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Based on review of medical records, Medical Staff Bylaws and Rules and Regulations, review of policy and procedures, interviews and review of other documentation, it was determined that the facility failed to promote and protect the rights of one patient (P#7) of five sampled patients.

Findings included:

Cross refer to A-0144 as it relates to the failure of the facility to ensure that P#7 received care in a safe environment.

Based on review of medical records, Medical Staff Rules and Regulations, Graduate Medical Committee, Supervision of Residents policy, policy & procedures, and interviews, the facility failed to provide oversight of resident supervision appropriate to ensure that Patient (P) #7 received care in a safe setting on 4/2/2021. As a result, Patient #7's significant drop in blood pressure was not evaluated, treated, or clinically managed by a physician despite medical staff being informed by a RN of P#7's change in the patient's condition.

A review of the medical record revealed that P#7 was admitted to the facility on 4/1/21 for a planned removal of a pelvic mass. P#7 reported a past medical and surgical history of cervical cancer, hysterectomy (removal of uterus) high blood pressure. P#7 was allergic to antihistamine (can relieve allergy symptoms) and NSAIDS (widely used to relieve pain, reduce inflammation). P#7's vital signs on 4/1/21 at 7:17 a.m. were temperature: 36.6 Celsius (C)) (facility's normal range was 36.2 -37.7), heart rate: 84 (facility's normal range was normal 60-100), respiratory rate: 16 (facility's normal range was 12-20), blood pressure: 169/76 facility's normal range was 100-160/60-90), oxygen saturation: 99% (facility's normal range was 94-100%).

A review of the surgical progress note dated 4/1/21 at 7:30 a.m. revealed P#7 had an explorative laparotomy with bilateral salpingo-oophorectomy (incision into her abdomen to remove her ovaries and fallopian tubes) . P#7 was stable at 10:51 a.m.

On 4/2/21 at 7:02 a.m., OB/GYN Resident Doctor (RD) FF documented that P#7 had surgery on 4/1/21 and was doing well overall, had a Foley catheter (plastic tube inserted in urethra to drain urine from bladder) and Fentanyl patch (opioid for pain through a patch on the skin) for pain control. RD FF documented that P#7 appeared comfortable. P#7 was on antidepressant, pain medications as well as blood pressure medications. P#7's vital signs on 4/2/21 at 7:02 a.m. were temperature: 36.9 C, heart rate: 79, respiratory rate: 18, blood pressure: 166/67, oxygen saturation: 99%.

A review of the surgical progress note dated 4/2/21 at 7:20 a.m., revealed that P#7 had an exploratory laparotomy with bilateral salpingo-oophorectomy (incision into her abdomen to remove her ovaries and fallopian tubes) due to a complex right ovarian cyst (a fluid-filled sac that develops in the ovary causing pelvic mass). P#7 was stable after the surgical procedure at 10:51 a.m.

On 4/2/21 at 4:05 p.m. P#7's vital signs were temperature: 36.8 C, heart Rate: 71, respiratory Rate: 18, blood pressure: 79/49, oxygen saturation: 93%. At 4:30 p.m., RN KK notified OB/GYN Resident Doctor (RD) EE
that P#7's blood pressure was 86/53.

Continued review of the medical record, revealed that on 4/2/21 at 6:30 p.m., P#7 was found pulseless and slumped over. Further review of the record, revealed that P#7 was last seen eating in a chair at 5:50 p.m. by RN KK.
Review of the Code Blue (when a patient experiences unexpected cardiac or respiratory arrest that requires resuscitation and activation of a hospital-wide alert) note revealed that Cardiopulmonary Resuscitation (CPR) (procedures performed to attempt to revive a person) were initiated at 6:33 p.m. Advanced Cardiac Life Support (ACLS) (measures taken by health professionals to attempt resuscitation of someone who was not breathing and/or had a fatal arrhythmia) protocols were followed and P#7 was transferred to the Medical Intensive Care Unit (MICU).

A review of a physician progress note by MD GG written on 4/2/21 at 8:40 p.m. revealed that RD FF had assessed P#7 that morning and P#7 had complained about abdominal pain. P#7 was given pain medication and hypertensive (someone exhibiting high blood pressure) medication to manage her high blood pressure postoperatively. Continued review of the note, revealed that MD GG received a call at 6:40 p.m. that informed her that P#7 had been found unresponsive and without a pulse. MD GG noted that P#7 was fine when the RN went to P#7's room around 6:00 p.m. P#7 was resuscitated and transferred to the intensive care unit. MD GG was not sure of the cause of the acute event chart reviewed revealed P#7 was hypotensive ( abnormally low blood pressure) before she coded.

A review of the discharge summary dated 4/11/21, 7:30 a.m., revealed the final diagnosis for P#7 was brain injury with confirmation of brain death. Further review of the record, revealed P#7 had a right ovarian mass removed at the facility without complications and was in a stable condition. On the first day after the operation, P#7 was doing well, and had received pain and blood pressure medications. On the second day after the operation, P#7 was observed eating and out of her bed to a chair. At 6:40 p.m., P#7 was found to be pulseless; a code was called, and P#7 was transferred to MICU. P#7 was observed without reflexes and a CT scan of her brain was found to be abnormal concerning acute ischemia (rapid decrease in blood flow). P#7 had suffered a severe anoxic brain injury (injury when the brain is deprived of oxygen), and her exam was consistent with brain death. On 4/6/21 at 12:11 p.m., P#7 was determined to be brain dead. P#7's official time of death was 4/10/21 at 1:30 p.m.

A review of the facility's ''Medical Staff Bylaws", last amended 11/2018 revealed:
3.A.4. Interns, Residents and Fellows
(a) Interns, Residents, and Fellows in training programs at the facility did not hold appointments to the medical staff and were not granted specific privileges. Rather, they were permitted to perform only those clinical functions set out in the curriculum, affiliation agreements, and/or other training protocols developed by the Program/Residency Director of each residency program and approved by the Board.

A review of the facility's 'Medical Staff Rules and Regulations', last amended 7/2019 revealed that policy number GME 9.1, approved by Medical Executive Committee (MEC) on 5/9/11 revealed the MEC was to ensure oversight of resident supervision and graded authority and responsibility that was appropriate for safe patient care and the educational needs of residents and complied with Medical Staff By-laws/Policies/Rules and Regulations and applicable program requirements.

The Graduate Medical Education Committee provided oversight for all resident educations and monitored compliance with ACGME (Accreditation Council for Graduate Medical Education-body responsible for accrediting all graduate medical training programs for physicians in the United States) Institutional Requirements and Common Program Requirements. Each program ensured that qualified supervisors provided appropriate supervision of residents in patient care activities. Each program-maintained job descriptions or promotion criteria, which described the basic competence level for each resident level. Clinical responsibilities for each resident were based not only on the PGY(post graduate year) level, but on patient safety, resident education, severity and complexity of patient illness/condition and available support services.

A review of the facility's 'Residency/Fellowship Agreement, last approved 3/18/2020 revealed the Resident/Fellow and facility agreed to adhere in all respects to all Graduate Medical Education Policies and Procedures. Further review of the Agreement revealed:
18. (a) Resident/Fellow agreed to perform satisfactorily and to the best of his/her ability the customary services of residency/fellowship during the entire term of the contract. (f) agreed to demonstrate in a manner consistent with specialty based educational objectives the following core competencies: Patient Care; Medical Knowledge; Practice-based learning and Improvement; Interpersonal and Communication Skills; Professionalism; and Systems-based Practice described in detail in the GME Policies and Procedures.

A review of the 'Ob/GYN Residency Program, Department Handbook 2021-2022' revealed that OB/GYN residents were always supervised by credentialed physicians who were either on the full-time faculty, part-time faculty, or fully credential members of the facility medical staff. Junior residents (1st -2nd year.) were also under the direct supervision of senior or chief residents (3rd - 4th year.).

A review of facility policy (no facility policy number), titled 'Chain of Command', revised 5/10/18, revealed that employees should use the chain of command to present areas of concern through the lines of authority until a resolution could be reached. The chain of command procedure was to be used to address issues where the quality of care or safety of a patient or staff member were questioned, when a family or visitor's concerns were presented that could not be resolved by the care provider, or when it was inappropriate or untimely to utilize usual management structures.
The chain of command is as follows :
1. Any unlicensed assistive personnel and allied health care providers would report to the Registered Nurse.
2. The Registered Nurse would report to the Charge Nurse or Clinical Lead.
3. The Charge Nurse would report to the Nurse Manager.
4. The Nurse Manager would report to the Department Director.
5. The Department Director would report to the Administrative House Supervisor.
6. The Administrative House Supervisor would report to the Assistant Vice President, Patient Care Services.
7. The Assistant Vice President, Patient Care services would report to the CNE or CMO.
8. The CNE or CMO would report to the Chief Executive Officer.

