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.

TUFTS MEDICAL CENTER 800 WASHINGTON STREET BOSTON, MA 02111 Aug. 9, 2019
VIOLATION: NURSING SERVICES Tag No: A0385
Based on interviews and document review, the Hospital failed (for one (Patient #1) of ten patients sampled) to ensure that its nurses abided by hospital policy to have a second nurse independently review medication orders for medications considered "high alert" to ensure accuracy in their administration.

See A-tag 0405 for details.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Findings include:
Based on interviews and document review, the Hospital failed (for one (Patient #1) of ten patients sampled) to ensure that its nurses abided by hospital policy to have a second nurse independently review medication orders for medications considered "high alert" to ensure accuracy in their administration.

The policy titled "High-Alert Medications Safe Practices," last revised 03/2014, states that an independent double check occurs when two licensed practitioners independently:

Compare the label and product contents in hand versus the written/electronic order,
Verify any calculations that are required,
Assure accuracy of infusion pump programming for continuous high-alert intravenous infusions of medications and,
Verify the "5 rights" (right patient, right medication, right dose, right time, and right route).

When nursing staff scan their badge for administration of a high alert medication they are attesting that they have performed all above criteria of an independent double check.

The policy titled "High Alert Medications Safe Practices," last revised 03/2014, defines under "Section III Definitions" that high alert medications are medications that are associated with a heightened risk of causing significant patient harm when they are used in error.

The policy titled "High Alert Medication Safe Practices," last revised 03/2014 lists on page 4 under "Appendix A. Adult High Alert Medications List" the drugs Hydromorphone, Morphine and Fentanyl Epidural and includes a section that states administration requires an independent double check by two practitioners.

The Surveyor identified that the above policy was in place prior to Patient #1's hydromorphone (an opioid drug) medication error that occurred on 07/08/2019. An order for Hydromorphone continuous infusion was placed for Patient #1 at a rate of 0.5 milligram (mg) per hour. The intravenous (IV) pump machine that controls the rate of medication administered into the patient was set incorrectly by Nurse #7. The pump was incorrectly set by Nurse #7 to administer the Hydromorphone at a rate much faster than the ordered dose, 0.5 mg per hour. This medication error resulted in Patient #1 receiving 30 mg of Hydromorphone within one hour, approximately 60 times the intended ordered dose, 0.5 mg per hour. As a result, Patient #1 was unarousable and required a reversal agent (Naloxone which helps reverse the effects of Hydromorphone) to be administered on three separate occasions. After the third round of Naloxone, Patient #1 was able to be aroused. This resulted in Patient #1 to remain intubated overnight and delayed transition of care out of the intensive care unit. The facility determined that the independent double check of a high-alert medication was not conducted in accordance with the above pre-existing policy.

The Surveyor interviewed Nurse #7 on 08/15/2019 at 3:00 P.M. On 07/08/2019, prior to administration of Patient #1's Hydromorphone infusion, Nurse #7 stated that she really wanted to get the pain medicine on board. Nurse #7 was seeking to get a second nurse to double check the Hydromorphone infusion (Hydromorphone is a high alert medication and a double check was required per the above policy guidelines for a high alert medication). Nurse #7 stated she looked out of her room and didn't see any nurses available. Nurse #7 then left her room, walked over with her scanner (when nursing staff scan their badge for administration of a high alert medication they are attesting that they have performed all above criteria of an independent double check) to Nurse #2's room. Nurse #7 stated she showed the Hydromorphone infusion bag to Nurse #2 in Nurse #2's room and then scanned Nurse #2's badge. Nurse #7 went back to Nurse #7's room (where Patient #1 resided) to administer the Hydromorphone infusion and programmed the wrong selection of Hydromorphone infusion in the pump programming system. As a result of the incorrect selection type, the medication pump infused at a much faster rate than intended. Nurse #7 stated she realized the error within one hour but by this time much of the Hydromorphone bag had infused, (facility approximated 30mg within one hour which was 60 times the intended dose ordered by the physician).

Record review of Patient #1 indicated a progress note by the critical care attending physician that described disclosure to Patient #1 that Patient #1 received a higher dose of Dilaudid (brand name of Hydromorphone) than was originally ordered and explained that this had caused him (Patient #1) to be left intubated overnight.

The Surveyor interviewed the Professional Developer Director and the Clinical Nursing Director (nursing management) of the intensive care units, on 08/08/2019 at 11:05 A.M. The Professional Developer and Clinical Nursing Director acknowledged that the independent double check was not conducted according to the above policy.

A Patient Safety Alert sent via e-mail to all nurses in the facility, dated 07/26/2019, notified staff that a medication error occurred identifying breakdowns in the system and highlighted the importance of the final safety measure in the existing system, the Independent Double Check.

The document titled Education Attendance Roster (in regards to the "Programming the IV Pump for Continuous Infusions; review of the Safety Huddle") dated between 07/29 and 08/02/19, indicated signatures of the nurses attesting that they had reviewed the safety huddle. The safety huddle included information on infusion pump safety as well as ensuring that the second nurse double check occurs as policy dictates. This was identified as part of the facility's corrective action plan.

The document titled Education Attendance Roster (in regards to the "Programming the IV Pump for Continuous Infusions; review of the Safety Huddle") dated between 07/29 and 08/02/19 indicated signatures of Nurse #1 and Nurse #6.

The Surveyor interviewed Nurse #1 on 08/08/19 at 3:20 P.M. Nurse #1 said that she was aware of the independent double check requirement. Nurse #1 said that, when she cannot find a second nurse to come into the patient room to correctly perform the double check, she will leave the patient room to find another nurse. Nurse #1 said she will explain to the second nurse that a particular medication needs to be started on her patient and shows the second nurse the intravenous (IV) medication bag. Nurse #1 will then receive the second nurse verification scan (required by the computer system) by taking Nurse #1's scanner remote, and scanning the badge of the second nurse (when nurse #1 scans the badge of the second nurse, this is equivalent to the second nurse attesting, that he/she has completed the independent double check according to the above hospital policy). At this point in time, the second nurse has not entered Nurse #1's patient room and fails to conduct the Independent Double Check in accordance with Hospital Policy.

The Surveyor interviewed Nurse #6 on 08/09/19 at 12:15 P.M. Nurse #6 stated that from the point of view as the "second check," nursing staff have approached Nurse #6 requesting the help of conducting a second check outside and away from the other nurse's patient room. At this point Nurse #6 would scan her badge (attesting that she has completed the independent double check according to the above hospital policy), without being in the patient room to verify patient identification, IV pump settings etc. as required in accordance with Hospital Policy.

Despite evidence of measures taken by the facility administration (Practice Safety Alert sent to all nurses highlighting importance of Independent Double Check, education attendance roster indicating nurse signatures attesting that they completed a review of the safety huddle, that entailed pump safety and ensuring a 2nd nurse double check occurs) nursing staff (including but possibly not limited to Nurse #1 and Nurse #6) continue to not adhere to the policy. Failure of staff to adhere to the "High-Alert Medications Safe Practices" policy can potentially lead to another significant re-occurrence, increasing risk of harm to the facility's patients.