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Based on observation and interview, it was determined three of seven operating rooms contained hazards that had the potential to affect the health and safety of staff and patients related to the installation of portable re-circulating air conditioning units and dehumidification units. The use of the units had the potential to affect the health and safety of all patients admitted for surgery due to the potential of contamination of the operating environment and also created a tripping hazard. The findings follow:
A. On a tour of the operating suite on 08/16/11 at 1230 with the Director of Facilities Management, the System Director of Surgical Services and the Chief Nursing Officer, portable recirculation air-conditioning units were observed in Operating Rooms #5, #6 and #8. Portable dehumidification units were also observed in Operating Rooms #5, #6, #8 and the Sterilizer Room located between Operating Room #5 and Operating Room #6. The portable air-conditioning units were located in the corner of each operating room. A section of round, flexible air conditioning duct was installed on the top of the units and routed to the ceiling, where a hole had been cut to accommodate the duct. The ductwork was attached to the units and the ceiling with duct tape, which provided the seal for the ductwork at the unit and ceiling. The duct tape located on top of the unit in Operating Room #6 was loose, allowing air exhausted from the unit into the room. The exposed ductwork, duct tape and the hole cut in the ceiling to allow the unit to exhaust from the room presented a hazard to the sterile environment with a potential for contamination. Condensate drain lines from the dehumidification units were routed along the floor into the floor drain located in the sterilizer room. A notch on the lower edge of the door separating Operating Room #5 and Operating Room #6 from the Sterilizer Room was cut to allow the condensate drain line to pass through the doorway without being pinched. An extension cord ran across the floor in front of the door separating Operating Room #5 and the Sterilizer Room to reach an electrical outlet.
B. In an interview conducted on 8/16/11 at 1300 the Director of Facilities Management verified the presence of the units and stated they were installed to supply supplemental cooling and dehumidification to the rooms in response to complaints from surgical staff.

Based on Temperature and Humidity Log review and interview it was determined the humidity level in seven of seven operating rooms was regularly maintained outside the required range (30% to 60%) from October 2010 to August 2011. Humidity levels outside the required range had the potential to affect the health and safety of all patients admitted for surgery due to the risk of static electricity with low humidity and mold and mildew creation with high humidity. The findings follow:

A. A review of the Temperature and Humidity logs for the Operating Rooms on 08/16/11 at 1430 revealed the following:
1) Operating Room #1 had 45 of 225 days of humidity outside the required range (30% to 60%). Humidity above 60% was recorded on one day and 44 days were recorded below 30%.
2) Operating Room #2 had 42 of 225 days of humidity below 30% was recorded.
3) Operating Room #3 had 37 of 226 days of humidity outside the required range (30% to 60%). Humidity above 60% was recorded on one day and 36 days were recorded below 30%.
4) Operating Room #5 had 33 of 228 days of humidity outside the required range (30% to 60%). Humidity above 60% was recorded on three days and 30 days were recorded below 30%.
5) Operating Room #6 had 43 of 227 days of humidity outside the required range (30% to 60%). Humidity above 60% was recorded on 13 days and 30 days were recorded below 30%.
6) Operating Room #7 had 56 of 224 days of humidity outside the required range (30% to 60%). Humidity above 60% was recorded on 15 days and 41 days were recorded below 30%.
7) Operating Room #8 had 59 of 224 days of humidity outside the required range (30% to 60%). Humidity above 60% was recorded on 30 days and 29 days were recorded below 30%.
B. In an interview on 08/17/11 at 0900 the Director of Facilities Management verified the temperature and humidity recorded in the log book and stated the readings were recorded only once per day, before surgeries began.

Based on a observation of surgery holding, operating suites, post anesthesia care, central sterile and surgical storage areas, interview, review of inservice records, sterilization logs, policy and procedure review, storage and removal of expired items, use of sterilization or flash sterilization, equipment and environmental sanitation, the cleaning between surgery cases and a recurrent deficiency cited on the complaint investigation conducted 10/01/2010, it was determined the Condition of Surgical Services 482.51 was not met. The decision was based on the following:

1. Interview with the OR Manager conducted 08/16/11 at 1307 verified the Hush Slush Machine (utilized for the warming and cooling of solutions during cardiac surgery) had been used to mix a lemon drink for staff to drink. That practice had the potential for increased infection and had the potential to affect all eight patients on the surgery schedule.

