HospitalInspections.org

Based on interviews, review of medical record and incident/event documentation for 10 of 14 patients who received hospital services (Patients 18, 20, 23, 25, 27, 28, 30, 31, 34, and 36), review of the hospital's plan of correction, review of policies and procedures, and review of other documentation, it was determined that the hospital failed to develop and enforce policies and procedures to ensure the provision of safe and appropriate care to patients in the hospital that complied with the Conditions of Participation in the following areas:
* Patient 23, who had impaired dexterity and episodes of confusion, was not appropriately supervised and evaluated. Staff gave the patient hot coffee, and the patient spilled the coffee and sustained burns and blisters.
* Policies and procedures were ineffective and failed to prevent surgical instrument count discrepancies; and surgical needles and/or sutures from being lost during surgical procedures involving Patients 25, 28, and 31.
* Processes to monitor, evaluate, and intervene were ineffective for Patient 34, as the patient who was at risk for suicide, experiencing increased behaviors, and was placed on "constant" observation, eloped from the ED; and code gray, security response, BARS evaluation, and LWBS processes were not effective or carried out.
* Regarding Patients 18, 20, 23, 25, 27, 28, 30, 31, 34, and 36, the hospital failed to conduct clear, complete and thorough investigations and follow up actions of incidents/events in accordance with the hospital's plan of correction and P&Ps, including those of potential or actual abuse and neglect that involved potential or actual harm, to ensure those events did not recur.
* RN supervision and evaluation of patients.

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 the findings cited under Tag A115, CFR 482.13 - COP Patient's Rights.

2. Refer to the findings cited under Tag A263, CFR 482.21 - COP Quality Assessment and Performance Improvement.

3. Refer to the findings cited under Tag A395, CFR 482.23(b)(3) - Standard: RN Supervision of Nursing Care.

Based on interviews, review of medical record and incident/event documentation for 10 of 14 patients who received hospital services (Patients 18, 20, 23, 25, 27, 28, 30, 31, 34, and 36), review of the hospital's plan of correction, review of policies and procedures, and review of other documentation, it was determined that the hospital failed to ensure the provision of safe care as follows:
* Patient 23, who had impaired dexterity and episodes of confusion, was not appropriately supervised and evaluated. Staff gave the patient hot coffee, and the patient spilled the coffee and sustained burns and blisters.
* Policies and procedures were ineffective and failed to prevent surgical instrument count discrepancies; and surgical needles and/or sutures from being lost during surgical procedures involving Patients 25, 28, and 31.
* Processes to monitor, evaluate, and intervene were ineffective for Patient 34, as the patient who was at risk for suicide, experiencing increased behaviors, and was placed on "constant" observation, eloped from the ED; and code gray, security response, BARS evaluation, and LWBS processes were not effective or carried out.
* Regarding Patients 18, 20, 23, 25, 27, 28, 30, 31, 34, and 36, the hospital failed to conduct clear, complete and thorough investigations and follow up actions of incidents/events in accordance with the hospital's plan of correction and P&Ps, including those of potential or actual abuse and neglect that involved potential or actual harm, to ensure those events did not recur.

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 the findings cited at Tag A144, CFR 482.13(c)(2) - Standard: Patient's Rights: Care in a Safe Setting. Those findings reflect the hospital's failure to ensure the patient's right to receive care in a safe setting.

2. Refer to the findings cited at Tag A145, CFR 482.13(c)(3) - Standard: Patient's Rights: Free from Abuse/Harassment. Those findings reflect the hospital's failure to ensure investigations and follow up actions to potential abuse and neglect incidents/events that involved potential or actual patient harm, were clear, complete and thorough.

Based on interviews, review of medical record and incident/event documentation for 10 of 14 patients who received hospital services (Patients 18, 20, 23, 25, 27, 28, 30, 31, 34, and 36), review of the hospital's plan of correction, review of policies and procedures, and review of other documentation, it was determined that the QAPI program was not effective to ensure the provision of safe and appropriate care to patients in the hospital that complied with the Conditions of Participation as follows:
* Patient 23, who had impaired dexterity and episodes of confusion, was not appropriately supervised and evaluated. Staff gave the patient hot coffee, and the patient spilled the coffee and sustained burns and blisters.
* Policies and procedures were ineffective and failed to prevent surgical instrument count discrepancies; and surgical needles and/or sutures from being lost during surgical procedures involving Patients 25, 28, and 31.
* Processes to monitor, evaluate, and intervene were ineffective for Patient 34, as the patient who was at risk for suicide, experiencing increased behaviors, and was placed on "constant" observation, eloped from the ED; and code gray, security response, BARS evaluation, and LWBS processes were not effective or carried out.
* Regarding Patients 18, 20, 23, 25, 27, 28, 30, 31, 34, and 36, the hospital failed to conduct clear, complete and thorough investigations and follow up actions of incidents/events in accordance with the hospital's plan of correction and P&Ps, including those of potential or actual abuse and neglect that involved potential or actual harm, to ensure those events did not recur.
* RN supervision and evaluation of patients.

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 the findings cited under Tag A115, CFR 482.13 - COP Patient's Rights.

2. Refer to the findings cited under Tag A395, CFR 482.23(b)(3) - Standard: RN Supervision of Nursing Care.

Based on interviews, review of medical record and incident/event documentation for 10 of 14 patients who received hospital services (Patients 18, 20, 23, 25, 27, 28, 30, 31, 34, and 36), review of the hospital's plan of correction, review of policies and procedures, and review of other documentation, it was determined that the hospital failed to develop and enforce policies and procedures to ensure patients' rights were recognized, protected and promoted as follows:
* Patient 23, who had impaired dexterity and episodes of confusion, was not appropriately supervised and evaluated. Staff gave the patient hot coffee, and the patient spilled the coffee and sustained burns and blisters.
* Policies and procedures were ineffective and failed to prevent surgical instrument count discrepancies; and surgical needles and/or sutures from being lost during surgical procedures involving Patients 25, 28, and 31.
* Processes to monitor, evaluate, and intervene were ineffective for Patient 34, as the patient who was at risk for suicide, experiencing increased behaviors, and was placed on "constant" observation, eloped from the ED; and code gray, security response, BARS evaluation, and LWBS processes were not effective or carried out.
* Regarding Patients 18, 20, 23, 25, 27, 28, 30, 31, 34, and 36, the hospital failed to conduct clear, complete and thorough investigations and follow up actions of incidents/events in accordance with the hospital's plan of correction and P&Ps, including those of potential or actual abuse and neglect that involved potential or actual harm, to ensure those events did not recur.

