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Based on interview and record review, the hospital failed to have an effective governing body that is legally responsible for the conduct of the hospital when:

1. Quality improvement activities to assess the quality of patient care provided to all Intensive Care Unit (ICU) patients by contracted eICU (remote monitoring of all ICU patients via camera) physicians in collaboration with the Hospital ICU medical director were not implemented in accordance with terms of the eICU contract. (refer to A084, finding 1)

2. eICU policies which outlined responsibility for patient care and communication pathways between eICU staff and Hospital ICU staff were not incorporated into the Hospital ICU policies. (refer to A084, finding 2)

3. The appraisal of medical staff members did not follow Medical Staff Bylaws and policies for five of six physicians (MD 1, MD 2, MD 3, MD 4. and MD 5). (refer to A049)

The cumulative effect of these systemic problems resulted in the hospital's inability to provide care in a safe and quality manner.

Based on interview and record review, the hospital's governing body failed to ensure the quality of care provided to patients by medical staff when the appraisal of medical staff members did not follow Medical Staff Bylaws and policies for five of six physicians (MD 1, MD 2, MD 3, MD 4. and MD 5).

These failures had the potential for privileges for patient care to be granted to physicians without demonstrated competence and placed patients at risk of not receiving quality of care.

Findings:

During a concurrent interview and record review on 3/8/24 at 2:15 p.m. with Medical Staff Coordinator (MSC) and the Director of Quality and Patient Safety (DQ), MD 1's credential file was reviewed. The MSC stated she is the one responsible for coordinating the credentialing, appointment and reappointment process, and the DQ is her supervisor. Review of MD 1's file indicated MD 1 was a hospitalist (a doctor who works in a hospital providing general medical care to hospitalized patients) and was not board certified. The file indicated MD 1 was last reappointed to the active medical staff on 1/1/24. The MSC stated MD 1 was also the medical director for the intensive care unit [ICU]. A review of the Internal Medicine Services Privilege Request Form, dated 8/31/23, indicated MD 1 requested and was granted privileges [specific services and procedures a healthcare provider is deemed qualified to provide or perform] for General Internal Medicine Core Privileges which consisted of a paragraph describing the core privileges as, "...Admission, work-up, diagnosis and provision of non-surgical inpatient and outpatient treatment including consultation for patients admitted or in need of care to treat general medical problems including EKG interpretation, thoracentesis, paracentesis, and lumbar puncture. Internist may provide comprehensive management of patients in critical care units, including, but not limited to ventilator management greater than 48 hours..." The privilege request form also had a list "Special Procedures," for the physician to request and be granted individually. The list included procedures such as colonoscopy, arthrocentesis, echocardiograph, cardioversion, bone marrow aspiration, arterial line placement, central line placement, and others. The criteria for any of these special procedures were, "Successful completion of an approved recognized course when such exists, or acceptable supervised training in residency, fellowship, or other acceptable experience, and documentation of competence to obtain and retain clinical privileges as set forth in medical staff policies governing the exercise of specific privileges." The request form indicated MD 1 had requested and been granted the privilege for the special procedure arthrocentesis (a procedure in which a sterile needle and syringe are used to drain fluid from a joint). The MSC stated the medicine privilege request form had been changed at the end of 2022, when the ICU Internal Medicine Core Privileges were combined with the General Internal Medicine Core Privileges. The MSC stated this was done because the qualifications for the ICU Internal Medicine Core Privileges were difficult to achieve. The MSC stated both versions of the privilege form are in use at this time, and are updated at the time of reappointment. Review of the earlier version of the internal medicine privilege request form prior to the revision indicated the "General Internal Medicine Core Privilege" bundle did not include ventilator management or management of patients in the critical care unit (ICU). The form indicated "ICU Internal Medicine Core Privileges" defined as, "In addition to core privileges in general internal medicine, comprehensive management of patients in critical care units, including but not limited to the use of such procedures as arterial line placement, arterial puncture, and ventilator management greater than 48 hours." The qualifications for ICU Internal Medicine Core Privileges were, "Current certification or active participation in the examination process leading to certification in critical care internal medicine by the American Board of Internal Medicine or demonstrated competency in critical care internal medicine." The MSC stated the current medicine request form does not delineate Critical Care/ICU privileges separate from general internal medicine privileges. The MSC stated on the current form, the privileges described in the paragraph indicating the core privilege group are requested and granted as one privilege. The privilege request form did not include check boxes next to anything in the core privilege group or provide direction or instructions on the ability to opt-out of a particular procedure within the core privilege group. On the last page of the form there was a place for the physician reviewing the privilege request form and recommending the privileges to include a condition or modification relative to the privilege and required that the specific condition or modification and the reason for it be documented on the form. MD 1's privilege request form indicated the department chairman signed the form approving the requested privileges on 11/13/23 and no conditions, modifications, or comments were made.

During a review of the minutes from the Bylaws/Credentials/Interdisciplinary Committee meeting held on 11/14/22, the minutes indicated, "...Delineation of Privileges- Internal Medicine Revised: The internal medicine privilege form was revised to reflect current practice. ICU privileges were moved to core privileges."

The MSC stated in preparation for reappointment, information is gathered regarding a physician's practice during the preceding two year period. The MSC stated there are no specific volume requirements (number of patients treated or managed and/or the number and type of procedure performed by the physician during the reappointment period) for the core medicine privileges or the arthrocentesis. The privilege form indicated, "...Reappointment Requirements, General Internal Medicine: Current demonstrated competence and an adequate volume of current experience with acceptable results in the privilege requested for the past 24 months as a result of quality assessment /improvement activities and outcomes..." The MSC could not define "adequate volume." The MSC stated they do not collect volume data to be used to evaluate the physician's performance of procedures in the "core" privilege bundle such as EKG interpretation, ventilator management, thoracentesis, paracentesis, or lumbar puncture, or for arthrocentesis, a specialty procedure. The "quality assessment/improvement activities and outcomes" information which was considered when MD 1 was reappointed was requested and the MSC provided the document reflecting the Ongoing Professional Practice/Performance Evaluation (OPPE) "Scorecard: Medicine" which consisted of 24 months of OPPE data divided into six-month periods. The MSC stated the scorecard is the same for all physicians with medicine privileges. The document indicated under the heading "Performance Details" a list of data being collected and how that physician compared to his peers. Information regarding cases reviewed by Peer Review and any negative findings associated with that review was tracked and the document indicated MD 1 had "No Occurrences," meaning no cases reviewed. Information regarding incidences of "Transfusions not meeting criteria," was reported, and indicated MD 1 had "No Occurrences." The MSC stated she did not know how many, if any, transfusions were ordered by MD 1. "Acute mortality observed [patient deaths]/expected [considers risk factors, likelihood of death]," and MD 1 had "No Occurrences" and the document indicated his peers had no occurrences as well. The MSC did not know whether this data meant no deaths occurred or whether a target observed/expected (O/E) value had to be exceeded before data was reported for this metric. There was no data on the scorecard specific to the privileges within the General Internal Medicine core privilege bundle, including ventilator management, paracentesis, thoracentesis, lumbar puncture, or comprehensive management of patients in the critical care unit.

During a concurrent interview and record review on 3/8/24 at 3:05 p.m. with Medical Staff Coordinator (MSC) and the Director of Quality and Patient Safety (DQ), MD 2's credential file was reviewed. The file indicated MD 2 was initially appointed to the medical staff on 9/5/19 with Pulmonary Disease (conditions that affect the lungs and other parts of the respiratory system) Core Privileges. The MSC stated MD 2 recently became the medical director of respiratory care services at the hospital. The MSC stated MD 2 was granted two extensions to his provisional status due to failure to complete proctoring and low volume. A letter to MD 2 from the administrator of Hospital A on 5/12/21 was reviewed and indicated MD 2 was granted the final extension to complete proctoring, and advised that failure to complete proctoring by 8/31/21 would result in voluntary relinquishment of membership and privileges. Review of the six proctoring reports in MD 2's file indicated the dates of the patient care being evaluated were 1/3/20, 2/19/20, 2/26/20, 8/5/20, 9/2/20 (two patients). All of the proctored cases were for pulmonary medicine consultations, and all cases were reviewed on 5/19/21 by MD 1. The MSC was unable to state how MD 1 who had internal medicine core privileges but no privileges in pulmonary disease was determined to be a qualified proctor for MD 2. Review of the proctoring reports indicated at the top of the report, "...Proctoring shall mean the direct observation of the proctored practitioner's diagnosis or treatment of an individual patient by a qualified member of the Medical Staff. Observation shall include a chart review and proctoring performed on no less than six (ICU-no less than three) medical cases by staff members who serve as observers. Observation may also include review of observation reports obtained from other hospitals..." The MSC acknowledged that since the cases were reviewed on 5/19/21 but occurred in 2020, they were not directly observed by MD 1.

Review of MD 2's file indicated on 6/15/21 an activity report listing all patient care occurrences for the period of 6/1/19 through 5/31/21 was generated and indicated all patient care activity was in the outpatient setting. The report consisted of a list of diagnoses but no dates of service or medical record numbers. The report reflected diagnoses such as "cirrhosis of liver," "nicotine dependence," and "other specified health status," in addition to diagnoses of pulmonary conditions and did not indicate which of the diagnoses were for the same patient, or the nature of the outpatient appointment. The MSC did not have any information regarding how many patients were seen during this two year period. Review of documents sent from another hospital (Hospital B) on 7/7/21 indicated MD 2 was an active member of the medical staff at Hospital B with primary privileges in pulmonary medicine and critical care and had completed proctoring at Hospital B in 2017. The documents included an activity report from Hospital B for the period of 7/1/19-6/30/21 showing sufficient patient care volume. Review of the minutes from the Bylaws/Credentials/Interdisciplinary Committee meeting held on 8/9/21, indicated MD 2's reinstatement to the Medical Staff, application for new privileges (withdrawal of General Internal Medicine core privileges and ICU medicine core privileges, withdrawal of special procedure privileges, and the addition of Pulmonary Disease Consultative Privileges), completion of proctoring for those consultative privileges requested, completion of the provisional year and status change from Provisional to Consulting. The meeting minutes for 8/9/21 also indicated revision of the Internal Medicine Privilege Form, "...The privilege form was revised to include consultative Pulmonary Disease privileges to accommodate [MD 2]'s practice at the rural health clinic as well as give him the ability to consult on med-surg and the ICU..."

Review of MD 2's file indicated he was last reappointed on 9/1/23. Review of MD 2's privilege request form dated 5/3/23, indicated MD 2 requested Pulmonary Disease Consultative Privileges which consisted of, "Evaluate, diagnose, treat, and provide consultation to patients of all ages presenting with conditions, disorders, and diseases of lungs and airways. May provide consultation to patients in the intensive care setting or provide care in the outpatient health clinic (non-procedural) in conformance with unit policies. Assess, stabilize, and determine the disposition of patients with emergent conditions consistent with medical staff policy regarding emergency and consultative call services." Information used in consideration of MD 2's reappointment was requested and the MSC provided the document, "Scorecard: Medicine" which consisted of 24 months of data divided into six-month periods. The MSC stated this report is run every six months. The document indicated under the heading "Performance Details" a list of data being collected and how that physician compared to his peers. Information regarding cases reviewed by Peer Review and any negative findings associated with that review was tracked and the document indicated MD 2 had "No Occurrences," meaning no cases reviewed. Information regarding incidences of "Transfusions not meeting criteria," was reported, and indicated MD 2 had "No Occurrences." The MSC stated she did not know how many, if any, transfusions were ordered by MD 2. "Acute mortality observed [patient deaths]/expected [considers risk factors, likelihood of death]," and MD 2 had "No Occurrences" and the document indicated his peers had no occurrences as well. The MSC did not know whether this data meant no deaths occurred or whether a target observed/expected (O/E) value had to be exceeded before data was reported for this metric. There was no data on the scorecard specific to the Pulmonary Disease Consultative Privileges held by MD 2, and no information which could be used as part of the evaluation of MD 2's performance. The MSC provided the activity report for the two year period between reappointments which consisted of a list of four diagnoses, one instance of each, two of which were not primary diagnoses indicating this list represented less than four patient encounters for the two year period. There was no information regarding the dates of the consults. The MSC did not have any additional information regarding the report. MD 2's privilege request form indicated the reappointment requirements for Pulmonary Medicine were, "Inpatient or consultative services for at least 100 patients, reflective of the scope of privileges requested, during the past 12 months." The last page of the form was completed by the medicine service chairperson who could approve all requested privileges, recommend privileges with specific conditions or modification, or not recommend specific privileges. There was a statement which indicated, "I have reviewed the requested clinical privileges and supporting documentation for the above-named applicant and make the following recommendations: Recommend all requested privileges." The form was signed by the chairperson of medicine on 7/7/23.

During an interview on 3/11/24 at 2:20 p.m. with the MSC, the MSC was asked what process was followed when the physician's volume is very low for the two year period between reappointments and does not meet the reappointment criteria. As occurred with MD 2, the MSC stated normally she would have flagged this file to bring it to the attention of the Medicine Service Chairperson who could request more information or recommend the privileges with specified conditions or modifications, or recommend the privileges are granted as requested. The chairperson is supposed to make a note about an exception to the volume requirement and their recommendations for consideration by the credentials committee and MEC. The MSC stated in this case she failed to flag the file or to discuss it with the medicine chairperson.

During a concurrent interview and record review on 3/11/24 at 2:45 p.m. with the MSC, MD 3's credential file was reviewed. The file indicated MD 3 was privileged in Family Medicine and was working as a hospitalist . The file indicated MD 3 had worked at other hospitals as a hospitalist and was board certified in Family Medicine. The file indicated MD 3 was appointed as a Provisional medical staff member on 1/5/23. Review of MD 3's Family Medicine Privilege Request Form indicated MD 3 had completed the request for privileges on 9/18/22, and indicated he requested "Adult Core Privileges," which included, "Inpatient and Outpatient management of patients over the age of 18 without life-threatening complications, including surgical first assisting." The Observation/Proctoring Requirements were "chart review and proctoring performed on no less than six (ICU-no less than three) medical cases." The request form indicated MD 3 had also requested the special procedures "Management of Intensive/Critical Care Unit patients without consult less than 48 hours," and "Ventilator Management less than 48 hours," and that the proctoring requirements for those special privileges/procedures was five cases (for each privilege/procedure). The last page of the form indicated the medicine service chairman recommended all requested privileges. The MSC stated MD 3 had not completed proctoring and his file did not have evidence that any cases had been proctored yet, even though MD 3 had been on staff for 14 months. The MSC stated she did not have information regarding MD 3's patient volume during this time and an OPPE scorecard had not yet been generated for MD 3. Both reports were requested.

During a record review on 3/11/24 at 4:30 p.m. MD 3's activity report for the period of 1/5/23 through 3/11/24 indicated during this time period, MD 3 was the admitting physician for 45 inpatients, attending physician for 33 inpatients (some patients are on both lists), and was listed as the performing provider on four patients for seven procedures, "Introduction of Vasopressor into Peripheral Vein, Percutaneous Approach; Introduction of Vasopressor into Central Vein, Percutaneous Approach; Transfusion of Red Blood Cells into Peripheral Vein, Percutaneous Approach [two occasions]; Assistance with Respiratory Ventilation, Less Than 24 Consecutive Hours, Continuous Positive Airway Pressure; Assistance with Respiratory Ventilation, 24-96 Consecutive Hours, Continuous Positive Airway Pressure; and Assistance with Respiratory Ventilation, Less Than 24 Consecutive Hours, High Nasal Flow/Velocity." The OPPE scorecard for MD 3 was not generated until 12:36 p.m. on 3/14/24 and provided on 3/14/24 at 9:05 p.m., after the survey exit. Review of the OPPE scorecard indicated the same things were being reported as were for MD 1 and MD 2, and the report did not include data specific to the privileges granted to MD 3.

During a concurrent interview and record review on 3/11/24 at 3 p.m. with the MSC, MD 4's credential file was reviewed. The file indicated MD 4 was an Obstetrician/Gynecologist whose most recent reappointment to the Active Medical Staff was 9/1/22. Review of MD 4's privilege request form indicated on 4/18/22 MD 4 requested Obstetrics Core Privileges which included cesarean sections, resuscitation of newborn, amniocentesis, and all other procedures related to normal and complicated delivery; and Gynecology Core Privileges, and Special Procedures: Hysteroscopy, diagnostic/operative; Hysteroscopic polypectomy and/or myomectomy, Hysteroscopy with thermal ablation; Cystocele/rectocele repair; Vaginal Hysterectomy; Total Abdominal Hysterectomy; Endometrial Ablation. The privilege request form indicated the reappointment criteria were, "Current demonstrated competence and an adequate volume of current experience with acceptable results in the privileges requested for the past 24 months as a result of quality assessment/improvement activities and outcomes." The MSC stated there are no volume requirements for reappointment for the core privileges or for the special procedure privileges. The OPPE scorecard-OB/GYN for MD 3 included 24 months of cumulative data, separated into six month time periods. There were OB/GYN specific indicators being monitored for all physicians in the OB/GYN group. The report indicated either a zero or "no occurrences" for the most recent six month period as well as the cumulative 24 month period for most of the indicators including Birth Trauma, Neonatal Birth Injury, and OB complications, post operative hemorrhage, and total number of Peer Review cases reviewed, and the report indicated all of MD 4's peers (OB/GYN physicians) had the same data. The MSC and DQ were asked if data is being collected for these indicators since it is unlikely there would be zero or no occurrences for all of them for a two year period. The DQ stated she would provide a list of the indicators which have data reported.

During a record review on 3/12/24 at 3:25 p.m., the list provided by the DQ of the OPPE indicators for which data is being reported for physicians was reviewed. The indicator list did not include Neonatal Birth Injury, OB Complications, and Birth Trauma. There was no explanation provided as to why those indicators are on the OPPE report cards for the OB/GYN physicians and reported as no occurrences or zero instances when no data was being collected.

During a concurrent interview and record review on 3/12/24 at 3:30 p.m. with the MSC, MD 5's credential file was reviewed. The file indicated MD 5 was an orthopedic surgeon who was initially appointed to the medical staff on 3/5/20, and who was last reappointed to the Active Medical Staff on 3/1/24. A review of the privilege request form for orthopedic surgery indicated the Observation/Proctoring requirements were "Appraisal shall be based on observation, which shall include proctoring, of at least six cases, at least three of which must be major cases, unless otherwise specified." The six forms "Surgery Service-Proctoring Report" were reviewed. The top of the form included the information regarding the number of cases required to be proctored and the instruction to the proctor completing the report, "A prompt written report shall be submitted to the Service Chief by the observer, not more than two weeks following the procedure performed. It is the responsibility of the surgeon to obtain a qualified observer before the procedure is scheduled." Review of the six forms indicated all of the forms had been signed by the proctor on 2/17/21. The first proctored case was performed on 7/2/20 and listed two names as proctors. The section of the form with the proctor's assessment of the physician's Pre-operative evaluation was left blank, as was the section of the form where the proctor's assessment of the post operative care provided. The MSC stated the form should have been filled out completely. In the section for the proctor to indicate the "Dates patient chart has been reviewed and comments," has two dates 7/2/20 and 2/17/21. The form is signed and dated 2/17/21. The signature is illegible and the MSC was unable to determine which of the two physicians listed as proctors signed the forms. The MSC stated it was important to know who the proctor was and stated the form needed a place for the physician to print his name. There was no indication on the proctoring report form whether this case was directly observed in the operating room during the procedure. There was no place on the form indicating whether the proctoring was done retrospectively or concurrently. The MSC stated they do not require that information.

Review of the second proctoring review form indicated the case was performed on 7/8/20. There was one physician listed as the proctor. The section of the form with the proctor's assessment of the physician's Pre-operative evaluation was left blank. There were two dates of review written on the form, 7/28/20 and 2/17/21. Since the procedure was on 7/8/20, this case likely was not concurrently proctored.

Review of the third proctoring review form indicated the case was performed on 10/5/20 and two names were listed as proctors. The form was complete, and the dates of review were 10/5/20 and 2/17/21, and the form was signed on 2/17/21. The signature was illegible. There is no indication on the form as to whether the case was directly observed by the proctor.

Review of the fourth proctoring review form indicated the case was performed on 10/30/20 and one name was listed as proctor. The form was complete except the post operative diagnosis was left blank. The dates of review were listed as 10/28/20 and 2/17/21, and the form was signed on 2/17/21. The signature was illegible. There is no indication on the form as to whether the case was directly observed by the proctor. The MSC stated it is not clear why the review would be two days before the date of the procedure and nothing on the day of the procedure.

Review of the fifth proctoring review form indicated the case was performed on 11/2/20 and one name was listed as proctor. The section of the form with the proctor's assessment of the physician's Pre-operative evaluation was left blank. The dates of review were 11/2/20 and 2/17/21, and the form was signed on 2/17/21. The signature is illegible. There is no indication on the form as to whether the case was directly observed by the proctor.

Review of the sixth proctoring review form indicated the case was performed on 12/28/20 and two names were listed as proctors. The form was complete, and the dates of review were 12/28/20 and 2/17/21, and the form was signed on 2/17/21. The signature was illegible. There is no indication on the form as to whether the case was directly observed by the proctor.

During a review of the hospital's policy and procedure (P&P) titled, "Medical Staff Peer Review," dated 5/18/21, the P&P indicated, "...PURPOSE: To ensure that the hospital, through the activities of its Medical Staff, assesses the Ongoing Professional Practice Evaluation [OPPE] of individuals granted clinical privileges and uses the results of such assessment to improve care...Peer Review: The evaluation and improvement of an individual practitioner's professional performance by other duly authorized practitioners for the core competencies... OPPE: The routine monitoring and evaluation of current competency for practitioners with granted privileges, primarily through the use of aggregate data and systematic case review...The Medical Staff will use the provider-specific peer review results in making its recommendations to the hospital regarding the credentialing and privileging process...Performance Measurement and OPPE/FPPE: Measures of practitioner performance will be selected to reflect the six core competencies using multiple sources of data..."

During a review of the hospital's document titled, "Medical Staff Bylaws," dated 4/1/21, the document indicated, "...The name of this organization shall be Medical Staff of [Hospital A]. The purpose of this organization shall be:...To strive to provide a high level of professional performance of all practitioners authorized to practice in the Hospital and through appropriate delineation of the clinical privileges that each practitioner may exercise in the Hospital and through an ongoing review and evaluation of each practitioner's performance in the Hospital...The Medical Staff's rights and responsibilities shall include:...To account to the Board of Directors for the quality and safety of patient care provided by all Members authorized to practice in the Hospital through the following measures: ... A credentials program, including mechanisms of appointment, reappointment and the matching of Clinical privileges to be exercised or specified services to be performed with the verified credentials and current demonstrated performance of the Medical Staff applicant or Member...The Medical Staff shall be divided into the following categories: Provisional, Active, Courtesy, Consulting and Telemedicine Staff...The Provisional Medical Staff: All initial appointments to the Medical Staff shall be to the Provisional category for a minimum period of one year, during which time the practitioner shall be subject to observation. The purpose of the observation is to enable the Medical Staff to determine eligibility for regular Staff membership and for exercising those clinical privileges provisionally granted. Such observation shall encompass those procedures customarily utilized for this purpose, including, but not limited to, concurrent and/or retrospective chart review, any required consultation, and direct proctoring. Proctoring as used in these Bylaws shall mean the direct observation of the proctored practitioner's diagnosis or treatment of an individual patient, by a qualified member of the Medical Staff in good standing. Ordinarily observation shall include a chart review and proctoring performed on no less than six (ICU-no less than three) medical cases by Staff members who serve as observers at the request of the Service Chief. Observation may also include review of observation reports obtained from other hospitals in the case of Provisional Staff members whose primary practices are at hospitals other than [Hospital A] ... In certain circumstances the Medical Executive Committee [MEC] may extend the provisional appointment for a period not to exceed one additional year..."

"Observation of Surgery and Anesthesia Privileges- In the case of surgery and anesthesia, appraisal shall be based on observation, which shall include proctoring, of at least six cases...such observation shall be done by a qualified observer, defined as an Active member in good standing of the Medical Staff who has the privilege to perform the procedure to be observed...Observations shall include an opinion of the pre-op and post-op care of the patient. A prompt written report shall be submitted to the Service Chief, by the observer, not more than two weeks following the procedure..."

"The Active Medical Staff: the member has principle place of practice (more than 20%) in [Name of City where Hospital A is located], has attended a minimum of 50% of department staff and assigned committees...The Courtesy Medical Staff: staff who are qualified for Staff membership but who only occasionally admit patients to the Hospital, or who are ineligible for Active Staff by reason of residence or office location, or the failure to meet attendance requirements... Courtesy Staff members must show evidence they are Active Staff members at an accredited acute care hospital...The Consulting Medical Staff: shall consists of specially qualified physicians for whom there is a need for patient consultations and for review of records that are referred from Medical Staff meetings. Must be an Active Staff member in good standing in an accredited hospital and must have privileges in the field he/she is reviewing..."
"In order for the Medical Executive Committee to make a recommendation to the Board of Directors concerning an applicant for appointment or reappointment to the Medical Staff, there must be adequate information for a comprehensive evaluation of the applicant's training, experience and background as measured against the unique professional standards of this Hospital."

"...Reappointment and Requests for Modification of Staff Status or Privileges...The reapplication form shall include all information necessary to update and evaluate qualifications of the applicant...The information requested may include, but not be limited to: Professional and clinical performance, including his/her patterns of practice, based at least in part on the findings of performance improvement measures, such as peer review, utilization management, infection control activities, medical record review, and pharmacy and therapeutics activities...The Medical Staff, in addition to criteria for Privileges shall develop areas of "general competencies" by which all Hospital Practitioners shall be measured for current proficiency. Each service shall define how to measure these general competencies as applicable to that Service and use them to regularly monitor and assess each Practitioner's current proficiencies on an ongoing basis..."

"...Basis for Privileges Determination: The Medical Staff shall make an objective and evidence based decision with regard to each request for privileges. Requests for privileges shall

Based on interview and record review, the governing body failed to ensure contracted services were provided in a safe and effective manner when:

1. Quality improvement activities to assess the quality of patient care provided to all Intensive Care Unit (ICU) patients by contracted eICU (remote monitoring of all ICU patients via camera) physicians in collaboration with the Hospital ICU medical director were not implemented in accordance with terms of the eICU contract.

These failures resulted the hospital's inability to assess whether the use of the eICU model was effective in contributing to improvement of patient care in the hospital's ICU.

2. eICU policies which outlined responsibility for patient care and communication pathways between eICU staff and Hospital ICU staff were not incorporated into the Hospital ICU policies.

This failure resulted in inconsistent understanding by hospital staff regarding the role of the eICU and had the potential to result in patient harm if the chain of command for patient care issues is not followed.


Findings:

1. During a review of the document titled, "eICU Physician Services Agreement," dated 12/1/21 and amended 11/1/23, the document indicated, "[Name of Healthcare System-(HS)] maintains an eICU Data Center from which critical care specialists are able to monitor patients who are being treated in the intensive care units of geographically dispersed Hospitals [Hospital ICU's] ... [Name of Physician Group] employs physicians specializing in critical care medicine who are qualified to monitor the Hospital ICU's from the eICU...Quality Improvement Efforts: The parties acknowledge that eICU services are intended to demonstrably improve patient care in the Hospital's ICUs. The parties will meet quarterly (or at such other times as mutually agreed by the parties) to collaborate with the clinical sites to improve quality improvement metrics such as those in HS's eICU Supported Performance Dashboard." The eICU Medical Director and other medical directors of the Hospital ICU's will work collaboratively to improve the quality of care provided to all ICU patients. The HS, after consultation with [Name of Physician Group], may from time to time update quality metrics to be tracked and discussed based upon issues at each facility..."

During an interview on 3/11/24 at 4:50 p.m. with the Director of Quality and Patient Safety (DQ), the DQ stated the hospital and eICU staff have not been participating in "Quality Improvement Efforts" as indicated in the eICU Physician Services Agreement. The DQ stated there have not been quarterly meeting scheduled or held and there is not an "eICU Supported Performance Dashboard," specific to their hospital. The DQ stated currently there are no Quality Assessment Performance Improvement (QAPI) activities being performed for the eICU service. The QAPI plan was requested. The DQ stated she can provide the 2023 plan, however she cannot provide the 2024 plan because it has not been approved yet.

