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Based on observation, interviews and photos and record reports reviewed, the hospital failed to ensure that surgical environment was maintained to ensure the safety and health of all surgical patients, when they failed to maintain the Operating Room (OR) ventilation system as required by health code, failed to store all OR equipment (sterile, clean and cleaning equipment) in a safe and appropriate environment per building code and fire safety requirements. This affects all staff working in the OR/Surgical Services and all patients receiving surgical services.
Findings Included:
On 03/02/12 starting at 9:02 a.m. concluding at 3:00 p.m. a tour, observations and interviews confirmed that hallways with exit and entrance corridors are being used to store OR equipment, OR supplies and other carts and supplies making this a fire safety hazard, and infection control hazard.
Clean, dirty and sterile rooms are open to each other and to common high traffic hallways causing an infection control hazard. The openings between these spaces allows a cross-contamination air-flow.
Sterile supply area was not enclosed, failing to meet sterility and building standards of practice.
The fall of 2011 when 5 (#3, 4, 5, 6 and 7) orthopaedics surgical site infections were identified, ventilation failed to function properly and was not properly monitored and maintained to meet health and building codes. One (1) of 16 OR suites (#7), used for orthopedic cases, was of negative pressure. All OR rooms require positive pressure by health and building codes and federal regulation CFR 482.41(a) requirements. (A701)

The cumulative affects of these systemic failures prevented surgical services from ensuring a clean and safe environment to all patients and staff in a high risk area (Operating Rooms) over a period of years to this area of the hospital.

Based on observation, record and log reviews and staff and outside vendor pictures, reports and interviews the hospital failed to ensure that surgical services environment was maintained to ensure a safe environment when the hospital's surgical services stored equipment in areas making those areas hazardous and an infection control hazard. The hospital failed to maintain to health code and infection control standards, the Operating Room (OR) ventilation systems, This affects all staff working in, and all patients receiving Operating Room/Surgical Services.

Findings include:

During an interview 02/27/12 at 11:30 a.m. Director Infection Control Practitioner (ICP)-C confirmed to Surveyor #22198, that Director ICP-C is a member of the Association for Professionals in Infection Control and Epidemiology (APIC) and the hospital follows APIC guidelines.

Director Infection Control Practitioner (ICP)-C confirmed to Surveyor #22198, that in the late summer early fall of 2011, the OR had 5 (#3, #4, #5, #6 and #7) orthopaedic surgical site infection patients who received surgery in 2011 when the air quality system was ineffective.

A total of 36 Surgical Site Infections (SSI) were review from the annual infection control log and data report of 2011 (calendar year). These all occurred during a time when the air quality system was ineffective. These included:

4 Coronary Artery Bypass Graft-Chest & Donor SSIs.
12 Colon Resection SSIs
4 C-Section SSIs
2 Spinal Fusion SSIs
1 Hip Prosthesis SSI
4 Abdominal Hysterectomy SSIs
2 Knee Prosthesis SSIs
3 Laminectomy SSIs
4 Pacer SSIs

Guide to the Elimination of Orthopedic Surgical Site Infections 2010 obtained from:

http://www.apic.org/Resource_/EliminationGuideForm/34e03612-d1e6-4214-a76b-e532c6fc3898/File/APIC-Ortho-Guide.pdf

[ANSI/ASHRAE/ASHE Standard 170: Ventilation of Health Care Facilities :

Guidelines for Environmental Infection Control in Health-Care Facilities obtained form:


02/27/12 at 11:30 a.m. ICP-C confirmed to Surveyor #22198, that as Director, ICP- C and two other staff were involved in Environmental Rounding throughout the hospital, including the OR/Surgical Service areas.

ICP-C told Surveyor hospital ICPs were not aware of the ventilation problems, storage problems or the ORs inability to separate, clean, dirty and sterile environmental based on OR/Surgical Service Standards of Practice requirements to ensure a clean and safe environment for the complexity of the services rendered.

On March 2, 2012 between 8:00 a.m. and 3:15 p.m. an onsite tour with interviews was conducted by Engineer Surveyors #18107 and #12187 and facility staff Maintenance Dept - Steam Fitter-FF, Director of Facilities Y and Safety Officer -D. The following observations, interviews and confirmation of findings occurred:

1. OR #7 (orthopaedic surgery room), was confirmed to be a negative air flow room. Operating rooms are required to be positive pressure per the state building code. Pressure testing occurred at the time of observation. This requirement has never changed since pre-1967.

2. Ortho. Clean Storage Room #1149A, was open to the corridor, compromising the clean and sterile items used in Orthopedic Surgery that were placed within this space. This practice fails to meet code compliance for State DHS-124, building code and current infection control standards of practice.

3. Surgery Corridor & Pre-Op Holding Alcove are being used to hold and prepare day surgery patients when other locations are full. This area is open to corridor and air supply is not separated from corridor air. Observation of space used for clean storage with sterile and clean pack items pushed up against walls. This failed to meet infection control standards of practice for storage.

Observed many Kimguard Sterile Packs (blue material to wrap sterile instruments) stacked on each other on several carts within the corridor and on metal carts within alcoves. Stacking Kimguard wrapped instruments is not an accepted Standard of Practice (SOP) for Infection Control (IC), the Association of Medical Instrumentation (AAMI) or per Kimguard manufacturers recommended use to ensure air flow between sterile instruments and avoid condensation and ensure the sterile package integrity.

Day Surgery re-used Kimguard. This was found folded and stacked on top of each other in many locations including all storage areas and supply areas waiting for re-use. No safe infection control or fire safety policies for re-use were provided.
All corridors before the red line were not clean according to surgery staff. since it is not considered a surgical area, no one is allowed beyond the red line without surgical gowns.

4. Soiled Utility and Clean Utility room doors where propped open to the corridor, adjacent to the Orthopaedic clean storage hallway, which allows clean to dirty air movement across clean supplies. An open window was observed between soiled and clean utility rooms and one of the doors to the corridor from the clean utility was held open.

5. A housekeeping closet next to OR #7 was missing an exhaust vent within the room.
The housekeeping room was used to hold sanitizing agents and cleaning fluids as well as other soiled and cleaning supplies used to clean spaces within the Surgery Department.
There was an apparent odor from the cleaning agents since there was no exhausting mechanism to remove the odors within the room.

6. The Clean Ortho Equipment Room #1147 was in an open alcove from the corridor and not within a room with positive air pressure to adjoining spaces. Surveyors #18107 and #12187 were told this space will be part of a larger surgery renovation that is in the planning stages now. No plans have been submitted to date for this Orthopaedic equipment room space change.

There was no air supply grille at ceiling of alcove. However HVAC documentation/drawing indicated an air supply vent was in this location.

7. The Cardiac Pump Room #1644 is being used as a surgical storage room with a lot of plastic encapsulated supplies on two carts (2 feet w x 5 feet L x 6 feet h), which render this space a hazardous space and room. This room, having a duel purpose intended for holding all the clean and sterile cardiac heart pump equipment for the open heart procedures and a hazardous space, was identified as positive pressure. The air flow ventilation temperature and humidity are different for a hazardous space and a sterile supply area.

8. The Tissue Bank room was being used as a storage space as well as the Tissue Bank.
Several carts and sterile supplies and equipment, not part of the tissue bank, were stored in the room. These were full-height supply carts and one piece of equipment on the floor was blocking a second/side door. Room was identified as positive pressure for a clean room however failed to meet the requirement for sterile supply storage.

9. The Clean Supply Room #1994A in the Post Anesthesia Care Unit (PACU) was of negative pressure. The air could be felt moving and was checked in the PACU using the tissue test at doors when they were closed. Health codes and building codes require a PACU to maintain positive pressure.

The return grille in the ceiling outside the Clean Supply Room #1994A had dust and dirt on the grille. Surveyors ##18107 and #12187 were told the PACU is cleaned regularly, however, ceiling grilles were dirty in Stage 1 Recovery area for patients.

10. The large Orthopaedic Supplies Storage area (a Hallway) 1660 (used as storage), Corridor 1560a, and Corridor 1646 were open to the storage hazards.

11. Operating Room #15 had only one patient exit, through the Alcove #1649A that is exposed to this large storage area #1660 & sterile storage room #1658 & #1650 and exceeded the exit distances for several rooms within the Suite due to the number of spaces a person would have to traverse to get to a corridor or exit. Inner spaces required going through three doors. The overall suite needed to be reduced to 50 feet maximum travel distance from these specific spaces.

Hazardous spaces needed to be separated from the other egress pathways (internal suite corridors), in the event of a fire - the staff and patients have the potential to be trapped in the event of a fire.

Infection control problems identified in the supporting OR ' s #15, #16, #14, #12, #11:

The OR is not allowed by code to traverse a hazardous space to get to an exit.
The general storage spaces are not supposed to be positive pressure to surrounding spaces or open to the corridor system. Both air flow and hazards were identified in the ORs present layout.

Through observation, discussion with the Air Cleaning Consultants with Air Maintenance, Inc. staff and document review, Surveyors identified that all "supply ducts" within the contract area of Duct Cleaning (Phases 1, 2 & 3) of Surgery, were dirty at numerous locations and specifically at the 90 degree turns of the ducts.

