through 10), review of incident documentation, review of policies and procedures and program evaluation documentation it was determined that the CAH failed to ensure its annual program evaluation included results of quality assurance review and audits of a representative sample of open and closed medical records.

Findings include:

1. The "Coquille Valley Hospital Joint Professional And Policy Advisory Council Meeting" dated 11/29/2018 was reviewed. The meeting documentation included "The following functions/responsibilities were performed per CAH requirements and our policy" and was followed by three sections.

The first section of the minutes reflected "Recommend and advise on the development of relevant policies concerning the care and treatment of patients and the provision of CAH services ... Assure that appropriate policies exist for specified areas relevant to the provision of acute care hospital services ... As a practical matter, all service areas, professional ancillary, and support department policies should be incorporated in the review whether specifically listed as required or not."

The second section of the minutes reflected that "JPAC is also responsible for conducting the annual Critical Access Program Evaluation. The evaluation shall include a comprehensive review of all aspects of the CAH's program and shall specifically incorporate reviews of at least the following: ... The effectiveness of all aspects of the hospital's Quality Improvement/Quality Assurance Program ... All (CAH) clinical care policies, documenting - for verification purposes - that the review has been performed ... The Council feels that all policies are in process and being sought and trained to in a timely manner, in that this requirements has been met satisfactorily ..."

The third section of the minutes reflected that "Coquille Valley Hospital is to perform an annual evaluation of all aspects of its CAH program ... There is agreement by the Board that CVH meets or exceeds these expectations ..."
The minutes reflected the following was evaluated "Whether the services rendered met quality standards(s)." The response recorded was "Yes."
The second item evaluated was "Whether established policies, procedures, work processes/care practices were following in actual practice." The response recorded was "Yes."
The third item written as evaluated was "Whether any changes (either in the services themselves or in the policies, processes, etc. guiding their delivery) are necessary." The response recorded was "No changes are needed."

The annual evaluation contained no documentation to reflect that quality assurance reviews and audits of open and closed medical records that were representative of all services provided by the CAH were conducted to determine whether policies and procedures were followed and ensured safe and appropriate care.

2. Refer to the deficiency cited at Tag C270, CFR 485.635, Condition of Participation: Provision of Services. Those findings reflect the CAH's failures to ensure care and services were in accordance with written policies and procedures.

Refer to the deficiency cited at Tag C320, CFR 485.639, Condition of Participation: Surgical Services. Those findings reflect the CAH's failures to provide safe and appropriate surgical and anesthesia services in accordance with written policies and procedures.

The annual evaluation contained no documentation to reflect that the CAH had evaluated its care and services and identified the failures found during this survey.

3. During interview with the CEO on 04/24/2019 at approximately 1745 he/she stated that the annual evaluation did not include quality assurance review of open and closed records.

Based on observation, interview, review of medical records for 8 of 20 patients (Patients 16, 17, 20, 21, 22, 23, 24 and 25), review of complaint/grievance documentation for 10 of 10 patients (Patients 1 through 10), review of incident documentation, review of policies and procedures and program evaluation documentation it was determined that the CAH failed to ensure its annual program evaluation included review of the CAH's health care policies.

Findings include:

1. The "Coquille Valley Hospital Joint Professional And Policy Advisory Council Meeting" dated 11/29/2018 was reviewed. The meeting documentation included "The following functions/responsibilities were performed per CAH requirements and our policy" and was followed by three sections. Refer to the details of the meeting minutes for those sections cited at Tag C333 under this Condition of Participation.

2. Refer to the deficiency cited at Tag C270, CFR 485.635, Condition of Participation: Provision of Services. Those findings reflect the CAH's failures to ensure care and services were in accordance with written policies and procedures.

Refer to the deficiency cited at Tag C320, CFR 485.639, Condition of Participation: Surgical Services. Those findings reflect the CAH's failures to provide safe and appropriate surgical and anesthesia services in accordance with written policies and procedures.

The annual evaluation contained no documentation to reflect that the CAH had evaluated its health care policies and identified the failures found during this survey.

Based on observation, interview, review of medical records for 8 of 20 patients (Patients 16, 17, 20, 21, 22, 23, 24 and 25), review of complaint/grievance documentation for 10 of 10 patients (Patients 1 through 10), review of incident documentation, review of policies and procedures and program evaluation documentation it was determined that the CAH failed to ensure its annual program evaluation was conducted to include evaluation of whether established policies were followed and if any changes are needed.

Findings include:

1. The "Coquille Valley Hospital Joint Professional And Policy Advisory Council Meeting" dated 11/29/2018 was reviewed. The meeting documentation included "The following functions/responsibilities were performed per CAH requirements and our policy" and was followed by three sections. Refer to the details of the meeting minutes for the first two sections cited at Tag C333 under this Condition of Participation.

The third section of the minutes reflected that "Coquille Valley Hospital is to perform an annual evaluation of all aspects of its CAH program ... There is agreement by the Board that CVH meets or exceeds these expectations ..."
The minutes reflected the following was evaluated "Whether the services rendered met quality standards(s)." The response recorded was "Yes."
The second item evaluated was "Whether established policies, procedures, work processes/care practices were following in actual practice." The response recorded was "Yes."
The third item written as evaluated was "Whether any changes (either in the services themselves or in the policies, processes, etc. guiding their delivery) are necessary." The response recorded was "No changes are needed."

2. Refer to the deficiency cited at Tag C270, CFR 485.635, Condition of Participation: Provision of Services. Those findings reflect the CAH's failures to ensure care and services were in accordance with written policies and procedures.

Refer to the deficiency cited at Tag C320, CFR 485.639, Condition of Participation: Surgical Services. Those findings reflect the CAH's failures to provide safe and appropriate surgical and anesthesia services in accordance with written policies and procedures.

The annual evaluation contained no documentation to reflect that the CAH had identified the failures found during this survey and instead concluded that quality standards were met, that policies and procedures were followed and that no changes were needed.

Based on observation, interview, review of medical records for 8 of 20 patients (Patients 16, 17, 20, 21, 22, 23, 24 and 25), review of complaint/grievance documentation for 10 of 10 patients (Patients 1 through 10), review of incident documentation, review of policies and procedures and program evaluation documentation it was determined that the CAH failed to ensure its annual program evaluation and quality assurance program were effective and included evaluation of all patient care services and other services affecting patient health and safety.

Findings include:

1. The "Coquille Valley Hospital Joint Professional And Policy Advisory Council Meeting" dated 11/29/2018 was reviewed. The meeting documentation included "The following functions/responsibilities were performed per CAH requirements and our policy" and was followed by three sections. Refer to the details of the meeting minutes for those sections cited at Tag C333 under this Condition of Participation.

2. Refer to the deficiency cited at Tag C270, CFR 485.635, Condition of Participation: Provision of Services. Those findings reflect the CAH's failures to ensure care and services were in accordance with written policies and procedures.

Refer to the deficiency cited at Tag C320, CFR 485.639, Condition of Participation: Surgical Services. Those findings reflect the CAH's failures to provide safe and appropriate surgical and anesthesia services in accordance with written policies and procedures.

The annual evaluation contained no documentation to reflect that the CAH had evaluated all care and services provided and identified the failures found during this survey.