A review of facility policy, (no policy number), titled 'Supervision of Residents', revised 1/11/21, revealed that the purpose was to ensure oversight of resident supervision and graded authority. It provided appropriate responsibility for safe patient care and the educational needs of residents. The policy complied with Medical Staff By-Laws, Policies, Rules and Regulations, and applicable program requirements. The Graduate Medical Education Committee provided oversight for all the resident's education and monitored compliance with ACGME Institutional Requirements and Common Program Requirements. Each residency/fellowship program ensured that qualified supervisors provided appropriate supervision of residents in patient care areas. Each program classified supervision for specific clinical assignments as "direct," "indirect," and "oversight." The program was in accordance with definitions in ACGME Common Program Requirements (July 2019). Each program-maintained job descriptions or promotion criteria that described each resident's basic competence level by year. Clinical responsibilities were based not only on the year but also on patient safety, resident education, severity, and complexity of the patient illness/condition, and the available support services. The faculty supervision assignments in each program were sufficient to assess each resident's knowledge and skills and delegate them the appropriate level of patient care authority and responsibility.

A review of the facility's policy titled 'Patient's Rights', effective 7/1/18, revealed the purpose of the policy was to provide guidelines for providing medical and nursing care for all patients and safeguard their right to privacy regardless of their race, gender, age, religion, sexual preference, disability, or ability to pay. The policy stated that every patient at the facility had the right to:

-Safety-the right of the patient to protection from the risks of the hospital environment was honored through the following: the hospital's safety committee sought to reduce or eliminate risk of illness or injury to the patient in the hospital environment.

An interview with RD EE took place on 7/20/21 at 2:41 p.m. in the conference room. RD EE stated she was in her second year of residency. She recalled receiving a call concerning P#7's blood pressure. RD EE stated the nurse informed RD EE that P#7's blood pressure was low, but RD EE could not recall the exact numbers. RD EE stated she did remember that it was not low enough to be urgent. She asked the nurse if P#7 was still receiving IV fluids and requested the continuation of those fluids. RD EE recalled asking the nurse about P#7's previous blood pressure readings. The nurse informed her that P#7 did not complain of any symptoms. RD EE explained that she had not met P#7, but stated she had been present a short time during P#7's surgery. RD EE further stated, that it was not uncommon for gynecology patients to have blood pressures in the lower ranges. RD EE explained her level of concern about a patient's blood pressure depended on the patient and how they were feeling. RD EE said if a concern arose which required her to see that patient, RD EE would inform the upper-level resident.

The facility failed to ensure that their Medical Staff Bylaws, Supervision of Residents, and the facility's Graduate Medical Committee were adhered to as evidenced by failing to provide oversight of resident supervision appropriate for safe patient care and activities for patient #7 on 4/2/2021. As this resulted in the facility's failure to ensure that Patient #7's significant drop in blood pressure was not evaluated, treated, or clinically managed by a physician despite medical staff being informed by the RN of the change in condition for P#7.

During an interview with RD FF on 7/20/21 at 4:00 p.m., in the facility conference room, RD FF explained that she was in her third year of residency. RD FF stated she remembered P#7 because she assisted during P#7's surgery and had been a part of the team that completed rounds on P#7 the day after P#7's surgery. She recalled P#7 was stable that morning and had met her post-operative goals for the day. RD FF recalled receiving a phone call from her attending physician the evening that P#7 was found unresponsive and pulseless. RD FF stated that it was standard practice to see a patient after being informed of a change in patient status. RD FF further stated, that since P#7 had a history of high blood pressure, it would have been concerning to hear that P#7 blood pressure was low. RD FF confirmed that an intern should always notify a resident with any concerning changes to a patient's health. RD FF explained because of this incident, upper-level residents carried a phone for calls along to communicate with other residents. RD FF developed and presented a presentation on 7/21/21 to the OB/GYN residents on post-operative management.

An interview with OB/GYN Medical Doctor (MD) GG took place on 7/20/21 at 4:30 p.m., in the conference room. MD GG confirmed that she was the attending physician who provided care for P#7. She stated that P#7's surgery was uneventful, and P#7 was doing well the morning after surgery. She explained that a low blood pressure would not have been normal for P#7 since she had a history of high blood pressure. MD GG continued to say that P#7's blood pressure had been elevated the evening that she had surgery and P#7 was started back on medication to treat the high blood pressure. She stated a lower blood pressure could have been normal for a GYN patient but not for an oncology patient. MD GG explained that her expectation was that RD EE contact RD FF when informed of the low blood pressure. In addition, she said that a physician should have examined P#7 after being informed about the low blood pressure. MD GG explained that not recognizing P#7's low blood pressure was a knowledge deficit and that lack of prioritization not workload was a factor.

An interview with Clinical Technician (CT) HH took place on 7/21/21 at 11:15 a.m. in the conference room. CT HH explained she had worked at the facility since 2016 on an Oncology and Medical unit. She recalled that P#7 had sat in a chair most of the day. CT HH explained that on the day that P#7 coded, there were three CT's working and they had 12 patients each. CT HH explained that ideally, she was assigned nine patients. CT HH further explained, that vital signs were usually taken every four hours and she rounded on her patients every two hours. CT HH stated that sometimes she was delayed in taking all of her assigned patients' vital signs and rounding due to patient care provided on other patients. CT HH explained that if she had an abnormal vital sign, she called the patient's nurse. All patient care givers on the unit had a phone. She did not recall an occasion when P#7's blood pressure was low. CT HH stated if the patient's nurse could not be reached, she contacted the charge nurse.

During an interview with Registered Nurse (RN) KK on 7/21/21, at 11:30 a.m. in the facility conference room. RN KK recalled that P#7 had sat in a chair with no complaints the last time she checked on P#7, before 6:00 p.m. RN KK recalled approximately at 4:00 p.m., CT HH had informed her that P#7's blood pressure was low. RN KK rechecked P#7's blood pressure manually ( non electronic device). RN KK stated she contacted MD EE and reported P#7's abnormal blood pressure. RN KK stated MD EE did not give any new orders concerning P #7's low blood pressure. RN KK further explained, the standard of care was to check vital signs on patients every four hours unless otherwise ordered by their doctor.

The facility failed to ensure that their policy and procedure regarding "Chain of Command" as evidenced by nursing staff failing to notify the charge nurse on 4/2/2021 that she had called the in-patient Resident Physician and informed her of the significant drop-in patient #7's BP and no clinical/medical interventions treatments were ordered. Additionally, the Resident on call nor his supervising physician came to the patient's room to evaluate the patient 's significant change in blood pressure S/P status post 24 hours after surgery.

Based on review of medical records, policy and procedures, Quality Assessment Performance Improvement Plan, interviews and facility documentation, it was determined that the facility failed to develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. In addition, the facility failed to ensure performance improvement data was collected, tracked, analyzed in order to implement changes that effected improvements in quality of care and patient safety.

Findings included:

Cross refer A-273, A-283, and A-0286 related to the facility's failure to ensure an effective process for tracking, analyzing, and implementing preventative actions and mechanisms including feedback and learning throughout the hospital.

Based on review of medical records, the facility's Quality Assessment Performance Improvement Plan, Quality Management System Oversight Committee (QMSOC) Meeting minutes, Governing Board Meeting minutes, Incident Report Logs, policy and procedures, and interviews the facility failed to identify opportunities for improvement in the quality of patient care and patient safety for two Patients (P), P#1 and P#5 of six sampled patients that developed hospital acquired pressure injuries during their hospitalizations.

Findings included:

A review of P#1's medical record revealed P#1 was admitted to the facility on 12/31/2020. Review of the Emergency Department (ED) admission assessment did not reveal the presence of pressure wounds. P#1 was discharged to a long-term care facility on 2/22/21 with pressure wounds to the coccyx and left buttock. P#1 was re- admitted to the facility on 3/26/21 with a chief complaint of fever. Review of the ED admission history and physical failed to document an existing pressure wound. P#1 was discharged from the facility on 6/24/21 with pressure wounds to the coccyx, right heel, left heel, right buttock and right hip.

A review of P#5's medical record revealed P#5 was admitted to the facility on 3/10/21. The Emergency Department (ED) assessment revealed that P#5 did not have any pressure wounds present on admission. P#5 was discharged to a skilled nursing facility on 7/22/2021 with a pressure wound to the coccyx.

A review of the facility's Quality Assessment Performance Improvement Plan (QAPI), last approved 12/2/2020 revealed that the QAPI plan was to provide a focus on patient-centered care in an environment that sought to prevent defects in the provision of care. This plan focused on Performance Improvement within four broad categories for internal and external customers: 1) Service Excellence 2) Clinical Excellence. The Board directed the Vision and Mission and was legally responsible for its governance including strategy, leadership structure and governance process, organizational ethics, and quality/patient safety/compliance.

The facility's Patient Safety Program and the QAPI Program were integrated to assure the flow of information to the appropriate area for review, action, and/or follow up. The QAPI, Patient Safety Program and Risk Management Programs sought to reduce the frequency and severity of adverse events. Continued review of the plan, revealed that the Board of Trustees (Board) retains overall responsibility and accountability for the quality of patient care, including the safety of the staff, visitors, and appropriate utilization of resources. The Board holds the Medical Staff accountable for the quality of patient care. The Board established the Quality and Safety Committee to implement and maintain an effective ongoing hospital-wide, quality driven Quality Assessment and Performance Improvement Program. The Board, Medical Staff, and Executive Leadership assure the facility implements and maintains an effective quality and safety program, which ensures corrective action taken are implemented, measured, and monitored.
The Patient Safety Officer reviewed designated root cause analysis, FMEAs (Failure Mode Means Analysis: quality analysis methodology), and other effects analysis and ensured documentation was in place to support findings and corrective/preventative actions. Reviews were performed as appropriate to measure and the effectiveness of improvement initiatives.
The Patient Safety Officer provided reports as specified by QSC including but not limited to patient safety reported at least quarterly, event reports that involved potential or actual quality issues, executive summary of the above will be reported at least quarterly.

