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 June 2, 2017
VIOLATION: PATIENT RIGHTS: GRIEVANCES Tag No: A0118
Based on record review and interview for 1 of 10 sampled patients (Patient #7), the Hospital failed to provide a written resolution to address the Family Member's grievance that Patient #7's sweatshirt was missing, as required by the Hospital's Grievance Policy.

Findings include:

The Hospital's Complaints and Grievances Policy, dated January 2014, indicated that a grievance is a verbal or written complaint received by the Hospital from a patient or his/her representative regarding the patient's care when the issue is not resolved at the time by staff present. The policy indicated that the goal is to resolve grievances within 7 business days. In the event a grievance is not resolved within 7 business days, the patient will receive an update verbally or in writing.

The Complaint/Grievance Report dated 5/16/17 indicated that, on 5/2/17, Patient #7 was discharged from the Hospital and that following discharge the Family Member called the Hospital (on 5/2/17) to report that Patient #7 was missing a white sweatshirt. The Family Member indicated he brought the sweatshirt to the Hospital when Patient #7 was an inpatient and he later observed Patient #7 wearing it in a common area. The Family Member also stated that, at discharge, a designer bag belonging to Patient #7 was found in another patient's closet.

The Complaint/Grievance Report indicated that, on 5/12/17, the Patient Experience Specialist conducted a chart review and determined that the belongings sheet did not list a sweatshirt.

The Complaint/Grievance report indicated that on, 5/16/17, the Patient Experience Specialist contacted staff from Patient #7's former unit to inquire about the missing sweatshirt.

Review of Patient #7's Complaint/Grievance Report file on 6/2/17 indicated there was no documentation that there was a response from unit staff or that there was a verbal or written update communicated to the Family Member, Patient #7, or a resolution to the grievance.

The surveyor interviewed the Patient Experience Manager on 5/31/17 at 12:25 P.M. The Patient Experience Manager said that Patient #7 had already been discharged when the Family Member contacted the Hospital to report the missing sweatshirt. The Patient Experience Manager said that when a concern cannot be immediately resolved it is categorized as a grievance, a time frame is given for its expected resolution and a letter is sent to to the complainant.
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observations, record review and interviews for one of 10 sampled patients (Patient #1), the Hospital failed to assure quality improvement activities thoroughly investigated, analyzed and implemented timely and completed corrective actions after Patient #1 was administered intravenous (IV) contrast, suffered an anaphylactic (allergic) reaction during a computed tomography (CT) Scan procedure and resuscitative efforts were unsuccessful.

Findings include:

A Hospital Report dated 4/21/17 indicated that, on 4/14/17, there was an incident/issue with Patient #1 receiving IV contrast, suffering an anaphylactic reaction and despite receiving immediate emergency care Patient #1 died . The report indicated that Patient #1's allergy to the IV contrast was in an area of the medical record under the allergy section where hospital staff did not know where to look/navigate and as a result the allergy information regarding the IV contrast remained out of sight to staff. The report indicated that Patient #1 had a inpatient admission from 4/1/17 to 4/13/17.

The Hospital's quality improvement activities failed to identify:

1.) That during Patient #1's inpatient hospitalized from [DATE] to 4/13/17, the IV contrast allergy information was not readily visible to medical staff, pharmacy staff and nursing staff who provided care either directly or indirectly to Patient #1 during his/her inpatient hospitalization .

2.) Patient #1's CT questionnaire for the CT procedure on 4/19/17 was not entered into Patient #1's medical record as required by hospital policy and procedure.

The Hospital's report and internal investigation indicated the radiology staff and emergency department nursing staff were sent a memo with instructions to review all allergy areas in patient medical records as well as checking a patient's allergy in the Hospital's former electronic record; however, the review indicated that the Hospital's education regarding this hidden allergy information had not yet been completed as of 5/31/17 by all Hospital registered nurses, pharmacy staff and all credentialed members of the medical staff.

The Surveyor interviewed the CT Scan Manager at 2:30 P.M. on 5/31/17. The CT Scan Manager said she did not find the required questionnaire for the CT scan for Patient #1 performed on 4/14/17.

The Surveyor interviewed CT Technologist #2 at 7:15 A.M. on 6/1/17. CT Technologist #2 said she completed the questionnaire form regarding allergies but did not know why it was not scanned into Patient #1's record.

