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Based on observation, interview and review of Infection Control Committee Minutes, it was determined the Facility failed to assure a sanitary environment was provided with regard to surgical services; have a system in place to monitor compliance with sterilization standards and policies to prevent patient exposure to likely sources of infection. The failed practice has the likelihood of affecting all patients who have surgical procedures at the Facility. See A-0940

Based on observation, interview, review of policies and procedures, and review of Infection Control Committee Minutes, it was determined the Infection Control Officer failed to have a system in place to monitor compliance with sterilization standards and policies for Surgical Services. Patient exposure to sources of infection and communicable disease due to Process Challenge Device (PCD) failures and reprocessing of implants were not identified. The failed practice has the liklilhood of affecting all patients who have surgical procedures at the facility. The findings were:

A. Observation of Surgical Services Reprocessing/Sterilization (R/S) and the Inner Core (OR) area of the surgical suite on 03/16/15, 03/17/16, and 03/18/16, revealed 3 R/S steam sterilizers (#1- #3) and 4 OR (#1 - #4) sterilizers. The Director of Surgical Services stated the OR sterilizers (Inner Core) #1-#4 were used for immediate use steam sterilization.

B. Review of the Steam Sterilizer Record Keeping Log for autoclave OR #3 on 02/15/16 revealed a processed biological indicator (BI) was documented as "positive" on 02/15/16 at 0450; on 02/15/16 at 0645, 1012 and 1015, the processed BI was documented as negative. The action taken was documented, "Positive bio, Ran 3 separate bios which all passed. Placing sterilizer back into service." A handwritten note dated 02/17/16 was attached to the OR #3 load log and read "The #3 Autoclave in the Inner Core passed the bio, but failed two dart tests. I put a note on it not to be used till it was checked out. This is the one that failed over the weekend."

C. On 03/17/16, (Named) Medical Equipment, Inc. work orders were reviewed for autoclaves from 01/01/15 to 03/16/16. The following work orders reveal BI failures (01/27/16 and 02/01/16) and failed BD (bowie-dick) (02/17/16) reported, with work dates and service documented as follows:

1) On 01/27/16, the RS #2 Steris Eagle #2, CN 11916 with the statement, "Reported bad bio test on the 25th. Attempt to check cycle in question. Printout not available. Additional complaint of condensate pooling on top of wrapped pack middle shelf, front (over drain). Start inspection check printouts available unit has passed test since positive bio. Temp and pressure readings correlate." "Steam leak found on supply ping filter o ring, replaced. Run vac leak test 7.1. Start looking found loose bolts on diaphragm. Remove clean and reseal diaphragm. Run vac test again 0.6 run bd test pass. Unit Returned to service."

2) On 02/01/16, the RS #1, Steris Eagle #1: CN 11917 with the statement, "Reported positive bi. Request printout for review, unable to locate. Inspect unit run vac leak test 0.0. Calibrate temp and pressure run bd test. Observe cycle test pass. Unit operational."

3) On 02/17/16, the work date for OR #3, Steris Century: CN 10712 with the statement "Fail bd test. Rebuild S1 valve replace S1 seat o ring run vac leak test. 0.0 returned unit to service."

D. The Director of Surgical Services provided documentation of Facility Monitoring Results of Biological Indicators (BI) from 01/01/15 - 03/17/16 for OR (IUSS) Autoclave #1- #4, R/S Autoclave #1 - #3 and Sterrad #5 and #6 on 03/17/16. In an interview with the Director of Surgical Services on 03/17/16 she stated the results were as reported to the Quality Assurance and Infection Control Committees. Review of the documents provided on 03/17/16 revealed all BI (biological indicator) results were documented as negative or "N/A".

E. The Director of Surgical Services was asked about the lack of documentation of biological indicator failures as noted on the work orders for 01/27/16 and 02/01/16. The Director of Surgical Services stated in an interview on 03/16/16 at 1025, "we have not experienced any true biological indicator failures, all of the failed BI had been operator errors and were corrected at the time". Review of Infection Control Committee Minutes for 2015 and to date 2016, on 03/18/16, revealed no report of process indicator failures.

