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200 HAWKINS DRIVE

IOWA CITY, IA 52242

No Description Available

Tag No.: A0442

Based on document review, observations, and staff interviews, the facility failed to protect all confidential information from unauthorized access in 5 of 29 out patient areas reviewed (Image Management, Digestive Disease Procedure Unit, PET CT, Bone Density Workroom, and Sleep Study).

The facility reported approximately 1000 ERCP (Endoscopic Retrograde Cholangio-Pancreatography - a diagnostic procedure used to examine diseases of the liver, bile ducts, and pancreas) procedures performed per year and approximately 10 Fluoroscopy (an x-ray procedure that produces visual examination of a part of the body or function of an organ) procedures performed per month in the Digestive Disease Procedures Unit.

The facility reported approximately 80 PET CT (Positron Emission Tomography and Computed Tomography - A specialized imaging technique to produce a three-dimensional colored image of those substances functioning within the body along with CT - an imaging technique that can reveal some soft-tissue and other structures of the body that can not be seen in conventional x-rays) procedures performed per day.

The facility reported approximately 150 Bone Density procedures performed per month.

The facility reported approximately 40 Sleep Study procedures performed per week.

Failure to secure medical records against unauthorized access could result in identity theft, theft of financial/insurance information, or unauthorized disclosure of personal medical information.

Findings include:

1. Review of facility policy/procedure titled "Confidentiality of Patient Information", dated July 10, 2012, found it stated, in part, ". . . No UIHC [University of Iowa Hospitals and Clinics] staff member will access patient data, either by means of the electronic medical record systems or the paper medical record, which is not required for the performance of his/her duties. All patient medical information, whether contained in the electronic medical record systems, the paper medical record, or obtained by any other means, must be treated as private and confidential. . . ."

2. An observation during a tour of the Image Management area on 12/12/12 at 3:50 PM, with Image Management Manager, revealed approximately 10 master file envelopes stored on an open shelving unit that contained confidential patient medical information.

During an interview on 12/12/12 at 3:50 PM, the Image Management Manager stated the master file envelopes contained confidential patient medical information and was available to housekeeping staff that cleaned the area two times per week, after imaging staff have left the area. The Image Management Manager further stated the housekeeping staff have a key to the Image Management area and can access the confidential patient information when Image Management staff were not in the area.

- An observation during a tour of the Digestive Diseases Procedure Unit on 12/20/12 at 8:30 AM, with the Digestive Diseases Clinic Nurse Manager, revealed a log book in the ERCP room, stored unsecured on top of a counter with patient names and procedures from 6/2012 to present (approximately 500 patient names).

- An observation during a tour of the Digestive Diseases Procedure Unit on 12/20/12 at 8:45 AM, with the Digestive Diseases Clinic Nurse Manager, revealed in the Fluoroscopy room a log book stored unsecured on top of a counter with patient names, date of birth, and procedures from January 2010 to present (approximately 340 patient names).

During an interview on 12/20/12 at 8:30 AM and 8:45 AM, the Digestive Diseases Clinic Nurse Manager stated the ERCP and Fluoroscopy log books are stored unsecured in the respective areas. The Digestive Diseases Clinic Nurse Manager further reported housekeeping staff accessed the ERCP and Fluoroscopy areas, to clean, after staff had left the area for the day.

- An observation during tour of the PET/CT area on 12/26/12 at 2:45 PM, with Medical Physicist B, revealed 1 binder stored unsecured in an unlocked cupboard in the preparation room that contained approximately 200 patient names and procedures for one year.

During an interview on 12/26/12 at 2:45 PM, Medical Physicist B stated the housekeeping staff accessed the PET/CT preparation room, to clean, after staff had left the area for the day. Medical Physicist B acknowledged the binder that contained confidential patient information was stored in an unlocked cupboard.

- An observation during tour of the Bone Density Workroom on 1/2/13 at 1:45 PM, with Staff R, Senior Imaging Technician, revealed unsecured confidential patient information stored as follows:

one month of papers that contained patient information stored in an open stack-type file container on a desk (approximately 150 patient's information)

Binders that contained patient information, from 1998 to present, stored in 4 - 30 inch open shelving unit and 4 - 36 inch open shelving unit.

