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909 SUMNER STREET 1ST FLOOR

STOUGHTON, MA null

QAPI

Tag No.: A0263

Based on records reviewed and interviews, the Hospital failed to implement corrective actions to prevent a like occurrence from happening for 1 Patient (#1) out of a sample of 20 patients.

Refer to tag A-0283.

NURSING SERVICES

Tag No.: A0385

Based on record review and interview the Hospital failed to ensure a Patient (#3) received the ordered level of oxygen supplementation and Bipap (Bilevel Positive Airway Pressure) out of a sample of 20 records.

Refer to tag A-0406

RESPIRATORY CARE SERVICES

Tag No.: A1151

Based on record review and interview, the Hospital failed to ensure adequate numbers of respiratory therapists (RT) were staffed to be available to respond to the respiratory care needs of the patient population being served for 3 Patients (#6, #7, and #15) out of a total sample of 20 patients.

Refer to tag A-1154.

QUALITY IMPROVEMENT ACTIVITIES

Tag No.: A0283

Based on records reviewed and interview the Hospital failed to ensure actions aimed at performance improvement were implemented for 1 patient (#1) out of a total sample of 20 patients, who used an unknown substance within the Hospital, was found unresponsive and pulseless, and expired and 2) a Patient who did not receive the ordered level of oxygen supplementation and Bipap (Bilevel Positive Airway Pressure) and was found unresponsive and pulseless and expired at the Hospital.

Findings include:

Review of the Hospital policy titled "Quality Assurance and Performance Improvement (QAPI) Plan", revised on December 21, 2021, indicated the following:
-The purpose of the Hospital QAPI plan is to ensure the hospital demonstrates a consistent endeavor to deliver optimal care in an environment of minimal risk.
-The overall objectives of the QAPI plan are to collect data to monitor on the Hospitals performance; compile and analyze the data; and improve performance on an ongoing basis.
-Functions of the QAPI Committee:
-Review, assess, and analyze data in order to assist in setting priorities for hospital-wide process improvement activities that are designed to improve patient care, processes, outcomes, and patient safety.
-Ensuring monitoring and follow-up of corrective action plans.

1. Patient #1 was admitted to the Hospital on 12/7/2021 with a diagnosis of left foot Osteomyelitis (infection in the bone from bacteria or fungi) and required intravenous (IV) Antibiotics for the infection.

Review of Patient #1's acute care hospital discharge summary, dated 12/7/21, indicated Patient # 1 had a PICC line (peripherally inserted central catheter; a specialty IV device that goes directly to the heart's circulation) for the delivery of the antibiotics. Patient #1's acute care hospital record indicated Patient #1 had a past medical history of Substance Use Disorder (SUD), had previously overdosed in a hospital by accessing an IV device and had signed an agreement with the acute care hospital indicating Patient #1 would not misuse the PICC (IV line) placed by the acute care hospital. Patient #1's acute care hospital discharge summary indicated Patient #1 was sober for 5 years and was managed for his/her SUD by an outpatient clinic that provided medication management (methadone), and services including cognitive behavioral therapy, community outreach, and relapse prevention by applying evidence-based approaches to addiction treatment.

Review of Patient #1's admission History & Physical, dated 12/7/2021, indicated Patient #1 was admitted for the IV antibiotic therapy due to a history of substance abuse and concern for noncompliance; the diagnoses and plan indicated the history of IV drug use and to continue methadone daily and indicated medication was obtained by patient through his/her outpatient clinic. Further review of Patient #1's medical record indicated a physician progress note dated 12/9/2021 noting Patient #1's history of SUD. Patient #1's medical record failed to indicate any evidence he/she was receiving services such as cognitive behavioral therapy, relapse prevention, or any other evidence-based approaches to addiction treatment, and failed to indicate Patient #1 ever continued to receive services from his/her outpatient clinic for the management of his/her SUD.

Further review of Patient #1's medical record indicated on 12/14/2021 around 5:00 P.M., a staff member found Patient #1 in a locked bathroom, not responding to staff. A nursing progress note dated 12/14/2021 indicated Security Staff was called to unlock the bathroom door; Patient #1 then fell forward to floor, pulseless and not breathing, and a Code Blue was called at 5:10 P.M. The Nursing Note further indicated Cardio-Pulmonary Resuscitation (CPR) was delayed due to the inability to perform compressions on Patient #1 because of patient being face down and too large to move, and when rolled over at 5:20 P.M. (10 minutes from when the Patient was first discovered pulseless), Patient #1's size limited the ability to perform adequate CPR. Patient #1's physician's note dated 12/14/22 indicated the Patient had expired on 12/14/2021 at 5:38 P.M., and indicated syringes that were not insulin-type, a spoon, and a powdered substance were found in proximity to Patient #1 in the bathroom.

