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Based on observation, interview, and document review, the Infection Control Officer (ICO) failed to implement aseptic cleaning procedures between surgeries in 1 (#6) of 2 of operating rooms; failed to develop and/or implement infection control policies & procedures for 2 (#6, #8) of 2 observations of instrument cleaning immediately following surgical cases; and failed to ensure staff received education and were deemed competent in infection control policies & procedures for surgical housekeeping staff and central sterile processing staff, resulting in the potential for unsatisfactory patient outcomes for all surgical patients served by the facility. A total of six surgical case observations were conducted. Findings include: See A748.

Based on observation, interview, and document review, the Infection Control Officer (ICO) failed to implement aseptic cleaning procedures between surgeries in 1 (#6) of 2 of operating rooms; failed to develop and/or implement infection control policies & procedures for 2 (#6, #8) of 2 observations of instrument cleaning immediately following surgical cases; and failed to ensure staff received education and were deemed competent in infection control policies & procedures for surgical housekeeping staff and central sterile processing staff, resulting in the potential for unsatisfactory patient outcomes for all surgical patients served by the facility. A total of six surgical case observations were conducted. Findings include:

Surgical suite cleaning of room seven, after case #6 (Between Case Cleaning) was observed on 8/29/16 between 1130 and 1215 revealed the following:

On 8/29/16 at approximately 1130, Surgical Housekeeping Aide K was noted to wipe down areas but not getting all surfaces of the Operating Room Table and wiping instrument cords but placing the cords low and near the blood stained floor. Cords later dropped to the blood stained floor at approximately 1145. Review of the employee's personnel file with Director S, revealed that the employee had infection control training documented 2/2/16, a satisfactory overall performance review dated 2/29/16, but a "Cleaning Step" overall percentage "Pass Score 48.39 %", also dated 2/29/16.

On 8/29/16 at approximately 1145, Surgical Housekeeping Aide L was observed mopping the blood stained floor without moving cleaned equipment and the dirty mop touched clean equipment cords. One cleaned cord fell to the floor and was picked up and placed back in a low position by staff L. Interview with Staff L, on 8/29/16 at approximately 1215, revealed that she did not usually work housekeeping in the surgical suite. She stated, "I usually work (in the) discharge (areas)." Review of the personnel file of Staff L with Director S, on 8/29/16 at approximately 1500, revealed that this employee had been hired in May 2016 and had documented 'Surgical Between Cases Housekeeper Training' on 6/3/16. Director S also stated, "It was too early for performance review."

On 8/29/16 at approximately 1200, Surgical Patient Care Assistant M was observed coming in to help with getting the room ready. Staff M pulled gloves out of the box, dropped some gloves on the dirty floor and placed the now dirty gloves back in the clean box of gloves. The surveyor stopped Staff M and queried, "Where did you put those gloves that you dropped?" At that point Staff M looked and then pulled the box off the cart and threw the box away. Review of Staff M's personnel file on 8/30/16 at approximately 1330, revealed that the employee had recent infection control training in August 2016 and a recent (2016) "Satisfactory" performance review.

Review of hospital policies & procedures, on 8/30/16 at approximately 0900, revealed the following: "Policy No. 2 ES 533, titled Surgery Suite Cleaning, dated 2/20/14," documented "Between Case Cleaning, 4. Wash OR table top to bottom, including the undersides of table pads. Move table and mop under it, return the table to its original position." "Policy No. 2 IC 022 & 2 POS 104 titled "Operating Room (OR) Infection Control, dated 10/18/13" documented, "4. Environment, A. OR Sanitation, b. Principles of aseptic technique must be followed meticulously." This had not been done by the above staff.

Interview with the ICO, on 8/30/16 at approximately 1230, regarding infection prevention, surveillance, and recent concerns of the operating room and surgical instrument cleaning, revealed that she "had made weekly and now every two weeks of environmental rounds," but had not observed cleaning in the operating room or cleaning of instruments.



26222

On 8/29/16 at 10:30 AM, during a tour of the Central Sterile Processing (CSP) department, a tray of dirty instruments was observed with dried blood on the instruments in the decontamination side of the department. In interview with Staff Q, he stated that the new CSP management is in the process of revising the policy to begin pre-cleaning in the OR but that the new policy is not yet in place.

