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Based on observations, interviews, review of the Hospital's policies/procedures, immediate use sterilization logs, Operating Room (OR) Environmental Services Master Schedule, OR Terminal Cleaning Checklists, personnel files and interviews, the Hospital failed to consistently ensure proper cleaning of equipment, a sanitary environment and staff adherence to infection control policies and procedures to prevent transmission of infections and communicable diseases for 2 (#1, #2) of 10 patients reviewed and that terminal cleaning in 21 of 21 ORs was consistently performed. Please refer to A749 for the specific deficient practices observed in support of the condition level non-compliance.

Based on observations, interviews, review of the Hospital's policies/procedures, immediate use sterilization logs, Operating Room (OR) Environmental Services Master Schedule, OR Terminal Cleaning Checklist, personnel files and interviews, the Hospital failed to consistently ensure an acceptable level of infection prevention practice for 2 (#1, #2) of 10 patients reviewed and that terminal cleaning was consistently performed.

Findings included:

1. Observations in operating room (OR) #4, from 10:00 A.M. to 11:15 A.M. on 11/26/12, included:

a. The flat, plastic board used to transfer patients to and from the OR bed was stored directly on the floor behind the patient entrance to the room.


b. According the Association of Perioperative Registered Nurses (AORN) Perioperative Standards and Recommended Practices, Recommended Practices for Aseptic Practice IV.5 reads, "All items should be delivered to the surgical field in a manner that prevents nonsterile objects or people from extending over the sterile field. Skin is a source of bacteria microscopic skin cells are constantly shedded. Therefore, maintaining distance from the sterile field decreases the potential for contamination when items are passed from a nonsterile area to a sterile area."

Certified Surgical Technologist (CST) #1 and Registered Nurse (RN) #4 were observed reaching over the sterile table approximately five times each, while delivering sterile supplies (e.g., gloves, gown) to the sterile OR table.


c. RN #4 failed to consistently maintain CDC Infection Control Standards of Practice. RN #4 failed to don clean gloves when providing direct care to Patient #2 in the OR as follows:
-Touched Patient #2 to position the patient for the procedure;
-Removed the patient's hospital gown;
-Touched the patient's legs and feet to apply SCD (sequential compression device) boots on the patient's legs. SCD boots are used to prevent formation of deep vein blood clots.
-After completing the above tasks, RN #4 took gloves from the clean glove box without first performing hand hygiene.
RN #4 failed to adhere to Hospital policy and AORN Standards of Practice.

Additionally, in preparation for the insertion of the urinary catheter and the surgical skin prep, the RN#4 removed the safety strap from the patient and the strap fell to the floor. After the catheter was inserted and the surgical prep was completed, the RN picked the safety strap from the floor and placed it on the patient. The RN failed to disinfect the strap before placing it on the patient, approximately 10 inches from the surgical field.

d. Review of the Hospital's Surgical Services Policy titled Surgical Shave Prep indicated that a shave prep should be done as close to the surgical procedure as possible in an area outside the OR.

AORN Perioperative Standards and Recommended Practice for Aseptic Practice IV.b.2, reads, "Hair removal should be performed the day of surgery in a location outside the OR."

Observations in OR #4, on 11/26/12, at approximately 11:00 A.M., after Patient #2 was anesthetized, indicated that Physician #4 shaved a significant amount of hair from the operative site on the patient's abdomen. [Observation in the preoperative holding area indicated the OR staff had an opportunity to remove hair from the patient's operative site outside the OR as observation indicated the Patient had been in the Preoperative Holding Area for approximately 30 minutes prior to entering the OR.]

e. Observations in OR #4 on 11/26/12 at approximately 11:10 A.M., indicated that Physician #3 failed to wear required personal protective equipment (PPE), i.e., gloves, before examining the patient's lower abdomen and groin area as required by CDC Infection Control Standards of Practice.