F. The Director of Surgical Services was interviewed in the presence of the Director of Nursing on 03/17/16 at 0845. The Director of Surgical Services was asked what the Facility process was for failed BI, to which the Director of Surgical Services replied, "I'll talk to my staff." A copy of the Facility policy and procedure for failed biological or chemical indicators was requested at the time of the interview.

G. On 03/17/16, a copy of the Facility process for failed biological or chemical indicators was provided by the Director of Surgical Services, "ANSI/AAMI ST79:2010& A2:2011 and A3: 2012 and A4:2013 (Consolidated Text: (R2014) - Comprehensive guide to steam sterilization and sterility assurance in health care facilities." The Director of Surgical Services stated, "This is the process we use." Review of the document as provided revealed the following statement "10.7 Routine sterilizer efficacy monitoring: 10.7.5 Actions to take when biological indicators, chemical indicators, or physical monitors indicate failure. 10.7.5.1 General Procedures." Item "a" states "PCDs (process challenge device) (BI (biological indicator) challenge test packs and CI (chemical indicator) test packs are used to release sterilized loads, and BI challenge test packs are used to routinely test sterilizer efficacy. A processed PCD with a positive BI or a failed Class 5 integrating CI or a Class 6 emulating indicator (CI challenge test pack) is demonstrating a failure for the entire load and should be immediately reported by phone or messenger to the appropriate supervisor and to the infection prevention and control department. This notification should be followed by a written report." The above document further stated "The report and notification should include the following information: the time and date of the questionable sterilizer; a description of the sterilizer and load, with reference to the appropriate lot control number; the results of physical monitoring and of internal CI (if applicable) as obtained from the user department; any other information that could be useful in determining whether the report is valid or is questionable because of operator error. If the cause of failure is immediately identified (usually operator error) and confined to one load or one item in the load (i.e. an item with a nonresponsive internal CI), the cause of the failure should be corrected and the load should be reprocessed. If the cause of the failure is not immediately identified, the load should be quarantined, and all loads back to the last negative BBI should be recalled. Items in these loads should be retrieved, if possible and reprocessed. The sterilizer in question should be taken out of service for further investigation of root causes. The heads of the microbiology department, sterilizing department, and infection prevention and control department or their designees, with appropriate facility maintenance and sterilizer service personnel, should attempt to determine the root cause of the sterilization process failure and arrange for corrective action. If the root cause of the sterilization failure has been determined to be sterilizer malfunction and major repair is required for correction, the sterilizer in question should be immediately re-challenged with a PCD in three consecutive cycles." For dynamic-air-removal sterilizers, and IUSS (immediate use steam sterilization) cycles, a "Bowie-Dick test pack should then be run in three consecutive empty-chamber cycles. Until the results of retesting are satisfactory three cycles with negative BIs and if applicable, three cycles with acceptable color change in the Bowie-Dick indicator, the performance of the sterilizer should be considered in question."

H. Review of Policy # EOC-ME6.21 on 03/21/16 as provided by the Director of Surgical Services revealed, "The Reprocessing and Sterilization department monitors the testing and documentation of sterilizer performance. The departments that utilize sterilizers maintain logs and monitoring strips. The Infection Prevention and Control staff checks compliance during environmental tours and independent audits. Results and compliance is reported to the Infection Control Committee. Biomedical Engineering monitors vendor performance of scheduled maintenance and maintains sterilizer maintenance records. "The policy further states "for the routine release of a load containing implantable devices it is mandatory to use a Biological Indicator."

I. In an interview on 03/17/16 at 1332 with Infection Preventionist #1, she stated the monitoring of the sterilization was done informally as part of the routine visits to the Surgical Services Department and occurs four to six times per year.