Findings include:

1. The hospital's Plan of Correction submitted in response to the survey conducted on 09/10/2019 reflected.
* "To ensure patients are provided care in a safe setting and the hospital conducts clear, thorough and timely investigations of incidents/events including those with potential and actual harm related to repeated falls, transport of critically ill patients, anesthesia services and skin alterations, and to ensure timely follow up and actions to ensure similar events do not recur, nurse leaders attended a mandatory educational session on the 'Unusual Occurrence Reporting' Providence Health and Services Oregon Region (PHSOR) general operating policy. The Providence system for patient safety, improving quality, risk management, incident and adverse event reporting is Datix. The mandatory education titled, 'Regional Information when Completing a Datix' was provided to all active leaders ... "
* "Supervisors, Nurse Managers, Nursing Directors, and Chief Nursing Officer (CNO) were educated on investigation requirements, timely review, and thorough documentation in the Datix event reporting system. Topics reviewed during this education session included but not limited to ... Completion deadline ... Steps of the investigation ... Determining level of harm and ensuring clear identification of details of harm ... Identifying policies and procedures related to event ... Identifying deviation from Generally Accepted Performance Standard and completion of follow up when deviation occurs ... Take action as indicated ... Follow up with applicable staff ... "
* "Routine review of Datix data looking for trends, patterns, improvement opportunities, prevention of similar events, and proactive process redesign."
* "To ensure patients are provided care in a safe setting and the hospital conducts clear, thorough and timely investigations of incidents/events including those with potential and actual harm related to skin alterations, the following processes were implemented ... Use of the 'Skin Tear Prevention & Management in Adult Patients' Policy when a skin tear occurs to ensure all steps of assessment and notification are followed ... Assessment of skin injury to ensure with sufficient detail to determine whether provider notification is indicated."
* "Educated the multi-disciplinary surgery team including physicians on the topic of situational awareness using Caring Reliability principles with initial training completed by October 9, 2020 to ensure 100% participation with active staff ... Formalize a post induction and post-position pause between Anesthesiologist and the circulating RN indicating the patient is stable to proceed with procedure."
* "All ED RNs, Crisis Interventionists ... and ED Technicians ... were given an educational in-service addressing completion of BH documentation in November 2019 ... Education included ... Documentation for behavioral health ... patients ... Pre-code gray and code gray ... Triage ... BH discharge ... Observation training based upon patient risk ... Process to monitor and evaluate increased behaviors ... prior to discharge and requirement to notify provider prior to discharge ... Annual training will be again provided to the group in November ... "
* "PSVMC has instituted practices to ensure that patients are assessed for escalating self-harm behaviors. To address the deficiency of BARS assessments were not conducted following self-harm behaviors ... "
* "PSVMC has instituted practices to ensure that skin assessments are complete ... "

2. a. The P&P titled "Counts: Instruments, Sharp and related Miscellaneous Items," dated last revised "05/2019," was reviewed and reflected:
* "Purpose: To protect the patient by establishing a process to count sponges, sharps, miscellaneous items and instruments to reduce the likelihood a foreign body will be retained."
* "Counts are the professional responsibility of the entire surgical team ... All counts are performed visually, audibly, and concurrently by 2 persons, one of them being an [RN] ... The scrub and circulator will work together, as a team, with a clear communication, peer checking ... to ensure the surgical counts are completed per policy and patient safety is the number one priority ... All items counted and/or of noted concern should be identified and accounted for in its entirety (example: disassembled, multiple parts, broken, etc.) ... Clear communication will be used to assure counts and count updates are heard and documented correctly ... Sharps counts are performed on all procedures ... Instrument counts are performed on all cases in which ... a major body cavity ... will be opened/entered ... "
* "Initial/Baseline/1st Instrument Count ... All instruments should be counted individually ... concurrently, audibly, and visually by two staff, one of which is an RN ... "
* "Correct Count: Number of instruments, sponges, sharps, and related miscellaneous items obtained from the initial baseline count with all additional items added to the sterile field during the procedure reconciled with final procedural count of instruments, sponges, sharps, and miscellaneous items."
* "Final Count: Indicates all counts are complete and all items are accounted for and out of the patient prior to the end of surgery/end of procedure/after surgery ... A final count should not be considered complete until all counted items used in the procedure have been visually accounted for by the circulator and scrub person concurrently."
* "Exception to discrepancy ... X-ray may be omitted for cases if ... using micro needles approximately 10mm and smaller (i.e. - eye, some plastic procedures, etc) ... "

2. b. The P&P titled "ED Practice Guideline: Suicide Screening and Care of Behavioral Health Patients," dated last revised "09/2020," was reviewed and reflected:
* "This practice guideline describes essential components of assessments and intervention ... "
* "Triage RN Safety Assessment and Interventions ... Place the patient in an appropriate location, considering safety needs to include ... Observation needs ... Possible need for restraints or seclusion ... "
* "All patients who present with potential behavioral health concerns ... must have their suicidal/homicidal risk level assessed. The Columbia Suicide Severity Rating Scale (CSSRS) Screening Tool in EPIC must be completed as part of the triage screening for patients ... In the event that the patient's condition changes and is unable to cooperate with treatment, a nursing reassessment including the Behavioral Activity Rating Scale (BARS), should be documented and further steps as indicated in collaboration with the treatment team."
* "Safety/Suicide Risk Classification ... Moderate safety/suicide risk: Patient requires Q15' close observation until seen by Provider ... High safety/suicide risk: Requires 1:1 continuous observation until seen by Provider ... "
* "Safety Observation ... Close Observation ... direct visual observation of the patient every 15 minutes ... Continuous Observation - Consider continuous observations for patients needing more frequent supervision than 15 minute observations. Security officers can be utilized to assist high risk patients to ensure safety."

2. c. The P&P titled "Code Gray," dated last revised "05/2020," was reviewed and reflected "The Code Gray team may be activated by any employee who believes it is necessary to manage aggressive/assaultive behavior. It is the responsibility of the Code Gray team to assume leadership and to direct the event, regardless of its origin, location ... "

2. d. The P&P titled "Patients Leaving ED Before Treatment is Completed," dated last revised "11/2017," was reviewed and reflected:
* "LWBS: When a patient leaves and/or decides to leave prior to an MSE, the circumstance should be documented ... Notify security and/or law enforcement of patients who leave before treatment is initiated and for whom it is determined that they might be at risk for harm to self and/or others. Document the notification in the medical record ... If possible, provide information to the patient on the potential risks and benefits of leaving prior to a MSE and attempt to have patient sign a LWBS/AMA form ... A note will be entered into the medical record reflecting any action taken ... "

3. Regarding Patient 23: An Event form and investigation reflected that on 10/14/2020 at 2200 the patient " ... spilled coffee on [his/her] upper chest which resulted in scattered small burns with blisters."
* The "Was there a deviation from generally accepted performance standards (GAPS)?" section was blank.
* The "Follow Up Notes" dated 11/05/2020 reflected "Reviewed the chart and spoke with Night shift RN regarding burns. [RN] stated that the pt had poor dexterity and spilled the coffee on [his/her] chest. Note was left at bedside to assist pt with liquids and not to give hot liquids. Education and care plan note 'risk for skin injury' (sic) Pt later that day transferred to ICU for circulatory shock and Cdiff issues ... "
* The "Actions Taken" notes dated 11/05/2020 at 1531 "Reviewed chart, spoke with RNs. Included hot liquids and pts with poor dexterity in safety story email to all staff. Pt was assessed for further injuries, cold applied, gown and bedding changed. Pt should be assisted with beverages."
There was no further investigation or follow up actions.

