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A. Based on observation, facility policy review, and staff interviews conducted on 12/15/15 and 12/16/15, it was determined that the facility failed to ensure that its Hand Hygiene policy is implemented.

Findings include:

Reference #1: Facility policy titled 'Hand Washing and Hand Hygiene Administrative Policies & Procedures' states, "... C. Hand Washing/Hand Hygiene Indications ... 7. before and after touching wounds, whether surgical, traumatic or associated with an invasive device.(sic) 8. after situations during which microbial contamination of hands is likely to occur, especially those involving contact with mucous membranes, blood or body fluid secretions or excretions. (sic) 9. after touching inanimate sources that are likely to be contaminated with pathogenic microorganisms, such as urine measure devices or secretions collection devices. (sic) 10. after removing gloves ... D. Hand Hygiene Compliance ... 1. In accordance with the CDC Guidelines for Hand Hygiene, compliance with hand hygiene practices will be monitored."

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 on 12/15/15 at 9:55 AM, Staff #6 stated that the facility follows CDC, OSHA, AAMI and AORN guidelines for its Infection Control program.

2. On 12/16/15, during a tour of the Operating Room (OR) between 9:15 AM to 11:15 AM, in the presence of Staff #6, Staff #12, Staff #32, and Staff #46, the surgical team in both OR #4 and OR #5 were observed during surgery.

a. Throughout the surgical procedure in OR #4, Staff #31, Staff #33, Staff #45 and Staff #56 were observed touching the patient without sanitizing their hands before and after patient contact.

i. This finding was confirmed with Staff #6, Staff #12, Staff #32, and Staff #46.

b. Throughout the surgical procedure in OR #5, Staff #42, Staff #43, Staff #44 and Staff #55 were observed touching the patient without sanitizing their hands, before and after patient contact.

i. This finding was confirmed with Staff #6, Staff #12, Staff #32, and Staff #46.

c. Throughout the surgical procedure in OR #4, Staff #31, Staff #33, Staff #45 and Staff #56 were observed removing soiled gloves without sanitizing their hands.

i. This finding was confirmed with Staff #6, Staff #12, Staff #32, and Staff #46.

d. Throughout the surgical procedure in OR #5, Staff #42, Staff #43, Staff #44, and Staff #55 were observed to remove soiled gloves without sanitizing their hands.

i. This finding was confirmed with Staff #6, Staff #12, Staff #32, and Staff #46.

e. Throughout the surgical procedure in OR #4, Staff #31, Staff #33, Staff #45, and Staff #56 were observed touching furniture and objects in the immediate vicinity of the patient without, sanitizing their hands after.

i. This finding was confirmed with Staff #6, Staff #12, Staff #32, and Staff #46.

f. Throughout the surgical procedure in OR #5, Staff #42, Staff #43, Staff #44, and Staff #55 were observed touching furniture and objects in the immediate vicinity of the patient, without sanitizing their hands after.

i. This finding was confirmed with Staff #6, Staff #12, Staff #32, and Staff #46.

2. At 10:05 AM Staff #46 stated, "We do not keep hand sanitizers in the ORs."

a. This finding was confirmed with Staff #32.

3. On 12/16/15, during an observation in OR #4 in the presence of Staff #16, the following was observed:

a. Staff #30 picked up a piece of equipment from the OR floor and placed the equipment under the OR table. He/she did not sanitize his/her hands after. He/she proceeded to assist Staff #31 with donning his/her sterile gown.

b. Staff #30 picked up blood covered four by fours from a metal container on the OR floor. Staff #30 counted the four by fours, disposed of the four by fours, and removed his/her gloves. Staff #31 did not sanitize his/her hands after removing his/her gloves.

c. These findings were confirmed with Staff #16 and Staff #32.

4. The facility failed to ensure compliance to its Hand Hygiene policy in the OR.

B. Based on observation, facility policy review, and staff interview conducted on 12/16/15, it was determined that the facility failed to ensure that its Surgical Attire policy is implemented.

Findings include:

Reference #1: Facility Policy titled 'Surgical Attire in Operative Areas OR, Cath Lab, IR, Endovascular' states, "... I. Surgical Attire ... All reusable attire shall be laundered after each use, by a laundry facility approved and monitored by the hospital (including restricted area cover coats, skull caps, and other reusable attire). ... In restricted area (operating room), non-scrubbed personnel should wear long sleeved jackets that are buttoned or snapped close during use. ... V: All personnel entering the semi restricted and restricted areas of the surgical suite should confine or remove all jewelry (including necklaces, piercings, and watches)."

1. At 9:15 AM Staff #44 was observed to wear a reusable cloth cap and earrings that are not fully confined within the blue disposable bouffant hat he/she is wearing.

a. This finding was confirmed with Staff #6, Staff #12, Staff #32, and Staff #46.

2. At 10:02 AM Staff #46 stated that the cloth hats worn by OR personnel are laundered at home.

a. This finding was confirmed with Staff #6 and Staff #32.

