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.

MASSACHUSETTS GENERAL HOSPITAL 55 FRUIT STREET BOSTON, MA 02114 Oct. 4, 2019
VIOLATION: OUTPATIENT SERVICES Tag No: A1076
The Condition of Participation for Outpatient Services was not met.

Findings included

1.) The Hospital failed to ensure that Outpatient Services were appropriately organized and integrated with inpatient services.

Refer to TAG: A-1077.

2.) The Hospital failed to ensure that Outpatient Services met the needs of the patients in accordance with acceptable standards of practice.

Refer to TAG: A-1081.
VIOLATION: INTEGRATION OF OUTPATIENT SERVICES Tag No: A1077
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on records reviewed and interviews the Hospital failed to ensure for six patients (Patients #2, #3, #6, #7, #8 & #9) in a sample of 10 patients that Outpatient Services were appropriately organized and integrated with inpatient services. The Hospital failed to ensure an established method in place to ensure continuity of medication therapies for its outpatients that reflected the scope and complexity of its Outpatient Services offered.

Findings included:

1.) The Surveyor interviewed the Vice President for Outpatient Services at 1:00 P.M. on 10/3/19. The Vice President for Outpatient Services said the Hospital had 250 outpatient sites that provided medical care for 12,000 patients daily.

2.) The Hospital failed to ensure provider communication between inpatient services and Outpatient Services to meet the needs of six patients (Patients #2, #3, #6, #7 #8 & #9).

Regarding Patient #2:

Medical Record Review of Patient #2's History & Physical, dated 6/27/19, indicated Patient #2 had a cancerous [DIAGNOSES REDACTED], a seizure disorder treated with medication, and was admitted to the Hospital after a seizure resulting in a small brain bleed. The Discharge Summary, dated 6/29/19, indicated instructions which included Keppra (a seizure medication) for 1500 milligrams to be taken twice a day.

The Surveyor interviewed Patient Safety & Quality Specialist #2 at 9:00 A.M. on 10/3/19. Patient Safety & Quality Specialist #2 said at a Neurology-Oncology (brain cancer) visit in 8/2019, Patient #2's Neuro-Oncologist discovered that a medication order was refilled for Keppra at a dosage of 1000 milligrams to be taken twice a day and not the intended planned dosage of 1500 milligrams to be taken twice a day by Nurse Practitioner #1. Patient Safety & Quality Specialist #2 said that the request for the medication refill was electronically sent to the Inpatient Neurosurgery (medication refill, electronic) "inbox" and that Inpatient Providers do not open this "inbox" because it was not Inpatient Providers' responsibility to refill Outpatient Service patients' medications. Patient Safety & Quality Specialist #2 said that the Hospital had concerns about care transitions between the Inpatient Service Providers (Neurosurgical-brain surgery Service) and Outpatient Service Providers (Neurology-brain specialists) about the intended dosage of Patient #2's seizure medication dosage. Patient Safety & Quality Specialist #2 said that the Neurosurgical Service and the Neurology Service Providers had not met together to discuss and implement medication refill procedure corrective actions. Patient Safety & Quality Specialist #2 said there was no information to indicate the Hospital had implemented corrective actions regarding the Inpatient Provider "Inbox" that accepted Outpatients' medication prescription refill requests.

The Surveyor interviewed Nurse Practitioner #1 at 9:00 A.M. on 10/3/19. Nurse Practitioner #1 said that she followed standard medication refill processes and that the Hospital had made no process changes for medication refills.

The Hospital provided no information or documents to indicate a corrective action plan regarding Patient #2's adverse medication event.

Regarding Patient #3:

Medical Record review of Patient #3's Emergency Department Record, dated 9/10/19, indicated Patient #3 with a history of a seizure disorder and depression that was treated with a medication for the depression. The Emergency Department Record indicated that Patient #3's presenting symptoms were consistent with the toxic levels of the seizure medication.

