HospitalInspections.org

Based on observation, interview and document review, the hospital failed to implement an infection control plan to maximize the prevention of infections and communicable diseases, as evidenced by:

1. The hospital failed to follow their Policy and Procedure (P&P) for Central Venous Catheter Care when a dressing change of a soiled Peripherally Inserted Central Catheter (PICC) was not performed for Patient 2.

2. The hospital failed to ensure that Infection Control P&P's and manufacturer's recommendations were followed for cleaning and disinfecting of a Point of Care (POC) devices (glucose meter) and of non-critical items (thermometers).

3. Staff failed to adhere to safe injection practices. Nursing staff did not dispose of sharps per accepted standards of practice.

4. The hospital failed to ensure that appropriate surgical attire and Personal Protective Equipment (PPE) were used by all Health Care Personnel (HCP) for each surgical and/or invasive procedure, consistent with the hospital infection control policies and according to standards of practice.

5. The hospital failed to implement their policy and procedure ensuring that staff performed hand hygiene with soap and water when caring for patients with Clostridium difficile.

6. The hospital failed to ensure that housekeeping staff correctly wore personal protective equipment, when terminally cleaning isolation room of a patient had methicillin resistant staphylococcus aureus (MRSA).

7. The hospital failed to ensure hospital linen was laundered in a manner that prevented contamination.

8. The hospital failed to implement a system to high level disinfect (reprocess) flexible endoscopes before use, if unused more than five days.

9. The hospital failed to ensure that personal clothing worn underneath surgical attire was completely covered in accordance with standards of practice.

10. The hospital failed to ensure that the sterilizers used to sterilize surgical instruments and equipment were cleaned and maintained according to manufacturer recommendations.

These practices increased the patients' risk of developing infections and surgical site infections. Failure to ensure that equipment was cleaned and disinfected between patients increases the risk of cross contamination between patients.

Findings:

1. On 10/5/11 at 3:30 p.m., Patient 2 was observed in the Critical Care Unit (CCU) with a PICC line in the left antecubital region (front of elbow). A PICC line, is a thin, soft plastic intravenous (IV) line placed into a large vein in the arm and guided up into the main vein near the heart and is used for fluids and medication administration. RN taking care of the patient in CCU, present in room, removed the bandage (outer gauze dressing) and revealed a translucent dressing over the PICC line insertion site, with bloody drainage underneath the clear dressing. There was no date of insertion documented on the dressing. The RN stated that per chart, the dressing was inserted by one of the PICC line nurses on 10/3/11 and was not due for dressing change until seven days from the insertion time. The RN was not concerned about the bloody drainage at the insertion site.

On 10/6/11 at 1:50 p.m. one of the RN's who routinely performed PICC line insertions in the facility stated, that the RN's caring for the patient with a PICC line were responsible for maintaining the lines, to include dressing changes within 5-7 days, or sooner, as needed if the dressing became wet or soiled. The RN stated that a bloody dressing would warrant a dressing change, regardless of the date of insertion.

The policy and procedure (P&P) titled "Central Venous Catheter Care and Maintenance" (revised 3/10), included PICC line maintenance and stipulated in part, that "Initial dressing will be changed 24 hours post insertion if soiled or gauze dressing in place."

2. During observations on 10/6/11 at 10 a.m., a perioperative nurse was observed cleaning a thermometer's sensor with an alcohol swab and placing the thermometer in a storage area available for use for the next patient, without disinfecting of the thermometer's case. The RN confirmed that alcohol swabs were routinely used for cleaning of the thermometer as observed.

Review of Infection Policy # IC 13 titled "Cleaning of Patient Care Equipment and Environment " in part indicated, that thermometers should be cleaned in between each patient use. The P&P indicated that alcohol swabs or disinfectant cloth could be used to wipe thermometers after each patient use. The policy did not instruct to follow the manufacturer's recommendations for use.

Review of the manufacturer's recommendations (presented by the facility for the thermometers used in the hospital), in part indicated that "thermometer case can be cleaned with any hospital approved disinfectant, alcohol, even bleach solutions."

According to the 2008 Center for Disease Control Guideline for Disinfection and Sterilization in Healthcare Facilities, page 38 indicated, "FDA has not cleared any liquid chemical sterilant or high-level disinfectant with alcohol as the main active ingredient."

During observations on 10/6/11 at 10 a.m. a perioperative nurse was observed cleaning a glucose meter after use with alcohol swab. The RN stated that alcohol swabs were approved way for cleaning glucose meters in the facility.