3. During an observation in OR #4 in the presence of Staff #16, the following was observed:

a. Staff #31 was preparing Patient #1 for surgery. Staff #31 shaved an area of Patient #1's abdomen. Staff #31 was not wearing a long sleeved jacket.

b. This finding was confirmed with Staff #16 and #32.

4. The facility failed to ensure that its Infection Control policy on Surgical Attire is implemented.

Reference #2: AORN [Association of Peri-Operative Registered Nurses] Clinical FAQs https://www.aorn.org/clinicalfaqs/attire/# states, "Perioperative team members should wear scrub attire that covers the arms when opening sterile supplies. Wearing long-sleeved attire helps contain skin squames shed from bare arms. Opening sterile supplies onto the sterile field without wearing a long-sleeved jacket may allow skin squames from the perioperative team member's bare arms to drop onto the sterile field and may increase the patient's risk for an SSI."

1. Between 9:15 AM to 10:05 AM, in the presence of Staff #6, Staff #12, Staff #32, and Staff #46, the non-scrubbed surgical team members in OR #4 were observed not wearing long-sleeved jackets while opening sterile supplies before, and throughout the entire surgical procedure.

a. This finding was confirmed with Staff #6, Staff #12, Staff #32, and Staff #46.

2. Between 9:15 AM to 11:15 AM, in the presence of Staff #6, Staff #12, Staff #32, and Staff #46, the non-scrubbed surgical team members in OR #5 were observed not wearing long-sleeved jackets while opening sterile supplies before, and throughout the entire surgical procedure.

a. This finding was confirmed with Staff #6, Staff #12, Staff #32, and Staff #46.

3. The facility failed to ensure its Surgical Attire policy is implemented in the OR.

C. Based on observation and staff interview conducted on 12/15/15 and 12/16/15, it was determined that the facility failed to ensure the Infection Control guidelines it has selected for its Infection Control program are followed.

Findings include:

Reference: CDC Guideline for Prevention of Surgical Site Infection, 1999 states on page 268, "... 3. Postoperative incision care ... a. Protect with a sterile dressing for 24 to 48 hours postoperatively an incision that has been closed primarily. ... b. Wash hands before and after dressing changes and any contact with the surgical site."

1. During the entrance interview on 12/15/15 at 9:55 AM, Staff #6 stated that the facility follows CDC, OSHA, AAMI and AORN guidelines for its Infection Control program.

2. On 12/16/15, at the conclusion of surgery in OR #5 at 11:10 AM, the primarily closed surgical incision on the patient was observed to be without a wound dressing. The surgical team was observed to cover the wound with the patient's gown. After a few minutes, Staff #42 and Staff #43 were observed to apply a dressing on the surgical wound.

a. The primarily closed surgical incision was not protected with a sterile dressing, in accordance with CDC guidelines.

b. Staff #42 and Staff #43 did not sanitize their hands before and after contact with the surgical incision, in accordance with CDC guidelines.

3. The facility failed to ensure implementation of CDC guidelines for the prevention of surgical site infection.

D. Based on observation, facility document review and staff interview conducted on 12/16/15, it was determined that the facility failed to ensure compliance to OSHA regulations.

Findings include:

Reference: 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. On 12/16/15, during a tour of the Operating Room (OR) and Sterile Processing Department (SPD)between 9:15 AM to 11:15 AM, in the presence of Staff #6, Staff #12, Staff #32, and Staff #46, the dirty case carts were observed without an affixed biohazard label warning during transport to the SPD.

2. This finding was confirmed with Staff #6, Staff #12, Staff #32, and Staff #46 at 11:15 AM.

Reference #2: OSHA (Occupational Safety and Health Administration) 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."

1. At 10:00 AM, during the cleaning of OR #5, Staff #34 was observed removing a suction canister filled with reddish fluid from the case cart, then placing the canister on top of the case cart while transporting it to the Dirty Utility Room.

a. The suction ports of the canister top were observed unsealed.

i. Blood and body fluids were not contained within a leakproof container.

b. There was no biohazard label on the container.

2. This finding was confirmed with Staff #6, Staff #12, Staff #32, and Staff #46 at 11:15 AM.

Reference #3: OSHA 29 CFR 1910.1030 (d) (3) (i) states, "Provision. When there is occupational exposure, the employer shall provide, at no cost to the employee, appropriate personal protective equipment such as, but not limited to, gloves, gowns, laboratory coats, face shields or masks and eye protection ..."

1. At 10:00 AM, while transporting the fluid-filled suction canister on top of the dirty case cart, Staff #34 was observed not wearing a gown, face shield and eye protection.

a. The facility failed to ensure that all employees don appropriate personal protective equipment (PPE) as required by OSHA regulation.

2. The facility failed to ensure compliance to OSHA regulations.

3. This finding was confirmed with Staff #6 and Staff #46.

E. Based on observation and staff interview conducted on 12/15/15, 12/16/15 and 12/18/15, it was determined that the facility failed to ensure a sanitary environment.

