HospitalInspections.org

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Based on observation, interview, document review, and review of hospital procedures, the Critical Access Hospital failed to ensure staff followed manufacturer's instructions for use when doing quality checks on episiotomy surgical scissors.

Failure to ensure staff follow manufacturer's instructions for use places patients at risk of harm from faulty surgical instruments.

Reference: Manufacturer's specifications for red "Thera Band" thickness is .2032 mm

Reference: Sklar stainless steel surgical instruments recommended care and cleaning instructions: Visibly check instruments to ensure surfaces are clean and free from damage, stains, and bioburden: Check instruments for proper function and condition.

Findings included:

1. Review of hospital's procedures posted on the wall in the central sterile processing department titled, "AESCULAP General Instrument Function Checks," Copy Right 2017, showed damaged instruments must be removed or returned to the manufacturer for repair; use manufacturers for suitable test methods, when using test materials ensure the respective manufacturer's instructions. The poster indicated the following checks for scissors: Check tip for damages; check tungsten carbide inlays for burrs; check both sides for cracks; check correct fit of the screw link. Information on the cutting test showed the following: According to DIN/ISO (Deutsches Institute for Normung Germany/ International Organization for Standardization) test material to be selected according to scissors: gauze bandage, cotton or rayon, tricot material. According to AESCULAP: Internal test material: 20" division/100% cotton, approx. 0.4 mm material thickness. The cutting test must be carried out transverse to the web ribs and perform 3 continuous cuts. The results of the cutting test should be that the material cuts are smooth, with no tearing, jamming, tugging, snagging, or pushing and to cut with 2/3 of the blade length effectively.

2. On 03/24/23 at 9:30 AM, Investigator #1 interviewed the Obstetric (OB) charge nurse (Staff #109) regarding episiotomy scissors used in labor and delivery unit. Staff #101 opened an OB surgical instrument kit and pulled out 2 types of scissors, the first set of scissors are "Sklar" episiotomy scissor (heavy scissor with an angle to the side) and the other one "Becton/Mayo" scissors (6 and ¾ inch straight scissor). Staff #109 indicated that both are used in an episiotomy procedure (a procedure where an incision is made to assist in childbirth). Investigator #1 observed pitting, a hair line crack near the tip, and a chip near the hinge on the episiotomy scissor. Staff #109 indicated when scissors are damaged or dull a red sticker is placed on the scissors and central sterile technicians send them out for repair or to get sharpened.

3. On 03/27/23 at 1:00 PM, Investigator #1 and OB charge nurse (Staff #108) opened an OB surgical instrument kit. Investigator #1 observed deep cuts and scratches on the tip of the episiotomy scissors.

4. On 3/24/23 at 11:00 AM, Investigator #1 interviewed central sterile technician (Staff #102) regarding the process of identifying dull scissors used in the OB department. Staff #102 indicated that they do a visual inspection of the scissors and check the sharpness by cutting on a red "Thera Band" (nonlatex resistance band typically used for strength training in physical therapy). Investigator #1 asked for a written policy and procedure of the process. Staff #102 was unable to find any hospital policy that describes the process but indicated that the poster on the wall "AESCULAP General Instrument Function Checks," provided procedures.

5. During the interview, Investigator #1 asked staff #102 to demonstrate the process. Staff #102 used the red Thera band that was very thin and worn out. The scissors cut the tip of the band easily. Investigator #1 was concerned that material used may not be sufficient for cutting human flesh. Investigator #1 asked about who approved the use of the Thera band as an acceptable material. Staff #102 did not know.

6. Investigator #1 asked staff #102 if they were tracking dull and damaged surgical instruments. Staff #102 provided a log titled, "Instrument sent out for repair" that showed scissor identified in the OB department from 2022-2023:

a) 2/22/22 episiotomy scissor, dull
b) 2/22/22 mayo straight scissor, dull
c) 3/10/22 episiotomy scissor, dull
d) 7/18/22 episiotomy scissor, dull
e) 7/18/22 episiotomy scissor, dull
f) 10/26/22 episiotomy scissor, pitted, and dull
g)11/7/22 mayo straight scissor, pitted.

7. On 03/27/23 at 11:30AM, Investigator #1 interviewed the central sterile processing supervisor (Staff #101) regarding the quality checks of the episiotomy scissors. Staff #102 indicated that the vendor of the company (Bramstedt Instrument) who repairs and sharpens the scissors indicated that the Thera Band was ok to use. Staff #102 had no documentation approving the use of the red Thera Band. Staff #102 had no contract for the vendor (Bramstedt instrument). Staff #102 was unable to provide manufacturer's instructions for use for the scissors.

