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The Hospital was out of compliance with the Condition of Participation for Quality Assessment and Performance Improvement Program (QAPI).

Findings included:

The Hospital failed, for three (Patients #1, #2 & #6) patients out of ten sampled patients, to ensure that Quality Assessment and Performance Improvement (QAPI) activities thoroughly analyzed data collected and monitored the effectiveness and safety of services and quality of care.

Refer to TAG: A-0273.

The Hospital failed, for three (Patients #1, #2 & #6) patients out of ten sampled patients, to ensure Quality Assessment and Performance Improvement (QAPI) activities identified opportunities for improvement.

Refer to TAG: A-0283.

The Hospital failed, for three (Patients #1, #2 and #6) patients out of ten sampled patients, to ensure that Quality Assessment and Performance Improvement (QAPI) activities included feedback and learning throughout all Surgical and Anesthesia Services provided in the Hospital following Patients #1, #2 and #6's adverse patient events.

Refer to TAG: A-0286.


Refer to TAG: A-0309.

Based on records reviewed and interviews the Hospital failed, for three (Patients #1, #2 & #6) patients out of ten sampled patients, to ensure Quality Assessment and Performance Improvement (QAPI) activities thoroughly analyzed data collected and monitored the effectiveness and safety of services and quality of care.

Findings included:

Regarding Patient #1:

The Cardiac Surgery Visit note, dated 9/30/19, indicated that the Cardiovascular Surgeon recommended to Patient #1's parents that Patient #1 undergo a mitral valve (valve between the left top chamber of the heart and the left bottom chamber of the heart) replacement (heart surgery).

The Informed Consent, dated 9/30/19, indicated Patient #1's parent consented to a mitral valve replacement.

The Cardiovascular Surgery Inpatient MD note, dated 10/1/19, indicated the Cardiovascular Surgeon told Patient #1's parents that an aortic valve was initially inserted and it was replaced with a mitral valve.

The Hospital policy titled Universal Protocol, dated 3/21/19, indicated the Universal Protocol included three actions to prevent wrong site, wrong procedure, or wrong person procedure which included preoperative verification procedure, site verification procedure and Time-Out procedure. The Universal Protocol indicated that the Time-Out procedure was initiated by a designated member of the surgical team. The Universal Protocol indicated the Time-Out procedure included confirmation that the Informed Consent matched the verbalized procedure. The Universal Protocol indicated that a second Time-Out was required when additional clinicians, who would be taking an active part in performing the procedure, joined the team after the initial Time-Out occurred and would include at a minimum the patient identification, the procedure, site and or side.

The Surveyor interviewed the Director for the Cardiac Intensive Care Unit and Cardiac Operating Rooms at 10:11 A.M. on 11/6/19 who presented the Hospital investigation regarding Patient #1. The Director for the Cardiac Intensive Care Unit said the root cause of the error was ineffective communication between cardiac team members about the type of cardiac valve to be implanted. The Director for the Cardiac Intensive Care Unit said several points of the root cause of the error included case setup (setting up the surgical equipment), the Time-Out procedure (Universal Protocol), secondary time out, nurse break handoff and verification of the valve on the surgical field. The Director for the Cardiac Intensive Care Unit said a physician assistant conducted the initial Time-Out procedure. The Director for the Cardiac Intensive Care Unit said the cardiac surgical team did not perform a secondary time out with the Cardiovascular Surgeon. The Director for the Cardiac Intensive Care Unit said the Hospital developed a practice plan (corrective action plan) that included the Cardiovascular Surgeon communication with the Surgical Team for specific implants (valve) to be used for the Surgery, a Secondary Time-Out would be conducted when the Cardiovascular Surgeon was not present for the First Time-Out and the Secondary Time-Out the Cardiovascular Surgeon would verify the implant name, size, type and read the information form the implant box (manufacturer packing). The Director for the Cardiac Intensive Care Unit said an SBAR (practice alert, information) was emailed on 10/2/19 to the Operating Room Cardiovascular Surgeon, the Medical Staff, Perfusionists (personnel that manage the cardiac by-pass machine), Registered Nurses & Technicians. The Director for the Cardiac Intensive Care Unit said that the SBAR was emailed on 10/3/19 to all Medical Staff Chiefs and on 10/10/19 the SBAR was mailed to procedure areas. The Director for the Cardiac Intensive Care Unit said an audit tool was being presented to Senior Leadership (Senior Hospital Executives) on 11/6/19 (during the Survey) for approval and that the verification processes (monitoring) for verification was on track to start on 11/15/19 (46 days after Patient #1's adverse patient event). The Director for the Cardiac Intensive Care Unit said monitoring of Time-Out behaviors in the Cardiac Operating Room had not started yet and was anticipating Senior Leadership approval of the audit tool. The Director for the Cardiac Intensive Care Unit said he did not know how many cardiac surgeries the Hospital performed after Patient #1's adverse patient event on 10/1/19. The Director for the Cardiac Intensive Care Unit said the plan included for Cardiac Operating Room Leadership to develop educational plan for Cardiac Operating Room Nurses and Cardiac Surgical Technicians. The Director for the Cardiac Intensive Care Unit said that the Cardiac Operating Room Leadership planned to start the education in 12/2019; however, the dates were to be announced pending the vendor (manufacturer) availability.

