HospitalInspections.org

Based on document review, interview, and observation, it was determined that the Governing Body failed to demonstrate it is effective in carrying out the responsibilities for the operation and management of the hospital. The Governing Body failed to provide necessary oversight and leadership as evidenced by the lack of compliance with the following Conditions of Participation:

CFR 482.42 Infection Control
CFR 482.51 Surgical Services

Based on a review of Medical Record #4 and staff interview on May 11, 2010, it was determined that the facility failed to ensure that the registered nurse supervised the care of all patients.

Findings include:

1. On 5/11/10 at 10:45 AM, Medical Record #4 was reviewed. The medical record contained a 1:1 observation sheet dated 5/11/10 that was filled out from 7:15 AM until 11:30 AM. The 1:1 observation sheet was filled out 45 minutes ahead of time stating that at 11:00 AM the patient was "awake," at 11:15 AM the patient was "awake," and at 11:45 AM, "1:1 DC'd [Discontinued]."

2. A Physicians order dated 5/11/10 at 10:20 AM stated "Discontinue Order for 1:1 Observation."

3. The above findings were verified by Staff #5.

Based on observation, review of facility documents and staff interview, it was determined that the facility failed to ensure that written physician's orders for the treatment of a dialysis patient were implemented.

Findings include:

A. On 5/10/10, Staff #15 displayed the treatment orders for Patient #3 on the Dialysis Treatment Area computer screen. The written orders dated 5/10/10 specified the use of a Rexeed 155 dialyzer for Patient #3 treatment. At 12:00 PM on 5/10/10, Patient #3 was observed during hemodialysis treatment using a Reviclear dialyzer. Staff #15 confirmed the use of the Reviclear dialyzer and presented a new Reviclear dialyzer, like the one in use for treatment, in original packaging, for review.

B. Staff #15 stated on 5/10/10 that the Rexeed 155 dialyzer was no longer used or available for use at this facility and the Reviclear dialyzer is used instead. A letter from the Medical Director of the Acute Dialysis Unit to "All Nephrologists" dated January 4, 2010 presented by Staff #14 states that the dialyzers used in the Acute Unit have been changed to Reviclear and Optiflux. However, there was no documentation presented to document that Reviclear dialyzer was to be substituted for an order for a Rexeed 155 dialyzer for patient treatment.

Based on observation on 5/11/2010 and 5/12/2010, it was determined that the facility failed to ensure that the overall hospital environment was maintained in such a manner that the safety and well-being of patients is assured.

Findings include:

1. On 5/12/2010 at 11:10 AM, in the presence of Staff #42, the Scrub Sinks located in the Cardiac Catheterization Lab tested at 90 degrees F [Fahrenheit]. Hot water for handwashing within State requirements [8:43G-13.18(b)] is to be 105 to 120 degrees F.

Princeton Behavioral Health
2. On 5/11/2010, at 2:10 PM, in the presence of Staff #42 and Staff
#44, the Wing 1 Patient Lounge Valuables Closet was overfilled with storage, so as not to facilitate cleaning [8:43G-13.4(q)].

3. On 5/11/2010 at 2:15 PM, in the presence of Staff #42 and Staff
#44, the Rotunda Janitors Closet walls were noted to be in need of repainting, and the ceiling grid was rusty.

4. On 5/11/2010 at 2:25 PM, in the presence of Staff #42 and Staff #44, it was confirmed that the Rotunda Janitors Supply Closet had cardboard boxes stored on the floor in violation of the State requirement for storage to be elevated from the floor and away from walls, ceilings, and air vents to facilitate cleaning [8:43G-13.4(q)].

5. On 5/11/2010 at 2:35 PM, in the presence of Staff #42 and Staff #44, it was confirmed that in the Wing A Mechanical Room, access to major equipment was blocked by an overflow of miscellaneous storage, in violation of the State requirement for storage to be elevated from the floor and away from walls, ceilings, and air vents to facilitate cleaning.

Miscellaneous storage was on top, on the sides, and in front of equipment, blocking access to, and limiting air circulation to and around the equipment. A space already designated as "hazardous" was provided with a setting of increased hazardous potential.