During a review of the hospital's Policy and Procedure (P&P) titled, "[HS] 2023 Performance Improvement Plan and Patient Safety Program, " dated 5/30/23, the P&P indicated, "The purpose of the Performance Improvement [PI] Plan is to define, implement, and maintain HS's effective, on-going, data-driven quality assessment and performance improvement program to ensure that patient care processes, health outcomes, and medical errors, are measured, analyzed and improved. The PI plan reflects the complexity of the hospital's organization and services and it involves all hospital departments, care, treatment, and services (including those furnished under contract or arrangement...The Governing Body...authorizes and defines this PI plan and PS program, and they, in partnership with each hospital's Medical Staff and their delegated Committees, have the ultimate authority and responsibility for the quality and safety of patient care and service provided...Contracted services impacting patient care are subject to the same hospital wide, quality assessment and performance improvement [QAPI] evaluation as other services provided directly by the hospital..."

During a review of "Attachment A- Performance Improvement and Patient Safety Goals" of the "2023 Performance Improvement Plan and Patient Safety Program," dated 5/30/23, Attachment A indicated the Department Specific Patient Safety goal for the ICU was improvement of "Blood Transfusion Documentation," and for Respiratory Therapy the goal was improvement of "Baseline EKG done within 10 minutes for patients with chest pain."

2. During an interview on 3/11/24 at 4:55 p.m. with the Director of Quality and Patient Safety (DQ), the DQ stated she was able to find a policy for the eICU but that the policy had not been incorporated into Hospital A's policies and procedures and it should have been.

During a review of the document, "ICU/eICU Policies and Protocol's for Intensive Care Unit," dated 9/26/22, the document indicated it was approved by a System eICU Director, a Valley Area Hub Telemedicine Manager, a Bay Area Hub Medical Director and a Valley Area Hub Medical Director. There was no one from Hospital A who reviewed or approved the policies. Review of the document's Table of Contents indicated ICU/eICU policies included Reporting Structure (Chain of Command), eICU Level of Assistance, Communicating with Managing Physicians, Handling Clinical Disagreements, Family Interactions, Requiring a Physician at the Bedside, Admission Assessments, Writing Orders, Transferring Patients, Cardiac/Respiratory Arrest situation (Code), Patient Death and others.

During a review of the hospital's P&P titled "ICU Scope of Services," dated 11/4/21, the P&P indicated, "...The Critical Care Department is a four-bed Intensive Care Unit [ICU] which admits patients with a presently or potentially life- threatening medical or surgical conditions...Management of Acute MI patients with the use of Thrombolytic Therapy is an important service of the Critical Care Unit (CCU). Management of patients requiring mechanical ventilation and respiratory support as well as the management of patients requiring the need of temporary transvenous pacemaker or permanent pacemaker placement are significant to the practice of the critical care nursing staff. All patients admitted to ICU also benefit from the eICU monitoring..." There is no other hospital policy that addresses the eICU.

Based on observation, interview and record review, the hospital failed to protect and promote each patient's rights when:

1. The family members of Pt 1 submitted on 3/10/23 multiple grievances related to the quality of care experienced by Pt 1. The family members of Pt 1 were not provided updates or resolution of the grievances by the 7-day or 30-day timeframes in accordance with the policy and procedures "Acute Patient Complaints and Grievances," dated 1/10/23. (refer to A118, finding 1)

2. Pt 29 submitted a grievance on 1/19/24 related to "a very terrible experience ..." in the hospital's Emergency Department on 1/15/24. Pt 29 and Pt 29's daughter were not provided updates or resolution by the 7-day, and 30-day time frames in accordance with policy and procedure. (refer to A118, finding 2)

3. Policy and professional standards for patient assessments and documentation before, during, and after rapid response and code blue events were not followed for 4 of 4 patients (Patient 1, Patient 2, Patient 3 and Patient 4), and the hospital did not review and evaluate rapid response and code blue events in accordance with hospital policies. (refer to A144, finding 1)

4. Two of four Bilevel Positive Airway Pressure (BiPAP) machines (a type of machine that helps patients breathe by delivering air by mask on the face) remained in patient use despite having a Class 1 recall by the Food and Drug Administration (FDA, Class 1 recall alerts the public regarding the risk of harm, injury or death by use of a product). Respiratory Department staff were unaware and did not follow manufacturer's instructions published in response to the FDA Class 1 recall for the two BiPAP machines. (refer to A144, finding 2)

5. The advance directives (a legal document for instructions regarding the patient specifications on what actions should be taken for their health when no longer able to make decisions) were difficult to locate in the medical records and were not documented accurately nor accessible. (refer to A132)

The cumulative effect of these systemic problems resulted in the hospital's inability to provide care in a safe setting.

Based on interview and record review, the hospital failed to implement a grievance process for prompt resolution of patient grievances in accordance with the hospital's policy and procedure for two of four patients, (Patient [Pt] 1 and Pt 29), when:

1. The family members of Pt 1 submitted on 3/10/23 multiple grievances related to the quality of care experienced by Pt 1. The family members of Pt 1 were not provided updates or resolution of the grievances by the 7-day or 30-day timeframes in accordance with the policy and procedures "Acute Patient Complaints and Grievances," dated 1/10/23.

2. Pt 29 submitted a grievance on 1/19/24 related to "a very terrible experience ..." in the hospital's Emergency Department on 1/15/24. Pt 29 and Pt 29's daughter were not provided updates or resolution by the 7-day, and 30-day time frames in accordance with policy and procedure.


These failures resulted in violating the rights of Pt 1's family members and Pt 29 to a prompt resolution of grievances and left Pt 1's family members and Pt 29 not knowing whether quality of care concerns that were experienced in the hospital were effectively investigated and resolved.


Findings:

1.During an interview on 3/6/24 at 10:45 a.m. with the son (Family Member [FM] 1) and daughter-in-law (FM 2) of Patient (Pt) 1, FM 1 and FM 2 stated they had spoken with hospital staff on several occasions about their many concerns regarding the care Pt 1 received during his hospital stay. FM 1 stated he spoke to an administrator at the hospital about his concerns with Pt 1's care twice on 3/3/23, once before Pt 1 had a cardiac arrest, and once afterwards, and again the week after Pt 1 died. FM 1 and FM 2 stated they also shared their concerns with the Social Worker (SW) after a meeting with Pt 1's physician. FM 2 stated she also called the SW sometime the week after Pt 1 died. FM 1 and FM 2 stated one of the patient care concerns shared with the administrator and SW was that Pt 1 was not transferred to another hospital that would have more resources and specialty doctors. FM 2 stated they had been told the hospital was very small and did not have all of the services or specialty doctors that a larger hospital had, and FM 1 and FM 2 did not understand why Pt 1 was not transferred in order to receive the care he needed. FM 2 stated they were concerned that the hospital did not have doctors for the Intensive Care Unit (ICU) so the patients are telemonitored by a doctor in Sacramento. FM 1 stated he was upset that Pt 1 was intubated even though he (FM 1) had told the Emergency Department staff, the physician who admitted Pt 1 to the hospital, and the nurses that Pt 1 was not supposed to be intubated. FM 1 and FM 2 stated they had questions about what happened leading up to Pt 1's cardiac arrest on 3/3/23, and were upset after Pt 1's nurse told them Pt 1's oxygen was off prior to his cardiac arrest and want to know why that happened and why no one heard the alarm on his oxygen monitor. FM 1 and FM 2 stated they also had concerns about a physician and felt that the death certificate was not accurate in terms of the cause of death and wanted it to be revised. FM 2 stated after they talked to the SW and the administrator they still did not get their concerns addressed. FM 2 stated she finally spoke to someone in charge of complaints, but that person was not helpful. FM 2 stated a few days after that they received a letter from the hospital saying the hospital was not going to give them any information, citing a California Evidence code. Both FM 1 and FM 2 expressed their frustration with not having answers to their questions a year after Pt 1's death.

During an interview on 3/7/24 at 11:35 a.m. with the Infection Preventionist (IP) and the Director of Quality and Patient Safety (DQ), the IP stated in addition to her duties as the IP, she also is responsible for processing patient complaints and grievances. The IP stated she reports to the DQ. The IP stated she received complaints and grievances from patients and family members, either by phone or email and enters them into the hospital's reporting system. The IP stated hospital staff can also enter information directly into the system if they receive a complaint. The IP stated she contacts the complainant for more information and the manager of the area where the patient received care will be tasked to investigate and is expected to enter the results of their investigation into the system. The IP stated ideally a grievance should be resolved within seven days after it is received, but if not then it should be resolved within 30 days The IP stated if it looks like they will not be able to resolve the grievance within seven days, the patient will be sent a letter explaining more time is needed.

During a record review on 3/7/24 at 11:45 a.m., with the IP and the DQ, Pt 1's grievance report and associated documents were reviewed. The report indicated the Ethics and Compliance Officer (ECO-[The person FM 1 referred to as a hospital administrator]) received a grievance on 3/10/23 during a phone call with FM 1 and entered it into the hospital's reporting system on 3/14/23 at 10:57 a.m. The grievance consisted of five paragraphs written by the ECO which described FM 1's concerns about the care his father (Pt 1) received during his hospital stay. The report indicated during the call on 3/10/23, FM 1 was concerned that Pt 1 was found with his oxygen mask off on 3/3/23, had a cardiac arrest, was transferred to ICU, and died on 3/5/23, and FM 1 felt the lack of oxygen made Pt 1's medical condition worse and contributed to his death, and FM 1 wanted this to be on the death certificate. The ECO informed FM 1 he could file a complaint against the hospital with the California Department of Public Health (CDPH). The report also indicated the ECO had "passed this complaint on to [name of the Chief Medical Executive of the hospital] for Peer Review."

During a record review on 3/7/24 at 11:55 a.m. with the IP and the DQ, the SW documentation about Pt 1's grievance was reviewed. The documentation indicated, on 3/15/23 the SW submitted a complaint she received on 3/14/23 from FM 2 about Pt 1's care. The SW listed the complaints FM 2 had communicated to the SW on 3/14/23, which included: poor communication between nurses and physicians, unprofessional nursing staff in ICU, the poor bedside manner of Pt 1's physician, the reasons given for not transferring Pt 1 to another hospital, that Pt 1 was intubated when FM 1 had told multiple staff Pt 1 was not to be intubated, and disagreement with the cause of death on the death certificate. The SW's note indicated the main issues were why did he (Pt 1) go into cardiac arrest, why was he intubated, and that they (FM 1 and FM 2) felt the death certificate needed to explain what actually caused Pt 1's death. The SW's report indicated, "They're [FM 1 and FM 2] requesting a sit down with [Name of the CEO/CNE] to discuss their concerns and improvement that could make this a better hospital, so that no other family would have to go through what they went through." The SW's report indicated she [the SW] "Took my concerns to [name of Manager of the med-surg unit and the ICU] and [name of the Medical Director of the ICU (MD 1)]."

During a concurrent interview and record review on 3/7/24 at 12 p.m. with the IP and the DQ, the IP's documentation in the grievance report was reviewed. The report indicated FM 2 called the IP on 3/16/23 and the IP told FM 2 that she (the IP) was aware of the complaints made by FM 1 to the ECO and the issues FM 2 had discussed with MD 1, and that the issues were being handled through the grievance process which takes time, and informed FM 2 that they should receive communication regarding their complaint within a week. The grievance report indicated the IP had resolved and closed this grievance a day later on 3/17/23 and sent a letter to FM 1. Review of the letter signed by the IP indicated because the complaint was about a physician, it was referred to the medicine department chairman to investigate the concerns. The letter indicated the "Quality Department tracks the issues to ensure actions taken have the desired effect, but that process is protected by California Evidence Code 1157 [A California statute which prevents discovery of proceedings and records of certain organized medical committees (peer review bodies) responsible for evaluating and improving the quality of care]," so the hospital would not share any results of the investigation with FM 1. The letter also included the contact information for the Medical Board of California, and that "I [the IP] will consider this matter closed as of 3/17/23." The grievance report did not have the results of the investigation of the family's concerns or the results of the peer review. The IP stated the family's concerns were not investigated through the grievance process because she interpreted the complaint to be about the physician changing the death certificate, so she referred it to peer review. The IP did not have an explanation for her determination that the grievance was only about the death certificate, since she indicated in her report that she was aware of FM 1's complaints to the ECO, and she herself spoke to FM 2 on 3/16/23 about the family's concerns regarding Pt 1 not receiving oxygen, having a cardiac arrest, and being intubated against FM 1's wishes, and more. As far as the results of the peer review, the IP stated the case was never taken to peer review because it was determined it did not meet review criteria. The IP stated she used the incorrect template for the letter she sent to FM 1.

During an interview on 3/7/24 at 1:40 p.m. with the Ethics and Compliance Officer [ECO], the ECO stated he first spoke with FM 1 the evening of 3/3/23 at the request of the CEO/CNE. The ECO stated FM 1 was very concerned about Pt 1 and about his (FM 1's) interaction with MD 7. The ECO stated he was surprised when he got called later that night after Pt 1 coded and stated he spoke to FM 1 again. As far as the grievance, the ECO stated he spoke with FM 1 again on 3/10/23 and FM 1 was concerned about the circumstances of Pt 1's cardiac arrest, Pt 1's oxygen being off, and disagreed with the cause of death indicated on the death certificate. The ECO stated he told FM 1 he would file this grievance on FM 1's behalf. The ECO stated he summarized FM 1's concerns in the grievance he entered into the hospital's system on 3/14/23. The ECO stated the death certificate had been amended but stated he did not know the specifics of what was changed.

During an interview on 3/7/24 at 1:50 p.m., The DQ stated they definitely have an opportunity here to improve their process. The DQ stated the grievance should not have been determined to be only a complaint about a physician, and should not have been closed on 3/17/23 because the concerns raised by Pt 1's family had not been investigated and the grievance was not resolved. The DQ stated given the seriousness of the concerns there should have been a thorough case review and that still had not been done.

2. During a concurrent interview and record review on 3/7/24 at 12:15 p.m. with the IP and the DQ, Pt 29's grievance was reviewed. The grievance report indicated Pt 29 was in the Emergency Department on 1/14/24 and was discharged on 1/15/24. The grievance report indicated Pt 29 described to the IP what Pt 29 called a "very terrible experience in the ER." The grievance report documented Pt 29's detailed account of her ED visit for back pain. Pt 29's concerns included her reaction to pain medication, her perceived lack of assistance by the respiratory therapist when she was panicked and in need of help, the fall she experienced and then being drug to the hallway so staff could use a lift to get her back in bed. The report indicated Pt 29 told the IP this was a really big thing for her, especially the treatment from the RT. The grievance report indicated on 1/22/24, 1/30/24, and 2/12/24 the IP referred the grievance to the RT's manager asking her to review. On 1/30/24, the IP referred the grievance to the manager of the ED and asker her to review since it happened in the ED. On 2/12/24, the ED manager added a note indicating she had reviewed the grievance and interviewed the RT. On 2/23/24, the RT's manager provided feedback which indicated, "Interview with RT aligns with [name of ED manager] response. No further comments." There was no more documentation in the grievance report by the IP or anyone else after 2/23/24, no referral to others for review and no indication that the managers reviewed Pt 29's adverse response to medication, condition of Pt 29 after the fall and use of the lift, or whether this complaint was discussed with the ED physician. Review of the letters sent to Pt 29, indicated on 1/26/24, the IP sent Pt 29 a letter informing her that "your concerns are being shared with and reviewed by our leadership staff in our Inpatient Services Department. You will a follow-up letter when our investigation of your concern is thoroughly completed, which may take several weeks. In return we ask for your patience, and we will respond within 30 days." The IP sent Pt 29 a second letter on 2/18/24, which indicated, "...Since our previous letter, sent on 1/26/24, your concern has been shared with the appropriate staff and is still under thorough review...We apologize for the delay and will follow up with you in writing once the review and investigation have been completed..." The letter did not provide Pt 29 with a reason for the delay or a date when Pt 29 could expect the review to be completed. The IP was asked what the status of this grievance was and what was being done in terms of investigating this grievance. The IP stated the grievance was still open and needed more investigation. The DQ stated the managers tasked to review the grievances needed to thoroughly review the concerns in a timely manner and that was not done in this case.

During a review of the hospital's policy and procedure (P&P) titled "Acute Patient Complaints and Grievances," dated 1/10/23, the P&P indicated, "... Purpose: To describe the process for providing a timely, effective, and coordinated response by hospital staff, management, and/or physicians to any concern, complaint, grievance, or compliment related to the quality of care or services provided, in compliance with regulatory, managed care, and third party contractual obligations... It is the policy of [name of Health Network] hospitals to acknowledge, investigate, and respond to concerns, complaints, or grievances in a confidential and timely fashion respecting the patient's throughout the process, and without reprisal in accordance with State and Federal guidelines... Procedure: The first step to resolution is at the point of service/care...If unable to resolve, escalate the grievance/complaint up the chain of command. The concerns shall be investigated, and conclusion/resolution shall be documented and sent to the hospital Patient Relations contact and escalated to risk management as appropriate. Handling of the grievance/complaint after the patient is discharged or left from the point of service. Grievances should be resolved within 7 calendar days, if possible. The goal is to resolve within 30 days...An acknowledgement letter will be sent to the complainant within 7 days if resolution is not possible within 7 calendar days. Party filing the grievance will be provided written notification of the outcome of the grievance review and investigation, including: 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. Appeal Rights: If resolution is not achievable and the complainant would like to pursue outside the hospital, the patient has appeal rights. The patient/family may contact the California Department of Public Health or the Joint Commission..."

During a review of the P&P titled, "Patient Rights and Responsibilities," dated 7/18/22, the P&P indicated, "...D. Each patient has the right to...22. File a grievance. If you want to file a grievance with this hospital, you may do so by calling [Hospital's telephone number]. a. Chief Executive Officer: [extension number] b. Chief Nursing Executive: [extension number] c. Quality Management Director: [extension number] d. Quality Management Department: [extension number] e. Business Office Manager: [extension number] f. Human Resources Manager: [extension number] g. or by writing [Name and Address of Hospital]. The grievance committee will review each grievance and provide you with a written response within seven days. The written response will contain the name of the person to contact at the hospital, the steps taken to investigate the grievance, the results of the grievance process, and the date of completion of the grievance process..."

Based on concurrent interview and record review on 3/8/24 with HIM-D and ANM, the advance directives (a legal document for instructions regarding the patient specifications on what actions should be taken for their health when no longer able to make decisions) were difficult to locate in the medical records and were not documented accurately nor accessibly.

This failure placed patients' rights at risk of their health care directive not being followed for their health care preferences and end of life treatment.

Findings:

During an interview on 3/6/24, PT 1's son stated that there was an advance directive for his father that was made available to the facility when admitted on 3/1/23.

During a concurrent interview and record review on 3/6/24 and 3/7/24 with the HIM-D, HIM Lead, and ANM, the medical record for the 3/1/24 admission for PT 1 showed clear indication that there was an advance directive available in the E.H.R. The Advance Directive attachment to the medical record showed only the first page scanned, which included PT 1's son's signature as AD medical decision maker but the remaining pages for health care choices were not part of the medical record, nor was the AD properly witnessed or notarized for a designated medical decision making document. The E.H.R. was reviewed thoroughly and a complete AD could not be located, even in previous admissions/encounters of the PT 1's E.H.R.

Prior to the Code Blue which occurred for PT 1 on 3/3/23, there are several documented entries between the son and the facility providers for resuscitation. On 3/3/23, with PT 1 transferred to the ICU, the son agrees to intubation (Insertion of an airway tube in the trachea).

During an observation, interview and E.H.R. viewing on 3/8/24, HIM-L was asked to navigate to the location of the advance directive for PT 1, which the homepage indicated was present. HIM-L was not able to locate an AD in the E.H.R., even in previous admissions/encounters of PT 1's medical record.

Based on observation, interview and record review, the hospital failed to ensure patients received care in a safe setting when:

1. Policy and professional standards for patient assessments and documentation before, during, and after rapid response and code blue events were not followed for 4 of 4 patients (Patient 1, Patient 2, Patient 3 and Patient 4), and the hospital did not review and evaluate rapid response and code blue events in accordance with hospital policies.

These failures resulted in missed opportunities to identify early warning signs of worsening clinical conditions and the need for resuscitation for Patients 1-4. Failure of the hospital to conduct reviews of code blue and rapid response events prevented the identification of trends and implementation of measures to prevent patient safety events in the future which affected all hospitalized patients.

2. Two of four Bilevel Positive Airway Pressure (BiPAP) machines (a type of machine that helps patients breathe by delivering air by mask on the face) remained in patient use despite having a Class 1 recall by the Food and Drug Administration (FDA, Class 1 recall alerts the public regarding the risk of harm, injury or death by use of a product). Respiratory Department staff were unaware and did not follow manufacturer's instructions published in response to the FDA Class 1 recall for the two BiPAP machines.

These failures resulted in the use of recalled BiPAP machines between 4/12/22 and 3/5/24, and the risk of not providing effective respiratory and oxygen support to patients who were provided respiratory care with BiPAP between those dates.

Findings:

1. During a concurrent interview and record review on 3/6/24 at 10 a.m. with the Med-Surg/ICU Assistant Nurse Manager (ANM), Pt 1's medical record, dated 3/3/23 was reviewed. The record indicated Pt 1's vital signs at 7:18 p.m. temperature 97.5 degrees Fahrenheit (F), heart rate 114 beats per minute (bpm), respirations 22 per minute, blood pressure 128/61 millimeters of mercury (mmHg), oxygen saturation 92% on oxygen 3 liters per minute (L/m). There was no documentation in the medical record of Pt 1's oxygen saturation between 7:18 p.m. and 8:30 p.m. Review of the Rapid Response (RR) record completed by the Rapid Response RN (RRN), indicated a RR was called on 3/3/23 at 8:35 p.m., the respiratory therapist (RT) was notified, and the RR ended at 8:42 p.m. when a code blue was called. The RR record indicated, "Rapid Assessment and Treatment-assessment summary: Pt found unresponsive, O2 [oxygen] off, no IV [intravenous] access. When arrived, O2 sat [saturation] 50-60%, went to 0, no pulse, code blue called overhead, CPR started. Pt intubated and transferred to ICU." There was no documentation regarding what happened during those seven minutes, and the section of the RR record for the documentation of the vital signs and patient assessment was left blank except for one untimed entry of an oxygen saturation of 77%. The RR record was signed by the RRN. Review of the code blue record dated 3/3/23, indicated a code blue was called at 8:42 p.m. when Pt 1 had no pulse and no blood pressure. The code blue record indicated at 8:44 p.m., Pt 1 was given 1 milligram (mg) of epinephrine and 50 milliequivalents (mEq) of bicarbonate; at 8:45 p.m., Pt 1's rhythm was ventricular tachycardia, Pt 1 was defibrillated, and also received 1 gram of calcium chloride IV; at 8:48 p.m., Pt 1 was given 150 mg of amiodarone IV and was intubated by the Emergency Department (ED) physician. The code blue record indicated the event was over at 8:48 p.m. when Pt 1 had return of circulation. There were no vital signs documented on the code blue record. The spaces on the form where the respirations, either spontaneous or assisted, would have been documented was left blank, the spaces where the pulse, either spontaneous or compressions, would have been documented was left blank, and the spaces where the blood pressure would have been documented had only one entry at the start of the code at 8:42 p.m. which indicated Pt 1 had no blood pressure. The next vital signs in the record are at 9:30 p.m. after Pt 1 had been transferred to the ICU. Review of the cardiac monitor strips for 3/3/23, indicated a monitor strip had been saved at 8:10 p.m. and indicated Pt 1's heart rate was 94 bpm. There were no saved monitor strips during the RR event. The next monitor strip in the record was at 8:46 p.m. when Pt 1 was being defibrillated, and the one after that was at 9:20 p.m. Review of the "Care Team Note" dated 3/3/23 at 9 p.m. and signed at 11:24 p.m. by RN 2, indicated, "8:30 p.m. noticed patient oxymask was off, put mask back on and checked O2, patient sating [referring to oxygen saturation] in 50s-60s [%]. Notified RT. 8:35 p.m. called rapid response overhead. 8:40 p.m. called code blue overhead, ED MD at bedside. 8:49 p.m. notified MD. MD aware and came to bedside. 8:55 p.m. notified family about patient's current condition. 9:10 p.m. patient transferred to ICU. 9:10 p.m. report given to [name of RRN]." There was no assessment or vital signs by RN 2 at 8:30 p.m. when Pt 1 was found with oxygen saturations in the 50s-60s prior to the rapid response call. There was no information in the record regarding the alarm on the pulse oximeter monitor being triggered and heard when Pt 1's oxygen saturation dropped. The ANM stated she did not have any information regarding the alarm on the monitor. The ANM stated typically the monitor would be set to alarm if the oxygen saturation drops to 88%. The ANM stated the primary nurse would have been the one taking vital signs and should have documented them. The primary nurse should have run a monitor strip during the rapid response and code and scanned it into the record. The ANM stated the RRN and the primary nurse (RN 2) no longer work at the hospital.

During a concurrent interview and record review on 3/8/24 at 1:05 p.m. with the Director of Quality and Patient Safety (DQ), the review log of code blue (a hospital term for a patient experiencing a cardiac or respiratory arrest) and rapid response team (RRT-a designated group of healthcare clinicians who assist and facilitate prompt treatment for deteriorating patients) events was reviewed. The log contained a chronological list of the events along with information about each event which included the location in the hospital where it occurred, whether the response by staff was timely, the quality of the Cardiopulmonary Resuscitation (CPR) performed, the time from recognition to compressions of less than two minutes, return of spontaneous circulation (ROSC), whether the patient was transferred to ICU or another hospital, the status of the patient at discharge (either expired or survived), whether or not Post Cardiac Arrest Care was provided, whether or not there were any supply or equipment issues during the code or RRT event, and there was also a space for comments. A blank copy of the form titled "[Name of Hospital] Resuscitation Performance Review Form was reviewed. The DQ stated whenever a code blue occurs the nursing staff are supposed to complete this form (referred to on the log as the "critique form") which is not part of the medical record. The form consisted of a series of questions designed to assess different aspects of the event and the completed form is sent to the quality department. The quality department uses that form and the code record to complete the log. The DQ stated the form should be completed within a couple of hours after the event. The form did not have a place to assess whether the vital signs were assessed per policy or whether the documentation surrounding the code or RRT was complete. The DQ stated the hospital had been only monitoring what was required by the Joint Commission. The log listed events from January 2023 through August 2023. The DQ stated the quality department puts this log together and had not put information in the log for the events that occurred since August 2023. A list of those events was requested. The log indicated there were 47 total events from 1/1/23-8/31/23, nine of those were RRT calls and 38 were code blue events. The log indicated in response to the questions about timeliness of code team response and the quality of the CPR performed, "No Critique Form" was entered on the form for 28 of the 38 code blue events, meaning a critique form was not completed so the information was not known. The log indicated 15 out of the 38 patients on the code blue list survived and eight out of those 15 were transferred to another hospital after the code. The log indicated for the seven patients who remained at the hospital, Post Cardiac Arrest Care was provided to one patient, there was no information for three patients, and three patients did not get Post Cardiac Arrest Care. The DQ stated the information is obtained by the quality department from the medical record. If there is an order set in the medical record for Targeted Temperature Management (TTM- a component of post cardiac arrest care, TTM is the process for lowering the patient's body temperature to specific level, maintaining it at the target level for a period of time, followed by gradual rewarming. If patient is not following commands after ROSC, TTM can help maintain neurological function and support recovery) then the log would indicate the patient received that care. The DQ stated there is no information on the log form to indicate whether a patient was assessed or not per ACLS guidelines and determined to be or to not be a candidate for TTM, just whether they had orders in the record. There was no explanation for why there was no information for three of the patients. The log indicated on 3/3/23 Pt 1 had a RRT call and a code blue. The log indicated the Pt 1 did not receive post cardiac arrest care and that a code blue critique form had not been completed. The comments section of the log for Pt 1's code indicated, "RRT to Code Blue. Pt placed on comfort care shortly after Code Blue." The record indicated Pt 1's code status was not changed from Full Code to Do Not Resuscitate until 3/4/23 at 3:10 p.m., approximately 18 hours after the code and was not placed on comfort care until 3/4/23 at approximately 11 p.m. over 24 hours after the code blue.