Findings include:

1. On 12/15/15, during a tour of the Oncology Outpatient Infusion department in the presence of Staff #4, Staff #6, Staff #13, and Staff #41 at 2:30 PM, the wall in the Outpatient Infusion area contained sticky, yellowish residue and gouges on the plaster wall below the ABHR dispenser.

a. These surfaces cannot be adequately cleaned.

b. This finding was confirmed with Staff #6 and Staff #41.

2. On 12/15/15 during a tour of the Oncology Outpatient Infusion department in the presence of Staff #4, Staff #6, Staff #13, and Staff #41 at 2:30 PM, dirty linen was stored directly in front of the handwashing sink, blocking the sink access.

3. At 2:45 PM in the Oncology Radiation Therapy department Cyber Knife Room, in the presence of Staff #4, Staff #6, Staff #13, and Staff #27, dirty linen was stored directly in front of the handwashing sink, blocking the sink access.

a. A transfer board was stored on the floor.

c. These findings were confirmed with Staff #4, Staff #6, and Staff #13.

Reference: AAMI Sterilization in Health Care Facilities, 2014 edition ST 79 section 8.9.2 states, "Sterile items should be stored in a manner that reduces the potential for contamination."

1. On 12/15/15, a tour of the Oncology Radiation Therapy department was conducted in the presence of Staff #4, Staff #6, Staff #13, and Staff #27. The Oncology Radiation Therapy department is located adjacent to a construction site.

2. At 2:40 PM, in one of the patient rooms, a cabinet labeled 'Patient Gown' was observed to contain the following items: patient gowns, otoscope equipment, sterile nasal cannula tubing extensions, nitrile gloves, disposable vaginal speculums, extra linen curtains, and an electric fan that is coated with a layer of dust.

a. Sterile, clean, and dirty items were stored together and co-mingled.

b. Staff #28 stated, "This is a temporary set-up because of the construction."

c. This finding was confirmed with Staff #4, Staff #6, Staff #13, Staff #27 and Staff #28.

3. At 2:45 PM in the Oncology Radiation Therapy department Cyber Knife Room, in the presence of Staff #4, Staff #6, Staff #13, and Staff #27, foam positioning devices were observed.

a. Staff #57 stated that the foam positioning devices are used for multiple patients.

b. Foam is an uncleanable surface.

c. This finding was confirmed with Staff #4, Staff #6, Staff #13, Staff #27 and Staff #28.

4. At 2:50 PM in the Oncology Radiation Therapy department Cyber Knife Room, in the presence of Staff #4, Staff #6, Staff #13, and Staff #27, the storage cabinet shelving containing patient-specific positioning devices were observed to contain a layer of dust.

a. Staff #28 stated that the cabinet is not routinely cleaned.

b. This finding was confirmed with Staff #4, Staff #6, Staff #13, Staff #27 and Staff #28.

5. The facility failed to ensure a sanitary environment for the provision of invasive procedures in the Oncology Radiation Therapy department.

6. During a tour of the OR on 12/16/15 between 9:50 AM and 9:55 AM, the following observations were made in OR #4:

a. Valleylab electrosurgical unit (ESU) was observed to contain chipped and rusted surfaces.

i. These surfaces are uncleanable.

b. The green anesthesia chair was observed to contain white stains.

7. During a tour of 4 South on 12/18/15 at 10:45 AM, the following was observed:

a. Yellowish residues were observed on the door frame of Room #472.

b. The wall outside Room #472 contained black and gray stains.

8. The facility failed to ensure a clean and sanitary environment.



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F. Based on observation, 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 include:

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 12/18/15, during an observation of Patient #12 in ICU, the following was observed:

a. Staff #58 was observed performing a triple lumen catheter insertion. Staff #58 opened three vials of sterile saline to use during the procedure. Staff #58 did not disinfect the rubber septum with alcohol prior to piercing.

2. The above finding was confirmed with Staff #58.

Based on medical record review, review of facility documentation, and staff interview, it was determined that the facility failed to ensure that a list of home health agencies was available and presented to all patients requiring home health care upon discharge.

Findings include:

1. On 12/15/15, review of Medical Record #4 revealed the following:

a. Home Health Services were recommended for Patient #4 at a Multidisciplinary Team Conference on 12/14/15.

b. There is no evidence that Patient #4 was provided with a list of home health agencies.

c. There is no evidence that Patient #4 was provided with a choice of home health agencies.

d. Upon interview, Staff #21, Patient #4's Social Worker, was not aware that a list of home health agencies existed.

2. On 12/18/15, review of Medical Record #11 revealed the following:

a. Patient #11 was discharged home on 11/03/15 with home health services.

b. There is no evidence that Patient #11 was provided with a list of home health agencies.

c. There is no evidence that Patient #11 was provided with a choice of home health agencies.

3. These findings were confirmed with Staff #16, #25, and #37.