During an interview on 1/2/13 at 1:45 PM, Staff R, Senior Imaging Technician, stated the housekeeping staff had their own key and accessed the Bone Density Workroom area, to clean, after staff had left the area for the day. Staff R acknowledged the binders contained confidential patient information were stored in an unlocked cupboard and available to housekeeping staff who did not have the need to know the confidential patient information.

- An observation during tour of the Sleep Study area on 1/7/13 at 2:15 PM, with the Sleep Lab Coordinator, revealed an unlocked 6 shelf cabinet in the utility room that contained patient information from 1/2003 - 8/2007.

During an interview on 1/7/13 at 2:15 PM, the Sleep Lab Coordinator acknowledged the patient information stored in an unlocked cabinet, in the utility room, was unsecured and available to housekeeping staff who cleaned the area after staff had left for the day. The Sleep Lab Coordinator further stated the utility room was locked with a keypad and housekeeping staff had the code to unlock the keypad to enter the utility room.

CONTENT OF RECORD: INFORMED CONSENT

Tag No.: A0466

Based on review of facility policies, medical records, and staff interviews, the facility staff failed to ensure patients and/or their representatives signed an informed consent for a hemodialysis procedure/treatment and/or CRRT (Continuous Renal Replacement Therapy) prior to receiving the treatment.

Failure to have a patient and/or their representative sign an informed consent could potentially allow a patient to receive a treatment without understanding risks and benefits of a hemodialysis or CRRT treatment and/or any alternative therapies available.

The hospital reported an inpatient hemodialysis census of 4 at the time of the survey. Findings for 4 of 4 inpatients (Patient #'s 1, 2, 3, and 4) and 2 of 2 patient's closed medical records reviewed (Patient #'s 5 and 6) that received hemodialysis and/or CRRT treatments without documentation of a signed informed consent include:

1. The hospital had a policy titled "ETHICS, RIGHTS, and RESPONSIBILITIES-PATIENT RIGHTS" Subject/Title "PROTOCOL FOR DOCUMENTATION OF INFORMED CONSENT", RJ-PR-05.07, Revision Date September 2010, which stated in part, "...Purpose...To provide an outline to ensure proper documentation of the information concerning the medical necessity, possible risks, and known alternatives provided to patients prior to the initiation of care...D. Major therapeutic and diagnostic interventions and procedures with known material risks..."

2. Review of the medical record for hemodialysis Patient #1 showed an order on 11/27/12 for a hemodialysis treatment/procedure to occur on 11/28//12. Review of the treatment flowsheet showed initiation of the hemodialysis treatment on 11/28/12 at 9:25 AM. Further review of the Patient's medical record failed to include an informed consent for a hemodialysis treatment signed by the Patient and/or patient representative prior to the hemodialysis treatment and failed to show documentation of discussion regarding the risks, benefits, alternatives, and consequences regarding hemodialysis.

- Review of the medical record for hemodialysis Patient #2 showed on 11/27/12 a hemodialysis treatment/procedure initiated at 3:50 AM. Further review of the Patient's medical record failed to include an informed consent for a hemodialysis treatment signed by the Patient and/or patient representative prior to the hemodialysis treatment and failed to show documentation of discussion regarding the risks, benefits, alternatives, and consequences regarding hemodialysis.

- Review of the medical record for Patient #3 showed an order on 12/4/12 for a CRRT treatment to occur on 12/4/12. Review of the treatment flowsheet showed initiation of the CRRT treatment on 12/4/12 at 1:14 PM. Further review of the Patient's medical record failed to include an informed consent for the CRRT treatment signed by the Patient and/or patient representative prior to the initiation of the CRRT treatment and failed to show documentation of discussion regarding the risks, benefits, alternatives, and consequences regarding CRRT.

- Review of the medical record for Patient #4 showed the patient admitted to the hospital on 12/3/12 and received hemodialysis on 12/4/12 at 2:55 PM. However, further review of the medical record failed to show documentation of informed consent to receive hemodialysis and failed to show documentation of discussion regarding the risks, benefits, alternatives, and consequences regarding hemodialysis.

- Review of the closed medical record for Patient #5 showed the patient admitted to the hospital on 12/2/12 and received a hemodialysis treatment on 12/4/12 at 2:30 PM. However, review of the medical record failed to show documentation of informed consent to receive hemodialysis and failed to show documentation of discussion regarding the risks, benefits, alternatives, and consequences regarding hemodialysis.