J. Clinical record review revealed Patient #20 was admitted to the Facility on 10/22/15 for removal of right total knee arthroplasty and placement of antibiotic spacer. The Operative Report, dated 10/22/15 included the Description of Procedure and a statement that "Gross purulence was identified and it was quite extensive". The procedure included synovectomy, removal of: polyethylene, femoral component, tibial component and patella. "All cement was removed. The knee was thoroughly irrigated. Multiple cultures were obtained. Then a 1 polyethylene liner was opened and backside was roughened. The first batch of antibiotic cement was used to cement the polyethylene into place. Femoral component had been autoclaved and then coated with second batch of antibiotic impregnated cement. It was impacted onto the femur."

K. Review of Sterilization Log on 03/21/16 revealed the documentation for OR Autoclave 3 for 10/22/15, revealed a sticker for (Patient #20). The contents of the load, reason for sterilization, cycle time and temperature were not documented. There was no documentation of biological indicator use with the load. This was confirmed by the Director of Surgical Services on 03/21/16 at 1430.

L. On 03/21/16 at 1720, the Infection Preventionist was asked if she was aware of the Facility practice of removal and reprocessing of infected joint components by IUSS for re-implantation into the patient and she stated "no".

Based on observation, interview, review of sterilization records, policies and procedures, Infection Control Committee Minutes and clinical record review, it was determined the Facility failed to assure Surgical Services were provided in accordance with standards of practice and its policies for implants, in that a biological indicator was not included with an implant (Patient #20) that was processed in an immediate use steam sterilization (IUSS) cycle. The efficacy of the sterilization process for the IUSS cycle containing the implant could not be assured and placed Patient #20 at risk of additional infection. The failed practice is likely to affect any patient with an implant in which a biological indicator is not used. The findings were:

A. Observation of Surgical Services Reprocessing/Sterilization (R/S) and the Inner Core (OR) area of the surgical suite on 03/16/15, 03/17/16 and 03/18/16 revealed 3 R/S steam sterilizers (#1- #3) and 4 OR (#1 - #4) sterilizers. The Director of Surgical Services stated the OR sterilizers (Inner Core) #1- #4 are used for immediate use steam sterilization.

B. In an interview with the Director of Surgical Services on 03/16/16 at 1342, in the presence of the Director of the CV OR (Cardio Vascular Operating Room), she stated the Facility did not reprocess infected implants for reinsertion into a patient.

C. In an interview on 03/18/15 at 1233, in the presence of the Director of Surgical Services, Reprocessing Sterilization Technician #1 stated a daily biological is done with the autoclaves in the Inner Core (used for flash or immediate use steam sterilization) and "if there is an implant done, a biological is supposed to be done".

D. In an interview on 03/18/15 at 1235, with the Director of Surgical Services, in the presence of Reprocessing Sterilization Technician #1, the Director of Surgical Services stated, "We never flash implants."

E. In an interview on 03/18/16 at 1415 the Assistant Director of the Operating Room stated, "We have one physician that has removed and placed part of the infected hip prosthesis, that will be put back in the patient, through an autoclave (IUSS cycle). It has maybe been a couple of years. He only did it occasionally, rarely. Someone talked to him and he doesn't do it anymore."

F. In the presence of the Director of Surgical Services on 03/21/16 at 1400, CST #1 was interviewed and stated the only implants that are autoclaved is "one of the orthopedic doctors does it when there is an infected joint implant. The joint is cleaned up, cement removed and part of it is put through one of the inner core sterilizers. A sticker with the patient name is placed on the autoclave load log." The name of the last patient (Patient # 20) this process was performed on was requested and received from the Director of Surgical Services on 03/21/16.

G. Clinical record review revealed Patient #20 was admitted to the Facility on 10/22/15 for removal of right total knee arthroplasty and placement of antibiotic spacer. The Operative Report, dated 10/22/15 included the Description of Procedure and a statement that "Gross purulence was identified and it was quite extensive". The procedure included synovectomy, removal of: polyethylene, femoral component, tibial component and patella. "All cement was removed. The knee was thoroughly irrigated. Multiple cultures were obtained. Then a 1 polyethylene liner was opened and backside was roughened. The first batch of antibiotic cement was used to cement the polyethylene into place. Femoral component had been autoclaved and then coated with second batch of antibiotic impregnated cement. It was impacted onto the femur."

