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Based on observation, interview, and record review, the facility failed to ensure they had an effective infection, active, system wide infection control program for the prevention,control, and investigation of infections and communicable diseases. The infection control program did not meet the needs of all patients receiving care and supportive healthcare in the hospital as evidenced by:

1. The hospital did not have a process in place for cleaning loaner surgical instruments (surgical instrument trays rented from vendors and used for patient surgeries) according to manufacture instructions and the National Infection Control Standards the facility followed (Refer to A749 Finding 1);

2. Terminal cleaning in the SPD was not performed according to the National Infection Control Standards the hospital followed (Refer to A749 Finding 2);

3. Two of 2 sterilizers (machines used to sterilize reusable patient surgical instruments) were not cleaned according to the manufacturer's instructions for use (IFUs) (Refer to A749 Finding 3);


4. Multiple instruments which were previously cleaned, sterilized, and ready for use contained brown, red staining, jagged chips, black residue, sticky residue, and sterilized in the locked position (Refer to A749 Finding 4);

5. A neuro (neurological) implantable loaner surgical tray (reusable surgical instrument used for brain surgeries) was not cleaned according to manufacture instructions and the National Infection Control standards the facility followed (Refer to A749 Finding 5);

6. Contaminated reusable surgical instruments were not pre-cleaned according to the National Infection Control standards the facility followed (Refer to A749 Finding 6);

7. An "Electric Driver 3" loaner surgical instrument was not processed according to manufacture instructions and the National Infection Control Standards the facility followed (Refer to A749 Finding 7);

8. A loaner surgical instrument used for spine surgeries was not cleaned according to the manufacture instructions and the National Infection Control Standards the facility followed (Refer to A749 Finding 8);

9. Bristle brushes used in SPD were not cleaned and disinfected according to manufacturer's IFUs. (Refer to A749 Finding 9);

10. Reusable lenses used to perform patient eye surgeries were not sterilized according to manufacture's instructions (Refer to A749 Finding 10); and,

11. Five (5) flexible scope storage cabinets were not located in clean environments and in accordance with the National Infection Control Standards the facility followed (Refer to A749 Finding 11).

The cumulative effects of these systemic problems resulted in the hospital's inability to provide an effective hospital wide Infection Control Program.

Based on observation, interview, and record review, the hospital failed to ensure a system was in place for identifying, reporting, investigating, and controlling infections and communicable diseases when:

1. The hospital did not have a process in place for cleaning loaner surgical instruments (surgical instrument trays rented from vendors and used for patient surgeries) according to manufacture instructions and the National Infection Control Standards the hospital followed.

2. Terminal cleaning in the SPD was not performed according to the National Infection Control Standards the hospital followed.

3. Two (2) of two sterilizers (machines used to sterilize reusable patient surgical instruments) were not cleaned according to the manufacture instructions (IFUs).

4. Multiple instruments which were previously cleaned, sterilized, and ready for use, contained brown, red staining, jagged chips, black residue, sticky residue, and sterilized in the locked position.

5. A neuro implantable loaner surgical tray (reusable surgical instrument used for brain surgeries) was not cleaned according to manufacture instructions and the National Infection Control standards the facility followed.

6. Contaminated reusable surgical instruments were not pre-cleaned according to the National Infection Control standards the facility followed.

7. An "Electric Driver 3" loaner surgical instrument was not processed according to manufacture instructions and the National Infection Control Standards the facility followed.

8. A loaner surgical instrument used for spine surgeries was not cleaned according to the manufacture instructions and the National Infection Control Standards the facility followed.

9. Reusable instrument cleaning brushes were not cleaned and disinfected according to manufacture's instructions.

10. Reusable lenses used for patient surgeries were not sterilized.

11. Five flexible scope storage cabinets were not located in clean environments and in accordance with the National Infection Control Standards the facility followed.

Findings:

1. On October 1, 2019, at 9:05 a.m., a tour of the facility Sterile Processing Department (SPD - an area used to sterilize and store reusable patient surgical instruments) was conducted with the facility Infection Control Manager who stated the facility followed National Infection Control Standards and practices from the following organizations:

a. AORN - Association of Perioperative Registered Nurses;

b. AAMI - Association for the Advancement of Medical Instrumentation; and,

c. CDC -Centers for Disease Control.

At 9:15 a.m., the Perioperative Services Director (PSD), the Perioperative Services Manager (PSM), and three Sterile Processing Technicians (SPDT 1, 2, and 3) were present during the tour. The PSM stated that SPD followed AAMI and AORN standards and manufacture guidelines.

At 10 a.m., SPDT 2 was asked by surveyor to explain the facility practice for re-processing loaner instruments. SPDT 2 stated, "Loaners don't get manually washed they only go through the ultra sonic machine and then through the washer. They don't get brushed because they're supposedly clean." SPDT 1 stated, "Sometimes they only go through the washer because of time because they need them fast in the OR (operating room)."

At 10:03 a.m., the PSD stated they did not have a policy that addressed cleaning of loaner trays.

According to the National Infection Control Guidelines the facility followed, AAMI guidelines, 2017 Comprehensive Guide to steam sterilization and sterility assurance in healthcare settings, Decontamination of loaned instruments "sterility assurance related to loaned instruments should begin at the point at which the health care organization assumes responsibility for the items. All loaned instruments, regardless of whether they were processed in another health care facility, should be considered contaminated and delivered directly to the sterile processing area for decontamination. Instruments should be thoroughly cleaned and dried before sterilization ..." In addition, "Policies and procedures should be developed for all methods of decontamination of reusable items ..."

2. On October 1, 2019, at 9:15 a.m. the Perioperative Services Director (PSD), the Perioperative Services Manager (PSM), and three Sterile Processing Technicians (SPDT 1, 2, and 3) were present during a tour of SPD. The PSM stated that SPD followed AAMI and AORN standards and manufacture guidelines.