The Quality and Safety Committee (QSC) was a sub-committee of the Governing board with responsibilities to provide overall guidance for the QAPI program, assessed and prioritized performance improvement activities, reported performance improvement activities to the Board, oversight and review of the QAPI plan to improve quality of care and safety at the facility. QSC approved the QAPI program, including the indicators used to measure performance. The QSC's primary responsibilities included but were not limited to: Health Outcomes, Medical Error Reduction, Quality Indicators, Patient Safety, Prioritization, Improvement, PI Projects. The facility utilized the Model for Improvement of Plan Do, Check, Act.

A review of the Quality Management System Oversight Committee (QMSOC) Meeting minutes for January 2021 to June 2021 revealed that meetings were held monthly. Standing agenda items included but was not limited to: Quality and Safety Committee update, update on data measures and reported measures.
Review of the QMSOC meeting notes on 1/6/21 update was received from the Quality and Safety Committee that included review of the Patient Safety Plan and Mortality Review, to be reported to the next MEC, and Board meeting. Further review, revealed the system Quality and Patient Experience Goals were reviewed, but the goals failed to include hospital acquired pressure injuries.


A review of the QMSOC meeting notes on 5/5/21 revealed a report on Hospital Acquired Pressure Ulcers (HAPI). Notes included: physician sponsor needed; steering committee being formed. HAPI prevention coordinator position remained open, prevention audits conducted in three units of the hospital.

A review of the facility's monthly Governing Board Meeting minutes from January 2021 to July 2021 revealed no documentation to reflect specific quality measures, data collected, analyzed related to HAPI.

A review of the facility's policy titled 'Plan for Nursing Care' policy 206.1017, effective 11/30/17, last revised 11/29/17 revealed that the purpose was to outline general responsibilities for nursing practice. Continued review of the policy revealed that administrative support: Department/unit staff meetings were held on a periodic and regular basis, and no less than once a quarter. Review of the policy revealed that all skill levels of staff were provided review of quality improvement findings, opportunities to improve care, problem identification/solution and activities designed to improve knowledge, skills and abilities. Further review revealed QI plans were used to monitor and evaluate the scope and key aspects of service for departments to ensure the activities of the department function effectively to benefit patients, staff and the system. A staffing plan defined the number and mix of nursing personnel was developed and reviewed annually to address the care needs of the patients served in the nursing areas. Each area defined a process for the assessment and response to staffing variances.

A review of the patient incident log from 01/01/21 through 07/12/21 revealed a total of 24 reported hospital acquired pressure injuries that included a report of P#1.

During an interview with the Unit Director (RN) PP on 8/2/21 at 11:35 a.m., in the conference room, RN PP stated she completed a quarterly review of all patient's charts. In addition, RN PP stated charts were reviewed for accuracy and appropriateness of care. RN PP stated that she trained the eight nurse managers and clinical leaders to conduct chart audits. RN PP further stated once chart reviews were completed, the wound care audits were turned into the wound director for review. RN PP stated the results from the quarterly audits were also sent to quality for any trends. RN PP stated the quality department provided her An Apparent Cause Analysis (ACA), and based on the outcomes, she would determine a root cause analysis (RCA) based on any trends or concerns. RN PP stated she was not surprised that documentation was not sufficient because she had reviewed the audits. RN PP stated she discussed turning and wound documentation with staff during real-time. RN PP confirmed that the staff was not following departmental or facility policy when they did not document patient turns or wound care.


During an interview with the Wound Care Director on 8/2/21 at 1:30 p.m. in the conference room, the Wound Care Director stated she worked with facility quality department when there was a question or concern related to wound care. The Wound Care Director further stated, the facility had a Harm Committee that evaluated wound care outcomes. The Wound Care Director explained the facility utilized the National Data Base of Nursing Quality Indicators (NDAQI) to determine if skin care standards were met at the facility. In addition, the Wound Care Director stated the facility completed and reviewed a quarterly skin condition for all patients admitted to the facility. The Wound Care Director stated the facility also collected would care for any Root Cause Analysis (RCA) if any aspect of patient care determined an RCA was required. The Wound Care Director stated that after the facility's quality department analyzed the data, the Wound Care Director received it back with benchmarks. The Wound Care Director further explained, she did not have any specific data for the wound care department, and she did not submit any detailed data from the wound care department for review. The Wound Care Director said she occasionally shadowed her employees, and they discussed patient outcomes and individualized care plans. The Wound Care Director stated her schedule did not allow her time to conduct chart audits. The Wound Care Director further stated she reviewed the raw data from all the reviews, but the Wound Care Director explained there was no system to audit wound care outcomes or care in the wound care department. The Wound Care Director confirmed there was no tracking tool in place for follow-up or new consult time frames.

The facility failed to have effective systems in place that addressed patients at risk for skin breakdown and reporting skin breakdown/wounds acquired while hospitalized for P #1 and P#5. The facility also failed to ensure that the Wound Care Director reported the hospital acquired wound findings as per the Quality Assessment Performance Plan (QAPI). This multi system failure related to hospital acquired wounds resulted in poor quality outcomes for patients P#1 and P #5.

Based on review of medical records, facility's Quality Assessment Performance Improvement Plan, policies and procedures, facility's Patient Safety Program, Quality Management System Oversight Committee meetings, Governing Body meetings, incident report log, and interviews, it was determined the facility failed to identify opportunities for improvement and changes that would lead to improvement for quality of patient care and patient safety for patients identified as high risk and problem prone areas for two Patients (P), P#1 and P#5 of six sampled patients who developed hospital acquired pressure injuries during their hospitalizations.

Findings included:

A review of P#1's medical record revealed P#1 was admitted to the facility on 12/31/2020. Review of the admission assessment did not reveal the presence of pressure wounds. P#1 was discharged to a long-term care facility on 2/22/21 with pressure wounds to the coccyx and left buttock. P#1 was re- admitted to the facility on 3/26/21 with a chief complaint of fever. Review of the admission history and physical failed to document an existing pressure wound. P#1 was discharged to an out-of-state long-term adult care facility on 6/24/21 with pressure wounds to the coccyx, right heel, left heel, right buttock and right hip.

A review of P#5's medical record revealed P#5 was admitted to the facility on 3/10/21. The Emergency Department (ED) assessment revealed that P#5 did not have any pressure wounds present on admission. P#5 was discharged to a skilled nursing facility on 7/22/2021 with a pressure wound to the coccyx area.

A review of the facility's 'Quality Assessment Performance Improvement Plan (QAPI), last approved 12/2/2020 revealed that the QAPI plan was to provide a focus on patient-centered care in an environment that sought to prevent defects in the provision of care. QAPI activities were integrated across the care service areas. The processes and outcomes of care were designed, measured, and analyzed by appropriate departments. The Board directed the Vision and Mission and was legally responsible for its governance including strategy, leadership structure and governance process, organizational ethics, and quality/patient safety/compliance.

The facility's Patient Safety Program and the QAPI Program were integrated to assure the flow of information to the appropriate area for review, action, and/or follow up. The QAPI, Patient Safety Program and Risk Management Programs sought to reduce the frequency and severity of adverse events, thus minimizing loss and contributing to Performance Improvement through assessment, evaluation, control, and education. Further review of the QAPI plan revealed the program integrated patient safety, hospital quality and provider quality into a comprehensive system of continual performance improvement. Review of the plan revealed integration was facilitated through leadership focus on efficiency, quality, safety, and experience of internal and external customers metrics embedded in hospital operations as well as through the quality monitoring and improvement activities of the Medical Affairs Division.
The Board holds the Medical Staff accountable for the quality of patient care. The Board, Medical Staff, and Executive Leadership assure the facility implements and maintains an effective quality and safety program, which ensures corrective action taken are implemented, measured, and monitored.
The Patient Safety Officer reviewed designated root cause analysis, FMEAs (Failure Mode Means Analysis: quality analysis methodology), and other effects analysis and ensured documentation was in place to support findings and corrective/preventative actions. Reviews were performed as appropriate to measure and the effectiveness of improvement initiatives.
The Patient Safety Officer provided reports as specified by QSC including but not limited to patient safety reported at least quarterly, event reports that involved potential or actual quality issues, executive summary of the above will be reported at least quarterly.
The Quality and Safety Committee (QSC)'s primary responsibilities included but were not limited to: Health Outcomes, Medical Error Reduction, Quality Indicators, Patient Safety, Prioritization, Improvement, PI Projects. The facility utilized the Model for Improvement of Plan Do, Check, Act.
A review of the Quality Management System Oversight Committee (QMSOC) Meeting minutes for January 2021 to June 2021 revealed that meetings were held monthly. Standing agenda items included but was not limited to: Quality and Safety Committee update, update on data measures and reported measures.
Review of the QMSOC meeting notes on 1/6/21 update was received from the Quality and Safety Committee that included review of the Patient Safety Plan and Mortality Review, to be reported to the next MEC, and Board meeting. Further review, revealed the system Quality and Patient Experience Goals were reviewed, but the goals failed to include hospital acquired pressure injuries.