The Surveyor interviewed Patient Safety & Quality Specialist #3 at 2:00 P.M. on 10/3/19. Patient Safety & Quality Specialist #3 said that Patient #3's (Outpatient) Provider intended Patient #3 be prescribed a dosage of 150 milligrams of the seizure medication to be taken twice a day. Patient Safety & Quality Specialist #3 said the Emergency Department discovered, on 9/10/19, that Patient #3 had a prescription for the seizure medication for a dosage of 300 milligrams to be taken twice a day and Patient #3 was taking the 300 milligrams twice a day (300 milligrams more than the intended dosage). Patient Safety & Quality Specialist #3 said the Outpatient Provider wrote a prescription for the seizure medication and in the comments section of the prescription, the Outpatient Provider wrote 300 milligrams twice a day (this would be 600 milligrams taken twice a day, this was the dose Patient #3 was taking, and potentially contributed to Patient #3's toxic levels of the seizure medication) and the Outpatient Provider intended Patient #3 to be taking 150 milligrams twice a day. Patient Safety & Quality Specialist #3 said Patient #3 had a blood level of the seizure medication at 20.3 (therapeutic range for seizure control is 3 - 14) and Patient #3's usual blood level of the seizure medication) was 12.

Medical Record review of Patient #3's prescriptions for the seizure medications indicated unclear (confusing) orders to the retail pharmacy.

A Hospital Report, dated 1/7/19-10/2/19, indicated medications issues regarding four patients (Patients #6, #7, #8 & #9) from Outpatient Services.

Regarding Patient #6:

Medical Record review of Patient #6's outpatient office visit, dated 8/26/19, indicated Patient #6 with a diagnosis of [DIAGNOSES REDACTED]

The Hospital report indicated issues regarding Patient #6's medication refill for chemotherapy (medication to treat cancer). The cancer medication refill was canceled, in error, and Patient #6's Provider intended to continue Patient #6's cancer medication.

Regarding Patient #7:

Medical Record review of Patient #7's outpatient office visit, dated 9/16/19, indicated Patient #7 with a diagnosis of [DIAGNOSES REDACTED]. Hospital outpatient location (Location A) notified Oncology that Patient #7's cancer medication was discontinued; however, the cancer medication was not discontinued-the cancer medication refill was prescribed from another Hospital outpatient location (Location B). The Hospital Report indicated communication concerns regarding current medication regime to treat Patient #7's cancer.

Regarding Patient #8:

Medical Record review of Patient #8's outpatient office visit, dated 8/29/19, indicated Patient #8 (47-year-old) with a diagnosis metastatic [DIAGNOSES REDACTED]. The Hospital report indicated issues regarding Patient #8's medication refill, the medication refill prescription was sent to a retail pharmacy and was not sent to the Hospital research pharmacy as intended.

Regarding Patient #9:

Medical Record review of Patient #9's Neurology Progress Note, dated 8/14/19, indicated Patient #9 with a diagnosis [DIAGNOSES REDACTED] Encephalitis (conditions when the body's immune system mistakenly attacks healthy brain cells, leading to brain inflammation, neurologic and or psychiatric symptoms). The Hospital report indicated issues regarding Patient #9's medication refill prescription. The medication was prescribed from an old medication order after a recent medication dose increase for an anti-rejection medication. The Hospital Report indicated communication concerns regarding current medication regime to treat Patient #9's [DIAGNOSES REDACTED] Encephalitis.

The Senior Vice President for Outpatient Services said that the Hospital had started to consider medication safety as one of the top goals for the fiscal year 2020. The Senior Vice President for Outpatient Services said that the Hospital had made no immediate changes to the Outpatient Services process for medication refill orders.

3.) The Hospital failed to thoroughly integrate Inpatient and Outpatient Quality Assessment and Performance Improvement (QAPI) activities.

The Hospital provided no information to ensure active, coordinated QAPI activities between Inpatient & Outpatient Services that thoroughly investigated and implemented corrective actions for medication prescription refill adverse events (medication errors) that occurred in its Outpatient Services.

Refer to TAG: A-1081.
VIOLATION: STANDARD TAG FOR OUTPATIENT SERVICES Tag No: A1081
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on records reviewed and interviews, the Hospital failed for six patients (Patients #2, #3, #6, #7, #8 & #9) out of a total of ten sampled patients, to ensure Outpatient Services met the needs of patients in accordance with acceptable standards of Quality Assessment & Performance Improvement (QAPI) practice.

Findings included:

1.) Regarding Standards of Care:

The Institute of Medicine (IOM) at http://www.ihi.org/resources/Pages/ImprovementStories/WhatMedicationsDoesYourPatientTake.aspx indicated medication reconciliation (processes to confirm an accurate patient medication list) spanned the health care continuum and high numbers of medication events occur during transitions in care. Medication reconciliation should occur at every transfer point including outpatient settings.

