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1493 CAMBRIDGE STREET

CAMBRIDGE, MA 02138

QAPI

Tag No.: A0263

Based on record review and interview for three (Patient #1, #9 and #10) of ten patients sampled, the Hospital failed to have implemented preventative corrective actions to improve care related to three serious events.

Findings include:

The Hospital Report regarding Patient #1's discharge, dated 10/13/17, indicated Patient #1 was transferred to a skilled nursing facility with an incorrect list of medications. The event was reviewed by a multidisciplinary group and included educational opportunities related to admission medication reconciliation. The Report indicated that education about medication reconciliation with emphasis on transitions of care, and sources for identifying the current medication list was provided for the ordering physician. There was no documentation to indicate that a corrective action plan had been implemented that included all physicians who document on Patient Care Referrals.

Refer to TAG A-286

The Hospital's Internal Investigations for Patient #9 and Patient #10 indicated no implemented corrective actions and no monitoring of corrective actions, after Patient #9 and Patient #10's uterine ruptures (rare event of a tear in the uterus of life-threatening concerns for the mother and fetus).

Refer to TAG: 0283


31678

QUALITY IMPROVEMENT ACTIVITIES

Tag No.: A0283

Based on records reviewed and interviews the Hospital failed for two of ten patients sampled (Patient #9 & Patient #10) to ensure the implementation of corrective actions and monitoring of corrective actions, after Patient #9 and Patient #10's uterine ruptures (rare event of a tear in the uterus of life-threatening concerns for the mother and fetus).

Findings included:

The Anesthesia Record, dated 11/12/17 from 6:53 P.M. through 8:33 P.M., indicated Patient #9 delivered at 7:14 P.M. on 11/12/17 a well newborn by emergency Cesarean section. The Anesthesia Record indicated a post-operative diagnosis of uterine rupture. The Operative Report, dated 11/20/17 at 3:08 P.M., indicated the infant was in the process of extruding (coming out) from the uterus of Patient #9. The Operative Report, dated 11/20/17 at 3:08 P.M. indicated Patient #9 with a postoperative diagnosis of uterine rupture.

The Progress Note, dated 11/12/17 at 7:30 P.M. and documented by a Certified Nurse Midwife (CNM), indicated a Registered Nurse gave Patient #9 an epidural (administration of pain medication into the epidural space in the spinal column) bolus.

The Anesthesia Record, dated 11/11/17 from 7:46 A.M. through 8:56 A.M., indicated Patient #10 delivered, at 8:07 A.M. pm 11/11/17, a well newborn by emergency Cesarean section. The Anesthesia Record indicated a post-operative diagnosis of uterine dehiscence (rupture). The Operative Report dated, 11/20/17 at 3:08 P.M., indicated the infant's shoulder extruded through the opening of Patient #10's hysterotomy (incision in the uterus). The Operative Report indicated Patient #10 with a postoperative diagnosis of uterine rupture.

I.) The document titled Hospital Report, dated 10/8/17-1/8/18, indicated two events of uterine ruptures; one event occurred on 11/11/17 and one event occurred on 11/12/17.

The Surveyor interviewed the Risk Manager at 9:30 A.M. on 1/10/18. The Risk Manager said that the Hospital conducted an Internal Investigation on 12/20/17 that included review of both Patients #9 & #10's uterine ruptures. The Risk Manager said a Certified Nurse Midwife (CNM) was the provider for both patients (Patients #9 & #10) who were Trials of Labor after Cesarean (TOLAC) patients.

The policy titled Midwifery and Advanced Practice Nurse Guidelines, dated 12/1/17, indicated Collaborative Management was the care of women with medical and obstetric complications jointly managed by the nurse midwife and physician.

The document titled Internal Investigation, dated 12/20/17, indicated the following seven (7) contributing factors:

1.) There was inconsistency in how co-management (Collaborative Management) occurred and needed formalization of this process with greater clarity needed regarding the consent process for a TOLAC patient required induction of labor as well as when a formal Obstetrician (physician) consult was warranted.

2.) There was no policy or guideline for when a TOLAC patient was to be cross-matched (a blood test to determine blood compatibility between patient and blood donor before a blood transfusion).

3.) Assure the empowerment of the nursing staff to advocate for patients for robust integrated clinical management.

4.) Consider development of a communication guideline as twice-daily rounds (meetings) was not sufficient for proper patient management and awareness of birth treatment plan as labor evolved.

5.) Consider implementing a proactive anesthesia consult for TOLAC patients at 28-30 weeks gestation and again intrapartum (during labor) prior to urgent need for anesthesia services.

6.) Review screening process for Certified Nurse Midwife (CNM) patients for planning for co-management.

7.) Devise mechanism for advanced notice of Obstetric education sessions to promote nursing and Physician Assistant attendance.

The Risk Manager said the Hospital had not implemented corrective actions. The Risk Manager said the Hospital postponed the follow-up meeting that was to discuss the seven (7) contributing factors. The Risk Manager said the Chief Medical Officer set the deadline for an update to the contributing factors to identify corrective actions, by 1/30/2018.

The Surveyor interviewed the Chief Medical Officer, at on 1/10/18. The Chief Medical Officer said he directed Hospital Obstetric Providers and Hospital staff for the update to the identified contributing factors in the Internal Investigation, by 1/31/18.

II.) The policy titled Care of Patients Receiving Epidural Medications, dated 4/2016, indicated only an Anesthesia Provider may administer epidural medications.