The duct cleaning was scheduled to be done in 3 phases: Phase 1, January 30, 2012 for ORs 12, 14, 15 & 16. Phase 2 includes ORs 3, 4, 5, & 6. Phase 3 includes the remaining Surgery ORs 1, 2, 7, 8 & 9.

OR #7 with negative air flow is within this grouping.

The hospital issued the Orders in November 2011 but due to the heavy usage of these ORs, they could not start until January 30th, 2012. Surveyors ##18107 and #12187 were told by Air Maintenance, Inc., photographs where taken before and after at each segment of ducts cleaned.

On 03/06/2012 Project Progress Report given to Surveyor ##18107 via email entitled, Job: Waukesha Memorial Hospital Surgery Department provided by Air Maintenance, Inc., confirmed as of the date of Survey 03/02/12 the air supply and returns were dirty. All duct systems would require cleaning based on the Cleanliness verification in the NADCA standard ACR 2006. (Report Date: 03/05/12. Report Author: Director of Operations, Air Maintenance Inc.-OO)

The report confirmed that cleaning supply, return and exhaust ductwork was performed in surgery rooms # 2 through #15 and adjacent areas between January 30th and February 8th 2012. This report confirms that at the time this complaint was filed (11/22/11) these OR air ducts were not cleaned.

Surveyors #18107 and #12187 were told the reason for the "humidification issues" within the operating room department was related to the AHUs (Air Handling Units) that were installed. Originally, the humidifier component was placed incorrectly within the Air Handling Units. The lack of humidification control within the Operating Room suites and one of the reasons for the Air Handling Units Modification and Replacement Project on AHU ' s #31, #25 & #24 was identified at WMH-AHU Study by Pearson Engineering, Inc. 2/24/2006 final

Surveyors #18107 and #12187 were informed that the AHUs are designed at a MERV 8 = Filtration at 30%, with final HEPA filtration at 99.97%. Humidification is taken through the BDC (Building Design Controls) system - daily and hourly. Prior to the duct cleaning project, the last air samples where taken before the November 2011 AHU modifications.

AHU (air handling unit) #31 controls: ORs 12, 14, 15 & 16 and AHU modifications were made early November 2011. AHU #25 controls: ORs 3, 4, 5 & 6 and PACU and AHU modifications were made 11/24/2011. AHU #24 controls: ORs 1, 2, 7, 8 & 9 and this AHU #24 (371A1) is in the process of being replaced and the old unit removed from mechanical space B154.

Surveyors #18107 and #12187 toured the locations of these different Operating Room - AHUs, and confirmed that AHU #25 (421A2), located on the roof, is located where the fresh-air intake is within several feet of a condensate water line. A black mucky material was observed growing on the roof surface next to the drain. The condensate line did not go directly into the drain, but it drops the condensate on the roof 6 to 8 inches from the AHU, allowing constant water build-up between the pipe and the drain. This has the potential environment for "mold" growth in warmer months of the year, when the heat builds up. The hospital could not validate AHU #25 (421A2) testing in this area and its filters for mold growth.

When touring the AHU #31 (884A3) located in the Sub-Lower Level, the fresh air intake is below grade and about 5 feet below elevation from where the access road is, and within 25 feet horizontal feet. This intake is in a Cul-de-Sac of buildings.

On 03/02/12 at 3:15 p.m. during the exit conference the hospital was informed of all physical environment non-compliant findings as they relate to infection control.

Based on observations, staff interviews and record and policy reviews, the hospital failed to ensure infection control practices were adhered to, and that surgical services was comprehensively incorporated into infection control plan and processes for 16 of 16 Operating Room (OR) suites and 6 of 6 areas identified as surgical procedure areas within the hospital. The hospital failed to follow current accepted nationally recognized standards of practice. The infection control failures had the potential to affect every surgical patient admitted to the hospital for at minimum 2 1/2 years.

Findings include:

Infection Control Officer failed to assure the high risk surgical services areas adhered to current hospital infection policies and procedures. The hospital failed to ensure that the current policies and procedures incorporated current accepted Standards of Practice for the surgical services in the 6 OR areas. The hospital failed to have infection control policies and procedure that covered all critical areas of the high risk surgical services. (A -748)

The Infection Control Officer failed to ensure the critical areas of the high risk surgical services had an internal monitoring system for identifying and controlling infections for all surgical patients and all surgical personnel. (A-749)

The Infection Control Officer failed to ensure the log of incidences related to infections included critical areas of the high risk surgical services air and ventilation system (air temp and humidity requirements for healthcare) in the main OR, OR suites, sterile supply areas, dirty utility areas and clean storage areas and janitor closet. (A-750)
The hospital failed to ensure the administrative staff required to have oversight to the Infection Control Program, followed through for at minimum 2 1/2 years, when the same infection control issues were identified bi-annually in environmental rounds in the main OR area. The hospital administrative staff and Quality Assurance Process Improvement (QAPI) failed to implement successful corrective action plans when review of environmental rounding sheets identified the same infection control issues for 2 1/2 years. (A -756)
The cumulative affects of these systemic failures prevented the hospital from having a comprehensive infection control program in a high risk area.

Based on staff interviews, observations, and Infection Control (IC) Plan review for 2011 and 2012, the hospital's Infection Control Practitioner (ICP) failed to have an organized IC program to ensure current hospital infection policies and procedures were implemented, or adhered to, failed to ensure that the current policies and procedures incorporated current accepted Standards of Practice (SOP) for the surgical services in the 6 of 6 departments (Main OR, Cardiac Catheter Lab, OB C-section suites, GI Lab, Interventional Radiology and Interventional Pain defined as procedure suite/Operating Room (OR)) in the hospital, and failed to have infection control policies relevant to all areas in this high risk, critical care area like OR. This has the potential to affect every staff working in the OR and every patient receiving surgical services.

Findings include:

On 02/26/12 at 6:00 p.m. during a telephone interview with Anonymous-P, P told Surveyor #22198, the hospital is aware that current surgical services is not compliant with current Standards of Practice. P stated, there is a not a clear understanding of who is in charge in the OR. Both Managers (B and H) are working between two different hospitals and there is not a current Surgical Director.

Anonymous-P told Surveyor #22198, that the facility has been cited by the local Fire Marshall because of the equipment and storage that is blocking the halls and entrances and exits. Storage of sterile items is a problem and out-dates are a problem and staff are not following policies and procedures for basic things like Personal Protective Equipment (PPE) and surgical attire.

Anonymous P identified as having knowledge of these conditions that fail to meet standards of practice included Director IC-C, VP Nursing for Pro-Health Care (also the Interim Director of Surgical Services-O), OR Business Manger-H, OR Clinical Manager-B, Safety Officer-D, OR Educator-II and Chief of Surgery-RR

Anonymous-P told Surveyor #22198, Environmental Rounds and infection control issues have been brought to the hospital's administrative leaders of Surgery (nursing and Medical Staff), Quality Assurance Process Improvement (QAPI) and Infection Control (IC), however nothing is changing.

Anonymous-P stated, that there have been several infections. ICP staff are not looking at basic things like staff not following basic OR protocol, and not accurately documenting Flash (Immediate Use) Sterilization, and they are aware of it.

#1. Infection control related to sterile/clean and dirty failed to have appropriate space and storage areas defined for supplies, and policies and procedures and current practice failed to meet current accepted national SOP.

The hospital failed to follow the CDC's Healthcare Infection Control Practices Advisory Committee (HICPAC) as well as professional infection control organizations' standards of practice and recommendations based on the complexity of the surgical service for ventilation and air flow:


The hospital ICP failed to include all complex (i.e. H-VAC air handling system) and simple surgical services specific concerns (i.e. hand hygiene or surgical hand scrub per CDC and AORN SOP) of its healthcare in determining the size and scope of the resources it commits to infection control specific to the OR:

www.cdc.gov/mmwr/preview/mmwrhtml/rr5116a1.htm
www.aorn.org/PracticeResources/AORNStandardsandRecommendedPractices /
The hospital failed to have adequate storage space to ensure the separation between clean, dirty and sterile supplies and utility rooms, and failed to store sterile materials to allow for air circulation in the room, or in a manner that ensured package integrity to ensure sterility:
AORN Journal / May, 2008

References based on the most current requirements: 2010 ed. Guidelines for the Design and Construction of Health Care Facilities by the Facility Guidelines Institute (FGI) with assistance from the U.S. Department of Health and Human Services (DHHS) ISBN: 978-0-87258-859-2
Reference: www.fgiguidelines.org

On 02/27/12 during a tour and observation of the Main OR (referred to as OR proper) a 16 surgical suite area, Surveyor #22198 along with RN Charge Nurse-E observed the following:

Numerous racks of uncovered unprotected sterile surgical equipment lined the hall way throughout the 16 suite OR department. Sterile supplies not within closed/protected wall units or enclosed carts were noted in 16 of the 16 OR suites. Sterile supplies were noted on open racks, and laying on counters within the 16 OR suites. Open wire racks of sterile supplies were noted inside procedures room in 5 of the 6 OR areas (Main OR, Cardiac Catheter Lab, OB C-section suites, GI Lab, Interventional Radiology).

For a minimum of 2 1/2 years, a lack of storage has been identified as a problem in a Quality and Safety Environmental Rounds conducted by the Quality department (interview 02/27/12 at 11:15 a.m. with Quality and Safety Officer-D).