- Review of the closed medical record for Patient #6 showed the patient admitted to the hospital on 12/4/12 and received a hemodialysis treatment on 12/5/12 at 10:00 AM. However, review of the medical record failed to show documentation of informed consent to receive hemodialysis and failed to show documentation of discussion regarding the risks, benefits, alternatives, and consequences regarding hemodialysis.

3. During an interview on 12/6/12 at 11:30 AM, the Dialysis Nurse Manager reported the hospital considered hemodialysis treatments as a regular patient treatment and the hospital did not require the patient to sign an informed consent for a hemodialysis and/or CRRT treatment.

-During an interview on 12/10/12 at 3:40 PM with Advanced Practice Nurse and Dialysis Nurse Manager, both acknowledged that the hospital does not require a patient to sign an informed consent prior to receiving a hemodialysis and/or CRRT treatment. The Advanced Practice Nurse agreed the facility's policy lacked clarification concerning informed consent by a patient prior the initiation of a hemodialysis and/or CRRT treatment.

MAINTENANCE OF PHYSICAL PLANT

Tag No.: A0701

I. Based on observation, review of documentation, and staff interview, the facility failed to ensure current safety inspection of 1 of 1 steam sterilizers, used to sterilize all clinic instruments, in the only sterile processing area at the off-site location (Iowa River Landing). The facility reported approximately 4 loads of clinic instruments sterilized per day in the steam sterilizer.

Failure to ensure current safety inspections of the steam-sterilizer could potentially result in the sterilizer failing kill bacteria on clinic instruments and could result in infections to patients. In addition, the lack of safety inspection of the pressure vessel could potentially result in harm to the operator if the steam sterilizer would malfunction.

Findings include:

1. During tour of the sterile processing area on 12/27/12 at 11:45 AM, Staff Q, Central Sterile Supply, stated they were not aware of a boiler certificate for the one steam sterilizer and a certificate of current safety inspection could not be found.

2. During an interview on 1/8/13 at 3:30 PM, the Administrative Vice President for Compliance stated there was not a boiler certificate available to verify current safety inspection for the steam sterilizer at Iowa River Landing and the sterilizer had not been inspected since the clinic began sterilizing instruments on 10/12/12.


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II. Based on observations, document review, and staff interviews the facility failed to maintain hot water temperatures between 110 and 120 degrees Fahrenheit in patient care areas in 2 of 2 off site locations (Iowa River Landing, Institute of Orthopaedics, Sports Medicine, and Rehabilitation). The average monthly volume of patients at the 2 off sites was 11,200.

Failure to maintain water temperatures between 110 and 120 degrees Fahrenheit in patient care areas could potentially result in skin burns.

Findings include:

1. Observation on 12/27/12 at 8:20 AM, with the Iowa River Landing Nurse Manager, revealed the following water temperatures in patient exam rooms:

Exam room 4217 = 124.2 Fahrenheit
Exam room 4264 = 123.6 Fahrenheit
Exam room 3215 = 76.3 Fahrenheit

The Nurse Manager verified the water temperatures.

- Observation on 1/8/13 at 9:19 AM, with the Sports Medicine and Rehabilitation Nurse Manger, revealed the following water temperatures in patient exam rooms:

Exam room I-2 = 135.5 Fahrenheit
Exam room O-2 = 135 Fahrenheit
Exam room W-2 = 136.2 Fahrenheit
Exam room A-3 = 133.9 Fahrenheit

The Nurse Manager verified the water temperatures.

2. According to the Centers for Medicare and Medicaid Services, the acceptable range for water temperature in patient care areas is 110-120 degrees Fahrenheit.

3. Review of the Policy and Procedure titled, Water Supply/Testing, reviewed on 10/12, stated in part. The Manager of Maintenance/Engineering shall establish procedures to ensure that hot water in the University Hospitals and Clinics is temperature set in a range between 120 and 130 Fahrenheit.

4. During an interview on 12/27/12 Staff O, Area Mechanic for Iowa River Landing, at 8:20 AM, reported the hot water temperature was set at 120 Fahrenheit. A follow-up interview at 8:40 AM, with Staff O revealed staff turned the hot water temperature to 110 Fahrenheit.

An additional interview on 1/8/13 at 11:30 AM, the Director of Engineering Services verified that staff at the offsite clinics did not take hot water temperatures.