8. On 03/27/23 at 2:00 PM Investigator #1 interviewed the Director of Materials management (Staff #107) regarding the contract for Bramstedt Instruments. Staff #107 indicated that she has never seen a contract for Bramstedt Instruments and was unable to locate one.

9. On 03/27/23 at 2:30 PM Investigator #1 interviewed the CEO (Staff #110) and asked if the central sterile processing department reports to the quality committee. Staff #110 indicated no.

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Based on interview and review of the hospital's quality plan, governing body bylaws, medical staff bylaws, credentialing files, and performance data, the Critical Access Hospital's Governing Body failed to meet the requirements for the Condition of Participation for Organizational Structure.

Failure to provide sufficient oversight and monitoring of the Hospital's Medical Staff credentialing and perfornance, and Quality Program puts patrients at risk of harm from substandard care and non-compliance with state law and practice standards.

Findings included:

1. The Critical Access Hospital's Governing Body failed to ensure that the hospital developed, implemented, and maintained an effective ongoing hospital process for granting of delineated clinical privileges.

Cross Reference: C 0962

2. The hospital failed to develop, implement, and maintain a hospital-wide, data-driven quality assessment and performance improvement program that included systematic data collection, analysis, and implementation of process improvement with oversight of the hospital's Governing Body.

Cross Reference: C 1300

Due to the scope and severity of deficiencies cited under 42 CFR 485.627, the Condition of Participation for Organizational Structure was NOT MET.

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Based on interviews, document review, and review of hospital policies and procedures, the Critical Access Hospital's Governing Body failed to ensure that all medical staff with obstetrics privileges maintained current neonatal resuscitation certification as required by the Medical Staff Rules and Regulations for 2 of 5 records reviewed (Staff #1207 and Staff #1208) (item #1), and failed to verify clinical competence prior to granting core OB privileges for 2 of 2 Family Practitioners with less than 10 OB deliveries in the past year (Staff #1210 and Staff #1212) (item #2).

Failure to ensure that all medical staff maintain current neonatal resuscitation certification and failure to verify clinical competence prior to granting core OB privileges, places patients at risk for harm from substandard or inadequate care, including death.

Item #1 - Neonatal Resuscitation

Findings included:

1. Review of the hospital document titled, "Medical Staff Bylaws, Rules and Regulations," last approved 08/14/18, showed that all practitioners seeking clinical privileges in obstetrics shall be certified in neonatal resuscitation.

2. Investigators #12 and #13 reviewed the personnel records of 7 providers with core obstetrics privileges. The review showed that 2 of 7 provider files were missing documentation of current neonatal resuscitation certification (Staff #1207 and #1208).

3. On 03/27/23 at 12:40 PM, Investigator #13 interviewed the Medical Staff Coordinator (Staff #1209). During the interview Staff #1209 confirmed that the hospital did not have a process to ensure that all providers with core obstetrics privileges maintained current neonatal resuscitation certification.

Item #2 - Verification of Competence

Findings included:

1. Review of the hospital document titled, "Medical Staff Bylaws, Clinical Privileges," last approved 08/14/18, showed the following:

a. Each application for Medical Staff appointment or reappointment must contain a request for the specific clinical privileges requested. Requests for privileges must be supported by documentation of the requisite training, experience, qualifications, and competency to exercise such privileges.

b. The applicant shall have the burden of establishing his qualifications and current competence in clinical privileges and providing specific documentation of the experience if requested by the Medical Executive Committee.

c. Applications for appointment and reappointment shall require detailed information that includes, but is not limited to, qualifications, including professional training and experience, verification of current competency, and continuing medical education information related to the clinical privileges to be exercised by the applicant.

d. The elements to be considered in making determinations regarding privileges shall include education, training, direct observation of clinical performance and judgement, performance of a sufficient number of procedures each year to develop and maintain the practitioner's skills and knowledge, a review of the records of patients treated, and a review of the records of the Medical Staff which document the clinical evaluation of the practitioner's delivery of care.

