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Based on review of policies and procedures and interview, it was determined the Operating Room staff failed to follow established processes to assure unsterile instruments were not used in two of two (#1 and #2) patient's surgical procedures reviewed. The failed practice did not assure the sterility of instruments utilized during surgical procedures and had the likelihood to affect all surgical patients admitted to the facility. See CMS-2567, A951.

Based on review of policies and procedures and interview, it was determined the Operating Room staff failed to follow established processes to assure unsterile instruments were not used in two of two (#1 and #2) patient's surgical procedures reviewed. The failed practice did not assure cross contamination did not occur between patients and had the likelihood to affect all surgical patients admitted to the facility. Findings follow:

A. During interview 02/19/14 at 1330, the Director of Surgical Services stated, "There had been two occasions where the sterility of surgical instruments had been doubted. The first occurred 02/13/14 and involved Patient #1 the second occurred 02/14/14 and involved Patient #2".
1. The Director of Surgical Services described Patient #1's event which included Scrub Nurse #1 stating, "something's not right" when she received a set of instruments from Sales Representative #1 which were not wrapped, were on a white towel, were wet and did not contain a sterile indicator. Scrub Nurse #1 did not stop the procedure. Physician #1 used a screw driver and one other instrument out of the set for the surgical procedure. 2. The Director of Surgical Services described Patient #2's event when a foreign object was discovered underneath a sterile towel which was not in contact with the pan of instruments. Scrub Nurse #3 had doubts as to the sterility of the pan but used the set of instruments. Scrub Nurse #3 reported it to the Director of Surgical Services after the procedure.
B. During interview on 02/20/14 from 0900 to 1130 regarding Patient #1's incident 02/13/14, the Hospital Legal Counsel stated separate interviews were held with Physician #1, Sales Representative #1, Scrub Nurses #1 and #2 and Instrument Technician #1. Each was asked to describe their side of the story. Physician #1 stated he thought the instruments had been flashed. Sales Representative #1 stated he thought the instruments were sterile. Scrub Nurse #1 stated she told Physician #1 on three occasions that "something wasn't right" and she could not find a sterile indicator. Instrument Technician #1 stated she told Sales Representative #1 the instruments were "ready" but this meant they were ready to be sterilized. Hospital Legal Counsel commented there had been a miscommunication between Sales Representative #1 and Instrument Technician #1.
C. Review of Policy, "Surgical Asepsis" revealed all items used within a sterile field must be sterile. All persons working in the OR (Operating Room) must maintain a diligent watch over sterile areas and point out any contamination at once. The state of sterility is an absolute, items are either sterile or unsterile. The application of the principles of Surgical Asepsis depends on you, your understanding and your conscience. Just remember: When in Doubt, Don't!
D. Review of Policy, "Steam Sterilizing Infection Control Central Sterile" revealed "place internal chemical (indicator) on instruments with ink side up so it is easily readable. Wrap sequentially keeping in mind the reason why it is wrapped that way. Secure with autoclave tape, write name of tray and sign your initials. An autoclave lot control sticker is placed on item as it is loaded onto autoclave cart. This sticker provides information, autoclave number, load, date of sterilization and date of expiration".
E. During interview 02/19/14 at 1330, when asked about Sales Representative training in preparation to be in the OR, the Director of Surgical Services stated, "All Sales Reps are given a packet with OR policies and procedures and must sign that they have received it".
F. During interview on 02/19/14 at 1330, the Director of Surgical Services stated, "Sales Representative #1 took contaminated instruments from Scrub Nurse #1 and carried them to Central Sterile for processing". Instrument Technician #1 cleaned the instruments and placed them through the washer. Once the washer was complete, Instrument technician #1 placed the wet instruments on a white bath towel and told Sales Representative #1 the instruments were ready for the OR. Sales Representative #1 took the instruments (unsterile) into the OR where Scrub Nurse #1 received them.
G. Review of Policy, "Health Care Industry Representatives in the OR" (Sales Reps) revealed #1. The Representative will have documentation or demonstrated the knowledge of sterile technique, surgical attire, universal precautions, etiquette, traffic patterns and OR hazards. #7. Representative may not scrub, or assist on any procedure; they may not manipulate the equipment or have any contact with the patient during the procedure. Their participation is limited to verbal consultation only.
H. Findings were confirmed with the Director of Surgical Services at the time of interview on 02/19/14 at 1330.