INFECTION CONTROL PROGRAM

Tag No.: A0749

I. Based on document review, observation, and staff interview, the facility failed to ensure staff performed hand hygiene, in accordance with facility policies and procedures during 16 observations of hand hygiene on 4 of 35 in patient units (Adult Bone Marrow Transplant, 2-JCP, 3-JCP, Intensive Care Unit). The facility identified a current patient census of 590 upon surveyor entrance.

Failure to perform adequate hand hygiene (washing hands or using an alcohol hand cleaner) could result in the spread of an infection between patients.

Findings include:

1. Observation on 12/4/12 beginning at 11:33 AM on the Adult Bone Marrow Transplant unit, 7 Roy Carver South, revealed RN S preparing to perform a stem cell transplant for Patient #12. During the observation, the Patient reported having undergone chemotherapy to prepare for this transplant. Later review of the Patient's medical record showed the Patient received a type of chemotherapy called d-PACE, a high dose chemotherapy that decreases cancer cells and allows stem cells to grow. The stem cells are harvested and frozen until ready to use. Patient #12 was in protective isolation in a private room for patients who need to be isolated because one of the most common side effects of this chemotherapy is risk of infection. Since chemotherapy decreased the patient's cancer cells, it usually also decreases antibodies the patient would need to fight any bacterial infection.

At 11:43 AM, RN S left the Patient's room with gloves on her hands, went into the hall, spoke with the Laboratory person thawing the stem cells, touched a table (a surface that potentially has infectious bacteria present) then returned to Patient #12's room. RN S, without removing the gloves applied hand sanitizer in the palm of her gloved hand and rubbed the hand sanitizer around both gloved hands. Without changing gloves, RN S continued to pick up an IV bag and connect it to the IV tubing without sanitizing the access hub (the place where the IV tubing connects to the bag). At 11:47 RN S left the Patient's room with the same gloves on, went into the medication room, touching the door to open it (a potentially contaminated surface) and returned to the Patient's room without changing gloves or sanitizing her hands. RN S then obtained the Patient's vital signs. At 11:55 AM, still with the same gloves on, RN S left the Patient's room, went to the Nurses' station, back to the Patient's room, applied hand sanitizer over the same gloves, received the bag of stem cells, used the computer (a surface that may potentially have infectious bacteria present) to scan the stem cells and the Patient's armband twice, attached the bag of stem cells to the IV tubing and opened the clamp to deliver the stem cells to the Patient.

- Observation on 12/4/12 beginning at 11:33 AM, on the Adult Bone Marrow Transplant unit, 7 Roy Carver South, revealed Laboratory Med Technician (MT) KK thawing stem cells for Patient #12's transplant. MT KK was wearing gloves while cleaning the machine used to thaw the stem cells. Without changing gloves or sanitizing hands, MT KK moved the garbage can, moved the computer, and plugged it into an outlet. MT KK continued, without changing gloves or sanitizing hands, to open 7 bottles of sterile water. After opening the first bottle, MT KK pulled the garbage closer to her workstation then, without changing gloves or sanitizing her hands, MT KK opened the rest of the sterile water bottles and poured the sterile water into the warming container of the machine. With the same gloves on MT KK took the empty bottles to the recycle container outside the unit in the soiled hold touching the doors with her gloved hands. MT KK removed the gloves upon return to the unit but did not wash her hands or use hand sanitizer prior to turning on the computer and plugging in the scanner. At 11:49 AM, MT KK, without washing or sanitizing her hands, donned clean gloves, put oven mitts over the gloves to remove the frozen stem cells from the container of liquid nitrogen then placed the stem cells in the warm water, removed the oven mitts, and manipulated the bag with her gloved hand. With the same gloves on, MT KK used the computer. At 12:10 PM, MT KK donned the oven mitt only and removed the second bag of stem cells from the liquid nitrogen. Without donning gloves, MT KK picked up the bag of stem cells and placed them in a bag. Without washing or sanitizing her hands, MT KK donned gloves and put the stem cells in the warm water then used the computer.