Review of the document titled, "Family Practice Delineation of Privileges," undated, showed that core obstetrics/gynecology (OB/GYN) privileges include the performance of normal spontaneous vaginal delivery, including antepartum and postpartum care, repair of minor vaginal, perineal, and cervical lacerations and the care of noncomplicated nongynecological patients. For reappointments, less than 10 obstetrical cases during the previous year will prompt a chart review to verify clinical competence for maintaining OB privileges.

2. Review of the hospital's delivery logs showed that 2 Family Practitioners with core and specialty OB privileges failed to complete 10 deliveries in 2022 (Staff #1210 and Staff #1212). Further review showed that Staff #1210 completed 6 deliveries in 2021 and 3 deliveries in 2022, and Staff #1212 completed 5 deliveries in 2021 and 3 deliveries in 2022. Investigators found no evidence in either provider file showing that the hospital completed a chart review to verify clinical competence for maintaining OB privileges.

3. On 03/27/23 at 12:40 PM, Investigator #13 interviewed the Medical Staff Coordinator (Staff #1209). Staff #1209 confirmed the investigator's findings that the credentialing files did not contain chart reviews or documentation verifying the provider's qualifications, current competency, or continuing medical education.

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Based on interviews, document review, and review of hospital policies and procedures, the Critical Access Hospital's Governing Body failed to ensure that medical staff appointment/reappointment and clinical privileges were granted based on individual character, competence, training, experience, and judgement.

Failure to ensure that medical staff appointment/reappointment and clinical privileges are granted based on individual character, competence, training, experience, and clinical judgement places patients at risk for substandard or inadequate care.

Findings included:

1. The Critical Access Hospital failed to implement periodic review of clinical performance of diagnoses and treatment for 9 of 9 medical staff credentialing files reviewed.

Cross Reference: C 999

Due to the scope and severity of deficiencies cited under 42 CFR 485.631, the Condition of Participation for Staffing was NOT MET.

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Based on interviews, document review, and review of hospital policies and procedures, the Hospital's Governing Body failed to ensure that medical staff appointment/reappointment and clinical privileges were granted based on individual character, competence, training, experience, and judgement for 5 of 5 records reviewed (Staff #1207, #1210, #1211, #1212, and #1213).

Failure to ensure that medical staff appointment/reappointment and clinical privileges are granted based on individual character, competence, training, experience, and clinical judgement places patients at risk for substandard or inadequate care.

Findings included:

1. Review of the hospital document titled, "Medical Staff Bylaws, Clinical Privileges," last approved 08/14/18, showed the following:

a. Each application for Medical Staff appointment or reappointment must contain a request for the specific clinical privileges requested. Requests for privileges must be supported by documentation of the requisite training, experience, qualifications, and competency to exercise such privileges.

b. The applicant shall have the burden of establishing his qualifications and current competence in clinical privileges and providing specific documentation of the experience if requested by the Medical Executive Committee.

c. Applications for appointment and reappointment shall require detailed information that includes, but is not limited to, qualifications, including professional training and experience, verification of current competency, and continuing medical education information related to the clinical privileges to be exercised by the applicant.

d. The elements to be considered in making determinations regarding privileges shall include education, training, direct observation of clinical performance and judgement, performance of a sufficient number of procedures each year to develop and maintain the practitioner's skills and knowledge, a review of the records of patients treated, and a review of the records of the Medical Staff which document the clinical evaluation of the practitioner's delivery of care.

Review of the document titled, "Family Practice Delineation of Privileges," undated, showed the following:

a. Core obstetrics/gynecology (OB/GYN) privileges include the performance of normal spontaneous vaginal delivery, including antepartum and postpartum care, repair of minor vaginal, perineal, and cervical lacerations and the care of noncomplicated nongynecological patients. Initial appointments require 10 proctored vaginal deliveries during the first year. For reappointments, less than 10 obstetrical cases during the previous year will prompt a chart review to verify clinical competence for maintaining OB privileges.

b. Special OB/GYN privileges must be applied for individually, and the applicant must include documentation of training/experience/current competence. Special OB/GYN privileges include the following options: augmentation and induction of labor at term, manual extraction of placenta, non-stress test, episiotomy and repair, monitor placement, ultrasound for fetal position and placental location, low forceps delivery, vacuum extraction delivery, bilateral salpingectomy/tubal ligation (elective), laparoscopy, dilation and curettage, dilation and evacuation for first trimester miscarriage, cesarian section (C-section), and 4th degree repair.