H. Review of Sterilization Log on 03/21/16 revealed the documentation for OR Autoclave 3 for 10/22/15, revealed a sticker for (Patient #20). The contents of the load, reason for sterilization, cycle time and temperature were not documented. There was no documentation of biological indicator use with the load. This was confirmed by the Director of Surgical Services on 03/21/16 at 1430.

I. Review on 03/21/16 of the Facility policy #WRMS-SSI13.6014, "Routine release of loads containing implantable devices," revealed the policy "For routine release of loads containing implantable devices, a PCD (Process Challenge Device) containing a BI and a Class 5 integrating a CI (a BI challenge test pack) should be used to monitor the load. The sterilized item containing the implant needs to be quarantined until the biological "rapid read-out" or incubation result is confirmed negative."

J. Review of Policy # EOC-ME6.21 on 03/21/16 as provided by the Director of Surgical Services revealed "The Reprocessing and Sterilization department monitors the testing and documentation of sterilizer performance. The departments that utilize sterilizers maintain logs and monitoring strips. The Infection Prevention and Control staff checks compliance during environmental tours and independent audits. Results and compliance is reported to the Infection Control Committee. Biomedical Engineering monitors vendor performance of scheduled maintenance and maintains sterilizer maintenance records." The policy further states "for the routine release of a load containing implantable devices it is mandatory to use a Biological Indicator."

K. On 03/21/16 at 1720, the Infection Preventionist was asked if she was aware of the Facility practice of removal and reprocessing of infected joint components by IUSS for re-implantation into the patient and she stated "no". The Infection Preventionist then asked for an additional explanation of the process from the Director of Surgical Services.

L. On 03/21/16 at 1720, the Administrator was asked if he was aware of the practice of removal of infected joint components and reprocessing for implantation back into the patient. The Administrator stated "I know that particular physician was doing something but, no I was not aware of that particular thing."



Based on observation, interview, review of sterilization records, policies and procedures, it was determined the Facility failed to assure Surgical Services were provided in accordance with standards of practice and its policies for Process Challenge Device failure. The failed practice did not assure the Facility could identify if conditions necessary for sterilization had been met so that patients would be protected from exposure to sources of infection. The failed practice was likely to affect all surgical patients. The findings were:

A. Observation of Surgical Services Reprocessing/Sterilization (R/S) and the Inner Core (OR) area of the surgical suite on 03/16/15, 03/17/16 and 03/18/16 revealed 3 R/S steam sterilizers (#1- #3) and 4 OR (#1 - #4) sterilizers. The Director of Surgical Services stated the OR sterilizers (Inner Core) #1- #4 are used for immediate use steam sterilization.

B. Review of the Steam Sterilizer Record Keeping Log for autoclave OR #3 on 02/15/16 revealed a processed biological indicator (BI) was documented as "positive" on 02/15/16 at 0450; on 02/15/16 at 0645, 1012 and 1015, the processed BI was documented as negative. The action taken was documented "Positive bio, Ran 3 separate bios which all passed. Placing sterilizer back into service." A handwritten note dated 02/17/16 was attached to the OR #3 load log and read "The #3 Autoclave in the Inner Core passed the bio, but failed two dart tests. I put a note on it not to be used till it was checked out. This is the one that failed over the weekend."

C. On 03/17/16, (Named) Medical Equipment, Inc. work orders were reviewed for autoclaves from 01/01/15 to 03/16/16. The following work orders reveal BI failures (01/27/16 and 02/01/16) and failed BD (Bowie-Dick) (02/17/16) reported, with work dates and service documented as follows:

1) On 01/27/16, the RS #2 Steris Eagle #2, CN 11916 with the statement "Reported bad bio test on the 25th. Attempt to check cycle in question. Printout not available. Additional complaint of condensate pooling on top of wrapped pack middle shelf, front (over drain). Start inspection check printouts available unit has passed test since positive bio. Temp and pressure readings correlate." "Steam leak found on supply ping filter o ring, replaced. Run vac leak test 7.1. Start looking found loose bolts on diaphragm. Remove clean and reseal diaphragm. Run vac test again 0.6 run bd test pass. Unit Returned to service."

