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.

HEALTH ALLIANCE - CLINTON HOSPITAL 60 HOSPITAL ROAD LEOMINSTER, MA 01453 Nov. 21, 2018
VIOLATION: QAPI Tag No: A0263
The Hospital was out of compliance with the Condition of Participation of Quality Assessment & Performance Improvement (QAPI) Program.

Findings included

Hospital QAPI activities failed for one (Patients #1) of ten sampled patients to ensure a thorough investigation and analysis of clinical data obtained before Patient #1's cardiovascular arrest and autopsy results after Patient #1's unexpected death.

Refer to TAG: A-0273.

Hospital QAPI activities failed for five (Patients #1, #7, #8, #9 & #10) of ten sampled patients to ensure identification and implementation of opportunities for improvement regarding: 1.) Maternal blood loss after Patient #1's unexpected death, 2.) A process to identify perinatal infections and 3.) A process for obtaining actual patient weights.

Refer to TAG: A-0283.

Hospital QAPI activities failed for one (Patient #1) of ten sampled patients to ensure implementation of identified corrective actions regarding the Hospital's emergency code program improvements after Patient #1's unexpected death and prior to the Survey.

Refer to TAG: A-0286.

Hospital Executives failed for one (Patient #1) of ten sampled patients to ensure corrective actions were implemented after Patient #1's unexpected death.

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, Hospital Quality Assessment & Performance (QAPI) activities failed for one patient (Patient #1) of ten sampled patients to ensure a thorough investigation and analysis of clinical data obtained before Patient #1's cardiovascular arrest and autopsy results after Patient #1's unexpected death.

Findings included:

The Patient Demographics indicated Patient #1 (MDS) dated [DATE] at 7:16 P.M. and diagnosed with [DIAGNOSES REDACTED]

The Emergency Department Provider Note, dated 8/12/18 at 7:16 P.M., indicated Patient #1 with an elevated heart rate of 136 and an elevated white blood cell count of 11.2 (reference range was 4.3-10.8), a low potassium blood level of 3, a low magnesium blood level of 1.5, a high urine glucose (sugar) count and a high blood sugar count of 134 (possible sign of diabetes). The Emergency Department Provider Notes, dated 8/12/18, indicated no documentation of a change in plan regarding Patient #1's abnormal ECG and low potassium level (a low potassium level may be caused by vomiting and diarrhea and a low potassium level may cause abnormal heart beats).

The Problem List indicated Patient #1 had a medical history of [DIAGNOSES REDACTED]

The Results History, dated 8/12/18 at 10:36 P.M. & 8/13/18 at 5:00 A.M. indicated Patient #1's electrocardiogram (ECG) as abnormal with a fast heart rate of 135 and possible inferior myocardial infarction (a heart attack of undetermined age).

The History & Physical, dated 8/13/18 at 1:19 A.M., indicated the Hospital admitted Patient #1 to Labor & Delivery for an incomplete miscarriage.

The Nursing Flow Sheets, dated 8/12/18 through 8/13/18, indicated Patient #1's heart rate was fast and ranged from 120-136 beats per minute. The Nursing Flow Sheets indicated Patient #1 had a high blood pressure of 155/83 on presentation to the Emergency Department and 107/61 at 2:30 A.M. on 8/13/18 before the procedure.

The Operative Note, dated 8/13/18 at 4:36 A.M., indicated Patient #1 tolerated a procedure for a retained placenta "well." (However, review of documentation included that Patient #1 arrested and died at the end of the procedure on the operating table.)