The medical record reflected the 82-year old patient was admitted to the hospital on 09/26/2020 for excision of an infected right leg bypass graft.
* Physician notes dated 10/11/2020 at 1116 reflected "Per nursing, forgetful at times."
* RN notes dated 10/12/2020 at 0227 reflected "[patient] ... somewhat forgetful and confused to situation."
* RN "Flowsheets" documentation dated 10/13/2020 at 2137 reflected "[Patient] Appropriate for Room Service ... [with] assistance ... Diet/Feeding Assistance ... tray set-up."
* RN "Flowsheets" documentation dated 10/14/2020 at 1949 reflected "Skin Integrity ... burn(s) ... scattered blisters over the chest ... Memory Deficit ... forgetful." The sections for recording "Diet/Feeding Assistance" and "Diet/Feeding Tolerance" at that time, were blank.
* RN notes dated 10/15/2020 at 0730 reflected "Waxed and waned with orientation through the night, restless this morning ... [Patient] spilled coffee on [his/her] chest due to poor dexterity. [He/she] has scattered isolated blisters over [his/her] chest this morning ... "
* RN "Flowsheets" documentation dated 10/15/2020 at 0946 reflected "Skin Integrity ... burn(s) ... Wound 10/14/20 2244 Burn upper chest ... Base blistered ... "
* Physician notes dated 10/15/20 at 1920 reflected " ... waxing and waning mental status throughout the night 10/14-10/15 ... [he/she] apparently spilled hot coffee on [him/herself] overnight."
* Physician notes dated 10/16/2020 at 1032 reflected "Continues to have pain from wounds and from spilling coffee on [his/her] chest."

During an interview and review of the investigation with the NMN on 11/19/2020 at 1500, the NMN confirmed the patient, who had poor dexterity, sustained a burn injury from hot coffee. The NMN stated the RN gave the patient a cup of hot coffee and witnessed the patient spill the coffee on his/her chest.

The investigation was unclear, and was not thorough. For example, there was no investigation related to:
* Whether the patient was or was not provided assistance with the hot coffee.
* Although the medical record reflected the patient needed assistance for room service, meal tray set up, was forgetful, and was experiencing "waxing and waning mental status throughout the night," there was no investigation that reflected if these were considered or contributed to the incident.
* There was no investigation that reflected what the patient's "dexterity" was prior to being given the hot coffee.
* There was no evaluation or identification of potential deviations from generally accepted performance standards, and completion of follow up when deviations occurred, in accordance with the hospital's plan of correction.
* There was no investigation that reflected the incident/event was evaluated for compliance with hospital P&Ps. For example, P&Ps related to RN assessment, supervision and monitoring relevant to the patient's individualized needs, with respect to the patient's impaired dexterity and being given hot coffee.
* There was no investigation related to whether the hot coffee was an appropriate temperature to be given to the patient.
* There was no investigation that reflected whether abuse and neglect were ruled out.
* The follow up actions included that a "Note was left at bedside to assist pt with liquids and not give hot liquids," however, it was not clear when this was done to prevent similar events from recurring to the patient.

Due to the failure to conduct a thorough investigation and follow up actions in accordance with the hospital's plan of correction, there was no assurance similar incidents/events involving other patients would not occur.

4. Regarding Patient 25: An Event form and investigation reflected that on 10/15/2020 at 1900 the patient underwent a surgical procedure. The event was described as "Incorrect counts. Surgeon was notified. Xray was taken. Xray was given the all clear by the radiologist ... "
* The event was categorized as "Intra-Operative Issue" and "Count Discrepancy."
* The "Harm Level" reflected "No Detectable Harm."
* The "Other People Involved" section was blank.
* The "Was there a deviation from generally accepted performance standards (GAPS)?" section was blank.
* The Follow Up Notes" dated 10/16/2020 at 1312 reflected "Policy followed for incorrect count. Debrief done with team members to identify opportunities."
* The "Actions Taken" notes dated 10/16/2020 at 1312 reflected "Enforce attention to detail Closer look at the instruments during the initial count."
There was no further investigation or follow up actions.

The medical record for the patient reflected he/she underwent a cardiac surgery on 10/15/2020.
* The intraoperative "Counts" section documented as counted by an RN and verified by another RN reflected:
- "Sponge" and "First Close" followed by "No" under the column for "Correct?"
- "Needles/Sharps" and "First Close" followed by "No" under the column for "Correct?"
- "Instruments" and "First Close" followed by "No" under the column for "Correct?"
- "Other" and "First Close" followed by "No" under the column for "Correct?"
- "Sponge" and "Final Skin" followed by "No" under the column for "Correct?" This was followed by "Xray Taken Read as all Clear ... "
- "Needles/Sharps" and "Final Skin" followed by "No" under the column for "Correct?" This was followed by "Xray Taken Read as all Clear ... "

The "Intra-Op Briefing" reflected " ... Before Patient Leaves OR ... Counts are correct: No"

The documentation lacked a clear and thorough investigation in accordance with the hospital's plan of correction. For example:
* There was no further description of the event.
* The investigation did not clearly identify the type of instrument that the "count discrepancy" pertained to as it reflected only "Closer look at the instruments during the initial count."
* There was no investigation related to the medical record entries that reflected counts were not correct for sponge, needles/sharps, and "Other."
* There was no investigation that reflected what the discrepancy was, including how many instruments were involved as it reflected only "incorrect count" and "count discrepancy."
* There was no evaluation or identification of potential deviations from generally accepted performance standards, and completion of follow up when deviations occurred.
* The "Follow Up Notes" reflected the P&P for "incorrect count" was followed. However, the investigation was unclear related to what P&P this pertained to, including if it pertained to a P&P intended to prevent a count discrepancy. Refer to the P&P above that reflects " ... All instruments should be counted individually and not in groups ... concurrently, audibly, and visually by two staff, one of which is an RN ... "
* The "Follow Up Actions" reflected that a debrief was done with team members to identify "opportunities", but did not identify what, if any, opportunities were identified.
* The "Actions Taken" reflected "Enforce attention to detail Closer look at the instruments during the initial count." However, it was unclear if the investigation identified that enforcing "attention to detail" and a "closer look at the instruments" were contributing factors and/or determined necessary to prevent reoccurrence, and if so, what contributed to the lack of "attention to detail" and the lack of ensuring a "closer look at the instruments."

