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.

SOUTHCOAST HOSPITALS GROUP 363 HIGHLAND AVENUE FALL RIVER, MA 02720 Jan. 17, 2020
VIOLATION: LICENSURE OF PERSONNEL Tag No: A0023
Based on record review and interviews for five of five Surgical First Assistants, the Hospital failed to assure that seven (7) Surgical Technologist Certified First Assistants (STFA) were licensed to provide surgical services within the State. Findings included:

State Hospital Licensure Law found at 105 CMR 130.860 described a surgical technologist as any person who provided surgical technology services who was not licensed or registered under M.G.L. c. 112, 2, 16, 74 or 74A or who was not an intern, resident, fell ow or medical officer who conducted or assisted with the performance of surgery. The category of Certified Surgical Technologists First Assistants was not recognized in the Commonwealth of Massachusetts State Hospital Licensure Law.

The documents titled Job Descriptions for STFA, OB/GYN, Surgical Technologist-First Assistant, Registered Nurse-First Assistant, undated, indicated duties included:

-providing first assistance to the primary surgeon during surgical incision, excision and repair of pathology throughout the perioperative period,

-performing duties by applying the appropriate tissue dissection techniques, implementing tissue handling techniques based on the assessment of tissue location type and health status, providing exposure to operative site; suction surgical site as necessary to remove smoke, blood and fluids from the site to improve visualization and decrease biohazard; preserve homeostasis during tissue manipulation,

-responsible for selecting the appropriate suture material based on the type of closure and use of appropriate suturing techniques for specific wound, demonstrate proficiency in knot-tying techniques.

During an interview on 1/17/2020 at 11:00 A.M., the Director of Perioperative Services (a Registered Nurse) said that the Hospital employed seven Surgical Technologists as First Assistants. The Director of Perioperative Services said the Surgical Technologist First Assistants do not cut skin and could suture (close) superficial skin. The Director of Perioperative Services said that the Surgical Technologist First Assistants do not suture a uterus (womb). The Director of Perioperative Services said that the Surgical Technologist First Assistants do not go through the Provider (Medical Staff) credentialing process.

During an interview on 1/17/2020 at 12:15 P.M., STFA #1 said responsibilities included cutting a newborns umbilical cord and suturing skin. STFA #1 said responsibilities included observation of hemostasis (patient not bleeding) with the surgeon.

During an interview on 1/17/2020 at 1:45 P.M., the Chief of Surgical Services said the Surgical Technologist First Assistants do not close fascia (connective tissue beneath the skin) or cut tissue. The Chief of Surgical Services said he did not know how the Surgical Technologists First Assistants or Registered Nurse First Assistants were credentialed for competency and privileges.

During an interview on 1/17/2020 at 2:00 P.M., STFA #2 said he cuts skin to extend fascia sutures fascia with the direction of the surgeon.

During an interview on 1/17/2020 at 2:30 P.M., the Risk Services Vice President said that the Surgical Technologists and the Registered Nurse were not credentialed through the Medical Staff process as Surgical First Assistants.

Medical Record review indicated that with four patients (Patients #1, #3, #5 & #10), a Surgical Technologist First Assistant assisted the surgeon.

Review of Patient #1's Medical Record Cesarean section Operative Report, dated 9/6/19, indicated Surgical Technologist First Assistant #1 assisted the surgeon.

Review of Patient #3's Medical Record Cesarean section Operative Report, dated 11/23/19, indicated Surgical Technologist First Assistant #2 assisted the surgeon.

Review of Patient #5's Medical Record Cesarean section Operative Report, dated 8/28/18, indicated Surgical Technologist First Assistant #1 assisted the surgeon.