Review of the RCA (Root Cause Analysis), undated, for the 12/14/2021 event involving Patient #1 indicated the following:
1) Nurse assessments were not completed for five of Patient #1's seven days
2) Staff knowledge deficit or lack of competency caring for patients with addiction
3) Patient did not comply with the agreement signed at another hospital
4) Patient may have been bored
5) Visitor log was illegible and not monitored
6) No deficiencies with code blue response; Patient was large and difficult to do chest compressions
7) Effective communication regarding patient risks identified at admission
8) Locks on patient bathroom doors may not be advised on this population (undefined)
9) Low engagement of staff due to changes in leadership and ownership
10) Communication between front line staff and Hospital leaders is not effective and often absent

The Hospital analysis failed to identify any root cause type or causal factors regarding the following:
1) The Hospital identified syringes found were not insulin-type, however, did not investigate if syringes for medications or IV flushes were accessible to Hospital visitors, patients, or any non-clinical persons.
2) The Hospital identified Patient may have been bored but did not identify if any boredom mitigation strategies would be enacted, failed to identify Patient #1 was being treated for SUD prior to admission, and only his/her medication treatment was continued, not the three other components provided by the Patient' outpatient clinic.
3) The Hospital identified Patient #1 was large and difficult to do chest compressions on but did not identify any corrective measures to ensure all patients (bariatric) would receive high quality and timely CPR, nor did the Hospital identify this as deficient in the Code Blue response.
4) The Hospital identified communication between clinical staff and Hospital leaders was absent, however, did not identify any Corrective Actions for the finding.

Review of Corrective Actions implemented by the Hospital indicated the following were put in place:
1) Re-educate RNs on the required assessment every 24 hours, initiate audits to ensure compliance
2) Key (for bathroom doors) placed at nurses' station, evaluate changing doors to delete lock
3) Activate Visitor Log for all visitors; Monitor visitor screening (undefined)
4) Staff knowledge enhancement regarding the real and/or potential triggers that results in risky behavior (undefined) on behalf of the patient


The Hospital auditing document titled "Open Chart Audit" indicated a monthly audit. The document indicated the indicators should be monitored for a greater than ninety percent compliance with fifteen different indicators identified.

The Hospital Document titled "Open Chart Audit", dated June 2022, indicated two of the fifteen indicators were "Not applicable" for the charts reviewed, leaving thirteen indicators. The Hospital document indicated 8 of 13 indicators were below the ninety percent compliance rate.

The Hospital Document titled "Open Chart Audit", dated July 2022, indicated two of the fifteen indicators were "Not Applicable" for the charts reviewed, leaving thirteen indicators. The Hospital document indicated two indicators of thirteen failed to be audited, and one indicator of the eleven that were audited was below the ninety percent compliance rate.

During an interview with Director of Quality on 7/18/2022 at 10:30 A.M, she said the auditing of the charts was the responsibility of the Director of Quality and the Chief Nursing Officer, however, was unable to explain the interventions the Hospital would take when the audits indicated non-compliance with the Hospital-identified indicators.

During an interview with Director of Quality on 7/18/2022 at 11:15 A.M., she said there had been no education provided to staff on treating patients with SUD (regarding the real and/or potential triggers that results in risky behavior).

The Hospital failed to provide documentation of any audits of the Hospital visitor log as identified in RCA corrective action plan.

The Hospital failed to identify and implement corrective action to ensure similar incidents to the event with Patient #1 on 12/14/22 could not occur with other patients.

STANDING ORDERS FOR DRUGS

Tag No.: A0406

Based on record review and interview, the Hospital failed to ensure 1 Patient (#3) out of 20 sampled records received the ordered level of oxygen supplementation and Bipap (Bilevel Positive Airway Pressure); the Patient was found unresponsive and pulseless, and expired at the Hospital.

Findings include:


Patient #3 was admitted to the Hospital on 1/14/22 with diagnoses of COVID-19 Pneumonia and Respiratory Failure.