2. Review of the Record of Immediate Use Sterilization Log for steam sterilizer #1 and #2 from 08/01/11-08/15/11 revealed the staff failed to document biological indicator testing or results, date or time, load number, cycle time and cycle temperature for implantables. That failed practice created a potential for increased risk of transmission of infection of the surgical site for patients that required an implantable and had the potential to affect all eight patients on the surgery schedule.

A. Surgery Policy and Procedure Manual review "Hospital Sterilized Implantables" with a last revision date of 04/09 stated "Policy: Hospital sterilized implantable items will be sterilized with a biological spore indicator and are quarantined until a negative spore test is read. In emergency situations, if items are implanted during quarantine period, the Physician is informed. The spore test will be monitored and the Surgeon and Infection Control Office informed of a positive reading." Policy "Flash Sterilization", Reference # 5072, last revision date of 02/16/10, item #18 stated "Implants shall be flash sterilized only if there is insufficient time to sterilize using the preferred wrapped method and if results of the biological indicator are available before implantation." The findings were confirmed by the OR Manager on 08/15/11 at the time of the observation.

B. The "Record of Immediate Use Sterilization" log for steam sterilizer #1 and #2, 08/01/11 - 08/15/11, revealed 2 of 2 surgical implant sets were documented.

C. Sterilizer #1, Patient #18 was listed on the log 08/10/11. The "Cause for Immediate Use Sterilization" was documented as "Brought in by Sales Rep/Doctor". The times listed for sterilization was 1259 for 10 minutes at 270 degrees Farenheit. The procedure start time was documented as 1302 on the "Surgery Record". The staff failed to document biological indicator testing or results for the "Ortho Locking Mini Frag" (fragment) set. The findings were confirmed by the OR Manager on 08/15/11 at 1215.

D. Sterilizer #2, Patient #20 was listed on the "Record of Immediate Use Sterilization" log and staff failed to document date or time, load number, cycle time, cycle temperature, biological indicator or chemical indicator results of the immediate use cycle for a "tibial nail set".

E. Patient #20 "Surgery Record" dated 08/07/11 and "Record of Implant, Implants with no label" revealed one titanium end cap and three titanium locking screws were implanted. The findings were confirmed by the OR Manager on 08/15/11 at 1335.

F. The Surgery Department Policy and Procedures provided by facility staff were reviewed on 08/16/11. The policy "Implantation of Medical Devices "stated the "definition/purpose" as "To decrease the risk to the patient of infection or rejection." "Procedure" stated "Only implants verified as having been subject to the sterilization process are implanted." The "Flash Steam Sterilization" policy stated the "purpose: to provide guidelines for flash steam sterilization of items within the Operating Room by a reliable, rapid, standardized method."

G. "Flash sterilization should only be used in carefully selected clinical situations when certain parameters are met." "a chemical indicator is placed in the pan with the instruments to be sterilized." "Information recorded will include the autoclave used, date and time of cycle, contents of load, time and temperature of exposure, the operator's initials and the reason for flash sterilization. Biological indicator testing is performed using live spores to ensure sterility." The policy "Monitoring Sterilizer Efficiency" stated "objective; Measure sterilizer performance and meet requirements for sterilization." Procedure: "Run biological spore test/test packs in all gravity displacement and high vacuum sterilizers (if used) daily". "Use chemical indicator outside and inside each package to be sterilized."

H. On 08/16/11, Sterilization logs #1 - #3 for the Main Operating Room were reviewed from 05/01/11 - 07/31/11 and revealed five of five (05/11/11, 05/17/11 ,06/15/11, 06/17/11 and 07/22/11) instances in which implantable devices were documented on the "Record of Flash Sterilization Log" (05/2011) and "Record of Immediate Use Sterilization" (06/2011 - 07/2011) logs without documentation of biological testing or results.

I. On 08/16/11 at 1335 the Corporate Perioperative Services Administrator was interviewed. She stated "(Surgical Services) are not expected to use flashing. Only in emergencies. Biological testing should be done with implants."

J. Review of the "3M Attest 1291 Rapid Readout Biological Indicator" package insert provided by the facility 08/16/11 contained the statement "Monitor every load that contains a critical medical device or implant with an Attest 1296 RRBI (Rapid Read Biological Indicator)" Incubate the positive control and sterilized Attest 1291 RRBI for one hour in an Attest auto-reader."