During a concurrent interview and record review on 3/11/24 at 12:20 p.m. with the DQ, the list of Code Blue events for the period from 9/1/23 to 3/10/24 were reviewed. There were fourteen patient names on the list, along with the date of occurrence, the department and the patient's primary diagnosis. The list did not have the information that the code blue/RRT log had, and the events had not yet been reviewed. The DQ stated she was responsible for coordinating the committee meetings where these events are reviewed. The DQ stated the committee should meet quarterly, however in 2023, they met only once, in December. Review of Pt 1's RR and code blue events would have been included in this meeting. The DQ stated Pt 1's code blue was not reviewed in the detail it should have been. The DQ stated improvement is needed for the process of reviewing the code blue and RRT events. The DQ stated the staff stopped consistently completing the code blue critique form and the incidents were not being entered into the hospital's system for Pt Safety Event reporting as they should have been. The DQ stated when they are entered then risk management is notified and the manager where the event occurred is tasked to review the code or RRT event. This way the code blue committee can have the information they need to review the cases and identify trends. The DQ stated when the code is entered in the system as a patient safety event, the hospital can identify opportunities for improvement at the time and act on them in order to prevent recurrence. As to the reason the staff stopped completing the critique form, the DQ stated frontline staff may not find value in it, so it was easier not to do it.

During an interview on 3/13/24 at 5:30 p.m. with the DQPS, the DQPS stated during her review of the code blue policy, she discovered that the link in the policy which was supposed to open up the Up to Date recommendations for initiation of TTM did not work.

During a review of Pt 2 ' s History & Physical (H&P) dated 1/30/24, the H&P indicated, Pt 2 who had a history of Diabetes, Hypertension (high blood pressure), and Atrial fibrillation (Abnormal heart rhythm with extremely fast and irregular beats) came to the Emergency Department with shortness of breath and was admitted to telemetry (Unit where patients have continuous cardiac monitoring-Electronic signals are transmitted from the electrodes and leads on a patient to a central monitor where they are stored and interpreted) on 01/30/24 with acute respiratory failure.

During a concurrent interview and record review on 3/11/24 at 9:00 am. with the ANM, Pt 2's medical record, dated 1/30/24 to 2/4/24 was reviewed. The record indicated Pt 2 was in the ICU on 2/4/24. RN 11's nurses note dated 2/4/24, indicated, "... 0213 [2:13 a.m.] Call to eICU, by [RN 12] re: pt ' s status, HR still uncontrolled, pt trying to pull off his BiPAP mask and getting extremely restless. Precedex on max dose. 0426 [4:26 a.m.] Code Blue called. Started pt on compressions. Pt ' s HR suddenly dropped from 130 ' s down to 100 ' s and then dropped further. [MD 7- (Pt 2's attending physician)] informed ..." The ANM was unable to find any documentation that indicated MD 7 was notified when the eICU physician was notified or at any other time prior to the code. The ANM stated the eICU physician ordered digoxin (medication used to improve the strength and efficiency of the heart, or to control the rate and rhythm of the heartbeat) but the record did not indicate it was administered. The ANM stated she does not know why MD 7, who was in the hospital, was not contacted or updated until after the code. The ANM stated there is no documentation by MD 7 to indicate interventions or assessment by MD 7 on 2/4/24 between 2:13 a.m. and 4:26 a.m. when Pt 2 coded. Review of the code blue record indicated Pt 2 coded twice on 2/4/24. The first code was on 2/4/24 at 4:26 a.m. until 4:50 a.m. and ended due to return of circulation. The second code occurred four minutes later on 2/4/24 at 4:54 a.m. and efforts were terminated at 5:07 a.m. and the nurses note indicated Pt expired and was pronounced by MD 7. The ANM stated MD 7 was not listed on the code blue record as being present during the code, MD 8 was the physician present. The ANM was unable to find any documentation in the record by MD 7 or MD 8 pronouncing the patient dead. Review of the code blue record indicated no vital signs were documented for either code, and the electronic medical record did not reflect that vital signs were assessed every five minutes. The ANM stated vital signs should have been attempted every five minutes and documented on the code blue record. The ANM stated she could not locate a cardiac monitor strip for the first code, but there was one for the second code. The code blue record indicated Pt 2 was intubated during the first code, but the ANM was unable to find any documentation by MD 7 or MD 8 regarding intubation.

During an interview on 3/12/24 at 5:30 p.m. with the DQPS, the DQPS stated she was unable to find any documented interventions by the in house physician [MD 7] between 2:13 a.m. to 4:26 a.m., when the first code blue started. The DQPS stated without documentation, she cannot determine if the care was coordinated between the eICU physician and the inhouse physician. The DQPS validated there was no documentation by either MD 7 or MD 8 regarding the intubation or about the death pronouncement. The DQPS stated physician performing intubation should have placed a procedure note. The DQPS stated it was the policy of the facility that the physician who pronounced a patient is to make a notation in the patient's record.

During a review of Patient 3 ' s medical record, the "Emergency Department [ED] Provider note" dated 3/4/24 indicated Patient 3 was brought to the ED by ambulance on 3/4/24. The note indicated Pt 3 received CPR while in the ambulance on the way to the hospital and had an LMA (Temporary method to maintain an open airway as an immediate life-saving measure in a patient with a difficult or failed airway) inserted.

During a concurrent interview and record review on 3/12/24 at 9:30 a.m. with the ANM, Patient 3 ' s medical record was reviewed. Review of the code blue record (form where the details of the code blue are documented) indicated on 3/5/24 at 3:02 a.m., a code blue was called, CPR was started, and efforts were terminated at 3:23 a.m. There were no vital signs documented on the code blue record or in the electronic health record (EHR). The code blue record indicated Pt 3 was on a cardiac monitor, Pulse oximeter (electronic device that measures the saturation of oxygen carried in red blood cells) and a Blood Pressure (BP) monitor. There was no documentation on the code blue record or in the EHR indicating staff were unable to obtain vital signs. The ANM stated she was unable to locate any cardiac monitor strips in the record that were printed and scanned into the record during the code.

During a review of Pt 4 ' s medical record, the History and Physical (H&P)," dated 2/7/24, indicated, on 2/7/24, Pt 4 was found at home with altered mental status. When Emergency Medical Services (EMS) arrived, Pt 4 had pinpoint pupils, and was given Narcan (a medication given to reverse the effects of an opioid overdose) and brought by ambulance to the ED.

During a concurrent interview and record review on 3/11/24 at 1:30 p.m., with the ED Manager (RNM 3), Patient 4 ' s medical record was reviewed. Review of record indicated Pt 4 arrived in the ED on 2/7/24 at 4:07 p.m., was triaged at 4:21 p.m. and assigned an Emergency Severity Index (ESI) level of 2 (ESI 2- a high risk patient who should not wait to be seen by a physician). At 4:35 p.m., Pt 4's Glasgow Coma Scale (a system to "score" or measure a person's level of consciousness, a score of 3 is unconscious, 15 is fully awake and responsive) was 14, and his fall risk score was 11. (need to define what this means- moderate or high risk, etc). The record indicated a CT scan was ordered at 4:36 p.m. and RNM 3 stated Pt 4 was transported by the CT tech to radiology in a wheelchair for the CT scan. The RNM stated the RN did not document what time Pt 4 left the ED, and the RN did not accompany Pt 4 to the CT and Pt 4 was not on a monitor when he was taken to CT. The code blue record indicated Pt 4 coded at 5:15 p.m. in CT. At 5:17 p.m., Pt 4 was given 4 mg of Narcan. The code blue record indicated at 5:27 p.m., Pt 4 was in sinus rhythm, was intubated at 5:29 p.m., and the code continued until 5:57 p.m. There were no vital signs documented in the ED record from 4:15 p.m. until 6 p.m., and on the paper code blue record there were no vital signs documented between 5:17 p.m. and 5:44 p.m., then vital signs at 5:44 p.m. and not again until 5:57 p.m. when the code ended. RNM 3 validated the vital signs were not done in accordance with the hospital policy of every 5 minutes during a code. RNM 3 stated the RN should not have sent Pt 4 unaccompanied and without monitors to radiology for a CT scan.

During a review of the hospital ' s policy and procedure (P&P) titled, "Code BLUE: Cardiopulmonary Resuscitation [CPR] - Adult, Pediatric & Newborn Patients," dated 6/21/22, the P&P indicated, "When a Code Blue is called and resuscitative measure are initiated, a member of the nursing team shall record the sequential events and other data on the code blue sheet. Complete as follows...initial monitor reading, procedures to include respiratory assist, chest compressions, lab studies, EKG...Defibrillation-if done, complete joules used, response and time for each defibrillation ...Vital Signs ...record at time Code started and include BP, Pulse, resp and pupillary response. Record each subsequent 5 minutes or as indicated ...ABG determinations...Report incident...Resuscitative Performance Review- the Resuscitative Performance Review Form is to be completed by the nursing supervisor and forwarded to the Chairman of the Code Blue Committee [Quality Department]. A copy of the code blue record must be attached to the review form..."

During a review of the P&P titled, "Rapid Response Team (RRT) Interventions, Standardized Procedure," dated 3/16/23, indicated, "...The RRT brings immediate critical care expertise to the patient. RRT is available to provide a higher level of nursing and respiratory therapy assessment and intervention until the patient's physician arrives. The intent is to "rescue" the patient prior to a full cardiopulmonary arrest and to expedite transfer to a higher level of care when necessary...RRT roles and responsibilities- The primary nurse [staff nurse assigned to the patient]-Document RRT actions and interventions...complete RRT documentation record...RRT leader [Critical Care RN]-Perform intensive patient assessment...Respiratory Therapist-Perform an intensive respiratory assessment...The RT will be responsible for airway management, providing oxygenation and respiratory treatments, obtaining EKGs, and blood gases. Documentation- The following documentation will be completed for each RRT event: RRT Documentation record: Document all nursing and respiratory interventions. A copy will be scanned into the patient's electronic medical record and placed in the ICU manager's mailbox. Submit completed document to the Code Blue committee for review. RRT Data Collection Record: submit to the code blue committee for review. Care Team Note: The primary nurse will document a Care Team Note within the patient's electronic medical record. The note should include the following:...Assessment findings, Interventions, outcome...Incident Report: Primary Nurse will complete prior to the end of the shift to include summary of RRT event, debriefing information...The Code Blue Committee will review all RRT events for: functionality of team and structure, findings from debriefing, educational opportunities for physicians and staff, failure to respond and recognize, need for additional review..."


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2. During an observation on 3/5/24 at 12:25 p.m. with Nurse Executive (NE) 1, in Intensive Care Unit (ICU), Respiratory Therapist (RT) 1 placed Pt 8 on BiPAP. RT 1 removed the patient from nebulizer treatment, started the BIPAP, completed the check and documented the actions provided. RT 1 left the ICU after placing the patient on BiPAP.

During an interview on 3/5/24 at 1:52 p.m. with Respiratory Therapist (RT) 1, RT 1 stated she has been working at the facility for 10 years. RT 1 stated the facility have four BiPAP machines. RT 1 stated Bio Med Technicians (trained to repair, maintain, and calibrate medical equipment) are responsible for any maintenance on the BIPAP machines. RT 1 stated she was not aware of any active recall on any of the BiPAP machines at the facility. RT 1 stated she has not been made aware of any special precautions while using BiPAP machines. RT 1 stated all BiPAP machines at the facility were safe to use without any special consideration. RT 1 stated she was unsure if the BIPAP used on PT 8 had any recalls or if she had to use any special precautions.

During an interview on 3/6/24 at 1:38 pm with the Lead Respiratory Therapist (LRT), the LRT stated all BIPAPs at the facility have been serviced by manufacturer and Bio-Med. The LRT stated he was not aware of any special considerations while using BIPAPs. The LRT stated that Bio-Med would have notified him and the team in case of any recall on respiratory equipment. The LRT stated, "might have been recall in the past but all equipment have been repaired and updated".

During a concurrent interview and record review on 3/6/24 at 1:48 p.m. with BioMed Manager (MBM) 1, and LRT, FDA's "Class 1 Device recall", dated 6/3/2022 was reviewed. The Class 1 recall indicated " ...the FDA issued a recall summary for all Philips V60 and V60 Plus ventilators because an internal power fluctuation may cause the ventilator to shut down unintentionally either with or without any visible or audible alarms. The power fluctuation causes a reboot of the backup alarm controller, which may lead to a complete shutdown of the ventilator without warning ...Recall Status: Open ...On March 14, 2022, Respironics California, LLC, issued an Urgent Medical Device Correction to all affected consignees. The firm advised customers to keep the affected Philips V60 and V60 Plus ventilators in service and use them in accordance with the instructions for use and the following guidance ...Connect the Philips Respironics V60/V60 Plus to a nurse call/remote alarm system. The company strongly recommends using this strategy to provide a backup signal to the clinician if the ventilators primary alarm system does not activate ...Verify the operation of any nurse call/ remote alarm device before connected to the ventilator ...Respond to all alarms. Immediate response to high-priority alarms from the ventilator and prompt response to low priority alarms are recommended ...Install an oxygen analyzer/monitor. Follow the manufacturer's instructions for setup, alarms, and calibration of this device. Provide pulse oximetry to inform the clinician of a change in the patient's condition ...Ensure access to an alternative ventilation device. Always have immediate access to an alternative means of ventilation. If a Philips Respironics V60/V60 Plus ventilator experiences a shutdown, Disconnect the patient, and immediately start ventilation with an alternate device. The company also requested that customers acknowledge receipt of the recall notification by fax or email ... On April 22, 2022, Respironics California, LLC, issued an update to its Urgent Medical Device Correction ...disclaimer to all affected consignees, advising its customers to conduct a risk/benefit analysis to evaluate whether the impacted devices should continue to be used, if mitigations mentioned previously are not available ...". MBM 1 stated this was a serious recall and it would have affected all BiPAP machines at the facility. MBM 1 stated he had to go back and check facility's Bio-Med record to make sure all machines at the facility were serviced by the manufacturer to address the recall. MBM 1 stated all facility's BiPAP should have been fixed by the manufacturer but he needed to validate. MBM 1 stated this recall was serious and using BIPAP with recalls could lead to equipment failure while in use with patient and may compromise patient safety.

During an interview on 3/8/24 at 12:01 p.m. with RNM 1, RNM 1 stated she was the manager for RTs. RNM 1 stated she does not recall receiving notifications for recall on BIPAPs. RNM 1 stated all patients on BIPAPs get monitored in ICU and she was not aware of any additional risk mitigation strategies being implemented related to recall.

During an interview on 3/11/24 at 3:27 p.m. with Bio- Med Manger (MBM) 2, MBM 2 stated all four BiPAP machines at the facility were part of this recall. MBM 2 stated Bio-Med team did receive and signed an urgent device recall notice from manufacturer on 4/12/22. MBM 2 stated two out of four BiPAPs at the facility were serviced and repaired to address the recall by manufacturer on 12/11/23. MBM 2 stated the other two BiPAP machines still needed repair to address active recall. MBM 2 stated the recall was critical and the facility did receive an Urgent Medical Device Correction notice from manufacturer. MBM 2 stated information regarding mitigation strategies and guidance on the use of BIPAP with active recall provided by manufacturer was shared with the team. MBM 2 stated it was important for staff to know about these recalls as these machines had the potential to shut down without any alarms. MBM 2 stated this would potentially deprive the patient of the oxygen and needed breathing support.

During a concurrent interview and record review on 3/12/24 at 09:00 a.m. with the Director of Quality and Patient Safety (DQPS), FDA's "Class 1 Device recall", dated 6/3/2022 was reviewed. The DQPS stated "Bio-Med went back to validate with their records, and it appears that [facility] had a break down in the process and communication". The DQPS stated 2 out of the 4 machines did not have a repair and update to resolve the FDA Class 1 recall and were actively in use since the recall was issued on 4/12/22. The DQPS stated staff should have been aware and educated on the mitigation actions that were required by the manufacturer to use BIPAP with active recall. The DQPS validated facility's BioMed team received urgent medical device correction from manufacturer and signed a response form on 04/12/22 acknowledging receipt and understanding of urgent device correction letter. The DQPS stated it was not acceptable to use BIPAPs without mitigation strategies. The DQPS stated two BIPAPs with active recall should not have been used without proper training and awareness. The DQPS stated facility should have done risk assessment and have all safety mitigation steps in place prior to placing these affected devices on the patient. The DQPS stated using recall devices on the patient had the potential to significantly harm patients. The DQPS stated she expects the facility's Bio Med team to appropriately communicates about recalls with each stakeholder. The DQPS stated the facility progress of keeping track of recall equipment needs improvement.

During an interview on 3/12/24 at 11:58 with the Registered Nurse (RN) 1, RN 1 stated he has been working in the ICU as RN for three years. RN 1 stated he has been working with patients on BIPAP machines consistently. RN 1 stated he was not made aware of any recall related to BIPAPs electrical issues or need for any special precautions while caring for patient on BIPAPs. RN 1 stated it was important for nursing team to know about any recall associated with respiratory equipment. RN 1 stated BIPAP was critical support to patient requiring help with breathing. RN 1 stated failure of BIPAP while in use can significantly harm the patient.

During a professional reference review retrieved from (https://www.philips.com/a-w/about/news/archive/standard/news/press/2022/20220422-philips-respironics-issues-voluntary-recall-notification-field-safety-notice-for-the-v60-ventilator-product-family.html.) titled, "Philips Respironics issues voluntary recall notification/field safety notice* for the V60 ventilator product family", dated 4/22/22, the reference indicated " ...Philips Respironics is notifying customers of its V60/V60 Plus and V680 ventilators about a potential issue with the electrical circuit in these ventilators that controls the 35V power supply to the ventilator and alarm. Philips Respironics has already notified the relevant competent authorities. Philips Respironics has identified that there is a possibility that affected ventilator units may cease to operate, potentially without setting off an audible/visual alarm (a so-called silent shutdown), and the patient may no longer receive respiratory assistance. Philips Respironics projects an average of less than one silent shutdown among one million uses per year. Philips Respironics is advising customers that they must implement one or more of the following actions to mitigate the rare possibility of the hazard caused by the 35V electric circuit issue ...Implement an oxygen analyzer with appropriate alarm settings for each V60/V60 Plus, or V680; and/or ...Connect the V60/V60 Plus or V680 to a nurse call/remote alarm system, as documented in the instructions for use; upon request, Philips Respironics can provide technical assistance to implement this nurse call/remote alarm capability; and/or ...Monitor the patient with pulse oximetry or other physiological monitoring appropriate to the institution's capabilities and patient needs ...Additionally: An alternative means of ventilation should be available whenever the V60/V60 Plus or V680 ventilator is in use. If a fault is detected in the ventilator, disconnect the patient from it and immediately start ventilation with such an alternative device. The ventilator must be removed from clinical use and serviced by authorized service personnel. If these mitigations are not available, Philips Respironics recommends each institution deliberately make a decision that balances the risks and benefits of continued use of the V60/V60 Plus and V680 against the risks and benefits of ceasing use and/or substituting other ventilators.

Based on observation, interview and record review, the hospital's medical staff failed to operate under bylaws approved by the governing body when five of six members of the medical staff did not have a professional performance appraisal to assess competence for the specific privileges granted. (Refer to A0340)

The cumulative effect of this systemic problem resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and responsible manner.

Based on interview and record review, the hospital failed to appraise the professional performance of the medical staff members in accordance with the Medical Staff Bylaws and policies, and to consider that appraisal when determining whether privileges will be granted, renewed, revised or revoked for five of six physicians (MD 1, MD 2, MD 3, MD 4. and MD 5).

These failures had the potential for privileges for patient care to be granted to physicians without demonstrated competence and placed patients at risk for harm.

Findings:

During a concurrent interview and record review on 3/8/24 at 2:15 p.m. with Medical Staff Coordinator (MSC) and the Director of Quality and Patient Safety (DQ), MD 1's credential file was reviewed. The MSC stated she is the one responsible for coordinating the credentialing, appointment and reappointment process, and the DQ is her supervisor. Review of MD 1's file indicated MD 1 was a hospitalist (a doctor who works in a hospital providing general medical care to hospitalized patients) and was not board certified. The file indicated MD 1 was last reappointed to the active medical staff on 1/1/24. The MSC stated MD 1 was also the medical director for the intensive care unit [ICU]. A review of the Internal Medicine Services Privilege Request Form, dated 8/31/23, indicated MD 1 requested and was granted privileges [specific services and procedures a healthcare provider is deemed qualified to provide or perform] for General Internal Medicine Core Privileges which consisted of a paragraph describing the core privileges as, "...Admission, work-up, diagnosis and provision of non-surgical inpatient and outpatient treatment including consultation for patients admitted or in need of care to treat general medical problems including EKG interpretation, thoracentesis, paracentesis, and lumbar puncture. Internist may provide comprehensive management of patients in critical care units, including, but not limited to ventilator management greater than 48 hours..." The privilege request form also had a list "Special Procedures," for the physician to request and be granted individually. The list included procedures such as colonoscopy, arthrocentesis, echocardiograph, cardioversion, bone marrow aspiration, arterial line placement, central line placement, and others. The criteria for any of these special procedures were, "Successful completion of an approved recognized course when such exists, or acceptable supervised training in residency, fellowship, or other acceptable experience, and documentation of competence to obtain and retain clinical privileges as set forth in medical staff policies governing the exercise of specific privileges." The request form indicated MD 1 had requested and been granted the privilege for the special procedure arthrocentesis (a procedure in which a sterile needle and syringe are used to drain fluid from a joint). The MSC stated the medicine privilege request form had been changed at the end of 2022, when the ICU Internal Medicine Core Privileges were combined with the General Internal Medicine Core Privileges. The MSC stated this was done because the qualifications for the ICU Internal Medicine Core Privileges were difficult to achieve. The MSC stated both versions of the privilege form are in use at this time, and are updated at the time of reappointment. Review of the earlier version of the internal medicine privilege request form prior to the revision indicated the "General Internal Medicine Core Privilege" bundle did not include ventilator management or management of patients in the critical care unit (ICU). The form indicated "ICU Internal Medicine Core Privileges" defined as, "In addition to core privileges in general internal medicine, comprehensive management of patients in critical care units, including but not limited to the use of such procedures as arterial line placement, arterial puncture, and ventilator management greater than 48 hours." The qualifications for ICU Internal Medicine Core Privileges were, "Current certification or active participation in the examination process leading to certification in critical care internal medicine by the American Board of Internal Medicine or demonstrated competency in critical care internal medicine." The MSC stated the current medicine request form does not delineate Critical Care/ICU privileges separate from general internal medicine privileges. The MSC stated on the current form, the privileges described in the paragraph indicating the core privilege group are requested and granted as one privilege. The privilege request form did not include check boxes next to anything in the core privilege group or provide direction or instructions on the ability to opt-out of a particular procedure within the core privilege group. On the last page of the form there was a place for the physician reviewing the privilege request form and recommending the privileges to include a condition or modification relative to the privilege and required that the specific condition or modification and the reason for it be documented on the form. MD 1's privilege request form indicated the department chairman signed the form approving the requested privileges on 11/13/23 and no conditions, modifications, or comments were made.

During a review of the minutes from the Bylaws/Credentials/Interdisciplinary Committee meeting held on 11/14/22, the minutes indicated, "...Delineation of Privileges- Internal Medicine Revised: The internal medicine privilege form was revised to reflect current practice. ICU privileges were moved to core privileges."

The MSC stated in preparation for reappointment, information is gathered regarding a physician's practice during the preceding two year period. The MSC stated there are no specific volume requirements (number of patients treated or managed and/or the number and type of procedure performed by the physician during the reappointment period) for the core medicine privileges or the arthrocentesis. The privilege form indicated, "...Reappointment Requirements, General Internal Medicine: Current demonstrated competence and an adequate volume of current experience with acceptable results in the privilege requested for the past 24 months as a result of quality assessment /improvement activities and outcomes..." The MSC could not define "adequate volume." The MSC stated they do not collect volume data to be used to evaluate the physician's performance of procedures in the "core" privilege bundle such as EKG interpretation, ventilator management, thoracentesis, paracentesis, or lumbar puncture, or for arthrocentesis, a specialty procedure. The "quality assessment/improvement activities and outcomes" information which was considered when MD 1 was reappointed was requested and the MSC provided the document reflecting the Ongoing Professional Practice/Performance Evaluation (OPPE) "Scorecard: Medicine" which consisted of 24 months of OPPE data divided into six-month periods. The MSC stated the scorecard is the same for all physicians with medicine privileges. The document indicated under the heading "Performance Details" a list of data being collected and how that physician compared to his peers. Information regarding cases reviewed by Peer Review and any negative findings associated with that review was tracked and the document indicated MD 1 had "No Occurrences," meaning no cases reviewed. Information regarding incidences of "Transfusions not meeting criteria," was reported, and indicated MD 1 had "No Occurrences." The MSC stated she did not know how many, if any, transfusions were ordered by MD 1. "Acute mortality observed [patient deaths]/expected [considers risk factors, likelihood of death]," and MD 1 had "No Occurrences" and the document indicated his peers had no occurrences as well. The MSC did not know whether this data meant no deaths occurred or whether a target observed/expected (O/E) value had to be exceeded before data was reported for this metric. There was no data on the scorecard specific to the privileges within the General Internal Medicine core privilege bundle, including ventilator management, paracentesis, thoracentesis, lumbar puncture, or comprehensive management of patients in the critical care unit.

During a concurrent interview and record review on 3/8/24 at 3:05 p.m. with Medical Staff Coordinator (MSC) and the Director of Quality and Patient Safety (DQ), MD 2's credential file was reviewed. The file indicated MD 2 was initially appointed to the medical staff on 9/5/19 with Pulmonary Disease (conditions that affect the lungs and other parts of the respiratory system) Core Privileges. The MSC stated MD 2 recently became the medical director of respiratory care services at the hospital. The MSC stated MD 2 was granted two extensions to his provisional status due to failure to complete proctoring and low volume. A letter to MD 2 from the administrator of Hospital A on 5/12/21 was reviewed and indicated MD 2 was granted the final extension to complete proctoring, and advised that failure to complete proctoring by 8/31/21 would result in voluntary relinquishment of membership and privileges. Review of the six proctoring reports in MD 2's file indicated the dates of the patient care being evaluated were 1/3/20, 2/19/20, 2/26/20, 8/5/20, 9/2/20 (two patients). All of the proctored cases were for pulmonary medicine consultations, and all cases were reviewed on 5/19/21 by MD 1. The MSC was unable to state how MD 1 who had internal medicine core privileges but no privileges in pulmonary disease was determined to be a qualified proctor for MD 2. Review of the proctoring reports indicated at the top of the report, "...Proctoring shall mean the direct observation of the proctored practitioner's diagnosis or treatment of an individual patient by a qualified member of the Medical Staff. Observation shall include a chart review and proctoring performed on no less than six (ICU-no less than three) medical cases by staff members who serve as observers. Observation may also include review of observation reports obtained from other hospitals..." The MSC acknowledged that since the cases were reviewed on 5/19/21 but occurred in 2020, they were not directly observed by MD 1.