2) On 02/01/16, the RS #1, Steris Eagle #1: CN 11917 with the statement "Reported positive bi. Request printout for review, unable to locate. Inspect unit run vac leak test 0.0. Calibrate temp and pressure run bd test. Observe cycle test pass. Unit operational."

3) On 02/17/16, the work date for OR #3, Steris Century: CN 10712 with the statement "Fail bd test. Rebuild S1 valve replace S1 seat o ring run vac leak test. 0.0 returned unit to service."

D. The Director of Surgical Services provided documentation of Facility Monitoring Results of Biological Indicators (BI) from 01/01/15 - 03/17/16 for OR (IUSS) Autoclave #1- #4, R/S Autoclave #1 - #3 and Sterrad #5 and #6 on 03/17/16. In an interview with the Director of Surgical Services on 03/17/16 she stated the results were as reported to the Quality Assurance and Infection Control Committees. Review of the documents provided on 03/17/16 revealed all BI (Biological Indicator) results were documented as negative or "N/A".

E. The Director of Surgical Services was asked about the lack of documentation of biological indicator failures as noted on the work orders for 01/27/16 and 02/01/16 and stated in an interview on 03/16/16 at 1025, "we have not experienced any true biological indicator failures, all of the failed BI had been operator errors and were corrected at the time". Review of Infection Control Committee Minutes for 2015 and to date 2016 on 03/18/16 revealed no reports of process indicator failures.

F. The Director of Surgical Services was interviewed in the presence of the Director of Nursing on 03/17/16 at 0845. The Director of Surgical Services was asked what the Facility process was for failed BI, to which the Director of Surgical Services replied "I'll talk to my staff". A copy of the Facility policy and procedure for failed biological or chemical indicators was requested at the time of the interview.

G. On 03/17/16, a copy of the Facility process for failed biological or chemical indicators was provided by the Director of Surgical Services, "ANSI/AAMI ST79:2010& A2:2011 and A3: 2012 and A4:2013 (Consolidated Text: (R2014) - Comprehensive guide to steam sterilization and sterility assurance in health care facilities." The Director of Surgical Services stated, "This is the process we use." Review of the document as provided revealed the following statement "10.7 Routine sterilizer efficacy monitoring: 10.7.5 Actions to take when biological indicators, chemical indicators, or physical monitors indicate failure. 10.7.5.1 General Procedures. Item "a" states "PCDs (process challenge device) BI (biological indicator) challenge test packs and CI (chemical indicator) test packs are used to release sterilized loads and BI challenge test packs are used to routinely test sterilizer efficacy. A processed PCD with a positive BI or a failed Class 5 integrating CI or a Class 6 emulating indicator (CI challenge test pack) is demonstrating a failure for the entire load and should be immediately reported by phone or messenger to the appropriate supervisor and to the infection prevention and control department. This notification should be followed by a written report." The above document further stated "The report and notification should include the following information: the time and date of the questionable sterilizer; a description of the sterilizer and load, with reference to the appropriate lot control number; the results of physical monitoring and of internal CI (if applicable) as obtained from the user department; any other information that could be useful in determining whether the report is valid or is questionable because of operator error. If the cause of failure is immediately identified (usually operator error) and confined to one load or one item in the load (i.e. an item with a nonresponsive internal CI), the cause of the failure should be corrected and the load should be reprocessed. If the cause of the failure is not immediately identified, the load should be quarantined, and all loads back to the last negative BBI should be recalled. Items in these loads should be retrieved, if possible and reprocessed. The sterilizer in question should be taken out of service for further investigation of root causes. The heads of the microbiology department, sterilizing department, and infection prevention and control department or their designees, with appropriate facility maintenance and sterilizer service personnel, should attempt to determine the root cause of the sterilization process failure and arrange for corrective action. If the root cause of the sterilization failure has been determined to be sterilizer malfunction and major repair is required for correction, the sterilizer in question should be immediately re-challenged with a PCD in three consecutive cycles." For dynamic-air-removal sterilizers, and IUSS (immediate use steam sterilization) cycles, a "Bowie-Dick test pack should then be run in three consecutive empty-chamber cycles. Until the results of retesting are satisfactory (three cycles with negative BIs and if applicable, three cycles with acceptable color change in the Bowie-Dick indicator, the performance of the sterilizer should be considered in question."