During observations in the Surgical Intensive Care Unit on 10/5/11 at 3:30 p.m., nursing staff used a glucose meter for one of the patients on the unit. The glucose meter was placed and used outside the room on a table/stand. The nurse cleaned the glucose meter with a disinfecting wipe after use stating that she used the wipe because the glucose meter became soiled. The usual practice was to clean the glucose meter between patients only if it became soiled, if the meter was not taken into a patient room. The glucose meter was routinely disinfected at the end of each day.

Review of the manufacturer's recommendations for the glucose meter (provided by the facility for the glucometer used) indicated to clean the outside of the meter with a cloth dampened with a 10% bleach solution.

The July 30, 2009 APIC (Association for Professionals in Infection Control and Epidemiology) Position Paper: Safe Injection, Infusion and Medication Vial Practices in Healthcare, indicated, for Blood Glucose Monitoring Devices, to clean and disinfect glucometer if they must be reused between patients. The position paper indicated to thoroughly clean all visible soil or organic material (e.g., blood) from glucometer prior to disinfection. It further indicated to disinfect the exterior surfaces of the glucometer after each use, even if there was no visible blood or soil, following the manufacturer's directions and using an EPA-registered disinfectant effective against HBV, HCV and HIV.

According to the 2008 Center for Disease Control Guideline for Disinfection and Sterilization in Healthcare Facilities indicated, "Because blood-containing aerosols are generated by applying a blood sugar test strip into a glucometer machine, and also by use of a spring-loaded lancet injector, such equipment must be properly disinfected between use for multiple patients. Isopropyl alcohol and antimicrobial soap did not appear on the March 2009 FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices list (retrieved at www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/...), but 10% bleach was considered an effective disinfectant.

3. During observations on 10/6/11 at 10:45 a.m., a perioperative nurse was observed kneeling on the floor near Patient 1's bed while starting an IV. The RN placed sharps (used syringe with a sharp needle and IV catheter needle) on the floor as she secured the IV line for Patient 1. The RN stated that the sharp container was too high and located too far to use it when starting IV at the patient's bedside.

The July 30, 2009 APIC (Association for Professionals in Infection Control and Epidemiology) Position Paper: Safe Injection, Infusion and Medication Vial Practices in Healthcare, indicated, to utilize sharps safety devices whenever possible, discard syringes, needles and cannulas after used directly on an individual patient or in their IV administration system and dispose of used needles at the point of use in an approved sharps container.

4. On 10/5/11 at 12:30 p.m., observation was made that during a procedure in the endoscopy suite not all staff was wearing surgical attire. The surgeon was noted wearing street clothing covered by a surgical gown, with pants not covered. The OR Manger stated that endoscopy suites were not surgery suites, therefore surgical attire was not required, even though the endoscopy suite was located and was accessible from the OR core area (where surgical attire was required). The Manger stated that the endoscopy surgeons were allowed to wear street clothing, covered by a surgical gown. The surgeons had a separate entrance to the endoscopy suite so they did not have to go through the sterile core.

On 10/6/11, starting at 10 a.m., Patient 3 was observed undergoing an invasive procedure, a lung biopsy (Percutaneous needle biopsy), in the radiology department (CT). The physician explained that risk of the procedure included a collapsed lung (pneumothorax). The staff prepared a chest tube that would need to be inserted into the patient's lung (through the chest wall) to expand the lung in case of pneumothorax. The physician was observed performing the procedure in street clothes, without any protective clothing (other than gloves). Other staff/technicians assisting in the procedure were also observed not wearing surgical attire (RN was the exception).

In an interview with Radiology Director on 10/6/11 at 1:30 p.m., the Director stated that per the facility Dress Code policy, scrub clothing was required in Departments including Surgery and Special Procedures. "Special Procedures" in the Radiology Department were performed in a designated area of the Radiology Department and surgical attire was there required. All procedures, regardless of the type of procedure, if performed in the CT room, as it was in case for Patient 3, did not require surgical attire.

Review of policy "Radiology-Preps for Special Radiologic Procedures" (Originated October 1994) included percutaneous biopsy as special procedure.

Review of the "Dress Code" policy (rev 04/03) indicated in part, that scrub clothing is required in departments including "Special Procedures."