Review of Patient #10's Medical Record Cesarean section Operative Report, dated 8/26/19, indicated Surgical Technologist First Assistant #1 assisted the surgeon.
VIOLATION: MEDICAL STAFF - ACCOUNTABILITY Tag No: A0049
Based on records reviewed and interviews for five of five Surgical Tech First Assistants (STFA), the Governing Body failed to determine delineation of privileges for five STFAs and one Registered Nurse First Assistant to ensure that the medical staff was accountable for the quality of care provided to patients by these practitioners.
Findings included:

State Hospital Licensure Law found at 105 CMR 130.860 described a surgical technologist as any person who provided surgical technology services who was not licensed or registered under M.G.L. c. 112, 2, 16, 74 or 74A or who was not an intern, resident, fell ow or medical officer who conducted or assisted with the performance of surgery. The category of Certified Surgical Technologists First Assistants was not recognized in the Commonwealth of Massachusetts State Hospital Licensure Law.

The document titled Advisory Ruling on Nursing Practice, dated 6/14/19, indicated the Massachusetts Board of Registration in Nursing recognized registered nurses as First Assistants in Surgery through additional, extensive education and training practices in collaboration with and interdependently with a surgeon licensed in the Commonwealth of Massachusetts.

Medical Staff Bylaws and Rules & Regulations, dated 11/19/14, indicated no documentation of credentialing or delineation of privileges based on competencies for Registered Nurse First Assistant or for the STFAs. The Medical Staff Bylaws and Rules & Regulations indicated no documentation that Certified Surgical Technologists/Surgical First Assistants were approved as surgical practitioners in the Hospital. The STFA's were not privileged or approved to provide surgical services beyond the scope of a surgical technician to Hospital patients, in accordance with State Law.

The documents titled Job Descriptions for Surgical Technician, First Assist, OB/GYN, Surgical Technologist-First Assistant, Registered Nurse-First Assistant, undated, indicated duties included:

-providing first assistance to the primary surgeon during surgical incision, excision and repair of pathology throughout the perioperative period,

-performing duties by applying the appropriate tissue dissection techniques, implementing tissue handling techniques based on the assessment of tissue location type and health status, providing exposure to operative site; suction surgical site as necessary to remove smoke, blood and fluids from the site to improve visualization and decrease biohazard; preserves homeostasis during tissue manipulation,

-responsible for selecting the appropriate suture material based on the type of closure and use of appropriate suturing techniques for specific wound, Demonstrate proficiency in knot-tying techniques.

During an interview on 1/17/2020 at 11:00 A.M., the Director of Perioperative Services (a Registered Nurse) said that the Hospital employed seven Surgical Technologists as First Assistants. The Director of Perioperative Services said the Surgical Technologist First Assistants do not cut skin and could suture (close) superficial skin. The Director of Perioperative Services said that the Surgical Technologist First Assistants do not suture a uterus (womb). The Director of Perioperative Services said that the Surgical Technologist First Assistants do not go through the Provider (Medical Staff) credentialing process.

During an interview on 1/17/2020 at 12:15 P.M., Surgical Technologist First Assistant #1 said responsibilities included cutting a newborns umbilical cord and suturing skin. Surgical Technologist First Assistant #1 said responsibilities included observation of hemostasis (patient not bleeding) with the surgeon.

During an interview on 1/17/2020 at 1:45 P.M., the Chief of Surgical Services (a Physician) said the Hospital had one Registered Nurse First Assistant. The Chief of Surgical Services said the Surgical Technologist First Assistants and the Registered Nurse First Assistant do not close fascia (connective tissue beneath the skin) or cut tissue. The Chief of Surgical Services said he did not know how the Surgical Technologists or Registered Nurses were given privileges to perform surgery as first assistants.

During an interview on 1/17/2020 at 2:00 P.M., Surgical Technologist First Assistant #2 said he cuts skin to extend fascia with the direction of the surgeon and sutures fascia with the direction of the surgeon.

During an interview on 1/17/2020 at 2:30 P.M., the Risk Services Vice President said that the Surgical Technologists and the Registered Nurse were not credentialed through the Medical Staff process as Surgical First Assistants.

