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.

VENICE REGIONAL BAYFRONT HEALTH 540 THE RIALTO VENICE, FL 34285 March 21, 2012
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
Based on a review of incident reports, and interview with administrative and physician staff, the hospital failed to ensure 1 (Patient #8) was notified of an untoward incident which occurred during his surgical procedure..

The findings include:

1. On 3/5/12, there was an incident involving Patient #8. During the operation for a fractured femur, it was noted the guide pin from the previous patient was stuck in the reamer. (This instrument is used to drill a hole in the bone to allow the placement of a lag screw to hold all of the rods in place in the femur. The guide wire is placed in the patient under fluoscopy to determine each position, then is guided into the reamer, and the reamer is then placed against the bone and the hole is made to allow the placement of the screw.) The guide pin tip was visible only 1/4 inch, per interview with scrub technician on 3/14/12 at 4:12 p.m. revealed the reamer had been sterilized with the guide pin in place. All of the indicator strips were present and indicated this piece of equipment had been sterilized. He further stated it is normally the responsibility for the scrub technician to remove the previous pin and then it is sent to the processing center for cleansing. He further stated the pin had biomatter on it at the time of discovery.

Observation of the guide pin on 3/15/12 at 10:30 a.m. revealed 4 inches approximately of brown discoloration on it.

An interview was held on 3/14/12 at 4:30 p.m. with the physician who indicated he had not notified either the patient or power of attorney of the incident in the operating room. He further indicated "he was waiting for risk management to tell him whether he should tell the patient about the incident." Risk Management, who was present during this interview, indicated she had not spoken to the physician about the incident as it was still in review.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on a review of clinical records, review of hospital documents, and interview with clinical and administrative staff, the hospital did not ensure effective cleansing of surgical instruments prior to sterilization, resulting in potential infection issues for 2 (Patients #5 and #8) of 10 patients reviewed, resulting in unsafe care being rendered.

The findings include:

1. On 3/5/12, there was an incident involving Patient #8. During the operation for a fractured femur, it was noted the guide pin from the previous patient was stuck in the reamer. (This instrument is used to drill a hole in the bone to allow the placement of a lag screw to hold all of the rods in place in the femur. The guide wire is placed in the patient under fluoscopy to determine each position, then is guided into the reamer, and the reamer is then placed against the bone and the hole is made to allow the placement of the screw). The guide pin tip was visible only 1/4 inch per interview with scrub tech a on 3/14/12 at 4:12 p.m. revealed the reamer had been sterilized with the guide pin in place. All of the indicator strips were present and indicated this piece of equipment had been sterilized. He further stated it is normally the responsibility for the scrub technician to remove the previous pin and then it is sent to the processing center for cleansing. He further stated the pin had biomatter on it.

Observation of the guide pin on 3/15/12 at 10:30 a.m. revealed 4 inches approximately of brown discoloration on it.

The scrub technician further related the physician removed the old pin from the reamer and dropped the pin on the floor. The question was asked if there was a another reamer available for use and it was determined this was the only reamer available. The option at that time was either to flash sterilize the reamer, which would take 30-45 minutes, or use the reamer as it was with a new guide wire.

Interview with the surgeon on 3/14/12 at 4:30 p.m. indicated he thought the lodged guide pin that he removed looked "pristine" and as the patient was bleeding significantly, was [AGE] years old, and as the contact would be for 5 seconds to drill the hole, he would use the reamer.

The scrub technician further indicated in the interview the usual practice under these circumstances would be to break the room down and start over. The reamer would then be flashed sterilized taking 30-45 minutes. This reamer issue was not found prior to the surgery.

Staff interviews with other operating room staf indicated they were hurrying as there was an emergency case to follow in this room, and they were being forced to hurry to accommodate the emergency.

2. On 3/9/12, an incident occurred with Patient #5. In this case, the equipment was again found to be contaminated with biomatter. The room was broken down, the tables were scrubbed, and the instruments were replaced. All staff was regowned and gloved. Instruments that were needed from previous trays were flashed sterilized.

During this surgery, one of the instruments had darker stains on it, but it was decided this was from the patient as the instrument had been on the field. From the operative report from the physician was the following statement; "it should be noted that in the midst of the case there was soiling noted of some of the instruments that were utilized. Instrumentation difficulty with this case provided added significant length to the operation."

3. Interview on 3/14/12 at 3:30 p.m. with a different scrub technician, indicated the hospital has been trying to get more instruments, but they have had other instances. These are usually tears in the packages. She indicated she has never had this happen in the middle of a case.

4. A scrub technician interview on 3/15/12 at 4 p.m. indicated the wraps around trays get holes, but they have processes in place to catch this. The wraps are held up to the light to check for holes and the equipment is not placed on the table until this check is completed. If this occurs, the tray is not placed within the sterile field and is removed prior to contamination of the field. This scrub technician further indicated the metal tray has a lock that indicates the metal tray has been sterilized, but 3-4 times since she stated, the lock has not been placed properly, so the staff will not use that tray and they get another. Risk Management present during this interview stated she was unaware of this issue.