3. Observation on 08/15/11 revealed multiple expired items located in the supply cabinet, OR #1- #3, #5-#8, sterile disposable supply and sterile instrument room. That failed practice had the potential for increased risk of infection from the use of expired items available or patient use and had the potential to affect all eight patients on the surgery schedule. This is a recurrent deficiency from the complaint investigation conducted on 10-01-11.


A. Observation on 08/15/11 revealed multiple expired items located in the supply cabinet, OR #1- #3, #5-#8, sterile disposable supply and sterile instrument room. The following are examples of expired items:

B. The supply cabinet across from Sterilizer #1 contained: Medtronic Heparin Dose Response Cartridges, 2 of 2, 9 count boxes, expired 01/18/11; Biological Monitoring Kit for the Steris Process, 11 of 11, expired 01/03/2011; Medtronic Heparin Assay Cartridges, 2 of 2 boxes were expired, 1 box of nine, expired 01/15/10, and one box of eight, expired 05/11/2010; Guidewire, straight stiff shaft, one of one, expired 03/2010.

C. OR #1, identified by the OR Manager as the "Heart Room back up room or for any clean case," contained Persona Plus Surgical Blade, #10 blade, 1 expired 04/2010; 3 expired 09/2010; 6 expired 10/2010; 7 expired 02/2011; 3 expired 03/2011 and 1 expired 05/2011.

D. The Sterile Instrument Room contained 62 items in dust cover with a sticker that stated "Contents sterile unless package opened" and also had a date of expiration visible inside the dust cover on the inner wrap. Examples of expired items included: Osteomed screws, 1 of 1 package, expired 12/03/10; Large Frag Plate, 1 of 1, expired 07/27/11; Large Frag Screws, 1 of 1, Expired 07/27/11; Large Frag Instruments, 1 of 1, expired 07/27/11; Synthese 3.5 mm (millimeter) med (medium) distal tibia, 1 of 1 expired 04/07/11; Wire Driver, 1 of 1, expired 05/18/11. Expired sterile packs (without dust covers) included: Olympus Scope, 30 degree x 5 mm, expired 08/14/11; Balfore Retractor, 2 of 2 were expired on 07/23/11 and 08/12/11; Myerdines, 1 of 1 expired 07/06/11; Hip femur retractor, 1 of 1, expired 07/03/11; Arthroscopy set, 1 of 1, expired 08/06/11; Fracture set, 1 of 1, expired 07/21/11. Wide Collins Blade, in sterile wrap without a dust cover was observed with an expiration date of 12/17/10. The above findings were confirmed 08/15/11 at 1355 with the OR Manager and OR Charge Nurse.

E. In OR #5 a "Gyn 12 degree scope" 1 of 1, expired 01/07/11, and was confirmed by OR Manager 08/15/11 at 1410.

F. In OR #6, syringe, 60 milliliter, 7 of 7 expired 04/2008; Biogel size 7.5 Latex gloves, 10 expired 10/2008; Kiwi Palm Pump, 1 of 1 expired 06/2011
the above was confirmed 08/15/11 at 1435 by the OR Manager and the Corporate Administrative Director.

G. OR #5 was identified by the OR Manager as the "OB/GYN (obstetrics/Gynecology)room. Expired items included: Bardex, IC urinary catheter tray, 1 of 1, expired 12/2009; Kiwi Palm Pump, 2 of 2 expired 05/2011. Confirmed by the OR Manager 08/15/11 at 1450.

H. In the Sterile Disposable Supply room, expired items included: Granufoam Dressings, 26 x 15, 5 of 5, expired 05/28/11; Granufoam Dressing, 10 x 7.5, 1 of 1 expired 05/28/11; Y Connectors, 2 of 2, expired 02/2011; Arrow CVC multi lumen, 2 of 2, expired 01/2011.
The above findings were confirmed by the Corporate Administrative Director 08/15/11 at 1520.