During the tour of SPD, metal racks used to store sterile supplies and the top surfaces of two (2) of 2 sterilizers contained large amounts of grey fuzzy matter. The PSD was asked what the cleaning schedule was for SPD and he indicated it was performed "bi-weekly" but would ask an Environmental Staff to explain.

At 10:23 a.m., the Environmental Services Manager (EVSM) stated that terminal cleaning was performed bi-weekly because their "Corporate" informed them that cleaning daily was "over-kill". The PSM stated, "I know our standards say to clean daily, at end of the day but Corporate said to change it to bi-weekly because it was over-kill."

On October 2, 2019, at 3:30 p.m., a record review was conducted of a document provided by the facility, titled, "Environmental Sanitation, Terminal Cleaning, and Disinfection Study Guide, 2013." The document provided detailed information specific to cleaning the environment according to the AORN guidelines the hospital followed. The document stipulated the following:

"Terminal Cleaning and disinfection of the perioperative environment decreases the amount of pathogens, dust, and debris left behind during the normal course of the day. Terminal cleaning and disinfection should be performed when all scheduled procedures have been completed and at least daily during the regular work week or more often as appropriate. Particular attention should be paid to the following areas of the perioperative suite ...sterile storage areas; substerile, hallways and floors, all exposed environmental surfaces (eg. Tops of cabinets, sterilizers ..."

On October 3, 2019, at 2:30 p.m., a concurrent record review and interview were conducted with the Environmental Services Director (EVSD) who presented and explained a document titled, "OR/SPD Terminal Clean Schedule. The EVSD stated, the document shows that terminal cleaning is performed in SPD bi-weekly.

3. On October 1, 2019, at 10:05 AM, during a tour of the SPD, two of two sterilizers (machines used to sterilize reusable patient surgical instruments), contained large amounts of brown, red, green and white staining.

SPDT 1 and SPDT 2 were asked to explain the cleaning schedule of the sterilizers. SPDT 1 and 2 both stated they did not clean the internal surfaces of the chambers. PSD validated their responses and stated that he had the vendor clean them a year ago and their staff did not clean the internal chambers. In addition, they did not have logs to show they were cleaned.

On October 1, 2019, at 11:18 a.m., a concurrent record review of the sterilizer manufacture instructions and interviews were conducted with SPDT 1 and SPDT 2. After reviewing the manufacture instructions, they stated they did not know what the manufacture required cleaning the internal chambers and they did not have the cleaning solution "Liqui-Jet" or a comparable solution, the manufacture recommended to use. There was no documented evidence to show that the manufactures "Weekly Maintenance" of the sterilizer was performed.

4. On October 1, 2019, at 10:30 a.m., during a tour of SPD, a basic surgical tray (their more common surgical tray), was inspected in the presence of SPDT 1, SPDT 2 and PSD. During the inspection the following concerns were identified on 20 of 82 previously cleaned, sterilized and ready for use surgical instruments. Some of the instruments had multiple concerns:

a. 13 instruments contained brown staining,

b. Two instruments contained jagged pitting,

c. Four instruments contained coarse and irregular non-manufactured engraving, and;

d. Three instruments contained dark residue and sticky residue.

At 11:20 a.m., a neuro (neurological) implantable surgical tray (reusable surgical instrument used for brain surgeries) was inspected. The following concerns were identified: A handle of a pair of scissors contained brown staining.

On October 1, 2019, at 3:45 p.m., during a third inspection of a previously cleaned, sterilized and ready for use instruments were inspected. The tray indicated it was a "Bookwalter" (reusable surgical instruments used for various surgeries). The following concerns were identified:

a. Seven of 7 tilt rachets (reusable surgical instrument) were in the closed/locked position;

b. Two of seven tilt rachets contained jagged non-manufacture engraving;

c. Three Richardson instruments contained jagged non-manufacture engraving;

d. One malleable instrument contained jagged non-manufacture engraving;

e. One rachet contained jagged non-manufacture engraving; and,

f. One malleable ring contained a jagged chipped surface.

At 3:53 p.m., surveyor requested from PSD to see policies specific to assembly of instruments, cleaning and sterilizing of instruments. The PSD stated they were working on developing updated policies because their existing policies were "old." The PSD stated they were supposed to follow AORN and AAMI standards for cleaning and disinfecting of instruments.

The PSD validated above findings and stated the instruments should be re-processed in the open position and they should replace the instruments that have jagged chipping and engraving. SPDT 1 stated, "We have the engraving machine and we use it sometimes to engrave, not on all instruments only some." The PSD instructed SPDT 1 to stop engraving the instruments. SPDT 1 stated, "I didn't know we couldn't."

According to AAMI, the National Infection Control standards the hospital followed, "Preparation and assembly of surgical instrumentation General considerations ...Multipart instruments should be disassembled for sterilization unless the device manufacturer has provided validated instructions to the contrary ...Inspection - Instruments should be carefully inspected for cleanliness and flaws or damage and dried before packaging ...Instrument placement - All jointed instruments should be in the open or unlocked position with ratchets not engaged.

According to AAMI, "Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities", CDC (Centers for Disease Control) Guidelines, and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare) guidelines, their recommendations, stipulated the following:

"Instruments should undergo an inspection for proper function and cleanliness. Instruments should be inspected for a) cleanliness b) proper functioning and alignment, corrosion, pitting, burrs, nick, and cracks, sharpness of cutting edges c) any other defects."

5. On October 1, 2019, at 11:20 a.m., during the tour of SPD, a concurrent interview with SPDT 1 and an observation was made of a neuro implantable surgical tray (reusable surgical instrument used for brain surgeries) that had been previously cleaned, sterilized and was ready for use. The following concerns were identified:

a. The handle of a pair of scissors contained brown staining;

b. SPDT 1 stated that not every piece of instrument in the set gets individually washed or brushed because, "It is not our practice;"

c. SPDT 1 stated the implants (various removable pieces of the surgical tray) got soaked in the case/caddie, they did not get removed;

d. SPDT 1 stated the screws located in the surgical set "only" get soaked; and,

e. The screws and implants got soaked with the rest of the sets surgical instruments that were used for the surgical procedure.