Medical Record review indicated that with four patients (Patients #1, #3, #5 & #10), a Surgical Technologist First Assistant assisted the surgeon.

Review of Patient #1's Medical Record Cesarean section Operative Report, dated 9/6/19, indicated Surgical Technologist First Assistant #1 assisted the surgeon.

Review of Patient #3's Medical Record Cesarean section Operative Report, dated 11/23/19, indicated Surgical Technologist First Assistant #2 assisted the surgeon.

Review of Patient #5's Medical Record Cesarean section Operative Report, dated 8/28/18, indicated Surgical Technologist First Assistant #1 assisted the surgeon.

Review of Patient #10's Medical Record Cesarean section Operative Report, dated 8/26/19, indicated Surgical Technologist First Assistant #1 assisted the surgeon.
VIOLATION: QAPI Tag No: A0263
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

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

Findings included:

1.) Hospital Quality Assessment & Performance Improvement (QAPI) activities failed for one (Patient #1) patient of 11 patients sampled to ensure analysis and evaluation of obstetric processes of care, Hospital obstetric service and operations following Patient #1's unexpected death.

Refer to TAG: A-0273.

2.) Hospital QAPI activities failed to implement opportunities for improvement regarding hypertension in pregnancy that could lead to preeclampsia (toxemia of pregnancy), preeclampsia could lead to [DIAGNOSES REDACTED] (a life-threatening condition that occurs in pregnant women, characterized by Hemolysis (destruction of red blood cells), Elevated Liver enzymes and Low Platelet count. Activation of the coagulation cascade is considered a cause. Hypertension, bleeding, edema, abdominal tenderness, headache, and nausea are the common symptoms) and [DIAGNOSES REDACTED] could lead to Disseminated Intravascular Coagulation, (DIC, a life-threatening condition of widespread blood clotting (coagulation) throughout the body's small blood vessels and the most common cause of an abnormal hemorrhage tendency during pregnancy. DIC is an emergency in pregnant women as it can lead to bleeding, organ failure and death because of the depletion of platelets and blood clotting factors. DIC is a complication of childbirth or surgery where its presence in a pregnant patient invariably is evidence of an underlying obstetric disorder) and maternal death. Hospital QAPI activities failed to implement opportunities for improvement regarding maternal opioid use disorder.

Refer to TAG: A-0283.

3.) Hospital Executives failed to ensure Quality Assessment and Performance Improvement resources conducted a Root Cause Analysis (RCA, a processes for identifying causal factor(s) that underlie variation in performance, including the occurrence of a death as a sentinel event) in accordance with Hospital policy.

Refer to TAG: A-0309.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on records reviewed and interviews the Hospital Quality Assessment & Performance Improvement (QAPI) activities failed for one (Patient #1) patient of 11 patients sampled to ensure analysis and evaluation of obstetric processes of care, Hospital obstetric service and operations following Patient #1's unexpected death.

Findings included:

The Hospital policy titled Sentinel Event Review and Reporting, dated 11/12/19, indicated that a sentinel event would be analyzed by the Root Cause Analysis process and implementation of an appropriate action plan would be monitored by the committees responsible for the quality improvement. The Sentinel Event Review and Reporting Policy indicated that a Root Cause Analysis was a process for identifying the most basic or causal factor(s) that underlie variation in performance, including the occurrence of a death as a sentinel event. The Sentinel Event Review and Reporting Policy indicated a Sentinel Event Review Team would be gathered to conduct a Root Cause Analysis within 30 days of the sentinel event and for events considered serious enough to warrant intensive review.

The History and Physical Examination, dated at 5:29 P.M. on 9/4/19, indicated the Physician's impression was that Patient #1 had preeclampsia (a pregnancy complication characterized by high blood pressure and signs of damage to another organ system), elevated blood pressures and swelling with a plan to admit Patient #1 to the Hospital for induction of labor to avoid potential severe morbidity developing preeclampsia.