The Agency for Healthcare Research and Quality at https://search.ahrq.gov/search?q=quality+definition., indicated a definition of Quality Assessment & Performance Improvement as quality and safety determined by the degree to which health care improved important patient outcomes (accurate patient medication list).

2.) Regarding coordinated QAPI activities:

Medical record review of Patient #2's History & Physical, dated 6/27/19, indicated Patient #2 had a cancerous [DIAGNOSES REDACTED] and a seizure disorder treated with medication.

The Surveyor interviewed Patient Safety & Quality Specialist #2 at 9:00 A.M. on 10/3/19. Patient Safety & Quality Specialist #2 said that at a neurology-oncology (brain cancer) visit in 8/2019, Patient #2's Out-Patient neuro-oncologist discovered that a medication order was refilled for Keppra at a dosage of 1000 milligram to be taken twice a day and not the intended planned dosage of 1500 milligrams to be taken twice daily (a Provider did not order the planned 1500 milligrams). The Hospital provided no information or documents to indicate a corrective action plan regarding Patient #2's adverse medication event.

A.) Patient Safety & Quality Specialist #2 said that the request for a medication refill was electronically sent to the inpatient neurosurgery (medication refill, electronic) "inbox" and that inpatient providers do not open this "inbox" because it was not inpatient providers' responsibility to refill Outpatient Service patients' medications.

The Hospital provided no immediate corrective actions to correct the "inbox" issue.

B.) Patient Safety & Quality Specialist #2 said that the Hospital had concerns about care transitions (communication between the Inpatient Providers neurosurgical (brain surgery) service and Outpatient Service (neurology, brain specialists) Providers about the intended dosage of Patient #2's seizure medication dosage.

The Hospital provided no corrective action plan regarding provider communication between inpatient services and Outpatient Services.

Regarding Patient #3:

Medical record review of Patient #3's Emergency Department Record, dated 9/10/19, indicated Patient #3 presented to the Emergency Department with symptoms consistent with toxic levels of the seizure medication prescribed for Patient #3's seizure disorder.

The Surveyor interviewed Patient Safety & Quality Specialist #3 at 2:00 P.M. on 10/3/19. Patient Safety & Quality Specialist #3 said that Patient #3's provider intended Patient #3 be prescribed a dosage of 150 milligrams of the seizure medication to be taken twice a day and the Emergency Department discovered, on 9/10/19, that Patient #3 was taking the 300 milligrams twice a day as prescribed.

Patient Safety & Quality Specialist #3 said the Hospital was still investigating Patient #3's adverse patient medication event. Patient Safety & Quality Specialist #3 provided no information regarding corrective actions.

Regarding Hospital Medication Reports:

A Hospital report, dated 1/7/19-10/2/19, indicated medications issues regarding four patients (Patients #6, #7, #8 & #9) in Outpatient Services; Patient #6's medication refill for chemotherapy (medication to treat cancer); Patient #7's prescription about chemotherapy and the same issue as Patient #6, Patient #8's medication refill was not sent to the Hospital research pharmacy, Patient #9's medication refill was prescribed from an old order.

The Surveyor interviewed the Vice President for Outpatient Services at 1:00 P.M. on 10/3/19. The Senior Vice President for Outpatient Services said that the Hospital had started to consider medication safety as one of the top goals for the fiscal year 2020. The Senior Vice President for Outpatient Services said that the Hospital had made no immediate changes to the Outpatient Services process for medication refill orders.

3.) Regarding documentation of medication events in the patient's medical record:

Medical record review indicated no outpatient documentation regarding the medication events concerning Patients #6, #7, #8 & Patient #9.

4.) The Hospital provided no information to ensure that Outpatient Services were thoroughly integrated into its Hospital-wide QAPI program. The Hospital provided no information to ensure active, coordinated QAPI activities between Inpatient & Outpatient Services that:

-thoroughly investigated medication prescription refill adverse events (medication errors) that occurred in Outpatient Services.

-implemented preventative, corrective actions of medication prescription refill adverse events (medication errors) that occurred in Outpatient Services.

-provided no information to ensure Outpatient Services considered medication reconciliation as a current priority for its performance improvement activities focusing on the high-volume of outpatient visits for patients with complex medical needs including cancers and seizure disorders requiring complicated medication management to treat the patients severity of problems to identify and reduce medical errors regarding incorrect medication refill processes of Outpatient Services.