1 of 6 areas (Interventional Pain) the sterile storage room is open to a common high traffic hallway, and buckets of sterile and clean supplies were on the counter next to the sink, and the sink was noted as leaking with green, stained and bubbling boards.

5 of the 6 defined surgical areas (Main OR, Cardiac Catheter (Cath) Lab, OB C-section suites, GI Lab, Interventional Radiology), utilize their OR surgical suites for equipment storage. Observation and interviews confirmed the extra equipment is not cleaned between procedures (this was confirmed 02/27/12 during an observation of OR #12 being cleaned after a procedure).

A hallway just off the "Great Room" is the "Ortho Hallway" where all the sterile orthopaedic (ortho) equipment was stored.

In the "ortho hallway" was a dirty utility room (janitors closet) and a house keeping storage area. The dirty utility room was open and three (3) Neptune Suction/Smoke evacuation machines were being drained and processed during this observation. One (1) Neptune Suction/Smoke evacuation machine was just sitting in the "Ortho hallway" waiting to be cleaned. Non-cleanable tape was covering the smoke connection ports; some of the tape was dark gray and peeling back. The Janitor closet door was open, this fails to meet CDC, APIC or Health codes for separation of clean, dirty and sterile spaces, including ventilation, temperature and humidity requirements for each of these spaces.

The "Great Room" identified as the "sterile supply room" had three (3) entrance areas. 2 of the 3 entrances did not have doors to ensure the air flow remained positive.

Equipment covered in Kimguard was stacked 3 and 4 high on sterile supply racks through out the OR. Stacking of instruments fails to meet AORN and AAMI standards. This was observed with cardiac, endoscopy, ortho and neurological equipment.

Un-useable medical supplies (defined as supplies to be given to the missions) were in bags on racks and not removed from the sterile area. Cardboard boxes were being used to store sterile medical supplies and equipment in the Sterile Supply area.

Outside shipping was identified by their shipping labels. Outside shipping was observed in (1) the Perfusionists storage that contained both clean and sterile supplies and equipment, (2) the Tissue Bank where organ and tissues are preserved

Staff food found in the Tissue bank refrigerator in a container and moldy. 5 large metal carts of sterile supplies, a rack of paper and other non-sterile supplies and a piece of equipment on the floor, blocked a second doorway. This room is used for clean, dirty and sterile supplies, however identified as the tissue bank.

Numerous sterile items were noted as being stored on x-ray machine and Stryker equipment towers. These multiple pieces of equipment were identified as "clean" and ready to be taken into a surgical procedure.

On 02/17/12 between 8:25 a.m. and 11:00 a.m. while on tour Registered Nurse (RN)
Charge Nurse-E confirmed to Surveyor #22198, that the sterile supplies are stored openly on the equipment and equipment carts and do not get removed or discarded after the surgical procedure. These pieces of equipment with sterile supplies stored on them are transferred from surgery to surgery, with the potential for cross contamination.

Towers of stacked cautery equipment, light sources, video and TV equipment had dust and debris between them, however were considered clean and ready for use.

OR #7, negative air flow was observed in this operating room. A test was conducted by air current under the door using a tissue to measure air flow direction. Operating rooms are required to be positive pressure to adjoining spaces per the state building code. Air ducts had not been cleaned prior to January 30, 2012.

Interview with Facilities Manager -Z on 02/28/12 at 2:00 p.m. confirmed to Surveyor #22198, that with the doors to clean, sterile and dirty utility rooms being left open, sterile supplies through the OR stored in multiple locations, and sterile supply room missing doors, it was not possible for the OR Managers (B and H), OR Director (O) or the Director of ICP (C) to maintain the appropriate temperature, humidity and air flow to meet current standards of practice to adhere to infection prevention and control recommendations. Facilities Manager -Z told Surveyor #22198 the current air exchange in the OR surgical suites was at 15 air exchanges per hour. Current standards confirm 20 air exchanges are required.

On 02/27/12 at 11:15 a.m. Safety Officer-D confirmed the same things that were observed on the OR tour were documented in the Environmental Rounds logs. Safety Officer-D confirmed that these have been identified and taken to the Quality Committee for approximately 2 1/2 years, however no changes were implemented.

On 02/27/12 at 11:30 a.m. Surveyor #22198 conducted an interview with the Director of ICP-C and 2011 IC data reviewed . The IC Plan for the OR for 2011 and 2012 failed to include the over crowded OR, the lack of separation of clean and sterile, the ventilation, temperature or humidity of the OR specific areas that require specific air handling, temperature and humidity. Director of IC-C confirmed that C was unaware of the requirements for sterile supply areas, or that the OR ventilator system would potentially be contributing to infections in the OR. This was not a part of tracking or trending for the 36 total infections for the 2011 calendar year.

#2. Infection control related to personal protective equipment, staff failed to comply with hospital Policy and Procedure # OR-A-5 "Surgical Attire in the operating Room."

Improper use of personal protective equipment (PPE) and appropriate surgical attire were observed. Personal glasses were used as eye protection (main OR).
RN conscious Sedation Nurse during the procedure in the Cardiac Catheter Lab was observed not wearing any eye protection. Manager X told Surveyor #22198, it was not necessary.

Gloves were not changed between clean and dirty tasks (GI Lab). This failed to meet OSHA, CDC and AORN standards of practice for appropriate eye protection in a high risk area, and CDC and AORN glove changes and hand hygiene between clean and dirty tasks.

On 02/27/12 at 11:30 a.m. Surveyor #22198 conducted an interview with the Director of ICP-C and 2011 infection control data was reviewed. The IC Plan for the OR for 2011 and 2012 failed to include the high risk OR specific surgical hands scrub monitoring that are included in the hospital-wide hand hygiene monitoring.

Director of ICP-C confirmed to Surveyor, with the exception of national benchmark monitoring and pay for performance monitoring of surgical site infections, the IC program does not incorporate the complex services in high risk surgical services fully in the IC annual.

#3. IC re medication and safe injection practice to prevent cross contamination:

On 02/28/12 at 7:45 a.m. in the OB-C-section room, 1 vial of multi-dose medication was found in the C-section OR suite in the anesthesia cart open and not labeled to identify who had opened it. Certified Registered Nurse Anesthetist (CRNA) - W confirmed to Surveyor #22198 that CRNA-W was going to use the multi dose medication for other patients, and draws up during the cases.

On 02/28/12 at 9:15 a.m. 3 items were found:
One (1) vial multi use medication was open and not labeled to identify the date it was opened or who opened it. The multi-dose vial of medication was located in the medication cart in the cardiac catheter procedure room. One (1) single use 50 milliliter (ml) vial was also found opened and not labeled to identify the date it was opened or who opened it, in the medication cart in the cardiac catheter procedure room. One (1) bag of 50 ml IV fluids found open and not labeled to identify the date it was removed from its original packaging, in the medication cart in the cardiac catheter procedure room.

Manager-X confirmed X was not able to identify how many patients these were used for and X confirmed that if items were inside the medication cart and not the discarder, they would be used on more patients(s).

Director of ICP-C confirmed to Surveyor #22198, that the hospital follows Association for Professionals in Infection Control and Epidemiology (APIC) Infection Control SOP, and APIC incorporates the CDC safe injection practice. Director of ICP-C confirmed multi-dose vial being draw up in a surgical suite during surgery is not considered a sterile environment and IV fluid bags and single dose medication are to be discarded after single patient use.
Reference: http://www.cdc.gov/injectionsafety/IP07_standardPrecaution.html

#4. Infection control related to "Flash sterilization": staff not following current policy and procedure, and current policy and procedure failed to incorporate manufacturer's recommendations.

Staff are failing to document all instruments being processed by Flash sterilization (Immediate Use Sterilization). This was confirmed in a record review of the Immediate Use Sterilization machine log compared to the OR staff documentation completed on 02/28/12 at 12:50 p.m. with OR tech KK, Peri-Operative RN-JJ and OR Educator-II.

The Flash Sterilization (Immediate Use Sterilization) requires a test be run daily to ensure the machine is running Biologicals and Bowie Dick testing at the correct time and temperature. This is also included in the hospital policy entitled: " Sterilizer Use, Care, maintenance, Monitoring and Flash" a six page document not numbered, effective date 01/27/11.

On 02/28/12 at 12:50 p.m. during the review and comparison of the Flash sterilization use with OR tech KK, Peri-Operative RN-JJ and OR Educator-II, Surveyor #221198, identified a holiday 09/05/11, load # 20119 where instruments were run in the autoclave, however, no documentation was identified for the machining testing (chemical indicator and a daily biological) prior to running instruments to ensure the Immediate Use Sterilization was functioning to ensure sterility.

OR technician (tech) KK, Peri-Operative RN-JJ and OR Educator-II told Surveyor #22198, there are 6 holidays they are not required to run tests, even if the on call OR staff get called in during a hospital.

On 02/29/12 at 1:30 p.m. Peri-Operative RN-JJ provided Surveyor #22198 the manufacturer's recommendations for daily testing. The manufacturers recommendation for the Flash sterilization (Immediate Use Sterilization) machine states: "Testing Prevacuum Efficiency. Run a DART (Bowie Dick test) cycle daily before processing any loads. The first prevacuum cycle of each day should be used to test the adequacy of air removal from the chamber and load, so that steam can penetrate the load.