Review of MD 2's file indicated on 6/15/21 an activity report listing all patient care occurrences for the period of 6/1/19 through 5/31/21 was generated and indicated all patient care activity was in the outpatient setting. The report consisted of a list of diagnoses but no dates of service or medical record numbers. The report reflected diagnoses such as "cirrhosis of liver," "nicotine dependence," and "other specified health status," in addition to diagnoses of pulmonary conditions and did not indicate which of the diagnoses were for the same patient, or the nature of the outpatient appointment. The MSC did not have any information regarding how many patients were seen during this two year period. Review of documents sent from another hospital (Hospital B) on 7/7/21 indicated MD 2 was an active member of the medical staff at Hospital B with primary privileges in pulmonary medicine and critical care and had completed proctoring at Hospital B in 2017. The documents included an activity report from Hospital B for the period of 7/1/19-6/30/21 showing sufficient patient care volume. Review of the minutes from the Bylaws/Credentials/Interdisciplinary Committee meeting held on 8/9/21, indicated MD 2's reinstatement to the Medical Staff, application for new privileges (withdrawal of General Internal Medicine core privileges and ICU medicine core privileges, withdrawal of special procedure privileges, and the addition of Pulmonary Disease Consultative Privileges), completion of proctoring for those consultative privileges requested, completion of the provisional year and status change from Provisional to Consulting. The meeting minutes for 8/9/21 also indicated revision of the Internal Medicine Privilege Form, "...The privilege form was revised to include consultative Pulmonary Disease privileges to accommodate [MD 2]'s practice at the rural health clinic as well as give him the ability to consult on med-surg and the ICU..."

Review of MD 2's file indicated he was last reappointed on 9/1/23. Review of MD 2's privilege request form dated 5/3/23, indicated MD 2 requested Pulmonary Disease Consultative Privileges which consisted of, "Evaluate, diagnose, treat, and provide consultation to patients of all ages presenting with conditions, disorders, and diseases of lungs and airways. May provide consultation to patients in the intensive care setting or provide care in the outpatient health clinic (non-procedural) in conformance with unit policies. Assess, stabilize, and determine the disposition of patients with emergent conditions consistent with medical staff policy regarding emergency and consultative call services." Information used in consideration of MD 2's reappointment was requested and the MSC provided the document, "Scorecard: Medicine" which consisted of 24 months of data divided into six-month periods. The MSC stated this report is run every six months. The document indicated under the heading "Performance Details" a list of data being collected and how that physician compared to his peers. Information regarding cases reviewed by Peer Review and any negative findings associated with that review was tracked and the document indicated MD 2 had "No Occurrences," meaning no cases reviewed. Information regarding incidences of "Transfusions not meeting criteria," was reported, and indicated MD 2 had "No Occurrences." The MSC stated she did not know how many, if any, transfusions were ordered by MD 2. "Acute mortality observed [patient deaths]/expected [considers risk factors, likelihood of death]," and MD 2 had "No Occurrences" and the document indicated his peers had no occurrences as well. The MSC did not know whether this data meant no deaths occurred or whether a target observed/expected (O/E) value had to be exceeded before data was reported for this metric. There was no data on the scorecard specific to the Pulmonary Disease Consultative Privileges held by MD 2, and no information which could be used as part of the evaluation of MD 2's performance. The MSC provided the activity report for the two year period between reappointments which consisted of a list of four diagnoses, one instance of each, two of which were not primary diagnoses indicating this list represented less than four patient encounters for the two year period. There was no information regarding the dates of the consults. The MSC did not have any additional information regarding the report. MD 2's privilege request form indicated the reappointment requirements for Pulmonary Medicine were, "Inpatient or consultative services for at least 100 patients, reflective of the scope of privileges requested, during the past 12 months." The last page of the form was completed by the medicine service chairperson who could approve all requested privileges, recommend privileges with specific conditions or modification, or not recommend specific privileges. There was a statement which indicated, "I have reviewed the requested clinical privileges and supporting documentation for the above-named applicant and make the following recommendations: Recommend all requested privileges." The form was signed by the chairperson of medicine on 7/7/23.

During an interview on 3/11/24 at 2:20 p.m. with the MSC, the MSC was asked what process was followed when the physician's volume is very low for the two year period between reappointments and does not meet the reappointment criteria. As occurred with MD 2, the MSC stated normally she would have flagged this file to bring it to the attention of the Medicine Service Chairperson who could request more information or recommend the privileges with specified conditions or modifications, or recommend the privileges are granted as requested. The chairperson is supposed to make a note about an exception to the volume requirement and their recommendations for consideration by the credentials committee and MEC. The MSC stated in this case she failed to flag the file or to discuss it with the medicine chairperson.

During a concurrent interview and record review on 3/11/24 at 2:45 p.m. with the MSC, MD 3's credential file was reviewed. The file indicated MD 3 was privileged in Family Medicine and was working as a hospitalist . The file indicated MD 3 had worked at other hospitals as a hospitalist and was board certified in Family Medicine. The file indicated MD 3 was appointed as a Provisional medical staff member on 1/5/23. Review of MD 3's Family Medicine Privilege Request Form indicated MD 3 had completed the request for privileges on 9/18/22, and indicated he requested "Adult Core Privileges," which included, "Inpatient and Outpatient management of patients over the age of 18 without life-threatening complications, including surgical first assisting." The Observation/Proctoring Requirements were "chart review and proctoring performed on no less than six (ICU-no less than three) medical cases." The request form indicated MD 3 had also requested the special procedures "Management of Intensive/Critical Care Unit patients without consult less than 48 hours," and "Ventilator Management less than 48 hours," and that the proctoring requirements for those special privileges/procedures was five cases (for each privilege/procedure). The last page of the form indicated the medicine service chairman recommended all requested privileges. The MSC stated MD 3 had not completed proctoring and his file did not have evidence that any cases had been proctored yet, even though MD 3 had been on staff for 14 months. The MSC stated she did not have information regarding MD 3's patient volume during this time and an OPPE scorecard had not yet been generated for MD 3. Both reports were requested.

During a record review on 3/11/24 at 4:30 p.m. MD 3's activity report for the period of 1/5/23 through 3/11/24 indicated during this time period, MD 3 was the admitting physician for 45 inpatients, attending physician for 33 inpatients (some patients are on both lists), and was listed as the performing provider on four patients for seven procedures, "Introduction of Vasopressor into Peripheral Vein, Percutaneous Approach; Introduction of Vasopressor into Central Vein, Percutaneous Approach; Transfusion of Red Blood Cells into Peripheral Vein, Percutaneous Approach [two occasions]; Assistance with Respiratory Ventilation, Less Than 24 Consecutive Hours, Continuous Positive Airway Pressure; Assistance with Respiratory Ventilation, 24-96 Consecutive Hours, Continuous Positive Airway Pressure; and Assistance with Respiratory Ventilation, Less Than 24 Consecutive Hours, High Nasal Flow/Velocity." The OPPE scorecard for MD 3 was not generated until 12:36 p.m. on 3/14/24 and provided on 3/14/24 at 9:05 p.m., after the survey exit. Review of the OPPE scorecard indicated the same things were being reported as were for MD 1 and MD 2, and the report did not include data specific to the privileges granted to MD 3.

During a concurrent interview and record review on 3/11/24 at 3 p.m. with the MSC, MD 4's credential file was reviewed. The file indicated MD 4 was an Obstetrician/Gynecologist whose most recent reappointment to the Active Medical Staff was 9/1/22. Review of MD 4's privilege request form indicated on 4/18/22 MD 4 requested Obstetrics Core Privileges which included cesarean sections, resuscitation of newborn, amniocentesis, and all other procedures related to normal and complicated delivery; and Gynecology Core Privileges, and Special Procedures: Hysteroscopy, diagnostic/operative; Hysteroscopic polypectomy and/or myomectomy, Hysteroscopy with thermal ablation; Cystocele/rectocele repair; Vaginal Hysterectomy; Total Abdominal Hysterectomy; Endometrial Ablation. The privilege request form indicated the reappointment criteria were, "Current demonstrated competence and an adequate volume of current experience with acceptable results in the privileges requested for the past 24 months as a result of quality assessment/improvement activities and outcomes." The MSC stated there are no volume requirements for reappointment for the core privileges or for the special procedure privileges. The OPPE scorecard-OB/GYN for MD 3 included 24 months of cumulative data, separated into six month time periods. There were OB/GYN specific indicators being monitored for all physicians in the OB/GYN group. The report indicated either a zero or "no occurrences" for the most recent six month period as well as the cumulative 24 month period for most of the indicators including Birth Trauma, Neonatal Birth Injury, and OB complications, post operative hemorrhage, and total number of Peer Review cases reviewed, and the report indicated all of MD 4's peers (OB/GYN physicians) had the same data. The MSC and DQ were asked if data is being collected for these indicators since it is unlikely there would be zero or no occurrences for all of them for a two year period. The DQ stated she would provide a list of the indicators which have data reported.

During a record review on 3/12/24 at 3:25 p.m., the list provided by the DQ of the OPPE indicators for which data is being reported for physicians was reviewed. The indicator list did not include Neonatal Birth Injury, OB Complications, and Birth Trauma. There was no explanation provided as to why those indicators are on the OPPE report cards for the OB/GYN physicians and reported as no occurrences or zero instances when no data was being collected.

During a concurrent interview and record review on 3/12/24 at 3:30 p.m. with the MSC, MD 5's credential file was reviewed. The file indicated MD 5 was an orthopedic surgeon who was initially appointed to the medical staff on 3/5/20, and who was last reappointed to the Active Medical Staff on 3/1/24. A review of the privilege request form for orthopedic surgery indicated the Observation/Proctoring requirements were "Appraisal shall be based on observation, which shall include proctoring, of at least six cases, at least three of which must be major cases, unless otherwise specified." The six forms "Surgery Service-Proctoring Report" were reviewed. The top of the form included the information regarding the number of cases required to be proctored and the instruction to the proctor completing the report, "A prompt written report shall be submitted to the Service Chief by the observer, not more than two weeks following the procedure performed. It is the responsibility of the surgeon to obtain a qualified observer before the procedure is scheduled." Review of the six forms indicated all of the forms had been signed by the proctor on 2/17/21. The first proctored case was performed on 7/2/20 and listed two names as proctors. The section of the form with the proctor's assessment of the physician's Pre-operative evaluation was left blank, as was the section of the form where the proctor's assessment of the post operative care provided. The MSC stated the form should have been filled out completely. In the section for the proctor to indicate the "Dates patient chart has been reviewed and comments," has two dates 7/2/20 and 2/17/21. The form is signed and dated 2/17/21. The signature is illegible and the MSC was unable to determine which of the two physicians listed as proctors signed the forms. The MSC stated it was important to know who the proctor was and stated the form needed a place for the physician to print his name. There was no indication on the proctoring report form whether this case was directly observed in the operating room during the procedure. There was no place on the form indicating whether the proctoring was done retrospectively or concurrently. The MSC stated they do not require that information.

Review of the second proctoring review form indicated the case was performed on 7/8/20. There was one physician listed as the proctor. The section of the form with the proctor's assessment of the physician's Pre-operative evaluation was left blank. There were two dates of review written on the form, 7/28/20 and 2/17/21. Since the procedure was on 7/8/20, this case likely was not concurrently proctored.

Review of the third proctoring review form indicated the case was performed on 10/5/20 and two names were listed as proctors. The form was complete, and the dates of review were 10/5/20 and 2/17/21, and the form was signed on 2/17/21. The signature was illegible. There is no indication on the form as to whether the case was directly observed by the proctor.

Review of the fourth proctoring review form indicated the case was performed on 10/30/20 and one name was listed as proctor. The form was complete except the post operative diagnosis was left blank. The dates of review were listed as 10/28/20 and 2/17/21, and the form was signed on 2/17/21. The signature was illegible. There is no indication on the form as to whether the case was directly observed by the proctor. The MSC stated it is not clear why the review would be two days before the date of the procedure and nothing on the day of the procedure.

Review of the fifth proctoring review form indicated the case was performed on 11/2/20 and one name was listed as proctor. The section of the form with the proctor's assessment of the physician's Pre-operative evaluation was left blank. The dates of review were 11/2/20 and 2/17/21, and the form was signed on 2/17/21. The signature is illegible. There is no indication on the form as to whether the case was directly observed by the proctor.

Review of the sixth proctoring review form indicated the case was performed on 12/28/20 and two names were listed as proctors. The form was complete, and the dates of review were 12/28/20 and 2/17/21, and the form was signed on 2/17/21. The signature was illegible. There is no indication on the form as to whether the case was directly observed by the proctor.

During a review of the hospital's policy and procedure (P&P) titled, "Medical Staff Peer Review," dated 5/18/21, the P&P indicated, "...PURPOSE: To ensure that the hospital, through the activities of its Medical Staff, assesses the Ongoing Professional Practice Evaluation [OPPE] of individuals granted clinical privileges and uses the results of such assessment to improve care...Peer Review: The evaluation and improvement of an individual practitioner's professional performance by other duly authorized practitioners for the core competencies... OPPE: The routine monitoring and evaluation of current competency for practitioners with granted privileges, primarily through the use of aggregate data and systematic case review...The Medical Staff will use the provider-specific peer review results in making its recommendations to the hospital regarding the credentialing and privileging process...Performance Measurement and OPPE/FPPE: Measures of practitioner performance will be selected to reflect the six core competencies using multiple sources of data..."

During a review of the hospital's document titled, "Medical Staff Bylaws," dated 4/1/21, the document indicated, "...The name of this organization shall be Medical Staff of [Hospital A]. The purpose of this organization shall be:...To strive to provide a high level of professional performance of all practitioners authorized to practice in the Hospital and through appropriate delineation of the clinical privileges that each practitioner may exercise in the Hospital and through an ongoing review and evaluation of each practitioner's performance in the Hospital...The Medical Staff's rights and responsibilities shall include:...To account to the Board of Directors for the quality and safety of patient care provided by all Members authorized to practice in the Hospital through the following measures: ... A credentials program, including mechanisms of appointment, reappointment and the matching of Clinical privileges to be exercised or specified services to be performed with the verified credentials and current demonstrated performance of the Medical Staff applicant or Member...The Medical Staff shall be divided into the following categories: Provisional, Active, Courtesy, Consulting and Telemedicine Staff...The Provisional Medical Staff: All initial appointments to the Medical Staff shall be to the Provisional category for a minimum period of one year, during which time the practitioner shall be subject to observation. The purpose of the observation is to enable the Medical Staff to determine eligibility for regular Staff membership and for exercising those clinical privileges provisionally granted. Such observation shall encompass those procedures customarily utilized for this purpose, including, but not limited to, concurrent and/or retrospective chart review, any required consultation, and direct proctoring. Proctoring as used in these Bylaws shall mean the direct observation of the proctored practitioner's diagnosis or treatment of an individual patient, by a qualified member of the Medical Staff in good standing. Ordinarily observation shall include a chart review and proctoring performed on no less than six (ICU-no less than three) medical cases by Staff members who serve as observers at the request of the Service Chief. Observation may also include review of observation reports obtained from other hospitals in the case of Provisional Staff members whose primary practices are at hospitals other than [Hospital A] ... In certain circumstances the Medical Executive Committee [MEC] may extend the provisional appointment for a period not to exceed one additional year..."

"Observation of Surgery and Anesthesia Privileges- In the case of surgery and anesthesia, appraisal shall be based on observation, which shall include proctoring, of at least six cases...such observation shall be done by a qualified observer, defined as an Active member in good standing of the Medical Staff who has the privilege to perform the procedure to be observed...Observations shall include an opinion of the pre-op and post-op care of the patient. A prompt written report shall be submitted to the Service Chief, by the observer, not more than two weeks following the procedure..."

"The Active Medical Staff: the member has principle place of practice (more than 20%) in [Name of City where Hospital A is located], has attended a minimum of 50% of department staff and assigned committees...The Courtesy Medical Staff: staff who are qualified for Staff membership but who only occasionally admit patients to the Hospital, or who are ineligible for Active Staff by reason of residence or office location, or the failure to meet attendance requirements... Courtesy Staff members must show evidence they are Active Staff members at an accredited acute care hospital...The Consulting Medical Staff: shall consists of specially qualified physicians for whom there is a need for patient consultations and for review of records that are referred from Medical Staff meetings. Must be an Active Staff member in good standing in an accredited hospital and must have privileges in the field he/she is reviewing..."
"In order for the Medical Executive Committee to make a recommendation to the Board of Directors concerning an applicant for appointment or reappointment to the Medical Staff, there must be adequate information for a comprehensive evaluation of the applicant's training, experience and background as measured against the unique professional standards of this Hospital."

"...Reappointment and Requests for Modification of Staff Status or Privileges...The reapplication form shall include all information necessary to update and evaluate qualifications of the applicant...The information requested may include, but not be limited to: Professional and clinical performance, including his/her patterns of practice, based at least in part on the findings of performance improvement measures, such as peer review, utilization management, infection control activities, medical record review, and pharmacy and therapeutics activities...The Medical Staff, in addition to criteria for Privileges shall develop areas of "general competencies" by which all Hospital Practitioners shall be measured for current proficiency. Each service shall define how to measure these general competencies as applicable to that Service and use them to regularly monitor and assess each Practitioner's current proficiencies on an ongoing basis..."

"...Basis for Privileges Determination: The Medical Staff shall make an objective and evidence based decision with regard to each request for privil

Based on interview and record review, the hospital failed to have an organized nursing service that provides 24-hour nursing services when:

1. Registered nurses failed to follow policies and procedures when vital signs, assessments, interventions and documentation was not performed in accordance with the code blue and rapid response team policies for four of four patients (Patient 1, Patient 2, Patient 3, and Patient 4). (refer to A398)

2. Registered Nurses did not follow physicians' orders in administering medications for four of five patients (Patient [Pt] 1, Pt 2, Pt 4 and Pt 5). For Pt 1 dopamine administration was started without clinical indication and not in accordance with administration goal criteria in physician order. Dexmedetomidine titration for Pt 2 was not followed per physician order. For Pt 4 the administration dose for Fentanyl was started at the higher initial dose rate of 100 mcg/hr on 2/7/24 at 9:21 p.m. than the physician medication order to start administration at 25 mcg/hr. For Pt 5's hyperglycemia (high blood sugar), the Insulin dose rate was not titrated hourly in accordance with the Physician MO of Insulin Algorithm (guidance to assist nurses in titrating insulin dose to maintain a goal blood glucose level). (refer to A405, findings 1, 2, 3 and 4)

The cumulative effect of these systemic problems resulted in the hospital's inability to provide care in a safe and quality manner.

Based on interview and record review, the hospital failed to ensure registered nurses followed policies and procedures when vital signs, assessments, interventions and documentation was not performed in accordance with the code blue and rapid response team policies for four of four patients (Patient 1, Patient 2, Patient 3, and Patient 4).

These failures resulted in missed opportunities to identify early warning signs of worsening clinical conditions and the need for resuscitation for Patients 1-4.

Findings:

During a concurrent interview and record review on 3/6/24 at 10 a.m. with the Med-Surg/ICU Assistant Nurse Manager (ANM), Pt 1's medical record, dated 3/3/23 was reviewed. The record indicated Pt 1's vital signs at 7:18 p.m. temperature 97.5 degrees Fahrenheit (F), heart rate 114 beats per minute (bpm), respirations 22 per minute, blood pressure 128/61 millimeters of mercury (mmHg), oxygen saturation 92% on oxygen 3 liters per minute (L/m). There was no documentation in the medical record of Pt 1's oxygen saturation between 7:18 p.m. and 8:30 p.m. Review of the Rapid Response (RR) record completed by the Rapid Response RN (RRN), indicated a RR was called on 3/3/23 at 8:35 p.m., the respiratory therapist (RT) was notified, and the RR ended at 8:42 p.m. when a code blue was called. The RR record indicated, "Rapid Assessment and Treatment-assessment summary: Pt found unresponsive, O2 [oxygen] off, no IV [intravenous] access. When arrived, O2 sat [saturation] 50-60%, went to 0, no pulse, code blue called overhead, CPR started. Pt intubated and transferred to ICU." There was no documentation regarding what happened during those seven minutes, and the section of the RR record for the documentation of the vital signs and patient assessment was left blank except for one untimed entry of an oxygen saturation of 77%. The RR record was signed by the RRN. Review of the code blue record dated 3/3/23, indicated a code blue was called at 8:42 p.m. when Pt 1 had no pulse and no blood pressure. The code blue record indicated at 8:44 p.m., Pt 1 was given 1 milligram (mg) of epinephrine and 50 milliequivalents (mEq) of bicarbonate; at 8:45 p.m., Pt 1's rhythm was ventricular tachycardia, Pt 1 was defibrillated, and also received 1 gram of calcium chloride IV; at 8:48 p.m., Pt 1 was given 150 mg of amiodarone IV and was intubated by the Emergency Department (ED) physician. The code blue record indicated the event was over at 8:48 p.m. when Pt 1 had return of circulation. There were no vital signs documented on the code blue record. The spaces on the form where the respirations, either spontaneous or assisted, would have been documented was left blank, the spaces where the pulse, either spontaneous or compressions, would have been documented was left blank, and the spaces where the blood pressure would have been documented had only one entry at the start of the code at 8:42 p.m. which indicated Pt 1 had no blood pressure. The next vital signs in the record are at 9:30 p.m. after Pt 1 had been transferred to the ICU. Review of the cardiac monitor strips for 3/3/23, indicated a monitor strip had been saved at 8:10 p.m. and indicated Pt 1's heart rate was 94 bpm. There were no saved monitor strips during the RR event. The next monitor strip in the record was at 8:46 p.m. when Pt 1 was being defibrillated, and the one after that was at 9:20 p.m. Review of the "Care Team Note" dated 3/3/23 at 9 p.m. and signed at 11:24 p.m. by RN 2, indicated, "8:30 p.m. noticed patient oxymask was off, put mask back on and checked O2, patient sating [referring to oxygen saturation] in 50s-60s [%]. Notified RT. 8:35 p.m. called rapid response overhead. 8:40 p.m. called code blue overhead, ED MD at bedside. 8:49 p.m. notified MD. MD aware and came to bedside. 8:55 p.m. notified family about patient's current condition. 9:10 p.m. patient transferred to ICU. 9:10 p.m. report given to [name of RRN]." There was no assessment or vital signs by RN 2 at 8:30 p.m. when Pt 1 was found with oxygen saturations in the 50s-60s prior to the rapid response call. There was no information in the record regarding the alarm on the pulse oximeter monitor being triggered and heard when Pt 1's oxygen saturation dropped. The ANM stated she did not have any information regarding the alarm on the monitor. The ANM stated typically the monitor would be set to alarm if the oxygen saturation drops to 88%. The ANM stated the primary nurse would have been the one taking vital signs and should have documented them. The primary nurse should have run a monitor strip during the rapid response and code and scanned it into the record. The ANM stated the RRN and the primary nurse (RN 2) no longer work at the hospital.


During a review of Pt 2's History & Physical (H&P) dated 1/30/24, the H&P indicated, Pt 2 who had a history of Diabetes, Hypertension (high blood pressure), and Atrial fibrillation (Abnormal heart rhythm with extremely fast and irregular beats) came to the Emergency Department with shortness of breath and was admitted to telemetry (Unit where patients have continuous cardiac monitoring-Electronic signals are transmitted from the electrodes and leads on a patient to a central monitor where they are stored and interpreted) on 01/30/24 with acute respiratory failure.

During a concurrent interview and record review on 3/11/24 at 9:00 am. with the ANM, Pt 2's medical record, dated 1/30/24 to 2/4/24 was reviewed. The record indicated Pt 2 was in the ICU on 2/4/24. RN 11's nurses note dated 2/4/24, indicated, "... 0213 [2:13 a.m.] Call to eICU, by [RN 12] re: pt's status, HR still uncontrolled, pt trying to pull off his BiPAP mask and getting extremely restless. Precedex on max dose. 0426 [4:26 a.m.] Code Blue called. Started pt on compressions. Pt's HR suddenly dropped from 130's down to 100's and then dropped further. [MD 7- (Pt 2's attending physician)] informed ..." The ANM was unable to find any documentation that indicated MD 7 was notified when the eICU physician was notified or at any other time prior to the code. The ANM stated the eICU physician ordered digoxin (medication used to improve the strength and efficiency of the heart, or to control the rate and rhythm of the heartbeat) but the record did not indicate it was administered. The ANM stated she does not know why MD 7, who was in the hospital, was not contacted or updated until after the code. The ANM stated there is no documentation by MD 7 to indicate interventions or assessment by MD 7 on 2/4/24 between 2:13 a.m. and 4:26 a.m. when Pt 2 coded. Review of the code blue record indicated Pt 2 coded twice on 2/4/24. The first code was on 2/4/24 at 4:26 a.m. until 4:50 a.m. and ended due to return of circulation. The second code occurred four minutes later on 2/4/24 at 4:54 a.m. and efforts were terminated at 5:07 a.m. and the nurses note indicated Pt expired and was pronounced by MD 7. The ANM stated MD 7 was not listed on the code blue record as being present during the code, MD 8 was the physician present. The ANM was unable to find any documentation in the record by MD 7 or MD 8 pronouncing the patient dead. Review of the code blue record indicated no vital signs were documented for either code, and the electronic medical record did not reflect that vital signs were assessed every five minutes. The ANM stated vital signs should have been attempted every five minutes and documented on the code blue record. The ANM stated she could not locate a cardiac monitor strip for the first code, but there was one for the second code. The code blue record indicated Pt 2 was intubated during the first code, but the ANM was unable to find any documentation by MD 7 or MD 8 regarding intubation.

During a review of Patient 3's medical record, the "Emergency Department [ED] Provider note" dated 3/4/24 indicated Patient 3 was brought to the ED by ambulance on 3/4/24. The note indicated Pt 3 received CPR while in the ambulance on the way to the hospital and had an LMA (Temporary method to maintain an open airway as an immediate life-saving measure in a patient with a difficult or failed airway) inserted.

During a concurrent interview and record review on 3/12/24 at 9:30 a.m. with the ANM, Patient 3's medical record was reviewed. Review of the code blue record (form where the details of the code blue are documented) indicated on 3/5/24 at 3:02 a.m., a code blue was called, CPR was started, and efforts were terminated at 3:23 a.m. There were no vital signs documented on the code blue record or in the electronic health record (EHR). The code blue record indicated Pt 3 was on a cardiac monitor, Pulse oximeter (electronic device that measures the saturation of oxygen carried in red blood cells) and a Blood Pressure (BP) monitor. There was no documentation on the code blue record or in the EHR indicating staff were unable to obtain vital signs. The ANM stated she was unable to locate any cardiac monitor strips in the record that were printed and scanned into the record during the code.

During a review of Pt 4's medical record, the History and Physical (H&P)," dated 2/7/24, indicated, on 2/7/24, Pt 4 was found at home with altered mental status. When Emergency Medical Services (EMS) arrived, Pt 4 had pinpoint pupils, and was given Narcan (a medication given to reverse the effects of an opioid overdose) and brought by ambulance to the ED.

During a concurrent interview and record review on 3/11/24 at 1:30 p.m., with the ED Manager (RNM 3), Patient 4's medical record was reviewed. Review of record indicated Pt 4 arrived in the ED on 2/7/24 at 4:07 p.m., was triaged at 4:21 p.m. and assigned an Emergency Severity Index (ESI) level of 2 (ESI 2- a high risk patient who should not wait to be seen by a physician). At 4:35 p.m., Pt 4's Glasgow Coma Scale (a system to "score" or measure a person's level of consciousness, a score of 3 is unconscious, 15 is fully awake and responsive) was 14, and his fall risk score was 11. (need to define what this means- moderate or high risk, etc). The record indicated a CT scan was ordered at 4:36 p.m. and RNM 3 stated Pt 4 was transported by the CT tech to radiology in a wheelchair for the CT scan. The RNM stated the RN did not document what time Pt 4 left the ED, and the RN did not accompany Pt 4 to the CT and Pt 4 was not on a monitor when he was taken to CT. The code blue record indicated Pt 4 coded at 5:15 p.m. in CT. At 5:17 p.m., Pt 4 was given 4 mg of Narcan. The code blue record indicated at 5:27 p.m., Pt 4 was in sinus rhythm, was intubated at 5:29 p.m., and the code continued until 5:57 p.m. There were no vital signs documented in the ED record from 4:15 p.m. until 6 p.m., and on the paper code blue record there were no vital signs documented between 5:17 p.m. and 5:44 p.m., then vital signs at 5:44 p.m. and not again until 5:57 p.m. when the code ended. RNM 3 validated the vital signs were not done in accordance with the hospital policy of every 5 minutes during a code. RNM 3 stated the RN should not have sent Pt 4 unaccompanied and without monitors to radiology for a CT scan.