A request was made to conduct a record review of the manufacture's cleaning instructions.

SPDT 1 stated they did not have the manufacture instructions, she was not familiar with the manufacture's cleaning instructions but would contact the vendor to obtain the instructions.

During an interview at 11:25 a.m., with SPDT 2, who was present for the inspection of the neuro implantable surgical set, he stated that he also performed the cleaning on the instrument set the same as SPDT 1; he had never seen the manufacture instructions and did not receive training on how to clean implants or loaner instruments.

On October 1, 2019, at 4:35 p.m., a concurrent record review of the neuro manufacture implants cleaning instructions and an interview were conducted with PSD. The manufacture instructions stipulated the following:

"Prior to sterilization, all implants and instrumentation must be carefully cleaned and inspected. It is important to confirm that implants which are returned for processing from the operating room have not touched the defect, entered the operative site, or come in contact with a patient's blood or other fluid as them bay have been compromised. Compromised implants should be discarded and may not be cleaned and re-sterilized. Cleaning should be performed by trained medical personnel. The scope of the following methods is to be used to implantation for implants that HAVE NOT BEEN COMPROMISED, as described above and for instrumentation, including soiled instrumentation as applicable. Compromised implants should be discarded and may not be cleaned and re-sterilized ..."

The PSD stated according to the manufacture's instructions, the national guidelines the facility followed and their current cleaning practice of the implants, they would be considered contaminated or compromised because their guidelines indicates that any instrument opened in the operating room was to be considered contaminated. In addition, PSD stated that they soaked the implants with the rest of the instruments that were used during the OR procedure which are contaminated. Surveyor asked PSD if the manufacture had more detailed instructions, PSD stated, they were the only instructions provided.

On October 2, 2019, at 8:30 a.m., during an interview with the Quality Director (QD), she stated that after reviewing the manufacture of the neuro implants, she understood the instructions to say that the implants should not be processed but she will contact the manufacture for clear instructions.

According to AAMI, the infection control guidelines the hospital used, stipulates, "Manufacturer's instructions: The written instructions of the device manufacturer should always be followed. The reusable medical device manufacturer is responsible for ensuring that the device can be effectively cleaned and sterilized ..."

6. During an earlier tour of SPD, on October 1, 2019, at 9:05 a.m., the Perioperative Services Director (PSD) stated that SPD followed AAMI and AORN standards and manufacture guidelines.

On October 1, 2019, at 1:45 p.m., during a tour of the hospital decontamination room (a room used for the purpose of cleaning contaminated reusable patient surgical instruments and equipment) was conducted. The following concerns were identified:

a. Four of four cart cases (carts carrying contaminated surgical instruments from four different patient surgeries) were located on metal racks covered with red plastic bags and filled with contaminated surgical instruments, which included sharp instruments; and,

b. Three of four cart cases contained instruments that had dried red/brown matter and tissue.

SPDT 2, who was present during the tour, stated the operating room (OR) staff did not always spray the soiled instruments with pre-klenz (surfactant-based gel with corrosion inhibitors used at point-of-use to begin the cleaning of instruments and prevents blood and tissue from drying on instruments).

The PSD stated he was aware the OR was not consistent in pre-cleaning soiled instruments at the point of use, and he would be re-educating them.

During a second observation in the hospital decontamination room on October 2, 2019, at 10:54 a.m., it was observed that seven of eleven soiled instrument trays contained dried red matter. SPDT 2 stated, "You see, they come back with dried blood."

According to the manufacture instructions for use of the pre-cleaning solution, it is designed to be used at point of surgical procedures. The solution is used to initiate pre-cleaning, making future reprocessing easier and it initiates pre-cleaning without handling surgical instruments and prevents drying of soils on instruments.

A record review was conducted of the AAMI guidelines the facility followed. The document was provided by the facility and according to the document, "Cleaning of instruments: Instruments should be maintained as free of gross soil as possible during the surgical or other health care procedure. Cleaning and decontamination should begin as soon as possible after items have been used ..." and "Containment ...Puncture resistant, leak-proof, closable, and labeled containers must be used for devices with edges or points capable of penetrating container or skin ...Immediately after use, items should be avoided; if items are soaked in water or an enzymatic solution at the point of use ..."

7. During an earlier tour of SPD, on October 1, 2019, at 9:05 a.m., the Perioperative Services Director (PSD) stated that SPD followed AAMI and AORN standards and manufacture guidelines.

On October 1, 2019, during the tour of the hospital decontamination room, SPDT 2 was observed cleaning a patient reusable instrument. SPDT 2 stated that the instrument was used to perform bone surgeries and it was a loaner "Electric Driver 3" surgical instrument. SPDT 2 wiped the tubing portion of the instrument and stated he only has to wipe the tubing with a sponge that contained enzymatic solution (a cleaning solution), rinsed it under running water and then passed it to the clean side through a pass thru window.

SPDT 2 was asked what the manufacture's cleaning instruction requirements were. SPDT 2 stated that they did not have the manufacture instructions and he did not know what they indicated. The PSD also stated that staff did not receive training on how to clean the loaner instrument because they did not have a "trainer who specialized in cleaning instruments". According to PSD, the vendor who provided them the loaner did not provide education regarding the cleaning.

On October 2, 2019, at 2:50 p.m., concurrent record reviews of the manufacture cleaning instructions for the Electric Driver 3 and interviews with PSD and SPDT 2 were conducted. After reviewing the manufacture instructions, SPDT 2 stated, "Yesterday was the first time I re-processed the instrument, I didn't receive training on how to re-process it and I know now after reviewing the instructions that I didn't clean the internal surface as the manufacture instructed." SPDT 2 also stated, they did not receive training on re-processing loaner instruments, and that he was taught by a previous employee who no longer works for the facility.