#5. Infection control related to implementing a policy or procedure for re-use of Kimguard and surgical gowns to prevent cross contamination.
.
On 02/27/12 Surveyor #22198 along with RN Charge Nurse- E observed while on a tour of the main 16 suite OR, that blue Kimguard used to wrap instruments for sterile processing, was stored in the back of the OR suite (#12) during a procedures. Kimguard covered sterile instruments were being stored in non-sterile areas throughout the OR on open racks, in OR suites and hallways and being stacked one of top of the other 3 and 4 high on some racks. RN Charge Nurse- E confirmed, the hospital did not have a policy for re-using opened items that were no longer sterile, or re-using Kimguard.

Surgical technicians transported surgical gowns that were not opened per sterile procedure on the bottom of a contaminated instrument cart. The technician removed those gowns and put them in the decontamination room and explained they would be used later and were "clean."

RN Charge Nurse- E confirmed that these two observed practices were unacceptable, and failed to meet infection prevention and control standards. E confirmed that the gowns and Kimguard could be used anywhere.

The Perfusionists room contained 4 cardiac perfusion pumps stocked with sterile supplies documented as ready for use. 1 of 4 was covered with a surgical gown, 3 of 4 were covered with used Kimguard.

On 02/27/12 at 11:30 a.m. Surveyor #22198 conducted an interview with the Director of ICP-C. C failed to develop and implement policies for re-use of Kimguard and surgical gowns to avoid cross contamination, failed to ensure compliance with currently implemented policies governing the control of infections or check with manufacturers recommendations of re-use of gowns and Kimguard. Director of ICP-C failed to have a system for monitoring compliance with current standards of practice for the OR, a high risk area to prevent infections and cross contamination with items being re-used.

#6. Infection control failed to have a policy or procedure to ensure sterility and package integrity for sterile medical supplies that do not have defined expiration dates.

On 02/28/12 from 7:45 a.m. to 11:30 a.m. during a tour of 5 OR defined areas (OB c-section, GI lab, Cardiac Catheter Lab, Interventional Radiology, and Interventional Pain) sterile items not containing a expiration date included:

Sterile pens, sterile specimen cups, chlorascrub swabs, 30 cc sealed up of mineral oil and sterile eye ointment, all in the OB-c-section room. Sterile gloves, sterile tubing and sterile syringes in the GI lab and sterile needles in the Cardiac Catheter Lab and Interventional Pain room.

Needles were bundled by size. 5 bundles of sterile needles were individually rubber banded to keep them together. This potentially destroys the integrity of sterile packages.

The hospital failed to have a policy or procedure to identify and ensure rotation of sterile items by the manufacturers defined shelf life. This was confirmed in the OB c-section suite with OB Clinical Manager U and OB Educator -V and Technician-QQ during the OB c-section tour and confirmed with Accreditation & Licensure Coordinator -A, prior to exit 02/29/12 at 3:50 a.m.

On 02/29/12 at 3:00 p.m. Surveyor #22198 concluded all surgical tours, interviews and review of policies and final findings review. Director of ICP-C confirmed the ICPs failed to have oversight to surgical services to ensure current accepted standards of practice were adhered to and implemented into policies and procedures or to surgical policies and procedures in this high risk high volume complex service.

Based on observations, staff interviews and record and infection control data reviews, the hospital failed to develop a comprehensive system for identifying, reporting, investigating, and controlling infections in the 6 of 6 (Main OR, OB c-section, GI lab, Cardiac Catheter lab, Interventional Radiology, Interventional Pain) high risk, critical care Operating Room (OR) areas, when 5 of 5 patients (#3, 4, 5, 6,and 7) were identified as having surgical site infections (SSIs.) The Infection Control Program Director failed to:
? Monitor or investigate the correlation of the faulty ventilation system that failed to meet IC parameters and healthcare physical plant requirements.;
? Monitor or investigate the correlation of temperature and humidity logs that failed to meet IC parameters for patient care and medical products;
? IC failed to include any type of internal OR monitoring of staff compliance with IC practice, policies and procedures throughout the OR (for detailed findings for all infection control issues at A748).
? IC failed to include the 6 of 6 OR areas in their hand hygiene hospital wide compliance monitoring; and,
? IC failed to ensure that the OR functioned using current nationally accepted Standards of Infection Control Practice (SOP)
?
Findings Include:

March 6, 2012 Project Progress Report, Job: Waukesha Memorial Hospital Surgery Department: Project Description: Cleaning supply, return and exhaust ductwork in surgery rooms 2-8, and 12-15 and adjacent areas. Work performed between January 30th and February 23rd.
Findings of Progress Report: The exhaust and return duct system have a significant accumulation of debris throughout the systems. The supply system has very slight accumulation of debris. All duct systems would require cleaning based on the Cleanliness verification in the NADCA standard ACR 2006.

Report dated 3/5/12, by Director of Operations, Air Maintenance Inc. OO confirms the return ducts and air supply system had accumulation of debris during the time frames identified when Patients #3, 4, 5, 6 and 7 received surgical services, after surgery acquired a Healthcare Acquired Infection (HAI) SSI.
Reference: 2010 ed. Guidelines for the Design and Construction of Health Care Facilities by the Facility Guidelines Institute (FGI) with assistance from the U.S. Department of Health and Human Services (DHHS) ISBN: 978-0-87258-859-2
Reference: www.fgiguidelines.org

On 02/29/12 at 1:40 p.m. to 2:10 p.m. Surveyor along with OR RN- S and OR Clinical Manager-B reviewed the records for Patient #3, 4, 5, 6 and 7. Temperature and humidity logs for OR suites #8, #9, #11 and #15 were reviewed and confirmed with Accreditation and Licensure Coordinator -A and OR Clinical Manager-B for Patients #3, 4, 5, 6 and 7 and findings included below:

? Patient #5 was admitted 08/16/11 for a Total Knee Arthroscopy and received surgical services in OR suite # 9 from 8:32 a.m. to 10:20 p.m.(1 hour and 50 minutes.) For 1 hour and 40 minutes while Patient #5 underwent surgery, the humidity in OR suite #9 between 8:30 a.m. and 10:30 a.m. was above 60%. Surgical suite humidity parameters allowed (30% to 60%.) The temperature in OR suite #9 from 8:32 a.m. to 10:20 p.m.(1 hour and 50 minutes) the entire time of Patient #5's surgery was below 68 degrees F. Design Temperature = 68-75 F.
.
? Patient #6 was admitted on 08/03/11 for a laminectomy and received surgical services in OR suite #11 from 2:05 p.m. to 4:10 p.m. (2 hours and 5 minutes.) For 1 hour and 50 minutes while Patient #6 underwent surgery, the humidity in OR suite #11 between 2:05 p.m. to 4:10 p.m. was above 60%. Surgical suite humidity parameters allowed (30% to 60%.) The temperature in OR suite #11 for 1 hour and 55 minutes of the 2 hours and 5 minutes surgery, Patient #6 ' s OR room temperature was below 68 degrees F. Design Temperature = 68-75 F.

? Patient #7 was admitted on 07/35/11 for a laminectomy and received surgical services in OR suite #8 from 3:20 p.m. - 5:25 p.m. (2 hours and 5 minutes.) For 15 minutes while Patient #7 underwent surgery, the humidity in OR suite #8 was above 60%. Surgical suite humidity parameters allowed (30% to 60%.) The temperature for OR suite #8 for 2 hours and 5 minutes, the entire surgery, Patient #7 ' s OR room temperature was below 68 degrees F. Design Temperature = 68-75 F.

? Patient #3 was admitted on 11/05/11 for a laminectomy and received surgical services in OR suite # 15 from 8:16 p.m. to 9:30 p.m.(1 hour and 14 minutes.) Complete Temperature and humidity logs were not supplied for the entire duration of the case. Documentation to determine compliance or non compliance with temperature and humidity 44 minutes were missing. Logs were reviewed 8:55 p.m. to 9:25 p.m. to indicate the room temperature was below 68 degrees F. Design Temperature = 68-75 F.

? Patient #4 was admitted on 08/22/11 for a laminectomy and received surgical services in OR suite # 8 from 8:33 a.m. to 9:45 a.m. (1 hour and 12 minutes.) Complete Temperature and humidity logs were not supplied for Patient #4 on 08/22/11. 32 minutes during the surgical services had missing documentation. The temperature for OR suite #8 from 8:55 a.m. to 9:35 a.m. (1 hour and 12 minutes) was below 68 degrees F. Design Temperature = 68-75 F.

On 02/29/11 at 3:05 p.m. after review of surgeries, ventilation temperature and humidity logs, Surveyor #22198 interviewed Director ICP-C, who indicated C was lead to believe the OR ventilation system, temperature and humidity were functioning within the defined healthcare required parameters.

A total of 36 SSI were identified on the IC data for calendar year 2011. However, Director ICP-C confirmed ventilation, temperature and humidity were never considered as a potential source for infections, even though the hospital facilities management staff and the hospital president identified the need to purchase a new ventilation system because the old one could not keep up with the air requirements and humidity failures of the (then) current system.

Director ICP-C confirmed to Surveyor #22198, the temperatures are kept cooler in the OR suites than the defined design parameters (68-75 F) because physicians like them that way, and avoid excessive sweating over the surgical patients.