H. Review of Policy # EOC-ME6.21 on 03/21/16 as provided by the Director of Surgical Services revealed "The Reprocessing and Sterilization department monitors the testing and documentation of sterilizer performance. The departments that utilize sterilizers maintain logs and monitoring strips. The Infection Prevention and Control staff checks compliance during environmental tours and independent audits. Results and compliance is reported to the Infection Control Committee. Biomedical Engineering monitors vendor performance of scheduled maintenance and maintains sterilizer maintenance records." The policy further states "for the routine release of a load containing implantable devices it is mandatory to use a Biological Indicator."



Based on observation on 03/17/16 and 03/18/16, it was determined the Facility failed to assure soiled instruments were processed to prevent blood and tissue from drying on the surfaces. Dried blood and tissue increase the bioburden and can prevent cleaning prior to sterilization. The failed practice was likely to affect all patients who have a surgical procedure at the Facility. The findings were:

A. Observation on 03/17/16 at 1400 revealed one red biohazard bin with the lid partially open and three trays of instruments with dried blood on their surface on a cart in the decontamination room. The presence of the dried blood was confirmed by the Director of Surgical Services at the time of observation.

B. Observation on 03/18/16 at 1202 revealed three instrument trays with dried blood sitting in the decontamination room. The presence of the dried blood was confirmed by Reprocessing/Sterilization Technician #2 and the Director of Surgical Services at the time of observation. Reprocessing/Sterilization Technician #3 was interviewed in the presence of the Director of Surgical Services and he stated the instruments had not been sprayed or precleaned prior to or at the time they were delivered to the decontamination room at 1145 on 03/18/16.

C. In an interview with the Director of Surgical Services on 03/18/16 at 1230, she stated the Surgical Services department was in the process of changing their precleaning product, but stated "In the mean time, they are supposed to spray the instruments on arrival to the decontamination room."




Based on observation and interview it was determined the Facility failed to assure equipment and sterile supplies were stored and maintained to prevent contamination in the Breakout Room, clean Equipment Storage Room and Operating Rooms (#2, #5, #6 and Hybrid) of 6 (#1- #3, #5, #10 and Hybrid). Failure to store equipment and sterile items to prevent contamination did not assure patients would be protected from likely sources of infection. The failed practice is likely to affect all surgical patients treated at the Facility. The findings were:

A. Observation on 3/16/16 at 0845 revealed the following: The "Breakout Room", was identified by the Director of Nursing and described the process of "sterile items are taken from delivery cardboard boxes and placed in plastic bins. The bins are then utilized for the delivery of sterile supplies and taken to where the sterile supplies are stored. There were four of four blue plastic bins with an accumulation of dust on the inside surface of the hinged lids. The Director of Surgical Service confirmed the presence of dust on the boxes at the time of observation.

B. On 03/16/16 at 0850, the Clean Equipment Storage Room was identified by the Director of Surgical Services and stated "Everything in here is clean." Observation revealed a mixture of sterile, clean and soiled items for use in the operating room. Examples include:

1) Monopolar elctrocautery machine stored on the surface of the floor.
2) Berkely suction machine glass jar, stored on the surface of the floor.
3) Ring stand brought to the room by the Assistant Director of the Operating Room. The stand had three pieces of tape observed on the legs of the device. The Assistant Director of OR stated the ring stand was clean. The Director of Surgical Services placed the Monoplar electrocautery machine just picked up from the floor on the ring stand.
4) Three large cardboard boxes of Endo Shears and Disposable Lab clips. The Director of Surgical Services stated "we discontinued a service line in February and are waiting for these to be picked up." A nine drawer plastic cart empty and stacked on another, seven wire shelves,14 positioning pillows on a cart and two surgical saddles. This was to the right of the door. A desk chair was turned on its side resting on the boxes.
5) Red metal cart with tape residue, manuals and two partially used boxes of face masks observed beneath. The cart had an accumulation of dust.
6) BioVac Laser smoke Suction evacuation unit with tape residue on the tubing and reusable filter.
7) Soiled foot switch that had been placed on top of a Spectrometics laser.
8) Sufex Shoulder Holder with an accumulation of tape residue and dust on the surface
9) A wire cart with four shelves included sterile and non-sterile supplies:
a) (top shelf) Abthera open abdomen sterile dressing (4); non-sterile plastic suction canister lids lying beside and touching the sterile packaging.
b) (2nd Shelf) V.A.C. white foam dressing, large (7), 500 ml canister with gel for inforvac and vaculta therapy systems (3).
c) (3rd shelf) V.A.C Granufoam dressing, small (4); VAC Granu foam dressing, large (3); Abthera open abdomen tubing set (4) all in plastic bins.
10) Zeiss Microscope with instrument tape wrapped around the light cord, sticky residue noted.
11) Dyonics RF System on three shelf cart with an accumulation of dust on each shelf.
The findings of a mixture of clean and dirty equipment as observed were confirmed by the Director of Surgical Services and Assistant Director of CVOR on 03/16/16 at 0920.

The Operating Rooms (#1-#10, and Hybrid and Hybrid Room storage area) were observed on 03/16/16 as follows:
C. Observation on 03/16/16 2 of OR #2 revealed an accumulation of dust on a CD player,window sill and wall room vent. A paper magazine was observed on top of a plastic drawer cart, tape residue noted on the cart. A large red sharps container, partially full was observed on the floor beside the anesthesia cart with the lid pushed back so the top was open and accessible. A bin was noted on the bottom shelf of a stainless steel cart with the following items: (6) Oxivir TB Sanitizer, Diversey; (1) Good Sense RTU Odor controller, one quart; (1) Sani cloth bleach; (1) Super Sani Cloth Germicidal disposable wipes, whiteboard wipe aways; Steris Pre-Klenz 22 oz bottle; (8) blue cloths, 91_ #11 blade; (1) 4 oz PVP scrub solution; (1) 16 oz opened Isopropyl Alcohol 70%; (1) 4 oz Alcohol; (10 14 oz Hydrogen Peroxide. In an interview at the time of observation on 03/16/16 at 1010, the Director of Surgical Services and the Assistant Director of OR stated "Some of the techs will use the hydrogen peroxide to get blood spills from the wheels. They then use the Oxivir. The hydrogen peroxide and alcohol are not used on patients."

D. Observation on 03/16/16 of OR #3 revealed a window sill with dust and flaking paint. A Coviden Force Triad Cautery machine was observed with 4 silk tape on the surface. The findings were confirmed by the Assistant Director of Surgical Services on 03/16/16 at 1012.

E. Observation of OR #5 revealed window paint chipping and dusted accumulation on the surface. Dust was observed on the wall vent. An IV pole was observed with rust to five wheel covers; one of two arm rests to anesthesia chair handle surface cracked and suction tubing and yankeur type suction tubing unpackaged and set up for use. The findings were confirmed by Assistant Director of Surgical Services on 03/16/16 at 1032,

F. Observation of OR #6 revealed the nursing computer on wheels with silk and paper type tape to the edge of the monitor surface. Peeling paint and dust were noted to the window surface. The findings were confirmed at 1054 on 03/16/16.

G. Observation of the Hybrid Operating Room on 03/16/16 at 1420 revealed a total of 30 ET (endotracheal tubes) 6 each, that were bound with rubber bands in the anesthesia cart. The rubber bands crushed the packages and increased the likelihood of package integrity compromise. The ET tubes secured with rubber bands was verified by the Director of Surgical Services at time of observation.

H. Observation of the Hybrid Operating Room Supply room revealed two large stackable bins sitting on floor. The bins contained Medallion sterile needles in the lower bin and Zero Gravity equipment sterile equipment covers in the top bin. The findings of sterile supplies stored on the floor were verified by the Director of Surgical Services on 03/16/16 at 1430.