According to the manufacture's instructions, the internal surface of the instrument should be brushed with a soft bristled brush. The PSD stated, "We need to instruct the staff on processing instruments according to manufacture's instructions."

SPDT 2 stated, "I just process them the same as the other instruments that may be alike but now I will look at manufacture instructions."

According to AAMI, the infection control guidelines the facility used, stipulates, "Manufacturer's instructions: The written instructions of the device manufacturer should always be followed. The reusable medical device manufacturer is responsible for ensuring that the device can be effectively cleaned and sterilized ..."

8. During an earlier tour of SPD, on October 1, 2019, the Perioperative Services Director (PSD) stated the SPD followed AAMI and AORN standards and manufacture guidelines.

On October 2, 2019, at 3 p.m., a tour was conducted of the facility's decontamination room (a room used to clean soiled and contaminated reusable surgical instruments).

A cart covered with a red plastic bag and carrying four of 4 surgical trays with soiled surgical instruments were filled with instruments that contained dried red and white tissue matter and red brown matter. SPDT 1 removed one of the instruments, located in the tray/caddie which contained dried red matter. SPT 1 indicated the soiled instrument should not have been placed back in the caddie and should have been separated from the unused instruments. According to SPDT 1, they did not always remove the individual instruments from the caddie; they got soaked in the case with the rest of the soiled instruments unless they see "blood like this one."

SPDT 2 who was present during the tour stated, the instruments were loaners and used for spine surgeries. SPDT 2 also stated, the instruments often are delivered dried from the operating room (OR) and they get sprayed with pre-klenz in the decontamination room. SPDT 2 stated, "That's the argument we have with OR, they don't spray the instruments that were used but they sometimes come back with blood and the blood is dry."

SPDT 1 who was also present during the tour stated, "Yes, they don't spray everything at point of use. We tell them to, some do and some don't." SPDT 2 stated, "We need consistent practice, so they always come to us the same with pre-klenz."

On October 2, 2019, at 9:30 a.m., a record review was conducted of the manufacture cleaning instructions for the loaned spine surgical instrument. The instructions stipulated, "Instruments should be wiped clean of gross soil and kept moist to prevent drying before transferring instruments to the central processing department. Do not place used instruments back into the (name of manufacture) spine tray before cleaning. Transport used instruments in a closed puncture-proof container to the reprocessing area to avoid potential environmental contamination ..."

A record review was conducted of the AAMI guidelines the facility followed. The document was provided by the facility indicated, "Cleaning of instruments: Instruments should be maintained as free of gross soil as possible during the surgical or other health care procedure. Cleaning and decontamination should begin as soon as possible after items have been used ..." and "Containment ...Puncture resistant, leak-proof, closable, and labeled containers must be used for devices with edges or points capable of penetrating container or skin ...Immediately after use, items should be avoided; if items are soaked in water or an enzymatic solution at the point of use ..."

9. During a tour of the facility's decontamination room on October 1, 2019, at 2:53 p.m., it was noted that SPDT 2 was re-using instrument brushes to clean various soiled and contaminated surgical instruments.

SPDT 2 was asked how they brushed were cleaned and disinfected, he stated, "They get re-used throughout the day and cleaned at the end of the shift.

The PSD who was present during the tour validated the findings and indicated the brushes got cleaned at the end of the shift.
On October 2, 2019, at 12:05 p.m., the manufacture's cleaning instructions for the instrument brushes were reviewed and stipulated, "Brushes must be cleaned and disinfect prior to reuse ...Cleaning and disinfection: Clean brushes after each use and disinfect between cases or daily at a minimum ..."

10. On October 2, 2019, at 12 p.m., during a tour of the facility decontamination room, a Certified Surgical Technician (CST 1) was observed walking into the decontamination room, picked up a plastic basin covered with a towel and preceded to walk towards the door. CST 1 was asked what was in the basin and where he was going.

CST 1 stated, he had a lens (used for eye surgeries) soaking in a high level disinfectant for an hour, was taking it back to the sub sterile room located between OR 5 and 6 to rinse it with water and would be taking it to the OR for the surgeon to use for a patient surgery. After the lens was used, CST 1 takes it back to decontamination to soak until the next time it is needed for a patient surgery. CST 1 stated he did not know what the manufacture instructions were for cleaning the lens and he was taught by a previous employee who no longer works for the hospital.

The PSD who was present during the tour stated that he did not know the lens was being cleaned in that manner. A request was made to review the manufacture cleaning instructions.

On October 3, 2019, at 9:50 a.m., a concurrent record review of the lens manufacture's cleaning instructions were provided and reviewed with PSD. PSD stated after reviewing the instructions, "They have incorrectly been re-processing those lenses. The manufacture says to steam sterilize."

The Quality Director who was present during the record review stated the lenses were not re-processed according to the manufacture's instructions and they would immediately stop the current practice of how they were cleaned.

11. A tour was conducted of the hospital GI Department (Gastrointestinal) on October 2, 2019, at 3:25 p.m., with the PSD who indicated he had oversight of the department. PSD stated that the GI Department followed National Infection Control Guidelines from:

a.AORN - Association of Perioperative Registered Nurses;

b. AAMI - Association for the Advancement of Medical Instrumentation; and

c. SGNA - Society of Gastroenterology Nurses and Associates.

It was observed that GI Procedure Room 2 contained a flexible scope (reusable patient tubular instruments used for visualizing the interior of a hollow organ or part such as the bladder or esophagus and used for diagnostic or therapeutic purposes that typically has one or more channels to enable passage of instruments) storage cabinet with seven flexible scopes in the cabinet.

GI Procedure Room 3 contained a flexible scope storage cabinet with 8 flexible scopes in the cabinet. In decontamination "Clean up Room" (a room used to clean and disinfect soiled reusable flexible scopes), was a flexible scope storage cabinet with 3 flexible scopes inside.