The Discharge Summary, dated at 3:19 A.M. on 9/7/19, indicated Patient #1's Hospital course included an induction of labor and a Caesarean section for arrest of descent (baby did not descend through the birth canal). The Discharge Summary indicated Patient #1 had low blood pressures, a high heart rate and unresponsiveness requiring emergency resuscitation and massive blood transfusions postoperatively. The Discharge Summary indicated Patient #1 returned to the Operating Room and underwent a hysterectomy for bleeding and there was an abdominal hematoma (blood clot) with bleeding from many sites. The Discharge Summary indicated Patient #1 was transferred to the Intensive Care Unit where Patient #1 died .

During an interview on 11/20/19 at 3:30 P.M., Risk Manager #1 said that the Hospital Investigation (Root Cause Analysis, RCA) was not conducted by the time of the Survey because the Hospital wanted the Peer-Review (Physician review) completed and Patient #1's autopsy results prior to conducting the RCA. Risk Manager #1 said that RCAs were usually conducted earlier; however, the new Executive Director of the Maternal Child Service wanted to conduct the RCA. Risk Manager #1 said that the RCA was not scheduled (at the time of the Survey on 11/20/19) and that Patient #1 died on [DATE] (two months after Patient #1's death).

2.) Regarding Patient #1's autopsy analysis.

Patient #1's autopsy, dated 9/11/19, indicated Patient #1 had cardiomegaly (almost twice the weight of a normal heart) and hepatomegaly (almost twice the weight of a normal liver).

During an interview on 11/20/19 at 11:30 A.M., the Chief of Obstetrics said that Patient #1's autopsy did not offer much.

During an interview on 12/4/19 at 1:30 P.M., the Chief Medical Officer said that Patient #1 had [DIAGNOSES REDACTED] (chronic disease of the heart muscle) and that Patient #1's heart was twice the normal size..
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on records reviewed and interviews the Hospital Quality Assessment & Performance Improvement (QAPI) activities failed for two (Patients #1 & #2) patients of 11 patients sampled to ensure opportunities for improvement were identified.

Findings included:

1.) Hospital QAPI activities failed to implement opportunities for improvement regarding hypertension in pregnancy that could lead to preeclampsia (toxemia of pregnancy), preeclampsia could lead to [DIAGNOSES REDACTED] (a life-threatening condition that occurs in pregnant women, characterized by Hemolysis (destruction of red blood cells), Elevated Liver enzymes and Low Platelet count. Activation of the coagulation cascade is considered a cause. Hypertension, bleeding, edema, abdominal tenderness, headache, and nausea are the common symptoms) and [DIAGNOSES REDACTED] could lead to Disseminated Intravascular Coagulation, (DIC, a life-threatening condition of widespread blood clotting (coagulation) throughout the body's small blood vessels and the most common cause of an abnormal hemorrhage tendency during pregnancy. DIC is an emergency in pregnant women as it can lead to bleeding, organ failure and death because of the depletion of platelets and blood clotting factors. DIC is a complication of childbirth or surgery where its presence in a pregnant patient invariably is evidence of an underlying obstetric disorder) and maternal death.

Regarding Patient #1:

The article titled, The painful truth about maternal deaths, from the Association of American Medical Colleges at https://www.aamc.org/, indicated the leading causes of maternal death range broadly, from hemorrhage and cardiovascular (heart) conditions to infection and drug overdose.

The article titled, What are some common complications of pregnancy?, https://www.nichd.nih.gov/health/topics/pregnancy/conditioninfo/complications, indicated common complications of pregnancy included high blood pressure, gestational diabetes, infections and preeclampsia.

The article titled Preeclampsia, Pathophysiology, Challenges, and Perspectives, https://www.ahajournals.org/doi/pdf/10.1161/CIRCRESAHA.118. 6, indicated hypertensive disorders of pregnancy included chronic hypertension, gestational hypertension, and preeclampsia. The article indicated preeclampsia was one of the most feared complications of pregnancy and that preeclampsia could progress rapidly to serious complications, including death of both mother and fetus.