Director ICP-C confirmed to Surveyor #22198, that the OR did not have a system for monitoring sterile and medical supplies that would not sustain the cooler temperatures for long periods of time like medication, IV fluids and glued sterile packaging seams.

On 02/27/12 at 11:30 a.m. Surveyor #22198 reviewed the IC Programs from 2011 and the current IC plan for 2012 with Director ICP-C. Director ICP-C acknowledged that both hospital-wide IC programs failed to include the 6 of 6 (Main OR, OB c-section, GI lab, Cardiac Catheter lab, Interventional Radiology, Interventional Pain) OR areas in their hand hygiene hospital wide compliance monitoring (See A 748 for infection control problems)

Director ICP-C confirmed to Surveyor #22198, the 2011 and 2012 IC programs failed to include any type of internal OR monitoring of staff compliance with IC practice, policies and procedures through out the OR (for infection control issue details at A748), to ensure that the OR functioned using current nationally accepted Standards of Infection Control Practice (SOP) to include APIC, CDC AORN and Guidelines for the Design and Construction of Health Care Facilities.

The hospital ICP failed to include all complex (i.e. H-VAC air handling system) and simple surgical services specific concerns (i.e. hand hygiene or surgical hand scrub per CDC and AORN SOP) of its healthcare in determining the size and scope of the resources it commits to infection control specific to the OR.

www.cdc.gov/mmwr/preview/mmwrhtml/rr5116a1.htm
www.aorn.org/PracticeResources/AORNStandardsandRecommendedPractices /

The hospital failed to have adequate storage space to ensure the separation between clean, dirty and sterile supplies and utility rooms, and failed to store sterile materials to allow for air circulation in the room, or in a manner that ensure package integrity to ensure sterility.

AORN Journal / May, 2008

Based on observations, staff and vendor interviews, review of infection data logs and 2011 and 2012 Infection Control (IC) plan and vendor photos and detailed cleaning reports, the Infection Control Practitioner (ICP) responsible for tracking and trending infections, after becoming aware of ventilation issues approximately 1 year ago in the Operating Room (OR), failed to investigate or trend surgical site infections (SSI) logged on the IC reports to identify or rule out any correlation for the 36 of 36 2011 infections to the malfunctioning and uncleaned ventilation system for the main Operating Room (OR) department.

Findings include:

On 02/28/12 at 10:55 a.m. during an interview Hospital President-MM confirmed to Surveyor #22198, that approximately one (1) year ago when MM was hired into the hospital president position, the hospital was aware of the failing ventilator system, storage issues, floor times, and brought this to MMs attention. MM stated that some of these projects were easier to address and were repaired or completed more quickly, and gave examples of the floor tiles and a storage room that was built.

Hospital President-MM stated that the Operating Room (OR) air handling system being unable to maintain humidity level and air flow was addressed at the meeting approximately one year ago. MM stated this was a bigger project and required more time to implement, however it is almost completed.

The Infection Control Officer failed to ensure the log of incidences related to infections included the potential healthcare acquired infections, when the OR failed to meet requirements for the surgical department including OR suites, and procedure rooms, sterile supply areas, dirty utility areas and clean storage areas.
Reference: 2010 ed. Guidelines for the Design and Construction of Health Care Facilities by the Facility Guidelines Institute (FGI) with assistance from the U.S. Department of Health and Human Services (DHHS)
Reference: www.fgiguidelines.org

Based on observations, interviews, and infection control data reviewed, the Infection Control Leadership failed to act upon all infection issues; failed to incorporate them into the IC Program to provide sustainable changes; and, ensure all problem areas were incorporated into the Quality Assurance Process Improvement (QAPI) program. This failure for leadership to act upon infection control identified issues has the potential to affect all patients receiving surgical service and all staff working in surgical services.

Findings include:

On 02/25/12 at 6:00 p.m. Surveyor #22198 conducted a telephone interview and review of documented information provided by Anonymous-P. Anonymous P stated that some staff (including P) had been complaining to managers, with identified habitual infection control practices that included:
? inappropriate surgical attire,
? lack of environmental cleaning practices,
? staff not wearing gloves when handling bloody mucus covered instruments,
? staff wearing jewelry,
? staff sitting in window sills during surgical cases,
? scrub technicians breaching sterility after being sterile gowned and gloved for surgery,
? staff not wearing eye protection.

Anonymous P stated although P could not give names or dates there were 3 or 4 infections last fall, and no one was monitoring staff compliance.

Anonymous P stated that there were two OR managers (later identified as B and H) however B (identified during survey as OR Clinical Manager-B responsible for clinical practice in the OR) was rarely in the OR, and the old Manager (identified as OR Business Manager H) was covering both clinical and business, and staff were confused as to which manager was responsible for what. P confirmed that both OR Managers (B and H) were informed of the issues P provided to Surveyor#22198.

Anonymous P also stated that quality and safety rounds are done twice a year, but did not believe infection control is looked at based on the fact nothing has improved and staff's compliance behaviors have gotten worse. P stated quality and safety rounds identify the same things over and over and those issues are brought up at monthly meetings, things like fire safety blocking doors do not change either.

On 02/28/12 at 10:55 a.m. during an interview, Hospital President-MM confirmed to Surveyor #22198 that approximately one (1) year ago when MM was hired into the hospital president position, the hospital was aware of the failing ventilator system, storage issues, floor times, and brought this to MMs attention. Hospital President-MM stated that some of these projects were easier to address and were repaired or completed more quickly, and gave examples of the floor tiles and a storage room that was built.

Hospital President-MM confirmed to Surveyor #22198, that the Operating Room (OR) air handling system was addressed at the meeting approximately one year ago, and issues included the inability to maintain humidity level and air flow. MM stated this was a bigger project and required more time to implement, however it is almost completed. Also present during this interview was Chief Innovation Officer-BB.

On 02/27/12 at 11:30 a.m. Surveyor #22198, along with Director ICP-C, reviewed the IC Plan from 2011 and the current IC plan for 2012, and on 02/29/11 at 3:05 p.m. reviewed the surgeries, ventilation, temperature and humidity logs. Director ICP-C acknowledged the IC Program does not comprehensively cover surgical services based on the complexity of the service or as a defined high risk critical care area. Director ICP-C stated she was not aware of the infection control issues in the OR.

On 02/28/12 at 2:15 a.m. Surveyor #22198 reviewed the IC measures and IC data for the Surgical Care Improvement Project (SCIP) measure provided by OR Business Manager-H. OR Business Manager-H stated that H was aware of the Infection control and other safety issues in the OR. However, the hospital is still transitioning OR managers into their new roles. OR Business Manager-H stated that H and B were hired over 1 year ago for their current positions.

Business Manager-H confirmed to Surveyors #22198, that infection control as well as the safety issues had been brought to OR meetings and some education was provided. H confirmed that observations on tour were the same habitual infection control and quality and safety issues that the leadership, including H, failed to implement sustainable changes. Business Manager-H confirmed that currently H is not aware of any ICP structured system based on clinical ICP and OR Standard of Practice (SOP) to review IC problems in the OR that would include staff compliance.

During an interview with the OR Clinical Manager-B on 02/27/12 at 3:15 p.m. Surveyor #22198, asked "who monitors infection control practice in the OR?" OR Clinical Manager-B responded that B thought that was Director ICP-C. OR Clinical Manager-B stated that B did not have a system for monitoring non-compliant infection control practices based on current SOP.

OR Clinical Manager-B confirmed to Surveyor, that as the manager B was aware of non-compliant infection control practices in the OR, but even though B was hired over a year ago, Manager B has been covering two hospitals within one system and does not know B Managers position and since August 2011 has been just getting to know staff.

On 02/27/12 11:15 a.m. Surveyor #22198, during an interview asked Quality and Safety Officer- D if the habitual issues identified in D's logs were presented to the Quality and Safety Committee of the hospital. Quality and Safety Officer- D stated the items that were reviewed on the logs for the past year are habitual, and is aware of the habitual problems for approximately 2 years or more.
Quality and Safety Officer- D identified (AA) as the Director of Performance Excellence- who is head of the Quality Assurance Process Improvement.
On 02/29/11 at 3:05 p.m. Surveyor #22198 and Director ICP-C reviewed the findings presented by Facilities Management (Y and Z) regarding surgeries ventilation, temperature and humidity logs. ICP-C stated the IC Program does not comprehensively cover surgical service based on the complexity of the service or as a defined high risk critical care area.
Director ICP-C told Surveyor #22198, C- would expect each clinical area to be conducting internal monitoring and report any specific trends. Director ICP-C told Surveyor #22198, that C or one of the three other ICPs would attend committee meeting for ICP. However, Director ICP-C denied knowing the full extent of Infection control issues in the OR areas seen by Surveyor on tour.
On 02/28/12 at 11:40 a.m. Surveyor #22198 conducted an interview with Director of Performance Excellence (the head of QAPI) -AA (also present VP Nursing, Pro-Health Care (O), Accreditation & Licensure Coordinator, Pro-Health Care (A), Chief Innovation Officer, Pro-Health Care (BB), VP Nursing, Pro-Health Care (O), Chief Medical Executive-Medical Staff Services Dr.-LL and Vice President Medical Quality and Safety Dr.-R).
AA stated that AA, as the Director of the hospital wide QAPI service was not aware of all the infection control issues and safety issues Surveyor #22198 identified while touring. AA told Surveyor that AA had attended committee meetings. Interim Director of Surgical Service-O confirmed O too had attended committee meetings. However, both Director of Performance Excellence (the head of QAPI) -AA as well as the interim Director of Surgical Service-O denied knowing the full extent of Infection control or safety issues in the OR areas seen by Surveyor on tour.
On 02/18/12 at 10:55 a.m. during an interview and findings review, Hospital President-MM acknowledged to Surveyor #22198, MM was already aware of the lack hospital leadership. Also present during this interview was Chief Innovation Officer-BB.