I. OR #7 was identified by the OR Manager as the "C. V" (Cardiovascular) room. Expired items in OR #7 included: Medtronic Heparin Assay Cartridge, tan 9 of 9, expired 02/08/10; Medtronic Heparin Assay Cartridge, tan 9 of 9, expired 11/27/06; Medtronic Heparin Assay Cartridge, green 9 of 9, expired 05/11/10; Medtronic Dose Cartridge, 9 of 9, expired 10/28/10; Medtronic Heparin Assay Control, 1 of 1 unopened box, expired 03/27/07; Medtronic Clot Trac, 3 of 3 unopened boxes were expired on 03/28/06, 08/23/06 and 05/01/07; Heparin Assay Control, red/yellow, 1 of 1 unopened box, expired 10/15/07. Heparin Assay Control,tan/silver, 1 of 1 unopened box, expired 10/04/07; Heparin Assay Control, green/white, 1 of 1 unopened box, expired 10/04/07; Excel Soft Vascular Graft, 1 of 1, expired 07/2011; Fidelity 8 French Insertion Kit, 34 cc (cubic centimeter) expired 05/2011; Prolene 6.0 Suture, 30 inch, C-1, 25 expired 07/2011; Prolene 1 Suture, 30 inch, CTX, 35 expired 07/2011; Prolene 1 Suture, 30 inch, CTX, 2 expired 07/2010 and 1 expired 01/2010; Surgisteel #5, CCS, 22 expired 07/2011; Surgisteel #6, CCS, 28 expired 07/2011.

The above findings were confirmed 08/15/11 at 1625 by the Corporate Administrative Director.

4. Observation of OR #1 that was clean and ready for use on 08/15/11 at 1248 revealed items that could not be sanitized, equipment that was not labeled as clean, an accumulation of dust and soiled equipment. That failed practice had the potential for increased infection from the use of equipment that had not been cleaned properly and had the potential to affect all eight patients on the surgery schedule.

A. OR #1 was identified by the OR Manager as clean and ready for use. Observation of OR #1 on 08/15/11 at 1248 revealed:

B. A foam "patient positioner" wrapped in a clear plastic bag, on the lower shelf of an enclosed cabinet beside sterile supplies. The OR Manager identified the item as reusable and stated it had been "cleaned and ready for re-use". The item was porous and therefore could not be sanitized.

C. The cabinet also contained a "gel type positioner" with an open area in the covering exposing the gel material and created an irregular surface. The surface of the gel positioner was soiled and discolored. On 08/15/11 at 1252 the OR Manager used a cleansing wipe on the surface and removed an area of soiling.

D. Equipment stored in the alcove of the surgery corridor was identified by the OR Manager as "clean" on 08/15/11. Observation on 08/15/11 at 1304 revealed a Zeiss ENT Microscope with an accumulation of dust on the surface; Superlux 75 with a cloth type tape across the knob area with a note written "Do not turn knobs" across the tape. The item had an accumulation of dust. The "Leica" neurology microscope, had an accumulation of dust on the surface and tape on the unit. The equipment was not labeled or identified as "clean". The OR Manager confirmed the findings at the time of observation.

5. Observation of the breakdown and cleaning of OR #7 immediately following the completion of a CABG (Coronary Artery Bypass Graft) revealed policies and procedures for the " Seven Step Cleaning Process " were not followed and the approved cleaning agent was not used. That practice had the potential for increased infection and had the potential to affect all eight patients on the surgery schedule.

6. Review of the inservice material for the cleaning and disinfection of the OR suites revealed no evidence staff had been trained regarding the cleaning and disinfection of the OR suites and equipment. That failed practice had the potential for increased infection based on the lack of knowledge for the correct cleaning techniques and had the potential to affect all eight patients on the surgery schedule.

A. In an interview on 08/15/11 at 1605, the OR Manager stated " The SaniMaster 4 was the product used for cleaning the OR and after each case, but "I'm not for sure. It's the same thing housekeeping uses." An interview was conducted on 08/15/11 at 1615 with Environmental Services employees assigned to the OR. Environmental Services Employee #1 and #2 stated the products used for "end of day" cleaning were "Light Duty Cleaner to mop the floors" and "All Purpose Cleaner to clean everything else."

B. The Policy and Procedure for "Operating Room Sanitation", effective date 11/07 stated "Prior to the first surgical procedure of the day: All horizontal surfaces within the OR are damp dusted with an approved germicidal agent. Horizontal surfaces include furniture, surgical lights and equipment. Preparation of the OR includes visual inspections for cleanliness before supplies and instrument sets are brought into the room." "Post Operative Cleaning: After each surgical procedure, a visibly clean environment is reestablished. Equipment and furniture visibly soiled are cleaned with an approved agent at the end of each surgical procedure."