Immediately after examining the patient, Physician #3, opened a sterile indwelling urinary catheter set, donned sterile gloves and catheterized the patient. The physician failed to perform hand hygiene before donning sterile gloves and catheterizing the patient.

2. Observations in OR #19, on 11/26/12 at approximately 11:40 A.M. indicated the following breeches in Infection Control Standards of Practice for Patient #1 and the manufacturer's directions for use, as follows:

a. In preparation for insertion of an arterial line (A-line), Physician #1 donned clean gloves, opened a sterile A-Line insertion kit, removed the Chloro-Prep (an antiseptic) applicator and prepped the patient's skin at the line insertion site. The Physician only prepped the area for approximately 10 seconds.

Review of the Manufacturer's directions for use (DFU) on 10/26/12, read as follows:
"Use repeated back and forth strokes of the sponge for approximately 30 seconds. Completely wet the area with the antiseptic. Let dry for 30 seconds."

b. RNs #5 and #6 had set up a sterile surgical table (#1) for Patient #1's scheduled case and then RN #5 went on break. Certified Surgical Technologist (CST) #2 relieved the RN#5 for his break. To make room for a second sterile (surgical table #2), CST #2 moved surgical table #1 to a distance of approximately 3 to 4 inches from the wall.

Review of AORN Standard for Aseptic Practice V.3. subsequent to survey on 11/28/12, indicated that a distance of 12 inches should be maintained from a sterile field (e.g., surgical table #1). By moving the sterile surgical table close to the unsterile wall, the CST increased the risk for cross-contamination of the sterile supplies that were on surgical table #1.


3. Observations in the Floating Building Post Anesthesia Care Unit (PACU), from approximately 1:50 P.M. to 2:30 P.M. on 11/26/12, included the following:

According to AORN Standard for Environmental Cleaning in the Perioperative Setting Recommendation I, indicated that the patient should be provided a safe, clean environment.

In an interview during the observations, RN #10 acknowledged that the below identified areas could not be effectively cleaned and disinfected.

-The shelf and drawers along the headwall in PACU recovery bays #1 to #5 were wooden and not smooth, non-porous, washable surfaces.
-The wall, shelves and drawers were painted with scenes and characters familiar to children. (The above bays were primarily used for pediatric patients).
-The paint was chipped off the corners of the wood drawers in recovery bays #3, #4, and #5, exposing the old, bare wood and increasing the risk for bacterial growth and cross contamination.
-The inside of the drawers in these bays were dirty with dust and debris, stained from spillage, and had adhesive tape and adhesive tape residue.
- In PACU Recovery Bay #6, an approximate 8 inch by 4 inch section of the laminate was broken, and hanging off from the counter apron, creating a risk for bacterial growth and cross contamination.


4. Observations in the Floating Building OR (the main OR), at approximately 8:30 A.M., on 11/27/12, indicated the hospital failed to consistently follow it's policy for immediate-use sterilization, an abbreviated cycle of sterilization for surgical items that are required on short notice (formerly know as "flash sterilization."). Findings include:

a. Observation of the immediate-use sterilization logs and sterilizer tapes for 4 of 6 sterilizers reviewed (#3, #4, #5, and #6), indicated approximately 35 immediate-use sterilization cycles had been performed from 10/26/12 to 11/27/12. According to the hospital policy, documentation of the patient's name, the reason for sterilizing the instrument(s), the general contents of the load and the signature of the operator of the sterilizer were to be entered into immediate-use sterilization logs. Of the 35 sterilizer run cycles, only 18 (53%) met the documentation requirements. Of the cycles that were run, 8 were not entered into the log. Instead, the strips were tucked into the log book holder.
b. According to current Association of Perioperative Registered Nurses (AORN) guidelines, documentation of the reason for immediate-use sterilization is also necessary to determine the validity of using immediate-use sterilization.