Review of Patient #3's acute care hospital discharge summary, dated 1/14/22, indicated he/she was discharged from an acute care hospital to the Hospital following an admission with COVID-19 pneumonia. Based on Computed Tomography (CT) exams, there was concern for Patient #3 developing diffuse fibrosis (lung disease in which lung tissue becomes damaged and scarred) in his/her lungs secondary to the COVID-19 infection. Patient #3 was stable on 50L (liters)/50% oxygen and was anticipated to have a continued need for significant oxygen supplementation indefinitely.

Review of Patient #3's medical record indicated paper admission orders dated 1/14/22 for 50L of oxygen at hi flow to maintain oxygen saturations greater than 92% and for Bipap without any specifications signed by the Nurse Practitioner (NP). Patient #3's electronic orders indicated an order dated 1/14/22 for hi flow oxygen via nasal cannula to maintain oxygen saturations > 92%, however, failed to indicate any Bipap orders or settings. The Hospital History and Physical performed by the NP on 1/14/22 acknowledged Patient #3 was stable on high-flow nasal cannula 50L of oxygen and Bipap of 14/8 and respiratory rate of 10 and 45% at night while in the acute care hospital. The Respiratory Therapist (RT) documented at 1:40 P.M., on 1/14/22 Patient #3 was at rest on 13L of oxygen via high flow nasal cannula. An assessment performed on 1/15/22 at 12:51 A.M., indicated Patient #3 was receiving oxygen at 12L via high flow nasal cannula, with an elevated heart rate of 104. At 1:10 A.M. on 1/15/22, Patient #3 was found unresponsive and unarousable with no pulse, Cardio-Pulmonary Resuscitation (CPR) was initiated, and Patient #3 was pronounced expired at 1:45 A.M.

Patient #3's medical record review failed to indicate the patient had ever received oxygen at a rate/flow of 50L (the level which he/she had been stable at) nor did the medical record review indicate a Bipap device was ever initiated for the Patient at night.

Review of the Hospital RCA for Patient #3's event on 1/15/22 indicated the following:
-Conflicting admission oxygen orders between paper and electronic. RT followed last electronic orders.
-RN did not verify paper admission orders however did verify electronic orders.
-No equipment issues identified.
-RT-to-RT handoff between Hospitals did not occur.
-Staff would benefit from re-education regarding documentation in the medical record.
-Admission orders entered by NP O2 via 50L hi flow to maintain SPO2 greater than 92%. RT did not acknowledge paper orders.
-Corrective measures included Nursing and Respiratory staff re-education, staff meetings, tracking/auditing of newly implemented RN hand off communication form for 6 months or 3 months of 100% compliance.
The RCA for Patient #3's event on 1/15/22 failed to indicate the identification of unclarified Bipap orders for Patient #3.

The Hospital failed to provide evidence of the tracking/auditing of records indicated in the corrective action identified in the RCA.

During an interview with the Director of Quality on 7/18/22 at 3:30 P.M., she said there were no recorded audits for the RCA for the event involving Patient #3 on 1/15/22. She said the Nursing and Respiratory managers reviewed the new patient's records and these were discussed at the morning meetings, however, there were no audits physically maintained.

During an interview with the Cardiopulmonary Manager on 7/19/22 at 9:20 A.M., she said the Hospital had the ability to provide equipment for patients to deliver higher rates/levels of oxygen. She said orders are necessary for specific devices if higher flow/rates of oxygen are necessary for patients.

The Hospital failed to implement/clarify orders written by a Nurse Practitioner for respiratory care for Patient #3; and subsequently failed to implement corrective action to ensure similar incidents could not occur with other patients.

ADEQUATE RESPIRATORY CARE STAFFING

Tag No.: A1154

Based on record review and interview, the Hospital failed to ensure adequate numbers of respiratory therapists (RT) were staffed to be available to respond to the respiratory care needs of the patient population being served for 3 Patients (#6, #7, and #15) out of a total sample of 20 patients; for all three Patients, a RT was unavailable to assess them while on mechanical ventilator support to maintain their respiratory function and health.

Findings include:

Review of the Hospital policy titled "Guidelines Respiratory Care Routine Responsibilities", revised on 11/20/2020, indicated the following:
-Define routine responsibilities within the Respiratory Therapy Department.
-Patient Assessments per policy
-Perform Ventilator checks every 4 hours.
-Ensure vent alarms and other alarms have been visually and audibly inspected.
-Respond to all STAT, Rapid Response calls, and resuscitation attempts.

