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TUFTS MEDICAL CENTER 800 WASHINGTON STREET BOSTON, MA 02111 Dec. 6, 2013
VIOLATION: MEDICAL STAFF ACCOUNTABILITY Tag No: A0347
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interviews, the Attending Surgeon did not ensure that the contrast he ordered and intended to give was the contrast he actually administered to one (Patient #1) of six patients reviewed related to the placement of a Baclofen pump (an infusion pump used to give medication to control muscle [DIAGNOSES REDACTED]), from a total sample of 10 records.

Findings include:

The Attending Surgeon's Operative Report, dated 11/6/13 indicated Patient #1 was taken to the Operating Room for placement of an intrathecal (first of three membrane spaces covering the spinal cord and brain) catheter to support a Baclofen pump.

The Surveyor interviewed the Attending Surgeon at 8:45 A.M. on 11/19/13. The Attending Surgeon said he did not remember a label or remember reading a label on the syringe that contained the contrast dye which he administered intrathecally to Patient #1 during the placement of a Baclofen pump.
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on observations, record review and interviews the Hospital failed to ensure the Condition for Surgical Services was met.

Findings include:
1.) The Hospital was found to be in Immediate Jeopardy, on 11/21/13, related to Surgical Services due to failure to follow policies and procedures for verbal orders for Patient #1when a surgeon gave Patient #1 the wrong contrast dye that was for intrathecal (first of three membrane spaces covering the spinal cord and brain) use. This medication error caused the patient to suffer from seizures, decline in overall condition and expire the next day. An immediate corrective action plan to prevent any surgeon from ordering and administering the incorrect contrast dye as well any incorrect medications and failing to ensure staff followed an established policy for verification of verbal orders given by a surgeon during surgery for all medications ordered during surgery was not implemented until 12/2/13.


Please refer to A-942 and A-951

2) The Hospital initiated the following corrective actions that were implemented and in place as of 12/2/2013:
a) The Operating room staff must write verbal orders for all medications ordered by the surgeon in the operating room and present the written verbal order to the OR pharmacy in order to have the medication filled. The verbal order must specify the procedure being done, if not the order will not be filled.
b) Only use ionic contrast for gastrointestinal/genito-urinary procedures. The hospital will decide next week to discontinue the use of all ionic contrast dyes.
c) Ionic contrast dyes are available in the Pyxis medication delivery system. A hard stop has been installed with a warning to the user that must be acknowledged before staff can access the contrast.
d) Education of physicians, pharmacists and nursing took place immediately and has been ongoing on medical orders, verification processes in the OR and medication safety.

The Immediate Jeopardy was removed as of 12/6/2013 but the Condition of Surgical Services remains out of compliance.
VIOLATION: OPERATING ROOM SUPERVISION Tag No: A0942
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview the Hospital failed to ensure the operating room was effectively supervised because the contrast solution ordered by the Attending Surgeon was not the correct contrast dye administered for one (Patient #1) of ten patients. Findings include:

The Surveyor interviewed the Attending Surgeon at 8:45 A.M. on 11/19/13. The Attending Surgeon said he gave a verbal order for Omnipaque (a contrast dye) during Patient #1's surgery.

The Surveyor interviewed the Circulating Nurse at 11:10 A.M. on 11/19/13. The Circulating Nurse said the Attending Surgeon requested Omnipaque during Patient #1's surgery. The Circulating Nurse said she told the Attending Surgeon that she believed the Omnipaque was not carried in the satellite Operating Room Pharmacy. The Circulating Nurse said when she asked the Pharmacist for the Omnipaque, the pharmacist said "we don't carry Omnipaque, we carry this" indicating a medication labeled "MD-76" and handed her two 50 milliliter bottles of MD-76. The Circulating Nurse said she brought the two bottles of MD-76 to the operating room and showed a bottle of MD-76 to the Attending Surgeon and said "this is what we have". The Circulating Nurse said the Attending Surgeon said "just put it on the table".

