The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

NORTH SHORE MEDICAL CENTER - 81 HIGHLAND AVENUE SALEM, MA 01970 Oct. 11, 2018
VIOLATION: QAPI Tag No: A0263
The Hospital was out of compliance for the Quality Assessment & Performance Improvement (QAPI) Condition of Participation.

Findings include:

1.) The Hospital failed for one (Patient #1) of ten sampled patients (Patient #1) to ensure thorough data collection, analysis and other aspects of care, after Patient #1's unanticipated death.

Refer to TAG: A-0273.

2.) The Hospital failed to identify opportunities for improvement.

Refer to TAG: A-0283.

3.) The Hospital failed for one (Patient #1) of ten sampled patients to ensure investigation and implementation of preventative actions after Patient #1's unanticipated death.

Refer to TAG: A-0286.

4.) Hospital Executives failed for one (Patient #1) of ten sampled patients to ensure that QAPI activities implemented performance improvement efforts in accordance with the Patient Care Assessment Plan, after Patient #1's unanticipated death.

Refer to TAG: A-0309.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on observations, records reviewed and interviews, the Hospital failed for one (Patient #1) of ten sampled patients to ensure thorough data collection, analysis and other aspects of care, after Patient #1's unanticipated death.

Findings included:

1.) The Discharge Summary, dated 4/9/18, indicated Patient #1 presented to the Hospital for elevated blood pressures, a twin gestation pregnancy and a history significant for chronic hypertension. The Discharge Summary indicated Patient #1 presented with chest discomfort, burning sensation and a headache at time of arrival. The Discharge Summary indicated she became non-responsive (approximately 2-1/2 hours after arrival). The Hospital activated emergency response teams, implemented advanced life support efforts and performed a Cesarean section for twin deliveries. The Discharge Summary indicated advanced life support efforts were unsuccessful and Patient #1 died .

The Hospital policy titled External Regulatory Reporting of Adverse Events, dated 6/2017, indicated the Hospital reviewed unanticipated deaths through Root Cause Analysis. The External Regulatory Reporting of Adverse Events Policy indicated patient events that required a Root Cause Analysis included the following activities: a planned improvement process, monitoring of the implementation and measurement of the effectiveness of the improvement process. The External Regulatory Reporting of Adverse Events Policy indicated the Quality Department and Senior Hospital Leaders coordinated this process and these activities occurred under the support of the Peer Review Committee structures.

The Hospital provided no indication of documentation that the Hospital conducted a Root Cause Analysis in response to Patient #1's unanticipated death.

The Surveyor interviewed the Quality Vice President at 9:40 A.M. on 10/4/18. The Quality Vice President said that the Hospital did not conduct a Root Cause Analysis.

The Surveyor interviewed the Special Care Nursery Director at 11:50 P.M. on 10/10/18. The Special Care Nursery Director said she spoke with staff the night of Patient #1's death and provided staff support. The Special Care Nursery Director said she did not conduct an investigation regarding Patient #1's death.

2.) The Patient Care Assessment Plan, dated 2/18/2018 and provided by the Hospital as the Quality Plan, indicated Hospital and Medical Staffs were responsible for reporting patient events not consistent with anticipated outcomes into the Hospital computerized reporting system for the purposes of performance improvement activities and education of Hospital and Medical Staff.

The Hospital policy titled Safety Reporting, dated 1/21/18, indicated the individual who discovered the event was responsible for completing the safety event report. The Safety Reporting Policy indicated individuals reported adverse patient events computerized reporting system that included adverse patient events that were not consistent with routine patient care and unexpected events involving death for the process of identifying opportunities for improvement and learning experiences for the Hospital. The Safety Reporting Policy indicated the individual accountable for the department where the safety event occurred was responsible for investigating the event. The Safety Reporting Policy indicated the accountable person documented investigation details in the computerized reporting system. The Safety Reporting Policy indicated the Quality Department was responsible for identifying adverse patient events that required an in-depth evaluation (Hospital investigation) through Root Cause Analysis or Failure Mode Effects Analysis (methods to conduct in-depth Hospital investigation). The policy did not identify responsibility for thorough implementation of an Action Plan developed resulting from a Hospital investigation that included implementation of corrective actions following an adverse patient event.