A review of the QMSOC meeting notes on 5/5/21 revealed a report on Hospital Acquired Pressure Ulcers (HAPI). Notes included: physician sponsor needed; steering committee being formed. HAPI prevention coordinator position remained open, HAPI prevention audits conducted in three units of the hospital.

A review of the facility's monthly Governing Board Meeting minutes for 2021 revealed no documentation to reflect specific items related to quality measures or data of hospital acquired pressure sores.

A review of the facility's policy titled 'Plan for Nursing Care' policy 206.1017, effective 11/30/17, last revised 11/29/17 revealed that the purpose was to outline general responsibilities for nursing practice. Continued review of the policy revealed that administrative support: Department/unit staff meetings were held on a periodic and regular basis, and no less than once a quarter. Review of the policy revealed that all skill levels of staff were provided review of quality improvement findings, opportunities to improve care, problem identification/solution and activities designed to improve knowledge, skills and abilities. Further review revealed QI plans were used to monitor and evaluate the scope and key aspects of service for departments to ensure the activities of the department function effectively to benefit patients, staff and the system.

A review of the patient incident log from 01/01/21 through 07/12/21 revealed a total of 24 reported hospital acquired pressure injuries that included a report of P#1.

During an interview with the Unit Director (RN) PP on 8/2/21 at 11:35 a.m., in the conference room, RN PP stated she completed a quarterly review of all patient's charts. RN PP stated charts were reviewed for accuracy and appropriateness of care. RN PP stated she trained the eight nurse managers and clinical leaders to conduct chart audits. RN PP further stated once chart reviews were completed, the wound care audits were turned into the wound director for review. In addition, RN PP stated the results from the quarterly audits were also sent to quality for any trends. RN PP stated the quality department provided her An Apparent Cause Analysis (ACA), and based on the outcomes, she would determine a root cause analysis (RCA) based on any trends or concerns. RN PP stated she was not surprised that documentation was not sufficient because she had reviewed the audits. RN PP stated she discussed turning and wound documentation with staff during real-time. RN PP confirmed that the staff was not following departmental or facility policy when they did not document patient turns or wound care.


During an interview with the Wound Care Director on 8/2/21 at 1:30 p.m. in the conference room, The Wound Care Director stated she worked with facility quality department when there was a question or concern related to wound care. The Wound Care Director further stated, the facility had a Harm Committee that evaluated wound care outcomes. The Wound Care Director explained the facility utilized the National Data Base of Nursing Quality Indicators (NDAQI) to determine if skin care standards were met at the facility. In addition, the Wound Care Director stated the facility completed and reviewed a quarterly skin condition for all patients admitted to the facility. The Wound Care Director stated the facility also collected would care for any Root Cause Analysis (RCA) if any aspect of patient care determined an RCA was required. The Wound Care Director stated that after the facility's quality department analyzed the data, the Wound Care Director received it back with benchmarks. The Wound Care Director further explained, she did not have any specific data for the wound care department, and she did not submit any detailed data from the wound care department for review. The Wound Care Director said she occasionally shadowed her employees, and they discussed patient outcomes and individualized care plans. The Wound Care Director LL stated her schedule did not allow her time to conduct chart audits. The Wound Care Director further stated she reviewed the raw data from all the reviews, but the Wound Care Director explained there was no system to audit wound care outcomes or care in the wound care department. The Wound Care Director confirmed there was no tracking tool in place for follow-up or new consult time frames.


The facility failed to ensure that their QAPI plan was followed, maintained as evidenced by failing to focus on patient care centered care areas (Hospital Acquired Pressure Injuries) to prevent defects in provision of care when the facility identified through incident report reviews revealed that from 1/1/21 through 7/12/2021, 24 HAPIs were reported. The facility's Governing Board, Medical Staff and Executive Leadership failed to maintain an effective QAPI program, and safety program to ensure corrective actions, were taken and implemented, measured and consistently monitored for P#1 and P#5 as stated in the facility's QAPI plan.

Based on review of medical records, policy and procedures review, facility's Quality Assessment Performance Improvement Plan (QAPI) review, policy and procedure review, staff interviews, it was determined that the facility failed to have an effective ongoing program that showed measurable improvement indicators with evidence of identification to track adverse events, analyze causes, and implement preventative actions and measures including feedback and learning throughout the facility for one Patient #7 (P#7) of five sampled patients who had a significant drop in blood pressure the nurse notified the on-call Resident of the change; but the resident failed to evaluate the patient nor provide medical treatment for the change in condition. It was also determined that the facility failed to ensure that their QAPI plan was followed and maintained by failing to focus on patient care centered care areas (Hospital Acquired Pressure Injuries) to prevent defects in provision of care for two Patients (P), (P#1) and (P#5) of six sampled medical records reviewed.


Findings included:

A review of P#7's discharge summary dated 4/11/21 revealed the final diagnosis for P#7 was brain injury with confirmation of brain death. Further review of the record, revealed that P#7 had a right ovarian mass removed at the facility without complications and was in a stable condition. On the first day after the operation, P#7 was observed without issues, and had received pain and blood pressure medications. On the second day (4/2/2021) after the operation, P#7 was observed eating and out of her bed to a chair. At 4:30 p.m. on 4/2/2021 it was noted that Patient #7 had a significant drop in blood pressure. The nurse notified the on-call resident of the significant change in the patients' blood pressure. There was no documentation in the Medical record to indicate that Patient #7 was evaluated by the Resident on call, or that clinical medical treatment was provided/ordered for the patient's significant drop in Blood pressure.

At 6:40 p.m., P#7 was found pulseless; a code was called, and P#7 was transferred to the MICU (Medical Intensive Care Unit). P#7 was observed without reflexes and a CT scan of her brain was found to be abnormal concerning acute ischemia (rapid decrease in blood flow). P#7 had suffered a severe anoxic brain injury (injury when the brain is deprived of oxygen), and her examination was consistent with brain death, with unclear etiology. On 4/6/21 at 12:11 p.m., P#7 was determined to be brain dead. P#7's official time of death was 4/10/21 at 1:30 p.m.

A review of the facility's work instructions titled 'Sentinel Event', last revised 12/12/19 revealed that the policy outlined procedures to be followed in the event of a sentinel event. Definitions included: A sentinel event was defined as an unexpected occurrence that involved death, or serious physical or psychological injury or other risk thereof. 'Unexpected' was defined as the outcome was not within range of risk reasonably associated with an activity. Such outcomes could be the result of a process failure or deviation. An event was considered 'reportable' (to the immediate supervisor or CEO) if it resulted in an unanticipated death, major permanent loss or use of limb. An occurrence report was required.

Process Flow: it was the responsibility of employees, agency staff, students, physicians, volunteers to immediately report to their supervisor or CEO any event previously described. When notified, the Risk Manager, Senior Leadership, or CEO called together the Patient Safety Committee. Committee members included but were not limited to: Risk Manager, Safety officer, CEO, Patient Care Services Director, Nursing Supervisor(s), or others.

Responsibility of the Patient Safety Committee Team revealed the following:
Stage 1. Immediately following the alleged event, within 24 hours, the Patient Safety Committee
-Did everything possible to provide follow up care and services to ensure the best possible outcome.
-Ensure everyone involved receive appropriate information to avoid miscommunication.
-Determine if the event qualified as reportable or a sentinel event. The CEO ultimately decided on if it was a sentinel event and needed reported. If the event was deemed reportable, the event was reported to the Department of Community Health (DCH) within five days of becoming aware of the event.
-All proceedings were documented.
-Legal counsel consulted or other as necessary.
-Secure and preserve any evidence.
-Maintain confidentially of the event.
Stage II. Within 24 hours to one week of the event, the Patient Safety Committee will:
-Conduct an internal investigation including interviews.
-Determine root causes of the event
-Determine potential improvements in processes or systems that would decrease the likelihood of such an event occurring again.
-Establish a plan of action that addressed the identified opportunities for improvement. The plan included a time frame, person responsible, and criteria to evaluate.

Stage III. Post Event Reporting
1. If the event met the definition of 'sentinel event', the facility submitted a Root Cause Analysis (RCA- techniques used to uncover causes of problems).
to the accrediting organization or the state Department if necessary, within 45 days of becoming aware of the event. The CEO determined.

A review of the facility's 'Patient Safety Plan', approved by the facility's Board on 2/4/21 revealed that the Plan was designed to create a culture that viewed safety as the foundation to improve patient safety, reduce risks with a focus on process improvement to ensure a safe environment to those served. Leadership assumed a role in establishing a culture of safety that minimized hazards and patient harm by focusing on processes of care.
Continued review of the policy revealed that the Culture of Safety Committee (CoS) functioned as the Patient Safety Committee, which was an interdisciplinary group that managed the Patient Safety Program through various systematic, coordinated, continuous approach. The team met quarterly.