The Anesthesia Encounters, dated at 4:58 A.M. on 8/13/18, indicated the Anesthesiologist used a laryngeal mask airway (LMA, a medical device) for Patient #1's procedure. The Anesthesia Encounters indicated Patient #1's End-Tidal Carbon dioxide (ETCO2, a device to monitor ventilation, breathing) level as low, with a value of 16 at 4:45 A.M. through 5:00 A.M. on 8/3/18. The Anesthesia Encounters indicated the Anesthesiologist administered Ketorolac (pain medication) just prior to Patient #1's arrest. Anesthesia Encounter indicated Patient #1 coughed and had massive aspiration of bile through the Laryngeal Mask Airways (LMA) at 4: 58 A.M., the Anesthesiologist removed the LMA and intubated Patient #1 with a breathing tube, Patient #1 had breath sounds in both lungs (breathing tube placed correctly) and that the ETCO2 was low.

The Code Blue Worksheet indicated resuscitation started at 5:07 A.M. on 8/13/18.

Review of the Anesthesia Documentation, dated 8/13/18, indicated Patient #1 arrested during replacement of a breathing tube and, after attempting resuscitation by the code team, the physician pronounced Patient #1 dead.

The Autopsy Report, dated 8/13/18, indicated coronary arteries with chronic inflammation, no thickening and no evidence of a heart attack. The Autopsy Report indicated the cause of the fetal demise was most likely from chorioamnionitis (an infection of the fetal membranes due to a bacterial infection). The Autopsy Report indicated it could not exclude cardiac arrhythmias (abnormal heart beats) and metabolic (chemical processes in the body) abnormalities. The Autopsy Report indicated Patient #1's liver showed centrilobular microvesicular steatosis (liver injury) possibly due to pregnancy or a drug reaction.

The Surveyor interviewed Patient Safety Specialist #1 & #2, on 11/7/18 at 11:30 A.M. Patient Safety Specialist #1 & #2 said Patient #1 presented to the Emergency Department at 16 weeks pregnant because Patient #1 thought the baby was delivering. Patient #1 had constant heartburn, vomiting and diarrhea. In the Emergency Department Patient #1 received an electrocardiogram (ECG) that was abnormal, a pelvic ultrasound that revealed the baby was well, intravenous fluids, and an antibiotic for a urinary tract infection. Blood tested to have a low potassium blood level and Patient #1 was stable for discharge. Patient Safety Specialist #1 & #2 said as Patient #1 prepared for discharge she began cramping and delivered a stillborn infant; however, the placenta did not deliver and the Hospital admitted Patient #1 to the Labor & Delivery Unit. Patient Safety Specialist #1 & #2 said Patient #1 had a surgical procedure to remove the retained placenta. Patient Safety Specialist #1 & #2 said at the end of the procedure Patient #1 coughed, vomited, the anesthesiologist reinserted the breathing tube for decreased breath sounds, her heartbeat declined to 30 beats per minute, noted to be without a heartbeat and after resuscitative efforts, Patient #1 died .

The Surveyor interviewed the Chief Medical Officer on 11/7/18 at 2:00 P.M. The Chief Medical Officer and Patient Safety Specialist #1 & #2 said that the Hospital investigation did not analyze Patient #1's abnormal ECG and low potassium level. The Chief Medical Officer said that the Hospital investigation did not consider Patient #1's abnormal ECG was an issue, Patient #'1 fast heartbeat was because she was stressed, it did not come up as a cardiac event and Patient #1's clinical picture [DIAGNOSES REDACTED]

The Surveyor interviewed Anesthesiologist #1 on 11/8/18 at 11:00 A.M. Anesthesiologist #1 said a low End-Tidal Carbon Dioxide level (ETCO2, normal 34-38) indicated either that a patient's endotracheal (breathing) tube was incorrectly placed or a change in the patient's cardiovascular status or both.