The Surveyor interviewed the Quality Vice President and Risk Manager #1 at 2:00 P.M. on 10/4/18. The Quality Vice President and Risk Manager #1 said that Hospital personnel did not file a safety event report regarding Patient #1's unexpected death.

The Hospital provided no indication of documentation that an individual filed a safety event report regarding Patient #1's unexpected death, in accordance with Hospital policy.

3.) Regarding Quality Assessment and Performance Improvement (QAPI) activities failure to ensure review and analysis all Obstetric Emergency Codes (cardiac-pulmonary arrest events) and all Neonatal Emergency Codes consistent with the Code Blue Committee responsibilities for Medical, Surgical and Intensive Care patients cared for by the Hospital following Code Blues.

The Discharge Summary, dated at 11:38 P.M. on 4/9/18, indicated the Obstetric Critical Response and Code Blue Teams responded to Patient #1's cardiac-pulmonary arrest.

The Hospital policy titled, Cardiac-Pulmonary Resuscitation, dated 12/2016, indicated the Code Blue (cardiac-pulmonary arrest) response system as designated to ensure emergency care to patients. The Cardiac-Pulmonary Resuscitation Policy indicated the Code Blue Committee was responsible for the oversight (supervision) of cardiopulmonary resuscitation, including cardiac-pulmonary resuscitation policy and quality improvement methods. The Cardiac-Pulmonary Resuscitation Policy indicated the Code Blue Committee responsibilities included Code Blue and Critical Response Team event reviews for identifying and implementing methods for obtaining Code Blue information, education of Code Blue and Critical Response Teams and evaluating equipment issues. The Cardiac-Pulmonary Resuscitation Policy did not indicate the Code Blue Committee Composition included Obstetric or Neonatal staff representation.

The Hospital policies titled Management of the Neonatal Code Blue, dated 8/2015 and the Obstetric Critical Response Team, dated 7/21/17, did not indicate a QAPI process for review and analysis.

The Code Blue, Critical Response Team Committee Meeting Minutes, dated 5/31/18, indicated review of Critical Response Team activity for April 2018. The Code Blue, Critical Response Team Committee Meeting Minutes did not indicate an Obstetric Critical Response Team activation or Code Blue Team activation in April 2018.

The Surveyor interviewed the Quality Vice President and Risk Manager #1 at 2:00 P.M. on 10/4/18 and the Medical OB/GYN Chair and Quality Vice President at 11:40 A.M. on 10/5/18. The Quality Vice President, Risk Manager #1 and Medical OB/GYN Chair said the Code Blue Critical Response Team Committee did not review Obstetric or Neonatal Codes.

The Surveyor interviewed the Obstetrics Director and the Obstetrics Educator at 1:15 P.M. on 10/5/18. The Obstetrics Director and the Obstetrics Educator said that they did not know if the Code Blue Critical Response Team Committee reviewed all obstetric codes; however, they assumed that the Code Blue Critical Response Team Committee reviewed all obstetric codes.

The Surveyor interviewed the Intensive Care Unit Director at 9:30 A.M. on 10/11/18. The Intensive Care Unit Director said she led the Code Blue Critical Response Team Committee. The Intensive Care Unit Director said the Code Blue Critical Response Team Committee did not review Obstetric Critical Responses, Obstetric Code Blues or Neonatal Codes. The Intensive Care Unit Director said the purpose of the Code Blue Critical Response Team Committee was to identify opportunities for improvement and identify educational needs. The Intensive Care Unit Director said that the Obstetric and Special Care Nursery Directors attended the Code Blue Critical Response Team Committee by invitation.


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4.) Regarding QAPI activities failure to track quality aspects of performance that assess processes of care, Hospital service and operations by failing to remove expired procedural kits (Paracervical Pudendal Block trays used to administer a nerve block for labor pain management).

