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.

SOUTH SHORE HOSPITAL 55 FOGG ROAD SOUTH WEYMOUTH, MA 02190 Feb. 15, 2019
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on records reviewed and interviews, Hospital Quality Assessment & Performance Improvement activities failed for one (Patient #1) of ten patients surveyed to identify opportunities for improvement.

Findings included:

Regarding cardiac arrest #1:

The History and Physical Note, dated 8/1/18, indicated Surgeon #1's plan for Patient #1's surgery (Surgery, dated 8/21/18) for a concern over a new cancer site.

The Discharge Summary, dated 8/23/18, indicated Patient #1's surgery was stopped when Patient #1 went into cardiac arrest after the start of general anesthesia. Patient #1 was admitted to the Intensive Care Unit. The Discharge Summary indicated the event may have been related to a combination of factors including, hypovolemia (low fluid level in the body), blood pressure medicine, epidural (spinal catheter) placement and or possible reaction to vecuronium (anesthesia medicine). The Discharge Summary indicated heart tests and cardiology consultation showed Patient #1 had no cardiovascular (heart) issues. The Discharge Summary indicated a plan for Patient #1 to return for evaluation with surgery rescheduled for the following day.

The Progress Note, dated 8/27/18, indicated Surgeon #1's plan for induction of general anesthesia for surgery planned for 8/28/18, following Patient #1's cardiac arrest during the surgery of 8/21/18. The Progress Note indicated the plan was developed with Anesthesia and Cardiology. The Progress Note indicated Surgeon #1 had a candid conversation with Patient #1 and family.

Regarding cardiac arrest #2:

The History and Physical Note, dated 8/28/18, indicated Patient #1 was admitted to the Intensive Care Unit after suffering a cardiac arrest lasting greater than one hour after the start of general anesthesia for the rescheduled surgery (of 8/21/18). The History and Physical Note indicated anesthesia medications were changed. The History and Physical Note indicated Patient #1 had a latex urinary catheter placed for both the 8/23/18 and 8/28/18 surgeries. The History and Physical Note indicated it was unclear if Patient #1 had an allergy to benzodiazepines (medication), latex rubber (in the urinary catheter), a response to stimulation of the tumor, another tumor or other sensitivities to perioperative substances.

The Anesthesia Pre-Procedure Evaluation, dated at 11:19 A.M. on 8/28/18, indicated Patient #1 had a presumed anaphylaxis (life-threatening allergic reaction) and skin testing was not possible given Patient #1's growing tumor. The Anesthesia Pre-Procedure Evaluation indicated a plan for pre-operative medication with Benadryl and a steroid (medications for allergies) and no epidural (spinal catheter). The Anesthesia Pre-Procedure Evaluation indicated the plan and risks were discussed with Patient #1.

1.) QAPI activities failed to identify an opportunity for improvement regarding physician documentation in patient medical records.

The Surveyor interviewed the Director of Risk Prevention at 8:00 A.M. on 1/12/19. The Director of Risk Prevention said that the Peer (Physician) Review Process reviewed Patient #1's care and that the Hospital multidisciplinary reviewers did not review Patient #1's care. The Director of Risk Prevention said that the Hospital used The Joint Commission's framework to conduct a Root Cause Analysis (Hospital investigation).

The document titled Framework for Root Cause Analysis and Corrective Actions, undated, indicated the Joint Commission's framework that the Hospital used for conducting a Root Cause Analysis. The Framework focused on analysis of a patient event and factors that influenced patient outcome. The Framework indicated no guidance or prompt for the Hospital to review for opportunities for improvement.

The Cardiology Consultation, dated 8/28/18, indicated Patient #1 was pre-medicated with Benadryl and steroids preoperatively based on consultation with an allergist. The Cardiology Consultation indicated a tryptase blood test was obtained during the cardiac arrest to have an evaluation of a possible allergic type of reaction which was done at the suggestion of the allergist consultation. The Cardiology Consultation indicated the Cardiology and Anesthesia team's plan for Patient #1 was safe for general anesthesia for the surgery of 8/28/18 based on holding Patient #1's cardiac medications, administering Patient #1 with Benadryl and steroids before the surgery, changing the anesthesia medication and to not use an epidural.

Hospital Meeting Minutes indicated discussion regarding allergy recommendations that included writing (the recommendation in the patient's medical record) rather than a phone conversation.

The Surveyor interviewed the Director of Risk Prevention at 11:00 A.M. on 2/8/19. The Director of Risk Prevention said the physicians' review process did not identify an opportunity for improvement regarding the telephone conversation between Allergist #1 and Anesthesiologist #1 as a written note in Patient #1's medical record.

The Surveyor interviewed the Chief of Anesthesia at 10:30 A.M. on 2/12/19. The Chief of Anesthesia said Patient #1's tryptase level increased from 2 (normal) to 184.

The Surveyor interviewed Anesthesiologist #1 at 11:15 A.M. on 2/12/19. Anesthesiologist #1 said Patient #1 had a complete cardiac evaluation and Patient #1's cardiac event during the Surgery, dated 8/28/18, was not due to Patient #1's heart. Anesthesiologist #1 said the cardiac event during the surgery was most likely due to an anaphylactic (life-threatening allergy) reaction. Anesthesiologist #1 said he had a telephone conversation with Allergist #1 the evening prior to Patient #1's Surgery regarding the plan for anesthesia medications. Anesthesiologist #1 said allergy testing was not possible because allergy testing for anesthesia medications would take 6-8 weeks and Patient #1's body already had an immune response (that would alter the test results). Anesthesiologist #1 said the surgery could not be canceled or postponed due to the aggressive nature of Patient #1's cancer.