- Observation on 12/4/12 at 8:00 AM, on the Adult Bone Marrow Transplant unit, 7 Roy Carver South, revealed RN JJ passing Patient #13's medications who was in protective isolation and scheduled to receive an ATG (an immunosupressant) at 9:00 AM. After obtaining the mediations from the medication room on the unit, RN JJ entered the Patient's room, donned a gown, and applied hand sanitizer to the palm of her hand. RN JJ failed to rub the sanitizer between her fingers and nail beds as required by facility policy. RN JJ donned gloves, touched her hair, glasses, and nose just before putting the blood pressure cuff on the Patient. RN JJ picked up the pulse ox probe (a device applied to the finger that measures the amount of oxygen in the blood) off the floor and, without sanitizing, placed the probe on the Patient's finger.

- Observations on the Respiratory Specialty Care Unit 7 JCP 12/11/12 at 2:00 PM, revealed RN HH providing patient for Patient #13 who was in isolation for Vancomycin-resistant Enterococcus (VRE) in the urine.

VRE is a type of bacteria called enterococci that have developed resistance to many antibiotics especially Vancomycin. VRE, like many bacteria, can be spread from one person to another through casual contact or through contaminated objects. Most often, VRE is spread from the hands of a healthcare giver to a patient in a hospital or other health care setting.
Patient #13 was receiving Continuous Venovenous Hemodialysis (CVVHD) (a way to filter or clean toxins from a person ' s blood when their kidneys are not functioning). RN HH went to the dialysis machine, and removed the effluent (Effluent is the waste products removed from the blood, such as urea, creatinine, potassium, extra fluids, and may contain blood) bag from the machine. RN HH drained the effluent bag into the only sink in the patient's room. While the effluent bag was still draining, RN HH washed her hands in the sink contaminated by the effluent concurrently draining into the same sink. When RN HH washed her hands, she also failed to rub the soap into a lather for 15-seconds and wash all surfaces of her hands and nails as required by the facility's policy on hand hygiene. RN HH turned on the water, wet her hands, applied soap, and rinsed her hands all in less than 10-seconds.

During the same observation, a Fellow physician (A physician who enters a training program in a medical specialty after completing residency) was performing a procedure with a physician instructor. When the Fellow left the room, he removed his gown and gloves and placed them in the garbage, but failed to wash or sanitize his hands before leaving the Patient's room. Staff in the Patient's room did not stop the Fellow and request that he come back to sanitize hands; this surveyor did request the Fellow return and sanitize his hands before moving on to other rooms or tasks.

- Observations on the Respiratory Specialty Care Unit 12/11/12 at approximately 2:45 PM, revealed RN FF entered Patient #11's room to provide care .

Patient #11 was receiving Continuous Venovenous Hemodialysis (CVVHD) (a way to filter or clean toxins from a persons blood when their kidneys are not functioning). While RN FF was in the room, she put on gloves and changed the bag of dialysate (a solution used to help convey impurities from the blood through the filter and into the effluent). RN FF drained what was left in the bag of dialysate she had removed into the sink in the patient's room. As RN FF left the room, she removed her gloves, and washed her hands in the same sink she had used to drain the dialysate a few minutes earlier. RN FF used a potentially contaminated sink to wash her hands, and failed to follow the facility's policy on hand hygiene when she failed to wash the back of her hands and nail beds with soap and water and failed to wash for 15-seconds as required by the facility's policy on hand hygiene.

At 3:00 PM, RN FF went back into Patient 11's room to provide additional care. RN FF used alcohol based hand sanitizer when she entered the room. RN FF failed to rub the alcohol based hand sanitizer onto the back of her hands or nail beds, as required by the facility's policy on hand hygiene. RN FF went to the dialysis machine, and removed the effluent (Effluent is the waste products removed from the blood, such as urea, creatinine, potassium, extra fluids, and may contain blood) bag from the machine. RN FF drained the effluent bag into the sink in the patient's room. While the effluent bag was still draining, RN FF washed her hands in the sink contaminated by the effluent concurrently draining into the same sink. When RN FF washed her hands, she also failed to wash the back of her hands or her nail beds and failed to rub the soap into a lather for 15-seconds as required by the facility's policy on hand hygiene.

While RN FF was providing care to the patient, a resident physician entered the room, assessed the patient, spoke with the patient's spouse, and then left the room without washing his hands or using alcohol based hand rub.

During an interview on 12/11/12 at 3:10 PM, Assistant Nurse Manager GG said staff should wash their hands with soap for at least 30 seconds to 1 minute and should not wash their hands in the same sink where they drain the effluent. Assistant Nurse Manager GG said they should have a separate dedicated sink for draining contaminated fluids such as, the effluent. There was only 1 sink in the Patient's room.