6. On 5/11/2010 at 2:40 PM, in the presence of Staff #42 and Staff #44, in the Old Generator Room, there was an abandoned generator, with access to it blocked by an overflow of miscellaneous storage. There was also dirt and debris on the floor, equipment and items of storage.

7. On 5/11/2010 at 2:50 PM, in the presence of Staff #42 and Staff #44, in the Administration Wing Paper Storage Closet, there were boxes stored on the floor in violation of the State requirement for storage to be elevated from the floor and away from walls, ceilings, and air vents to facilitate cleaning [8:43G-13.4(q)].

Based on observation and review of facility documents, it was determined that the facility failed to ensure that written facility policy and equipment manufacturer's recommendations for the monitoring, cleaning and maintenance of hemodialysis machines and water treatment systems was implemented.

Findings Include:

Reference #1: Facility Policy titled, "Minimum Components for Portable Reverse Osmosis (RO) Systems" states, "8. Sample ports are located post each carbon filter/tank and post RO."

Reference #2: Facility Policy titled, "Total Chlorine Monitoring of Portable Reverse Osmosis (RO) Water Treatment Systems " states, "5. Samples for Total Chlorine testing are drawn from the sample port located downstream of the first (primary) carbon tank."

1. On 5/10/10, the carbon tanks attached to the Reverse Osmosis (RO) water treatment system WRO 300 #4 (5305) were observed with no sample port installed between the two carbon tanks from which to obtain a sample for chlorine monitoring, post primary carbon tank, as required by facility policy.


Reference #1: Fresenius Medical Care 2008K2 Hemodialysis Machine Operator's Manual, (Rev. E) presented by Staff #16 on 5/10/10, page 112, Cleaning the Exterior Surface section states, "The exterior of the dialysis machine should be cleaned after every treatment. It can be cleaned with very dilute bleach or other suitable hospital disinfectant. Use surface cleaning agents sparingly to avoid excess cleaner from entering the interior of the machine. Rinse off cleaning solution with a water-dampened cloth, especially if a corrosive, cleaning agent such as bleach is used. Freshly prepared dilute bleach solution (1:100) is currently recommended by the Center for Disease Control as a suitable disinfectant for the Hepatitis virus. Because surface contamination is the general mode of transmission for this type of virus, thorough cleaning of the 2008K2 machine exterior is essential."

Reference #2: Fresenius Medical Care 2008K2 Hemodialysis Machine Operator's Manual, (Rev. E) presented by Staff #16 on 5/10/10, page 113, Cleaning the Blood Pressure Cuff section states, "Do not use chlorine solutions or autoclave the cuff."

Reference #3: Facility Acute Services Policy: Hospital Dialysis Setting Hygiene section states, "31. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials. Use an appropriate disinfectant such as 1:100 bleach solution for environmental surfaces. For gross blood spills, a 1:10 bleach solution must be utilized. After all visible blood is cleaned with the 1:10 bleach solution, teammates are to use a new disposable towel soaked with 1:10 bleach solution and clean area a second time. 34. The outside surfaces of all equipment will be wiped with a bleach solution prior to removal from treatment area."

2. On 5/10/10 at 1:15 PM, Staff #15 was observed cleaning the equipment used for dialysis treatment of Patient #3.

a. Staff #15 prepared a 1:10 bleach solution and used the 1:10 bleach solution to clean the exterior of the hemodialysis machine, rather than the 1:100 bleach solution required by facility policy and manufacturer's instructions.

2. Staff #15 did not rinse off the bleach solution from the exterior of the hemodialysis machine as required by manufacturer's instructions.

3. Staff #15 used the 1:10 bleach solution to clean the blood pressure cuff which is prohibited by manufacturer's instructions.

Based on observation and review of facility documents, it was determined that the facility failed to ensure that infection control policies that are based on CDC recommendations were implemented.

Findings include:


Reference #1: CDC publication "Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients, MMWR, Vol. 50, No. RR-5, April 27, 2001 states, "Any item taken to a patient's dialysis station could become contaminated with blood and other body fluids and serve as a vehicle of transmission to other patients either directly or by contamination of the hands of personnel. Therefore, items taken to a patient's dialysis station, including those placed on top of the dialysis machines, should be either disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being returned to a common clean area or used or other patients." The document also states, "After each patient treatment, clean environmental surfaces at the dialysis station, including the dialysis bed or chair, countertops, and external surfaces of the dialysis machine, including containers associated with the prime waste."