The Surveyor interviewed Allergist #1 at 12:10 P.M. on 2/12/19. Allergist #1 said she provided a telephone conversation with Anesthesiologist #1 regarding Patient #1's medications for anesthesia and to obtain tryptase (blood test to detect an allergic reaction) levels. Allergist #1 said the telephone conversation was not a consultation, she did not document the conversation in Patient #1's medical record and she did not know if she had access to Patient #1's medical record. Allergist #1 said documenting phone conversations was potentially something that needed to change. Allergist #1 said Patient #1's tryptase increased to a "super high" (or to that effect) level and this high level indicated a huge allergic reaction.

The Surveyor interviewed Surgeon #1 at 11:30 A.M. on 2/14/19. Surgeon #1 said Anesthesiologist #1 spoke with Allergist #1 because Patient #1's heart evaluation was negative (normal), Patient #1's event (during the Surgery, dated 8/28/18) was a reaction to anesthesia medications and they wanted the Allergist's opinion on their planned change of anesthesia medications.

The Surveyor interviewed the Medical Staff President, the Quality Vice President & the Director of Risk Management at 2:45 P.M. on 2/14/19. The Medical Staff President said the expert reviewers (reviewers for the physician review process) identified no system wide process(es) for improvement. The Medical Staff President said the expert reviewers determined that Patient #1's care met the teaching standard of care (care provided as one would teach it).

The Surveyor interviewed the Cardiology Chief at 7:15 A.M. on 2/15/19. The Cardiology Chief said that he reviewed Patient #1's cardiac (heart) tests. The Cardiology Chief said Patient #1's tests did not show Patient #1 had a heart attack or had coronary (heart) artery disease and Patient #1's stress test was normal.

2.) QAPI activities failed to identify that the Anesthesia Services Policy & Procedure Manual was not current and that the Hospital had similar policies with differing content that could possibly cause staff confusion as to which policy to follow.

A.) The Surveyor interviewed the Anesthesia Chief and Director of Risk Prevention at 2:15 P.M. on 2/12/19. The Director of Risk Prevention said that the Medical Staff Bylaws did not contain Anesthesia Services Policies & Procedures. The Anesthesia Chief said that the Hospital had Anesthesia Policies and Procedures. The Anesthesia Chief said that the Anesthesia Services Policy & Procedure Manual was antiquated and not updated.

The Surveyor interviewed Anesthesiologist #3 at 11:00 A.M. on 2/15/19. Anesthesiologist #3 said the Operating Rooms (outpatient operating rooms) did not have a copy of the Anesthesia Services Policies & Procedure Manual. Anesthesiologist #3 said that they used the Anesthesia Policies & Procedures on the Hospital system computer.

Anesthesia Services Policy & Procedure Manual, dated 9/2018, indicated an anesthesia policy titled Resuscitation Orders, undated, with content guidelines for Do Not Resuscitate (DNR) orders that had references dated 1981 and 1988.

Hospital policy titled DNR, dated 10/1/17, indicated a Hospital wide policy for Do Not Resuscitate orders with different content to the Anesthesia Services DNR policy.

Anesthesia Services Policy & Procedure Manual, dated 9/2018, indicated an anesthesia policy titled [DIAGNOSES REDACTED] Suspect Patient and the Hospital had a Hospital wide policy titled [DIAGNOSES REDACTED] Emergency, dated 8/7/18.

Anesthesia Services Policy & Procedure Manual, dated 9/2018, indicated an Anesthesia policy titled Blood and Blood Component Transfusion with references dated 1987 and 1999; and the Hospital had a Hospital wide policy titled Criteria For Transfusion, dated 1/24/19.

B.) The Surveyor interviewed the Director of Risk Prevention at 10:35 A.M. on 2/15/19. The Director of Risk Prevention said Anesthesia Services administered per-medications according to a Hospital algorithm and the Director of Risk Prevention said that Anesthesia did not follow this algorithm for pre-medication.

Contrast Medium (IV or Oral) Allergy Pre-Medication Algorithm, dated 3/18/14, indicated a guideline used in the Radiology Department. The Algorithm indicated intravenous steroids had not been shown effective when administered less than 4-6 hours prior to the contrast (medication) injection. The algorithm did not indicate guideline for pre-medications for anesthesia.

The Pre-Medication Administration Record, regarding Patient #1, indicated Patient #1 received Benadryl at 12:11 P.M. and Solucortef (steroid medication) at 12:12 P.M. on 8/28/18.

The Anesthesia Summary, dated at 12:19 P.M. on 8/28/18, indicated Patient #1's anesthesia started.
VIOLATION: PATIENT SAFETY Tag No: A0286
QAPI activities failed to ensure that Anesthesia Services implemented anesthesia education related to anaphylaxis by the time of the Survey.

Findings included:

The Surveyor interviewed the Director of Risk Prevention at 11:00 A.M. on 2/8/19. The Director of Risk Prevention said that Physicians' review process identified an opportunity for improvement that included education regarding allergic reactions and she did not know if the Physicians' review process implemented the education.

The Surveyor interviewed the Anesthesia Chief at 10:30 A.M. on 2/12/19. The Anesthesia Chief said Physicians assumed Patient #1's event during the surgery was related to his/her heart and may be an allergic reaction to anesthesia medications or antibiotics.

The Hospital provided no documentation of implementation of physician education regarding anesthesia medications and allergic reactions.