2. Investigators #12 and #13 reviewed the personnel records of 5 Family Practice physicians with core and specialty OB/GYN privileges. The review showed the following:

a. Staff #1207's application for reappointment showed a request for core OB/GYN privileges and special OB/GYN privileges including augmentation and induction of labor at full term, manual extraction of placenta, non-stress test, episiotomy and repair, monitor placement, ultrasound for fetal position and placental location, low forceps delivery, and vacuum extraction delivery. The Governing Board approved the privileges as requested on 12/28/22. Investigators found no evidence that the application included documentation of the provider's qualifications, including professional training and experience, verification of current competency, and continuing medical education information related to the requested clinical privileges.

b. Staff #1210's application for reappointment showed a request for core OB/GYN privileges and special OB/GYN privileges including augmentation and induction of labor at full term, manual extraction of placenta, non-stress test, episiotomy and repair, monitor placement, ultrasound for fetal position and placental location, and vacuum extraction delivery. The Governing Board approved the privileges as requested on 12/09/21. Investigators found no evidence that the application included documentation of the provider's qualifications, including professional training and experience, verification of current competency, and continuing medical education information related to the requested clinical privileges. Investigators found no evidence that the hospital completed a chart review to verify Staff #1210's clinical competence for maintaining core OB privileges.

c. Staff #1211's application for reappointment showed a request for core OB/GYN privileges and special OB/GYN privileges including augmentation and induction of labor at full term, non-stress test, episiotomy and repair, monitor placement, ultrasound for fetal position and placental location, vacuum extraction delivery, bilateral salpingectomy/tubal ligation, and C-section. The Governing Board approved the privileges as requested on 12/28/22. Investigators found no evidence that the application included documentation of the provider's qualifications, including professional training and experience, verification of current competency, and continuing medical education information related to the requested clinical privileges.

d. Staff #1212's application for reappointment showed a request for core OB/GYN privileges and special OB/GYN privileges including augmentation and induction of labor at full term, non-stress test, episiotomy and repair, monitor placement, ultrasound for fetal position and placental location, and vacuum extraction delivery. The Governing Board approved the privileges as requested on 12/28/22. Investigators found no evidence that the application included documentation of the provider's qualifications, including professional training and experience, verification of current competency, and continuing medical education information related to the requested clinical privileges. Investigators found no evidence that the hospital completed a chart review to verify Staff #1212's clinical competence for maintaining core OB privileges.

e. Staff #1214's application for reappointment showed a request for core OB/GYN privileges and special OB/GYN privileges including augmentation and induction of labor at full term, non-stress test, episiotomy and repair, monitor placement, ultrasound for fetal position and placental location, vacuum extraction delivery, bilateral salpingectomy/tubal ligation, and C-section. The Governing Board approved the privileges as requested on 12/28/22. Investigators found no evidence that the application included documentation of the provider's qualifications, including professional training and experience, verification of current competency, and continuing medical education information related to the requested clinical privileges.

3. On 03/27/23 at 12:40 PM, Investigator #13 interviewed the Medical Staff Coordinator (Staff #1209). Staff #1209 confirmed the investigator's findings that the credentialing files did not contain chart reviews or documentation verifying the provider's qualifications, current competency, or continuing medical education.

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Based on interview and record review, the hospital failed to conduct periodic staff performance evaluations as evidenced by 5 of 5 staff personnel files requested for review (Staff #1201, #1202, #1203, #1204, and #1205) (item #1), and the hospital failed to ensure that all registered nurses (RNs) working in the obstetrics (OB) department maintained current advanced cardiac life support (ACLS) certification as required by hospital policy for 2 of 5 records reviewed (Staff #1203 and #1204) (item #2) .

Failure to conduct periodic employee performance evaluations, and failure to ensure that all staff RNs maintain current ACLS certification, places patients at risk for poor quality, inadequate, or unsafe nursing care and patient death.

Item #1 - Performance Evaluations

Fiindings Included:

1. Review of the hospital policy titled, "Staff Evaluation," Policy #6939702, approved 10/19, showed that after the 3-month probationary period, each employee shall receive a written evaluation, and comprehensive performance evaluations must be done on a periodic basis not to exceed two years.