- Observations during a tour on 12/5/12 at 2:00 PM on the 2-JCP Pediatric Unit revealed 2 of 2 Resident physicians (a physician who is undergoing advanced training in a specialty area of study) walked out of room 24-1, and failed to perform hand hygiene after leaving the room.

During an interview at the time of the observations, the Assistant Nurse Manager for 2-JCP stated all staff members exiting a room needed to perform hand hygiene when they left the room.

Review of the policy "HAND HYGIENE", revised 3/11, revealed in part, "Perform [hand hygiene] with an alcohol-based hand rub: 1. Before and after contact with patients and their environment, ... After removing gloves, because hands may be contaminated during or after glove removal."

- Observations on 12/11/12 at 9:00 AM, in the Medical Psychiatric Unit, revealed Registered Nurse (RN) X entered Patient #7's room, and administered Patient #7's morning medications. RN X washed her hands with soap and water prior to administering the medications. After administering the medications, RN A washed her hands again with soap and water. During both observations, RN X failed to wash the back of her hands and nail beds, as required by the facility's policy on hand hygiene.

- Observations on 12/6/12 at 8:20 AM, in the Bone Marrow Transplant Unit, revealed RN Y administering medications to a patient. RN Y used alcohol based hand sanitizer to cleanse her hands prior to administering the medications. When RN Y left the patient's room, she again used alcohol based hand sanitizer to cleanse her hands. During both observations RN Y failed to rub the alcohol based hand sanitizer onto the back of her hands and nail beds, as required by the facility's policy on hand hygiene.

- Observations on 12/6/12 at 8:35 AM, in the Bone Marrow Transplant Unit, revealed RN Z administering Patient #8's morning medications. Patient #8's morning medications included 2 Intravenous (directly into a vein) medications. RN Z used alcohol based hand sanitizer to cleanse her hands prior to administering the medications. When RN Z left Patient #8's room, she again used alcohol based hand sanitizer to cleanse her hands. During both observations RN Z failed to rub the alcohol based hand sanitizer onto the back of her hands and nail beds, as required by the facility's policy on hand hygiene.

- Observations on 12/6/12 at 9:55 AM, in the 3-JCP unit, revealed RN AA administering Patient #9's morning medications. RN AA used alcohol based hand sanitizer to cleanse her hands prior to administering the medications. When RN AA left the room, she again used alcohol based hand sanitizer to cleanse her hands. During both observations RN AA failed to rub the alcohol based hand sanitizer onto the back of her hands and nail beds, as required by the facility's policy on hand hygiene.

- Observations on 12/6/12 at approximately 10:05 AM, in the 3-JCP unit, revealed RN AA administering Patient #10's morning medications. RN AA used alcohol based hand sanitizer to cleanse her hands prior to administering the medications. When RN AA left the room, she again used alcohol based hand sanitizer to cleanse her hands. During both observations of RN AA failed to rub the alcohol based hand sanitizer onto the back of her hands and nail beds, as required by the facility's policy on hand hygiene.

- Observations on 12/5/12 at approximately 2:00 PM, in the 2-JCP unit, revealed Certified Nursing Assistant (CNA) BB cleaning a patient room after the patient was discharged. While CNA BB was cleaning the room, she received a message on her hospital issued cell phone. CNA BB reached into her pocket with the gloves she was wearing while cleaning the room, and picked up the cell phone. CNA BB read the message, and returned the phone to her pocket while wearing the dirty gloves she used to clean the room. CNA BB failed to cleanse her hands prior to, or after, using the cell phone. CNA BB also failed to follow the facility's policy on hand hygiene by failing to remove her gloves prior to using the cell phone, and then cleanse her hands prior to returning to a task involving soiled objects.

- Observations on 12/5/12 at 3:10 PM, in the 2-JCP unit, revealed Housekeeper CC was cleaning room 22 after a patient was discharged. After Housekeeper CC finished cleaning the room, she removed the gloves she was wearing, and cleansed her hands with alcohol based hand sanitizer. Housekeeper CC failed to rub the alcohol based hand sanitizer on the back of her hands and her nail beds, as required by the facility policy on hand hygiene.