Based on staff interviews, record review and observations, the hospital failed to have a surgical service that provided care within an acceptable standard of practice including maintaining compliance, when the hospital had 1 OR clinical manager (B) and 1 OR interim Director (O) that were unable to provide leadership and ensure that the hospital's policies and procedures were adhered to, and the surgical services implemented current Surgical Standards of Practice.

Findings include:

Surgical services failed to have an organized surgical service when they divided the OR managers position into two positions 1 year ago (Business OR Manager- and Clinical OR Manager B), related to managing both the clinical and financial aspects of the 16 suite OR. Then the hospital split the two managers to cover a sister hospital's OR for 8 months (August 2011). The OR has been without an OR Director for over 12 months, and Interim OR Manager-O had no OR clinical knowledge to ensure the surgical services were conducted to follow current hospital policies and procedures, and that the policies and procedures followed current nationally accepted Standards of Practice (SOP). (A -941)

Surgical services failed to have policies and procedures that met current accepted standards of practice, staff failed to comply with current surgical policies and procedures, and failed to have a monitoring system to ensure the surgical service stayed updated with current standards of practice for staff compliance.

2 of 2 (#1 and #2) patient medical records reviewed showed staff failed to complete accurate outs resulting in a wrong side surgery and four (4) months earlier the same surgeon had a near miss wrong side surgery under similar circumstances.

In 2 of 6 (C-section Suite and Cardiac Catheter Lab) surgical areas, multi dose vials were found opened, not labeled appropriately and left in medication carts to be re-used. This is not compliant with current Standards of Practice for multi dose vials.
The hospital failed to have a policy and procedure for re-use for 2 of 2 items identified being re-used (Kimguard and sterile gowns). The hospital failed to have a process for ensuring outdates on packages not clearly defined with an expiration date. 6 of 6 ORs had no internal monitoring system to ensure staff were compliant with current policies and procedures, or that policies covered all OR specific areas.(A-0951)

The cumulative affects of these systemic failures prevented the hospital from having an effective Surgical Service organized and providing complex high risk surgical services within their scope of practice.

Based on observations, interviews, review of job descriptions, clinical records, policies and procedures, and surgical services organizational structure, the hospital failed to ensure surgical services was provided in a safe an effective manner consistent with the scope and complexity of the service provided. This had the potential to effect every surgical patient, and every OR staff working at or employed by the hospital.

Findings include:

After conclusion of tours of the main OR area on 02/27/12 from 8:25 a.m. - 11:00 a.m. and five (5) additional Operating Room (OR)/procedural areas (OB c-section, GI Lab, Cardiac Catheterization, Interventional Radiology and Interventional Pain) on 02/28/12 from 7:45 a.m.- 10:30 a.m., Surveyor #22198 reviewed all non-compliant findings with Accreditation & Licensure Coordinator-A, Hospital President-MM, OR Clinical Manger- B, OR Business Manager- H and V.P. Nursing Services (interim Director of Surgical Services)-O, as follows;
The hospital is non-compliant based on infection control observations. There are potential fire safety issues. Equipment and clean, sterile and dirty storage observations confirmed non-compliance. Flash sterilization logs and use, were non-compliant with hospital policy and the hospital's policy on Flash sterilization was non-compliant with the manufacturers recommendations. Tours also confirmed that staff were non-compliant based on hospital policies and procedures as well as current Standards of Practice (SOP). (see A 748 and A 701 for details and descriptions of all findings)
The following interviews were conducted:
On 02/28/12 at 10:55 a.m. during an interview, Hospital President-MM confirmed to Surveyor #22198, that approximately one (1) year ago the hospital restructured and MM along with OR Clinical Director were new to their roles. MM stated that the OR Management Position was too much for 1 Manager and that the OR Managers position was divided into OR Clinical(B) and OR Business (H)Management positions (Job descriptions entitled "Clinical Manager, Surgical Service" and "Operations Manager, Surgical Services.") Managers B and H were also required to cover positions at another Pro-Healthcare Systems hospital approximately 20 miles away.

Hospital President-MM stated the Surgical Directors position has been vacant for about 1 year. MM stated that the hospital did not want to hire just anyone to fill the position, the hospital wanted someone qualified and competent. MM stated that MM was already aware of the lack of hospital leadership. Also present during this interview was Chief Innovation Officer-BB.

On 02/27/12 at 3:25 p.m. during an interview OR Clinical Manger- B confirmed to Surveyor #22198 that B was hired 1 year ago as the Clinical Manager of the Main OR and was working for approximately 8 of the last 12 months as OR Clinical Manager-B at this hospital and as continued as the OR Director at a sister system hospital approximately 20 miles away. OR Clinical Manger- B acknowledged that as a Manager and a Director for both jobs, B was to be on site at two different hospitals.

Surveyor reviewed the OR Clinical Managers job description with OR Clinical Manager-B, entitled "Clinical Manager, Surgical Services, Job Code:950 last reviewed 06/09/10: "Responsible for efforts to objectively and systematically assess, monitor, evaluate and improve the processes that affect the quality of patient care ensuring compliance with the hospital mission and vision, Medical staff by-laws, rules and regulations, CMS, The Joint Commission, and all other applicable agencies or regulatory bodies."

Director, Surgical Services Job Summary states "Represents the Director, Surgical Services in all matters related to Surgical Services clinical performance."

When Surveyor #22198 asked OR Manager-B who B reports any clinical performance issues to, OR Clinical Manger- B told Surveyor #22198, the hospital does not currently have a Director of Surgical Services. B acknowledged (O) Vice President (VP) of Nursing is covering as an interim Director for the OR. OR Clinical Manger- B stated it difficult to do either job completely, and realizes now it was not a good idea. OR Clinical Manger- B stated that after 1 year in this OR Clinical Managers position, B has acclimated or fulfilled the duties required for the position of OR Clinical Managers.

On 02/28/12 at 2:15 p.m. during an interview, OR Business Manager- H told Surveyor #22198, that previously H had been the only OR Manager for the hospital, but the position was too much for one person and the hospital split the position in two to cover the clinical and business side of Surgery.

OR Business Manager- H confirmed to Surveyor #22198, that since H accepted the Business Managers position a year ago through today (02/28/12), H has helped out covering aspects of the OR Clinical Managers position while the OR Clinical Manager-B is transitioning.

When Surveyor #22198 reviewed Hs job description entitled "Operations Manager, Surgical Services" last reviewed 01/04/10, the last sentence under "JOB SUMMARY" "Represents the Director, Surgical Services in all matters related to Surgical Services operational performance." OR Business Manager- H acknowledged, it has been over a year, and H can not continue to cover Hs full time business position and cover part-time Bs clinical position.

OR Business Manger- H confirmed the hospital does not have an OR Director qualified to support all areas of Surgical Services.

Per Surveyors facility review prior to onsite investigation, the hospital has 400 licensed hospital beds.

On 02/29/12 at 3:15 p.m. during an interview V.P. Nursing Services (also interim Director of Surgical Services)-O confirmed to Surveyor #22198, that based on job description requirements for the Director of Surgical Services, a minimum experience of "3 to 5 years in a previous supervisory/leadership role in a Surgical service environment required", "AORN certified (or the ability to achieve within 12 months.)" O confirmed that O does not have the surgical background or knowledge based on training or education in Surgical Services to assist with the day to day needs and oversight to the surgical issues and concerns.

At the time of this onsite investigation (02/27/12 - 02/29/12), Department of Surgery, Department Chair MD-RR was not available.

On 02/29/12 at 10:25 a.m. Surveyor #22198 during an interview and a summary review of findings with Executive Officer, Vice Chief of Staff-F, F confirmed he is a surgeon at the hospital, and works in the OR.

Surveyor asked Executive Officer, Vice Chief of Staff-F, as a Surgeon and a part of the Medical Staff Executive Committee, was the Executive Committee aware of the infection control and safety issues observed and confirmed by Surveyor #22198 while on tour? Executive Officer, Vice Chief of Staff-F confirmed the Executive Committee was not.

Executive Officer, Vice Chief of Staff-F confirmed the leadership of the hospital and/or Surgical Services (Managers, Directors, Department Chairs, Infection Control Practitioners, and Director of Performance Excellence-AA) had not reported this to the Medical Staff Executive Committee.

Executive Officer, Vice Chief of Staff-F, as a Surgeon and a part of the Medical Staff Executive Committee, had the Medical Staff Executive Committee been informed of the Surgical Services failure to comply with the hospital's policies and procedures, and surgical services current Standards of Practice, it would have been acted on.

Based on tour, observation, staff interviews and standards of practice, policy and medical record review the surgical services failed to have systems in place to monitor staff compliance with surgical service policies and procedures and failed to have policies and procedures governing surgical care designed to assure and maintain current accepted standards of surgical service practices and patient care, in 6 of 6 surgical service areas (Main OR, OB C section, GI Lab, Cardiac Catheterization Lab, Interventional Radiology and Interventional Pain) and had the potential to effect all surgical staff and patients receiving surgical services.