The article titled Preeclampsia, Updates in Pathogenesis Definitions, and Guidelines, Clinical Journal of the American Society of Nephrology 2016 Jun 6; 11(6): 1102-1113, indicated preeclampsia was a hypertensive (high blood pressure) disorder of pregnancy. The Article indicated the disorder was not fully understood and thought to be a defect of the baby's placenta attachment to the mother's uterus (womb) causing placental ischemia (inadequate blood supply) causing endothelial (cells that line blood vessels) damage in the mother. The Article indicated endothelial dysfunction may result in blood vessel constriction and reduced blood to multiple maternal organs, including the heart, kidney, and brain.

The article titled Disseminated intravascular coagulation in the [DIAGNOSES REDACTED]: how much do we really know?; The Journal of Maternal-Fetal & Neonatal Medicine, Volume 30, 2017 - Issue 7 as https://www.ncbi.nlm.nih.gov/pubmed/ 089, indicated preeclampsia and [DIAGNOSES REDACTED] were prevalent causes of DIC and one of the leading causes was postpartum hemorrhage.

The article titled Disseminated Intravascular Coagulation (DIC) in pregnancy, https://www.ncbi.nlm.nih.gov/m/pubmed/ 2/, indicted the DI[DIAGNOSES REDACTED] was the most common cause of an abnormal hemorrhage tendency during pregnancy and the puerperium (six weeks postpartum). Its presence in a pregnant patient invariably was evidence of an underlying obstetric disorder such as[DIAGNOSES REDACTED] (convulsions occur in a pregnant woman suffering from high blood pressure) resulting in massive bleeding. Treatment consisted of prompt removal of the source of procoagulant material (delivery of the baby) and blood transfusions.

The History and Physical Examination, dated at 5:29 P.M. on 9/4/19 indicated the Physician's impression was that Patient #1 had preeclampsia, elevated blood pressures and swelling.

A laboratory report dated 9/6/19 at 12:45 P.M., indicated Patient #1 had elevated liver enzymes.

The Discharge Summary, dated 9/7/19 at 3:19 A.M. indicated Patient #1's blood tests were consistent with the DIC that was clinically evident (extreme coagulopathic, bleeding). The Discharge Summary indicated Patient #1 died .

Regarding Maternal Warning Signs:

The document titled Implementing Obstetric Early Warning Systems, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC 60/, indicated severe maternal morbidity and mortality are often preventable and obstetric early warning systems that alert care providers of potential impending critical illness may improve maternal safety. The document indicated Maternal Early Warning Systems were efforts to incorporate quality improvement efforts for obstetric hemorrhage, severe hypertension, that identified vital sign triggers and vital sign abnormalities, such as tachycardia (heart rate greater than 100 beats per minute), hypotension and other life-threatening conditions.

During an interview on 11/20/19 at 11:30 A.M., the Chief of Obstetrics and the Obstetric Nurse Manager said that the Maternity Units did not use Maternal Early Warning Signs.

During an interview on 11/21/19 at 12:00 P.M., the Maternity Nurse Director said that the Maternity Units did not use early warning signs because their electronic medical record computer system did not have a Maternal Early Warning System and the Hospital was deciding what to build it into the electronic medical record computer system.

Review of Patient #1's medical record indicate Patient #1 frequently was tachycardic (a heartbeat ranged from 104 beats per minute at 10:53 P.M. on 9/6/19 to 165 beats per minute at 2:55 P.M. on 9/6/19).

Regarding Quantitative Blood Loss:

The article from the Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN) titled Quantification of Blood Loss: AWHONN Practice Brief Number 1, at https://www.jognn.org/article/S0884-2175(15) -8/abstract and dated 2014, indicated AWHONN recommended cumulative blood loss be formally measured or quantified after every birth.

During an interview on 11/20/19 at 11:30 A.M., Obstetric Nurse Manager said that the Maternity Units were not quantifying maternal blood loss.