During a review of the hospital's policy and procedure (P&P) titled, "Code BLUE: Cardiopulmonary Resuscitation [CPR] - Adult, Pediatric & Newborn Patients," dated 6/21/22, the P&P indicated, "When a Code Blue is called and resuscitative measure are initiated, a member of the nursing team shall record the sequential events and other data on the code blue sheet. Complete as follows...initial monitor reading, procedures to include respiratory assist, chest compressions, lab studies, EKG...Defibrillation-if done, complete joules used, response and time for each defibrillation ...Vital Signs ...record at time Code started and include BP, Pulse, resp and pupillary response. Record each subsequent 5 minutes or as indicated ...ABG determinations...Report incident...Resuscitative Performance Review- the Resuscitative Performance Review Form is to be completed by the nursing supervisor and forwarded to the Chairman of the Code Blue Committee [Quality Department]. A copy of the code blue record must be attached to the review form..."

During a review of the P&P titled, "Rapid Response Team (RRT) Interventions, Standardized Procedure," dated 3/16/23, indicated, "...The RRT brings immediate critical care expertise to the patient. RRT is available to provide a higher level of nursing and respiratory therapy assessment and intervention until the patient's physician arrives. The intent is to "rescue" the patient prior to a full cardiopulmonary arrest and to expedite transfer to a higher level of care when necessary...RRT roles and responsibilities- The primary nurse [staff nurse assigned to the patient]-Document RRT actions and interventions...complete RRT documentation record...RRT leader [Critical Care RN]-Perform intensive patient assessment...Respiratory Therapist-Perform an intensive respiratory assessment...The RT will be responsible for airway management, providing oxygenation and respiratory treatments, obtaining EKGs, and blood gases. Documentation- The following documentation will be completed for each RRT event: RRT Documentation record: Document all nursing and respiratory interventions. A copy will be scanned into the patient's electronic medical record and placed in the ICU manager's mailbox. Submit completed document to the Code Blue committee for review. RRT Data Collection Record: submit to the code blue committee for review. Care Team Note: The primary nurse will document a Care Team Note within the patient's electronic medical record. The note should include the following:...Assessment findings, Interventions, outcome...Incident Report: Primary Nurse will complete prior to the end of the shift to include summary of RRT event, debriefing information...The Code Blue Committee will review all RRT events for: functionality of team and structure, findings from debriefing, educational opportunities for physicians and staff, failure to respond and recognize, need for additional review..."

Based on interview and record review, the hospital failed to ensure registered nurses (RNs) administered medications in accordance with physician orders for four of five patients, (Patient [Pt] 1, Pt 2, Pt 4, and Pt 5) when:

1. On 3/4/23 RNs administered Dopamine (medication use to treat low blood pressure, low heart rate, and cardiac arrest) & Dexmedetomidine for Pt 1. Dopamine administration was started without clinical indication and not in accordance with administration goal criteria in physician order. RNs did not follow the physician's Medication Order (MO) for Dexmedetomidine titration dose for 0.10 mcg/kg/hour every 10 minutes and Pt 1 was administered higher dose three times between 3/4/23 at 2:00 p.m. to 3/4/23 at 3:15 p.m.

2. On 2/2/24 at 0800 administration of Dexmedetomidine (medication to keep you asleep) continuous infusion was stated by RNs for Pt 2 at 0.4 [micrograms (mcg-unit of measurement) per kilogram (kg-unit of measurement) per hour (hour- time)] higher than the physician MO to start administration at 0.2 mcg/kg/hr and RNs did not follow the physician MO for Dexmedetomidine titration (slowly increasing the dose of a medicine to see how your body will react to it) dose for 0.10 mcg/kg/hour every 10 minutes. Pt 2 was administered higher dose for titration than the physician order four times between 2/2/24 at 8:00 a.m. to 02/4/24 at 3:06 a.m.

3. On 2/7/24 RNs administer Fentanyl (medication used for pain relief) and Norepinephrine (medication used for blood pressure support in serious condition) for Pt 4. The administration dose for Fentanyl was started at the higher initial dose rate of 100 mcg/hr on 2/7/24 at 9:21 p.m. than the physician MO to start administration at 25 mcg/hr. RNs did not notify the physician or obtain an order. RNs did not follow the physician MO for Norepinephrine titration dose for 1mcg/min and Pt 4 was administered higher dose than physician MO five times between 2/7/24 at 7:35 p.m. to 2/7/24 at 8:21 p.m.

4. On 3/7/24, RNs administered insulin continuous intravenous drip (administration of a fluid into a blood vessel, usually over a prolonged period of time) for Pt 5 to treat hyperglycemia (high blood sugar) and Insulin dose rate was not titrated hourly in accordance with the Physician MO of Insulin Algorithm (guidance to assist nurses in titrating insulin dose to maintain a goal blood glucose level) on 3/7/24 at 01:04 a.m. util 3/7/24 at 5:07 a.m. RNs paused the insulin administration 3/7/24 at 5:07 a.m. until 3/7/24 at 7:57 a.m. without first notifying the physician and obtaining a physician order. RNs did not follow the "Insulin Algorithm" instructions to administer the insulin to target a goal of Blood Glucose of 120-180mg/dl.

These failures resulted in not providing the medication as written by physicians and placed patients at risk of harm, injury, and death. For Pt 5 the risk was not treating the hyperglycemia, For Pt 1, Pt 2, and Pt 4 the risk for ineffective pain management, sedation and ineffective blood pressure management.


Findings:


1. During a review of Pt 1's, "ED provider note," dated 3/1/23, the "ED provider note" indicated, Pt 1 brought in by ambulance to the ED on 3/1/23 due to discoloration of his urine, complain of abdominal pain, denies vomiting. Pt 1 had past medical history of COPD (is a common lung disease causing restricted airflow and breathing problems), CHF (congestive heart failure - is a chronic condition in which the heart doesn't pump blood as well as it should). Patient was admitted to the hospital due to pneumonia (is an infection in one or both lungs).

During a review of Pt 1's physician "MO", dated 3/4/23, the MO for Dexmedetomidine indicated, " ...Ordered dose: 0-1.4 mcg/kg/hr ... Frequency: Titrate ...Admin Instructions ...Start at 0.2 mcg/kg/hr. Titrate by 0.10 mcg/kg/hr every 10 minutes to maintain a RASS score of -4 up to maximum dose of 1.4 mcg/kg/hr ..."

During a concurrent interview and record review on 3/6/24 at 3:30 p.m. with ANM, Pt 1's MAR dated 3/1/23 to 3/5/23 and physicians MO dated 3/1/23 to 3/5/23 were reviewed. The MAR indicated Dexmedetomidine administration was started on 3/4/23 at 10:30 a.m. at the initial dose of 0.2 mcg/kg/hr. The MAR indicated on 3/4/23 at 1400 administration time Dexmedetomidine dose rate was titrated from 0.2 mcg/kg/hr to 0.5 mcg/kg/hr higher than the physician MO to titrate Dexmedetomidine by 0.1 mcg/kg/hr every 10 minutes. The MAR indicated on 3/4/24 at 1500 administration time Dexmedetomidine dose rate was titrated from 0.5 mcg/kg/hr to 1 mcg/kg/hr higher than the physician MO to titrate Dexmedetomidine by 0.1 mcg/kg/hr every 10 minutes. The MAR indicated on 3/4/23 at 1551 administration time Dexmedetomidine dose rate was titrated from 1 mcg/kg/hr to 1.4 mcg/kg/hr higher than the physician MO to titrate Dexmedetomidine by 0.1 mcg/kg/hr every 10 minutes. ANM validated that these administrations were not done in accordance with physician MO for Dexmedetomidine. ANM stated there was no documentation in chart by nurses or physician for titration of Dexmedetomidine at a higher rate than physician.

During a review of Pt 1's Physician "MO", dated 3/4/23, the MO for Dopamine indicated, " ...Ordered Dose 0-20 mcg/kg/min ...Route: Intravenous ...Starting dose ...2.5 mcg/kg/min ...Titrate interval: Every 10 min ...Goal: MAP (mean arterial pressure - is an average calculated blood pressure in an individual during a single cardiac cycle) 65 ..."

During a review of Pt 1's Physician "MO", dated 3/4/23, the MO for Norepinephrine (Blood pressure support medication and used to treat low blood pressure and heart failure) indicated, "Ordered dose:0-20 mcg/min ...Route: Intravenous ...Starting dose 5 mcg/min ...Incremental dose: 1 mcg/min ...Titration Interval: Every 1 minute ...Goal MAP greater than 65 [millimeter of mercury (mmHg)- unit of pressure]

During a concurrent interview and record review on 3/12/24 at 11:58 with RN 1 and RNM 1, Pt 1's MAR dated 3/1/23 to 3/5/23, physicians MO dated 3/1/23 to 3/5/23, vitals dated 3/1/23 to 3/5/23, all nurses' notes and physician notes were reviewed. The MAR indicated on 03/4/23 at 7:41 p.m. Dopamine administration was started at 2.5 mcg/kg/min by RN 1. The MAR indicated Dopamine administration was stopped at 8:10 p.m. on 3/4/23. The MAR indicated patient was on Dopamine for 29 minutes. Pt 1's vitals indicated on 3/4/23 at 7:00 p.m. Pt 1's MAP was 90, on 3/4/23 at 7:19 p.m. Pt 1's MAP was 86, on 3/4/20 at 8:00 pm Pt 1's MAP was 92. The physician's MO for Dopamine indicated the goal MAP 65. Pt 1 vitals indicated patient MAP was already higher than goal when Dopamine was initiated. RN1 stated he remembered taking care of Pt 1. RN 1 stated he called the physician to get the verbal order for Dopamine at the start of his shift. RN 1 stated he "wanted to have another medication started to prepare for the night". RN 1 stated it was normal to have second medication running to avoid any crises in the middle of the night. RN 1 stated he did not file vitals and the documentation does not reflect what was going on with the patient. RN 1 stated physician did not come to the bed side to assess patient. RN 1 stated he discussed his plan to add another medication to support patient's blood pressure with physician and received a verbal order from physician. RN 1 stated he did not document anything regarding calling the physician for Dopamine order. RN1 stated he stopped the Dopamine due to increase in heart rate, notified the physician and documented in his notes. The MAR also indicated Pt 1 was receiving Norepinepherine administration at 12 mcg/min with MAP greater than 65 on 3/4/23 at 3:40 p.m. The MAR indicated no changes to administration dose on 3/4/23 from 3:40 p.m. to 7:00 p.m. The MAR indicated Norepinepherine administration dose was titrated down by RN 1 from 11 mcg/min at 7:00 p.m. on 3/4/23 to 6 mcg/min at 7:30 p.m. on 3/4/30 while the MAP was greater than goal of 65. RN 1 stated he was weaning patient of Norepinephrine to start Dopamine. RN 1 stated generally he would not start another medication for blood pressure if the MAP goal was met and medication that patient was on was already being titrated down to lower administration rate. RN 1 stated Pt 1's documentation of titration times was not documented accurately by him. RN 1 stated vitals were missing, and he did not get a chance to file them.

During an interview on 3/12/24 at 12:55 p.m. with RNM 1, the RNM 1 stated she was familiar with the Pt 1, and she have reviewed the medical record. RNM 1 stated it was her expectation that vital signs should have been documented every 15 minutes when the Dopamine and Norepinepherine administration were being titrated up and down or if the patient was unstable. RNM 1 stated she expected hourly documentation of vitals with no dose change while patient was on these medications for blood pressure support. RNM 1 stated verbal order were only for emergencies. RNM 1 stated in reviewing Pt 1 nurses notes, vitals, physician MO, and MAR she was unable to find documentation for the clinical need to start dopamine.

During an interview on 3/12/24 at 4:00 p.m. with the Director of Quality and Patient Safety (DQPS), the DQPS stated clinical pharmacist have reviewed the above findings and have validated these missed opportunities. The DQPS she expects staff to follow physicians order and administration instructions. The DQPS stated any titration with dose outside the physician order should be discussed with a physician and should have physician order. The DQPS stated it was important to titration with ordered dose was important to keep patient safe.

2. During a review of Pt 2's "History & Physical (H&P)" dated 1/30/24, the H&P indicated, Pt 5 with past medical history of Diabetes, Hypertension (high blood pressure, heart is working harder), Arterial fibrillation (Abnormal heartbeat with extremely fast and irregular beats) presented to ED with shortness of breath and was admitted to telemetry on 01/30/24 with acute respiratory failure.

During a review of Pt 2's physician "MO", dated 2/2/24, the MO for Dexmedetomidine indicated, " ...Ordered dose: 0-1.4 mcg/kg/hr ... Frequency: Titrate to See Admin instructions ...Admin Instructions ...Start at 0.2 mcg/kg/hr. Titrate by 0.10 mcg/kg/hr every 10 minutes to maintain a RASS score of -1 to -2 up to maximum dose of 1.4 mcg/kg/hr ..."

During a concurrent interview and record review on 3/11/24 at 9:00 a.m. with Assistant Nurse Manager (ANM), Pt 2's MAR dated 1/30/24 to 2/4/24 and physicians MO dated 1/30/24 to 2/4/24 were reviewed. The MAR indicated Dexmedetomidine administration was started at 0.4 mcg/kg/hr on 2/2/24 at 0800 higher than the physician MO to start administration at 0.2 mcg/kg/hr. The MAR indicated on 2/2/24 at 2:00 p.m. administration time the dose rate for Dexmedetomidine was titrated from 0.4 mcg/kg/hr to 0.2 mcg/kg/hr higher than the physician MO to titrate Dexmedetomidine by 0.1 mcg/kg/hr every 10 minutes. The MAR indicated on 02/3/24 at 10:00 a.m. administration time the dose rate was titrated from 0.4 mcg/kg/hr to 0.7mcg/kg/hr higher than the physician MO to titrate Dexmedetomidine by 0.1 mcg/kg/hr every 10 minutes. The MAR indicated on 02/3/24 at 7:40 p.m. administration time the dose rate was titrated from 0.8 mcg/kg/hr to 1 mcg/kg/hr higher than the physician MO to titrate Dexmedetomidine by 0.1 mcg/kg/hr every 10 minutes. The MAR indicated on 02/4/24 at 3:06 a.m. administration time the dose rate was titrated from 0.8 mcg/kg/hr to 1.4 mcg/kg/hr higher than the physician MO to titrate Dexmedetomidine by 0.1 mcg/kg/hr every 10 minutes. ANM stated there was no physician order to start Dexmedetomidine at 0.4 mcg/kg/hr. ANM stated she was unable to locate documentation as to why the rate was started at 0.4 mcg/kg/hr and not the physicians MO of 0.2 mcg/kg/hour. ANM also validated the above four titration doses were not done in accordance with physician MO. ANM stated the nurses should have documented and notified the physician if the patient was needing a higher dose than the physician ordered dose. ANM stated it was her expectations for staff to administer and titrate medications according to the physician instructions.

3. During a review of Pt 4's "History and Physical (H&P)," dated 2/7/24, the (H&P) indicated, Pt 4 with history of chronic renal failure was found in home altered with pinpoint pupils on arrival by Emergency Medical Services (EMS). Pt 4 was given Narcan 2mg and brought into the ED by EMS.

During a review of Pt 4's Physician "Medication Orders (MO)" dated 2/7/24, the MO for Fentanyl indicated " ...Ordered dose: 100 mcg/hr Route: Intravenous ...Admin instructions: Initial dose: 25 mcg/hr ...incremental dose 10 mcg/hr ...Titration interval: Every 30 minutes ... Maximum Dose: 100 mcg/hr.. Goal: RASS -1 to 0."

During a concurrent interview and record review on 3/11/24 at 9:20 a.m. with ANM, Pt 4's MAR dated 2/7/24 to 2/8/24 and physicians MO dated 2/7/24 to 2/8/24 were reviewed. The MAR indicated Fentanyl administration was started at the initial dose rate of 100 mcg/hr on 2/7/24 at 9:21 p.m. higher than the physician MO to start administration at the dose rate of 25 mcg/hr. ANM stated unable to find any documentation by nurses or physician as to why the Fentanyl was started higher initial dose of than the physician MO. ANM stated Fentanyl was started at max order dose and was not titrated in accordance with physician MO.

During a review of Pt 4's Physician "Medication Orders (MO)" dated 2/7/24, the MO for Norepinephrine indicated " ...Ordered dose 0-20 mcg/min (Minutes- Time) ...Route ...Intravenous ...Admin Instructions ...Starting dose 5mcg/min, incremental dose: 1mcg/min ... titration interval: 1 minutes ...goal ...SBP greater than 90 mm Hg ..."

During a concurrent interview and record review on 3/11/24 at 9:25 a.m. with ANM, Pt 4's MAR dated 2/7/24 to 2/8/24 and physicians MO dated 2/7/24 to 2/8/24 were reviewed. The MAR indicated on 2/7/24 at 7:35 p.m. administration time the dose rate for Norepinephrine was titrated from 6 mcg/min to 10 mcg/min higher than the physician MO to titrate Norepinephrine by incremental dose of 1 mcg/min and titration interval of one minute. The MAR indicated on 2/7/24 at 7:47 p.m. administration time the dose rate for Norepinephrine was titrated from 11mcg/min to 20 mcg/min higher than the physician MO to titrate Norepinephrine by incremental dose of 1 mcg/min and titration interval of one minute. The MAR indicated on 2/7/24 at 7:57 p.m. administration time the dose rate for Norepinephrine was titrated from 20 mcg/min to 18 mcg/min higher than the physician MO to titrate Norepinephrine by incremental dose of 1 mcg/min and titration interval of one minute. The MAR indicated on 2/7/24 at 8:10 p.m. administration time the dose rate for Norepinephrine was titrated from 18 mcg/min to 10 mcg/min higher than the physician MO to titrate Norepinephrine by incremental dose of 1 mcg/min and titration interval of one minute. The MAR indicated on 2/7/24 at 8:21 p.m. administration time the dose rate for Norepinephrine was titrated from 10mcg/min to 8 mcg/min higher than the physician MO to titrate Norepinephrine by incremental dose of 1 mcg/min and titration interval of one minute. ANM validated the above five titration doses were not done in accordance with physician MO. ANM stated the nurses should have documented and notified the physician if the patient was needing a higher dose than the physician ordered dose. ANM stated it was her expectations for staff to administer and titrate medications according to the physician instructions. ANM stated titrations done at a higher dose could harm the patient and affect patient's heart and blood pressure.


4. During a review of Pt 5's "History and Physical (H&P)" dated 3/7/24, the H&P indicated, Pt 5 brought in by ambulance to the Emergency Department (ED) with shortness of breath on 3/6/24 and was diagnosed with be in Hyperosmolar Hyperglycaemic State (HHS) complication of diabetes that happens when blood sugar levels are very high for a long period of time) and was admitted to the hospital on Medical-Surgical floor on 3/7/24.

During review of Pt 5's Physician "Medication Orders (MO)" dated 3/07/24, the MO for insulin indicated, " ...Insulin - REGULAR human (MYXREDLIN) (medication used to control blood sugar) 100 units (unit of measurement) in 0.9% NaCl 100 [milliliter (ml -unit of measurement)] IV (intravenous - medical technique that administers fluids, medications and nutrients directly into a person's vein) DRIP ...Frequency: Titrate ...Route: Intravenous ...Order rate ...0-75 ml/hr... Titrate ...Admin Instructions...Titrate according to blood glucose with rate adjustments as shown in the Insulin Algorithm table [Table with 4 levels, each level have blood glucose (BG) value ranges and required insulin dose adjustment for that BG value range next to it. Instructions with algorithm which dose level to start and how to move up or down dosage based on BG level] ..."

During a review of facility's "Insulin Algorithm", the "insulin algorithm indicated", " ...Goal blood glucose (BG) 121-180 [milligram (mg-unit of measurement) per deciliter (dL- unit of measurement of volume)]. When above goal range, target an hourly rate of decrease of 50-100 mg/dL ...Start at Level 1[dosage to start insulin based on patient medical history and BG] except for the following patients (Per provider order) ...Patient Monitoring ...Check BG hourly until within goal range for 4 consecutive hours, then check every 2 hours ...Moving Up/Down parameters (otherwise, if pt BG decreasing 50-100 mg/dL or BG 121-180, remain on current level. Re-Check BG in 1 hour"

During a concurrent interview and record review on 3/8/24 at 3:00 p.m. with the Registered Nurse manager (RNM) 3, Pt 5's "Medication Administration Record (MAR)," dated 3/7/24, physician MO for Insulin dated 3/7//24 and lab results for blood glucose dated 3/7/24 were reviewed. The MAR indicated Insulin IV administration to Pt 5 was started on 3/7/24 at 1:04 a.m. at the dose rate of 5 units/hour (hr - Unit of measurement for time). The MAR indicated insulin was paused at 5:07 a.m. and restarted at the dose rate of 5units/hr at 7:57 a.m. The MAR indicated no hourly changes were made to the administration dose on 3/7/24 from 1:04 a.m. until 5:07 a.m. when the insulin was paused. The RNM 3 validated the no changes were made to the dose rate between 1:04 am to 5:07am and Insulin was paused from 5:07 a.m. to 7:57 a.m. RNM 3 stated Insulin dose rate was not titrated hourly in accordance with the Physician MO of Insulin Algorithm. RNM 3 reviewed the laboratory results for blood glucose and validated blood glucose results on 3/6/24 at 11:34 p.m. was very high greater than 600 mg/dL, blood glucose on 3/7/24 at 2:05 a.m. was 537 mg/dL, blood glucose on 3/7/24 at 3:08 a.m. was 480 mg/dL, blood glucose on 3/7/24 at 3:59 a.m. was 424 mg/dL, blood glucose on 3/7/24 at 5:02 a.m. was 428 mg/dL. The RNM 3 stated patient blood glucose was greater than 450 mg/dL and based on Algorithm the initial starting dose rate of 5 units was accurate, however, the subsequent hourly titration were not done accurately. RNM 6 stated blood sugar remained higher than the goal range for blood glucose level of 121-180 mg/dL and the insulin rate should have been adjusted at 0200, 0300, 0400, & 0500 on 3/7/24 in accordance with algorithm. RNM 6 stated dose rate titration as required by the algorithm would have allowed better control of patient's blood glucose levels. RNM 6 stated unable to find any documentation or physician's order to pause insulin. RNM 6 stated protocol does not have any instructions to pause insulin. RNM 6 stated unable to find any indication or documentation by nursing staff for pausing insulin. RNM 6 validated Pt 5's blood glucose level on 3/7/24 at 5:02 a.m. was 428 mg/dL, on 3/7/24 at 6:01 a.m. was 391 mg/dL, on 3/7/24 at 7:06 a.m. was 412 mg/dL and was higher than the physician MO goal of blood glucose (BG) 121-180 mg/dL. The RNM 6 stated she expects all staff to follow algorithm to ensure that patients were getting safe dose as prescribed by physician.

During a concurrent interview and record review on 3/8/24 at 4:45 p.m. with the Director of Pharmacy (DOP), Pt 5's "Medication Administration Record (MAR)," dated 3/7/24, physician MO for Insulin dated 3/7//24 and lab results for blood glucose dated 3/7/24 were reviewed. The DOP stated titration of Insulin dose rate were not done according to the physician MO algorithm. The DOP stated nursing staff should have adjusted dose rate each hour using algorithm as the blood glucose level were outside the goal range. The DOP stated pausing insulin on 3/7/24 at 5:07 a.m. to 7:57 a.m. was not indicated.

Based on interview and record review, the hospital failed to have medical service that has administrative responsibility for medical records when:

1. Prompt completion of medical records through timely processing for quality assurance data for six of eight in a sample of expired patients was not done. (refer to A432)

2. Complete and accurate patient medical records for four of seven inpatients (Patient [Pt] 2, Pt 20, Pt 21 and Pt 22) were missing expiration summaries well beyond the required 15 days. (refer to A438)

3. There was not an accurate system of coding and indexing medical records for two of two inpatient deaths and failed to report six of 12 deaths. (refer to A440)

4. Did not provide an Accounting of Disclosures for Patient 1 upon request for a patient medical record release of information tracking. (refer to A441)

5. Accurate, timely and complete documentation of Code Blue events in 3 out of 5 such events in January and February of 2024 were not done. (refer to A465)

6. Accurate and timely discharge summary completion for four of six inpatient expirations (PT 2, PT 20, PT 21, and PT 22) in January - February 2024 were not done. (refer to A468)

The cumulative effect of these systemic problems resulted in the inability of the hospital to provide care in a safe and quality manner.

Based on interview and record review, the facility failed to ensure prompt completion of medical records through timely processing for quality assurance data for 6 of 8 in a sample of expired patients. This failure resulted in the facility not being in compliance with state law for a complete record within 15 days of discharge or expiration.

FINDINGS:

During an interview on 3/5/24 at 1:30 PM with Health Information Management Director (HIM-D) and HIM Manager (HIM-M) the organization and staffing for the facility's Medical Record Service was discussed. HIM-M covered three facilities in the Central Valley area, and for this hospital of 38 licensed beds there was a staff of 1.5 full time equivalents, to handle functions of some on-site Release of Information and quality checking of Scanning (when hardcopy documents are digitally committed to the Electronic Health Record /E.H.R.) for medical records. Scanning of documents were entered in the E.H.R. "as soon as possible" and by the area "point of service" scanners located in patient care areas. The medical record functions of E.H.R. Integrity were handled by a remote centralized staff for the hospital system by HIM-D. Also Coding and on-line Release of Information were done by remote centralized staff. Any question of patient medical record privacy were handled by a regional Privacy Officer. Information security (I.S.) of the E.H.R. were handled by the IS team, not HIM / Medical Records.

During a concurrent interview and record review on 3/8/24 with the Quality & Patient Safety Director (QPSD), HIM Director (HIM-D) and HIM Lead (HIM-L) a list of expired patients from 1/1/24 to 3/7/24 was reviewed with viewing of the patient electronic health record. (E.H.R.) navigated by the Assistant Nurse Manager (ANM) A list titled "Expired Patients for Prior Visit Departments" was provided by the facility's Healthcare Risk Officer (HRO) on 3/8/24 with patient information of 23 patients. During the interview and review, 6 of 23 patients listed were those who had expired at the facility between January 2024 and March 2024. Of these deaths from the facility's list, three were found to be incomplete and without an expiration summary in the medical records:

" PT 20, 97 year old female, expired 1/30/24 - without an expiration summary as of 3/8/24
" PT 21, 84 year old female, expired 1/8/24 - without an expiration summary
" PT 22, 86 year old female, expired 1/16/24 - without an expiration summary as of 3/8/24

During a record review on 3/8/24 of Code Blue (critical medical emergency involving cardiac arrest or respiratory failure) patients, it was discovered that PT 2, a 66 year old male who had a coded in the ICU for acute respiratory failure, had expired on 2/4/24 and was not reported by the facility on the expired patient list. PT 2's medical record was incomplete and without an expiration summary as of 3/8/24 and the medical record was missing vital signs documentation for 2/4/24.

During a record review on 3/8/24 of Code Blue patients, PT 1, a 75 year old male who had expired on 3/5/23, the medical record indicated that an Advance Directive (AD, a legal document that tells a physician instructions about one's health care and to name someone to make health care decisions) was in the record and when located in the E.H.R.. only page 1 of the AD with the patient's next of kin's signature. The Code Blue record (a hardcopy document with signatures of providers involved in the medical emergency event) for 3/5/23, showed a delayed date-stamp of 4/14/23 to indicate it was digitally scanned into the E.H.R. Vital record measurements were missing in PT 1's medical record for the 2000 nurse observation time on 3/5/23. Record review showed there was an erroneous insertion of a wrong patient's entry (female) on 3/4/23 mixed in with PT 1's medical record, that had not been corrected more than a year later as of 3/7/24.

During a review on 3/13/24 of the E.H.R. audit trail (a tracking of all entries in the electronic health record) of PT 1's medical records, late entries were noted on 1/9/24 for social worker notations. A clarification of the facility policy and procedure for medical record amendments and addendums (changes and additions to the medical record documentation) was requested on 3/8/24 from HIM-D, and was not provided by the facility.