On 8/29/16 at 11:05 AM, during interview with Staff R regarding training of CSP employees it was stated that the previous CSP manager had thrown away training records prior to leaving the department, but there were some training records that had been found. When asked for all the training records for 2016 a folder of sign in sheets was provided by Staff R. During record review of these training records, it was noted that many employees had not attended the trainings, as demonstrated by not signing the sign in sheet. Review of the sign in sheets for the 18 training sessions conducted in 2016 are noted below. Additionally, supporting documentation for the specific content of the 18 training sessions conducted in 2016 was only available for 3 trainings: "AAMI ST79 Updates...", "Dress Code", and "Dispatch Cleaner Disinfectant".

Training dated 1/13/16 titled "Weekend request/shift change forms/Weekend shift makeup..."; 39 of 74 employees did not attend the training.
Training dated 1/27/16 titled "AAMI ST79 Updates..."; 26 of 75 employees did not attend the training.
Training dated 2/10/16 titled "IMS Surgical Instrument Testing & Inspection Standards"; 47 of 74 employees did not attend the training.
Training undated titled "BK Transducer Probes & Leak Testing"; 46 of 76 employees did not attend the training.
Training dated 3/9/16 titled "Hitachi Aloka Ultrasound"; 25 of 74 employees did not attend the training.
Training dated 3/16/16 titled "Emergency Doors"; 23 of 74 employees did not attend the training.
Training dated 3/16/16 titled "Holiday policy"; 21 of 74 employees did not attend the training.
Training dated 3/30/16 titled "Power Equipment"; 46 of 74 employees did not attend the training.
Training dated 3/31/16 titled "Matrixnuero ULP"; 38 of 74 employees did not attend the training.
Training dated 4/18/16 titled "Use of Alex Gold in Decontamination"; 37 of 74 employees did not attend the training.
Training dated 6/7/16 titled "Synthes Matrix ULP cart for refill"; 27 of 74 employees did not attend the training.
Training dated 6/15/16 titled "Biological Indicator & Documentation"; 25 of 74 employees did not attend the training.
Training dated 6/20/16 titled "dress code"; 34 of 74 employees did not attend the training.
Training dated 6/28/16 titled "Dispatch Cleaner Disinfectant"; 46 of 74 employees did not attend the training.
Training dated 6/29/16 titled "Back to Basics - Instrument Inspection"; 28 of 74 employees did not attend the training.
Training dated 7/26/16 titled "Back to Basics"; 27 of 76 employees did not attend the training.
Training dated 8/3/16 titled "CSP/Perioperative Services"; 39 of 76 employees did not attend the training.
Training dated 8/4/16 titled "Implementation of Yellow DRH OR Instrumentation"; 51 of 74 employees did not attend the training.
Of 18 training sign in sheets, 3 sign in sheets had supporting documentation of material that was covered during the training.

On 8/29/16 at approximately 1130, Staff R was then asked how employees are trained if they miss the training date and how it is documented. Staff R then stated that the employee is trained on the missed subject at a future time but there is no follow up sign in sheet or other documentation. Staff R was also queried as to the availability of supporting documentation for what was covered during the remaining 15 training sessions. No additional documentation was available for review.



27713

On 8/29/16 at 1100, during observations at the end of surgery for Patient #8, Staff AA was observed collecting the surgical instruments and equipment at the end of surgery. Surgical instruments that were visibly contaminated with blood were observed resting on a table. The instruments were not wiped off or soaked to prevent tissue and blood from drying on the instruments. Staff AA collected the surgical instruments and piled them on top of each other in the instrument containers without wiping off the visible blood.

On 8/29/16 at 1115, Staff AA sprayed the top of the visibly bloody instruments in each container with an enzymatic spray and closed the containers. The instruments were not completely saturated with the enzymatic spray, and were not covered with a moist towel before the containers were closed.

On 8/29/16 at 1120, Staff AA Placed all the instrument containers from Patient #8's surgery into a case cart and took the cart to the hallway. At this time Staff AA was asked how surgical instruments were initially processed by the operating room ( OR) staff before they were sent down to Central Supply Processing (CSP) for sterilization. Staff AA stated, "We mainly spray the bloody spots. We never wash or soak the instruments in the OR, just spray them with the (enzymatic spray product) and hold them in this cart until they do the massive cleaning downstairs."