2. On 03/22/23 at 2:00 PM, Investigator #12 and the nurse educator (Staff #1206) reviewed the personnel records of 5 registered nurses assigned to work with obstetrics patients. The review showed that 5 of 5 records did not contain documentation of a performance evaluation according to the hospitals' policy time frame (every 2 years). The following staff did not have a performance evaluation within the hospital's policy time frame:

a) Staff #1201 - Last Evaluation 12/19/20
b) Staff #1202 - Last Evaluation 12/19/20
c) Staff #1203 - Last Evaluation 02/11/21
d) Staff #1204 - Last Evaluation 12/22/20
e) Staff #1205 - Hire date 03/24/22, no documentation of evaluation since completion of 3-month probationary period

3. At the time of the review, Staff #1206 stated that the hospital did not do 90-day performance evaluations. Staff #1206 confirmed that the performance evaluations for Staff #1201, #1202, #1203, and #1204 were overdue.

Item #2 - ACLS Certification

Findings Included:

1. Review of the hospital policy titled, "Nursing Staff Qualifications in Obstetrics," policy #12299882, last approved 09/22, showed that Obstetrics (OB) staff will complete advanced cardiac life support (ACLS) training within one year of hire.

2. On 03/22/23 at 2:00 PM, Investigator #12 and the nurse educator (Staff #1206) reviewed the personnel and training records of 5 staff nurses working in the OB department. The review showed that 2 of 5 employees did not have documentation of current ACLS certification (Staff #1202 and #1203) as required by hospital policy.

3. At the time of the review, Staff #1206 confirmed that Staff #1202 and Staff #1203 were working in the OB unit without current ACLS certification.

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Based on interview, document review, and review of the hospital's quality program, the hospital failed to develop, implement, and maintain a hospital-wide, data-driven quality assessment and performance improvement program that included systematic data collection, analysis, and implementation of process improvement with oversight of the hospital's Governing Body.

Failure to systematically collect and analyze hospital-wide performance data limited the hospital's ability to identify problems and formulate action plans. This reduced the likelihood of sustained improvements in clinical care and patient outcomes.

Findings included:

Interview, record review, and review of the hospital's quality documents showed the following:

1. Failure to develop and implement an ongoing and comprehensive quality program that involved all departments of the hospital and services including services furnished under contract.

Cross Reference C 1306

2. Failure to identify, investigate, and report adverse events.

Cross Reference C 1311

3. Failure of leadership and governing body to provide oversight to ensure full implementation of the quality assessment and performance improvement (QAPI) plan that included and evaluated all hospital departments and services, collection and analysis of performance improvement data for all hospital quality indicators, and included implementation of process improvement for indicators not meeting hospital goals.

Cross Reference C 1313

4. Failure to develop a systematic process for creating, implementing, monitoring, and evaluating performance improvement action plans for identified deficiencies.

Cross Reference C 1321

Due to the cumulative effect of deficiencies cited under 42 CFR 485.641, the Condition of Participation for Quality Assessment and Performance Improvement Programs was NOT MET.
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Based on interview, document review, and review of the hospital's quality program, the hospital failed to develop and implement an ongoing and comprehensive quality program that involved all departments of the hospital and services including services furnished under contract.

Failure to develop and implement a comprehensive quality program that involves all departments and services risks poor patient outcomes, and limits the hosptal's ability to provide high quality care.

Findings included:

1. Review of the hospital's document titled, "Performance Improvement Plan 2022/2023," no number, approved 04/28/22, showed that the Performance Improvement Committee was responsible for ensuring that the quality, safety and appropriateness of patient care/services provided were monitored and evlauated, and ensured appropriate action was taken when indicated and to ensure that the quality, safety, and appropriateness of patient care contracts provided through outside contractors were monitored and evaluated annually.

2. Review of the hospital's quality data 01/01/22 through 03/22/23 showed that there were no quality reports from the Central Sterile department. There were no quality reports related to instrument repair/sharpening done by an outside company.

3. On 03/27/23 at 3:00 PM, during an interview with Investigator #13, the Chief Executive Officer (Staff #1301) stated that the Central Sterile department did not report quality data to the Performance Improvement Committee and that there was no contract with the instrument repair/sharpening company.
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Based on interview and document review, the facility failed to identify, investigate, and report an adverse event.

Failure to identify, investigate, and report such events, limited the hospital's ability to implement interventions to prevent reoccurrence of the adverse event, potentially resulted in failure to submit information to the state to track and analyze in an effort to prevent similar recurrences, and put patients at risk of harm..

References:

RCW 70.41.380: Hospitals shall have in place policies to assure that, when appropriate, information about unanticipated outcomes is provided to patients or their families or any surrogate decision makers, identified pursuant to RCW 7.70.065.