A.) Regarding the practice plan SBAR alert:

The document titled Incorrect Device Implant, dated 10/2/19, indicated the SBAR (information) emailed to operating room staff after Patient #1's adverse event. The SBAR indicated that an incorrect device was implanted. The SBAR indicated that the reader was instructed to review the current policy tiled "Implants" where the policy stated the team verification process, that included that the Circulator (nurse) and Scrub person would verify the type of implant with the Surgeon, inspect the integrity of the packaging, verify implant outdate, verify sterilization indicator, prior to dispensing the implant onto the surgical field. The SBAR indicated instruction to review the current policy and practice related to implant confirmation and to raise awareness across the operating rooms and procedural areas. The SBAR did not indicate the person with the ultimate responsibility for conducting a Time-Out procedure.

The Hospital policy titled Implants, dated 3/24/19, indicated the (Surgical) Team Verification of implant (cardiac valve) procedure. The Implant policy indicated responsibilities of the circulator (nurse) and scrub person to verify the implant to be used with the surgeon prior to dispensing the implant onto the surgical field.

The Surveyor interviewed the Director of Clinical Regulatory Compliance and Patient Safety, at 2:30 P.M. on 11/8/19. The Director of Clinical Regulatory Compliance and Patient Safety said that the Hospital required SBAR education completion by 11/4/19.

The document titled Netlearning Report, dated 11/8/19, indicated an education regarding the Incorrect Device Implant SBAR with a total user compliance rate of 73%.

The document titled Netlearning Curriculum Compliance, undated, indicated physician education regarding the Incorrect Device Implant SBAR with a compliance rate of 81%.

The Hospital provided no plan for staff or physician noncompliance with the practice plan SBAR requirement.

B.) Regarding the Time-Out Procedure:

The Surveyor interviewed the Director of Clinical Regulatory Compliance and Patient Safety at 1:30 P.M. on 11/7/19. The Director of Clinical Regulatory Compliance and Patient Safety said that the Universal Protocol (Time-Out policy) was unclear and that the ultimate responsibility for the Time-Out Procedure was the responsibility of the surgeon.

The Hospital policy titled Implants did not indicate the Surgeon's responsibility.

The Surveyor interviewed the Chief Quality Officer at 11:00 A.M. on 11/7/19. The Chief Quality Officer said that the Hospital had not started audits (regarding the Hospital's practice plan following Patient #1's adverse patient event). The Chief Quality Officer said the Senior Clinical Leadership Committed (SCLC) assigned review of Time-Out Procedures of all surgical areas to the Surgeon in Chief.

The meeting minutes titled Senior Clinical Leadership Committee, dated 10/9/19, indicated redacted meeting minutes which included a review of the surgical safety checklist and Time-Out procedures as a further opportunity for improvement based on adverse events assigned to the Surgeon in Chief with a recommendation to the Senior Clinical Leadership Committee within 60 days (69 days after Patient #1's adverse patient event).

C.) Regarding heart valve surgeries the Hospital performed after Patient #1's adverse patient event (on 10/1/19):

The document titled Patients with Valve (Heart) Replacements, dated 11/6/19, indicated nine patients, from 10/1/19 through 11/6/19, received heart valve replacement surgery.