The Hospital document titled Infection Prevention Program and Surveillance Plan, dated 2018, indicated the Environment of Care Committee conducted environmental rounds. The Infection Prevention Program and Surveillance Plan indicated the Infection Control individual as a member of the Environment of Care Committee and responsible for review of storage of medical equipment and medical devices.

The Surveyor toured the Maternity, Labor Delivery Department, and interviewed the Obstetric Director and Charge Nurse, at 8:30 A.M. on 10/4/18. The Surveyor observed, in a locked cabinet, five expired Paracervical Pudendal Block trays, one opened 100 ml bag of 0.9% Sodium Chloride with an expiration date of 6/2019 and one sealed 500 ml bag of 0.9% Sodium Chloride with an expiration date of 1/2018. The Obstetric Director said that open saline bags need to be labeled when opened otherwise the saline bag was considered expired. The Charge Nurse said that all five of the Paracervical Pudendal Block trays were expired and should have been removed from the cabinet.

The Surveyor interviewed the Quality Vice President at 10:00 A.M. on 10/11/18. The Quality Vice President said her department was responsible for the Infection Prevention Program, Surveillance Plan and the Environment of Care Rounds. The Quality Vice President said the Environment of Care Rounds staff checked for expired medications.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on records reviewed and interviews, Quality Assessment & Performance Improvement (QAPI) activities failed to identify opportunities for improvement based on evaluation of Patient #1's unanticipated death.

Findings included:

1.) Regarding QAPI activities failure to ensure authentication of verbal orders on a Resuscitation Record in accordance with Hospital policy.

The Hospital policy titled Verbal, Telephone Orders, dated 6/20/18, indicated requirements for documentation and signing of verbal orders in the patient's medical record. The Verbal, Telephone Orders policy indicated Licensed Independent Practitioners (Physician, Physician Assistant, Nurse Practitioner, Certified Nurse Midwife, Registered Nurse Anesthetist) were responsible for signing verbal orders according to Hospital's Bylaws.

Medical Staff Bylaws, dated 9/19/17, indicated Telephone Orders were countersigned by the physician within two calendar days. Medical Staff Bylaws did not indicate terms consistent with the Verbal, Telephone Orders policy regarding Verbal, Telephone Orders.

The form titled Resuscitation Record, dated 4/9/18, indicated resuscitation interventions and medications administered during Patient #1's cardiac-pulmonary resuscitation. The Resuscitation Record indicated no documentation that verbal orders were signed by an Licensed Independent Practitioner according to the Verbal, Telephone Orders policy.

The Hospital provided no established policy for the signing verbal orders documented on Resuscitation Records.

The Surveyor interviewed the Intensive Care Unit Director at 9:30 A.M. on 10/11/18. The Intensive Care Unit Director said she led the Code Blue Critical Response Team Committee. The Intensive Care Unit Director said the medications documented as administered on a Resuscitation Record represented verbal orders for the administered medications. The Intensive Care Unit Director said the Hospital did not have a policy or documentation to indicate that a physician signature on the Resuscitation Form represented authentication of verbal orders.

2.) Regarding QAPI Activities failure to ensure updated and clear directions for the forwarding of a Resuscitation Record and Code Blue Debrief Critique Form for Hospital review and analysis. As a result quality improvement activities post incident review was unclear following Patient #1's unanticipated death in April 2018.

The Hospital policy titled Adult Code Blue, dated 10/30/15, the medical record form titled Resuscitation Record, dated 12/2009, and the Hospital form titled Code Blue Debrief, Critique Form, dated 7/2018, indicated instructions for how Hospital staff were to send patient resuscitation information for Hospital review. The Adult Code Blue policy and Hospital forms titled Resuscitation Record and Code Blue Debrief; Critique did not indicate consistent terminology correlating policy and forms with updated information. The policy and forms indicated unclear processes for Hospital review of patient resuscitative efforts.

Obstetrics Director, Obstetrics Educator, Intensive Care Unit Director and the Quality Vice President provided inconsistent information regarding the process for quality review of Resuscitation Records.