RCW 70.56.020 (2) When a medical facility confirms that an adverse event has occurred, it shall submit to the department of health: (a) Notification of the event, with the date, type of adverse event, and any additional contextual information the facility chooses to provide, within forty-eight hours; and (b) A report regarding the event within forty-five days.

WAC 246-320-131: The governing authority must: (1) Establish and review governing authority policies including requirements for: (e) Reporting adverse events and conducting root cause analyses according to RCW 70.56.020.

WAC 246-320-146 : The National Quality Forum identifies and defines twenty-nine serious reportable events (adverse health events) as updated and adopted in 2011.(1) Hospitals must report adverse health events to the department.(2) Hospitals must comply with the reporting requirements under chapter 246-302 WAC.(3) Adverse health events are listed in chapter 246-302 WAC.

Findings included:

Item #1 Adverse Event Evaluation

1. Document review of the hospital's policy and procedure titled, "Adverse Events Policy," #6939721, approved 10/19, showed that all events the hospital suspects meet the DOH Adverse Events criteria would be evaluated with the Quality Improvement and/or Peer Review Program. Strategies identified in the Quallity Improvement Process would be implemented, monitored, and re-evaluated as necessary. Staff should: a) preserve evidence-sequester any packaging, specimens, and for equipment involved in the potential adverse event; b) Notify the person responsible for risk management and quality improvement and/or designee, and c) follow the organization's incident notification policy and procedure.

Review of the hospital policy titled, "Vacuum Extractor," number 11910936, revised 06/22 showed that the procedure was established to enhance the safety and minimize risk to the mother and fetus, and was based upon the recommendations of the vacuum manufacturer's and national standards of practice. Obvious progress in fetal descent should occur with the first or second pull. After 4 pulls, delivery should be imminent. Otherwise, the procedure should be carefully reconsidered or abandoned.

On 03/22/23 at 11:35 AM, during an interview with Investigator #13, the Chief Executive Officer, (Staff #1301) stated the hospital did not have a policy or procedure for root cause analysis or incident report/notification.

2. Medical record review showed that on 07/15/22 between 7:50 AM and 8:02 AM, Provider #1 performed a vacuum-assisted delivery using 7 pulls, 3 more pulls than what is recommended by the manufacturer and what is allowed by hospital policy. Following delivery of the head, severe shoulder dystocia prevented delivery of the body for over 5 minutes. At 8:08 AM, the delivery was complete, and immediate resuscitation efforts ensued. Apgar scores 0/0/2. Following placement of the endotracheal tube, the confirmation x-ray showed a 1.3 cm gap between the C-4 and C-5 vertebrae. The neonate was transferred via air lift to another facility and died at 9:04 PM. Autopsy reports showed that the spinal cord was severed between the C-4 and C-5 vertebrae (Patient #1301).

3. On 03/22/23 at 11:35 AM, during an interview with investigator #13, the Chief Executive Officer, (Staff #1301) stated that no report had been filed with Washington Deparrtment of Health because they were waiting for a report from the Washington Medical Commission to confirm that an adverse event had occurred. Staff #1301 stated that there had been no root cause analysis or investigation by the hospital, but that they had contacted their contracted Peer Review organization to have the case reviewed. There had been no change in processes or education since the event on 07/15/22.

4. On 03/27/23 at 12:55 AM, during an interview with investigator #13, Staff #1301 shared an email from the peer review company that showed that on 08/25/23 at 3:51 PM, the company sent policies and procedures for how to prepare and send charts for review. The next email in the string was from the peer review company dated 03/18/23 at 12:59 PM asking if the peer review was still needed, as the company had not received any records to review.

Item #2 Notification of Unanticipated Events

1. Review of the hospital policy titled, "Disclosure of Unanticipated Outcomes to Patients, Families, or Surrogate Decision Makers," number 6939704, revised 10/19, showed that notification shall be made as soon as practicable, such as when the patient is stabilized. The attending physician should notify the patient (or family or surrogate decision maker) an unanticipagted outcome had occurred. The attending physician must document in the patient's medical record that notification was made, how it was made, and by whom. The information in the chart should include: whether the discussion was in person or on the phone, the date, time, and who was present if the discussion was during a meeting, what the physician or other hospital personnel said, and what the patient's (or family member/surrogate decision maker's) response was.