Reference #2: Facility Acute Services Policy: Hospital Dialysis Setting Hygiene section states, "31. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials. Use an appropriate disinfectant such as 1:100 bleach solution for environmental surfaces. For gross blood spills, a 1:10 bleach solution must be utilized. After all visible blood is cleaned with the 1:10 bleach solution, teammates are to use a new disposable towel soaked with 1:10 bleach solution and clean area a second time. 34. The outside surfaces of all equipment will be wiped with a bleach solution prior to removal from treatment area."

On 5/10/10 at 1:15 PM, Staff #15 was observed cleaning the equipment used for dialysis treatment of Patient #3. Staff #15 failed to clean all equipment and surfaces after patient treatment, according to CDC Guidelines and facility policy.

1. Staff #15 was observed rinsing the prime bucket that was attached to the side of the dialysis machine with water and did not disinfect the prime bucket with bleach solution.

2. Staff #15 failed to clean or disinfect the overbed table used in the patient treatment area before moving it near the window for storage.

3. Staff #15 failed to wipe the clipboard that had been used in the patient treatment area before placing it on the nurse's station counter.

Based on observation, review of facility documents, and staff interview, it was determined that the facility failed to ensure that surgical services are provided in accordance with acceptable standards of practice, including compliance with applicable Federal and State law.

Findings include:

Reference #1: CDC's Hospital Infections Program, "Guideline for Prevention of Surgical Site Infection" states in Sterilization of surgical instruments (Section II C. 2-d-2), "Perform flash sterilization only for patient care items that will be used immediately (e.g., to reprocess an inadvertently dropped instrument). Do not use flash sterilization for reasons of convenience, as an alternative to purchasing additional instrument sets, or to save time."

1. A review of Operating Room (OR) steam sterilization control record envelopes for the month of April 2010 showed approximately 106 loads were flashed sterilized under a prevac cycle.

Reference #2: Facility Policy and Procedure titled CS 2-9 Storage of Sterile Supplies states under Procedure, "In house sterilized items will not be compressed or stacked."

1. OR Rakes sterilized in peel packs and stored in the OR sterile supply room were compressed into a storage bin.
a. Eight of the packages contained holes and tears in the wrapping.

Reference #3: The Association for the Advancement of Medical Instrumentation (AAMI) requirements, ST 79 "Comprehensive guide to steam sterilization and sterility assurance in health care facilities, "states under 3.4.2 Traffic Control, "Criteria for authorized entry, movement within processing areas, and attire should be specified in written policies and procedures."

1. Between 11:20 AM and 12:15 PM on 5/10/10, four different OR nurses holding various surgical equipment, were observed entering and/or exiting through the OR's clean prep and pack room into the decontamination room.

2. A review of the Facility's Policy and Procedure Manual did not include traffic control criteria as stated in Reference #3.

Reference #4: The Association for the Advancement of Medical Instrumentation (AAMI) requirements, ST 79 "Comprehensive guide to steam sterilization and sterility assurance in health care facilities, "states under 10.3.1 Lot Control Numbers, "For flash sterilization, labels with lot number are not used; however, a lot number should be assigned to each flash sterilization load and a load removed should be generated for each sterilization cycle. The load record should document a) the assigned lot number, including sterilizer identification and cycle number."

1. A review of the OR steam sterilization control record envelopes from April 1 to May 1, 2010, revealed that the assigned lot number, including cycle number, were not provided for items which were flash sterilized.

Reference #5: Facility Policy and Procedure titled, "Striation Process and Assurance CS-2-5 stated under Procedure, " At the completion of each sterilization cycle, the cycle parameters will be checked, verified, and documented on the sterilizer printout by the operator."

1. Approximately 20% of the OR's sterilizer printouts were not initialed by the operator during the month of April 2010, as required in Reference #5.