C. Review of training provided to OR technicians and nursing staff in 2011 for cleaning of the OR revealed a document that listed the following steps: "Room Cleaning: Correctly performs 7 step room cleaning procedure: high dust, sanitize spot clean, bathroom cleaning, waste baskets, dry mop/vacuum, Sanitize floor, Inspection. Chemical Handling: Demonstrates/verbalizes knowledge of proper dilution rates for chemicals including: SaniMaster 4, Glass Clene, Wall Glide, Scrub n Shine, Bowl Care, Odor Go. Waste Handling: Demonstrates/verbalizes knowledge of proper procedure for handling infectious waste including documentation. Equipment Use: Demonstrates knowledge of proper use of equipment encountered/used by environmental services aides including: Wet floor signs, Needle boxes, Carts, Vacuums. Body Mechanics: Demonstrates knowledge of proper procedures for lifting, moving and climbing." In an interview on 08/17/11 the OR Manager stated the training document for between case cleaning was from environmental services and used for training of OR personnel. Surveyor #1 asked the OR Manager if the content was applicable to the OR Technicians and nursing staff, The OR Manager stated "It's a start. We will have competencies in October." There was no evidence.

7. Observation on 08/15/11 from 1200-1630 revealed OR # 5, #6 and #8 had portable re-circulating air conditioning units and dehumidifier units in each room. That failed practice had the potential for increased infection based on the movement of air over the sterile field and had the potential to affect all eight patients on the surgery schedule.

A. Observation on 08/15/11 from 1200-1630 revealed OR # 5, #6, and #8 had portable re-circulating air conditioning units and dehumidifier units in each room.

B. OR #5 had an air conditioning unit blowing directly into the room. OR #6 had a portable air conditioning unit blowing across the room and toward an infant warmer. The temperature on the air conditioning unit was 63 degrees Farenheit. OR #8 had a portable air conditioning unit blowing into the room. The findings were confirmed by the OR Manager and Corporate Administrative Director on 08/15/11 at the time of observation.

C. On 08/17/11, facility policy #SOR, "Surgery Policy and Procedure Manual: Environmental Factors" was reviewed. The policy stated "Dust is partially controlled by filters in the ventilating system. However, movement of personnel, equipment and doors create additional air currents within the Operating Room. Dust particles and lint circulated by these currents may settle on the operative field or in an open wound. Therefore, traffic in, out, and through the room should be kept to a minimum. Forced expiration, which occurs when talking, or laughing forces bacteria through the mask into the air."

D. The presence of the portable air conditioning units in OR #5, #6, and #8 created additional air currents within the rooms.

8. Observation and interview on 08-16-11 revealed three of seven operating roms contained hazards that had the potential to affect the health and safety of staff and patients related to the installation of portable re-circulating air conditions and dehumidification units. That failed practice had the potential to affect all eight patients on the surgery schedule. (See A724)

9. Review of the Temperature and Humidity Log and interview it was determined the humidity level in seven of seven operating rooms was regularly maintained outside the required range (30% to 60% from October 2010 to August 2011). That failed practice had the potential to affect all eight patients on the surgery schedule. (See A726)

Based on observation, policy and procedure review and interview, it was determined the facility failed to implement and enforce policies and processes for environmental sanitation between surgical cases, control of dust and airflow in OR rooms, removal of expired supplies and expired sterilized instruments. The lack of enforcement and adherence to policies and procedures created the potential for unmet surgical needs and poor outcomes. The failed practice had the potential to affect all eight patients on the surgery schedule 08/15/11 and any patient who received surgical services at the facility.

Based on observation, interview, policy and procedure review and review of inservice documents, it was determined the facility failed to assure operating room staff adhered to processes for the maintenance of a sanitary environment in the peri-operative area, that included safe air handling systems in OR (Operating Room) # 5, #6 and #8 and failed to assure processes for sterilization of instruments met established policies and infection control requirements. Lack of monitoring infection control processes and staff adherence to infection control standards within the peri-operative area created the potential for increased infection and negative outcomes for patients. The failed practice had the potential to affect all eight patients on the surgery schedule 08/15/11 and any patient who received surgical services.