2 .Review of the medical record showed that the family requested that the attending provider deliver the news to the patient, and the provider delivered the news to the patient in the presence of her parents and nursing staff. Investigators found no documentation of what was disclosed during the discussion or how the patient and family members responded to the information (Patient #1302).

3. On 03/23/23 at 9:55 AM, during medical record review with Investigator #12, the Obstetrics Department Supervisor (Staff #1302) was unable to show any information in the record what was disclosed, or how the patient and family members responded to the information (Patient #1302).

4. On 04/04/23 at 11:05-11:40 AM, during an interview with Investigators #12 and #13, the Chief Nursing Officer (CNO) (Staff #1307) stated that they were unaware of anyone taking over risk management position or a person assigned for monitoring disclosures of adverse events or unanticipated outcomes and stated that if a disclosure needed to occur, it would usually include the Human Resources Director, the CEO, the provider, and the CNO and/or the department head for nursing or patient care issues.

5. Medical record review from the receiving facility showed that family was notified that the infant would not survive (Patient #1301). Prior to arrival to see her infant in the Neonatal Intensive Care Unit, the mother (Patient #1302) was unaware of the severity of the infant's condition. Family asked if sedation would be handy when the mother arrived as they were worried about how she would respond to the devastating news.
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Based on interview, document review, and review of the hospital's quality and performance improvement program, the hospital's leadership and governing body failed to provide oversight to ensure full implementation of the quality assessment and performance improvement (QAPI) plan.

Failure to include and oversee the quality and performance of all patient care services, departments, and locations risks provision of improper or inadequate care, adverse patient outcomes, and limits the hospital's ability to provide high quality clinical care and improve patient outcomes.

Reference:

42 CFR 485.641 Condition of Participation: Quality assessment and performance improvement (QAPI) program

The Critical Access Hospital's (CAH) QAPI program must:
· Be appropriate for the complexity of the CAH's organization and services provided
· Be ongoing and comprehensive
· Involve all departments of the CAH and services (including those services furnished under contract or arrangement)
· Use objective measures to evaluate its organizational processes, functions, and services
· Address outcome indicators related to improved health outcomes and the prevention and reduction of medical errors, adverse events, CAH-acquired conditions, and transitions of care, including readmissions.

Findings included:

Item #1 Governing Body

1. Document review of the hospital's policy titled, "Performance Improvement Plan 2022/2023, no number, approved 04/28/22 showed the following:

· The Board of Commissioners has the ultimate responsibility and authority for the resource, support, development, and implementation of an effective Performance Improvement (PI) Program.

· The Board of commissioners, through the Performance Improvement committee, delegates the responsibility for implementation of the PI program.

2. Document review of the Governing Body meeting minutes for 08/25/22, 09/22/22, 10/27/22, 11/30/22, 12/22/22 showed no quality reports. The meeting minutes showed no discussion, approval or recommendations related to Performance Improvement initiatives or incidents.

3. On 03/23/23 at 11:40 AM, during an interview with Investigator #13, the Chief Executive Officer (Staff #1301) stated that quality reporting to the Governing Body is under the Executive Session and is not recorded in the minutes. There are no printed documents, but the quality data is shown on a screen during the executive session. There were no historical reports available. The quality report to be presented that evening at the 03/23/23 Governing Body meeting was reviewed. The indicator for blood administration showed that the vital signs frequency was less than threshold. The action plan showed that nursing staff would be educated, and monitoring would be continued. The action plan for every indicator in the Governing Body quality report showed that nursing staff would be educated and monitoring would be continued. Staff #1301 stated that there had been no improvement over time in the documentation of vital signs during blood transfusions, but no additional analysis or action had been taken. There was no evidence that nursing education had been provided.

Item #2 Incident Reporting

1. Document review of the hospital's Incident Report logs dated 01/29/22 through 03/21/23 showed that there were no reports related to obstetric deliveries or poor obstetric or neonatal outcomes.

2. On 03/22/23 at 9:35 AM, during an interview with Investigator #13 the OB Supervisor, (Staff #1302) stated that they had heard from nursing staff about a traumatic delivery [on 07/15/22] and was asked by the Chief Nursing Officer to review the case to see if there were any opportunities for improvement. Staff #1302 stated they had done the chart review, but there was no written report.