The Association of perioperative Registered Nurses (AORN) 2011 Edition recommended the following in the Recommended Practices for Traffic Patterns in the Perioperative Practice Setting, page 95, Recommendation I: "Traffic patterns should be designed to facilitate movement of patients and personnel into, through, and out of defined areas within the surgical suite. Signs should clearly indicate the appropriate environment controls and surgical attire required." Traffic pattern areas were defined in item 1 as: (1) "unrestricted," a central control point established to monitor the entrance of patients, personnel, and materials; (2) "semi-restricted," the peripheral support areas of the surgical suite with storage for clean and sterile supplies, work areas for storage and processing of instruments, scrub sinks, and corridors leading to the restricted areas of the surgical suite; surgical attire and hair coverings required; (3) "restricted," includes operating rooms, procedure rooms, and the clean core area; surgical attire and hair coverings required, masks required when sterile supplies open. Item 2 documented, "Movement of personnel from unrestricted areas to either semi-restricted or restricted areas should be through a transition zone. A transition zone exists where one can enter the area in street clothing and exit into the semi restricted or restricted zone in surgical attire..."

The Association of perioperative Registered Nurses (AORN) 2011 Edition recommended in the section "Recommended Practices for Surgical Attire," Recommendation II, that "Clean surgical attire, including shoes, head covering, mask, jackets, and identification badges should be worn in the semi restricted and restricted areas of the surgical or invasive procedure setting."


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5. The hospital failed to implement their policy and procedure directing staff to use only soap and water for hand hygiene when caring for patients diagnosed with Clostridium Difficile

On 10/5/11 at 2 p.m., a tour was conducted of the 4 th floor medical / surgical unit. During the tour a sign was posted outside room 402, indicating that the patient was in contact precautions.

During a concurrent interview, the Management Staff 1, stated that the patient was in contact precautions for Clostridium Difficile (gram-positive, anaerobic, spore-forming bacillus that is responsible for the development of antibiotic-associated diarrhea). During the interview, a registered nurse (RN), was observed leaving the patient's room. Upon leaving the room the RN performed hand hygiene using an alcohol based hand rub. Management Staff 1, was asked if use of an alcohol based hand rub was the usual method for performing hand hygiene when caring for patients with Clostridium Difficile. Management Staff 1, stated that the hospital had done such a good job of educating staff to, "gel in and gel out" that they were having difficulty changing staff practice to only use soap and water for hand hygiene when caring for patients with Clostridium Difficile.
On 10/5/11 at 4 p.m., the hospital's policy and procedure dated 9/09, titled, "Clostridium Difficile" was reviewed. On page 2, of the policy and procedure, under section B, titled, "Hand Hygiene" item 2, staff were directed to, "Do not use alcohol hand sanitizers. Alcohol will not kill C difficile spores."

6. The hospital failed to ensure that housekeeping staff correctly wore personal protective equipment, when terminally cleaning isolation rooms where the previous patient had methicillin resistant staphylococcus aureus.

On 10/5/11 at 2:48 p.m., a tour was conducted of of the respiratory intensive care unit. During the tour Housekeeper 5, was observed cleaning room 6.

During a concurrent interview, Management Staff 2, stated that a patient who had a methicillin resistant staphylococcus aureus infection (MRSA), and had been transferred from that room, and Housekeeper 5, was terminally cleaning the room.

While observing Housekeeper 5, during the terminal cleaning process, it was noted that the the housekeeper was wearing protective gloves and a gown during the cleaning process. It was noted that Housekeeper 5's personal protective gown was tied together in the front, and the front of the housekeepers uniform was exposed to potential contamination.

During a concurrent interview, Management Staff 2, was asked if housekeepers usually wore protective gowns, open in the front when terminally cleaning isolation rooms. Management Staff 2, stated that the housekeeper was wearing the protective gown backwards, and that her uniform was potentially contaminated with MRSA.

On 10/5/11 at 4 p.m., Centers for Disease Control and Prevention (CDC), 2007, Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings, was reviewed. Documentation on page 51, under section II.E.2., directed that, "... Isolation gowns are always worn in combination with gloves, and with other PPE when indicated....Gowns are usually the first piece of PPE to be donned. Full coverage of the arms and body front, from neck to the mid-thigh or below will ensure that clothing and exposed upper body areas are protected...Isolation gowns should be removed in a manner that prevents contamination of clothing or skin. The outer, " contaminated " , side of the gown is turned inward and rolled into a bundle, and then discarded into a designated container for waste or linen to contain contamination."