The document titled Measurement of Implant Verification in the Cardiovascular Operating Room (CVOR) Audit Tool, dated 11/6/19, indicated nine patients had cardiovascular implants (valve replacements) from 10/1/19 through 11/5/19. The Audit Tool indicated one patient receiving a valve replacement, on 10/14/19, (un-sampled Patient A)'s chart (medical record) did not have a time-out procedure documented.

The Surveyor interviewed the Director of Clinical Regulatory Compliance and Patient Safety, at 10:50 A.M. on 11/7/19 and at 2:45 P.M. on 11/7/19. The Director of Clinical Regulatory Compliance and Patient Safety said she did not know that the Hospital conducted chart reviews on 100% of the nine heart valve replacement surgeries. The Director of Clinical Regulatory Compliance and Patient Safety said the reviews were completed as real time visual monitoring according to the practice plan.

The Surveyor interviewed the Cardiac Operating Room Clinical Coordinator at 1:10 P.M. on 11/12/19. The Cardiac Operating Room Clinical Coordinator said that she conducted chart reviews (Audits) on 11/6/19 for patients (receiving heart valve replacements) from 10/1/19 through 10/5/19. The Cardiac Operating Room Clinical Coordinator said the nurse forgot to document the time-out procedure as completed (on un-sampled Patient A's medical record). The Hospital provided no further corrective actions or adjustments to their practice plan.

D.) Regarding the physician assistant role:

The Director for the Cardiac Intensive Care Unit and the Director of Clinical Regulatory Compliance said that the Hospital investigation following Patient #1's adverse patient event did not analyze the physician assistant's role in Time-Out procedures.

The Credential File titled Practice Privileges Physician Assistant, dated 3/26/19, did not indicate the delegation of privileges for conducting the Universal Protocol (Time-Out procedure).

The document titled 263 CMR: Board of Registration of Physician Assistants 263 CMR 5.00: Scope of Practice, Employment of Physician Assistants and Standards of Conduct, at https://www.mass.gov/doc/263-cmr-5-scope-of-practice-employment-of-physician-assistants-and-standards-of-conduct/download, indicated the scope of services which may be performed. A physician assistant may, under the supervision of a licensed physician, perform any and all services which are: within the competence of the physician assistant in question, as determined by the supervising physician's assessment of his or her training and experience; and within the scope of services for which the supervising physician can provide adequate supervision to ensure that accepted standards of medical practice are followed. A physician assistant may approach patients of all ages and with all types of conditions; elicit histories; perform examinations; order, perform and interpret diagnostic studies; order and perform therapeutic procedures; instruct and counsel patients regarding physical and mental health issues; respond to life-threatening situations; and facilitate the appropriate referral of patients; consistent with his or her supervising physician's scope of expertise and responsibility and the level of authority and responsibility delegated to him or her by the supervising physician. A supervising physician may use a physician assistant to assist him or her in the process of gathering data necessary to make decisions and institute patient care plans. A physician assistant shall not, however, supplant a licensed physician as the principal medical decision-maker.

The Surveyor interviewed the Cardiovascular Surgeon, at 2:00 P.M. on 11/6/19. The cardiovascular Surgeon said that the physician assistant conducted the initial Time-Out (Universal Protocol) at the start of the procedure. The Cardiovascular Surgeon said that he did not know of Hospital policy or Medical Staff By-laws regarding the role of a physician assistant and the Universal Protocol. The Cardiovascular Surgeon said that he did not know if it was documented that all Cardiac Surgeons were conducting the Time-Out in the operating room in accordance with the Hospital Implant policy.

The Surveyor interviewed the Surgeon in Chief at 2:45 P.M. on 11/7/19. The Surgeon in Chief said that, for most surgical services, the resident (surgical resident physician) staff conducted the Time-Out procedure. The Surgeon in Chief said that a physician assistant could conduct the Time-Out procedure if the Hospital had privileged the physician assistant to conduct the time-out procedure.

