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A. Based on observation and staff interview, it was determined that the facility failed to implement its policy and procedure for Contact Precautions.

Findings include:

Reference: Facility policy ISOLATION GUIDELINES: OVERVIEW states, "... II. transmission -based Precautions ... C. Contact Precautions are designed to reduce the risk of transmission of epidemiologically important microorganisms by direct or indirect contact. ... Contact Precautions apply to patients known or suspected to be infected or colonized ... with epidemiologically important microorganisms that can be transmitted by direct or indirect contact. ... ISOLATION GUIDELINES OVERVIEW [chart] PRECAUTIONS CATEGORY... Contact ... INSTRUCTIONS ... [first bullet] Private room [second bullet] Gowns and gloves must be worn when: [first sub-bullet] Entering the room [second sub-bullet] anticipating contact with patient and or patient care item [third sub-bullet] Contact with environmental surfaces ..."

1. On 7/7/15 at 11:15 AM, Unit Seton 6 was toured in the presence of Staff #4, #9, and #10. A Contact Isolation sign was posted outside of patient Room #S618.

a. A family member was observed sitting in a chair within the room. The family member had a plastic cover gown on, but no gloves.

b. A nurses aide was observed carrying linen to the patient room. The aide had the head piece of the gown on and was placing the gown over his/her front upon entering the room. He/she did not tie the back of the gown. The aide did not don gloves until he/she was within the patient room.

2. On 7/8/15 at 11:30 AM Unit Regan 3 North was toured in the presence of Staff #2, #7, #8, and #29. A Contact Isolation sign was posted outside patient Room #345.

a. One family member was observed at the foot of the patient's bed with a plastic cover gown on, but no gloves.

b. A second family member was observed at the head of the patient's bed, talking to the patient, holding the bed side-rail. The second family member was observed without any gown or gloves.

c. In interview on 7/7/15, Staff #29 stated family members are provided a fact sheet for infection control isolation precautions and are shown how to use and wear the PPE (personal protective equipment).

d. Medical Record #2 was reviewed in the presence of Staff #29 and #63. There was no evidence of education to all the patient's family members regarding contact isolation and PPE. The only documented education regarding infection control was to the patient's son on 6/2/15 and 6/28/15.

e. The first family member was later observed to remove his/her gown in the hallway outside the patient's room. The patient's primary nurse escorted the family member back to the patient's room to discard the gown and perform hand hygiene.


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B. Based on observation, facility policy review and staff interview conducted on 7/7/15 and 7/8/15, it was determined that the facility failed to ensure that its Hand Hygiene policy is implemented.

Findings include:

Reference #1: Facility policy titled Hand Hygiene IC 2002 states, "... 6.0 Procedure: HAND WASHING INDICATIONS When hands are visibly dirty or contaminated with proteinaceous material or are visibly soiled with blood or body fluids, wash hands with an antimicrobial soap and water. If hands are not visibly soiled, use an alcohol-based hand rub for routinely decontaminating hands in all other clinical situations. ... Before and after taking care of each patient. ... Before and after glove use."

Reference #2: Guideline for Hand Hygiene in Health Care Settings: Recommendation of the Healthcare Infection Control Practices Advisory Committee [HICPAC] and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force, published in the CDC (Centers for Disease Control and Prevention) Morbidity and Mortality Weekly Report at MMWR 2002; 51 (No. RR-16) page 32 states, "Recommendations: 1. Indications for Handwashing and Hand antisepsis ... C. Decontaminate hands before having direct contact with patients. ... E. Decontaminate hands before inserting ... peripheral vascular catheters, or other invasive devices ... F. Decontaminate hands after contact with a patient's intact skin ... G. Decontaminate hands after contact with ... a patient's nonintact skin ... I. Decontaminate hands after contact with inanimate objects ... in the immediate vicinity of the patient. J. Decontaminate hands after removing gloves."

1. During the entrance interview with Staff #6 at 10:30 AM on 7/7/15, he/she stated that the facility's Infection Control program follows OSHA, CDC, AAMI and AORN guidelines.

2. On 7/8/15 at 10:40 AM in Operating Room (O.R.) #8, Staff # 41 was observed to remove a pair of soiled gloves without sanitizing his/her hands.

a. This finding was confirmed with Staff #41.