During an interview on 11/21/19 at 12:00 P.M., the Maternity Nurse Director said that the Maternity Units were not quantifying maternal blood loss and were planning to implement quantitative blood loss measurements. The Maternity Nurse Director said she did not know when the Hospital would be implementing quantitative blood loss.

Medical Record review indicated that seven (Patients #1, #3, #4, #5, #8, #10 & #11) patients of seven patients sampled who underwent a Cesarean section had blood loss estimated.

Cesarean section Operative Report, dated 9/6/19, indicated Patient #1 had an estimated blood loss of 500 milliliters.

Cesarean section Operative Report, dated 11/23/19, indicated Patient #3 had an estimated blood loss of 400 milliliters.

Cesarean section Operative Report, dated 7/13/19, indicated Patient #4 had an estimated blood loss of 500 milliliters.

Cesarean section Operative Report, dated 8/28/18, indicated Patient #5 had an estimated blood loss of 500 milliliters.

Cesarean section Operative Report, dated 6/2/19, indicated Patient #8 had an estimated blood loss of 500 milliliters.

Cesarean section Operative Report, dated 8/26/19, indicated Patient #10 had an estimated blood loss of 500 milliliters.

Cesarean section Operative Report, dated 12/4/19, indicated Patient #11 had an estimated blood loss of 800 milliliters.

2.) Hospital QAPI activities failed to implement opportunities for improvement regarding maternal opioid use disorder.

Regarding Patient #2:

The article titled, The painful truth about maternal deaths, from the Association of American Medical Colleges at https://www.aamc.org/, indicated a leading cause of maternal death as drug overdose.

The Massachusetts Department of Public Health's Circular Letter, dated 5/9/13, indicated that screening of all pregnant women for alcohol and substance use disorders should occur at the beginning of pregnancy, at 28 weeks and at the time a women presents for delivery though interviews using a standard tool.

The American College of Obstetricians and Gynecologists (ACOG) opinion, dated August 2017, reaffirmed in 2019, indicated routine screening for pregnant women with opioid use disorder should be part of comprehensive obstetric care which include screening, brief interventions and referral for treatment.

A.) During an interview on 12/4/19 at 11:00 A.M., the Executive Director of Clinical Integrated Care Services said that the Hospital's Social Workers working in the Family Centered Unit do not use a screening tool for pregnant women with substance use disorders and that improvements could be made in that area.

Patient #2's History and Physical Examination, dated 11/12/19 at 9:31 A.M., indicated she was admitted on [DATE] in active labor to the Labor and Delivery Unit. The History and Physical Examination indicated Patient #2 had no known prenatal care. The History and Physical Examination indicated Patient #2 had a history of alcohol abuse and was diagnosed with [DIAGNOSES REDACTED].

Patient #2's treatment plan, dated 11/12/19, at the time of admission, documented in her History and Physical Examination by the attending physician, included to contact social service postpartum as Patient #2 wished to give her infant up for adoption.

The Social Worker's note, dated 11/12/19 at 3:11 P.M., indicated the Social Worker discussed with Patient #1 filing a report of alleged child abuse and neglect regarding alcohol and substance use disorder.

The Social Worker's note, dated 11/12/19 at 4:44 P.M., indicated Patient #1 met with an Investigator (non-hospital employee) regarding abuse and neglect allegation.

The Social Worker's note, dated 11/13/19 at 11:04 A.M., indicated the Social Worker spoke with Patient #2 about the custody of her infant.

The Social Worker's note, dated 11/13/19 at 12:40 P.M., indicated Patient #2 declined any substance abuse or mental health resources from the Investigator (non-hospital employee).

The Social Worker's note, dated 11/14/19 at 1:28 P.M., indicated the Social Worker met with Patient #2 regarding the infant's status.

Patient #2's Discharge Plan, dated 11/15/19 at 10:27 A.M., indicated that no coordinated discharge planning needs regarding opioid abuse was identified.