Findings include:

#1) For 2 of 2 Patients (#1 and #2), staff failed to accurately document and follow policy and procedures for time out. This resulted in a near miss in October 2011 and a wrong side surgery in February 2012.

On 02/29/12 at 1:40 p.m. during a medical record review Surveyor #22198 along with OR Clinical Manager B and OR Registered Nurse (RN)-S the following was identified:
Patient #1 was admitted as a direct admit to the OR from another hospital related to a brain bleed and loss of consciousness on 02/17/12 at 3:40 p.m. No Consent or History or Physical were identified as completed prior to surgery. Medical record confirmed Patient #1 was an emergent case. No neurological assessment was completed to determine the correct surgical side for the brain bleed related to Patient #1 being sedated and intubated upon arrival.

2 of the 3 time outs required by policy and procedure were inaccurate, and the final time out was not completed. Patient #1 was surgically prepped for a right craniotomy, however films noted a left craniotomy was to be conducted. Post operative note confirmed the surgical procedure included both the right and left craniotomy.

Review of the current "Site and Procedure Verification" 7 page policy and procedure last revised 09/12/11, pages 3 and 4 define a 3 step process for surgical time outs, 1) in pre-op, 3) on admission to the OR suite/procedural area, and 5) Final Team Time Out verification process. All steps require site marking and/or verification of surgical site.

On 02/28/12 at 11:40 p.m. Vice President (VP) of Medical Quality and Safety MD-R confirmed to Surveyor #22198, the time out was not completed for Patient #1. R stated that the "time out" was critical in this case because Patient #1 was not conscious to complete a neurological assessment and the information received about Patient #1 was conflicting, and no family was present to confirm the correct surgical side was identified prior to starting the surgery.

VP of Medical Quality and Safety MD-R stated that the time out also includes a review of any films as confirmation of correct surgical site. R told Surveyor that the Quality and Safety Committee had reviewed this case and conducted interviews.

VP of Medical Quality and Safety MD-R confirmed to Surveyor #22198, the Surgeon MD (T) in this case (Patient #1) had reviewed the head films that identified the left side was the correct surgical side. However, the entire time out was not completed and the right side of Patient #1's head was prepped, and Surgeon -T initiated surgery on the right not the left side of the brain. This was confirmed in the post -operative report.

An additional Patient record, Patient #2 was also discussed. Patient #2 was a near miss wrong side surgery; craniotomy 10/14/11 (4 months before Patient #1's wrong side surgery). Patient #2 was also intubated and sedated so a neurological exam was unattainable. 2 of 3 time outs required by policy and procedure were conducted, however staff failed to shave and prep the correct surgical side.

During the final time out prior to incision, Surgeon-T noted the prepped side of Patient #2's head and the films for Patient #2 did not match. Surgeon T halted the procedure to speak to the family to confirm the correct procedural side.

VP of Medical Quality and Safety MD-R confirmed to Surveyor #22198, that this was a near miss, however was not reviewed at that time (10/2011) because the Quality and Safety Committee was not informed of the near miss wrong side surgery. R stated that had the Medical Quality and Safety Committee been aware of this "near miss" the hospital could have reviewed the near miss and implemented changes to potentially avoid the wrong side surgery. R confirmed that both Patient #1 and Patient #2's surgeries were conducted by the same Surgeon (T).

#2) Staff failed to comply with policies and procedures of surgical attire.

2a.) Jewelry
On 02/27/12 at 8:25 a.m. during the start of the tour Surveyor #22198 along with OR Charge Nurse E observed in the OR main area, an OR staff (Q) passing by wearing 2 large rings with multiple stones on her hand. Surveyor #22198 asked OR Charge Nurse-E about the policy for surgical attire. E confirmed to Surveyor #22198, that while working in the OR jewelry is not allowed.

The current 4 page policy OR-A-5 "Surgical Attire in the Operating Room" last revised 08/2009, provided to Surveyor #22198 by Accreditation & Licensure Coordinator-A on 02/27/12 at 1:30 p.m. confirmed:
Page 2 "Procedures"
10. All personnel entering the semi restricted areas of the surgical suites should confine or remove all jewelry. "Key points": Rings should be removed from hands. These items may harbor organism that can not be removed during hand washing. Higher bacterial counts have been noted when jewelry is worn. Policy references include; Occupational Safety and health Administration (OSHA), Association of Peri-Operative Registered Nurses (AORN) 2009, and Essentials of Peri-Operative Nursing 2009.

2b.) Appropriate PPE
On 02/27/12 during the tour of the main OR 16 procedure rooms (from 8:25 a.m. - 11:00 a.m., Surveyor #22198 and Charge Nurse-E observed 2 of 2 (L and M) surgical technicians wearing their personal glasses during a surgical procedure in OR #12. E told Surveyor #22198, that E was not sure if personal glasses could be worn as PPE eye protection during surgery.

Review of current 4 page policy OR-A-5 "Surgical Attire in the Operating Room" last revised 08/2009, on page 3 provided to Surveyor #22198 by Accreditation & Licensure Coordinator-A on 02/27/12 at 1:30 p.m. confirmed:
Procedures: 14) Protective Eye Wear with side protectors or face shield must be worn for all patient procedures in the operating room. If contaminated, the eyewear must be discarded as soon as possible.

OSHA requirements obtained from: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9778,

#3) Staff failed to follow standards of pharmacy and infection control practices when using multi dose vials:

On 02/28/12 at 7:45 a.m. during a tour and interview OB Manager -U and OB Educator- V and Surveyor #22198 found an open multidose, 20 milliliters (ml) vial of Glycopyrrolate in the Anesthesia cart in C-Section Suite #1. Hand written on the vial was "expires 03/21/12." However, no staff initialed the vial as required. Certified registered Nurse Anesthetist (CRNA) -W, was available for interview, and was asked about the multi-dose vial. CRNA-W stated, the multidose vial of Glycopyrrolate would be used on more than one patient. CRNA-W told Surveyor #22198 that W draws up using a sterile needle during the C-section procedure, and this practice is acceptable.

OB Manager -U and OB Educator- V confirmed they were not sure about using multi-dose vials on multiple patients.

The CDC minimum standard for Infection prevention and control can be obtained from:
http://www.cdc.gov/injectionsafety/IP07_standardPrecaution.html

Additional findings on 02/28/12 at 9:15 a.m. during a tour and interview of the Cardiac Catheter Lab Manager-X, Surveyor #22198 noted in a procedure suite medication cart, 3 solutions/medications were opened and failed to meet current standards of practice for multidose vial use and labeling for outdates as follows:

? Dextrose 100 ml bag was outside its original package and not labeled with the new outdate of 30 days once removed from its original packaging.

? Heparin 1000, multidose vial was opened. No medication label to identify who opened the vial, or the expiration date of the vial.

Cardiac Catheter Lab Manager-X, confirmed to Surveyor #22198, the opened already used multidose Heparin vial in the medication drawer, had the potential to be used on another patient

? Nitroglycerin 200 micrograms (mcg)/per ml w/ 5% Dextrose 50 ml glass bottle labeled for single use, was opened an approximately 1/2 of the liquid content was gone. Two (2) entry holes were noted in the rubber top of the vial. Nitroglycerine in the glass vial container is a single use medication.

Cardiac Catheter Lab Manager-X, confirmed to Surveyor #22198, the opened already used multi dose Heparin vial in the medication drawer, had the potential to be used on another patient and does not meet current Standards of Practice for single or multidose vials.

#4) Surgery failed to have policies and procedures for reuse for 2 of 2 items (Kimguard and surgical gowns) identified as being re-used.

On 02/27/12 from 8:25 a.m. to 11:00 a.m. Surveyor #22198 and RN-Charge Nurse-E observed Surgical Tech (ST)-G going into the small decontamination room in the main OR. ST-G was observed reaching under a table of covered contaminated instruments and removed a stack of 4 surgical gowns. ST-G confirmed to Surveyor #22198, these were surgical gowns opened for surgery use however, were not open sterile, and were saved and re-used by staff in the OR. ST-G confirmed the surgical gowns were brought out of an OR Room after the OR case was completed along with the contaminated instruments from that case.

ST-G confirmed she was not aware that placing what G thought were re-useable clean gowns on the table containing contaminated instruments, that the gowns were no longer useable and were contaminated. RN-Charge Nurse-E confirmed E was also unaware that the gowns were no longer useable.

RN-Charge Nurse-E was asked if the hospital had a policy about re-using sterile medical items such as gowns if they were not used during a case. ST-G told Surveyor #22198, she was not aware of one.

Additional observations during the tour of re-use items:
During the observation of a case ending in OR 12 and the room being cleaned, Surveyor #22198, noted a bundle of Kimguard was on the counter in the back of the OR suite and was left there after the OR 12 was cleaned and staff were leaving the area. ST-L confirmed the Kimguard is re-used.

In the Storage area identified as the Cardiac Perfusion Room, 4 cleaned Perfusion pumps were identified as clean, with sterile equipment and supplies of all 4 cardiac perfusion pumps. 3 of the 4 cardiac perfusion pumps that had sterile supplies were covered in used Kimguard. 1 of the 4 cardiac perfusion pumps was covered in a surgical gown.