Reference #6: The Association for the Advancement of Medical Instrumentation (AAMI) requirements, ST 79 "Comprehensive guide to steam sterilization and sterility assurance in health care facilities, "states under 8.6.1, "If a rigid sterilization container system or a sealed containment device designed for flash sterilization is used as packaging, the container system manufacturer's written recommendation regarding exposure time should be consulted and reconciled with those of the sterilizer manufacturer."

1. The OR uses the Riley Medical brand Flashpak to flash sterilize instruments in a prevac cycle.

2. Staff #10, #11, #12, and #13 were asked, during the survey, to provide the manufactures guidelines for sterilization parameters of various instrument flashed in the Flashpak.

a. An accurate list could not be obtained by the completion of the on-site survey for instrument exposure times when used in a Flashpak.

b. When interviewed during the survey, Staff #10, #11, #12, and #13 were unaware that any deviations in sterilization parameters could exist.

Reference #7: The Instruction manual titled, FlashPak Sterilization container system by Riley Medical Inc. Instructions for Use states under " Daily:
#2. Check the valves. The valves located in the top and bottom of the container should be vented at least once a day, when the container is cool ....Do not use the container if there is any area that the metal valve cover does not seat securely on the silicone gasket. "

1. A review of Facility's Policy and Procedure manual did not address the use of a container system for flashing or the daily maintenance for its use.

2. Upon interview, Staff #10 was unaware of any special precautions when using the Flashpak.

Based on observation, review of facility documents, and staff interview, it was determined that the facility failed to ensure that policies and procedures were implemented.

Findings include:

Reference #1: The Association for the Advancement of Medical Instrumentation (AAMI) requirements, ST 79 "Comprehensive guide to steam sterilization and sterility assurance in health care facilities" states under 10.7.1, "All steam sterilizers should be routinely tested using appropriate PCDs (BI challenge test packs or BI challenge test trays) to ensure their effectiveness in sterilizing medical devices."

Reference #2: Facility Policy and Procedure titled, "CS 2-3 Use of Biological Indicators" states under Steam Gravity Displacement Sterilizer (flashes),
"This biological challenge test is run daily at 270°F gravity steam sterilizer in the 1st load of the day."

Reference #3: Facility Policy and Procedure titled "CS 2-3 Use of Biological Indicators" states under Steam high vac terminal sterilizer and steam flush pressure pulse sterilizer, "This biological challenge test is run daily on the steam high vac and steam flush pressure pulse sterilizer in the 1st normal load of the day."

1. A review of the biological monitoring log book from January 1, 2010 to May 1, 2010, for the three OR sterilizers revealed that no routine biological monitoring for the flash gravity sterilization cycles were being performed as required by Reference #1 and Reference #2.

a. Upon interview on May 11, 2010, Staff #10 stated that he /she was unaware of the need to include a biological indicator in the flash gravity cycle.

2. A review of the steam sterilization control record envelopes from April 1, 2010 to May, 2010 revealed that 100% of the biological challenge tests were run in an empty chamber and not the 1st normal load of the day as required by Reference #3.

Reference #4: Facility Policy and Procedure titled "US 2.1 Disinfection and Sterilization of Ultrasound Probes" states under Procedure #4, "The probe shall be sterilized by soaking in Cidex for 15 minutes."

Reference #5: Cidex OPA manufacturer instruction states under B.
"RINSING PROCEDURE a) all Devices THREE (3) SEPARATE LARGE VOLUME WATER IMMERSION RINSE ARE REQUIRED. Following removal from CIDEX OPA Solution, thoroughly rinse the medical device by immersing it completely in a large (e.g.) 2 gallons) of water. Remove the device and discard the rinse water. Repeat this procedure TWO (2) additional times."

1. It was observed and confirmed by Staff #41 during interview, that two of the three canisters used to disinfect the probes contained Cidex OPA Solution and the middle canister contained water.

2. It was observed that a probe was immersed in the first canister containing Cidex OPA Solution. Staff #41 could not accurately document when the probe was first inserted into the Cidex OPA Solution.

a. There was no means to accurately and consistently determine the length of time when a probe is immersed in the Cidex OPA Solution.

3. The Policy and Procedure titled, "Disinfection and Sterilization of Ultrasound Probes" does not address or refer to the manufacturer's instructions for rinsing, as stated in Reference #5.