All components of the organization were integrated into the program though collaborative effort of multiple disciplines by reporting actual or potential occurrences, communication with Patient Safety Officer and Environmental Officer, reporting safety measures to the Performance Improvement oversight group and Quality Management.

The mechanism for identification and reporting an Adverse Event/error were in the policies. Any RCA of processes was submitted for review, recommendations, and approval to the Cause Analysis Approval Committee. Notification of approved action plans were reported to the CoS and QMSC via the QMSOC. They will then be reported to MEC and Board.

The procedures for immediate response to medical/health care error were:
-Staff will immediately report the event to the supervisor.
-The supervisor immediately communicated the event to Risk, VP, and Patient Safety Officer to investigation and follow up actions.
-Staff completed the Incident/Occurrence (CQIR). Report to preserve information.
-The Safety Officer was notified of any potential risk to others.
-The Patient Safety Officer followed usual protocols to investigate the error and coordinate information for presentation, review, and action to the Declaration committee as applicable.
-Methods to assure ongoing in-services, education and training programs for maintenance and improvement of staff competence and to support to an interdisciplinary approach to patient care was accomplished by providing information and reporting to new staff in orientation, providing ongoing education, evaluation of staff knowledge.

A review of the facility's work instruction titled 'Plan for the Provision of Care', last revised 5/10/18 revealed that the various health care disciplines communicated and collaborated to meet the identified needs and followed physician's orders to provide patient and family centered care. Further review of the policy revealed, coordination and collaboration occurred via in person, by telephone, email, fax, radio, and the patient's medical record. Communication occurred between caregivers at all points of patient transfer. Health care professionals were involved when appropriate in integrated assessment, care planning, education, re-assessment, treatment and discharge of patients. Interdisciplinary communication and collaboration were expected to assure the patients care and safety needs were met.

An interview with the Assistant Vice President of Quality and Patient Safety Coordinator (PSC) DD took place on 7/21/21 at 1:30 p.m., in the conference room. The facility's Chief Nursing Officer and Director of Quality Improvement were present during the interview. The Assistant Vice President of Quality explained that PSC DD reviewed all patient incidents reported via the facility's online reporting system. The Assistant Vice President of Quality recalled that an incident with P#1 was reported electronically on 4/2/21. The facility's quality improvement department initiated an investigation on 5/11/21 that included a Root Cause Analysis (RCA- techniques used to uncover causes of problems). The Assistant Vice President of Quality explained the outcome of the RCA was pending but the initial investigation revealed that the facility had opportunities for improvement. In addition, The Assistant Vice President of Quality stated the cause of P#1's death was not determined, but one of the root causes determined revealed there were gaps in communication amongst the medical staff. The Assistant Vice President of Quality stated, as a result, the Chief Resident for obstetrics/gynecology (OB/GYN) currently carried a 'hip phone'(phone easily accessible on one's hip) and required to be always available. The Assistant Vice President of Quality stated Chief Resident FF developed and disseminated a presentation to the medical staff that included reminders about monitoring post-operative vital signs and communication with the Chief Resident and Attending physician. PSC DD explained that the outcome of the RCA included corrective actions around the medical staff and no actions regarding the nursing staff. The Assistant Vice President of Quality explained facility's policy determined corrective actions developed from the facility's RCAs within 30 days and those corrective actions implemented in 90 days. The Assistant Vice President of Quality stated that Resident (MD) EE participated in the RCA meeting.

A review of the facility's Quality Assessment Performance Improvement Plan (QAPI), last approved 12/2/2020 revealed that the QAPI plan provided guidance for the overall quality program. The aim was to provide a focus on patient-centered care in an environment that sought to prevent defects in the provision of care. This plan focused on Performance Improvement within four broad categories for internal and external customers: 1) Service Excellence 2) Clinical Excellence 3) Cost Excellence and 4) Workforce Experience. QAPI activities were integrated across the care service areas. The processes and outcomes of care were designed, measured, and analyzed by appropriate departments. A QAPI self-assessment was completed annually, and service areas included but were not limited to obstetrical services, oncology services, and surgical services. Further review of the facility's QAPI plan revealed the facility's Governing Body was legally responsible for its governance including strategy, leadership structure and governance process, organizational ethics, and quality/patient safety/compliance.

The facility's Patient Safety Program and the QAPI Program were integrated to assure the flow of information to the appropriate area for review, action, and/or follow up. The QAPI, Patient Safety Program and Risk Management Programs sought to reduce the frequency and severity of adverse events, thus minimizing loss and contributing to Performance Improvement through assessment, evaluation, control, and education.
The Patient Safety Officer reviewed designated root cause analysis, FMEA's, and other effects analysis and ensured documentation was in place to support findings and corrective/preventative actions. Reviews were performed as appropriate to measure and the effectiveness of improvement initiatives.
Further review of the plan revealed, the Patient Safety Officer provided reports including but not limited to patient safety reports at least quarterly, event reports that involved potential or actual quality issues, and executive summary of the above will be reported at least quarterly.
Review of the plan revealed the Quality and Safety Committee (QSC) was a sub-committee of the Governing board with responsibilities to provide overall guidance for the QAPI program, assessed and prioritized performance improvement activities, reported performance improvement activities to the Board (Governing Body), oversight and review of the QAPI plan to improve quality of care and safety at the facility. QSC approved the QAPI program, including the indicators used to measure performance. The QSC's primary responsibilities included but were not limited to: Health Outcomes, Medical Error Reduction, Quality Indicators, Patient Safety, Prioritization, Improvement, PI Projects. The facility utilized the Model for Improvement of Plan Do, Check, Act.

A review of the Quality Safety Oversight Committee Meeting minutes for January 2021 to June 2021 revealed that meetings were held monthly. Standing agenda items included but was not limited to: Quality and Safety Committee update, update on data measures and reported measures.

Review of the Quality Safety Oversight Committee meetings dated 5/5/21 and 6/21/21 revealed no documentation that the Patient Safety Officer reported to the committee findings and corrective/preventative actions related to the sentinel event that occurred on 4/2/21 with P#7's significant drop in blood pressure, resident MD notified, and no clinical treatment was provided to P#7.

The facility identified through incident report reviews revealed from 1/1/21 through 7/12/21, 24 HAPIs were reported. The facility's Governing Board, Medical Staff and Executive Leadership failed to maintain an effective QAPI program, and safety program to ensure corrective actions, were taken and implemented, measured and consistently monitored for Patient #1 (P#1) and Patient #5 (P#5) HAPI as stated in the facility's QAPI plan.

Based on medical records reviewed, review of facility policies and procedures, review of wound care staffing schedules, Pressure Ulcer prevention work instruction protocols review, and staff interviews it was determined that Nursing Services failed to provide adequate staffing and patient care for two Patients (P), P#2 and P #5 of six sampled patients with Hospital Acquired Pressure Injuries.


Refer to findings in Tag A-392

Based on medical record reviews, staff interviews, unit tours, wound care staffing schedules, Pressure Ulcer prevention work instruction protocols, and review of facility policies and procedures, it was determined the facility failed to ensure the nursing staff and other personnel provided adequate wound care,and failed to document wound assessments for two Patients (P), P #1 and P#5 of six sampled patients who developed hospital acquired pressure injuries.


Findings:

A review of P#1's medical record revealed that he was admitted to the emergency department on 12/16/2020 at 10:22 a.m., with a MVA (motor vehicle accident). A review of P#1's History and Physical (H&P) dated 12/16/2020 at 10:00 a.m., revealed P#1 was not alert or oriented and was intubated to assist with his breathing. P#1 was admitted to the facility's Surgical Intensive Care Unit (SICU) with a traumatic brain injury (TBI) diagnosis. P#1 was discharged from the facility on 12/26/2020 and transferred to a skilled nursing facility.
In addition, a review of P#1's medical record revealed he transferred from a local skilled nursing facility to the facility's ED on 12/31/20 at 8:25 p.m., with a complaint of sepsis. Further review of P#1's H&P dated 1/1/21 at 2:53 a.m., revealed that P#1 had a history of a traumatic brain injury (TBI) related to an MVA. A review of P#1's skin assessment revealed P#1's skin was warm, dry, and pink. P#1 was admitted to the Medical Intensive Care Unit (MICU) on 1/1/21. A review of the medical record revealed P#1 was transferred from the facility's MICU to the facility's cardiology, medical, surgical unit on 1/10/21.

A review of P#1's nutrition consult completed on 1/2/21 at 11:19 a.m. revealed P#1's Braden score (assessment tool to predict pressure sore risk) was 13 (score of 13-14 is moderate risk). Nutrition goals included supporting advanced nutrition and maintaining skin integrity.

A review of P#1's medical record revealed that a wound ostomy nurse assessed P#1 on 1/11/21 at 3:38 p.m. and noted that no wounds were present on exam.

A review of P#1's nursing assessment dated 1/31/21 at 10:10 p.m. revealed that P#1's buttocks were pink and red, and a foam dressing was applied.