7. The hospital failed to ensure hospital linen was laundered in a manner that prevented contamination.

On 10/5/11 at 3:15, a tour was conducted of the hospital's onsite laundry facilities. During the tour, a metal roll-up door, approximately eight to 10 feet wide was observed open. It was noted that the metal roll-up door was open about three to four feet from the floor. It was noted that four or five bins of clean unfolded linen were nearby. Through the open metal roll-up door it was noted that it was raining and the wind was blowing outside.

During a concurrent interview, Management Staff 3, was asked if the metal roll-up door was usually open. Management Staff 3, stated that it was against hospital practice for the metal roll-up door to be open to the outside.

On 10/5/11 at 4:30 p.m., CDC's, Guidelines for Environmental Infection Control in Health-Care Facilities, published 6/3/03, was reviewed. Under the section titled, "IV. Laundry Process" CDC recommended that, "Package, transport, and store clean textiles and fabrics by methods that will ensure their cleanliness and protect them from dust and soil during inter-facility loading, transport, and unloading..."

8. The hospital failed to ensure that flexible endoscopes were high level disinfected (reprocessed), before use, if not used more than five days.

On 10/6/11 at 9:30 am, a tour was conducted of the surgical suite where flexible endoscopic procedures are performed. Sitting on a table in the back room a flexible endoscope was observed coiled in a plastic container wrapped in plastic wrap.

During a concurrent interview, the Management Staff 4, stated that all flexible endoscopes were reprocessed at the surgery center next door. Management Staff 4, stated that when the flexible endoscopes were needed they were transported to the hospital in the plastic covered containers.

On 10/6/11 at 10 am, a tour was conducted of the surgery center next door. Staff working at the surgery center were asked if the flexible endoscopes were reprocessed before use, if unused more than five days. Staff working at the surgery center stated that they did not have a system in place to reprocess flexible endoscopes before use, if unused more than five days.

On 10/6/11 at 10:15 am, the flexible endoscope reprocessing log was reviewed. The reprocessing log contained no evidence that a system had been implemented ensuring that flexible endoscopes were reprocessed before use, if unused after five days.


On 10/6/11 at 11 am, the 2011 perioperative standards and recommended practices published by the Association of periOperative Registered Nurses (AORN), was reviewed. On page 421, Recommendation IX.b. indicated: "Flexible endoscopes should be reprocessed before use, if unused more than five days."


9. The hospital failed to ensure that attire worn within the surgical services area was in accordance with national standards of practice.

On 10/6/11 at 9:30 am, a tour was conducted of the surgical services area. During the tour Management Staff 4, was observed wearing surgical attire. It was noted that Management Staff 3's T-shirt, (round collar up to the neckline, and the lower part of the sleeves), were exposed outside the hospital provided surgical attire.

During a concurrent interview, the Infection Preventionist (IP) 5, stated that surgery staff had voiced concerns that Management Staff 4's personal clothing was not completely covered by surgical attire, and was not in accordance with standards of practice. When asked if Management Staff 3 worked in areas where sterile supplies and equipment were open, the IP 4, replied, "Yes."

On 10/6/11 at 11 am, the 2011 perioperative standards and recommended practices published by the Association of periOperative Registered Nurses (AORN) was reviewed. AORN recommended on page 62, under, Recommendation III.b.1., that, "All personal clothing should be completely covered by surgical attire. Undergarments such as T-shirts with a V-neck, which can be contained underneath the scrub top may be worn; personal clothing that extends above the scrub top neckline or below the sleeve of the surgical attire should not be worn."

10. The hospital failed to ensure that the sterilizers used to sterilize surgical instruments and equipment were cleaned and maintained according to manufacturer recommendations.

On 10/6/11 at 10:30 am, a tour was conducted of the sterile processing area. During the tour, sterile processing staff were asked about the frequency for cleaning inside the steam sterilizers.

During a concurrent interview, sterile processing staff stated the inside of the sterilizers hadn't been cleaned for two or three months. Sterile processing staff stated that the person who used to clean the inside of the sterilizers no longer worked in the department, and that new staff needed to be trained in the process.

On 10/6/11 at 10:45 am, a request was made to review the manufacture's recommended guidelines for cleaning inside the sterilizer.

On 10/6/11 at 1 p.m., the manufacture's recommended maintenance guidelines were provided and reviewed. Documentation in section of 7.2.1, of the manufacturer recommended under the weekly maintenance guidelines, that the inside of the sterilizer was to be cleaned at least weekly, using detergent, and whenever the line was clogged.