On October 2, 2019,at 3:50 p.m., the PSD stated he was aware the scopes should not be stored in the decontamination room or in the two procedure rooms. The PSD also stated he was aware there were guidelines which indicated to store the scopes in a clean environment, The decontamination room and procedure rooms were not considered clean environments.

According to AORN Flexible Endoscopes guidelines, provided by the hospital, "Recommendation IX" stipulates, "Cabinets used for storage of flexible endoscopes should be situated in a secure location in the clean workroom of the endoscopy processing room in a two-room design or in a separate clean area close to, but not within, the endoscopy procedure
room."

AAMI ST 91 "The endoscope should be hung vertically with the distal tip hanging freely in a well ventilated, clean area."

According to SGNA "Standards of Infection Prevention in Reprocessing Flexile Gastrointestinal Endoscopes" guidelines, scopes "must be stored in an area that is clean, well-ventilated and dustfree in order to keep the endoscopes dry and free of microbial contamination."

Based on observations, interviews, and record reviews, the facility failed to provide surgical services in a well-organized manner and in accordance with acceptable standards of practice. This failure had the potential of transmission of infectious agents and foreign material from the instruments to patients and staff. The hospital failed to comply with the §482.51 Condition of Participation for Surgical Services when:

1. The facility did not have a process in place for cleaning loaner surgical instruments (surgical instrument trays rented from vendors and used for patient surgeries) according to manufacture instructions and the National Infection Control Standards the facility followed (Refer to A951 Finding 1).

2. Two of two sterilizers (machines used to sterilize reusable patient surgical instruments) were not cleaned according to the manufacture's instructions (IFUs) (Refer to A951 Finding 2).

3. Multiple instruments which were previously cleaned, sterilized, and ready for use, contained brown, red staining, jagged chips, black residue, sticky residue, and sterilized in the locked position (Refer to A951 Finding 3).

4. A neuro implantable loaner surgical tray (reusable surgical instrument used for brain surgeries) was not cleaned according to manufacture instructions and the National Infection Control standards the facility followed (Refer to A951 Finding 4).

5. Contaminated reusable surgical instruments were not pre-cleaned according to the National Infection Control standards the facility followed (Refer to A951 Finding 5).

6. An "Electric Driver 3" loaner surgical instrument was not processed according to manufacture instructions and the National Infection Control Standards the facility followed (Refer to A951 Finding 6).

7. A loaner surgical instrument used for spine surgeries was not cleaned according to the manufacture instructions and the National Infection Control Standards the facility followed (Refer to A951 Finding 7).

8. Reusable lenses used to perform patient eye surgeries were not sterilized according to manufacture's instructions (Refer to A951 Finding 8).

9. There was no documented evidence in the employee files to indicate that three of 3 Sterile Processing Technicians (SPDT 1, 2, and 3) were provided job specific competencies specific to their job for cleaning reusable patient instruments (Refer to A951 Finding 9).

The cumulative effects of these systemic problems resulted in the hospital's inability to provide effective facility wide surgical services and failed to ensure patient care requiring surgical services were provided in a safe and effective manner.

Based on observations, interviews, and record reviews, the facility failed to provide surgical services in a well-organized manner, in accordance with acceptable standards of practice and in a manner to prevent the risk of cross contamination, when:

1. The facility did not have a process in place for cleaning loaner surgical instruments (surgical instrument trays rented from vendors and used for patient surgeries) according to manufacture instructions and the National Infection Control Standards the facility followed.

2. Two (2) of 2 sterilizers (machines used to sterilize reusable patient surgical instruments) were not cleaned according to the manufacture's instructions (IFUs).

3. Multiple instruments which were previously cleaned, sterilized, and ready for use, contained brown, red staining, jagged chips, black residue, sticky residue, and sterilized in the locked position.

4. A neuro (neurological) implantable loaner surgical tray (reusable surgical instrument used for brain surgeries) was not cleaned according to manufacture instructions and the National Infection Control standards the facility followed.

5. Contaminated reusable surgical instruments were not pre-cleaned according to the National Infection Control standards the facility followed.

6. An "Electric Driver 3" loaner surgical instrument was not processed according to manufacture instructions and the National Infection Control Standards the facility followed.

7. A loaner surgical instrument used for spine surgeries was not cleaned according to the manufacture instructions and the National Infection Control Standards the facility followed.

8. Reusable lenses used to perform patient eye surgeries were not sterilized according to manufacture's instructions.

9. There was no documented evidence in the employee files to indicate that three of 3 Sterile Processing Technicians (SPDT 1, 2, and 3) were provided job specific competencies specific to their job for cleaning reusable patient instruments.


Findings:

1. On October 1, 2019, at 9:05 a.m., a tour of the facility Sterile Processing Department (SPD - an area used to sterilize and store reusable patient surgical instruments) was conducted with the facility Infection Control Manager who stated the hospital followed National Infection Control Standards and practices from the following organizations:

a. AORN - Association of Perioperative Registered Nurses

b. AAMI - Association for the Advancement of Medical Instrumentation

c. CDC -Centers for Disease Control

At 9:15 a.m., the Perioperative Services Director (PSD), the Perioperative Services Manager (PSM), and three Sterile Processing Technicians (SPDT 1, 2, and 3) were present during the tour. The PSM stated that SPD followed AAMI and AORN standards and manufacture guidelines.

At 10 a.m., SPDT 2 was asked by the surveyor to explain the facility's practice for re-processing loaner instruments. SPDT 2 stated, "Loaners don't get manually washed they only go through the ultra sonic machine and then through the washer. They don't get brushed because they're supposedly clean." SPDT 1 stated, "Sometimes they only go through the washer because of time because they need them fast in the OR (operating room)."

At 10:03 a.m., the PSD stated they did not have a policy that addressed cleaning of loaner trays.