During an interview and review of the investigation with the COSC on 11/19/2020 at 1300, the COSC stated at the end of the surgical procedure, an extra surgical instrument was found. The COSC stated the process to ensure the instrument count is correct is to perform a "4 eyes process" where 2 individuals count the surgical instruments at the beginning of the case, and again at the end of the case. The COSC stated the staff who counted at the beginning of the case thought the initial instrument count was 23, but at the end of the case there were 24 instruments. The COSC stated he/she followed up with the individuals who conducted the surgical instrument counts and those individuals said they followed the "4 eyes process." The COSC stated the usual number of instruments used for the procedure was 23, but in this case there were 24 instruments, and that contributed to the count discrepancy. However, the COSC acknowledged the investigation was incomplete as it did not include this information. No further information was provided related to how the count discrepancy may have occurred when staff reportedly followed the "4 eyes process" as described. No further information was provided related to the lack of a thorough investigation.

Email documentation from the IDQM dated 12/10/2020 at 1740 regarding Patient 25 reflected " ... no further investigation documents exist ... I did speak with the [NM] ... [he/she] recalls the following: This cases involved an incorrect count for towel clip only. All other instruments, sponges, and needles/sharps were present and accounted for. The medical record documentation is in error. I discussed the event directly with the involved circulators and scrub for this case ... They all recounted that is (sic) was only the (sic) instrument count (sic) was off ... "

Email documentation from the IDQM dated 12/11/2020 at 0836 and 0915, regarding Patient 25 reflected " ... whenever an incorrect count is documented, the EPIC flowsheet marks all of the areas as incorrect. There is an area for an optional, explanatory comment to describe the detail of the incorrect count" and "There was no explanatory comment entered into the EPIC EMR for this event."

Due to the failure to conduct a thorough and timely investigation, and follow up actions in accordance with the hospital's plan of correction, there was no assurance similar incidents/events involving other patients would not occur.

5. Regarding Patient 28: An Event form and investigation regarding the patient reflected that on 10/17/2020 at 0050 the "RN Circulator was informed by surgical scrub tech that they were missing 2 CV suture needles. The room was searched and 1 CV suture was found on the floor. the other missing suture was not found. Surgeon and charge nurse were made aware. No xray taken due to the size of the needle."
* The "Extent of Harm" and "Severity" sections both reflected "Harm Unknown."
* The "Names of other people present or involved:" section was blank.
* The "Was there a deviation from generally accepted performance standards (GAPS)?" section was blank.
* The "Follow Up Notes" dated 10/20/2020 at 0829 reflected only "Policy followed for incorrect count. Follow up with team completed."
* The "Actions Taken" section dated 10/20/2020 at 0829 reflected "Stressed need for attention to detail surgeon and charge nurse were informed."
There was no further investigation or follow up actions.

The medical record reflected the patient underwent a cardiac surgery beginning on 10/16/2020 at 1904 and concluded on 10/17/2020 at 0258.
* The intraoperative "Counts" section documented as counted by an RN and verified by another RN reflected:
" ... CV needle missing, per policy no xray required ... " This was documented under each of the following sections:
- "Sponge" and "Final Skin"
- "Needles/Sharps" and "Final Skin"
- "Sponge" and "First Close"
- "Needles/Sharps" and "First Close"
- "Instruments" and "First Close"
- "Other" and "First Close"
* However, the physician operative report dated 10/17/2020 at 0324 unclearly reflected "All sponge and needle counts were correct."

The documentation lacked a thorough investigation and follow up actions in accordance with the hospital's plan of correction. For example:
* The "Follow Up Notes" dated 10/20/2020 at 0829 reflected "Policy followed for incorrect count. Follow up with team completed." However, it was unclear if the P&P that was "followed for incorrect count" pertained to measures taken to prevent an incorrect count or measures taken after an incorrect count had been identified. There was no clear documentation that reflected the outcome of the follow up with the team, or the members on the team that the follow up was completed with.
* There was no evaluation or identification of potential deviations from generally accepted performance standards, and completion of follow up when deviations occurred.
* The "Actions Taken" section reflected "Actions taken and/or recommendations for prevention ... " followed by "Stressed need for attention to detail ... " There was no investigation that explained this action and/or recommendation. For example, there was no investigation that reflected whether "attention to detail" was evaluated and had been determined needed to be addressed, and if so, the contributing factors.
* There was no investigation that reflected whether the patient was or was not harmed. The documentation reflected only "Harm Unknown."
There was no further investigation or follow up actions.

During an interview and review of the investigation with the COSC on 11/19/2020 at 1345, the COSC stated 2 CV suture needles were missing at the end of the patient's surgical procedure. The COSC stated staff found 1 of the needles on the floor, but the other needle was never found. The COSC stated the hospital's policy was that if a needle smaller than 10mm was lost, an xray of the patient was not required. No further information was provided related to the lack of complete and thorough investigation.

Due to the failure to conduct a thorough investigation and follow up actions in accordance with the hospital's plan of correction, there was no assurance similar incidents/events involving other patients would not occur.

6. Regarding Patient 31: An Event form and investigation regarding the patient reflected that on 10/20/2020 at 1130 the " ... surgeon was given a double-armed 7-0 gortex suture on a Tc9 needle. Scrub tech ... observed the needle 'pop off' the suture towards the head of the field. Surgeon passed back suture and only one needle was present. Room searched, wound explored before closing, but the needle was never found ... we did not take ... Xray at the end of the case on account of the needle being too small to be visible."
* The event was categorized as "Intra-Operative Issue" and "Count Discrepancy."
* The "Extent of harm" section reflected "No Detectable Harm."
* The "Was there a deviation from generally accepted performance standards (GAPS)?" section was blank.
* The "Follow Up Notes" dated 11/06/2020 at 1950 reflected "Staff took necessary actions after the needle popped off the suture."
* The "Actions Taken" notes dated 11/06/2020 at 1950 reflected "Actions taken and/or recommendations for prevention ... Situational awareness when passing this suture to prevent the needle from being separated from the suture. Room searched with magnet, drapes and gowns searched. Wound explored thoroughly before closing."
There was no further investigation or follow up actions.

The medical record reflected the patient underwent a left carotid endarterectomy surgery on 10/20/2020 beginning at 0808. The record reflected:
* "Safe Surgery Checklist Debriefing: Before Patient Leaves OR ... Circulator reads all items out loud with entire team present ... Counts are correct: No ... " The next section in the record documented as "Counted by" an OR Tech and "Verified by" an RN reflected "Counts ... Needles/Sharps ... CV-7 on TTc-9 Gortex suture missing - surgeon declined Xray verification d/t needle being too small."
* The PA-C "Brief Op Note" dated 10/20/2020 at 1406 reflected "Counts: One needle unaccounted for during final count ... "
There was no documentation in the medical record that reflected the needle was found.