During a review on 3/22/24 of a report from CDPH Vital Records for deaths at the facility from 1/1/24 to 2/29/24, a total of 12 patients were listed as inpatient expirations, with 6 of the 12 not reported by the facility on the list provided on 3/8/24 by the facility Healthcare Risk Officer (HRO) showing a failure to accurately track expirations.

Based on Interview and record review the facility failed to have a system and process for maintaining accurate and timely completion for inpatient medical records, with 4 of 7 known inpatient expirations in the first two months of 2024. Additionally, a lack of a correction process for mismatched medical records, improper documentation of patients that were expired and not discharged, plus out of date medical record backup forms did not assure accurately written medical records

FINDINGS:

During a concurrent interview and record review on 3/7/24, and 3/8/24 with the HIM-D and Assistant Nurse Manager (ANM), medical records were not accurately documented and had not been promptly completed as noted in viewing the E.H.R.s. In an sample review of expired patients in January - February 2024, 4 of 7 inpatient deaths were missing expirations summaries well beyond the state requirement for a complete medical record within 15 days ( PT 2, PT 20, PT 21, and PT 22),

During a record review on 3/8/24, the medical record for PT 1, a 75-year-old male who expired 3/5/23, had a wrong patient's information (female) in the E.H.R. documentation of 3/4 /23 not corrected with an amendment or addendum (adjustments or corrections for documentation). The Policy and Procedure for Amendment or Addendum was requested of the facility but was not provided. During an interview with PT 1's family on 3/6/24, the son stated that he had viewed a wrong patient's documentation in the medical records they had received and requested on 3/10/23.

During a review on 3/12/24, the backup medical record forms to be used when the E.H.R. (electronic health record) system is down due to power failure, natural emergency, or cyberattack (when the computer system is maliciously interrupted by external parties) were reviewed. The Backup forms are paper documents to be used in patient care areas including the Emergency Department and Medical/Surgical units. The medical records provided on 3/11/24 included forms that had not been updated since 2016 and did not mirror the medical record formats of the current electronic health record that would be usable for care providers.

Based on interview and record review, the facility failed to have an accurate system of coding and indexing medical records for two of two inpatient deaths and failed to report six of 12 deaths.

These failures did not permit timely or accurate retrieval of patient records.

FINDINGS:

During a concurrent interview and record review on 3/14/24 with the Assistant Nurse Manager (ANM) and ICU Nursing Manager (RNM1), PT 1's, a 75 year old male who expired on 3/5/23, medical record included documentation in the medical record "Coding Summary" indicating Sepsis as the principal final diagnosis. PT 1 was admitted from the Emergency Department on 3/1/23 for shortness of breath, treated for pneumonia,, and expired following a Code Blue event and intubation on 3/4/23. The medical record during PT 1's inpatient episode from 3/1/23 - 3/5/23 did not have supportive clinical documentation that treatment was rendered for sepsis, nor septic shock that is indicated as Present on Admission (POA) on the Coding Summary. On 3/17/24 the facility responded that the coding was in error and had been corrected.

During a record review on 3/17/24 for PT 2, a 66 year old male who expired on 2/4/24, the expiration summary had been completed on 3/14/24 and was amended from a principal diagnosis of Sepsis to "hypertensive heart disease with heart failure" (complications of high blood pressure that affect the heart) and myocardial infarction (heart attack). PT 2's discharge summary following amendment indicated Acute hypoxic respiratory failure ( severe lack of oxygen in the blood).

During a review of the patients who expired from 1/1/24 - 3/7/24, the indexing for expired patients was inaccurate and failed to include 6 out of 12 deaths in the listing provided by the facility on 3/8/24 reflecting that PT 2, PT 24, PT 25, PT 26, PT 27, and PT 28 were not reported as expirations on the list provided by the HRO on 3/11/24.

Based on interview and record review, the facility failed to be able to provide an Accounting of Disclosures for Patient 1 upon request for a patient medical record release of information tracking.

This failure had the potential to result in non-compliance with HIPAA federal law for the patient's right to Privacy.

FINDINGS:

During a concurrent interview and record review on 3/ 8 /24 with Health Information Management-Director (HIM-D), Assistant Nurse Manager (ANM) and Registered Nurse Manager (RNM)1, copies of the release of information requests and Accounting of Disclosures (information that describes a facility's disclosure of protected health information other than for treatment, payment, and health care operations upon patient request) for PT 1's medical record was requested. PT 1's son had requested copies of the medical record on 3/1/23 and 1/12/24. The Accounting of Disclosures is a patient right required in federal HIPAA law (Health Insurance Portability and Accountability Act of 1996). The accounting for PT 1 was provided on 3/11/24, and did not list the patient family release of information requests.

During the interview on 3/8/24, HIM-D stated that any patient could walk up to the HIM Department to make request for the Accounting of Disclosures. The request would then be forwarded to the Privacy Officer for fulfillment within a reasonable timeframe as per the federal rule in the Code of Federal Regulations Title 45 §164.512 for the HIPAA Privacy Rule.

Based on interview and record review, the facility failed to have accurate, timely and complete documentation of Code Blue events in 3 out of 5 such events in January and February of 2024.

This failure created gaps in care documentation at a critical juncture in time for patients with cardiac or respiratory problems.

FINDINGS:

During a concurrent interview and record review on 3/11/24 with Assistant Nurse Manager (ANM) and Manager of the ICU & Respiratory (RNM 1), the facility failed to have critical CODE BLUE documentation:
· PT 1's, 75 year old male who expired 3/5/23, medical record was missing 3/4/23's 2000 pm assessment for hourly nursing notes and physical assessment by night shift RN on 3/4/23. Additionally PT 1's Code Blue record was not scanned into the E.H.R. until 4/13/23 for the event which occurred on 3/4/23.
· PT 2's, 66 year old male who expired 2/4/24, medical record was missing vital signs documentation on 2/4/24. The documentation of an adverse reaction to Amiodarone (medication for treating heart rhythm) and Levaquin (antibiotic medication to treat bacterial infection) noted in the progress note by the MD to possibly be causing PT 2's liver failure was not thoroughly documented nor the decision by the patient to 'do not resuscitate'.
· PT 3/s (female patient) code sheet was missing vital sign documentation and EKG (electrocardiogram tracings for heart monitoring) strips during the code were not available ANM stated that there was no notation in the progress notes by the physician pronouncing PT 3 as expired.

During a review of the hospital's policy and procedure titled: "Code BLUE: Cardiopulmonary Resuscitations ..." with an effective date of 6/21/22, indicated the expectation for staff medical record entries " ...to include Lab studies, EKG etc ...Documentation ... Vital Signs ... record at time Code started and include BP, Pulse, resp and pupillary response. Record each subsequent 5 minutes or as indicated ..."

Based on interview and record review, the facility failed to have accurate and timely discharge summary completion for four of six inpatient expirations (PT 2, PT 20, PT 21, and PT 22) in January - February 2024.

This failure resulted in the lack of documentation for disposition and follow up care.

FINDINGS:

During a concurrent interview and record review on 3/8/24 with HIM-D and ANM, the E.H.R. medical records were viewed for all patients who had expired from the 1/1/24 to 3/7/24 list provided by HRO. Of 23 patients on the list, only 6 were those who expired at the facility. 3 of the 6 expired patients from the facility list were missing discharge/expiration summaries. The document referenced as a "discharge summary" for a patient death was confusing and misleading, and would be accurately titled as an "expiration summary".

During a record review of PT 1, a 75 year old male who expired on 3/5/23, the medical record is documented as a "Discharge Summary" for 3/5/23 which generated medical record pages for an after visit summary and discharge instructions for the patient from page 9 to 30 in the medical record. The final diagnosis of Sepsis and Septic Shock are not supported for clinical documentation for PT 1 who was primarily treated for pneumonia and respiratory issues.

During a record review of PT 2, a 66 year old male who expired on 2/4/24, the patient "discharge summary" was completed by the attending physician on 3/14/24, with amendments for the PT 2's code status and principal diagnosis of hypertensive heart disease.

During record review, 3 expiration summaries were missing as of 3/7/24 and not documented for PT 20, a 96 year old male who expired on 1/30/24, PT 21, an 83 year old male who expired 1/8/24, and PT 22, an 85 year old female, who expired on 1/16/24.

Based on the observations, interviews and record review, the facility failed to maintain a clean and sanitary environment to avoid sources and transmission of infection when:

1.One of three sampled Ice Machines (Ice Machine 1) had white crusty deposits and were not cleaned in accordance with the hospital's policy and procedure and manufactures instructions for cleaning, sanitizing and maintenance of the Ice Machines.

2. Two of the two blood gas analyzer systems (equipment use to run blood sample to do blood gas test (test that measures the oxygen, carbon dioxide and pH balance (essential for the human body to help organ systems function and perform necessary tasks like oxygenating the blood and digesting food) level in the blood) had dried blood on the sample port and were not cleaned in accordance with manufactures instructions.

3. Combined Clean/Dirty utility room with clean supplies were stored next to a hopper (a flushing rim sink with a bedpan (container used to collect urine or feces, and it is shaped to fit under a person lying or sitting in bed) rinsing device used for disposal of liquid clinical waste such as contents of vomit bowls, drainage bags, bedpans, and urine bottles).

4. Respiratory Care Supplies were stored approximately 25 feet outside of the hospital and was stored directly on the floor and was not stored in a temperature controlled environment.

As a result of these failures all patients, visitors and staff were at risk for transmission of infections (an infectious agent is transferred from a reservoir to a susceptible host) and cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and increased the potential for hospital acquired infections, illnesses, and injury.

Findings:

1.During a concurrent observation and interview on 3/5/24 at12:50 p.m. with Nurse Executive (NE) 1 and Registered Nurse Manager (RNM) 2, on the Family birthing unit, Ice Machine 1 had a crusty white build up around the ice dispensing spout. NE 1 stated the white crusty build up was calcium deposits. NE 1 stated Ice Machine 1 should had been cleaned and calcium deposits were not acceptable. NE 1 stated calcium deposit could potentially contaminate the ice. NE 1 stated she will follow up with the plant services team to get the Ice Machine 1 cleaned up.

During an interview on 3/5/24 at 12:54 p.m. with RNM 2, RNM 2 validated the white crusty deposits and stated white deposits were calcium deposit on the ice dispensing spout on Ice Machine 1. RNM 2 stated "Ice Machine 1's ice dispensing spout needs cleaning". RNM 2 stated environmental services (EVS) team was responsible for daily cleaning and works with plant services to sanitize the machine and any preventative maintenance. RNM 2 stated calcium deposit could potentially harbor germs and could spread diseases. RNM 2 stated Ice Machine with calcium deposit was not an acceptable practice.

During an interview on 3/11/24 at 9:37 a.m. with Plant services technician (PST) 1, PST 1 stated he has been working at the facility for 15 years. PST 1 stated he sanitized the machines every three months. PST 1 stated EVS team notifies him for the need for cleaning and sanitizing inside the spouts of the Ice Machines if they notice calcium build up. PST 1 stated his team would sanitize the machines as needed in between every three months. PST 1 stated he was notified of the calcium build up and the need to sanitize after observation on 3/5/24 at 12:50 p.m. by NE 1. PST 1 validated Ice Machine 1's ice dispensing spout had white calcium deposits. PST 1 stated he replaced the spout on Ice Machine 1 after the observation on 3/5/24 at 12:50 p.m. PST 1 stated spout had a lot of deposits and he was not able to clean. PST 1 stated due to hard water and repeated sanitizing it was hard to keep it clean and without calcium build up.

During an interview on 3/11/24 at 11:19 a.m. with the Infection Preventionist (IP), The IP stated she was aware of the calcium deposits on the Ice Machine 1. The IP validated the observation from 3/5/24 at 12:50 p.m. and stated her expectation was that Ice Machines were maintained clean without any white crusty or calcium deposits. The IP stated calcium deposits can create a place for bacteria to grow. The IP stated calcium deposits or dirty spouts of Ice Machines had the potential to risk patient safety by cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect).

During a review of the facility's Ice Machine's Manufacturers instruction for, "Cleaning and Sanitizing", dated 3/25/2020, indicated, " ... the maintenance schedule below is a guideline. More frequent maintenance may be required depending on water quality, the appliance environment, and local sanitation ...Every six months ...Icemaker and Ice Storge Bin ...Clean and sanitize per the cleaning and sanitizing instructions provided in this manual ...The icemaker must be cleaned and sanitized at least twice a year. More Frequent cleaning and sanitizing may be required in some conditions ..."

During a review of the facility's P&P titled, "Engineering 1.14: Ice Machine Maintenance & Cleaning", with an effective date of 3/31/2021, the P&P indicated, " ...All ice machines will be cleaned and sanitized, internally and externally, and have preventative maintenance performed according to specific manufacturer's recommendations ...The interior of the ice machines will be cleaned, sanitized and have preventative maintenance at least quarterly and/or as often as necessary ..."

2. During a concurrent observation and interview on 3/6/24 at 1:34 p.m. with the Lead Respiratory Therapist (LRT) & Assistant Nurse Manager (ANM) in blood gas lab room, two [brand name] blood gas system was observed. Sample ports for both blood gas systems appeared to have dried blood on it. The LRT validated the observation and stated the sample port was where syringes with blood gets attached and dried blood was from running the sample on the sample port. The LRT stated Respiratory Therapist (RT) assigned to Emergency Room on each shift was responsible to make sure the blood gas systems were clean, calibrated, and ready to use. The LRT stated sample port should be clean and without any dried blood on the sample ports. The LRT stated the facility have extra sample ports readily available and were very easy to change. The LRT stated he had access to instruction on how to change and clean sample port. The LRT stated it was not acceptable to have dried blood on the sample port.

During an interview on 3/6/24 at 1:36 p.m. with the ANM, the ANM stated dried blood on the sample port was not acceptable. The ANM validated the observation on 3/6/24 at 1:34 p.m. and stated dried blood on blood gas system and sample port could be a source for infections. The ANM stated it was her expectation that blood gas systems were kept clean and sample ports were being evaluated for cleanliness each shift.

During a concurrent interview and record review on 3/11/24 at 11:19 a.m. with the IP, facility's [brand name] blood gas system's operator guide, dated 2-2023 was reviewed. The operator guide indicated, " ...Cleaning and Disinfecting the Exterior Surfaces: Clean the exterior surfaces as needed to remove dust, dirt, and splatters from the surfaces, and disinfect the surfaces ... Follow this procedure to clean and disinfect exterior surfaces ...Moisten the cloth with the sodium hypochlorite (bleach) solution so that the cloth is wet but not dripping ....Wipe the exterior surfaces of the system with the wet cloth and then thoroughly dry the surfaces ...". The IP stated sample port should not be left with blood on it. The IP stated dirty sample port with blood or dried blood on it was not acceptable by infection prevention standards. The IP stated it was not acceptable to have blood splatters or dried blood on any equipment as it could potentially cause contamination and spread diseases The IP Stated the facility team will need to evaluate current practice to keep patients safe.

3. During a concurrent observation and interview on 3/12/24 at 1:12 p.m. with the IP, in the Intensive Care Unit (ICU), observed in a very small space, combined cleaned and dirty utility room stocked with clean supplies on one side, hopper on the other side. The hopper appeared to have black stains on the inside, rusted outside screws where it was attached to the floors, Plexiglass next to hopper appeared to have several stains on it. The IP stated due to limitation on space, this room was shared as clean and dirty utility room. The IP agreed the current set up had the potential to cause cross contamination. The IP stated the Plexiglass, and the hopper was not clean and it was not acceptable. The IP agreed in current set up if the staff was flushing hopper, it had the potential to contaminate clean supplies stored in the room. The IP stated this was the only place for staff to empty bed pans, dispose urine and bodily fluids and hopper was being used all the time. The IP stated this had the potential to spread infections and diseases among patients.

During an interview on 3/13/24 at 10:42 with the SQPD, the SQPD stated she was aware of the combined cleaned and dirty utility room in the ICU behind nursing station. The SQPD stated she was also concerned about the patient safety due to the potential for cross contamination with limited space within the room. The SQPD stated small plexiglass was not enough to eliminate the risk for cross contamination while using the hopper and disposing urine and rinsing the bed pan.

4. During a concurrent observation and interview on 3/5/24 at 12:30 p.m. with the Assistant Nurse Manager, the supply storage containers located approximately 25 feet outside of the hospital were observed. There were three metal storage containers, each approximately 15 feet long and 8 feet wide and 8 feet tall, placed side by side on a concrete surface. The ANM stated these storage containers had been here for years The door to storage container (SC) #1 was open. The ANM stated SC 1 was used to store respiratory therapy patient care supplies. Inside the SC 1 were large metal racks with wheels against the wall on either side. There were cardboard boxes full of supplies, some open and some closed, stored directly on the floor and on the shelves of the racks, including the top rack where the tops of the boxes were close to the ceiling. Also on the racks were rows of smaller open blue storage bins with many individual packages of respiratory care supplies. Some of the supplies were sterile, some were not. There was a portable suction machine stored next to the racks. The ANM stated, when there is a need in the hospital for this portable suction machine, the machine would need to be cleaned prior to being used. The ANM stated the storage containers are not monitored for temperature and are not temperature controlled. The ANM stated supplies that need to be stored in a temperature controlled environment, should not be stored in these containers. The ANM stated if there is a thermometer symbol on the supply package, that means it has temperature requirements for storage. There were several different items stored in this storage container that had a thermometer symbol on the outside. The ANM stated the temperature limit on the packages would likely not be exceeded. The ANM stated she did not know what other criteria determined whether patient care supplies could be stored outside in these containers. The floor on the storage container had visible dirt and the area of floor near the door was heavily soiled with dark colored debris. There were small leaves from outside on the floor inside the storage container. Inside the storage container, where the door and the front wall of the container met, light could be seen coming through. The inside surface of the door was dirty and there were visible streaks where moisture had run down from the top of the door. There were small cobwebs on the inside of the door. The ANM stated she did not know how often the storage containers were cleaned.

During a concurrent observation and interview on 3/5/24 at 12:45 p.m. with the ANM, supply storage container (SC #2) was observed. The ANM stated housekeeping supplies are stored in SC 2. Inside SC 2 were the same type of metal storage racks with wheels up against one of the long walls of the SC, and the opposite wall near the bottom had an area several feet long and approximately six inches wide where the wall had been smashed in and the space between the storage units was visible. Hanging on one of the metal racks were wire hangers holding patient room privacy curtains. There were racks on the back wall with boxes of supplies including toilet seat covers, cleaning solutions, and paper towels for dispensers. There was also a large housekeeping cart used by housekeeping staff in the hospital, and the wheels of the cart had visible debris. Hanging on one of the metal racks were wire hangers holding patient room privacy curtains. On the floor of the storage container and on the wire racks were cardboard boxes full of supplies, some open, some closed. There was a large open cardboard box containing privacy curtains stored on the floor. The floor was dirty and there were small leaves and dark debris on the floor. Inside the storage container, where the door and the front wall of the container met, light could be seen coming through. The inside surface of the door was dirty and there were visible streaks where moisture had run down from the top of the door. There were small cobwebs and leaves on the inside of the door and in the corner on the floor.

During a concurrent observation and interview on 3/5/24 at 1 p.m. with the ANM, supply storage container (SC # 3) was observed. The ANM stated SC 3 contained some office supplies and nursery equipment. SC 3 was packed full and could not be entered all the way due to the two large cribs stored there, one in need of repair. A mattress with a white fitted sheet in one of the cribs had dirt and debris. The wheels on the bottom of the cribs had debris. There were shelves along one of the walls which stored various unknown non-patient care items.

During a concurrent observation and interview on 3/5/24 at 1:20 p.m. with the ANM, in SC 1, there was an open blue storage bin on a shelf on the wire rack full of Arterial Blood Gas (ABG) sampling kits. The kits were sterile and contained a three milliliter (ml) syringe which contained heparin 23.5 units per ml, with a 23 gauge 1-inch needle attached, a 22 gauge 1.5 inch needle, and other supplies needed for obtaining a blood sample.

During an interview on 3/7/24 at 12:40 p.m. with the IP and the Director of Quality and Pt Safety (DQPS), the IP stated, she was not aware of the condition of the storage containers, or that cardboard boxes with patient care supplies were being stored in the containers. The IP stated cardboard boxes should not be used to store supplies, and supplies should not be stored directly on the floor. The IP stated the ABG sampling kits should not have been stored in the outside storage containers. Syringes with needles are to be stored in a secured area. The DQ stated the storage containers outside had not been a part of the environmental rounds made weekly by the IP and others.

Based on interview and record review, the hospital failed to meet the requirements for providing respiratory care services and meeting the needs of patients when:

1. Medical Staff did not develop, review and approve the policy and procedure "Respiratory Therapy: Scope of Services" in accordance with professional standards of practice and hospital policy and procedure. (refer to A1152)

2. The Medical Director of Respiratoy Services (MD 1 and MD 2) were appointed as medical directors prior to determining MD 1 and MD 2 had the knowledge, experience and capabilities to supervise and administer the service properly. (Refer to A1153)

3. Respiratory care services were not delivered in accordance with medical staff directives. (Refer to A1160)

4. Blood gases were not performed in the respiratory care unit in accordance with 42 CFR 482.27 and failed to meet the needs of patients when 10 of 15 Respiratory Therapists (RT 1, RT 3, RT 4, RT 5, RT 7, RT 10, RT 12, RT 14, RT 15, LRT)) did not have annual competency to perform blood gases. (Refer to A1162)

The cumulative effect of these systemic problems resulted in the hospital's inability to provide care in a safe and quality setting.

Based on interview and record review, the hospital failed to ensure the scope of respiratory care services was appropriate for the facility when medical staff did not develop, review and approve the policy and procedure "Respiratory Therapy: Scope of Services" in accordance with professional standards of practice and hospital policies and procedures. The Medical Director for respiratory service did not develop, review or have input into the scope of respiratory care services in the hospital. Instead, a registered nurse manager and lead respiratory therapist developed, reviewed and approved the scope of service for respiratory care.

These failures resulted in providing respiratory care services in the hospital without the benefit and expertise of medical staff input and review of respiratory care practices and placed all patients receiving respiratory care at risk of harm and injury.

Findings:

During a concurrent interview and record review on 3/6/24 at 1:34p.m. with the Lead Respiratory Therapist (LRT) and Assistant Nurse Manager (ANM), the facility's policy and procedure (P&P) titled, "Respiratory Therapy: Scope of Services," with an effective date of 5/2/23 was reviewed. The P&P indicated, " ...Review/Revised by ... RN [Registered Nurse]-Inpatient Services Manager & ... - RT [Respiratory Therapist] Lead 05/23 ...Approval signatures: Policy owner ...Manager, Inpatient Nursing 5/2/2023." The LRT stated he has been working at the facility since 2007. The LRT stated he was the lead for the respiratory therapists and was appointed to oversee policies for respiratory care services with hospital management. The LRT stated the team of Respiratory Therapists did not have any scheduled meetings with medical director. The LRT stated the team did not have a formal process for Respiratory Medical Director to meet and review policies and procedures. The LRT stated the P&P does not reflect under reviewer section that it was reviewed by medical director or any medical staff. The LRT validated the policy was only approved by the department manager and no physician or medical staff was listed under approver section. The LRT stated it was important for Medical Director to review the P&P to ensure RT team is working within their scope and avoid any unintended harm to the patient by practicing outside their scope. The ANM validated the scope of services was only approved by the Manager. The ANM stated she works with LRT to review policies prior to manager approval. The ANM stated Medical Director for Respiratory was very busy and rarely comes to the facility. The ANM validated no other medical staff was listed on the P&P "Respiratory Therapy: Scope of Services," as approver.

During a concurrent interview and record review on 3/8/24 at 12:01p.m. with Registered Nurse Manager (RNM) 1, the facility's P&P titled, "Respiratory Therapy: Scope of Services," with an effective date of 5/2/23 was reviewed. RNM 1 stated she was the manager for the team of Respiratory Therapists and the lead RT reported to her. RNM 1 stated the P&P for "Respiratory Therapy: Scope of Services" did not reflect that it was reviewed by the Respiratory Medical Director or medical staff. RNM 1 stated the P&P only list her as the approver and should have been approved formally by the Respiratory Medical Director and medical staff. RNM 1 stated she does not have any formal meeting minutes or agendas where scope of practice for Respiratory Therapy was discussed with Respiratory Medical Director or medical staff. RNM 1 stated she does not recall any formal meetings to discuss respiratory care services scope of services. RNM 1 stated it was her practice to only send new policies to Respiratory Medical Director or medical staff and she approves all revision to the existing policies without sending to medical staff. RNM 1 stated she was not able to validate if the scope was aligned with professional standards for Respiratory Therapy.

During an interview with the Senior Director of Quality Director (SDQ) on 3/13/24 at 10:32 a.m., the SDQ stated it was her expectation that Respiratory Medical Director reviewed all policies and procedures guiding the practice of Respiratory Therapy in the facility. The SDQ stated current policy "Respiratory Therapy: Scope of Service" does not have any medical director or any physician listed as approver on the policy. The SDQ stated without that she was unable to tell when the policy was last reviewed by the Respiratory Medical Director and she expected that RNM and LRT were making sure that respiratory policies meet professional standards and were approved by Respiratory Medical Director and approved by the medical staff in writing.

During an interview on 3/8/24 at 3:31 p.m. with the Medical Director (MD) 2, MD 2 stated he was the new Medical Director for Respiratory Therapy. MD 2 stated he had not reviewed the scope for Respiratory Services and was not able to comment why it was not approved previously by medical staff. MD 2 stated oversight of Medical Director on the Scope was critical to provide safe care to patients and to ensure that staff were performing care that met professional standards. MD 2 stated it was his expectations that going forward, all policies and procedures under respiratory services were reviewed and approved by medical director and medical staff.

During a concurrent interview on 3/8/24 at 4:00 p.m. with the Chief Nursing Executive (CNE), the facility's "Medical Director Agreement Pulmonary Services (MDAPS)," with an effective date of 3/1/24 was reviewed. The "MDAPS" indicated " ...Physician shall serve as Medical Director of the Service, shall be responsible for the overall supervision of the service and shall perform the specific duties and responsibilities ...Develop, or review and comment on, a policy, procedure, protocol or clinical pathways used for the effective operations of the Service, including the activities of the Hospital's clinical and technical personal ...In cooperation with Hospital's formal quality assurance program, develop and implement appropriate quality assurance activities for the Service ...Continuous review and development of written bylaws, clinical protocols, rule and regulations, including but not limited to the following ...Respiratory care services provided by qualified licensed employees ...". The CNE stated the current policy and procedures does not reflect that it was approved by Medical Director and medical staff. The CNE stated that she expected that Respiratory Services scope was reviewed by the Medical Director as outlined in the MDAPS. The CNE stated it was her expectation that department manager was routing the policy for appropriate approval process [routing Respiratory Services Scope policy to medical staff], and it appears that the process was not followed.

During an interview on 3/13/24 at 1:13 p.m. with MD 1, MD1 stated he was the medical director for the team of Respiratory Therapists from 3/1/22 to 3/1/24. MD 1 stated he met with the team informally as needed. MD 1 stated he was always available to the team and provided input on the policies. MD 1 stated he has reviewed many policies but does not have a formal approval process in place. MD 1 stated he does not recall if he had reviewed the scope of practice for the Respiratory care services.

During a concurrent interview and record review on 3/12/24 at 12:55 p.m. with RNM 1, the facility's P&P titled, "Policies and Procedures - Development and approval," with an effective date of 4/22/2021 was reviewed. The P&P indicated " ... All division and departmental patient care policies and procedures will be approved in collaboration with medical staff committee (s), as appropriate, the valley area board of directors and the administrative team ...Written policies and procedures will be developed and maintained by the person responsible for the service/policy area in consultation with other appropriate health care professionals ...Each Policy/procedure will list the name(s) and title (s) of the individual (s) who originally authored or most recently revised/reviewed the policy/procedures and date (M/yr) under the "Reference" section of the policy/procedure ...". The RNM 1 validated no physician or Medical Director was listed under reference section as approver of the "Respiratory Therapy: Scope of Services". The RNM 1 stated policy author was listed as unknown. The RNM 1 stated "Respiratory Therapy: Scope of Services" policy did not go through the facility's development and approval process as listed in the facility's "Policies and procedures - Development and approval" policy.