Review of the Hospital policy titled "Mechanical Ventilation", revised 11/20/2020, indicated the following:
-Routine ventilator rounds are to be performed and documented every four hours.

1. Patient #6 was admitted to the Hospital on 7/15/22 with diagnoses of respiratory failure and esophageal perforation.

Review of Patient #6's medical record indicated the Patient had a tracheostomy (a hole created in the anterior neck to allow for a tube to be placed to assist with breathing) and was receiving mechanical ventilation for respiratory support. Review of Patient #6's Respiratory Therapy Ventilator Flow Sheets indicated the Patient was placed on ventilator support by the RT at 8:00 P.M. on 7/23/22. The next assessment performed for Patient #6 by a RT was at 7:24 A.M. on 7/24/22 (over 11 hours from when Patient #6 was placed on the mechanical ventilator on 7/23/22). Patient #6's Respiratory Therapy Ventilator Flow Sheets failed to indicate the Patient was ever assessed by a RT nor had a ventilator check performed from the time he/she was placed on mechanical ventilation at 8:00 P.M., on 7/23/22 to 7:24 A.M. on 7/24/22. Review of Patient #6's Nursing documentation indicated the Patient was on ventilator support on the second shift on 7/23/22 but failed to indicate any assessment/check of the Patient's mechanical ventilator settings or functioning.

Review of the Hospital's Unit Daily Sheets (schedule) failed to indicate a RT was staffed and available on the 7 P.M. to 7 A.M. shift on 7/23/22, nor was a RT staffed and available from 12:00 A.M. to 4 A.M. on 7/24/22.

During an interview with RT #1 on 8/22/22 at 3:14 P.M., she said scheduling has been difficult for the Respiratory Therapy department. She said when there are sick calls RTs, it is difficult to find coverage. She said there have been shifts that the Hospital was unable to cover for RT staffing.

During an interview with RT #2 on 8/23/22 at 10 A.M., she said generally the RT's work in the Hospital in 12 hours shifts with one RT staffed on each 12-hour shift. She said the RT on duty should be performing ventilator checks/assessments at least every 4 hours for patients on mechanical ventilation to ensure a patient's respiratory status is stable and to ensure the equipment is set and functioning properly.

During an interview with the Hospital Staffing Coordinator on 8/23/22 at 1:30 P.M., she said staffing for the Respiratory Therapy department has been difficult. She said currently the Hospital is using only 3 per diem RTs open shifts for the Respiratory Therapy department, but have not been able to utilize other sources such as staffing agencies for RT coverage in the case of an emergency, call out, etc. ...

The Hospital failed to ensure adequate RT coverage was available, and Patient #6, who had compromised respiratory function, went over 11 hours while on mechanical ventilation without any ventilator assessment or checks.

2. Patient #7 was admitted to the Hospital on 6/8/22 with diagnoses of respiratory failure and hypoxia.

Review of Patient #7's medical record indicated the Patient had a tracheostomy (a hole created in the anterior neck to allow for a tube to be placed to assist with breathing) and was receiving mechanical ventilation for respiratory support. Review of Patient #7's Respiratory Therapy Ventilator Flow Sheets indicated the Patient was placed on mechanical ventilation at 11:20 A.M. by the RT. Patient #7 was assessed by the RT on 7/23/22 at 4:39 P.M. and the next RT assessment/ventilator check was performed by a RT on 7/24/22 at 8:25 A.M. (almost 16 hours later). Patient #7's Respiratory Therapy Ventilator Flow Sheets also indicated he/she was place on mechanical ventilation on 7/24/22 at 10:47 P.M., and the Patient was next assessed by a RT on 7/25/22 at 6:30 A.M. (almost 8 hours later). Patient #7's Respiratory Therapy Ventilator Flow Sheets failed to indicate the Patient was ever assessed by a RT nor had a ventilator check performed while on mechanical ventilation from 7/23/22 at 4:39 P.M. until 7/24/22 at 8:25 A.M. nor from 7/24/22 at 10:47 P.M. until 7/25/22 at 6:30 P.M. Review of Patient #7's Nursing documentation failed to indicate any assessment/check of the Patient's mechanical ventilator settings or functioning was performed during the 7:00 P.M. to 7:00 A.M. shift on 7/23/22.