E.) Regarding Informed Consent:

The Director for the Cardiac Intensive Care Unit and the Director of Clinical Regulatory Compliance said that the Hospital investigation following Patient #1's adverse patient event did not analyze if Patient #1's informed consent for the cardiac surgery was included in Patient #1's first Time-Out procedure conducted by the physician assistant.

The Hospital policy titled Implants indicated no documentation that the Time-Out procedure included review of the surgical informed consent.

F.) The Hospital Quality Assessment and Performance Improvement (QAPI) activities did not investigate if the surgical team reported Patient #1's (Informed) Consent matched the verbalized procedure. The Universal Protocol did not require implant verification with the Second Time-Out procedure. The Universal Protocol did not indicate who designated the member of the surgical team to initiate the Time-Out procedure. The Universal Protocol indicated no documentation that an attending surgeon could delegate the Universal Protocol to a physician assistant. The Universal Protocol, indicated no clear documentation that the ultimate responsibility for the Universal Protocol was the responsibility of the attending surgeon.

Based on records reviewed and interviews the Hospital failed for three (Patients #1, #2 & #6) patients out of ten sampled patients to ensure Quality Assessment and Performance Improvement (QAPI) activities identified opportunities for improvement.

Findings included:

Refers to Patient #1:

The Cardiac Surgery Visit note, dated 9/30/19, indicated that the Cardiovascular Surgeon recommended to Patient #1's parents that Patient #1 undergo a mitral valve (valve between the left top chamber of the heart and the left bottom chamber of the heart) replacement (heart surgery).

The Surveyor interviewed the Director for the Cardiac Intensive Care Unit and Cardiac Operating Rooms at 10:11 A.M. on 11/6/19. The Director for the Cardiac Intensive Care Unit said the root cause of the error was ineffective communication between (cardiac team) members about the type of (cardiac) valve to be implanted. The Director for the Cardiac Intensive Care Unit said that the Hospital investigation following Patient #1's adverse patient event did not analyze the physician assistant role in Time-Out procedures as a process for improvement.

The document titled 263 CMR: Board of Registration of Physician Assistants 263 CMR 5.00: Scope of Practice, Employment of Physician Assistants and Standards of Conduct, at https://www.mass.gov/doc/263-cmr-5-scope-of-practice-employment-of-physician-assistants-and-standards-of-conduct/download, indicated the scope of services which may be performed. A physician assistant may, under the supervision of a licensed physician, perform any and all services which are: within the competence of the physician assistant in question, as determined by the supervising physician's assessment of his or her training and experience; and within the scope of services for which the supervising physician can provide adequate supervision to ensure that accepted standards of medical practice are followed. A physician assistant may approach patients of all ages and with all types of conditions; elicit histories; perform examinations; order, perform and interpret diagnostic studies; order and perform therapeutic procedures; instruct and counsel patients regarding physical and mental health issues; respond to life-threatening situations; and facilitate the appropriate referral of patients; consistent with his or her supervising physician's scope of expertise and responsibility and the level of authority and responsibility delegated to him or her by the supervising physician. A supervising physician may use a physician assistant to assist him or her in the process of gathering data necessary to make decisions and institute patient care plans. A physician assistant shall not, however, supplant a licensed physician as the principal medical decision-maker.

The document titled Physician Assistant, dated 11/7/19, indicated specific criteria for Surgical Physician Assistants.

The Physician Assistant Privileges form titled Requested Practice Privileges, Nurse Practitioners & Physician Assistant form, undated, indicated a list of practice privileges for diagnostic and therapeutic procedures and special types of patient care for Nurse Practitioners and Physician Assistants. The Physician Assistant Privileges form indicated no specific criteria for Surgical Physician Assistant privileges.

Refers to Patient #2
Refers to Patient #6

Based on records reviewed and interviews the Hospital failed, for three (Patients #1, #2 and #6) patients out of ten sampled patients, to ensure Quality Assessment and Performance Improvement (QAPI) activities included feedback and learning throughout all Surgical and Anesthesia Services that were provided in the Hospital following Patients #1, #2 and #6's adverse patient events.