3. Document review of the Performance Improvement committee minutes for 10/11/22 titled Medical Staff/Executive Medical Staff meeting/QA/PI showed there were no unanticipated outcomes for July 2022-September 2022 and review of the 12/13/22 minutes showed that there were no unanticipated outcomes or adverse events reported year-to-date 2022.

4. On 03/23/23 at 9:50 AM, during an interview with Investigator #13, an OB staff registered nurse (Staff #1303) stated that they would not write an incident report if the provider used more pulls on the vacuum-assisted delivery device than the policy shows. Staff #1303 stated that it isn't a policy to write an incident report.

5. On 03/23/23 at 10:15 AM, during an interview with Investigator #13, an OB staff registered nurse (Staff #1304) stated they were present at the delivery on 07/15/22. Staff #1304 stated that they would not write an incident report for the number of pulls in a vacuum-assisted delivery or for a maternal hemorrhage. If an incident report was needed, Staff #1304 stated they would have expected the Chief Nursing Officer to tell them to write it up and that the purpose of incident reports was so that they could get better.

6. On 03/23/23 at 11:40 AM, during an interview with Investigator #13, the Chief Executive Officer (Staff #1301) stated that the hospital had no policy for incident reporting or root cause analysis. The hospital did not have an incident report or root cause analysis performed regarding the delivery of Patient #1 on 07/15/22. There was no investigation, report, or corrective action taken following the delivery of Patient #1301.

Item #3 Peer Review

1. Document review of the hospital's policy titled, "Performance Improvement Plan 2022/2023, no number, approved 04/28/22, showed the following:

Medical Staff Peer review is through Washington Health Service (WHS) with outside physician review and follow-up.

The Performance Improvement Committee is responsible for:

· reviewing committee and departmental findings and assuring corrective measures are implemented to improve quality outcomes
· evaluation of the quality of care provided by physicians and Allied Health Professional is conducted through Peer Review

· reviewing serious or undesirable patient outcomes and adverse events

· ensuring that the quality, safety, and appropriateness of patient care services provided are monitored and evaluated and ensure appropriate action is taken when indicated.

2. Review of the Medical Staff Bylaws, Rules, and Regulations, updated 10/25/19 showed that clinical privileges were based on education, training, experience, and demonstrated ability and judgements. Elements included in periodic reappointment included education, training, direct observation of clinical performance and judgement, performance of a sufficient number of procedures each year to develop and maintain the practitioner's skills and knowledge, a review of the records treated in this or other hospitals, and a review of the records of the medical staff which document the clinical evaluation of the practitioner's delivery of care. Case review would be required if less than 10 cases were performed in a year.

3. Review of medical staff credentialing files by Investigator #13 and the Medical Staff Coordinator (Staff #1305), showed that there had been no peer review performed for 9 of 9 provider files reviewed (Provider #1301, #1302, #1303, #1305, #1306, #1307, #1308, #1309).

4. Review of the hospital delivery log showed that 2 of 8 providers credentialed to perform deliveries had less than 10 deliveries in the past year (Provider #1306 had 4 deliveries, Provider #1308 had 5 deliveries in the past year). One provider had only documented 1 delivery but was new to the medical staff and was still under the observation/proctoring process (Provider #1304). There was no evidence that medical record review was conducted for Provider #1306 or Provider #1308 to ensure delivery competence.

5. On 03/27/23 at 12:40 PM during an interview with Investigator #13, the Medical Staff Coordinator (Staff #1305) stated that there was no Ongoing Professional Practice Evaluation (OPPE) or peer review process. There have been no peer reviews done since 2021. Staff #1303 stated that they had not checked the medical staff files for evidence of education, training, or competence for special privileges requested.

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Based on document review and review of the hospital's quality program data, the hospital failed to prioritize quality indicators based on high risk, high volume or problem prone classifications.

Failure to prioritize quality indicators risks lack of improvement or poor patient outcomes.

Findings included:

1. Review of the hospital's document titled, "Performance Improvement Plan 2022/2023," no number, approved 04/28/22 showed that the Plan Do Study Act (PDSA) model for process improvement included recognition of the problems and establish priorities. There were no identified indicators or priorities included in the plan.

2. Review of the hospital's Performance Improvement Committee minutes showed no identification of high risk, high volume, or problem prone classifications.

3. On 03/23/23 at 11:40 AM, during an interview with Investigator #13, the Chief Executive Officer (Staff #1301) stated that the Performance Improvement Plan did not include prioritization of quality indicators.
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