The Surveyor interviewed Patient Safety Specialist #2 and the Risk Management Director on 11/9/18 at 10:40 P.M. Patient Safety Specialist #2 said there was no analysis of chorioamnionitis or any other analysis of differential (different) diagnoses (related to Patient #1's low potassium level). Patient Safety Specialist #2 and the Risk Management Director said the Hospital investigation did not discuss infectious disease (infections) regarding Patient #1. Patient Safety Specialist #1 and the Risk Management Director said that Patient #1's autopsy results were not available at the time the Hospital conducted their investigation on 8/16/18 regarding Patient #1's unexpected death. Patient Safety Specialist #1 and the Risk Management Director said Patient # 1's autopsy results indicated Patient #1 did not have cardiac involvement (heart attack) and that the Hospital did not conduct further discussion or evaluation regarding Patient #1's autopsy results.

The Hospital provided no indication that QAPI activities analyzed the autopsy finding that the fetal demise was most likely from chorioamnionitis. The Hospital provided no indication that the autopsy finding analyzed a potential relationship to Patient #1's clinical deterioration and death. The Hospital provided no indication that QAPI activities analyzed the autopsy finding that Patient #1's liver showed liver injury and its possible relationship to the administration of Ketorolac just prior to Patient #1's arrest. The Hospital provided no indication that QAPI activities analyzed the practice of Anesthesia using an LMA for a patient (Patient #1) at risk for aspiration, who was pregnant and obese.
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 (QAPI) activities failed for five (Patients #1, #7, #8 #9 & #10) of ten sampled patients to ensure identification and implementation of opportunities for improvement regarding:

1.) Maternal blood loss after Patient #1's unexpected death,

2.) A process to identify perinatal infections, and

3.) A process for obtaining actual patient weights.

Findings included:

1.) Regarding Hospital QAPI activities failure to identify and implement opportunities for improvement regarding maternal blood loss, after Patient #1's unexpected death.

The Association of Women's Health, Obstetric and Neonatal Nursing (AWHONN, Obstetric Professional Organization) Postpartum Hemorrhage Project, dated 2017, indicated maternal postpartum hemorrhage as a leading cause of pregnancy-related complication. The AWHONN Nursing Practice Brief, dated 2014, indicated women die from obstetric hemorrhage because effective interventions were not initiated early enough. The AWHONN Nursing Practice Brief indicated the use of visual estimated blood loss could result in under estimation of blood loss by 33-50%. The AWHONN Nursing Practice Brief indicated that they recommended cumulative blood loss be formally measured or quantified after every birth.

The Hospital policy titled Obstetrics Hemorrhage Protocol, dated 9/28/16, indicated if the total blood loss was over 1500 milliliters blood transfusions were implemented. The Protocol included no information to indicate measuring the blood loss as estimated or quantitative.

The Surveyor interviewed the Obstetric Nurse Director at 10:00 A.M. on 11/7/18. The Obstetric Nurse Director said staff used their best judgement to estimate maternal blood loss and measured blood loss for postpartum hemorrhage patients.

The Surveyor interviewed the Labor & Delivery Registered Nurse #2 and the Obstetric Nurse Director during the Medical Record Review at 11:30 A.M. on 11/9/18. Labor & Delivery Registered Nurse #2 said that doctors estimated Patient #1's blood loss from the suction machine.

Medial Record Review indicated five of five patients (Patients #1, #7, #8, #9 & #10) with obstetric hemorrhages; the Hospital did not formally document measured or quantify blood loss according to the AWHONN Nursing Practice Brief.

Regarding Patient #1:

Nursing Note, dated 8/13/18 indicated Patient #1 delivered a fetus at 12:15 A.M. and at 1:56 A.M. and at 2:19 A.M., Patient #1 had bleeding of small clots. The Nursing Notes indicated no documentation of the amount of bleeding.

Regarding Patient #7:

The History & Physical, dated 9/3/18, indicated Patient #7 presented to the Hospital for induction of labor and elevated blood pressures.

The Delivery Summary, dated 9/6/18 at 3:37 P.M., indicated Patient #7 had an estimated blood loss of 800 milliliters (approximately 1 quart).

The Discharge Summary, dated 9/6/18, indicated Patient #7 had a postpartum hemorrhage.