On 8/29/16 at 1145, Staff V was interviewed during setting up of surgical instruments on the sterile back table before surgery, and stated, "I always check inside (holding up hollow instrument). I've had it come up dirty before. The drill guide needs to be taken apart and cleaned inside. I always check it. Blood that's been through the autoclave (sterilizer) is easy to see because it's black."

On 8/29/16 at 1505 the OR Nurse manager, Staff I was interviewed and reported that during surgery, Surgical Technicians were supposed to wipe tissue and blood off of instruments with a sterile towel and irrigate (force sterile water through) any blood or tissue contaminated hollow instruments, and soak used instruments in a bucket of sterile water to keep blood and tissue from drying into the instruments.

On 8/30/16 at 1230 the hospital epidemiologist, Staff O was interviewed and stated that no infection control audits or direct observations of point of use initial cleaning of OR instruments had been done since 2015.

On 8/30/16 at 1330, the OR Nurse Educator, Staff FF was interviewed and stated that OR staff were supposed to wipe visible blood and tissue off instruments with a sterile towel as soon as possible during surgery, and were supposed to soak used instruments in a bucket of sterile water and spray out cannulated (hollow) instruments as soon as possible. Staff FF stated that staff were supposed to wipe off all visible blood and tissue, spray with (enzymatic spray product) and cover them with a moist towel before packing the instruments into the containers.

ON 8/30/16 at 1400, Staff FF provided documentation of an OR staff inservice (training) entitled, "Instrument Care Post Procedure", held on 7/20/16. Review of the inservice minutes revealed the following Association of Perioperative Registered Nurses (AORN) guidelines were covered during the inservice:

"Instruments must be cleaned and decontaminated as soon as possible after use. Preparation for decontamination of instruments begins at the point of use. Instruments must be kept free of gross soil during the procedure. During the procedure, the scrub person should remove gross soil from instruments by wiping the surfaces with a sponge and water. Instruments must be kept moist until they are cleaned in CSP. Spray (enzymatic spray product) and cover with a towel moistened with water."

On 8/30/16 at 1420 The Manager of Patient Care, Staff DD was interviewed and reported that broken, missing and contaminated instruments was a process improvement project in 9/24/15. Review of the provided Process improvement project event goals dated 7/10/15 indicated that "bioburden" (blood and tissue) was one of three number one quality concerns. An attached e-mail provided with the Process Improvement information, dated 6/23/15 at 1100 documented a goal as "no bioburden". Review of an attached OR staff inservice dated 8/5/15 revealed the following items in the inservice outline, "The department was held responsible for returned dirty case carts that were noted grossly bloodied... and instruments "thrown into pans or basins. Keep instruments debris free, flush suction tips and tubing and clean used instruments when no longer needed. Pre-soak instruments to prevent blood and debris from drying on the instruments and spray with enzymatic pre-cleaning solutions."

On 8/30/16 at 1430 Staff DD was asked whether audits of point of use surgical instrument cleaning and decontamination were done. Staff DD stated, "Doing audits has been a problem." When asked about this, Staff DD stated that residual bioburden on surgical instruments was a lower priority problem than the other two problems identified for process improvement, so no audits were done in 2016. When asked how surgical instruments should be cared for in the OR before they were sent down to CSP, Staff DD stated, "Instruments should be soaked or wiped down during the procedure to remove bioburden. I should keep instruments moist by covering with a towel and spraying with (enzymatic spray product) before they're sent down to CSP." Staff DD was asked if there was a policy for point of use cleaning and decontamination of surgical instruments and the following were provided:

A facility Epidemiology document dated 4/2015, entitled, "Medical Equipment Pre-Cleaning Concepts" noted the following, "Medical equipment should be cleaned immediately after use because dried blood, mucous, and other biological material on the surfaces of equipment reduces the effectiveness of disinfection and sterilization."

A facility policy dated 12/10/14, entitled, "Pre-Cleaning of Reusable Medical Instruments", noted the following, "Blood and body fluids can cause pitting of instruments and, if left to dry, can be difficult to remove. If blood and body fluids are not removed, they reduce the effectiveness of high level disinfection and sterilization. As soon as it is done being used, equipment should be soaked to keep it from drying out."

On 8/30/16 at 1440 the director of the facility's CSP contracted provider Q was interviewed regarding CSP expectations for OR cleaning and decontamination of surgical instruments and stated, "Gross contamination should be cleaned off, lumens (hollow centers) cleaned out. The instruments should be placed in the tray they came in on on top of a towel and sprayed with (enzymatic spray product) and covered."