At 8:00 A.M. on 6/1/17, the Surveyor toured the CT scan area in the Department of Radiology with the CT Department Manager and observed the picture archiving and communication system (PACS). Patient #9 and Patient #10's medical records were reviewed in PACS and did not contain the required questionnaire form.
VIOLATION: MEDICAL RECORD SERVICES Tag No: A0431
Based on observations, records reviewed and interviews for 10 of 10 patients sampled, it was determined that the hospital failed to meet the Condition of Participation for Medical Record Services (medical records include at least written documents, computerized electronic information, radiology films and scans, laboratory reports and pathology slides, videos, audio recordings, and other information regarding the condition of a patient).

1. The hospital failed to ensure that the Hospital's Medical Records Service had administrative responsibility for their policies and procedures approved by the governing body and that their Medical Records Service policies and procedures corresponded to the name of the hospital in their provider Medicare/Medicaid agreement.

See also A449.

2. The hospital failed to ensure that medical records contained information to describe patients' progress and responses for three of three patients who received a Computed Tomography (CT) Scan with intravenous contrast.

Findings included:

A policy and procedure titled Obtaining Authorization for Release of Protected Health Information (PHI) PH-123, dated 4/3/17, indicated the policy applied to all Partners HealthCare entities, workforce members and agents. The policy and procedure did not evidence that the Hospital's administrative staff read/agreed with or changed the policy procedure of the Partners Health Care System to indicate the policy/procedure was applied to this specific Hospital.

A policy and procedure titled Health Record Completion PH-151, dated 7/25/16, indicated the policy applied to all Partners HealthCare entities, workforce members and agents. The policy and procedure did not evidence that the Hospital's administrative staff read/agreed with or changed the policy procedure of the Partners Health Care System to indicate the policy/procedure was applied to this specific Hospital.

A policy and procedure titled Use and Disclosure of Protected Health Information (PHI) PH-102, dated 4/3/17, indicated the policy applied to all Partners HealthCare entities, workforce members and agents. The policy and procedure did not evidence that the Hospital's administrative staff read/agreed with or changed the policy procedure of the Partners Health Care System to indicate the policy/procedure was applied to this specific Hospital.

The Organizational Structure for the Medical Records Service, dated 3/3/17, indicated it was a Partners Enterprise Health Information Management System and the Organizational Structure operated within its own governance under one management umbrella, not the Hospital's administrative management.

The Medical Records Organizational Chart, dated 3/3/17, indicated the reporting structure, governance of the Hospital's Medical Record Service was to the Enterprise HIM Operations, not the Hospital's administrative governance.
VIOLATION: CONTENT OF RECORD Tag No: A0449
Based on observations, record review and interview, the hospital failed to ensure that a Computed Tomography (CT) questionnaire for patients receiving contrast was entered into three (Patient #1, #9 and #10) of three patient records, in a total sample of ten patients reviewed.

Findings include:

The Hospital's policy and procedure regarding contrast media, dated 1/1/13, indicated the Hospital's contrast information form must be completed for every intravenous (IV) contrast injection. The form is scanned into the picture archiving and communication system {(PACS) a healthcare technology database for the short- and long-term storage, retrieval, management, distribution and presentation of medical images} to be available for future reference.

The Surveyor interviewed the CT Scan Manager at 2:30 P.M. on 5/31/17. The CT Scan Manager said when she reviewed Patient #1's electronic record she did not find the required questionnaire for the CT scan that was performed on 4/14/17.

The Surveyor interviewed CT Technologist #2 at 7:15 A.M. on 6/1/17. CT Technologist #2 said she interviewed Patient #1 and reviewed his/her allergies with the patient. CT Technologist #2 said she always reviews a patient's history when she gets an order for a CT Scan. CT Technologist #2 said she completed the questionnaire form regarding allergies but did not know why it was not scanned into Patient #1's record. CT Technologist #2 said that, during the CT procedure, Patient #1 had an allergic reaction to the contrast and she immediately called the Emergency Department for help with Patient #1.

At 8:00 A.M. on 6/1/17 the Surveyor toured the CT scan area in the Department of Radiology with the Radiology Department Director and the CT Department Manager and observed the PACS. The PACS was opened and two randomly selected patient records, (Patient #9 and Patient #10) who received IV contrast by CT Technician #2 were selected. Patient #9 and Patient #10's medical record did not contain the required questionnaire form. The CT Manager then reviewed with the Surveyor the PACS for Patient #1, dated 4/19/17, and the Surveyor did not see the required form.

The CT Scan Manager said that the required questionnaire forms were not in Patient #1's, Patient #9's and Patient #10's records.

The Radiology Department Director said there were no written protocols to complete the questionnaires; however, a policy and procedure was provided to the Surveyor.