During a professional reference review retrieved from the American Association for Respiratory Care ((AARC) is the leading national and international professional association for Respiratory Care) (https://www.aarc.org/wp-content/uploads/2017/03/statement-of-scope-of-practice.pdf) titled, "Position statement: Respiratory Care Scope of Practice", dated 3/23, the reference indicated, " ...The practice of respiratory therapists is under the general direction of a physician ..."

During a professional reference review retrieved from the AARC (https://www.aarc.org/advocacy/aarc-model-practice-act/), "AARC Model Practice Act", indicated, " ...The practice of respiratory care may be performed in any clinic, hospital, skilled nursing facility, and private dwelling; or other place deemed appropriate or necessary by the Board; in accordance with the written or verbal order of a physician, and shall be performed under a qualified Medical Director ... Qualified Medical Director" means the medical director of any inpatient or outpatient respiratory care service, department or home care agency. The medical director shall be a licensed physician who has special interest and knowledge in the diagnosis and treatment of respiratory problems. The medical director should be qualified by special training and/or experience in the management of acute and chronic respiratory disorders. This physician should be responsible for the quality, safety and appropriateness of the respiratory services provided, and require that respiratory care be ordered by a physician who has medical responsibility for the patient. The medical director should be readily accessible to the respiratory care practitioners and should assure their competency ..."

Based on interview and record review, the hospital appointed Medical Doctor (MD) 1 to be the medical director of respiratory services prior to determining MD 1 had the knowledge, experience, and capabilities to supervise and administer the service properly. MD 1 was appointed from 3/1/2022 to 2/29/24 to be the medical director of respiratory services and did not have knowledge of and had not reviewed and commented on the policy "Respiratory Therapy: Scope of Services" in accordance with hospital policy and procedure. Respiratory Therapists provided day to day respiratory care services to patients in the hospital with no oversight by MD 1. MD 1 did not supervise respiratory care services provided to patients in the hospital and had not reviewed the competencies and training plan for Respiratory Therapists. Medical Doctor (MD) 2 was appointed to medical director for respiratory care services on 3/1/24 and had no knowledge and had not reviewed the policy Respiratory care: scope of services.

These failures resulted in the hospital providing respiratory care services without the benefit of having a medical director with knowledge, experience and oversight of the service and placed all patients requiring respiratory care at risk of harm and injury.


Findings:

During an interview on 3/5/24 at 1:52 p.m. with Respiratory Therapist (RT) 1, RT 1 stated she has been working at the facility for 10 years. RT 1 stated she did not know who the Medical Director for Respiratory Therapy was. RT 1 stated she does not recall her team having scheduled meetings, in-services, education, or training provided by Medical Director or other physician over the last few years. RT 1 stated she does not recall any physician listed under approval section on the Respiratory Therapy policies and procedures.

During a concurrent interview and record review on 3/6/24 at 1:34 p.m. with the Lead Respiratory Therapist (LRT) and Assistant Nurse Manager (ANM), the facility's policy and procedure (P&P) titled, "Respiratory Therapy: Scope of Services," with an effective date of 5/2/23 was reviewed. The P&P indicated, " ...Review/Revised by ... RN [Registered Nurse]-Inpatient Services Manager & ... - RT [Respiratory Therapist] Lead 05/23 ...Approval signatures: Policy owner ...Manager, Inpatient Nursing 5/2/2023." The LRT stated he has been working at the facility for 17 years. The LRT stated he was the lead for the respiratory therapist team and was appointed to oversee respiratory care policies and report to hospital management. The LRT stated respiratory therapist team did not have any scheduled meetings with the medical director. The LRT also stated the respiratory team did not have a process for Respiratory Medical Director to meet and review policies and procedures. The LRT stated the P&P, under reviewer section, does not reflect that it was reviewed by the medical director or any other medical staff. The LRT validated the policy was only approved by the department manager and no physician or medical staff was listed under approver section. The LRT stated it was important for the Medical Director to review the P&P to ensure Respiratory Therapy team was working within their scope (services that a qualified health professional is deemed competent to perform and permitted to undertake) and avoid any unintended harm to patients requiring respiratory care services.


During a concurrent interview and record review on 3/8/24 at 12:01 p.m. with Registered Nurse Manager (RNM) 1, the facility's P&P titled, "Respiratory Therapy: Scope of Services," with an effective date of 5/2/23 was reviewed. The P&P indicated, " ...Review/Revised by ...RN-Inpatient Services Manager & ...RT Lead 05/23 ...Approval signatures: Policy owner ...Manager, Inpatient Nursing 5/2/2023." RNM 1 stated she was the manager for respiratory team and the lead RT reported to her. RNM 1 stated the P&P for "Respiratory Therapy: Scope of Services" did not reflect that it was reviewed by the Respiratory Medical Director or medical staff. RNM 1 stated the P&P only list her as the approver and should have been approved formally by the Respiratory Medical Director and medical staff. RNM 1 stated she does not have any formal meeting minutes or agendas where scope of practice for Respiratory Therapy was discussed with Respiratory Medical Director or medical staff. RNM 1 stated she does not recall any formal meetings to discuss respiratory care service's scope of services and other policies. RNM 1 stated it was her practice to only send new policies to Respiratory Medical Director or medical staff and she approves all revision to the existing policies without sending to medical staff. RNM 1 stated she was not able to validate if the scope was aligned with professional standards for Respiratory Therapy.


During a concurrent interview and record review on 3/7/24 at 12:15 with Manager of Clinical Laboratory Services (MCL) and LRT the facility's P&P titled, "Blood Gas Laboratory: Arterial Blood Gas Procedure," with an effective date of 5/25/22 was reviewed. The P&P indicated, " ...Scope ...All Respiratory Care Practitioners ...Authority ...Medical Director of Respiratory Therapy ...Respiratory care practitioners who have experience and/or training as evidenced by task performance in the running of arterial blood gases may perform this procedure if he/she has demonstrated his/her ability to the satisfaction of the department manager or designee and medical director ...The quality control records are reviewed on a daily basis by the department manager/or designee. The results are additionally reviewed by medical director ...all blood gas results SHALL BE reviewed by the Respiratory Department Lead and medical director of the Blood Gas Laboratory. This review will be documented and the "Blood Gas Review" form. The LRT stated he was responsible for the RT competencies and Respiratory Medical Director does not review competency plan for Respiratory Therapists. The LRT stated all blood gases do not get reviewed by Respiratory Medical Director as indicated in the policy. The MCL stated Lab Medical Director also does not review all daily ABGs as indicated in the policy.


During a concurrent interview and record review on 3/13/24 at 9:00 a.m. with the LRT and Human Resources Manager (HRM), Respiratory Therapy employee files for "annual competencies" were reviewed. The annual competencies indicated 10 out of 15 RTs (RT 1, RT 3, RT 4, RT 5, RT 7, RT 10, RT 12, RT 14, RT 15, LRT) did not complete annual direct observation validation competency for blood gas analyzer. The HRM stated she was unable to locate competencies for rest of the RTs. The LRT stated annual direct observation was required by policy and facility standards. The LRT stated he was responsible to oversee RT competencies and sign off on their annual competencies. When asked to review annual competencies for all RTs, LRT stated the competencies were not available for 10 out of 15 RTs . The LRT stated competencies have not been reviewed and approved with the Respiratory Medical Director. The LRT stated his process was to work with the lab manager to sign off RTs on annual competencies. The LRT stated he was unable to locate competencies for remaining RTs that were not available in HR file. The LRT stated he does not recall Medical Director providing any in- services or training to the staff. The LRT stated he does not have any formal meeting with the Medical Director and manager to develop or to evaluate annual competency, education, and training plan for Respiratory Services.


During an interview with the Senior Director of Quality Director (SDQ) on 3/13/24 at 10:32 a.m., the SDQ stated it was her expectation that Respiratory Medical Director had reviewed all policies and procedures guiding the practice of Respiratory Therapy in the facility. The SDQ stated current policy "Respiratory Therapy: Scope of Service" does not have any medical director or any physician listed as approver on the policy. The SDQ stated without that she was unable to tell when the policy was last reviewed by the Respiratory Medical Director, and she expected that RNM & LRT were making sure that all respiratory policies met professional standards and were approved by Respiratory Medical Director and approved by the medical staff in writing as needed.


During a review of facility's, "Medical Director Agreement Pulmonary Services (MDAPS)", with an effective date of March 1st, 2022, the "MDAPS" indicated, " ...Group employs (MD 1) ...who is a physician duly licensed to practice medicine in the state of California and qualified in the specialty of internal medicine (the "Specialty") ...Physician shall serve as Medical Director of the Service, shall be responsible for the overall supervision of the Service and shall perform the specific duties and responsibilities ...Compliance with Rules and Laws ...Physician and, to the extent applicable, group shall at all times comply with all policies, bylaws, rules and regulations of Hospital and Hospital's Medical Staff, applicable standards and recommendation of The Joint Commission, and all applicable federal, state and local laws, rules and regulations ...Physician Administrative duties and services ...Policies and Procedures. Develop, or review and comment on, a policy, procedure, protocol, or clinical pathway used for the effective operations of the Service, including the activities of Hospital's clinical and technical personnel ...". The MDAPS indicated MD 1 was Respiratory Services Medical Director from 3/1/2022 to 2/29/24.

During a review of facility's, "Medical Director Agreement Pulmonary Services (MDAPS)", with an effective date of March 1st, 2024, the "MDAPS" indicated, " ...Group employs (MD 2) ...who is a physician duly licensed to practice medicine in the state of California and qualified in the specialty of pulmonary and critical care medicine (the "Specialty") ..." The MDAPS indicated MD 2 was Respiratory Services Medical Director effective 3/1/2024.

During an interview on 3/8/24 at 3:31 p.m. with the Medical Director (MD) 2, MD 2 stated he was the new Medical Director for Respiratory Therapy. MD 2 stated he had not reviewed the scope for Respiratory Services and was not able to comment why it was not approved previously by medical staff. MD 2 stated oversight of the Medical Director on the scope of service for Respiratory Therapy was critical to provide safe care to patients and to ensure that staff was performing care that met professional standards. MD 2 stated it was his expectations that going forward scope of Respiratory Services, all policies and procedures under respiratory services were reviewed and approved by medical director and medical staff. MD 2 stated he would be working with the team to ensure competency, training and care provide by the team of Reparatory Therapists meet professional standards.

During a concurrent interview and record review on 3/8/24 at 2:15 p.m. with Medical Staff Coordinator (MSC) and the Director of Quality and Patient Safety (DQ), MD 1's credential file was reviewed. The MSC stated she is the one responsible for coordinating the credentialing, appointment and reappointment process, and the DQ is her supervisor. Review of MD 1's file indicated MD 1 was a hospitalist (a doctor who works in a hospital providing general medical care to hospitalized patients) and was not board certified. The file indicated MD 1 was last reappointed to the active medical staff on 1/1/24. The MSC stated MD 1 was also the medical director for the intensive care unit [ICU] and previously Respiratory Services. A review of the Internal Medicine Services Privilege Request Form, dated 8/31/23, indicated MD 1 requested and was granted privileges [specific services and procedures a healthcare provider is deemed qualified to provide or perform] for General Internal Medicine Core Privileges which consisted of a paragraph describing the core privileges as, "...Admission, work-up, diagnosis and provision of non-surgical inpatient and outpatient treatment including consultation for patients admitted or in need of care to treat general medical problems including EKG interpretation, thoracentesis, paracentesis, and lumbar puncture. Internist may provide comprehensive management of patients in critical care units, including, but not limited to ventilator management greater than 48 hours..." The privilege request form also had a list "Special Procedures," for the physician to request and be granted individually. The list included procedures such as colonoscopy, arthrocentesis, echocardiograph, cardioversion, bone marrow aspiration, arterial line placement, central line placement, and others. The criteria for any of these special procedures were, "Successful completion of an approved recognized course when such exists, or acceptable supervised training in residency, fellowship, or other acceptable experience, and documentation of competence to obtain and retain clinical privileges as set forth in medical staff policies governing the exercise of specific privileges." The request form indicated MD 1 had requested and been granted the privilege for the special procedure arthrocentesis (a procedure in which a sterile needle and syringe are used to drain fluid from a joint).

The MSC stated the medicine privilege request form had been changed at the end of 2022, when the ICU Internal Medicine Core Privileges were combined with the General Internal Medicine Core Privileges. The MSC stated this was done because the qualifications for the ICU Internal Medicine Core Privileges were difficult to achieve. The MSC stated both versions of the privilege form are in use at this time, and are updated at their time of reappointment. Review of the earlier version of the internal medicine privilege request form prior to the revision indicated the "General Internal Medicine Core Privilege" bundle did not include ventilator management or management of patients in the critical care unit (ICU). The form indicated "ICU Internal Medicine Core Privileges" defined as, "In addition to core privileges in general internal medicine, comprehensive management of patients in critical care units, including but not limited to the use of such procedures as arterial line placement, arterial puncture, and ventilator management greater than 48 hours." The qualifications for ICU Internal Medicine Core Privileges were, "Current certification or active participation in the examination process leading to certification in critical care internal medicine by the American Board of Internal Medicine or demonstrated competency in critical care internal medicine." The MSC stated the current medicine request form does not delineate Critical Care/ICU privileges separate from general internal medicine privileges. The MSC stated on the current form, the privileges described in the paragraph indicating the core privilege group are requested and granted as one privilege. The privilege request form did not include check boxes next to anything in the core privilege group or provide direction or instructions on the ability to opt-out of a particular procedure within the core privilege group. On the last page of the form there was a place for the physician reviewing the privilege request form and recommending the privileges to include a condition or modification relative to the privilege and required that the specific condition or modification and the reason for it be documented on the form. MD 1's privilege request form indicated the department chairman signed the form approving the requested privileges on 11/13/23 and no conditions, modifications, or comments were made.

During a review of the minutes from the Bylaws/Credentials/Interdisciplinary Committee meeting held on 11/14/22, the minutes indicated, "...Delineation of Privileges- Internal Medicine Revised: The internal medicine privilege form was revised to reflect current practice. ICU privileges were moved to core privileges."

The MSC stated in preparation for reappointment, information is gathered regarding a physician's practice during the preceding two year period. The MSC stated there are no specific volume requirements (number of patients treated or managed and/or the number and type of procedure performed by the physician during the reappointment period) for the core medicine privileges or the arthrocentesis. The privilege form indicated, "...Reappointment Requirements, General Internal Medicine: Current demonstrated competence and an adequate volume of current experience with acceptable results in the privilege requested for the past 24 months as a result of quality assessment /improvement activities and outcomes..." The MSC could not define "adequate volume." The MSC stated they do not collect volume data to be used to evaluate the physician's performance of procedures in the "core" privilege bundle such as EKG interpretation, ventilator management, thoracentesis, paracentesis, or lumbar puncture, or for arthrocentesis, a specialty procedure. The "quality assessment/improvement activities and outcomes" information which was considered when MD 1 was reappointed was requested and the MSC provided the document reflecting the Ongoing Professional Practice/Performance Evaluation (OPPE) "Scorecard: Medicine" which consisted of 24 months of OPPE data divided into six-month periods. The MSC stated the scorecard is the same for all physicians with medicine privileges. The document indicated under the heading "Performance Details" a list of data being collected and how that physician compared to his peers. Information regarding cases reviewed by Peer Review and any negative findings associated with that review was tracked and the document indicated MD 1 had "No Occurrences," meaning no cases reviewed. Information regarding incidences of "Transfusions not meeting criteria," was reported, and indicated MD 1 had "No Occurrences." The MSC stated she did not know how many, if any, transfusions were ordered by MD 1. "Acute mortality observed [patient deaths]/expected [considers risk factors, likelihood of death]," and MD 1 had "No Occurrences" and the document indicated his peers had no occurrences as well. The MSC did not know whether this data meant no deaths occurred or whether a target observed/expected (O/E) value had to be exceeded before data was reported for this metric. There was no data on the scorecard specific to the privileges within the General Internal Medicine core privilege bundle, including ventilator management, paracentesis, thoracentesis, lumbar puncture, or comprehensive management of patients in the critical care unit.

During a concurrent interview and record review on 3/8/24 at 3:05 p.m. with Medical Staff Coordinator (MSC) and the Director of Quality and Patient Safety (DQ), MD 2's credential file was reviewed. The file indicated MD 12 was initially appointed to the medical staff on 9/5/19 with Pulmonary Disease (conditions that affect the lungs and other parts of the respiratory system) Core Privileges. The MSC stated MD 2 recently became the medical director of respiratory care services at the hospital. The MSC stated MD 2 was granted two extensions to his provisional status due to failure to complete proctoring and low volume. . Review of the six proctoring reports in MD 2's file indicated the dates of the patient care being evaluated were 1/3/20, 2/19/20, 2/26/20, 8/5/20, 9/2/20 (two patients). All of the proctored cases were for pulmonary medicine consultations, and all cases were reviewed on 5/19/21 by MD 1. The MSC was unable to state how MD 1 who had internal medicine core privileges but no privileges in pulmonary disease was determined to be a qualified proctor for MD 2. Review of the proctoring reports indicated at the top of the report, "...Proctoring shall mean the direct observation of the proctored practitioner's diagnosis or treatment of an individual patient by a qualified member of the Medical Staff. Observation shall include a chart review and proctoring performed on no less than six (ICU-no less than three) medical cases by staff members who serve as observers. Observation may also include review of observation reports obtained from other hospitals..." The MSC acknowledged that since the cases were reviewed on 5/19/21 but occurred in 2020, they were not directly observed by MD 1. Continued review of MD 2's file indicated on 6/15/21 an activity report listing all patient care occurrences for the period of 6/1/19 through 5/31/21 was generated and indicated all patient care activity was in the outpatient setting. The report consisted of a list of diagnoses but no dates of service or medical record numbers. The report reflected diagnoses such as "cirrhosis of liver," "nicotine dependence," and "other specified health status," in addition to diagnoses of pulmonary conditions and did not indicate which of the diagnoses were for the same patient, or the nature of the outpatient appointment. The MSC did not have any information regarding how many patients were seen during this two year period. Review of documents sent from another hospital (Hospital B) on 7/7/21 indicated MD 2 was an active member of the medical staff at Hospital B with primary privileges in pulmonary medicine and critical care and had completed proctoring at Hospital B in 2017. The documents included an activity report from Hospital B for the period of 7/1/19-6/30/21 showing sufficient patient care volume. Review of the minutes from the Bylaws/Credentials/Interdisciplinary Committee meeting held on 8/9/21, indicated MD 2's reinstatement to the Medical Staff, application for new privileges (withdrawal of General Internal Medicine core privileges and ICU medicine core privileges, withdrawal of special procedure privileges, and the addition of Pulmonary Disease Consultative Privileges), completion of proctoring for those consultative privileges requested, completion of the provisional year and status change from Provisional to Consulting. The meeting minutes for 8/9/21 also indicated revision of the Internal Medicine Privilege Form, "...The privilege form was revised to include consultative Pulmonary Disease privileges to accommodate [MD 2]'s practice at the rural health clinic as well as give him the ability to consult on med-surg and the ICU..." Review of MD 2's file indicated he was last reappointed on 9/1/23. Review of MD 2's privilege request form dated 5/3/23, indicated MD 2 requested Pulmonary Disease Consultative Privileges which consisted of, "Evaluate, diagnose, treat, and provide consultation to patients of all ages presenting with conditions, disorders, and diseases of lungs and airways. May provide consultation to patients in the intensive care setting or provide care in the outpatient health clinic (non-procedural) in conformance with unit policies. Assess, stabilize, and determine the disposition of patients with emergent conditions consistent with medical staff policy regarding emergency and consultative call services." Information used in consideration of MD 2's reappointment was requested and the MSC provided the document, "Scorecard: Medicine" which consisted of 24 months of data divided into six-month periods. The MSC stated this report is run every six months. The document indicated under the heading "Performance Details" a list of data being collected and how that physician compared to his peers. Information regarding cases reviewed by Peer Review and any negative findings associated with that review was tracked and the document indicated MD 2 had "No Occurrences," meaning no cases reviewed. Information regarding incidences of "Transfusions not meeting criteria," was reported, and indicated MD 2 had "No Occurrences." The MSC stated she did not know how many, if any, transfusions were ordered by MD 2. "Acute mortality observed [patient deaths]/expected [considers risk factors, likelihood of death]," and MD 2 had "No Occurrences" and the document indicated his peers had no occurrences as well. There was no data on the scorecard specific to the Pulmonary Disease Consultative Privileges held by MD 2, and no information which could be used as part of the evaluation of MD 2's performance. The MSC provided the activity report for the two year period between reappointments which consisted of a list of four diagnoses, one instance of each, two of which were not primary diagnoses indicating this list represented less than four patient encounters for the two year period. There was no information regarding the dates of the consults. The MSC did not have any additional information regarding the report. MD 2's privilege request form indicated the reappointment requirements for Pulmonary Medicine were, "Inpatient or consultative services for at least 100 patients, reflective of the scope of privileges requested, during the past 12 months." The last page of the form was completed by the medicine service chairperson who could approve all requested privileges, recommend privileges with specific conditions or modification, or not recommend specific privileges. There was a statement which indicated, "I have reviewed the requested clinical privileges and supporting documentation for the above-named applicant and make the following recommendations: Recommend all requested privileges." The form was signed by the chairperson of medicine on 7/7/23.

During an interview on 3/11/24 at 2:20 p.m. with the MSC, the MSC was asked what process was followed when the physician's volume is very low for the two year period between reappointments and does not meet the reappointment criteria. As occurred with MD 2,. the MSC stated normally she would have flagged this file to bring it to the attention of the Medicine Service Chairperson who could request more information or recommend the privileges with specified conditions or modifications, or recommend the privileges are granted as requested. The chairperson is supposed to make a note about an exception to the volume requirement and their recommendations for consideration by the credentials committee and MEC. The MSC stated in this case she failed to flag the file or to discuss it with the medicine chairperson.

During a professional reference review retrieved from the American Association for Respiratory Care ((AARC) is the leading national and international professional association for Respiratory Care) (https://www.aarc.org/wp-content/uploads/2017/03/statement-of-scope-of-practice.pdf) titled, "Position statement: Respiratory Care Scope of Practice", dated 3/23, the reference indicated, " ...The practice of respiratory therapists is under the general direction of a physician ..."

During a professional reference review retrieved from the AARC (https://www.aarc.org/advocacy/aarc-model-practice-act/), "AARC Model Practice Act", indicated, " ...The practice of respiratory care may be performed in any clinic, hospital, skilled nursing facility, and private dwelling; or other place deemed appropriate or necessary by the Board; in accordance with the written or verbal order of a physician, and shall be performed under a qualified Medical Director ... Qualified Medical Director" means the medical director of any inpatient or outpatient respiratory care service, department or home care agency. The medical director shall be a licensed physician who has special interest and knowledge in the diagnosis and treatment of respiratory problems. The medical director should be qualified by special training and/or experience in the management of acute and chronic respiratory disorders. This physician should be responsible for the quality, safety and appropriateness of the respiratory services provided, and require that respiratory care be ordered by a physician who has medical responsibility for the patient. The medical director should be readily accessible to the respiratory care practitioners and should assure their competency ..."

Based on interview and record review, the hospital failed to ensure respiratory care was delivered in accordance with medical staff directives when the hospital appointed Medical Doctor (MD) 1 to be the medical director of respiratory services prior to determining MD 1 had the knowledge, experience, and capabilities to supervise and administer the service properly. MD 1 was appointed from 3/1/2022 to 2/29/24 to be the medical director of respiratory services and did not have knowledge of and had not reviewed and commented on the policy "Respiratory Therapy: Scope of Services" in accordance with hospital policy and procedure. MD 1 did not supervise respiratory care services provided to patients in the hospital and had not reviewed the competencies, policies and training plan for Respiratory Therapists. Medical Doctor (MD) 2 was appointed to medical director for respiratory care services on 3/1/24 and had no knowledge and had not reviewed the policy Respiratory care: scope of services. Respiratory Therapists applied policies and procedures in the care of patients that were not reviewed and approved by medical staff in accordance with hospital policy and procedure. Twenty respiratory care service policies and procedures did not have medical staff review, comment and approval in accordance with hospital policy and procedure.

These failures resulted in providing respiratory care to patients without the benefit of medical staff direction and placed all patients at risk of harm, injury and death.

Findings:
During an observation on 3/5/24 at 12:25 p.m. with Nurse Executive (NE) 1, in Intensive Care Unit (ICU- a special hospital wards that provide treatment and monitoring for people who are very ill)), Respiratory Therapist (RT) 1 placed Pt 8 on Bilevel Positive Airway Pressure (BiPAP) machines (a type of machine that helps patients breathe by delivering air by mask on the face). RT 1 removed the patient from nebulizer treatment, started the BIPAP, completed the check and documented the actions provided. RT 1 left the ICU after placing the patient on BiPAP.

During an interview on 3/5/24 at 1:52 p.m. with Respiratory Therapist (RT) 1, RT 1 stated she has been working at the facility for 10 years. RT 1 stated she did not know who the Medical Director for RT services was. RT 1 stated she does not recall having scheduled meetings, in-services, education, or training provided by Medical Director or physician over the last few years. RT 1 stated she does not recall any physicians listed under approval section on the RT policies. RT 1 stated the eICU (Electronic Intensive Care Unit - is a care model that uses medical services delivered by a healthcare provider to a patient online to provide 24/7 critical care services for patients with complex, high acuity conditions) gives ventilator orders and BiPAP orders and the team of Respiratory Therapists uses department policies on BiPAP, Mechanical Ventilation guidelines and other Respiratory Services to manage patients.

During a concurrent interview and record review on 3/6/24 at 1:34 p.m. with the Lead Respiratory Therapist (LRT) and Assistant Nurse Manager (ANM), the facility's policy and procedure (P&P) titled, "Respiratory Therapy: Scope of Services," with an effective date of 5/2/23 was reviewed. The P&P indicated, " ...Review/Revised by ...RN [Registered Nurse]-Inpatient Services Manager & ...RT [Respiratory Therapist] Lead 05/23 ...Approval signatures: Policy owner ... Manager, Inpatient Nursing 5/2/2023." The LRT stated he has been working at the facility since 2007. The LRT stated he was the lead for the respiratory therapist team and was appointed to oversee respiratory care policies and report to hospital management. The LRT stated Respiratory team did not have any scheduled meetings with medical director. The LRT also stated the team did not have a formal process for Respiratory Medical Director to meet and review policies and procedures. The LRT stated the P&P does not reflect under reviewer section that it was reviewed by medical director or any medical staff. The LRT validated the policy was only approved by the department manager and no physician or medical staff was listed under approver section. The LRT stated it was important for Medical Director to review the P&P to ensure RT team is working within their scope and avoid any unintended harm to the patient by practicing outside their scope. The LRT stated current process was for him to work with department manager on the policies. The LRT stated most of the Respiratory Policies did not have formal approval or review documented from Medical Staff and/or Medical Director of Respiratory Services

During an interview on 3/6/24 at 1:40 p.m. with the ANM, the ANM stated she reviewed the Respiratory policies recently with LRT and have been updating pulmonary function testing (tests that show how well the lungs are working) policy with feedback from Medical Director. The ANM stated she have reviewed the Respiratory Therapy policies does not reflect that it has been reviewed and approved by the Medical director or Medical staff. The ANM stated Respiratory policies only list department manager as approver. The ANM stated "Medical Director for Respiratory services is a very busy man and often does not come to the hospital".