During an interview with OR Clinical Manager-B on 02/28/12 at 3:25 p.m., Director of Infection Control-C on 02/27/12 at 2:00 p.m., and Accreditation & Licensure Coordinator-A on 02/29/12 at 3:30 p.m., it was confirmed the hospital does not have a policy on re-use of Kimguard or sterile gowns, to avoid cross contamination.

#5) Surgery failed to have a monitoring system to ensure the hospital has policies and procedures to cover all areas of the surgical services it provides, and failed to ensure a current policy and procedures that incorporate current standards of practice and manufacturers recommendation.

On 02/28/12 at 12:50 p.m. Surveyor #22198 along with OR Educator-II, Peri-Operative Nurse Specialist-JJ and OR Distribution Technician KK, reviewed the Immediate Flash Sterilization policies and procedures entitled "Sterilizers: Use, Care, Maintenance, Monitoring and Flash," that had no policy number, was enacted and effective on 01/27/11, along with the immediate use machine log for each cycle, and staff documentation. The following concerns were identified:

5a.) Record documentation incomplete:
Staff failed to comply with documentation requirements when using the Immediate Use (Flash) Sterilizer. Policies and procedures stated:

"Documentation maintained to provide tracking of flash items(s) to the individual patient." #10 Documentation of flash sterilization will be kept for item so that it can be traced to the individual patient. Information to be recorded should include, but is not limited to: ID of sterilizer, cycle use, lot number, load contents, parameters of sterilization, patient identifier, date/time, reasons for flash sterilization.

The red sheets used to document Immediate Use (Flash) Sterilization failed to be completed by staff using the flash sterilizers. Findings include items like: if the cycle met parameters or failed, the patient information, lot number, and load contents.

OR Educator-II, Peri-Operative Nurse Specialist-JJ and OR Distribution Technician KK told Surveyor #22198 they have a second computerized system that is also completed to ensure if the information is not captured on paper, it would be in the computer. However, additional reviews confirmed Cycle dated 12/08/11 instrument load #07373 was never documented on paper or in the computer system.

? 09/21/11 load #20160 was not documented, aside from the fact it was run. Peri-Operative Nurse Specialist-JJ, confirmed the documentation was incomplete and investigated. 02/28/12 at 3:10 p.m. confirmed a femoral rod was removed from a patient and had gone through the decontamination, sterilization process; however a physician wanted to keep it as a teaching tool, so asked the staff to run it through the flash sterilizer too. JJ confirmed to Surveyor #22198, the physician was using this rod removed from a patient as a teaching tool and allowing other patients to handle it to alleviate their fears if they are going to do surgery requiring a rodding.
? 09/23/11 load #20165 was not documented. 02/28/12 at 3:10 p.m. Peri-Operative Nurse Specialist-JJ said the load was not documented because it was never used.

? 09/05/11 (Labor Day) load # 20119 was an instrument load run. However documentation was incomplete. 02/28/12 at 3:10 p.m. Peri-Operative Nurse Specialist-JJ brought documentation to confirm the load of instruments had not been used. JJ and KK confirmed, if staff do not document Immediate Use Sterilization per policy and procedure, they do not have a complete or accurately tracked system to ensure patient safety and infection control.

5b.) Failure to have policies and procedures
Surveyor #22198 asked Peri-Operative Nurse Specialist-JJ to provide the policy and procedure for decontamination of sterilization of implants removed from a patient and returned.
Accreditation & Licensure Coordinator, Pro-Health Care- A brought Surveyor #22198 a policy for sterilization of new implants that are going to be used. However, no policy was found for special handling, decontamination, and sterilization of implant being removed and returned to a patient (or the physician).
5c.) Protocols failed to comply with Standards of Practice set by the Manufacturer, and policy does not define what staff are to do on the days the surgical department is closed.
Policies and procedures entitled "Sterilizers: Used, Care, Maintenance, Monitoring and Flash", no policy number, was enacted and effective on 01/27/11, requires a chemical indicator and "daily" biological be run. The policy does not state when the machine testing is to be completed, or if there are exceptions to the daily testing.

09/05/11(Labor Day) load # 20119 was an instrument load run. The machine log did not show a test cycle had been run prior to the instruments being run. OR Educator-II, Peri-Operative Nurse Specialist-JJ and OR Distribution Technician KK told Surveyor #22198, that for 6 holidays when the OR is closed, OR staff called in for emergency cases are not required to run tests for the Immediate Use (Flash) Sterilizers.

Surveyor #22198 requested the manufacturers information for the Immediate Use (Flash) Sterilizers. 02/28/12 at 3:10 p.m. Peri-Operative Nurse Specialist-JJ provided Surveyor #22198 with the manufacturers information for the Immediate Use (Flash) Sterilizers, that requires testing to be done daily, noting: "The first prevacuum cycle of each day should be used to test the adequacy test of the adequacy of air removal from the chamber and load, so that steam can penetrate the load".

"Warning-Load sterility may be compromised if the biological indicator or leak test indicates a potential problem, refer the situation to a qualified service technician before using the sterilizer further."

Peri-Operative Nurse Specialist-JJ confirmed to Surveyor #22198, that the OR policy needed to be updated to include clear manufacturers recommendations, and staff need to be re-educated on the manufacturers requirements for use of the Immediate Use (Flash) Sterilizers, to ensure staff understand there are no holidays when sterilizing surgical instruments.

Surveyor #22198 conducted an interview and review of findings on 02/27/12 at 2:00 p.m. with Director of Infection Control- C who confirmed testing of any sterilization machines prior to sterilizing equipment is a standard of practice. C confirmed the IC program for 2011 and 2012 contained national benchmarks Care Improve Projects (SCIP) and National Healthcare Safety Network (NHSN), however failed to include a system for tracking, trending and monitoring internal infection failures specific to the OR/Surgical Services.

Director of Infection Control- C confirmed to Surveyor #22198, aside from bi-annual environmental rounds that looks at the environment not staff, there is no other monitoring system for the OR specific to things specific to infection control. C stated that 6 ORs had no internal monitoring system to ensure the OR staff were compliant with current hospital policies and procedures, including infection control.

Surveyor #22198 asked what OR Educator-II, Peri-Operative Nurse Specialist-JJ and OR Distribution Technician KK do with the documentation they analyze for staff compliance with the flash sterilizers and any problem specific issues identified during their analysis. II and KK told Surveyor it is provided to the OR Clinical Manager-B and any problems are discussed at meeting. II, JJ and KK confirmed that these issues identified during today's interview are re-occurring issues, and that currently there is no monitoring system to ensure changes including new policies and changes to policies are sustained.

#6) Surgery had no policy and procedure for ensuring sterile medical supplies with no clearly marked expiration date, could be tracked, monitored and rotated to ensure sterility and manufacturers outdates were adhered to and ensure medical supplies remained sterile and package integrity was maintained.

On 02/28/12 between 7:45 a.m. through 8:35 a.m. Surveyor #22198 along with OB Staff Manager -U and OB Educator-V observed and confirmed the following:

? Sterile marking pens stored outside their original containers. No expiration date was found on the package.

? Sterile Specimen cups stored outside their original containers. No expiration date was found on the package.

? Puralube Ointment-Petroleum Ophthalmic ointment stored outside its original packaging. No expiration date was found on the package.

OB Staff Manager -U and OB Educator-V, confirmed to Surveyor that the department had no system for identifying a manufacturers expiration dates on any sterile products that are not clearly marked with an expiration date. U and V did not realize, based on storage temperature and humidity, the sterile seal will eventually break down.

U and V had the Technician (QQ) responsible for rotating and maintaining supplies in the OB department, contact central supply directly to determine if the central supply had a system or had identified which sterile products did not come with a clearly defined expiration date to ensure sterility of their product.

OB Technician -QQ confirmed Central Supply was unaware of sterile items that did not have a clearly defined expiration date and no policies and procedures to ensure the manufacturer was contacted to obtain the maximum shelf life or a system for rotating these specific items. Also present were OB Staff Manager -U and OB Educator-V.

On 02/28/12 at 8:45 a.m. through 9:15 a.m., Surveyor #22198 along GI Manager -PP observed the following:

? 60 CC sterile syringes were stored outside their original containers. No expiration date was found on the package.
? Sterile suction tubing stored outside their original containers. No expiration date was found on the package.
? Sterile gloves stored outside their original containers. A manufacturers date was identified, however, no expiration date was found on the package.

GI Manager -PP, confirmed to Surveyor #22198, the department had no system for identifying a manufactures expiration dates on any sterile products that are not clearly marked with an expiration date.

GI Manager -PP, confirmed to Surveyor #22198, PP did not realize based on storage temperature, humidity the sterile seal will eventually break down.

On 02/28/12 from 9:15 a.m. - 9:30 Surveyor #22198 along with Cardiac Catheter Lab Manager - X found the following:

? 3 boxes of sterile needles that had no expiration date.

Cardiac Catheter Lab Manager - X, confirmed to Surveyor #22198, the department had no system for identifying a manufacturers expiration dates on any sterile products that are not clearly marked with an expiration date.

Cardiac Catheter Lab Manager - X, confirmed to Surveyor #22198, X did not realize based on storage temperature, humidity the sterile seal will eventually break down.