The documentation lacked a thorough investigation in accordance with the hospital's plan of correction. For example:
* The investigation reflected "Staff took necessary actions after the needle popped off the suture," but did not include any information related to actions taken, if applicable, to prevent the incident from occurring.
* There was no evaluation or identification of potential deviations from generally accepted performance standards, and completion of follow up when deviations occurred.
* There was no investigation that reflected whether applicable hospital P&Ps were considered and carried out.
* There was no documentation of interviews with staff involved in the incident/event in effort to determine contributing factors.
* The "Actions Taken" notes reflected "Situational awareness when passing this suture to prevent the needle from being separated from the suture ... " There was no investigation that explained this action. For example, there was no investigation that reflected whether situational awareness had been evaluated and determined needed to be addressed, and if so, the contributing factors.

During an interview and review of the investigation with the DSS on 11/19/2020 at 1320, the DSS confirmed a needle was lost during the surgical procedure and was never found. The DSS stated the needle was extremely small, "the size of a hair" and "this happens regularly, weekly in areas that use these small needles." The DSS stated "We can minimize this by paying attention when passing the needle, and passing it slowly." No further information was provided related to the lack of a thorough investigation and follow up actions.

Due to the failure to conduct a thorough investigation and follow up actions in accordance with the hospital's plan of correction, there was no assurance similar incidents/events involving other patients would not occur.

7. Regarding Patient 34: An Event form and investigation regarding the patient reflected that on 10/22/2020 at 2040 the patient with "significant mental health history was endorsing SI and stated that if we let [him/her] leave [he/she] would hurt [him/herself]. Called ED security phone number with no response. Simultaneously called code gray and never got any security response. No overhead page."
* The "Harm Level" section reflected "Harm Unknown."
* The "Was there a deviation from generally accepted performance standards (GAPS)?" section was blank.
* The "Actions Taken" notes dated 10/23/2020 at 0822 reflected "[COER] spoke with clinical team as they expressed concern in lack of security response to help. CN spoke to the dispatcher trying to get some security to be sent to the triage space, but the dispatcher was refusing to call code gray as patient wasn't violent, but eloping from ED and risky due to suicidal statements. security (sic) was not in triage during event, and the security spectralink rang with no answer ... "
* The "Follow Up Notes" dated 10/27/2020 at 1059 reflected " ... the ED officer was on a Code Gray ... could not answer the phone ... The supervisor's phone had a dead battery ... the ED caregiver had called dispatch direct rather than ... going through PBX ... Had the caregiver called PBX first there would have been an overhead page but since [he/she] called dispatch first there was no overhead page made."
* The "Actions Taken" notes dated 10/27/2020 at 1122 reflected "The security dispatch call taker will be coached on being more flexible ... "
* The "Follow Up Notes" dated 11/10/2020 at 1125 reflected "need to improve access to immediate support to be able to follow patient when leaving the grounds of the ED when spectralinks aren't working. I reviewed the process with the ED Charge for calling assistance when a patient elopes ... the CN felt that using the spectralink was the best way to obtain resources quickly ... discussed as a safety story at our CN meeting on 11/5."
* The "Follow Up Notes" dated 11/10/2020 at 1356 reflected " ... patient arrived in triage at 2024 ... denies SI and rates moderate on the CSSRS timed at 2031. 2034 a constant [observer] is placed at that time in triage awaiting a room. 2050 patient eloped from triage. attempts by multiple staff to reach security were delayed. ED security spectralink rang no answer. Security supervisor spectralink went nowhere (battery was dead), and they called 57777, but the security operator wasn't clear what to page out ... thus creating further delay ... "
There was no further investigation or follow up actions.

The medical record for the patient reflected he/she arrived to the ED on 10/22/2020 at 2016 with a chief complaint of "Mental Health Evaluation."
* RN triage notes at 2024 reflected "[Patient] thinks [he/she] has COVID ... [he/she] thinks someone it (sic) 'trying to kill [him/her] by injecting [him/her] with COVID. Pt reports multiple complaints ... Pt reporting increased stressors due to being homeless ... Denies any recent attempts to harm self. Is unwilling to answer if [he/she] has active thoughts of harming self. States to this RN 'you know what I am thinking so you can tell me that' ... patient alone on arrival ... Presenting with Behavioral Health Concerns?: Yes, Complete Suicide Risk Screen and Implement Observation."
* The Columbia-Suicide Severity Rating Scale documented by the RN at 2031 reflected:
- "Have you EVER done anything, started to do anything, or prepared to do anything to end your life? (!) Yes."
- "How long ago did you do any of these? Between 3 mo and a year ago" and "Pt unable to report to interviewing RN when [he/she] has last thought about killing self."
* RN notes at 2032 reflected " ... Risk of Suicide Moderate Risk."
* ED Tech notes at 2034 reflected "Started constant at Triage at this time."
* RN notes at 2040 " ... Attempted to call ED security, no answer. Code gray called to dispatch."
* RN notes at 2049 reflected "This RN called to front desk by constant observer. Pt highly anxious at this time, reporting that [he/she] is going to leave the department. This RN informed pat

Based on interviews, review of medical record and incident/event documentation for 10 of 14 patients who received hospital services (Patients 18, 20, 23, 25, 27, 28, 30, 31, 34, and 36), review of the hospital's plan of correction, review of policies and procedures, and review of other documentation, it was determined that the hospital failed to develop and enforce policies and procedures to ensure patients' rights were recognized, protected and promoted and all components of an effective abuse and neglect prevention program were evident, including thorough and complete investigations and follow up actions of potential abuse or neglect, as defined by CMS, to ensure those incidents did not recur.

The CMS Interpretive Guideline for this requirement at CFR 482.13(c)(3) reflects "Abuse is defined as the willful infliction of injury, unreasonable confinement, intimidation, or punishment, with resulting physical harm, pain, or mental anguish. This includes staff neglect or indifference to infliction of injury or intimidation of one patient by another. Neglect, for the purpose of this requirement, is considered a form of abuse and is defined as the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness."

Further, the CMS Interpretive Guideline reflects that components necessary for effective abuse protection include, but are not limited to:
o Prevent.
o Identify. The hospital creates and maintains a proactive approach to identify events and occurrences that may constitute or contribute to abuse and neglect.
o Protect. The hospital must protect patients from abuse during investigation of any allegations of abuse or neglect or harassment.
o Investigate. The hospital ensures, in a timely and thorough manner, objective investigation of all allegations of abuse, neglect or mistreatment.
o Report/Respond. The hospital must assure that any incidents of abuse, neglect or harassment are reported and analyzed, and the appropriate corrective, remedial or disciplinary action occurs, in accordance with applicable local, State, or Federal law.

