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.

ST FRANCIS HOSPITAL & MEDICAL CENTER 114 WOODLAND STREET HARTFORD, CT 06105 March 12, 2013
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
1. Based on a review of clinical records, review of policy and interview, for one of eleven patient's (Patient #82) that underwent knee revisions, the hospital failed to ensure that surgical counts were completed in accordance with hospital policy. The finding includes:

a. Review of the surgical record for Patient #82 identified that on 1/31/13, the patient underwent a left knee total joint revision secondary to severe failure of an initial total knee arthroplasty completed many years ago. Review of the operative report identified that the patient underwent an x-ray of the left knee, post-surgery, in the PACU (Post Anesthesia Care Unit). The surgeon (MD #22), upon review of the film, identified a metal object, possibly a screw, in the posterior medial aspect of the joint. The patient was informed and returned to the operating room for removal of the object, which was identfied as a small screw. Review of the operative record identified that counts for sponges and sharps were completed according to hospital policy, however, the record failed to reflect that miscellaneous items (items with potential for loss such as needles, safety pins, scalpel blades, etc) were counted.

During interview on 3/11/13 at approximately 2:30 PM, RN #9, Circulating Nurse, stated that s/he did not initiate a count of small items such as screws as that had never been done before.

During interview on 3/12/13 at 12:05 PM, MD #22 stated that s/he was unaware that the trial knee hardware that were handed to him/her by the scrub technician were screwed together.

During interview on 3/12/13 at approximately 11:40 AM, Nurse Manager#12 stated that the hardware was assembled and screwed together by the scrub technician prior to handing off the hardware to the surgeon. The Manager stated that when the trial piece was handed back to the scrub technician, the technician placed the part in a soiled instrument bucket without ascertaining how many screws were contained in the hardware piece.

Review of the Sponge, Sharps, and Instrument Counts policy identfied that the surgical team can choose to perform a miscellaneous count on any non-body cavity procedure where there is a potential for loss.


2. Based on a review of clinical records, interview, review of hospital policy, and the Medical Staff Bylaw Rules and Regulations, for six (6) of eleven (11) records reviewed, the hospital failed to ensure that the "time out" procedure was completed in accordance with hospital policy and/or that complete assessments were documented. The findings include:

a. Review of the surgical record for Patient #82 who underwent a left total knee joint revision on 1/31/13, identified that the patient received a left femoral nerve block prior to surgery. Review of the documentation for the nerve block/time-out procedure failed to identify who assisted with the procedure. During interview on 3/12/13 at approximately 1:15 PM, the Director of Patient Safety and Accreditation identified that the document should be signed by a second person present during the anesthetizing procedure as reflected within the policy for universal protocol which stipulates a time-out session prior to each invasive procedure which should then be documented.

Additionally, the record failed to reflect an assessment of the patient's awareness (awake versus, sedate with meaningful contact maintained) and/or pre and post procedure pain score.

b. Review of the surgical record for Patient #87, who underwent a left total knee joint revision on 1/25/13, identified that the patient received a left femoral nerve block prior to surgery. Review of the documentation for the nerve block/time-out procedure failed to identify who assisted with the procedure.

c. Review of the surgical record for Patient #88, who underwent a right total knee joint revision on 12/6/12, identified that the patient received right femoral catheter and a right posterior tibial nerve block prior to surgery. Review of the nerve block/time-out procedure failed to identify who assisted with the procedure.

Additionally, the record failed to reflect an assessment of the patient's awareness (awake versus, sedate with meaningful contact maintained) and/or pre and post procedure pain score.

d. Review of the surgical record for Patient #89, who underwent a right total knee joint revision on 1/14/13, identified that the patient received right femoral catheter insertion with a right sciatic nerve block prior to surgery. Review of the nerve block documentation failed to reflect pre and post procedure pain assessments.

e. Review of the surgical record for Patient #91, who underwent a right total knee joint revision on 2/12/13, identified that the patient received a right adductor canal and a right posterior/anterior injection prior to surgery. Review of the nerve block/time-out procedure failed to identify who assisted with the procedure. The record further failed to reflect who administered the conscious sedation and monitored the patient during the procedure.

f. Review of the surgical record for Patient #92, who underwent a left total knee joint revision on 12/7/12, identified that the patient received a left adductor canal block prior to surgery. Review of the nerve block documentation failed to reflect pre and post procedure pain assessments.

Review of the Universal Protocol policy identfied that patients undergoing surgical or invasive procedures that expose them to more than minimal risk must receive pre-procedure verification of patient , procedure, marking of procedure site and a time-out immediately prior to the start of the procedure. this process must be documented in the electronic intra-operative record.

3. Based on a review of surgical records and review of hospital policy, the hospital failed to ensure that one (1) of eleven (11) surgical records reviewed, the surgical counts were completed in their entirety per hospital policy. The finding includes:

a. Review of the surgical record for Patient #88, who underwent a right total knee joint revision on 12/6/12, identified that the surgical count process was not completed according to hospital policy. A review of the surgical count documentation reflected that an initial count of sharps and sponges was completed and then a closing count was completed, however, the final closing count was blank. Review of the surgeon's operative report dated 2/9/12, failed to reflect that an acknowledgment of a correct count occurred. Review of the hospital policy for sponges, sharps and instrument counts identified that closing counts should occur before wound closure begins and at skin closure.