5. Observations in the Sterile Central Core of the OR from approximately 9:15 A.M. to 10:00 A.M. on 11/26/12, included the following:

a. An electronic piece of OR equipment, the coagulation machine, was secured to its base with approximately 3 feet of 3 inch tape.

b. Eleven pieces of tape, indicating the 11 ORs (e.g., OR 1, OR 2, OR 3) , were taped to the wire rack located immediately next to Sterilizer #4. The Central Processing Department (CPD) Manager #1 said the staff used the pieces of tape, on an ongoing basis, to identify the room to which the contents of the sterilizer should be returned. Tape residue was observed on the wire rack, used to store sterile and clean OR supplies. Infection Preventionist (IP) #1 said tape residue harbors bacteria and doesn't permit effective disinfection of equipment. The OR Manager said the staff utilize this process with all six OR sterilizers.

6. During interviews with RNs #4, #7, #8, #11, and CST #2 between 10:30 A.M. and 3:00 P.M., the RNs and CST all said the lack of cleanliness of the Perioperative Suite was a major issue. For example:

a. RN #4 said she found blood on the wall in OR #4, first thing in the morning of 11/27/12. No cases had been performed in the room since the previous day.

b. CST#1 said she found a bloodied drape clip on the OR table drape holder in OR #2 on the 11/27/12. No cases had been performed in the room since the previous day.



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7. Review of the Hospital Policy/Procedure titled Terminal Cleaning and Disinfecting of Operating Rooms on 11/27/12, every OR was to be terminal cleaned every 24 hour period if the room had been opened and used for a surgical case. Based on the findings identified above, point a and b, terminal cleaning of the ORs (2 of 21) was not consistently performed.

a. The Environmental Services Department's (ESD) OR Master Schedule for the second and third shifts indicated that 2 ESD staff were scheduled the second shift and 3 ESD staff were scheduled the third shift Monday through Friday to terminally clean 21 OR rooms. The schedule indicated that 2 of the 3 ESD staff scheduled on the third shift were also scheduled to carry out duties in other areas of the Hospital as well as the OR. The schedule indicated that one ESD staff was scheduled the third shift Saturday and Sunday to clean the OR areas.

b. Surveyor #2 interviewed the ESD Director on 11/26/12 at 3:15 P.M. with Senior Risk Manager #2 present. The ESD Director said that terminal cleaning was done 5 nights a week in the secondary OR and 6 nights a week in the main OR. The ESD Director said that during the 2nd shift, the ESD staff were responsible for starting terminal cleaning in those OR rooms that were finished for the day. The ESD Director said that on the 3rd shift, there were 3 ESD staff assigned to do terminal cleaning, but 2 of the 3 ESD staff could be pulled to clean other areas of the Hospital. The ESD Director said that a fourth ESD staff was scheduled for the third shift twice weekly to perform extra cleaning duties.

c. Surveyor #2 interviewed one of the third shift ESD staff assigned to the OR on the third shift on 11/28/12 at 7:30 A.M. with Senior Risk Manager #2, the OR Clinical Director, the ESD Director and the Hospitality Director present. The ESD staff identified himself as the ESD Supervisor and said it was his job to check and ensure that terminal cleaning was performed and completed. The Supervisor said he looked at each OR room to ensure that cleaning was completed.

d. The ESD Director said that the ESD staff performing the terminal cleaning was supposed to complete the OR Terminal Cleaning Checklist and the ESD Supervisor was supposed to check that terminal cleaning was completed and sign the Checklist.

e. Surveyor #2 reviewed the OR Terminal Cleaning Checklists, dated 10/18/12 to 11/24/12, and determined that the OR Terminal Cleaning Checklists were not completed to indicate terminal cleaning was carried out for the following dates/rooms:

i. Checklists were not completed for any of the 23 OR rooms on 10/20/12, 10/27/12, 10/29/12, 10/31/12, 11/1/12, 11/3/12, 11/5/12, 11/10/12 and 11/23/12.