Observation of the Operating Room Pharmacy on 11/19/13, at approximately 9:50 A.M., indicated the label of a vial of MD-76 read as followed: "not for intrathecal use". Intrathecal refers to the first of three membrane spaces covering the spinal cord and brain.

The Manufacturer's Warning label indicated the following: SEVERE ADVERSE EVENTS have occurred with INADVERTENT INTRATHECAL ADMINISTRATION. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, [DIAGNOSES REDACTED], acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Special attention must be given to insure that this drug product is not administered intrathecally.

The Attending Surgeon's Operative Report, dated 11/6/13, indicated a catheter was placed into Patient #1's intrathecal space and the contrast was injected twice via the catheter.

The Perioperative Nursing Record, dated 11/6/13, indicated that 0.5 milliliter (ml) of a 50 ml vial of MD-76 was administered by the Attending Surgeon intravascularly, which was incorrect; the contrast was administered intrathecally, which is contraindicated for this dye.

Nursing notes and physician progress notes, dated from 11/6 - 11/8/13 indicated the following: Patient #1 awoke from surgery in severe pain, was displaying jerky, spastic type movements and began to have seizures; Patient #1 was treated for his/her symptoms and became less responsive, then unresponsive and additional advanced interventions were declined based on Patient #1's wishes. The treatment for Patient #1 was changed to comfort measures and Patient #1 expired the next day.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on observation, record review and interviews the Hospital failed to ensure the staff followed an established policy for verbal orders given by a surgeon during surgery.

Findings include:

Patient #1's physician orders, dated 11/6/13-11/8/13, indicated there was no documented order for the contrast requested by the Attending Surgeon.

The Hospital's policies and procedures related to Safe Administration of Medication indicated that telephone and verbal orders shall be managed in accordance with Hospital policy #4006 Patient Care Orders.

The Hospital's policy #4006, Patient Care Orders indicated the following: verbal and telephone orders may be given to a registered nurse; the policy applies to all clinical and administrative staff; all orders for medications, treatments, laboratory tests, consultants, activity levels, and diets must be clearly written; the clinician receiving the order will immediately document the order in writing and will read back the order as written, the telephone order read back (TORB) and or verbal order read back (VORB) may be documented as a means of communication that this process has been completed; the verbal and/or telephone order shall include the ordering practioner's name credentials and a medication order is complete when it contains the drug name, dose strength and/or concentration, route and/or dosage form and dosing frequency.

The Association of Perioperative Registered Nurses (AORN) standards indicate the use of verbal orders should be limited but when necessary, hospitals should provide mechanisms to ensure accuracy and safety such as 1.) the order is recorded in the patient record according to facility policy as soon as feasible 2.) the nurse performs a read back of the written order by verbally reading the order digit by digit and spelling out the medication name and 3.) allowing only licensed staff to receive verbal orders. Before administration of any medication a re-verification process should include a review of the product label for the medication name, strength and expiration date. This should be done in conjunction with review of the written medication order to confirm correct medication.


The Surveyor interviewed the Professional Development Manager at approximately 8:30 A.M. on 11/20/13. The Professional Development Manager stated that during surgery there are different professional practices for verbal orders and said the practice at Tufts Medical Center was for the circulator nurse to verbally confirm the order with the surgeon, obtain the requested medication/solution, bring it to the operating room and perform a visual confirmation with the scrub person. The Professional Development Manager said the circulator nurse would then document the drug/solution that was administered by the surgeon in the intra-operative record.

Despite the documented administration of MD-76, there was no documented order in the clinical record for the administration of MD-76 and no read back verification of the order with the physician per Hospital policy.

Although, the Hospital conducted a huddle to discuss and provide re-education regarding operating room safe medication practices, no policy changes were designed to assure the achievement and maintenance of high standard of medical and nursing practice and patient care regarding verbal medication orders during surgery by a surgeon to prevent any re-occurrence.