Findings included:

1. a. The P&P titled "General Operating Policy - Event Reporting Using Datix (Unusual Event Reporting - UOR)," dated last revised "12/2019," was reviewed and reflected:
* "It is the policy of the Providence Health and Services Oregon Region Hospitals and Clinics to ensure patient and staff safety by the identification of unusual events, near misses, and problem prone processes."
* "Datix Event Record (formerly Unusual Occurrence Report Form) Providence Health & Services tool for any caregiver/employee, physician/provider, or volunteer to report an unusual occurrence. Reports will be completed and submitted through the PH&S Intranet."
* "Each hospital has a Quality Council, which is a joint medical staff and hospital committee with responsibility for the review and coordination of quality assessment and improvement activities undertaken by the Medical Staff and hospital. This committee assesses the aggregate data, prioritizes identified opportunities for improvement, facilitates problem resolution, develops and/or assures responses to risk management concerns and monitors to determine the effectiveness of action taken ... The Safety Committee and the sub-committee can review Datix Event Record findings for unsafe conditions and practices. The work of these groups and other existing committees ... are coordinated and integrated to provide an overall Patient Safety Program."
* "When an unusual occurrence is discovered, the individual involved in the event and/or the individual discovering the event will complete a Datix Event Record as soon as possible ... It is expected that anytime an event of serious consequences occurs, the person who becomes aware of the event will notify their supervisor/manager immediately to provide assistance and take actions, if appropriate. The supervisor/manager should contact Quality Management as soon as possible. Action will be taken as appropriate to reduce any immediate danger to patients, visitors, or staff ... the facts of the event should be documented in the medical record if it has an impact on patient care ... The Datix Event Record will be reviewed by the unit manager or department head (or designee) who is responsible to investigate the situation, take actions as indicated, follow-up with applicable staff, and document their findings on the Datix Event Record. This individual also reviews the Datix Event Record for completeness and accuracy ... "

1. b. The P&P titled "Adult Universal: Assessment, Care Planning, and Discharge Practice Standard: Universal Adult," dated last revised "02/2018," was reviewed and reflected " ... It is recommended as best practice that all patients admitted to the hospital or transferred between units will have two RN's (sic), or a RN and CNA verify all skin care issues are documented ... It is expected that a completed head-to-toe skin assessment will be in place within four hours ... The double check will occur ... and shall be documented in the patient's electronic medical record ... "

2. Regarding Patient 18: An Event form and investigation reflected that on 10/12/2020 at 1402 the patient arrived to SSU and " ... When [spouse] came back [he/she] noticed abrasion/bruise to patient's nose. Anesthesiologist called to see if [he/she] knew anything. Pt was in OR for less than 1.5 hours. Per anesthesia ... pt was face down on a support pillow and [anesthesiologist] did not notice any signs of abrasion when taking patient to PACU. [Anesthesiologist] says [he/she] will come to see patient after current case or call patient later ... Patient reports no pain on nose ... Just appears reddened like a 'rug burn.'"
* The "Length and Width of Injury" section was blank.
* The "Skin Integrity Event Contributing Factors" section was blank.
* The "Harm Level" reflected "Extent ... No Detectable Harm" and "Severity ... Reached Patient/No Harm."
* The "Was there a deviation from generally accepted performance standards (GAPS)?" section was blank.
* The "Actions Taken" notes dated 10/14/2020 at 0749 reflected "Email sent to [anesthesiologist] and [anesthesiologist department chair] for follow up on 10/14/2020 Notified anesthesiologist."
* The "Follow Up Notes" dated 10/14/2020 at 0749 reflected " ... manager following up with anesthesiologist involved." The next documentation dated 10/28/2020 at 0944, 2 weeks later, was a message dated 10/26/2020 at 1546 from the anesthesiologist that read " ... I reached out to [patient] the Monday after [his/her] surgery ... [He/she] states that [his/her] nose redness was improving ... and that the problem was less bothersome ... My suspicion is that the foam pillow, while not pressing on [his/her] eyes, had encroached medially and put some pressure on [his/her] nose. This is hard to inspect by palpation, especially when the clear table insert is not used (as was the case, unfortunately) ... 'I have copied and pasted the follow up note which is in Epic, dated 10/12/2020: 'I called patient on 10/13/2020 ... regarding discoloration and redness of [his/her] nose which was noticed in the recovery area ... "
* "Follow Up Notes" dated 11/11/2020 at 1656 reflected "No injury noted by intraop team or caregivers in PACU. Abrasion not noted until patient arrived to SSU. Unclear how abrasion occurred. The patient's surgery took place on 10/12/2020 ... "

The medical record was reviewed and reflected the patient underwent a surgical procedure involving his/her spine on 10/12/2020 beginning at 1200.
* Physician operative notes at 1252 reflected general anesthesia was administered and "the patient was carefully rotated to a prone position ... All bony prominences were well padded. There was no pressure on [his/her] eyes, chin, or nose. The arms and legs were in a position of comfort. Significant time was taken to assure adequate padding of all prominences."
* Intraoperative "Positioning Information" reflected the patient was "Positioned by" an RN, PA-C, and 2 physicians. The documentation reflected " ... Head: Aligned ... Headrest Foam Prone."
* RN PACU "Flowsheets" notes dated 10/12/2020 at 1449 reflected "[Anesthesiologist] ... Phone call ... Review case pt has bruise/abrasion to nose, not present in preop ... Response ... unsure cause, face on pillow during surgery, will call pt."
* Physician notes dated 10/13/2020 1240 reflected "I called patient on 10/13/20 ... regarding discoloration and redness of [his/her] nose which was noticed in the recovery area. [He/she] states that the discoloration has improved ... "

The documentation lacked a clear, complete and thorough investigation and follow up actions in accordance with the hospital's plan of correction and P&Ps. For example:
* The documentation reflected the patient's spouse noticed the injury after the surgical procedure when the patient was in the SSU. However, there was no documentation that reflected how long the patient had been in SSU prior to when the injury was noticed. There was no documentation of interviews or other follow up with SSU staff to determine if SSU staff identified the injury prior to when the spouse noticed it, and if SSU staff were aware of contributing factors, or potential causes of the injury.
* There was no further investigation related to the "clear table insert, " including if it should have been used during the procedure.
* It was unclear why the documentation reflected there was no harm and no detectable harm, when it also reflected the patient had a "abrasion/bruise."
* There was no investigation that reflected the incident/event was evaluated for compliance with hospital P&Ps. For example, P&Ps related to appropriate transfer and positioning onto the OR table and throughout the procedure, and appropriate positioning devices.
* There was no evaluation or identification of potential deviations from generally accepted performance standards, and completion of follow up when deviations occurred, in accordance with the hospital's plan of correction.
* There was no further investigation regarding the follow up notes that reflected "My suspicion is that the foam pillow, while not pressing on [his/her] eyes, had encroached medially and put some pressure on [his/her] nose." For example, there was no investigation that reflected if anything unusual occurred during the process of staff positioning the patient on the pillow, during the time the patient was positioned on the pillow, or other potential causes during the surgical procedure.

During an interview and review of the investigation with the DSS on 11/19/2020 at 1415, the DSS stated the process for positioning the patient on the OR table and pillow involved 4-6 OR staff, and the "final" positioning on the pillow was done by the anesthesiologist. Although the investigation included a follow up note written by the anesthesiologist, the investigation included no interviews with any of the other individuals involved in this activity in the OR in effort to determine the cause or potential cause of the patient's injury.