The Surveyor interviewed Quality Vice President at 10:40 A.M. on 10/5/18. The Quality Vice President said that the copies of the Resuscitation Records were not sent to Quality Improvement.

The Surveyor interviewed the Obstetrics Director and the Obstetrics Educator at 1:15 P.M. on 10/5/18. The Obstetrics Director and the Obstetrics Educator said staff sent a copy of the Resuscitation Record to Quality Improvement and did not know the process after that.

The Surveyor interviewed the Intensive Care Unit Director at 9:30 A.M. on 10/11/18. The Intensive Care Unit Director said she let the Code Team Committee. The Intensive Care Unit said a copy of the Resuscitation Form went to Quality Improvement.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on records reviewed and interviews, the Hospital failed for one (Patient #1) of ten sampled patients to ensure investigation and implementation of preventative actions after Patient #1's unanticipated death.

Findings included:

The Patient Care Assessment Plan, dated 2/18/2018 and provided by the Hospital as the Quality Plan, indicated the Hospital implemented preventive measures, identified by critical review of patient care to identify problem(s) before they occur.

The Hospital document titled Report, dated 4/9/18, indicated Obstetric providers identified the need for ongoing education regarding how to evaluate and manage an obstetric patient with chest pain.

The Report indicated no documentation of the Obstetric providers's identified need for education regarding obstetric patients with chest pain was included as a corrective action in the Action Plan.

The Hospital provided no documentation to indicate that Quality Assessment & Performance Improvement activities implemented education regarding obstetric patients with chest pain, as a preventive measure, in accordance with the Patient Care Assessment Plan.
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on interviews and records reviewed, the Governing Body failed for one (Patient #1) of ten sampled patients to ensure that Quality Assessment & Performance Improvement (QAPI) activities implemented performance improvement efforts in accordance with the Patient Care Assessment Plan, after Patient #1's unanticipated death.

Findings included:

The Patient Care Assessment Plan, dated 2/18/2018 and provided by the Hospital as the Quality Plan, indicated the Hospital implemented preventive measures, identified by critical review of patient care to identify problem(s) before they occur.

The Hospital document titled Report, dated 4/9/18, indicated Obstetric providers identified the need for ongoing education regarding how to evaluate and manage an obstetric patient with chest pain.

The Report indicated no documentation of the Obstetric Medical Staff's identified need for education regarding obstetric patients with chest pain was included as a corrective action in the Action Plan.

The Meeting Schedule titled Department of Obstetrics & Gynecology, dated 1/2018-12/2018, indicated no documentation for education regarding obstetric patients with chest pain.

The Hospital provided no documentation to indicate the Medical Staff or QAPI activities implemented education regarding obstetric patients with chest pain to provide high quality medical care to patients at the Hospital, to identify life-threatening heart problems in pregnant patients before they occur and to make possible the implementation of preventive measures.

The Surveyor interviewed the Medical OB/GYN Chair and Quality Vice President at 11:40 A.M. on 10/5/18 and the Chief Medical Officer at 1:30 P.M. on 10/10/18. The Medical OB/GYN Chair and the Chief Medical Officer said the need for ongoing education regarding how to evaluate and manage an obstetric patient with chest pain should have been included on the Action Plan.
VIOLATION: MEDICAL STAFF PRIVILEGING Tag No: A0355
Based on Bylaws reviewed, the Medical Staff failed to ensure a clear statement of the duties and privileges of the category of Allied Health Professionals.

Findings Included:

The Medical Staff Bylaws and Rules and Regulations, dated 9/19/17, indicated Allied Health Professionals shall include, but not be limited to, licensed physician assistants, nurses practicing in the expanded role and individuals with a doctorate in psychology from an accredited college or university and individuals with a doctorate of education appropriately trained and licensed as a psychologist or neuropsychologist.

The Medical Staff Bylaws, Rules and Regulations indicated no documentation of clear duties, scope of medical staff specific privileges for the category of Allied Health Professionals indicated as "but not limited to" eligible for Medical Staff membership or privileges.