Regarding Patient #8:

The Encounter Note, dated at 3:21 A.M. on 8/30/18, indicated a physician evaluated Patient #8's blood loss between 700 to 800 milliliters and the Encounter Note, dated at 4:40 A.M. indicated Patient #8 underwent surgery for a retained fetal placenta. Patient #8's intraoperative blood loss was estimated at 500 milliliters and pre-operative estimated at 1200 milliliters.

Regarding Patient #9:

The Progress Note, dated 7/8/18 at 10:21 A.M., indicated Patient #9 passed a large amount of blood and had a postpartum hemorrhage. The Progress Note included no information to indicate documentation of either estimated blood loss or quantitative blood loss.

Regarding Patient #10:

The Operative Note, dated 7/8/18 at 4:08 P.M. indicated Patient #10 had a postpartum hemorrhage with an estimated blood loss of 600 milliliters during surgery for a retained placenta (afterbirth).

2.) Regarding perinatal infection:

The publication titled "Sepsis and pregnancy: do we know how to treat this situation?" from the US National Library of Medicine National Institutes of Health, indicated pregnant women may have different signs and symptoms of [DIAGNOSES REDACTED]

Sepsis Education, dated 9/2018, indicated the Hospital protocol. The Sepsis Education indicated if there was a known or suspected infection, think sepsis. Sepsis Education indicated to look for infection when a patient had two of the following five criteria:

-a temperature greater than 100.9 degrees Fahrenheit or less than 96.8 degrees Fahrenheit,

-a heart rate greater than 90 beats per minute,

-a respiratory rate greater than 20,

-a white blood cell count than 12 or less than 4,

- a lactate (blood level) greater than 2.

The Emergency Department Diagnoses, dated 8/12/18, indicated an Emergency Department physician diagnosed Patient #1 with a urinary tract infection at 10:30 P.M. and an incomplete miscarriage on 8/13/18 at 12:32 A.M.

The Emergency Department Provider Note, dated 8/12/18 at 7:16 P.M., indicated Patient #1 with an elevated heart rate of 136, a high White Blood Cell (WBC) count of 11.2, a high urine glucose (sugar) count (possible sign of Diabetes).

The Problem List indicated Patient #1 had past history of Group B [DIAGNOSES REDACTED] (GBS, bacterial infection) Urinary Tract Infection on 7/2/18.

The Autopsy, dated 8/13/18, indicated coronary arteries with chronic inflammation and the cause of the fetal demise was most likely from chorioamnionitis (an infection of the fetal membranes due to a bacterial infection).

The Medical Record indicated no documentation that a physician ordered a lactate blood level for Patient #1.

The Surveyor interviewed the Risk Management Director at 2:45 P.M. on 11/15/18 & at 1:15 P.M. on 11/21/18. The Risk Management Director said that the Sepsis Protocol included all patients and that the Sepsis Protocol did not specifically delineate obstetric patients. (White blood cell counts are elevated in pregnancy, 12-18 are considered normal. Risk factors for sepsis in pregnancy may include urinary tract infection, premature rupture of membranes, miscarriage, and diabetes.)

2.) Regarding weights:

The Article titled "Update on Medication Errors Associated with Incorrect Patient Weights" from the Institute of Safe Medication Practices, dated 6/16/16, indicated the standard of care was for accurate patient weight. Accurate patient weight measured in kilograms was the standard of care to give correct doses of medication.

The Surveyor interviewed Patient Safety Specialist #1 at 8:30 A.M. on 11/15/18. Patient Safety Specialist #1 said that the Hospital did not have a policy on patient weights. Patient Safety Specialist said it was true that the Obstetric Unit did not have a scale to weigh patients.