During a concurrent interview and record review on 3/8/24 at 12:01p.m. with Registered Nurse Manager (RNM) 1, the facility's P&P titled, "Respiratory Therapy: Scope of Services," with an effective date of 5/2/23 was reviewed. The P&P indicated, " ...Review/Revised by ...RN-Inpatient Services Manager & ...RT Lead 05/23 ...Approval signatures: Policy owner ...Manager, Inpatient Nursing 5/2/2023." RNM 1 stated she was the manager for respiratory team and the lead RT reported to her. RNM 1 stated the P&P for "Respiratory Therapy: Scope of Services" did not reflect that it was reviewed by the Respiratory Medical Director or medical staff. RNM 1 stated the P&P only list her as the approver and should have been approved formally by the Respiratory Medical Director and medical staff. RNM 1 stated she does not have any formal meeting minutes or agendas where scope of practice for Respiratory Therapy was discussed with Respiratory Medical Director or medical staff. RNM 1 stated she does not recall any formal meetings to discuss respiratory care services scope of services and other policies. RNM 1 stated it was her practice to only send new policies to Respiratory Medical Director or medical staff and she approves all revision to the existing policies without sending to medical staff. RNM 1 stated she was not able to validate if the scope was aligned with professional standards for Respiratory Therapy.

During an interview on 3/8/24 at 3:31 p.m. with the Medical Director (MD) 2, MD 2 stated he was the new Medical Director for Respiratory Therapy. MD 2 stated he had not reviewed the scope for Respiratory Services and was not able to comment why it was not approved previously by medical staff. MD 2 stated oversight of the Medical Director on the scope of service for Respiratory Therapy was critical to provide safe care to patients and to ensure that staff was performing care that met professional standards. MD 2 stated it was his expectations that going forward scope of Respiratory Services, all policies and procedures under respiratory services were reviewed and approved by medical director and medical staff. MD 2 stated he would be working with the team to ensure competency, training and care provide by the team of Reparatory Therapists meet professional standards.

During a concurrent interview on 3/8/24 at 4:00 p.m. with the Chief Nursing Executive (CNE), the facility's "Medical Director Agreement Pulmonary Services (MDAPS)," with an effective date of 3/1/24 was reviewed. The "MDAPS" indicated " ...Physician shall serve as Medical Director of the Service, shall be responsible for the overall supervision of the service and shall perform the specific duties and responsibilities ...Develop, or review and comment on, a policy, procedure, protocol or clinical pathways used for the effective operations of the Service, including the activities of the Hospital's clinical and technical personal ...In cooperation with Hospital's formal quality assurance program, develop and implement appropriate quality assurance activities for the Service ...Continuous review and development of written bylaws, clinical protocols, rule and regulations, including but not limited to the following ...Respiratory care services provided by qualified licensed employees ...". The CNE stated current policy and procedures does not reflect that it was approved by Medical Director and medical staff. The CNE stated that she expected that Respiratory Services scope was reviewed by the Medical Director as outlined in the MDAPS. The CNE stated it was her expectation that department manager was routing the policy for appropriate approval process [routing Respiratory Services Scope policy to medical staff], and it appears that the process was not followed.


During a concurrent interview and record review on 3/12/24 at 12:55 p.m. with RNM 1, the facility's P&P titled, "Policies and Procedures - Development and approval," with an effective date of 4/22/2021 was reviewed. The P&P indicated " ... All division and departmental patient care policies and procedures will be approved in collaboration with medical staff committee (s), as appropriate, the valley area board of directors and the administrative team ...Written policies and procedures will be developed and maintained by the person responsible for the service/policy Area in consultation with other appropriate health care professionals ...Each Policy/procedure will list the name(s) and title (s) of the individual (s) who originally authored or most recently revised/reviewed the policy/procedures and date (M/yr) under the "Reference" section of the policy/procedure ...". The RNM 1 validated no physician or Medical Director was listed under reference section as approver of Respiratory policies and procedures. The RNM 1 stated Respiratory policies did not go through the facility's development and approval process as listed in the facility's "Policies and procedures - Development and approval" policy.

During a review of the facility's P&P titled, "Standards of Care for Ventilator Management", with an effective date of 11/28/2023, the P&P indicated the Respiratory Medical Director was not listed under reviewed by section and no approval signature by Respiratory Medical Director.

During a review of the facility's P&P titled, "Respiratory Therapy: BiPAP- Bi-Level Positive Airway Pressure", with an effective date of 9/26/2023, the P&P indicated the Respiratory Medical Director or Medical Staff was not listed under reviewed by section and no approval signature by Respiratory Medical Director or by Medical Staff.

During a review of the facility's P&P titled, "Critical Care Patient Transports", with an effective date of 11/4/2021, the P&P indicated the Respiratory Medical Director or Medical Staff was not listed under reviewed by section and no approval signature by Respiratory Medical Director or by Medical Staff.

During a review of the facility's P&P titled, "Patients Transport with Oxygen", with an effective date of 11/4/2021, the P&P indicated the Respiratory Medical Director or Medical Staff was not listed under reviewed by section and no approval signature by Respiratory Medical Director or by Medical Staff.

During a review of the facility's P&P titled, "Transport of Mechanically Ventilated Patients", with an effective date of 11/4/2021, the P&P indicated the Respiratory Medical Director or Medical Staff was not listed under reviewed by section and no approval signature by Respiratory Medical Director or by Medical Staff.

During a review of the facility's P&P titled, "Respiratory Care Screening- Assessment of Patients" with an effective date of 3/3/22, the P&P indicated the Respiratory Medical Director or Medical Staff was not listed under reviewed by section and no approval signature by Respiratory Medical Director or by Medical Staff.

During a review of the facility's P&P titled, "Pulse Oximetry", with an effective date of 11/4/21, the P&P indicated the Respiratory Medical Director or Medical Staff was not listed under reviewed by section and no approval signature by Respiratory Medical Director or by Medical Staff.

During a review of the facility's P&P titled, "Oxygen Therapy Protocol", with an effective date of 09/07/2023, the P&P indicated the Respiratory Medical Director or Medical Staff was not listed under reviewed by section and no approval signature by Respiratory Medical Director or by Medical Staff.

During a review of the facility's P&P titled, "Admiration of Oxygen Via Nasal Cannula", with an effective date of 11/4/21, the P&P indicated the Respiratory Medical Director or Medical Staff was not listed under reviewed by section and no approval signature by Respiratory Medical Director or by Medical Staff.

During a review of the facility's P&P titled, "General Statement of the Administration of Oxygen", with an effective date of 11/4/21, the P&P indicated the Respiratory Medical Director or Medical Staff was not listed under reviewed by section and no approval signature by Respiratory Medical Director or by Medical Staff.

During a review of the facility's P&P titled, "Respiratory Care Screening - Assessment of Patients", with an effective date of 3/3/2022, the P&P indicated the Respiratory Medical Director or Medical Staff was not listed under reviewed by section and no approval signature by Respiratory Medical Director or by Medical Staff.

During a review of the facility's P&P titled, "Blood Gas Laboratory: Arterial Blood Gas Procedure", with an effective date of 5/25/22, the P&P indicated the Respiratory Medical Director or Medical Staff was not listed under reviewed by section and no approval signature by Respiratory Medical Director.

During a review of the facility's P&P titled, "Blood Gas Laboratory: Arterial Blood Gas Laboratory Proficiency - Competency of RCPS", with an effective date 6/15/2023, the P&P indicated the Respiratory Medical Director or Medical Staff was not listed under reviewed by section and no approval signature by Respiratory Medical Director or by Medical Staff.

During a review of the facility's P&P titled, "Procedure-RCS-MetaNeb Therapy Treatment Protocol MetaNeb System In-Line with Ventilator Protocol and Competency", with an effective date of 5/11/23, the P&P indicated the Respiratory Medical Director or Medical Staff was not listed under reviewed by section and no approval signature by Respiratory Medical Director or by Medical Staff.

During a review of the facility's P&P titled, "Mechanically Ventilation-ServoI", with an effective date of 3/3/2022, the P&P indicated the Respiratory Medical Director or Medical Staff was not listed under reviewed by section and no approval signature by Respiratory Medical Director or by Medical Staff.

During a review of the facility's P&P titled, "Blood Gas Proficiency Testing", with an effective date of 6/15/2023, the P&P indicated the Respiratory Medical Director or Medical Staff was not listed under reviewed by section and no approval signature by Respiratory Medical Director or by Medical Staff.

During a review of the facility's P&P titled, "Compressed Gas Standards Association Standards Safety Procedure for Gas Cylinders", with an effective date of 3/3/2022, the P&P indicated the Respiratory Medical Director or Medical Staff was not listed under reviewed by section and no approval signature by Respiratory Medical Director or by Medical Staff.

During a review of the facility's P&P titled, "Administration of Aerosol Medications via Hand held Nebulizer", with an effective date of 11/4/2021, the P&P indicated the Respiratory Medical Director or Medical Staff was not listed under reviewed by section and no approval signature by Respiratory Medical Director or by Medical Staff.

During a review of the facility's P&P titled, "Respiratory Therapy: Medical Record Documentation", with an effective date of 4/9/2021, the P&P indicated the Respiratory Medical Director or Medical Staff was not listed under reviewed by section and no approval signature by Respiratory Medical Director or by Medical Staff.


During an interview with the Senior Director of Quality Director (SDQ) on 3/13/24 at 10:32 a.m., the SDQ stated it was her expectation that Respiratory Medical Director had reviewed all policies and procedures guiding the practice of Respiratory Therapy in the facility. The SDQ stated current policy "Respiratory Therapy: Scope of Service" does not have any medical director or any physician listed as approver on the policy. The SDQ stated without that she was unable to tell when the policy was last reviewed by the Respiratory Medical Director and she expected that RNM & LRT was making sure that all respiratory policies meet professional standards and were approved by Respiratory Medical Director and approved by the medical staff in writing as needed.



During a concurrent interview and record review on 3/8/24 at 2:15 p.m. with Medical Staff Coordinator (MSC) and the Director of Quality and Patient Safety (DQ), MD 1's credential file was reviewed. The MSC stated she is the one responsible for coordinating the credentialing, appointment and reappointment process, and the DQ is her supervisor. Review of MD 1's file indicated MD 1 was a hospitalist (a doctor who works in a hospital providing general medical care to hospitalized patients) and was not board certified. The file indicated MD 1 was last reappointed to the active medical staff on 1/1/24. The MSC stated MD 1 was also the medical director for the intensive care unit [ICU] and previously Respiratory Services. A review of the Internal Medicine Services Privilege Request Form, dated 8/31/23, indicated MD 1 requested and was granted privileges [specific services and procedures a healthcare provider is deemed qualified to provide or perform] for General Internal Medicine Core Privileges which consisted of a paragraph describing the core privileges as, "...Admission, work-up, diagnosis and provision of non-surgical inpatient and outpatient treatment including consultation for patients admitted or in need of care to treat general medical problems including EKG interpretation, thoracentesis, paracentesis, and lumbar puncture. Internist may provide comprehensive management of patients in critical care units, including, but not limited to ventilator management greater than 48 hours..." The privilege request form also had a list "Special Procedures," for the physician to request and be granted individually. The list included procedures such as colonoscopy, arthrocentesis, echocardiograph, cardioversion, bone marrow aspiration, arterial line placement, central line placement, and others. The criteria for any of these special procedures were, "Successful completion of an approved recognized course when such exists, or acceptable supervised training in residency, fellowship, or other acceptable experience, and documentation of competence to obtain and retain clinical privileges as set forth in medical staff policies governing the exercise of specific privileges." The request form indicated MD 1 had requested and been granted the privilege for the special procedure arthrocentesis (a procedure in which a sterile needle and syringe are used to drain fluid from a joint). The MSC stated the medicine privilege request form had been changed at the end of 2022, when the ICU Internal Medicine Core Privileges were combined with the General Internal Medicine Core Privileges. The MSC stated this was done because the qualifications for the ICU Internal Medicine Core Privileges were difficult to achieve. The MSC stated both versions of the privilege form are in use at this time, and are updated at their time of reappointment. Review of the earlier version of the internal medicine privilege request form prior to the revision indicated the "General Internal Medicine Core Privilege" bundle did not include ventilator management or management of patients in the critical care unit (ICU). The form indicated "ICU Internal Medicine Core Privileges" defined as, "In addition to core privileges in general internal medicine, comprehensive management of patients in critical care units, including but not limited to the use of such procedures as arterial line placement, arterial puncture, and ventilator management greater than 48 hours." The qualifications for ICU Internal Medicine Core Privileges were, "Current certification or active participation in the examination process leading to certification in critical care internal medicine by the American Board of Internal Medicine or demonstrated competency in critical care internal medicine." The MSC stated the current medicine request form does not delineate Critical Care/ICU privileges separate from general internal medicine privileges. The MSC stated on the current form, the privileges described in the paragraph indicating the core privilege group are requested and granted as one privilege. The privilege request form did not include check boxes next to anything in the core privilege group or provide direction or instructions on the ability to opt-out of a particular procedure within the core privilege group. On the last page of the form there was a place for the physician reviewing the privilege request form and recommending the privileges to include a condition or modification relative to the privilege and required that the specific condition or modification and the reason for it be documented on the form. MD 1's privilege request form indicated the department chairman signed the form approving the requested privileges on 11/13/23 and no conditions, modifications, or comments were made.



During a review of the minutes from the Bylaws/Credentials/Interdisciplinary Committee meeting held on 11/14/22, the minutes indicated, "...Delineation of Privileges- Internal Medicine Revised: The internal medicine privilege form was revised to reflect current practice. ICU privileges were moved to core privileges." The MSC stated in preparation for reappointment, information is gathered regarding a physician's practice during the preceding two year period. The MSC stated there are no specific volume requirements (number of patients treated or managed and/or the number and type of procedure performed by the physician during the reappointment period) for the core medicine privileges or the arthrocentesis. The privilege form indicated, "...Reappointment Requirements, General Internal Medicine: Current demonstrated competence and an adequate volume of current experience with acceptable results in the privilege requested for the past 24 months as a result of quality assessment /improvement activities and outcomes..." The MSC could not define "adequate volume." The MSC stated they do not collect volume data to be used to evaluate the physician's performance of procedures in the "core" privilege bundle such as EKG interpretation, ventilator management, thoracentesis, paracentesis, or lumbar puncture, or for arthrocentesis, a specialty procedure. The "quality assessment/improvement activities and outcomes" information which was considered when MD 1 was reappointed was requested and the MSC provided the document reflecting the Ongoing Professional Practice/Performance Evaluation (OPPE) "Scorecard: Medicine" which consisted of 24 months of OPPE data divided into six-month periods. The MSC stated the scorecard is the same for all physicians with medicine privileges. The document indicated under the heading "Performance Details" a list of data being collected and how that physician compared to his peers. Information regarding cases reviewed by Peer Review and any negative findings associated with that review was tracked and the document indicated MD 1 had "No Occurrences," meaning no cases reviewed. Information regarding incidences of "Transfusions not meeting criteria," was reported, and indicated MD 1 had "No Occurrences." The MSC stated she did not know how many, if any, transfusions were ordered by MD 1. "Acute mortality observed [patient deaths]/expected [considers risk factors, likelihood of death]," and MD 1 had "No Occurrences" and the document indicated his peers had no occurrences as well. The MSC did not know whether this data meant no deaths occurred or whether a target observed/expected (O/E) value had to be exceeded before data was reported for this metric. There was no data on the scorecard specific to the privileges within the General Internal Medicine core privilege bundle, including ventilator management, paracentesis, thoracentesis, lumbar puncture, or comprehensive management of patients in the critical care unit.


During a concurrent interview and record review on 3/8/24 at 3:05 p.m. with Medical Staff Coordinator (MSC) and the Director of Quality and Patient Safety (DQ), MD 2's credential file was reviewed. The file indicated MD 12 was initially appointed to the medical staff on 9/5/19 with Pulmonary Disease (conditions that affect the lungs and other parts of the respiratory system) Core Privileges. The MSC stated MD 2 recently became the medical director of respiratory care services at the hospital. The MSC stated MD 2 was granted two extensions to his provisional status due to failure to complete proctoring and low volume. A letter to MD 2 from the administrator of Hospital A on 5/12/21 was reviewed and indicated MD 2 was granted the final extension to complete proctoring, and advised that failure to complete proctoring by 8/31/21 would result in voluntary relinquishment of membership and privileges. Review of the six proctoring reports in MD 2's file indicated the dates of the patient care being evaluated were 1/3/20, 2/19/20, 2/26/20, 8/5/20, 9/2/20 (two patients). All of the proctored cases were for pulmonary medicine consultations, and all cases were reviewed on 5/19/21 by MD 11. The MSC was unable to state how MD 1 who had internal medicine core privileges but no privileges in pulmonary disease was determined to be a qualified proctor for MD 2. Review of the proctoring reports indicated at the top of the report, "...Proctoring shall mean the direct observation of the proctored practitioner's diagnosis or treatment of an individual patient by a qualified member of the Medical Staff. Observation shall include a chart review and proctoring performed on no less than six (ICU-no less than three) medical cases by staff members who serve as observers. Observation may also include review of observation reports obtained from other hospitals..." The MSC acknowledged that since the cases were reviewed on 5/19/21 but occurred in 2020, they were not directly observed by MD 1. Continued review of MD 2's file indicated on 6/15/21 an activity report listing all patient care occurrences for the period of 6/1/19 through 5/31/21 was generated and indicated all patient care activity was in the outpatient setting. The report consisted of a list of diagnoses but no dates of service or medical record numbers. The report reflected diagnoses such as "cirrhosis of liver," "nicotine dependence," and "other specified health status," in addition to diagnoses of pulmonary conditions and did not indicate which of the diagnoses were for the same patient, or the nature of the outpatient appointment. The MSC did not have any information regarding how many patients were seen during this two-year period. Review of documents sent from another hospital (Hospital B) on 7/7/21 indicated MD 2 was an active member of the medical staff at Hospital B with primary privileges in pulmonary medicine and critical care and had completed proctoring at Hospital B in 2017. The documents included an activity report from Hospital B for the period of 7/1/19-6/30/21 showing sufficient patient care volume. Review of the minutes from the Bylaws/Credentials/Interdisciplinary Committee meeting held on 8/9/21, indicated MD 2's reinstatement to the Medical Staff, application for new privileges (withdrawal of General Internal Medicine core privileges and ICU medicine core privileges, withdrawal of special procedure privileges, and the addition of Pulmonary Disease Consultative Privileges), completion of proctoring for those consultative privileges requested, completion of the provisional year and status change from Provisional to Consulting. The meeting minutes for 8/9/21 also indicated revision of the Internal Medicine Privilege Form, "...The privilege form was revised to include consultative Pulmonary Disease privileges to accommodate [MD 2]'s practice at the rural health clinic as well as give him the ability to consult on med-surg and the ICU..."
Review of MD 2's file indicated he was last reappointed on 9/1/23. Review of MD 2's privilege request form dated 5/3/23, indicated MD 2 requested Pulmonary Disease Consultative Privileges which consisted of, "Evaluate, diagnose, treat, and provide consultation to patients of all ages presenting with conditions, disorders, and diseases of lungs and airways. May provide consultation to patients in the intensive care setting or provide care in the outpatient health clinic (non-procedural) in conformance with unit policies. Assess, stabilize, and determine the disposition of patients with emergent conditions consistent with medical staff policy regarding emergency and consultative call services." Information used in consideration of MD 2's reappointment was requested and the MSC provided the document, "Scorecard: Medicine" which consisted of 24 months of data divided into six-month periods. The MSC stated this report is run every six months. The document indicated under the heading "Performance Details" a list of data being collected and how that physician compared to his peers. Information regarding cases reviewed by Peer Review and any negative findings associated with that review was tracked and the document indicated MD 2 had "No Occurrences," meaning no cases reviewed. Information regarding incidences of "Transfusions not meeting criteria," was reported, and indicated MD 2 had "No Occurrences." The MSC stated she did not know how many, if any, transfusions were ordered by MD 2. "Acute mortality observed [patient deaths]/expected [considers risk factors, likelihood of death]," and MD 2 had "No Occurrences" and the document indicated his peers had no occurrences as well. The MSC did not know whether this data meant no deaths occurred or whether a target observed/expected (O/E) value had to be exceeded before data was reported for this metric. There was no data on the scorecard specific to the Pulmonary Disease Consultative Privileges held by MD 2, and no information which could be used as part of the evaluation of MD 2's performance. The MSC provided the activity report for the two year period between reappointments which consisted of a list of four diagnoses, one instance of each, two of which were not primary diagnoses indicating this list represented less than four patient encounters for the two year period. There was no information regarding the dates of the consults. The MSC did not have any additional information regarding the report. MD 2's privilege request form indicated the reappointment requirements for Pulmonary Medicine were, "Inpatient or consultative services for at least 100 patients, reflective of the scope of privileges requested, during the past 12 months." The last page of the form was completed by the medicine service chairperson who could approve all requested privileges, recommend privileges with specific conditions or modification, or not recommend specific privileges. There was a statement which indicated, "I have reviewed the requested clinical privileges and supporting documentation for the above-named applicant and make the following recommendations: Recommend all requested privileges." The form was signed by the chairperson of medicine on 7/7/23.


During an interview on 3/11/24 at 2:20 p.m. with the MSC, the MSC was asked what process was followed when the physician's volume is very low for the two year period between reappointments and does not meet the reappointment criteria. As occurred with MD 2,. tThe MSC stated normally she would have flagged this file to bring it to the attention of the Medicine Service Chairperson who could request more information or recommend the privileges with specified conditions or modifications, or recommend the privileges are granted as requested. The chairperson is supposed to make a note ab

Based on interview and record review, the hospital failed to provide blood gases performed in the respiratory care unit in accordance with 42 CFR 482.27 and failed to meet the needs of patients when 10 of 15 Respiratory Therapists (RT 1, RT 3, RT 4, RT 5, RT 7, RT 10, RT 12, RT 14, RT 15, LRT)) did not have annual competency to perform blood gases. The hospital upgraded the blood gas equipment on 2/7/24 and none of the RTs were trained or had a competency assessment. The quality control of daily blood gases were not reviewed by the Medical Director (MD 2) in accordance with hospital policy and procedure.

These failures resulted in possible inaccurate blood gases and could negatively affect the care of patient and patient outcomes.

Findings:

During an interview on 3/6/24 at 1:34 p.m. with the Lead Respiratory Therapist (LRT), The LRT stated he has been working at the facility for 17 years. The LRT stated he assisted with staff competency and training with performing blood gases on patients and using blood gas system. The LRT stated all RTs were required to run blood gas samples on blood gas system. The LRT stated facility policy was to do an annual competency for the blood gas system. The LRT stated annual competency assessment was important for staff using the blood gas system to ensure accuracy and reliability of the test results. The LRT stated the facility just updated to new blood gas system on 2/7/24. The LRT stated no documented training or competency assessment was completed with the new system for the Respiratory Team. The LRT stated the hospital should have done a competency and training when the vendor was at the facility to replace old machines with the new one. The LRT stated, "have not received any new training in few years, additional education or completed competency assessment". The LRT stated he completed a competency of blood gas in 2022 and have been training staff since then. The LRT stated he met with the vendor during the installation of new blood gas systems. The LRT stated he would reach out to the vendor to see if vendor can send him any training material and to see if the vendor can provide him with checklist of things they discuss during installation. The LRT stated hospital did not have any in-service or competency for the team of Respiratory Therapists on the use of new system. The LRT stated he would reach out to vendor and have them send information on in-service and training that he could use to provide in-service to the Respiratory Therapists. The LRT stated his process for signing off annual competency for staff was to record the staff performing competency and send the video to Manager of Clinical Laboratory Services (MCL) so that they can validate the staff was competent and sign off the competency. The LRT stated MCL was not able to perform direct observation on the competency and the facility process was to record the annual validation and send to MCL for signature.


During a concurrent interview and record review on 3/7/24 at 12:15 with Manager of Clinical Laboratory Services (MCL) and Lead Respiratory Therapist (LRT) the facility's policy and procedure (P&P) titled, "Blood Gas Laboratory: Arterial Blood Gas Procedure," with an effective date of 5/25/22 was reviewed. The P&P indicate, " ...Scope ...All Respiratory Care Practitioners ...Authority ...Medical Director of Respiratory Therapy ...Respiratory care practitioners who have experience and/or training as evidenced by task performance in the running of arterial blood gases may perform this procedure if he/she has demonstrated his/her ability under the satisfaction of the department manager or designee and medical director ...The quality control records are reviewed on a daily basis by the department manager/or designee. The results are additionally reviewed by medical director ...all blood gas results SHALL BE reviewed by the Respiratory Department Lead and medical director of the Blood Gas Laboratory. This review will be documented on the "Blood Gas Review" form." The LRT stated he was responsible for the RT competencies and Respiratory Medical Director does not review competency plan for RCPs. The LRT stated all blood gases do not get reviewed by Respiratory Medical Director as indicated in the policy. The MCL stated Laboratory Medical Director also does not review all daily ABGs as indicated in the policy. The MCL stated she was new to the facility and have not signed any staff member's competency using recorded videos. The MCL stated it was her understanding previous manager's process was to sign the staff using recorded video. The MCL stated it was required for the anyone using blood gas system to have annual competency and skill validation based on professional standards for point of care testing. The MCL stated she reviews the quality control record daily and unsure if Laboratory Medical director reviews quality control daily.

During an interview on 3/7/24 at 12:25 p.m. with the Executive of Lab Services (ELS), the ELS stated Laboratory Medical director reviews annual competency plan. The ELS stated Laboratory Medical Director does not review daily ABGs as listed in the policy. The ELS stated the practice does not align with the policy.

During a concurrent interview and record review on 3/13/24 at 9:00 a.m. with the LRT and Human Resources Manager (HRM), Respiratory Therapy employee files for "annual competencies" were reviewed. The annual competencies indicated 10 out of 15 RTs (RT 1, RT 3, RT 4, RT 5, RT 7, RT 10, RT 12, RT 14, RT 15, LRT) did not complete annual direct observation validation competency for blood gas analyzer. The HRM stated she was unable to locate competencies for (RT 1, RT 3, RT 4, RT 5, RT 7, RT 10, RT 12, RT 14, RT 15, LRT) in employee files. The LRT stated annual direct observation was required by policy and facility standards. The LRT stated he was responsible to oversee RT competencies and sign off on their annual competencies. When asked to review annual competencies for all RTs, LRT stated the competencies were not available for 10 out of 15 RTs. The LRT stated competencies have not been reviewed and approved with the Respiratory Medical Director. The LRT stated he was working with the lab manager to sign RTs. The LRT stated he was unable to locate competencies for remaining RTs that were not available in HR file. The LRT stated he does not recall Medical Director providing any in- services or training to the staff. The LRT stated he does not have any formal meeting with the Medical Director and manager to develop or to evaluate annual competency, education, and training plan for Respiratory Services.

During an interview with the Senior Director of Quality Director (SDQ) on 3/13/24 at 10:32 a.m., the SDQ stated it was her expectation that blood gas quality review, training and competencies were aligned with the hospital policies and professional standards. The SDQ stated recording and signing off competencies that required direct observation at later time was not an acceptable practice. The SDQ stated recording and signing off at later date was not direct observation as listed and required by the competency. The SDQ stated she expects that trainer have received training, education and competency validation before they start signing other staff on their competencies. The SDQ stated she agreed that staff should receive in-service on new equipment to ensure patient safety.

During a review of the facility's P&P titled, "Blood Gas Laboratory: Arterial Blood Gas Laboratory Proficiency - Competency of RCPS", with an effective date 06/15/23, the P&P indicated, " ...the process for completing arterial blood gas laboratory competency/proficiency testing for Respiratory Care Practitioners ...competency/proficiency will be completed and successfully passed annually ...blood gas competencies will be assessed by the Lead or designees annually."

During a professional reference review retrieved from (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8343045/) titled, "Training and Competency Strategies for Point-of-Care Testing (POCT)", dated 6/29/21, the reference indicated " ...staff performing POCT must have the proper training and experience to ensure test results are accurate and reliable ... Each qualified POCT user must complete initial training and orientation on each test method before initiation of testing and following any changes or update in instrumentation, kits, or test methods. Initial training must be completed before the user performing any patient testing and competence must be documented. This initial training must include direct observation, be documented, and the documentation retained in the individual's training record ... All training must be performed by a qualified individual such as a certified laboratory technical staff or the manufacturer/company representative and the competency of the tester verified before performing patient testing. A qualified trainer must have been trained and demonstrated competency for all methods for which training is being conducted ... for CLIA compliance, competency must be assessed for each non-waived POCT at six months and 12 months following initial training and assessment annually thereafter..."