According to the National Infection Control Guidelines the facility followed, AAMI guidelines, 2017 Comprehensive Guide to steam sterilization and sterility assurance in healthcare settings, Decontamination of loaned instruments "sterility assurance related to loaned instruments should begin at the point at which the health care organization assumes responsibility for the items. All loaned instruments, regardless of whether they were processed in another health care facility, should be considered contaminated and delivered directly to the sterile processing area for decontamination. Instruments should be thoroughly cleaned and dried before sterilization ..." In addition, "Policies and procedures should be developed for all methods of decontamination of reusable items ..."

2. On October 1, 2019, at 10:05 a.m., during a tour of the SPD, two of two sterilizers (machines used to sterilize reusable patient surgical instruments), contained large amounts of brown, red, green and white staining.

SPDT 1 and SPDT 2 were asked to explain the cleaning schedule of the sterilizers. SPDT 1 and 2 both stated they did not clean the internal surfaces of the chambers. PSD validated their responses and stated that he had the vendor clean them a year ago and their staff did not clean the internal chambers. In addition, they did not have logs to show they were cleaned.

On October 1, 2019, at 11:18 a.m., a concurrent record review of the sterilizer manufacture instructions and interviews were conducted with SPDT 1 and SPDT 2. After reviewing the manufacture instructions, they stated they did not know what solution the manufacture required for cleaning the internal chambers and they did not have the cleaning solution, "Liqui-Jet" or a comparable solution, the manufacture recommended to use. There was no documented evidence to show that the manufacture'ss "Weekly Maintenance" of the sterilizer was performed.

3. On October 1, 2019, at 10:30 a.m., during a tour of SPD, a basic surgical tray (their more common surgical tray), was inspected in the presence of SPDT 1, SPDT 2 and PSD. During the inspection the following concerns were identified on 20 of 82 previously cleaned, sterilized and ready for use surgical instruments. Some of the instruments had multiple concerns:

13 instruments contained brown staining,

2 instruments contained jagged pitting,

4 instruments contained coarse and irregular non-manufactured engraving, and;

3 instruments contained dark residue and sticky residue.

At 11:20 a.m., a neuro implantable surgical tray (reusable surgical instrument used for brain surgeries) was inspected. The handle of a pair of scissors contained brown staining

On October 1, 2019, at 3:45 p.m., during a third inspection of a previously cleaned, sterilized and ready for use instruments were inspected. The tray indicated it was a "Bookwalter" (reusable surgical instruments used for various surgeries). The following concerns were identified:

Seven (7) of 7 tilt rachets (reusable surgical instrument) were in the closed/locked position,

2 of 7 tilt rachets contained jagged non-manufacture engraving,

3 Richardson instruments contained jagged non-manufacture engraving,

1 malleable instrument contained jagged non-manufacture engraving,

1 rachet contained jagged non-manufacture engraving, and;

1 malleable ring contained a jagged chipped surface.

At 3:53 p.m., the surveyor requested from the PSD to see policies specific to assembly of instruments, cleaning and sterilizing of instruments. The PSD stated they were working on developing updated policies because their existing policies were "old." PSD stated they were supposed to follow AORN and AAMI standards for cleaning and disinfecting of instruments.

The PSD validated above findings and stated that the instruments should be re-processed in the open position and they should replace the instruments that have jagged chipping and engraving. SPDT 1 stated, "We have the engraving machine and we use it sometimes to engrave, not on all instruments only some." The PSD instructed SPDT 1 to stop engraving the instruments. SPDT 1 stated, "I didn't know we couldn't."

According to AAMI, the National Infection Control standards the hospital followed, "Preparation and assembly of surgical instrumentation General considerations ...Multipart instruments should be disassembled for sterilization unless the device manufacturer has provided validated instructions to the contrary ...Inspection - Instruments should be carefully inspected for cleanliness and flaws or damage and dried before packaging ...Instrument placement - All jointed instruments should be in the open or unlocked position with ratchets not engaged.

According to AAMI, "Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities", CDC (Centers for Disease Control) Guidelines, and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare) guidelines, their recommendations, stipulated the following:

"Instruments should undergo an inspection for proper function and cleanliness. Instruments should be inspected for a) cleanliness b) proper functioning and alignment, corrosion, pitting, burrs, nicks, and cracks, sharpness of cutting edges c) any other defects".

4. On October 1, 2019, at 11:20 a.m., during the tour of SPD, a concurrent interview with SPDT 1 and an observation was made of a neuro implantable surgical tray (reusable surgical instrument used for brain surgeries) that had been previously cleaned, sterilized and was ready for use. The following concerns were identified:

The handle of a pair of scissors contained brown staining. SPDT 1 stated not every piece of instrument in the set gets individually washed or brushed because, "It is not our practice." SPDT 1 stated the implants (various removable pieces of the surgical tray) get soaked in the case/caddie, they did not get removed. SPDT 1 further stated the screws located in the surgical set "only" get soaked and implants got soaked with the rest of the sets surgical instruments that were used for the surgical procedure.

A request was made to conduct a record review of the manufacture's cleaning instructions. SPDT 1 stated they did not have the manufacture instructions; she was not familiar with the manufacture's cleaning instructions but would contact the vendor to obtain the instructions.

During an interview at 11:25 a.m., with SPDT 2, who was present for the inspection of the neuro implantable surgical set, he stated he also performed the cleaning on the instrument set the same as SPDT 1; he had never seen the manufacture's instructions and did not receive training on how to clean implants or loaner instruments.

On October 1, 2019, at 4:35 p.m., a concurrent record review of the neuro manufacture implants cleaning instructions and an interview were conducted with PSD. The manufacture's instructions stipulated the following:

"Prior to sterilization, all implants and instrumentation must be carefully cleaned and inspected. It is important to confirm that implants which are returned for processing from the operating room have not touched the defect, entered the operative site, or come in contact with a patient's blood or other fluid as them bay have been compromised. Compromised implants should be discarded and may not be cleaned and re-sterilized. Cleaning should be performed by trained medical personnel. The scope of the following methods is to be used to implantation for implants that HAVE NOT BEEN COMPROMISED, as described above and for instrumentation, including soiled instrumentation as applicable. Compromised implants should be discarded and may not be cleaned and re-sterilized ..."