Findings included:

Regarding Patient #1:

The Surveyor interviewed the Director for the Cardiac Intensive Care Unit and Cardiac Operating Rooms at 10:11 A.M. on 11/6/19 who presented the Hospital investigation regarding Patient #1. The Director for the Cardiac Intensive Care Unit said he did not know if the SBAR was sent to the Hospital out-patient surgical areas and did not know what if any implants were used in the Hospital out-patient surgical areas.

The Surveyor interviewed the Director of Clinical Regulatory Compliance and Patient Safety, at 10:50 A.M. on 11/7/19. The Director of Clinical Regulatory Compliance and Patient Safety said that the Hospital Out-Patient Services for Interventional Radiology, Dentistry and Gynecology used implanted devices. The Director of Clinical Regulatory Compliance and Patient Safety said that Interventional Radiology implanted gastrostomy tubes, stents and central (intravenous) lines (catheters); Dentistry implanted dental implants and Gynecology implanted Intrauterine Devices (IUD's).

The Hospital provided no documentation that indicated learning opportunities regarding Time-Out procedures included Out-Patient Services.




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Regarding Patient #2 and Patient #6:

Based on record review and interviews the Hospital failed, for two (Patients #2 & #6) patients out of ten sampled patients, to appropriately analyze adverse patient events and ensure that effective corrective actions were implemented.

Review of the Patient #2's medical record indicated that Patient #2, a five month old weighing 7.75 kilograms, was scheduled for administration of chemotherapy intrathecally (injection into the spinal canal) on 9/5/19. Prior to the procedure, Patient #2 was administered Propofol at 300 mcg/kg/min intravenously at 7:43 A.M. Patient #2 was receiving oxygen via an oxygen mask and the oxygen saturation level was 100%. Patient #2 was then administered 100 mcg of Fentanyl ( a narcotic) intravenously at 7:50 A.M. by Resident #1. Patient #2 became cyanotic and apneic requiring emergent intubation, the oxygen saturation was measured at 84%. Patient #2 was stabilized and the procedure was completed. Patient #2 was extubated after the procedure and transferred to the Post Anesthesia Care Unit (PACU) without further incident.

Review of the Patient #2's Hospital's incident report indicated that Resident #1 administered a higher than intended dose of Fentanyl. Resident #1 had no previous pediatric anesthesia training where weight based dosing is a central part of practice and Resident #1 was not familiar with the Hospital's documentation system. The Hospital provided a simulation for medication administration but scheduling residents prior to starting clinical practice did not always happen. Resident #1 was not scheduled to receive this training until 09/12/19 (7 days after the incident).

Review of Patient #6's medical record indicated that Patient # 6, a two year old weighing 12.7 kilograms, was scheduled for ear tube placement on 9/25/19. Prior to the procedure, Resident #2 administered 3001 mcg/kg/min of Propofol instead of the intended 300 mcg/kg/min for 5 minutes. Patient #6 became hypotensive and required an additional venous access and the administration of a vasopressor infusion for continued hypotension.

Review of the Patient #6's Hospital's incident report indicated that Resident #2 programmed the infusion pump, containing Propofol, to 3001 mcg/kg/min. The pump immediately alarmed informing the user that the infusion rate/concentration was above the suggested maximum limit. Resident#2 acknowledged the warning and placed the pump on pause for several minutes before starting the pump and administering the wrong dose.

The Surveyor interviewed the Director of Clinical Regulatory Compliance and Patient Safety, at 10:50 A.M. on 11/7/19. The Director of Clinical Regulatory Compliance and Patient Safety said that an email SBAR (Situation, Background, Assessment, and Recommendation) was sent to all anesthesia staff on 9/11/19 as a reminder of appropriate Medication Administration. The Director of Clinical Regulatory Compliance and Patient Safety said that new residents will receive simulation for medication administration before they start their clinic practice starting on 11/1/19. The Director of Clinical Regulatory Compliance and Patient Safety acknowledged that no practice change was implemented after Patient #1's overdose by Resident #1 and prior to Patient #6's overdose by Resident #2.

Review of the Anesthesia Department's Resident Simulation Training schedule indicated that 10 resident's started clinical practice on 10/1/19 and did not receive any simulation training until 10/10/19. The hospital failed to implement any corrective actions after Resident #1's overdose of Patient #1 on 9/5/19 and before Resident #2's overdose of Patient #6 on 9/25/19. The Hospital did not implement any changes to resident training for eight weeks after Patient #1's medication overdose.