Flow Sheets, dated 6/19/18, 7/16/18, 8/27/18 & 8/28/18 indicated Patient #8's weight obtained by a stated method (patient reported). Flow Sheet, dated 8/29/18, indicated no documentation of the method used to obtain Patient #8's weight.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on records reviewed and interviews, Hospital Quality Assessment & Performance Improvement (QAPI) activities failed for one (Patient #1) of ten sampled patients to ensure implementation of identified corrective actions regarding the Hospital's Code Blue (emergency resuscitation) program improvements after Patient #1's unexpected death and prior to the Survey.

Findings included:

1.) The Surveyor interviewed Patient Safety Specialist #1 & #2, at 11:30 A.M. on 11/7/18. Patient Safety Specialist #1 & #2 said Patient #1 presented to the Emergency Department at 16 weeks pregnant because Patient #1 thought the baby was delivering. In the Emergency Department Patient #1's electrocardiogram (ECG) was abnormal, and blood tested to have a low potassium blood level. Patient Safety Specialist #1 & #2 said Patient #1 delivered a stillborn infant, the placenta did not deliver, and Patient #1 was admitted to Labor & Delivery. Patient Safety Specialist #1 & #2 said at the end of the procedure Patient #1's heartbeat declined to 30 beats per minute, then asystolic (without a heartbeat) and after resuscitative efforts (Code Blue) Patient #1 died .

Patient Safety Specialist #1 & #2 said the Hospital conducted an investigation following the death of Patient #1 and identified a corrective action that included designation of the Code Blue leader was clear. The Surveyor interviewed the Chief Medical Officer at 2:00 P.M. on 11/7/18. The Chief Medical Officer and Patient Safety Specialist #1 & #2 said the corrective action to identify the leader clearly for the resuscitative efforts (Code Blue) and restructure of the Code Blue team were not implemented by the time of the Survey.

Patient Safety Specialist #1 & #2 said the Hospital investigation identified a corrective action involving Anesthesia and Respiratory Therapy communication efforts. Patient Safety Specialist #1 & #2 said that the a corrective action involving Anesthesia and Respiratory Therapy communication efforts was not implemented by the time of the Survey.

2.) Regarding the failure of Hospital QAPI activities to identify an Emergency Department opportunity for learning regarding maternal blood loss.

The AWHONN Nursing Practice Brief, dated 2014, indicated that they recommended cumulative blood loss be formally measured or quantified after every birth.

The Hospital policy titled Precipitous Birth in the Emergency Department, dated 1/2017, indicated Hospital staff responsibilities including care of the mother and newborn. The Precipitous Birth in the Emergency Department indicated no procedure for maternal blood loss consistent with Association of Woman's Health Obstetric and Neonatal Nursing (AWHONN) Nursing Practice Brief.
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on records reviewed and interviews Hospital Executives failed, for one patient (Patient #1) of ten patients sampled, to ensure that Quality Assessment & Performance Improvement (QAPI) corrective actions were implemented.

Findings included:

1.) The Surveyor interviewed Patient Safety Specialist #1 & #2, at 11:30 A.M. on 11/7/18. Patient Safety Specialist #1 & #2 said Patient #1 presented to the Emergency Department at 16 weeks pregnant. In the Emergency Department Patient #1 received an electrocardiogram (ECG) that was abnormal and blood tested to have a low potassium blood level. Patient Safety Specialist #1 & #2 said as Patient #1 prepared for discharge she delivered a stillborn infant and was admitted to Labor & Delivery to remove the retained placenta. Patient Safety Specialist #1 & #2 said at the end of the procedure Patient #1's heartbeat declined and became asystolic (without a heartbeat) and after resuscitative efforts Patient #1 died .

The Surveyor interviewed the Chief Medical Officer at 2:00 P.M. on 11/7/18. The Chief Medical Officer and Patient Safety Specialist #1 & #2 said the corrective action to restructure of the Code Blue team was not implemented by the time of the Survey. Patient Safety Specialist #1 & #2 said that the a corrective action involving Anesthesia and Respiratory Therapy communication efforts was not implemented by the time of the Survey.