Due to the failure to conduct a complete and thorough investigation and follow up actions in accordance with the hospital's plan of correction and P&Ps, there was no assurance similar incidents/events involving other patients would not occur.

3. Regarding Patient 20: An Event form and investigation reflected that on 10/14/2020 the patient's blood pressure and heart rate dropped and at 1640 " ... code was officially called and compressions were started. Code button did not work ... charge RN, overhead pages (sic) all RN's (sic) and anesthesiologists to report to OR ... able to get a [blood pressure] reading and pick up a pulse ... [physicians] closed as quickly as possible after aborting procedure. Patient started deteriorating again and 2 min of chest compressions given ... patient transferred to NCCU." The form was categorized as an "Intra-Operative Issue." The "Harm Level" reflected "Moderate Harm ... Temporary Harm/Required Initial or Prolonged Hospitalization."
The "Follow Up Notes" and "Actions Taken" notes dated 10/26/2020 at 0800, 12 days later, reflected "[Manager] followed up with staff in the room. Code blue debrief completed by [ANM]. Appropriate actions taken" and "Reviewed code blue event in safety huddles, have reviewed in our leadership meeting and will reviewing (sic) again at our upcoming charge nurse meeting. Reached out to [name] about overhead paging delay for internal to department versus hospital wide pages. No change to current system needed. All code buttons tested and working. No additional follow up needed ... Intubation, code ... transfer to NCCU." There was no further investigation or follow up actions.

The documentation lacked a clear, thorough and timely investigation and follow up actions in accordance with the hospital's plan of correction and P&Ps. For example:
* There was no documentation that reflected if there was or was not a delay in staff response to the code blue as a result of the incident/event.
* The documentation reflected the patient's "Harm Level" was moderate, but the investigation did not include whether the "code button" not working contributed to the harm.
* Although the documentation reflected "All code buttons were tested and working," this was not documented until 12 days after the incident/event. There was no documentation that reflected when the code buttons were tested and working.

Due to the failure to conduct a thorough investigation and follow up actions in accordance with the hospital's plan of correction and P&Ps, there was no assurance similar incidents/events involving other patients would not occur.

4. Regarding Patient 27: An Event form and investigation regarding the patient reflected that on 10/18/2020 at 1530 "noted skin tear not documented prior."
* The "Skin Integrity Details" section reflected "When did the skin injury or condition occur? More than 24 hours after admission. Where is the skin injury on the patient? Arm (Right)."
* The "Event Subcategory" section reflected "Total Flap Loss."
* The "Harm Level" was followed by " ... No Detectable Harm ... Severity ... No Harm/Monitoring Required."
* The "Length and Width of Injury" section was blank.
* The "Skin Integrity Event Contributing Factors" section reflected "Select all applicable contributing factors" followed by "Unable to Determine."
* The "Names of other people present or involved:" section was blank.
* The "Was there a deviation from generally accepted performance standards (GAPS)?" section was blank.
* The "Follow Up Notes" reflected "No further intervention needed."
* The "Actions Taken" section reflected "[Lines Drains Airways] opened and documented current condition and interventions."
There was no further investigation or follow up actions.

The investigation and follow up actions were incomplete and were not thorough in accordance with the hospital's plan of correction and P&Ps. For example:
* There was no further description of the skin alteration including size, drainage, swelling, erythema, bruising, signs/symptoms of infection and pain.
* The investigation reflected "No Harm" and "No Detectable Harm." However, it was unclear how it was determined there was no harm or detectable harm when the documentation reflected the patient had a "Total Flap Loss" skin tear.
* There was no documentation of treatment provided.
* There was no investigation of the contributing factors, cause or potential causes of the skin injury.
* There was no investigation that reflected the incident/event was evaluated for compliance with applicable hospital P&Ps. For example, P&Ps that addressed RN assessments, skin assessments, and skin treatments.
* There was no evaluation or identification of potential deviations from generally accepted performance standards, and completion of follow up when deviations occurred.
* There was no investigation that reflected abuse and neglect were ruled out.

The medical record for the 84-year old patient reflected he/she presented to the ED on 10/16/2020 with significant dementia, increased confusion, and increased falling.
* ED RN notes dated 10/16/2020 at 2256 reflected "Issues needing assessment? Yes - skin tear to right upper arm." There was no assessment of the skin alteration, including but not limited to no length, width, depth, color, drainage, and signs/symptoms of infection; and no documentation of treatment provided.
* The next documentation of a skin alteration to the patient's right upper arm was recorded 2 days later in RN notes dated 10/18/2020 at 1548 and those reflected "Skin Tear Right upper arm skin tear ... Present on Hospital Admission: No ... ecchymotic ... Wound Length 7 cm ... Wound Width ... 1 cm ... "

During an interview and review of the investigation with the COT on 11/19/2020 at 1450, the COT provided the following information:
* The COT stated he/she reviewed the patient's medical record and identified that the patient had the skin tear on 10/16/2020, while he/she was in the ED.
* The COT stated the patient transferred to the cardiology unit on 10/17/2020 at 0121. The COT stated a "head to toe" assessment was normally done when a patient was admitted to the cardiology unit. However, the COT stated there was no documentation in the medical record that reflected cardiology unit staff identified and assessed the skin tear until 10/18/2020 at 1530, more than 38 hours after the patient was admitted to that unit. Refer to the P&P above that reflects " ... all patients ... transferred between units will have two RN's (sic), or a RN and CNA verify all skin care issues are documented ... It is expected that a completed head-to-toe skin assessment will be in place within four hours."
* The COT acknowledged there was no information in the investigation related to the cause or potential cause of the skin alteration.
* The COT provided no further investigation or follow up actions related to the incident/event.

5. Regarding Patient 30: An Event form and investigation reflected that on 10/20/2020 at 0900 the patient was undergoing a surgical procedure when the " ... vertex stealth arm moved from set position during draping. Because of the movement, the stealth mapping was lost, and patient had to be re-mapped, re-prepped and re-draped. The process took about 10 min of increased anesthesia time."
* The event was categorized as "Device Malfunction."
* The "Equipment Details" section reflected "Did equipment fail? No."
* The "Names of other people present or involved:" section was followed by a list of 6 individuals including 2 surgeons, an anesthesiologist, a ST, an RN and a VET.
* The "Follow Up Notes" dated 10/20/2020 at 1254 reflected "No patient injury, slight delay in case. Working with [VETS] to track unsterile arms for trends. This is the first event like this that I am aware of. Will continue to monitor."
* The "Was there a deviation from generally accepted performance standards (GAPS)?" section was blank.
* The "Actions Taken" notes dated 10/20/2020 at 1254 reflected "Actions taken and/or recommendations for prevention ... " followed by " ... Tagged Vertex arm #3 to be evaluated by Medtronic and repair if needed. Will keep it out of service unevaluated. The vertex stealth arm was repositioned and tightened before re-mapping. The Video Equipment Technician (VET) in the room will tag the piece and check for malfunction. The VETS will also work on labeling all the vertex arms, so they can be traced for malfunction in the future."
There was no further investigation or follow up actions.