Based on records reviewed and interviews the Hospital Governing Body failed to ensure Executive Responsibilities for Hospital-wide quality assessment and performance improvement activities were implemented and evaluated (monitored).

Findings included:

Regarding the Quality Assessment & Performance Program SBAR practice plan following Patient #1's adverse patient event.

The Cardiovascular Surgery Inpatient MD note, dated 10/1/19, indicated Cardiovascular Surgeon told Patient #1's parents that an aortic valve was initially inserted, and it was replaced with a mitral valve.

The Surveyor interviewed the Director for the Cardiac Intensive Care Unit and Cardiac Operating Rooms at 10:11 A.M. on 11/6/19 who presented the Hospital investigation regarding Patient #1. The Director for the Cardiac Intensive Care Unit said that, on 10/3/19, the SBAR was emailed to all Medical Staff Chiefs and on 10/10/19 the SBAR was mailed to procedure areas.

The Surveyor interviewed the Director of Clinical Regulatory Compliance and Patient Safety, at 2:30 P.M. on 11/8/19. The Director of Clinical Regulatory Compliance and Patient Safety said that the Hospital required completion by 11/4/19.

The document titled Netlearning Report, dated 11/8/19, indicated an education regarding the Incorrect Device Implant SBAR with a total user compliance rate of 73% and the document titled Netlearning Curriculum Compliance, undated, indicated Physician education regarding the Incorrect Device Implant SBAR with a compliance rate of 81%.

The Hospital provided no plan for staff or Physician non-compliance with the practice plan SBAR requirement.

Regarding the Quality Assessment & Performance Program SBAR practice plan for evaluation (monitoring) following Patient #1's adverse patient event.

The Director for the Cardiac Intensive Care Unit said an audit tool was being presented to Senior Leadership (Senior Hospital Executives) on 11/6/19 (during the Survey) for approval and that the verification processes (monitoring) for verification was on track to start on 11/15/19 (46 days after the event). The Director for the Cardiac Intensive Care Unit said monitoring of Time-Out behaviors in the Cardiac Operating Room had not start yet and was anticipating Senior Leadership approval of the audit tool. The Director for the Cardiac Intensive Care Unit said that the Cardiac Operating Room Leadership planned to start the education in 12/2019; however, the dates were to be announced pending the vendor (manufacturer) availability. The Director for the Cardiac Intensive Care Unit said he did not know how many Cardiac Valve Surgeries the Hospital performed after Patient #1's adverse patient event (on 10/1/19).

Regarding Quality Assessment and Performance Improvement activities identified opportunities for improvement.

The Surveyor interviewed the Director for the Cardiac Intensive Care Unit and Cardiac Operating Rooms, the Director of Clinical Regulatory Compliance and Patient Safety and the Manager of Patient Safety at 10:11 A.M. on 11/6/19. The Director for the Cardiac Intensive Care Unit and the Director of Clinical Regulatory Compliance said that the Hospital investigation following Patient #1's adverse patient event did not analyze the physician assistant role in Time-Out procedures (as a process for improvement).

Regarding Quality Assessment and Performance Improvement activities and feedback and learning throughout all Surgical Services and Anesthesia Services following Patients #1, #2 and #6's adverse patient events.

The Surveyor interviewed the Director for the Cardiac Intensive Care Unit and Cardiac Operating Rooms at 10:11 A.M. on 11/6/19 who presented the Hospital investigation regarding Patient #1. The Director for the Cardiac Intensive Care Unit said he did not know if the SBAR was sent to the Hospital out-patient surgical areas and did not know what if any implants were used in the Hospital out-patient surgical areas.

The Surveyor interviewed the Director of Clinical Regulatory Compliance and Patient Safety, at 10:50 A.M. on 11/7/19. The Director of Clinical Regulatory Compliance and Patient Safety said that Interventional Radiology implanted gastrostomy tubes, stents and central (intravenous) lines (catheters); Dentistry implanted dental implants and Gynecology implanted Intrauterine Devices (IUD's).

The Hospital provided no documentation that indicated learning opportunities regard Time-Out procedures included Out-Patient Services.