The PSD stated according to the manufacture's instructions, the national guidelines they followed and their current cleaning practice of the implants, they would be considered contaminated or compromised because their guidelines indicates that any instrument opened in the operating room was to be considered contaminated. In addition, the PSD stated that they soaked the implants with the rest of the instruments that were used during the OR procedure which are contaminated. Surveyor asked the PSD if the manufacture had more detailed instructions, PSD stated, they were the only instructions provided.

On October 1, 2019, at 8:30 a.m., during an interview with the Quality Director (QD), she stated that after reviewing the manufacture of the neuro implants, she understood the instructions to say that the implants should not be processed but she will contact the manufacture for clear instructions.

According to AAMI, the infection control guidelines the hospital used, stipulates, "Manufacturer's instructions: The written instructions of the device manufacturer should always be followed. The reusable medical device manufacturer is responsible for ensuring that the device can be effectively cleaned and sterilized ..."

5. During an earlier tour of SPD, on October 1, 2019, at 9:05 a.m., the Perioperative Services Director (PSD), stated the SPD followed AAMI and AORN standards and manufacture guidelines.

On October 1, 2019, at 1:45 p.m., during a tour of the facility's decontamination room (a room used for the purpose of cleaning contaminated reusable patient surgical instruments and equipment) was conducted. The following concerns were identified:

Four of four cart cases (carts carrying contaminated surgical instruments from four different patient surgeries) were located on metal racks covered with red plastic bags and filled with contaminated surgical instruments, which included sharp instruments.

Three of four cart cases contained instruments that had dried red/brown matter and tissue.

SPDT 2, who was present during the tour, stated that the operating room (OR) staff did not always spray the soiled instruments with pre-klenz (surfactant-based gel with corrosion inhibitors used at point-of-use to begin the cleaning of instruments and prevents blood and tissue from drying on instruments).

The PSD stated that he was aware that OR did were not consistent in pre-cleaning soiled instruments at point of use and would be re-educating them.

During a second observation in the hospital decontamination room on October 2, 2019,at 10:54 a.m., it was observed that seven of eleven soiled instrument trays contained dried red matter. SPD 2 stated, "You see, they come back with dried blood."

According to the manufacture's instructions for use of the pre-cleaning solution, it is designed to be used at point of surgical procedures. The solution is used to initiate pre-cleaning, making future reprocessing easier and it initiates pre-cleaning without handling surgical instruments and prevents drying of soils on instruments.

A record review was conducted of the AAMI guidelines the facility followed. The document was provided by the facility and according to the document, "Cleaning of instruments: Instruments should be maintained as free of gross soil as possible during the surgical or other health care procedure. Cleaning and decontamination should begin as soon as possible after items have been used ..." and "Containment ...Puncture resistant, leak-proof, closable, and labeled containers must be used for devices with edges or points capable of penetrating container or skin ...Immediately after use, items should be avoided; if items are soaked in water or an enzymatic solution at the point of use ..."

6. During an earlier tour of SPD, on October 1, 2019, at 9:05 a.m., the Perioperative Services Director (PSD) stated that SPD followed AAMI and AORN standards and manufacture guidelines.

On October 1, 2019, during the tour of the hospital decontamination room, SPDT 2 was observed cleaning a patient reusable instrument. SPDT 2 stated that the instrument was used to perform bone surgeries and it was a loaner "Electric Driver 3" surgical instrument. SPDT 2 wiped the tubing portion of the instrument and stated he only has to wipe the tubing with a sponge that contained enzymatic solution (a cleaning solution), rinsed it under running water and then passed it to the clean side through a pass thru window.

SPDT 2 was asked what the manufacture cleaning instruction requirements were. SPDT 2 stated that they did not have the manufacture instructions and he did not know what they indicated. PSD also stated that staff did not receive training on how to clean the loaner instrument because they did not have a "trainer who specialized in cleaning instruments". According to PSD, the vendor who provided them the loaner did not provide education regarding the cleaning.

On October 2, 2019, at 2:50 p.m., concurrent record reviews of the manufacture's cleaning instructions for the Electric Driver 3 and interviews with PSD and SPDT 2 were conducted. After reviewing the manufacture instructions, SPDT 2 stated, "Yesterday was the first time I re-processed the instrument, I didn't receive training on how to re-process it and I know now after reviewing the instructions that I didn't clean the internal surface as the manufacture instructed." SPDT 2 also stated, they did not receive training on re-processing loaner instruments, and that he was taught by a previous employee who no longer works for the facility.

According to the manufacture instructions, the internal surface of the instrument should be brushed with a soft bristled brush.

The PSD stated, "We need to instruct the staff on processing instruments according to manufacture instructions." SPDT 2 stated, "I just process them the same as the other instruments that may be alike but now I will look at manufacture instructions."

According to AAMI, the infection control guidelines the hospital used, stipulates, "Manufacturer's instructions: The written instructions of the device manufacturer should always be followed. The reusable medical device manufacturer is responsible for ensuring that the device can be effectively cleaned and sterilized ..."

7. During an earlier tour of SPD, on October 1, 2019, the Perioperative Services Director (PSD) stated that SPD followed AAMI and AORN standards and manufacture guidelines.

On October 1, 2019, at 3 p.m., a tour was conducted of the facility's decontamination room (a room used to clean soiled and contaminated reusable surgical instruments).

A cart covered with a red plastic bag and carrying four of four surgical trays with soiled surgical instruments were filled with instruments that contained dried red and white tissue matter and red brown matter. SPDT 1 removed one of the instruments, located in the tray/caddie which contained dried red matter. SPDT 1 indicated the soiled instrument should not have been placed back in the caddie and should have been separated from the unused instruments. According to SPDT 1, they did not always remove the individual instruments from the caddie; they got soaked in the case with the rest of the soiled instruments unless they see "blood like this one."