30562

On 8/29/16 at 1125, during observations at the completion of surgery for Patient #6, Staff Z brought the case cart from the Operating Room to the area outside of the soiled utility room. At approximately 1130 Staff JJ transported the case cart to the Central Sterile Processing (CSP) Department. Upon arrival to the decontamination area of CSP the case cart was opened, all instrument sets appeared dry, without evidence of enzymatic foam spray having been applied. Staff II confirmed the instrument sets had not been sprayed with enzymatic foam spray. Staff II stated, "All instrument sets are suppose to be sprayed before leaving the Operating Room and coming to CSP."

On 8/29/2016 at approximately 1200 surveyor examined the contents of three (3) sterile instrument sets that were stored on supply carts, available for patient use when requested for surgical cases. One (1) of three (3) sets examined, a Neuro Surgical tray, contained multiple weitlander retractors, found in the closed position with instrument surfaces touching. The Director of Clinical Operations (HH) and the Owner (GG) of the newly hired management organization, for the CSP Department, were present and confirmed the set had not been properly sterilized.

According to Perioperative Standards and Recommended Practices of the Association of Perioperative Registered Nurses (AORN); 2013: 485-504, "All hinged instruments should be sterilized in the open position ... The rationale behind the practice is to expose all surfaces to the sterilant."

Based on observation, interview, and document review, the Infection Control Officer (ICO) failed to implement aseptic cleaning procedures between surgeries in 1 (#6) of 2 of operating rooms; failed to develop and/or implement infection control policies & procedures for 2 (#6, #8) of 2 observations of instrument cleaning immediately following surgical cases; and failed to ensure staff received education and were deemed competent in infection control policies & procedures for surgical housekeeping staff and central sterile processing staff, resulting in the potential for unsatisfactory patient outcomes for all surgical patients served by the facility. A total of six surgical case observations were conducted. Findings include:

Surgical suite cleaning of room seven, after case #6 (Between Case Cleaning) was observed on 8/29/16 between 1130 and 1215 revealed the following:

On 8/29/16 at approximately 1130, Surgical Housekeeping Aide K was noted to wipe down areas but not getting all surfaces of the Operating Room Table and wiping instrument cords but placing the cords low and near the blood stained floor. Cords later dropped to the blood stained floor at approximately 1145. Review of the employee's personnel file with Director S, revealed that the employee had infection control training documented 2/2/16, a satisfactory overall performance review dated 2/29/16, but a "Cleaning Step" overall percentage "Pass Score 48.39 %", also dated 2/29/16.

On 8/29/16 at approximately 1145, Surgical Housekeeping Aide L was observed mopping the blood stained floor without moving cleaned equipment and the dirty mop touched clean equipment cords. One cleaned cord fell to the floor and was picked up and placed back in a low position by staff L. Interview with Staff L, on 8/29/16 at approximately 1215, revealed that she did not usually work housekeeping in the surgical suite. She stated, "I usually work (in the) discharge (areas)." Review of the personnel file of Staff L with Director S, on 8/29/16 at approximately 1500, revealed that this employee had been hired in May 2016 and had documented 'Surgical Between Cases Housekeeper Training' on 6/3/16. Director S also stated, "It was too early for performance review."

On 8/29/16 at approximately 1200, Surgical Patient Care Assistant M was observed coming in to help with getting the room ready. Staff M pulled gloves out of the box, dropped some gloves on the dirty floor and placed the now dirty gloves back in the clean box of gloves. The surveyor stopped Staff M and queried, "Where did you put those gloves that you dropped?" At that point Staff M looked and then pulled the box off the cart and threw the box away. Review of Staff M's personnel file on 8/30/16 at approximately 1330, revealed that the employee had recent infection control training in August 2016 and a recent (2016) "Satisfactory" performance review.

Review of hospital policies & procedures, on 8/30/16 at approximately 0900, revealed the following: "Policy No. 2 ES 533, titled Surgery Suite Cleaning, dated 2/20/14," documented "Between Case Cleaning, 4. Wash OR table top to bottom, including the undersides of table pads. Move table and mop under it, return the table to its original position." "Policy No. 2 IC 022 & 2 POS 104 titled "Operating Room (OR) Infection Control, dated 10/18/13" documented, "4. Environment, A. OR Sanitation, b. Principles of aseptic technique must be followed meticulously." This had not been done by the above staff.