ii. Checklists were not completed for certain OR rooms on the following dates: 10/22/12 OR Suites 1, 3 and 16-23; 10/23/12 OR Suite #19; 10/24/12 OR Suites 12 and 13; 10/31/12 OR Suites 10 and 13-23; 11/8/12 OR Suites 16, 17, 19 and 22; 11/15/12 OR Suites 16 to 23; 11/20/12 OR Suites 16-23; and 11/22/12 OR Suite 19.

f. Surveyor #2 reviewed the Main OR Terminal Cleaning Sheet which described task steps to be taken to clean specific areas of the OR. The task steps were coded as Spacecare QL (SCQL), which referred to the task steps to clean a workroom and Spacecare
MB (SCMB), which referred to the task steps to cleaning an OR room and included terminal cleaning.

g. Surveyor #2 reviewed the educational files for 14 ESD staff which included names identified on the OR Terminal Cleaning Checklists and determined that although the 14 ESD staff were trained in SCQL, they were not trained in SCMB.

Based on observations and interview, the Hospital failed to ensure that staff implemented policies for aseptic and sterile technique, disinfection procedures, and proper technique during the surgical skin prep.
Findings included:

1. Observations in OR #4, on 11/26/12, from 10:00 A.M. to 11:15 A.M., indicated that RN #4 and Certified Surgical Technologist #1 failed to adhere to AORN Standards of Care regarding the maintenance of a sterile field. Both staff reached over the sterile surgical table to dispense sterile supplies to the table.

Please refer to A749.

2. Observations in OR #4 at approximately 10:30 A.M. on 11/26/12, and in OR #19 at approximately 11:45 A.M., indicated that staff failed to adhere to AORN Standards of Aseptic Practice and manufacturer's directions for use when performing the shave prep and skin prep for Patient's #1 and #2.

Please refer to A749.

Based on medical record review and staff interview, the Hospital failed to ensure that Anesthesia Services were delivered in a manner that was consistent with recognized standards for anesthesia care regarding formulating the plan for anesthesia and anesthesia consent, for 1 (Patient #2) of 10 patients reviewed. Findings included:

1. According to review of a Hospital policy, subsequent to survey on 11/28/12, entitled "Center for Preoperative Assessment (CPA) Operating procedure" the Anesthesia Nurse Practitioners (NP), "see patients in the CPA under the direct supervision of an attending anesthesiologist. The NPs educate patients with respect to possible anesthetic options and the risks and benefits of each. The NPs do not formulate the anesthetic plan or consent the patient for anesthesia."

2. In an interview on 11/27/12 at approximately 10:15 A.M., the Chief of Anesthesia said that an attending anesthesiologist and an anesthesia resident were scheduled in the CPA daily, (Monday through Friday). The Chief of Anesthesia also said that the Anesthesia NPs in the CPA, performed the anesthesia assessment and under the direct supervision of the anesthesiologist. The Chief of Anesthesia additionally said that through consultation with the scheduled Anesthesiologist, an initial anesthesia plan is developed.

On the day of surgery, a CPA Patient Visit Checklist is completed and signed by the attending anesthesiologist to indicate that he/she approved the anesthesia plan, consented, and cleared the patient for anesthesia. He said NPs were not qualified to administer anesthesia and could not formulate an anesthesia plan or obtain an anesthesia consent.

3. Medical record review for Patient #2, on 11/26/12, indicated that the Preoperative Anesthetic Evaluation completed by the NP included (but was not limited to): Patient History and Review of Systems; Physical exam; Anesthesia Plan; and Consent. NP #1 then electronically signed and dated the form, indicating that she completed all the above. The form was not signed by a physician, as required.

Additionally, the CPA Patient Visit Checklist, was completed and signed by NP #1, on 11/20/12 at 10:08 A.M., indicating that she consented and cleared the patient for anesthesia. The Chief of Anesthesia said that the NP should not have signed the form and that the CPA Patient Visit Checklist should have been completed by the anesthesiologist scheduled in the CPA on that day.