The Nurse's Note, dated 11/15/19 at 7:47 A.M., indicated Patient #2 was unwilling to speak to anyone regarding the infant she just gave birth to or a staff person from an alcohol and drug rehabilitation service.

The Social Worker's Notes and the Nurse's Note indicated no documentation to indicate that the Hospital provided Patient #2 with a referral for treatment for substance use disorder in accordance with standards of care for opioid use.

B.) The Nursing Admission Assessment, dated 11/12/19 at 9:12 A.M., indicated physical, verbal and sexual abuse. The Nursing Admission Assessment indicated no documentation to indicate nursing interventions regarding the physical, verbal or sexual abuse.

The Social Worker's note, dated 11/12/19 indicated no documentation of interviews with Patient #2 using a standardized tool for women with a history significant for alcohol of substance use disorder in accordance with the Massachusetts Department of Public Health's Circular letter dated 5/9/13.

During and interview on 12/5/19 at 7:45 A.M., Maternity Nurse Manager #1 said that the Maternity Units did not use a universal tool for maternal opioid screening.
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on records reviewed and interviews Hospital Executives failed to ensure:

A.) Quality Assessment and Performance Improvement resources to conduct a Root Cause Analysis (RCA, a processes for identifying causal factor(s) that underlie variation in performance, including the occurrence of a death as a sentinel event) in accordance with Hospital policy and

B.) They determined First Assistant Medical Staff privileges as specified in the Medical Staff Bylaws, Rules, and Regulations in accordance with State Law.

Findings included:

A.) Regarding RCA:

The Hospital policy titled Sentinel Event Review and Reporting, dated 11/12/19, indicated that a Sentinel Event Review Team would be gathered to conduct an RCA within 30 days of the sentinel event to analyze and implement an appropriate action plan.

During an interview on 11/20 19 at 3:30 P.M., Risk Manager #1 said that the Hospital Investigation (Root Cause Analysis, RCA) was not conducted by the time of the Survey.

During an interview on 11/21/19 at 12:00 P.M., the Maternity Nurse Director said that she needed more direction from the Hospital in conducting an RCA because she had no experience in conducting an RCA.

The Hospital provided no documentation to indicate the Hospital initiated a plan to conduct the RCA or implement resources to facilitate the RCA process, following Patient #1's death on 9/7/19 by the time of the Survey on 11/20/19.

B.) Regarding First Assistants:

State Hospital Licensure Law found at 105 CMR 130.860 described a surgical technologist as any person who provided surgical technology services who was not licensed or registered under M.G.L. c. 112, 2, 16, 74 or 74A or who was not an intern, resident, fell ow or medical officer who conducted or assisted with the performance of surgery. The category of Certified Surgical Technologists First Assistants was not recognized in the Commonwealth of Massachusetts State Hospital Licensure Law.

The document titled Advisory Ruling on Nursing Practice, dated 6/14/19, indicated the Massachusetts Board of Registration in Nursing recognized Registered Nurses as First Assistants at Surgery, through additional, extensive education and training practices in collaboration with and interdependently with a surgeon licensed in the Commonwealth of Massachusetts.

Medical Staff Bylaws and Rules &Regulations, dated 11/19/14, indicated no documentation of credentialing or privileging procedures for Registered Nurse First Assistants in accordance with State Law. The Medical Staff Bylaws and Rules &Regulations indicated no documentation that Certified Surgical Technologists/Surgical First Assistants were approved as surgical practitioners in the Hospital nor were they privileged to provide surgical services beyond the scope of a surgical technician to Hospital patients, in accordance with State Law.

During an interview on 1/17/2020 at 2:30 P.M., the Risk Services Vice President said that the Surgical Technologists and the Registered Nurse were not credentialed through the Medical Staff process as Surgical First Assistants.

Medical Record review indicated that with four (Patients #1, #3, #5 & #10) patient's procedures, a Surgical Technologist First Assistant assisted the surgeon.