A review of P#1's medical record revealed no wound consult request on 1/31/21. P#1's Braden score was documented as 11 (10-12 is high risk for pressure ulcer)

A review of P#1's discharge summary dated 2/27/21 at 9:57 a.m., revealed that P#1 was discharged on 2/27/21 at 9:09 a.m. to a skilled nursing facility. P#1's discharge diagnosis included but was not limited to diabetes, high blood pressure, fever, respiratory failure, and history of TBI. A review P#1's skin integumentary assessment revealed that P#1's skin was warm with no pallor or rash. P#1's discharge condition was documented as improved.
A review of the medical record revealed P#1 was transferred from a local skilled facility to the facility's ED on 3/26/21 at 9:25 a.m., with a chief complaint of fever. A review of P#1's H&P dated 3/26/21 at 1:47 p.m. revealed that P#1 had a past medical history of a TBI, tracheotomy, percutaneous endoscopic gastrostomy (PEG) placement, chronic decubitus wounds, high blood pressure, and diabetes. P#1 was re-admitted on 3/26/21 at 6:30 p.m.

Further review of the medical record revealed that P#1 was transferred to the MICU on 5/13/21 at 5:48 a.m. A review of P#1's radiology CT scan (computed tomography: x-ray that produces an image) result dated 5/12/21 at 10:41 a.m., revealed P#1 had an abdominal and pelvis CT scan. Further review of P#1's scan revealed a decubitus ulcer (pressure ulcer/bedsore) that had increased in size since the prior exam. Documentation revealed a suspicion of osteomyelitis (bone infection) in the coccyx (tailbone) area and a bone scan was recommended. A review of P#1's surgical consultation dated 5/13/21 at 12:48 a.m. revealed P#1 had a sacral wound debridement(removal of damaged tissue or foreign objects from a wound) on 5/4/21.
A review of P#1's discharge summary dated 6/23/21 at 8:00 a.m. revealed that during P#1's admission, he had a sacral decubitus ulcer with a bone infection. P#1's physical exam noted that P#1's skin was warm and dry, and he was alert. P#1 had a discharge diagnosis that included sepsis, chronic respiratory failure, diabetes, high blood pressure, traumatic brain injury, and sacral decubitus ulcer. P#1 was transferred to an out-of-state long-term adult care facility.

A review of the wound ostomy orders revealed a wound care order on 2/2/21 at 4:22 p.m., for P#1's sacrum (lower back bone) to be cleaned with wound cleanser, Mepilex applied and dressings changed every three days.

A review of P#1's record revealed that a wound care consult was performed on 2/3/21 at 10:42 a.m. In addition, the record revealed the wound ostomy nurse documented that the coccyx wound was pink and red with dark purple discoloration. The wound was black in its center and was unstageable. Measurements were 3 cm. length (L) x 3 cm. width (W) x 0.2 cm deep (D).
A review of P#1's wound care orders dated 2/10/21 at 11:12 a.m. revealed an order for a wound consult related to groin excoriation (damage to the surface of the skin).
A review of a wound care consult on 2/11/21 at 12:13 p.m., revealed a consult was requested for a wound on P#1's coccyx. The wound was described as an unstageable pressure ulcer (PU). The PU measured 1.5 cm. (L) x 1.5 cm. (W), 0.3 cm.(D).
A review of P#1's wound care assessment dated 5/24/21 at 3:29 p.m. revealed that P#1's sacral ulcer was a Stage IV. No measurements were noted. P#1's right heel was unstageable and measured 4 cm. (L) x 6 cm. (W) x 0.1 cm. (D). The left heel was also unstageable and measured 5.5 cm. (L) x 6 cm. (W) x 0.1 cm. (D). The assessment revealed a Stage II right inner knee pressure ulcer. Measurements were 1 cm. (L) x 1 cm. (W) x 0.1 cm. (D).

Review of nursing assessments for P#1 revealed:
2/1/21 at 11:30 a.m. - Wound dressing was changed, and no documentation on physical assessment of the wound or treatment course at the bedside.
2/25/21 at 7:38 a.m.- No documentation of treatment or assessment was noted of the buttock wound.

A review of P#1's medical record revealed that a wound consult was ordered on 3/26/21 at 1:22 p.m.
A review of P#1's nursing admission assessment dated 3/26/21 at 7:22 p.m. revealed bilateral heel wounds and a coccyx wound, both were present on admission.
A review of P#1's medical record revealed a wound consult was triggered on 3/26/21 at 9:58 p.m.
In addition, P#1's medical record revealed wound care orders dated 3/30/21 at 5:19 p.m., for sacral ulcer treatment, which included dressing changes every day and as needed. The order stated that the dressings of the left and right heel ulcers were to be changed every three days and as needed when loosened or soiled. A further review revealed a right inner knee ulcer was observed and P#1's knee should be cleaned with Mepilex every three days and as needed. Instructions included strict turn protocols initiated with body aligners (foam wedge that helps maintain perfect position while reducing pressure in sensitive areas.) and pillows, heels were to be continually elevated while in the bed.

A review of P#1's wound care orders on 4/1/21 at 6:42 p.m. revealed a wound care consult automatically triggered because of P#1's Braden score of eight (score of 9 or less is very high risk for pressure ulcer). A review of P#1's wound care assessment dated 4/6/21 at 12:09 p.m. revealed P#1's sacral ulcer was unstageable and measured 9 cm. (L) x 7 cm. (W) x 3 cm. (D). P#1's wound healing was noted to be unchanged. The right and left heel wounds were unstageable, and each measured 3 cm. (L) x 3 cm. (W). A further review revealed P#1's right knee was not addressed in the documentation.
A review of P#1's wound care assessment dated 4/13/21 at 3:15 p.m. revealed P#1's sacral ulcer was unstageable and measured 9 cm. (L) x 9 cm. (W) x 1 cm (D). The right heel was unstageable and measured 3 cm. (L) x 3 cm. (W) L x 0 cm. (D). The left heel was also unstageable and measured 3 cm. (L) x 6 cm. (W) x 0 cm (D). A further review revealed the right knee was not addressed in the documentation.
A review of P#1's wound care assessment dated 4/20/21 at 11:50 a.m. revealed P#1's sacral ulcer was unstageable and measured 5 cm. (L) x 8 cm. (W) x 2 cm. (D). Bilateral heel ulcers were unchanged. A further review revealed the right knee was not addressed in the documentation.

A review of P#1's Infectious Disease (ID) Progress Note dated 4/21/21 at 12:49 p.m. revealed P#1's physical examination noted that P#1's skin was warm and dry. The sacral wound a Stage II and was described as tunneling and soupy, both heel ulcers were unchanged. Further review of P#1's ID progress note revealed, a small pressure ulcer was noted to the right knee.

A wound care assessment dated 4/27/21 at 12:34 p.m. revealed P#1's right knee was not addressed in the documentation.
A review of P#1's wound assessment dated 5/4/21 at 12:29 p.m. revealed P#1's sacral and left heel wounds healing had deteriorated. P#1's sacral ulcer measured 5 cm. (L) x 5 cm. (W) x 2 cm. (D). Further review revealed P#1's wound bed was covered 100% in a thick non-viable cream-colored slough. P#1's left heel ulcer measured 4 cm. (L) x 6 cm. (W) x 0.3 cm. (D). Black tissue with eschar and necrosis was present. In addition, P#1's wound assessment revealed the right knee was not addressed in the documentation.
A wound care assessment dated 5/11/21 at 12:28 p.m. revealed that P#1's sacral ulcer wound was unstageable and measured 8 cm. (L) x 6 cm. (W) x 2 cm. (D). A further review revealed P#1's right knee was not addressed in the documentation.
A review of a wound care assessment dated 6/2/21 at 11:20 a.m. revealed that P#1's sacral ulcer was a stage four and measured 8 cm. (L) x 8 cm. (W) x 2 cm. (D). The right heel was unstageable and measured 4 cm. (L) x 6 cm. (W) x 0 cm. (D). The left heel was also unstageable and measured 6 cm. (L) x 8 cm. (W) x 0 cm. (D). A further review revealed the right knee was not addressed in the documentation.
A review of P#1's nursing narrative note dated 6/12/21 at 6:40 p.m. revealed RN DD documented a blister to P#1's left hip that measured 4 cm. (L) x 4 cm. (W) x 2 cm. (D). Further review of P#1's nursing narrative revealed wound care was consulted.
A review of P#1's wound care consult orders revealed no documentation that a wound care consult was ordered on 6/12/21 for P#1's right hip wound.

A review of P#1's medical record revealed nursing skin assessments dated 3/26/21 to 6/23/21 revealed 43 assessments that P#1's right heel PU was not documented.
A review of P#1's medical record revealed that nursing skin assessments dated 3/26/21 to 6/23/21 revealed 43 assessments that P#1's left heel PU was not documented.
A review of P#1's medical record revealed that nursing skin assessments dated 3/26/21 to 6/23/21 revealed 68 assessments that P#1's sacral PU was not documented.
A review P#1's medical record revealed nursing skin assessments dated 3/30/21 to 6/23/21 revealed 104 assessments that P#1's right knee PU was not documented.
A review P#1's medical record revealed nursing skin assessments dated 6/14/21 to 6/23/21 revealed there were 11 assessments that P#1's right hip PU was not documented.