3. On 7/8/15 in the pre-operative area, Staff #52 did not perform hand hygiene before having direct contact with Patient #3.

a. This finding was confirmed by Staff #61.

4. On 7/9/15, Unit 2 South was toured in the presence of Staff #5, #64, #65, and #66.

a. Staff #57 was observed drawing blood from Patient #5. Staff #57 performed multiple glove changes without sanitizing his/her hands.

5. On 7/8/15 at 11:30 AM Unit Regan 3 North was toured in the presence of Staff #2, #7, #8, and #29. Staff #62 was observed performing bedside point of care glucose monitoring without issue. Staff #62 cleaned the glucometer with a sani wipe and removed his/her gloves. There was not a readily available hand cleansing agent to immediately wash his/her hands after glove removal. Staff #62 proceeded to pack the glucometer within its hand carrying case, open a drawer to a standard isolation cart to place the sani wipes away, and proceed to the medication room to wash his/her hands.

a. Staff #29 pointed out that a hand based hand sanitizer dispenser was mounted at the nurses station, close in proximity, that Staff #62 could have used. The hand sanitizer was below the level of the waist and not readily observable.

C. Based on observation, staff interview and facility document review conducted on 7/7/15 to 7/8/15, it was determined that the facility failed to ensure that its own policy and OSHA (Occupational Health and Safety Administration) regulations on the transport of soiled instruments are implemented.

Findings include:

Reference #1: Facility policy titled, "Transportation of Insturments (sic) for Sterilization from Offsite" states, "Procedure: 1. Instruments requiring sterilization must be pre-cleaned and have gross soil and debris removed. ... 2. Precleaned instruments shall be placed in a plastic bag and contents labeled contaminated. Bag will be placed in a closed, leak and puncture proof container that can be sealed with a breakaway seal."

Reference #2: OSHA 29 CFR part 1910.1030(d)(2)(xiii) states, "Specimens of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling, processing, storage, transport, or shipping."

Reference #3: OSHA 29 CFR part 1910.1030(g)(1)(i)(A) states, "Warning labels shall be affixed to containers of regulated waste, refrigerators and freezers containing blood or other potentially infectious material; and other containers used to store, transport or ship blood or other potentially infectious materials ..."

1. During the entrance interview with Staff #6 at 10:30 AM on 7/7/15, he/she stated that the facility's Infection Control program follows OSHA, CDC, AAMI and AORN guidelines.

2. During a tour of the Operating Room (OR) on 7/8/15 at 10:25 AM, in the presence of Staff #25 and Staff #26, case cart #21 was used to transport soiled instruments and equipment from the OR to the Sterile Processing Department (SPD).

a. Case cart #21 was observed to be missing a door. The instruments and equipment in the case cart were not contained in a plastic bag and not labeled as contaminated, in accordance with the facility policy and OSHA regulations.

b. This finding was confirmed by Staff #25 and Staff #26.

3. During a tour of the Dental OMF (Oral and Maxillofacial) Surgery Department on 7/8/15 at 1:05 PM, in the presence of Staff #45 and Staff #46, the soiled dental instruments were observed to be placed in a clear plastic bag.

a. Staff #45 stated, "Blood is rinsed off the instruments, then the instruments are placed in clear plastic bag. We tie it up then it gets sent to Central."

b. The bag was not labeled as "contaminated" in accordance with the facility policy and OSHA regulations.

c. This finding was confirmed by Staff #45 and Staff #46.

4. During a tour of the Endoscopy Unit on 7/8/15 at 1:20 PM, in the presence of Staff #38 and Staff #47, the soiled equipment was observed transported in green plastic bags.

a. The bags were not labeled as "contaminated" in accordance with the facility policy and OSHA regulations.

b. This finding was confirmed by Staff #38 and Staff #47.

D. Based on observation, facility document review and staff interview conducted on 7/7/15 and 7/8/15, it was determined that the facility failed to ensure that a sanitary environment for the provision of surgical services is provided.

Findings include:

Reference: Facility policy titled, "Surgical/ Invasive Areas and Delivery Rooms- Between Cases" states, "Procedure ... Inspect the room ... Correct any deficiencies ... Inspection Standards ... Floor is clean and free of dust, debris, and body fluids. Table, equipment, furniture (sic) waste receptacles and fixtures are clean and free of dust, soil, and body fluids."