Interview with the ICO, on 8/30/16 at approximately 1230, regarding infection prevention, surveillance, and recent concerns of the operating room and surgical instrument cleaning, revealed that she "had made weekly and now every two weeks of environmental rounds," but had not observed cleaning in the operating room or cleaning of instruments.



26222

On 8/29/16 at 10:30 AM, during a tour of the Central Sterile Processing (CSP) department, a tray of dirty instruments was observed with dried blood on the instruments in the decontamination side of the department. In interview with Staff Q, he stated that the new CSP management is in the process of revising the policy to begin pre-cleaning in the OR but that the new policy is not yet in place.

On 8/29/16 at 11:05 AM, during interview with Staff R regarding training of CSP employees it was stated that the previous CSP manager had thrown away training records prior to leaving the department, but there were some training records that had been found. When asked for all the training records for 2016 a folder of sign in sheets was provided by Staff R. During record review of these training records, it was noted that many employees had not attended the trainings, as demonstrated by not signing the sign in sheet. Review of the sign in sheets for the 18 training sessions conducted in 2016 are noted below. Additionally, supporting documentation for the specific content of the 18 training sessions conducted in 2016 was only available for 3 trainings: "AAMI ST79 Updates...", "Dress Code", and "Dispatch Cleaner Disinfectant".

Training dated 1/13/16 titled "Weekend request/shift change forms/Weekend shift makeup..."; 39 of 74 employees did not attend the training.
Training dated 1/27/16 titled "AAMI ST79 Updates..."; 26 of 75 employees did not attend the training.
Training dated 2/10/16 titled "IMS Surgical Instrument Testing & Inspection Standards"; 47 of 74 employees did not attend the training.
Training undated titled "BK Transducer Probes & Leak Testing"; 46 of 76 employees did not attend the training.
Training dated 3/9/16 titled "Hitachi Aloka Ultrasound"; 25 of 74 employees did not attend the training.
Training dated 3/16/16 titled "Emergency Doors"; 23 of 74 employees did not attend the training.
Training dated 3/16/16 titled "Holiday policy"; 21 of 74 employees did not attend the training.
Training dated 3/30/16 titled "Power Equipment"; 46 of 74 employees did not attend the training.
Training dated 3/31/16 titled "Matrixnuero ULP"; 38 of 74 employees did not attend the training.
Training dated 4/18/16 titled "Use of Alex Gold in Decontamination"; 37 of 74 employees did not attend the training.
Training dated 6/7/16 titled "Synthes Matrix ULP cart for refill"; 27 of 74 employees did not attend the training.
Training dated 6/15/16 titled "Biological Indicator & Documentation"; 25 of 74 employees did not attend the training.
Training dated 6/20/16 titled "dress code"; 34 of 74 employees did not attend the training.
Training dated 6/28/16 titled "Dispatch Cleaner Disinfectant"; 46 of 74 employees did not attend the training.
Training dated 6/29/16 titled "Back to Basics - Instrument Inspection"; 28 of 74 employees did not attend the training.
Training dated 7/26/16 titled "Back to Basics"; 27 of 76 employees did not attend the training.
Training dated 8/3/16 titled "CSP/Perioperative Services"; 39 of 76 employees did not attend the training.
Training dated 8/4/16 titled "Implementation of Yellow DRH OR Instrumentation"; 51 of 74 employees did not attend the training.
Of 18 training sign in sheets, 3 sign in sheets had supporting documentation of material that was covered during the training.

On 8/29/16 at approximately 1130, Staff R was then asked how employees are trained if they miss the training date and how it is documented. Staff R then stated that the employee is trained on the missed subject at a future time but there is no follow up sign in sheet or other documentation. Staff R was also queried as to the availability of supporting documentation for what was covered during the remaining 15 training sessions. No additional documentation was available for review.



27713

On 8/29/16 at 1100, during observations at the end of surgery for Patient #8, Staff AA was observed collecting the surgical instruments and equipment at the end of surgery. Surgical instruments that were visibly contaminated with blood were observed resting on a table. The instruments were not wiped off or soaked to prevent tissue and blood from drying on the instruments. Staff AA collected the surgical instruments and piled them o