The Surveyor interviewed the Risk Manager at 12:30 P.M. on 1/10/18. The Risk Manager said that the Hospital Internal Investigation did not discover or investigate that a CNM documented that a Registered Nurse gave (Patient #9) an epidural dose (administration of pain medication into the epidural space, in the spinal column).

The Hospital Investigation indicated no indication that the review identified that documentation in Patient #9's medical record indicated documentation that an RN gave an epidural bolus.

III.) The policy titled Safety Event Reporting, dated 5/1/16, indicated all Hospital staff were responsible for the timely reporting of observations or events not consistent with the desired operation of the Hospital or patient care.

The Risk Manager said she filed the uterine rupture event of 11/12/17 on 12/5/17 regarding Patient #10 after she verbally heard of the event and did know why the delay in reporting the event (by Hospital staff and or Hospital providers in accordance with Hospital policy).

The Risk Manager said the Hospital Investigation meeting on 12/20/17 discussed the delay in reporting Patient #10's uterine rupture event.

The Hospital Internal investigation indicated no indication of corrective actions regarding Hospital staff responsibility for the timely reporting of observations, or events not consistent with the desired operation of the Hospital or patient care, in accordance with Hospital policy.

PATIENT SAFETY

Tag No.: A0286

Based on documentation review and interview for three (Patient #1, #9 and #10) of ten patients sampled the hospital failed to have implemented and maintained quality improvement preventive actions following three serious adverse patient events.

Findings include:

Regarding Patient #1

The Hospital Report, dated 11/10/17, indicated Patient #1 was discharged from the Hospital and transferred to a skilled nursing facility (SNF) with an inaccurate medication list.

The Hospital's investigation reviewed on 1/8/18, indicated Patient #1's discharge prescriptions documented on the Patient Care Referral Form were documented from a previous admission/discharge which resulted in an inaccurate list of medications. A resident (physician in speciality training) did not use the most accurate medication list which was the list sent to the Hospital from the SNF.

The Hospital Corrective Action Plan, reviewed on 1/8/18, indicated educational opportunities related to medication reconciliation with an emphasis on transitions of care was identified. The Hospital provided no documentation to support that the corrective actions were implemented for all physicians.

The Surveyor interviewed Attending Physician #1 in person at 12:20 P.M. on 1/8/18. Attending Physician #1 said he spoke with the resident who documented Patient #1's discharge medications on the patient referral form. Attending Physician #1 said he reviewed with the resident that the most accurate list of medications for a patient admitted to the Hospital from another facility, such as a nursing home, is the list on that referral form. Attending Physician #1 said the education for the other residents will be implemented at a meeting on Tuesday 1/30/18.








31678

Regarding Patient #9 and Patient #10

The Anesthesia Records, dated 11/12/17 at 6:53 P.M. for Patient #9 and dated 11/11/17 at 7:46 A.M., for Patient #10 indicated post-operative diagnoses of uterine rupture. The Operative Report, dated 11/20/17 at 3:08 P.M., for Patients #9 and #10 indicated a postoperative diagnosis of uterine rupture.

The document titled Hospital Report, dated 10/8/17-1/8/18, indicated two events of uterine ruptures; one event occurred on 11/11/17 and one event occurred on 11/12/17.

The Surveyor interviewed the Risk Manager at 9:30 A.M. on 1/10/18. The Risk Manager said that the Hospital conducted an Internal Investigation on 12/20/17 that included review of both Patient #9 and Patient #10's uterine ruptures.

The document titled Internal Investigation, dated 12/20/17, indicated seven contributing factors:

The Risk Manager said the Hospital had not implemented corrective actions.

DISCHARGE PLANNING

Tag No.: A0799

Based on record review and interview for ten of ten patients sampled, the Hospital failed to have Discharge Planning policies and procedures that outline a discharge planning process and Patient #1 was transferred to a skilled nursing facility (SNF) with an inaccurate medication list.

Findings include:

The Surveyor requested, at 7:30 A.M. on 1/8/18 upon the entrance conference, the Hospital's Discharge Planning Policies and Procedures.

The Hospital provided no documentation to indicate Discharge Planning Policies and Procedures to indicate a four-stage discharge planning process that included:

-Screening of all patients to determine which ones are at risk of adverse health consequences post-discharge if they lack discharge planning;

- Evaluation of the post-discharge needs of inpatients identified in the first stage, or of inpatients who request an evaluation, or whose physician requests one;

-Development of a discharge plan if indicated by the evaluation or at the request of the patient's physician; and

-Initiation of the implementation of the discharge plan prior to the discharge of an inpatient.

Refer to TAG: A-837

TRANSFER OR REFERRAL

Tag No.: A0837

Based on record review and interview for one (Patient #1) of ten patients sampled, the Hospital failed to ensure accurate prescription medications were prescribed for Patient #1 when the Hospital transferred Patient #1 from the Hospital to the skilled nursing facility (SNF), resulting in Patient #1 receiving inaccurate medications which caused him/her to develop the complications of low blood sugar levels, low blood pressure and a required transfer to an acute care hospital.

Findings include:

The policy and procedure titled Utilization Review Plan, dated 9/29/16, outlined the Hospital's Utilization Review process and not the discharge planning process.

The Risk Manager was interviewed on at 9:30 A.M. on 1/8/18. The Risk Manager said there were no other Discharge Planning Policies and Procedures