Based on observation, review of intravenous(IV) solution storage information, and interview, the Facility failed to follow manufacturer guidelines for storage of IV solutions in that IV solutions were stored in one (Hybrid Operating Room Supply) area without the overwrap of the solutions intact before administration to patients. The integrity of the two IV solutions observed could not be assured. The failed practice was likely to affect all patients admitted to the Facility requiring surgery. Findings follow:
A. Observation on 03/16/16 between 0840-1230 revealed:
1) Two 1000 milliliter(ml) bags of Heparin 5000units in Sodium Chloride 0.9% were lying on a bin in Hybrid supply room without the overwrap intact to ensure the integrity of the IV solutions.
B. Storage information on the bags of IV solutions was reviewed during the tour. Manufacturer storage directions reflected the overwrap was to remain on the bags until ready for use.
C. Findings listed in A. were verified by the Director of Surgical Services at time of observation.



Based on observation, review of sterile package labeling and interview, it was determined the Facility failed to prevent the use of opened sterile supplies in the Inner Core Area of Surgical Suites. Failure to prevent the use of opened supplies for patient care did not assure sterility was maintained or patients were not exposed to contaminants. The failed practice was likely to affect all patients admitted to the Facility requiring surgery. Findings follow:
A. During a tour of Reprocessing/ Sterilization(R/S) on 03/16/16 between 1355-1545 the following was observed:
1) In the Inner Core Area of Surgical Suites three opened Pressure Monitoring Kit with TruWave Disposable Pressure Transducer were hanging on IV pole connected to 500ml Sodium Chloride 0.9% and placed inside pressure bag. Manufacturer's package instructions stated "TruWave disposable pressure transducers are supplied sterile in preconnected monitoring kits. They are for single use only. Contents sterile and fluid path nonpyrogenic if package is undamaged or unopened. Do not use if package is opened or damaged." The Operating Room Manager verified these are prepared in advance for emergency surgeries.
B. Findings listed as A were verified during interview with Operating Room Manager at the time of observation.



Based on review of KimGuard Sterilization Wrap manufacturer's directions for use, observation and interview, it was determined the Facility failed to assure sterile wrapped instrument sets were not stacked on top of one another in one of one (Sterile Instrument Room) area. Failure to assure sterile instruments sets were not stacked did not assure their sterility was not compromised from crushing. The failed practice was likely to affect all surgical patients admitted to the Facility. Findings follow:
A. On observation 03/16/16 at 1510 in the Sterile Instrument Room, greater than 10 sets of wrapped sterile instruments were on shelves and available for patient use.
B. Review of KimGuard Sterilization Wrap manufacturer's directions for use revealed, "Caution: Do no stack trays. Stacking trays can result in damage to the wrap caused by undue pressure from the weight."
C. Findings listed as A was verified during interview with the Director of Reprocessing/Sterilization at the time of observation.

Based on clinical record review and interview, it was determined the Facility failed to assure Operative Reports included the time of surgery in 19 (#1-#18 and #20) of 20 (#1-#18 and #20) surgical records. Failure to assure the time a surgical procedure took place did not establish a time-line of surgical events in the course of a patient's admission to the Facility. The failed practice was likely to affect all surgical patients admitted to the Facility. The findings were:

A. Clinical record review on 03/21/16 revealed the following Operative Reports that lacked the time of the surgical procedure:

Operative Report dated 01/29/16, Patient #20
Operative Report dated 02/02/16, Patient #11
Operative Report dated 03/10/16, Patient #17
Operative Report dated 03/15/16, Patient #1, #2, #3, #4, #6, #7, #8, #9,#10 #12
Operative Report dated 03/14/16, Patient #13, #14 #15 #16, #18
Operative Report dated 03/16/16, Patient #5

B. The lack of time for the surgical procedure for Patients #1 - #10 was verified by interview with RN(#1) on 03/21/16 from 1230-1615 and Patients #11-#18 and #20 were verified by RN #2 at 1400-1600.