During an interview with the Director (RN) PP on 8/2/21 at 11:35 a.m., in the conference room, RN PP stated she remembered P#1 and stated P#1 was in an MVC and had begun his admission in the Medical Intensive Care Unit (MICU). RN PP stated she remembered P#1 had a sacral ulcer. RN PP stated she could not recall the stage of P#1's sacral ulcer, or any complications associated with the wound. RN PP stated her expectation was for staff to turn a patient every two hours if a pressure ulcer was present. In addition, RN PP stated staff was expected to document anything on the patient's skin that was not a normal skin condition and any wounds on admission required a wound care consult, nurse staff were required to request a wound care consult. RN PP stated, the wound care staff carried a mobile phone while on duty, and the nursing staff would call them directly for a consult and any new skin breakdown was supposed to be reported to the wound care staff to follow up on the wound. RN PP stated all staff was expected to document each turning of the patient with a pressure ulcer. In addition, RN PP stated staff was required to document bandage changes and the treatment used, including all products used to care for the wound. RN PP stated all techs could document in the electronic system when they turned a patient, and expected that techs documented all turns of a patient. RN PP stated she was not surprised that documentation was not sufficient because she had observed the wound care audits. RN PP confirmed that the staff was not following departmental or facility policy when they did not document patient turns or wound care.


During an interview with Registered Nurse (RN) II on 8/3/21 at 8:15 a.m. in the conference room, RN II remembered P#1 and that P#1 suffered a TBI and required total care. RN II stated when she initially cared for P#1, there was a dressing on his sacrum and P#1 had on heel protectors (waffle boots). RN II stated she was aware of the importance of two-hour turns and keeping the involved areas clean and sterile. RN II stated when a patient's dressing was soiled, RN II changed the dressing even if the dressing was not due to be changed. RN II stated she obtained wound care training during orientation from the facility wound care nurse. RN II further stated if a wound worsened, the physician was notified. RN II stated she reported P#1's wounds to the oncoming shift (no date identified). RN II further stated she never photograph any wounds. RN II acknowledged she did not document anything related to P#1's wounds on 5/5/21.

During an interview with the Licensed Practical Nurse (LPN) FF on 8/3/21 at 11:03 a.m. in the conference room, LPN FF remembered P#1 and that P#1 required total care for pressure ulcers. LPN FF stated she recalled P#1's sacral wound because it needed extensive care. LPN FF stated she received wound care training while on the job, and did not receive any training during orientation or in any special education courses. LPN FF stated the day shift was responsible for the dressing changes, but if the bandage or wound was soiled, it was changed during the night shift. LPN FF explained that if she identified a new wound, it would be dressed with a special dressing and wound consult ordered. LPN FF stated she had not utilized the system for a wound consult and could not remember the process. LPN FF stated turning was provided every two hours, and wound care was documented in the medical record. LPN FF stated that if the dressing required a change, she documented the wound change and the supplies used for treatment. LPN FF stated she consistently documented when she assessed a wound, which was part of the department's protocol. LPN FF stated she could find the wound care orders in the facility's electronic medical record and it was not difficult to find them if needed. Record review revealed LPN FF worked on the following dates, 4/4/21, 4/5/21, 4/12/21, 5/10/21, 6/1/21, 6/2/21, 6/6/21, 6/7/21, 6/8/21, and 6/17/21 and acknowledged she did not document P#1's wounds on the aforementioned dates.

During an interview with Licensed Practical Nurse (LPN) GG on 8/3/21 at 2:00 p.m. in the conference room, LPN GG obtained training from the wound care nurse when the nurse came to treat patients at the bedside. LPN GG, stated patients were turned every two hours. LPN GG further stated the facility nurses were also responsible for ensuring that the patient care techs turned the patients. LPN GG stated that a new onset of skin breakdown was reported to the RN and wound care was consulted. LPN GG stated she applied a barrier ointment and bandage to new areas of concern. LPN GG stated that even if a wound only required a bandage assessment, the departmental policy was to document the assessment. LPN GG stated she remembered P#1 because he had been at the facility for a long time and that P#1 had a sacral wound and bilateral heel wounds. LPN GG further stated the sacral wound was big and required a lot of care. Record review revealed LPN GG worked on the following dates,3/30/21, 4/14/21, 4/16/21, 4/26/21, 4/27/21, 4/28/21, 6/15/21, 6/16/21, and 6/17/21, and acknowledged she did not document the wounds for P#1 on the aforementioned dates.

During an interview with Registered Nurse (RN) HH on 8/3/21 at 3:00 p.m. in the conference room, RN HH stated she had not trained for wound care. RN HH stated she conducted a head - toe assessment and assessed for skin breakdown or reddening for patients and if she found areas of concern, she used a barrier cream. In addition, RN HH stated if a patient's skin was beyond reddening, she notified the patient's physician. RN HH stated if the patient's physician requested a wound consult, she entered one in the facility's electronic medical record system. RN HH stated she had some knowledge about how to request a wound consult, but had not requested one in a long time. RN HH explained she documented patient turns and wound care in the charting system and documented the wounds even if the dressing did not require changing. Record review revealed RN HH worked on the following dates, 3/28/21, 5/10/21, 5/11/21, 6/9/21, 6/18/21, 6/19/21, and 6/20/21 and acknowledged that she did not document any wound assessments for P#1 on the aforementioned dates. RN HH stated she should have documented the wounds per departmental protocol.

During an interview with Registered Nurse (RN) EE on 8/3/21 at 3:35 p.m. in the conference room, RN EE stated her wound care training was obtained at the bedside during wound care treatments. RN EE stated when she found a new wound or area of concern, she applied Mepilex(foam dressing) and barrier cream. RN EE stated she notified wound care and the physician when she found any new skin issues. RN EE further stated that ordering a wound care consult was the same process in the facility's prior electronic medical record system and the facility's current electronic medical record system Cerner and Epic. RN EE explained she did not describe the wound unless it is worsening or improving. RN EE stated it was the policy of her department that wounds and turns were documented for each patient. RN EE remembered P#1 and cared for P#1 on multiple occasions. RN EE recalled P#1's heels, knee, and sacral wound. Record review revealed RN EE worked on the following dates, 4/2/21, 4/12/21, 4/23/21, and 4/29/21 and acknowledged she did not document the status of P#1's wounds on the aforementioned dates and acknowledged that she was required to document P#1's status of P#1's wounds RN EE stated she was busy on the days she did not document P#1's wounds assessments.

During an interview with LPN CC on 8/4/21 at 7:30 a.m. in the conference room, LPN CC stated she remembered P#1 because he had a motor vehicle accident (MVA) and could not care for himself. In addition, LPN CC stated P#1 had a skin breakdown that required dressing changes, but she could not recall P#1's specific wounds. LPN CC stated that total care patients required turning every two hours, which she documented under a specific tab in the facility's electronic medical record system. LPN CC explained that the nurses and physicians placed wound care consults. LPN CC further stated that after a patient evaluation, the wound nurse placed an order for treatment in the patient's record. LPN CC stated she received some wound care training during orientation and that most of her wound care experience came from the wound nurse during bedside wound care. Record review revealed LPN CC worked on the following dates, 3/29/21, 4/24/21, 4/29/21, 4/30/21, 5/29, 5/30, 5/31/21, 6/13, 6/15, and 6/16/21,
and acknowledged she did not document the status of P#1's wounds on the aforementioned dates and acknowledged she had not documented any care or assessment of P#1's pressure ulcers. LPN CC stated she was busy and unable to document P#1's wounds. LPN CC stated she had not informed her manager that she was too busy to document care or assessment of P#1's wounds. LPN CC stated that if a new skin breakdown was identified, she would call the patient's physician and chart the wound in a nursing note. LPN CC said she would cover the area of breakdown with a barrier cream and apply a Mepilex dressing, and placed a consult for wound care. LPN CC stated she was present on 6/15/21 at 6:01 a.m. when another nurse (RN DD) from the day shift spoke with her and a physician MD (MD TT) about a blister on P#1's right hip. LPN CC recalled the blister was the size of an orange or grapefruit and was the color of a yellowish interstitial fluid. LPN CC stated MD TT requested a fluid sample if the wound opened, and the MD TT wanted the fluid tested for herpes ( a type of transmitted infection).
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During a follow-up interview with RN AA on 8/4/21 at 9:19 a.m. in the conference room, RN AA stated she could not recall if she was aware of P#1's right knee wound when she assessed and treated P#1's wounds on 6/2/21. RN AA explained she had a heavy patient load, and may have missed the wound on P#1's right knee during a follow-up visit on 6/2/21. RN AA acknowledged that RN MM treated P#1's right knee wound on 5/24/21. In addition, RN AA added she reviewed a patient's previous wound care assessment before assessing and treating them. RN AA revealed she may not have reviewed P#1's previous assessment prior to assessing him on 6/2/21 because she was busy. RN AA acknowledged she treated P#1's right knee wound on 6/22/21. RN AA confirmed that all wounds should be assessed on follow-up visits and documented in the patient's medical record.