1. During a tour of Cardiothoracic OR #10 on 7/7/15 at 2:53 PM, in the presence of Staff #6, Staff #26, and Staff #32, the OR table was observed soiled with grayish stains at the base, and pieces of blue suture materials stuck within the wheel base of the table.

a. This finding was confirmed by Staff #6, Staff #26 and Staff #32.

2. On 7/8/15 at 10:45 AM, in the presence of Staff #25, Staff #42 and Staff #43, the floor under the OR table in OR #8 was observed with brownish stains.

a. This finding was confirmed with Staff #25, Staff #42 and Staff #43.

3. At 11:25 AM, in the presence of Staff #25, the "Level 1" stairwell was observed littered with papers and used gloves.

a. This finding was confirmed by Staff #25.

4. At 11:30 AM, in the presence of Staff #25, the hallway floor, in the Regan Building behind Rehab Medicine, was scuffed and stained.

a. This finding was confirmed by Staff #25.

5. At 11:32 AM, in the presence of Staff #25, several broken floor tiles were observed outside of Room #R1011.

a. This finding was confirmed by Staff #25.

6. During a tour of the Prep and Pack room of the SPD Department on 7/8/15 at 12:07 PM, in the presence of Staff #37, the floor was observed cracked and gouged throughout the room, starting from the front door to the end of the area that contained 6 (six) Sterrad sterilizers.

a. This finding was confirmed by Staff #37.

7. During a tour of the Dental OMF (Oral and Maxillofacial) Surgery Department Utility Room on 7/8/15 at 1:05 PM, in the presence of Staff #45 and Staff #46, the sink and counters were observed soiled with white residue.

a. Staff #45 stated that these were stains, and the sink and counters were cleaned after each decontamination procedure.

b. At 1:10 PM, Staff #45 demonstrated how the sink and counters were cleaned after each decontamination procedure.

c. At 1:12 PM, the white stains on the sink were removed after Staff #45 rinsed the sink with water.

d. This finding was confirmed with Staff #45 and Staff #46.

E. Based on observation, staff interview and facility document review conducted on 7/8/15, it was determined that the facility failed to ensure that reusable patient care equipment is cleaned in accordance with the manufacturer's Instructions for Use (IFU).

Findings include:

Reference #1: Facility document titled "Terminal Cleaning of Patient Care Equipment" states, "Procedure: ... 4. Refer to manufacturors (sic) instructions for cleaning."

Reference #2: Masimo LNC MP Series Patient Cables Directions For Use states, "Cleaning ... Clean the LNC MP Patient Cable by wiping it with 70% isopropyl alcohol pad and allow it to dry."

1. At 10:40 AM, Staff #44 was observed to clean the anesthesia equipment after a surgical procedure in OR #8.

a. Upon interview, Staff #44 stated that he/she uses PDI Super Sani wipes to clean all anesthesia equipment, including the Masimo LNC MP patient cable.

b. The manufacturer's IFU for the patient cables state that 70 % isopropyl alcohol should be used for cleaning.

c. The facility failed to implement its own policy for patient care equipment cleaning; ensuring that cleaning methods are in accordance with manufacturer's IFU.


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F. Based on observation on 7/9/15, it was determined that the facility failed to ensure that the rubber septum on all medication vials is disinfected with alcohol prior to piercing.

Findings:

Reference #1: Centers for Disease Control and Prevention (CDC) website <> titled 'FAQs Regarding Safe Practices for Medical Injections' states, "... 1. How should I draw up medications? ... Parenteral medications should be accessed in an aseptic manner. This includes using a new sterile syringe and sterile needle to draw up medications while preventing contact between the injection materials and the non-sterile environment. Proper hand hygiene should be performed before handling medications and the rubber septum should be disinfected with alcohol prior to piercing it."
1. On 7/9/15, Unit 2 South was toured in the presence of Staff #5, #64, #65, and #66.

a. Staff #58 was observed preparing an intravenous medication for Patient #7. Staff #58 did not disinfect the rubber septum with alcohol prior to piercing.