Review of the Hospital's Unit Daily Sheets (schedule) failed to indicate a RT was staffed and available on the 7 P.M. to 7 A.M. shift on 7/23/22, nor was a RT staffed and available from 12:00 A.M. to 4 A.M. on 7/24/22.

During an interview with RT #1 on 8/22/22 at 3:14 P.M., she said scheduling has been difficult for the Respiratory Therapy department. She said when there are sick calls RTs, it is difficult to find coverage. She said there have been shifts that the Hospital was unable to cover for RT staffing.

During an interview with RT #2 on 8/23/22 at 10 A.M., she said generally the RT's work in the Hospital in 12 hours shifts with one RT staffed on each 12-hour shift. She said the RT on duty should be performing ventilator checks/assessments at least every 4 hours for patients on mechanical ventilation to ensure a patient's respiratory status is stable and to ensure the equipment is set and functioning properly.

During an interview with the Hospital Staffing Coordinator on 8/23/22 at 1:30 P.M., she said staffing for the Respiratory Therapy department has been difficult. She said currently the Hospital is using only 3 per diem RTs open shifts for the Respiratory Therapy department, but have not been able to utilize other sources such as staffing agencies for RT coverage in the case of an emergency, call out, etc. ...

The Hospital failed to ensure adequate RT coverage was available, and Patient #6, who had compromised respiratory function, went over 11 hours while on mechanical ventilation without any ventilator assessment or checks.



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3. Patient #15 was admitted to the Hospital on 7/6/22 with diagnoses of Acute Respiratory Failure (the inability of the respiratory system to meet the oxygenation, ventilation, or metabolic requirements of the patient) and COPD (Chronic Obstructive Pulmonary Disease, a condition involving constriction of the airways and difficulty or discomfort in breathing).

Review of Patient #15's medical record indicated the Patient had a tracheostomy (a hole created in the anterior neck to allow for a tube to be placed to assist with breathing) and was receiving mechanical ventilation for respiratory support.

Review of Patient #15's Respiratory Therapy Ventilator Flow Sheet indicated on 7/23/22 at 3:30 P.M., Patient #15 required increased oxygen support to 100% due to having episodes of desaturation (when the percentage of oxygen in your blood is low) and the RT (Respiratory Therapist) would continue to monitor the Patient. Review of Patient #15's Respiratory Therapy Ventilator Flow Sheets indicated the Patient's last ventilator check and assessment done by a RT was on 7/23/22 at 4:16 P.M. The next Ventilator check and assessment performed for Patient #15 by a RT was on 7/24/22 at 8:00 A.M (almost 16 hours later). Patient #15's Respiratory Therapy Ventilator Flow Sheets failed to indicate a ventilator check and assessment performed by a RT between the hours of 7/23/22 at 4:16 P.M. and 7/24/22 at 8:00 A.M. for Patient #15 who was requiring full ventilator support. Review of Patient #15's Nursing documentation indicated the Patient was on ventilator support on the second shift on 7/23/22 but failed to indicate any assessment/check of mechanical ventilator settings or functioning.

Review of the Hospital's Unit Daily Sheets (schedule) failed to indicate a RT was staffed and available on the 7 P.M. to 7 A.M. shift on 7/23/22, nor was a RT staffed and available from 12:00 A.M. to 4 A.M. on 7/24/22.

During an interview with RT #1 on 8/22/22 at 3:14 P.M., she said scheduling has been difficult for the Respiratory Therapy department. She said when there are sick calls RTs, it is difficult to find coverage. She said there have been shifts that the Hospital was unable to cover for RT staffing.

During an interview with RT #2 on 8/23/22 at 10 A.M., she said generally the RT's work in the Hospital in 12 hours shifts with one RT staffed on each 12-hour shift. She said the RT on duty should be performing ventilator checks/assessments at least every 4 hours for patients on mechanical ventilation to ensure a patient's respiratory status is stable and to ensure the equipment is set and functioning properly.

During an interview with the Hospital Staffing Coordinator on 8/23/22 at 1:30 P.M., she said staffing for the Respiratory Therapy department has been difficult. She said currently the Hospital is using only 3 per diem RTs open shifts for the Respiratory Therapy department, but have not been able to utilize other sources such as staffing agencies for RT coverage in the case of an emergency, call out, etc. ...

The Hospital failed to ensure adequate RT coverage was available for Patient #15, who required full ventilator support, went just under 16 hours while on mechanical ventilation without any ventilator assessment or checks.