SPDT 2 who was present during the tour stated, the instruments were loaners and used for spine surgeries. SPDT 2 also stated, the instruments often are delivered dried from the operating room (OR) and they get sprayed with pre-klenz in the decontamination room. SPDT 2 stated, "That's the argument we have with OR, they don't spray the instruments that were used but they sometimes come back with blood and the blood is dry."

SPDT 1 who was also present during the tour stated, "Yes, they don't spray everything at point of use. We tell them to, some do and some don't." SPDT 2 stated, "We need consistent practice, so they always come to us the same with pre-klenz."

On October 2, 2019, at 9:30 a.m., a record review was conducted of the manufacture's cleaning instructions for the loaned spine surgical instrument. The instructions stipulated, "Instruments should be wiped clean of gross soil and kept moist to prevent drying before transferring instruments to the central processing department. Do not place used instruments back into the (name of manufacture) spine tray before cleaning. Transport used instruments in a closed puncture-proof container to the reprocessing area to avoid potential environmental contamination ..."

A record review was conducted of the AAMI guidelines the facility followed. The document was provided by the facility and according to the document, "Cleaning of instruments: Instruments should be maintained as free of gross soil as possible during the surgical or other health care procedure. Cleaning and decontamination should begin as soon as possible after items have been used ..." and "Containment ...Puncture resistant, leak-proof, closable, and labeled containers must be used for devices with edges or points capable of penetrating container or skin ...Immediately after use, items should be avoided; if items are soaked in water or an enzymatic solution at the point of use ..."

8. On October 2, 2019, at 12 noon, during a tour of the facility's decontamination room, a Certified Surgical Technician (CST 1) was observed walking into the decontamination room, picked up a plastic basin covered with a towel and preceded to walk towards the door. CST 1 was asked what was in the basin and where he was going.

CST 1 stated, that he had a lens (used for eye surgeries) soaking in a high level disinfectant for an hour, was taking it back to the sub sterile room located between OR 5 and 6 to rinse it with water and would be taking it to the OR for the surgeon to use for a patient surgery. After the lens was used, CST 1 took it back to decontamination to soak until the next time it is needed for a patient surgery. CST 1 stated he did not know what the manufacture instructions were for cleaning the lens and that he was taught by a previous employee who no longer works for the facility.

The PSD who was present during the tour stated that he did not know the lens was being cleaned in that manner. A request was made to review the manufacture cleaning instructions.

On October 3, 2019, at 9:50 a.m., a concurrent record review of the lens manufacture cleaning instructions were provided and reviewed with PSD. PSD stated after reviewing the instructions, "They have incorrectly been re-processing those lenses. The manufacture says to steam sterilize."

The Quality Director who was present during the record review stated the lenses were not re-processed according to the manufacture instructions and would immediately stop the current practice of how they were cleaned.

9. During multiple interviews conducted from October 1, 2019, to October 3, 2019, at various times, three Sterile Processing Technicians (SPDT 1, 2, and 3) verbalized they did not receive job specific training regarding cleaning reusable patient surgical instruments.

On October 1, 2019, at 11:20 a.m., SPDT 1 indicated that she was taught to clean instruments by a previous employee who no longer worked for the hospital.

On October 1, 2019, at 11:25 a.m., SPDT 2 stated that he had not received training on cleaning a surgical implant loaner set.

On October 1, 2019, at 1:45 p.m., the Perioperative Services Director (PSD) stated that staff train each other and that the hospital did not have a surgical services educator who specialized in cleaning of instruments.

On October 2, 2019, at 2:50 p.m., SPDT 2 stated he did not receive instructions on how to clean surgical instruments according to the national guidelines they followed and that he was taught by a previous employee.

On October 3, 2019,at 11 a.m., concurrent record reviews of SPDT 1, 2, and 3 employee files and an interview was conducted with PSD. During the review of the files, there was no documented evidence to indicate that SPDT 1, 2 and 3 received job specific competencies regarding cleaning of reusable surgical instruments.

On October 3, 2019, at 12 p.m., the PSD stated he was asked by the Quality Director to look for job specific competencies related to cleaning of instruments however; he was unable to find any. PSD also stated he did ask to hire additional staff that are proficient in SPD and can train their current staff.

Based on interview and record review, the facility failed for two of two sampled patients, (Patients 12 and 13), to have complete postoperative anesthesia documentation. This failure had the potential to impact the patients' ongoing medical care.

Findings:

A review of Patient 12's record was conducted. Patient 12 was admitted to the facility on September 30, 2019, for a laminectomy (surgery that creates space by removing the back part of a vertebra) in order to implant a spinal cord stimulator. A review of the anesthesia post operative summary, dated September 30, 2019, at 2:55 p.m. did not indicate the patients post operative hydration status, or if the patient was nauseated or vomited..

A review of Patient 13's record was conducted. Patient 12 was admitted to the facility on October 1, 2019, for a scheduled right sacroiliac joint instrumented fusion (fusion of the joint between the spine and hip). A review of the anesthesia post operative summary dated October 1, 2019, at 10:20 a.m., did not indicate the patients post operative hydration status, or if the patient was nauseated or vomited.

A review of the facility practice guideline, "Preoperative Safety Of The Patient (approved: 11/17/2015)" was conducted. The postoperative procedure indicated, "Postoperative documentation shall include: Status of patient on admission to post anesthesia care unit; Vital signs and level of consciousness; Amounts and types of intravenous fluids administered, including blood and blood products; Unusual events or postoperative complication during post anesthesia management of care;Post anesthesia visits."

An interview was conducted with the Director of Risk Management (DRM), on October 2, 2019, at 3:30 p.m. The DRM stated she spoke with the Medical Director of Anesthesia Services who stated the expectation is to have an immediate complete post operative summary.