During an interview with Registered Nurse (RN) MM on 8/4/21 at 9:59 a.m. in the conference room, RN MM stated she supervised the unit where P#1 received treatment but did not remember P#1. RN MM stated she submitted a referral for nutrition if a chronic wound was not healing. In addition, RN MM stated she contacted the patient's physician if she believed a patient's wound required an x-ray or surgical consult. RN MM stated she conducted follow-up visits on patients with a stage III or IV pressure ulcer once a week and added there were no protocols regarding the time frames to conduct follow-up visits. RN MM confirmed a patient could go 11, 13, or 20 days without seeing a wound care nurse, and wounds could worsen between visits.

During an interview with Registered Nurse (RN) NN on 8/4/21 at 10:30 a.m. in the conference room, RN NN stated she had completed a wound care training program, but was not yet certified. In addition, RN NN stated she trained at the facility for ten weeks and completed courses on ostomy care. RN NN remembered P#1 because he was a long-term patient and P#1 had frequent episodes of diarrhea, a sacral wound, and bilateral heel wounds. RN NN stated she attempted to assess patients for follow-up visits each week. RN NN stated she would instruct the staff nurses on wound treatment at the bedside and speak with them at the nurse's station. RN NN explained she focused mainly on P#1's sacral wound and stated P#1's other wounds were healing. RN NN said if she wrote orders on a wound or the wound required further treatment, she continued to assess and document each wound. RN NN stated she charted on each wound for P#1 during each visit but confirmed she did not document P#1's stage II knee wound on 4/6/21, 4/27/21, and 5/4/21. RN NN stated she did not document P#1's knee wound because she focused on P#1's sacral wound, and that P#1's primary nurses could treat P#1's knee. RN NN acknowledged that Stage II wounds could progress and become more extensive wounds.

During an interview with Registered Nurse (RN) DD on 8/4/21 at 11:05 a.m. in the conference room, RN DD stated wound care training was primarily obtained at the bedside by other nurses. RN DD stated he did not see the wound care nurse often during his work shifts. RN DD stated he notified a patient's physician if he observed an area of concern on a patient's skin. RN DD stated he remembered P#1, and he turned him every two hours. RN DD stated he looked in the chart for any wound care orders, and the orders were not difficult to locate in P#1's record. RN DD stated he was familiar with the process for ordering a wound consult. RN DD stated he turned P#1 every two hours and documented the turning in P#1's medical record. RN DD confirmed that all wound care and assessments were to be documented in P#1's medical record. Record review revealed RN DD worked on dates 4/10/21, 4/11/21, 4/18/21, 5/7/21, 6/4/21, 6/6/21, 6/12/21, and 6/13/21 and acknowledged that he did not document any wound assessment or bandage changes for P#1 on the aforementioned dates.

A review of P#5's medical record revealed P#5 was admitted to the facility on 3/10/21 after a 10-foot fall.
In addition, P#5's assessment revealed that P#5 did not have any wounds on admission except a head wound from the fall. Further review of P#5's nursing flow sheet dated 3/17/21, revealed P#5 had blisters on his buttocks. A review of P#5's nursing Flowsheet, revealed wound care notes from 4/12/21 through 4/18/21 that did not reveal documentation of a coccyx wound. Further review revealed that P#5's sacral wound dressing was changed on 15 of 24 (12 days) nursing shifts as ordered from 7/3/21 through 7/15/21.
Continued review of P#5's nursing flow sheets revealed that P#5 was to be turned approximately every two hours. Further review of P#5's nursing flow sheets revealed no documentation of turning from 4/18/21 at 4:00 p.m. until 8:00 a.m. on 4/19/21. In addition, there was no documentation of turning P#5 on 4/19/21 at 6:00 p.m. until 8:00 a.m. on 4/20/21.

A review of the facility's work instruction titled 'Pressure Ulcer Prevention', effective 7/26/16, last revised 1/25/19 revealed the facility was to provide nursing staff a standardized approach to (1) risk assessment of a patient's potential for or actual skin breakdown and (2) measures to maintain and/or improve patient's skin integrity. Standards included but not limited to:
1. Skin assessment was completed and documented on admission and upon arrival to a new unit. head to toe assessment of skin by two healthcare professionals (one must be a RN/LPN)
2. Using the Braden Risk Assessment Tool, the RN/LPN assessed the patient for risk factors for skin breakdown on admission and with every shift assessment (8-12 hours) or when there was a change in the patient's risk areas. The total score of the Risk Assessment determined the prevention measures initiated.
3. The RN developed and initiated the plan of care for skin/wound management.
4. The RN/LPN communicated with the Clinical Technicians the patients that were identified at high risk for skin impairment.
5. The RN/LPN ensured that documentation of prevention/therapeutic skin care interventions as outlined by the Braden Risk Assessment Tool.
6. In the event of an actual pressure injury/altered skin integrity was present on admission, the appropriate treatment protocol was initiated by the RN/LPN.
Scoring Key:
Routine skin care >19
Mild Risk 15-18
Moderate risk 13-14
High risk 10-12
Very high risk 9 or <
Braden scores less than 19 were considered 'at risk'
Prevention measures included but were not limited to:
Score 19-23:
1. Daily skin observation
2. Application of moisturizing location to arms, back, and legs.
3. Adequate nutrition and hydration.
4. Use personal cleanser and protective barrier cream if incontinent

Turn patient every two hours or individualize if signs of breakdown were present
1. Turn patient 30-40 degrees from supine to prevent pressure in a side lying position. Use pillows and foam wedges for positioning. Use pillows between knees when side lying.
2. If patient unstable, attempt hip tilt to offload sacrum.
3. Use appropriate lift equipment to prevent shearing.
4. Limit HOB to 30 degrees or less unless mealtime or medically necessary
5. Inspect skin every shift.
6. Apply sacral foam dressing to protect and comfort sacral/coccyx region if applicable.
7. Patient OOB as soon as possible. Reposition sitting patients every hour or return patient back to bed. Use chair cushion when OOB in chair.
8. Elevate heels off the bed with heel protectors.
10. Apply moisturizing cream to back, arms, legs, and feet daily if needed.
11. Minimize skin moisture and treat incontinence episodes with personal cleanser and protective barrier cream three times daily and as needed.
12. Nutritional consult for decreased oral intake and/or if wounds present.
13. Wound care nurse referral if wound present.
14. Educate patient/family about ulcer prevention/treatment.
Wound Classification/Staging
Stage 1 Pressure Injury: non-blanchable Erythema. An observable, pressure related alteration to skin integrity who indicators, as compared with the adjacent or opposite area on the body may include changes in one or more of the following: skin temperature, tissue consistency (firm or boggy feel), and sensation (pain, itching). The ulcer appeared well-defined area of persistent redness, in lightly pigmented skin, whereas in darker skin tones, the ulcer may appear with persistent red, blue, or purple hues. State 1 ulceration may be difficult to detect in individuals with dark skin tones. May indicate 'at risk' persons (a heralding sign of risk)
Stage 2 Pressure Injury/Partial Thickness Wound- Partial thickness loss of dermis presents as a shallow open injury/ulcer with a red/pink wound bed without slough. May also present as an intact or open/ruptured serum-filled blister. This category should not be used to describe skin tears, tape burns, perineal dermatitis, maceration, or excoriation.
Stage 3 Pressure Injury/Full Thickness Wound- Full thickness skin loss that involved damage or necrosis of subcutaneous tissue, that may extend down to but not through underlying fascia. The injury/ulcer present as a deep crater with or without undermining of adjacent tissue. Slough may be present but does not obscure the depth of tissue loss. Bone, tendon, or muscle were not exposed.
Stage 4 Pressure Injury/Full Thickness Wound- Full thickness skin loss with exposed (or directly palpable) bone, tendon, or muscle. Slough or eschar (dark leather-like covering) may be present on some parts of the wound bed. The injury/ulcer presented as a deep crater often with undermining and tunneling.
Unstageable- depth unknown Full thickness tissue loss with the base of the injury/ulcer covered by slough (yellow, tan, gray, green, or brown) and/or eschar (tan, brown, black) in the wound bed. Until enough slough and/or eschar could be removed to expose the base of the wound, the true depth, and therefore stage cannot be determined.
Suspected Deep Tissue Injury- Depth Unknown: purple or maroon localized area of discolored intact skin or blood-filled blister due to damage of underlying soft tissue from pressure and/or shear.
Pressure relief devices were not used as substitutes for a turning schedule.
Specialty support surfaces were approved by the inpatient wound care team prior to ordering. Any patient placed on a specialty bed or mattress was considered high risk and a turning schedule was part of the plan of care. Documentation of turning should be in the medical record. Specially mattress or bed was downgraded as the patient's condition improves and/or resolves. Order should be placed in the computer to discontinue. The inpatient Wound Care team can evaluate if an alternative surface was needed.
A review of the facility's work instruction titled 'Pre and Post Care of Cellular or Tissue Based Products', effective 7/26/16, last revised 4/23/18, revealed all clinical staff in the facility wound center were to adhere to the following procedures included but was not limited to:
Pre-application steps included aseptically removal of dressing, cleansing of wound as appropriate, dry peripheral skin, assess wound and removal of gloves and wash hands. During applications: the physician of advanced practice practitioner applied and anchor the product to the wound bed and document the amount of product that was discarded.
Post application: wound covered with non-adhering primary dressing, fill with a dressing, cover with secondary dressing. A review of the facility's work instructions titled ' Wound Care Center (WCC) Case Management'