The documentation lacked a thorough investigation and follow up actions. For example:
* There was no investigation related to why the stealth arm equipment moved from the set position, including whether it had been positioned and tightened appropriately as designed in accordance with manufacturer's instructions or P&Ps as applicable, prior to when it moved. Although the report reflected 6 individuals were present or involved in the event, there was no documentation of interviews with any of those individuals in effort to determine the cause of the event, that resulted in 10 minutes of increased anesthesia time for the patient.
* There was no identification of potential deviations from generally accepted performance standards, and completion of follow up when deviations occurred.
* The investigation was unclear where it reflected both "Device Malfunction" and "Did equipment fail? No." It was unclear if the equipment/device malfunctioned or failed, or did not malfunction or fail.
* There was no conclusion to the investigation, including the outcome of the "check for malfunction" and evaluation by "Medtronic and repair if needed."

During an interview and review of the investigation with the DSS on 11/19/2020 at 1410, the DSS stated the stealth arm equipment was involved in 3D imaging processes in the OR. The DSS stated the process of using the stealth arm equipment included "tightening down multiple elbow points to keep [the equipment] from moving." The DSS stated the surgeon "usually tightens down the arm ... nothing can move or it will disrupt the mapping." The DSS stated "I don't know if the person who did the investigation talked to the surgeon." The DSS confirmed the equipment moved and as a result of it moving, the patient had to be re-prepped and re-draped, and therefore required additional time under anesthesia. The DSS provided no further information related to the lack of thorough investigation.

Due to the failure to conduct a thorough investigation and follow up actions, there was no assurance similar incidents/events involving other patients would not occur.

6. Regarding Patient 36: An Event form and investigation reflected that on 10/28/2020 at 1655 the patient was undergoing a surgical procedure and the "ventilator on the [anesthesia] machine ... failed in the middle of the cardiac case ... A portable ventilator had to be used from respiratory therapy. The team called biomed at 1630, and they do not staff a person trained to work on ventilators at this time in the evening. The biomed call person that is responsible for issues past their working hours is also not trained to fix ventilators. Patient did not receive anesthetic gas during the failure, and [physician] had to switch to giving Propofol through the IV."
* "Equipment Sequestered? Yes"
* "Harm Level ... Unknown."
* The "Names of other people present or involved:" section was blank.
* The "Follow Up Notes" dated 10/29/2020 at 1323 reflected "Follow up done with Biomed. Patient tolerated interruption well per anesthesia record. Vital signs remained stable."
* The "Was there a deviation from generally accepted performance standards (GAPS)?" section was blank.
* The "Actions Taken" notes dated 10/29/2020 at 1323 reflected "Machine removed form (sic) service. Request to have the vendor do a deep dive on the machine. Replaced with a new machine Thursday 10/29."
* The "Actions Taken" notes dated 11/03/2020 at 1512 reflected " ... Field Engineer from ... [manufacturer] ...unable to isolate cause of vent stoppage. [He/she] downloaded all error logs and supporting folders for machine, and is opening a Customer Support complaint, which will escalate the ticket to a dedicated services team at [manufacturer]. This machine will remain out of service in Biomed awaiting satisfactory resolution. It has been permanently replaced ... by another anesthesia machine."

The medical record reflected the patient underwent a cardiac surgery on 10/28/2020, general anesthesia was started at 1252, and at 1631 the ventilator failed and the patient was manually "bag" ventilated "until RT arrived with portable ventilator. Biomed called but nobody in house that can work on machine ... "

The documentation lacked a thorough and complete investigation. For example:
* There was no interview with the anesthesiologist or other individuals who were present at the time of the event related to the ventilator failure, including but not limited to if the ventilator was functioning appropriately leading up to when it failed, or other potential contributing factors that may have caused the failure.
* There was no investigation related to the lack of availability of appropriately trained biomed staff.
* There was no investigation that reflected the incident/event was evaluated for compliance with applicable hospital P&Ps.
* There was no identification of potential deviations from generally accepted performance standards, and completion of follow up when deviations occurred.
* The documentation reflected the manufacturer's field engineer was " ... unable to isolate cause of vent stoppage ... downloaded all error logs and supporting folders for machine." However, there was no investigation that reflected if the anesthesia machine had been appropriately maintained prior to the event in accordance with the manufacturer's recommendations or instructions for use. There was no further investigation or follow up actions.

During an interview and review of the investigation with the COSC on 11/19/2020 at 1400, the COSC confirmed the ventilator stopped working during the patient's surgical procedure. The COSC confirmed the lack of investigation regarding whether or not the ventilator had undergone appropriate maintenance prior to the event. The COSC stated "If it's not listed here, I'd have to ask biomed."

Due to the failure to conduct a thorough investigation and follow up actions, there was no assurance similar incidents/events involving other patients would not occur.

7. Refer to the findings identified under Tag A144, CFR 482.13(c)(2) - Standard: Patient Rights: Care in a Safe Setting. Those findings reflect:
* The hospital's failure to ensure complete, thorough and clear investigations of incidents/events involving Patients 23, 25, 28, 31, and 34.
* The hospital's Plan of Correction submitted in response to the survey conducted on 09/10/2019 reflected "To ensure patients are provided care in a safe setting and the hospital conducts clear, thorough and timely investigations of incidents/events including those with potential and actual harm ... and to ensure timely follow up and actions to ensure similar events do not recur, nurse leaders attended a mandatory educational session ... "

Based on interview, medical record and incident/event documentation for 4 of 4 patients reviewed for provision of nursing services (Patients 23, 25, 27 and 34), and review of policies and procedures, it was determined that the hospital failed to ensure the RN supervised and evaluated patients to ensure the provision of safe and appropriate care in accordance with hospital policies and procedures including:
* Patient 23, who had impaired dexterity and episodes of confusion, was not appropriately supervised and evaluated. Staff gave the patient hot coffee, and the patient spilled the coffee and sustained burns and blisters.
* Processes to prevent surgical instrument count discrepancies and ensure instruments were counted correctly, were ineffective or were not carried out during a surgical procedure involving Patient 25.
* Skin alterations were not assessed for Patient 27.
* Processes to monitor, evaluate, and intervene were ineffective for Patient 34, as the patient who was at risk for suicide, experiencing increased behaviors, and required "constant" observation, eloped from the hospital; and BARS evaluation and LWBS processes were not carried out.

Findings include:

1. Refer to the findings identified under Tag A144, CFR 482.13(c)(2) - Standard: Patient Rights: Care in a Safe Setting. Those findings reflect the hospital's failure to ensure the RN appropriately supervised and evaluated Patients 23, 25 and 34.

2. Refer to the findings identified under Tag A145 CFR 482.13(c)(3) - Standard: Patient Rights: Abuse/Harassment. Those findings reflect the hospital's failure to ensure the RN appropriately evaluated Patient 27.