- Observations on 12/5/12 at approximately 3:30 PM, in the 2-JCP unit, revealed a CNA entered room 31 (where the patient was on contact isolation protocols, which required staff to wash their hands after leaving the room and wear a disposable gown when they entered the room). The CNA provided care to the patient, and then left the room. After the CNA removed her gloves, she used alcohol based hand sanitizer. The CNA failed to rub the alcohol based hand sanitizer on the back of her hands and nail beds, as required by the facility's policy on hand hygiene.

- Observations on 12/5/12 at approximately 4:00 PM, in the 2-JCP unit, revealed RN DD entered room 2376, and drew blood from the patient. The patient in room 2376 required contact isolation protocols. RN DD wore gloves and a disposable gown. RN DD reached under her disposable gown, grabbed a pen from her pocket, labeled the blood specimen, and returned the potentially contaminated pen to her pocket. As RN DD left the room, she washed her hands. When RN DD washed her hands, she failed to wash the back of her hands and nail beds, as required by the facility's policy on hand hygiene.

- Observations on 12/5/12 at 4:40 PM, in the 2-JCP unit, revealed RN EE entered room 2367, and assessed the patient. After RN EE assessed the patient, she left the room, and used alcohol based hand sanitizer to cleanse her hands. When RN EE used the alcohol based hand sanitizer, she failed to rub the alcohol based hand sanitizer onto the back of her hands and nail beds, as required by the facility's policy on hand hygiene. While RN EE was assessing the patient, Physician C entered the room, and assessed the patient. When Physician C left the room, he used the alcohol based hand sanitizer to cleanse his hands. Physician C failed to rub the alcohol based hand sanitizer onto the back of his hands and nail beds, as required by the facility's policy on hand hygiene.


2. Review of the policy "HAND HYGIENE" revised 3/11, revealed in part.

Perform hand antisepsis with an alcohol-based hand rub before and after contact with patients and their environment. Before putting on sterile gloves, when inserting a central line, and before inserting indwelling urinary catheters, peripheral vascular catheters, or other invasive devices that do not require a surgical procedure. If moving from a contaminated body site to a clean body site during patient care. After removing gloves, because hands may be contaminated during or after glove removal.

Perform hand hygiene with plain soap and water or an antimicrobial soap and water when caring for any patient with diarrhea, hands are visibly dirty or contaminated with blood and/or body fluids, before eating, and after using the restroom.

Procedures for hand hygiene

When using alcohol based waterless hand rubs be sure hands are not dirty. If hands are dirty wash first. Apply a thumbnail-sized amount of alcohol based hand rub to hands. Spread gel or foam all over hands; pay attention to the palms, backside of hands, fingers, fingertips, between fingers, and nail beds. Rub the gel or foam into hands until dry (approximately 12-30 seconds). After many uses, the hand rub may cause hands to feel 'sticky', at this point, wash hands with soap and water.

When washing hands only use warm water, wet hands, use enough soap to achieve a rich lather, rub soap into a lather for at least 15 seconds. Rub all areas of the fingers including fingertips, nail beds, palms, back and sides of hands, rinse hands well and dry with paper towels.

II. Based on document review, observation, and staff interview, the facility failed to ensure staff correctly placed the chemical indicator in packages sterilized at the facility in 2 of 2 sterile processing areas (Main OR and Ambulatory Surgery Center). The facility identified an average of 77 surgical procedures performed per day in the Main Operating Rooms, and 31 surgical procedures performed per day in the Ambulatory Surgical Center.

Failure to place the chemical indicators in the recommended location could potentially result in a false positive reading for sterility, and staff could potentially use a contaminated instrument on a patient, potentially resulting in the patient developing an infection.

Findings include:

1. Review of the policy "Assembly and Packaging," revised 9/09, revealed in part, "A chemical indicator is placed in the center of all packs and instrument trays and [sic] the tray is then wrapped."

2. Review of the undated manufacturer's directions for the chemical indicators (a mechanical device to show steam penetrated into the package undergoing sterilization using steam for heat and pressure to kill all the bacteria on the tools) revealed in part, "Place a ... steam chemical indicator in each pack ... to be steam sterilized in an area determined to be the least accessible to steam penetration."

3. Observations revealed:

- on 12/12/12 at 3:10 PM in the Ambulatory Surgical Center (ASC) revealed Central Sterile Technician (CST) T placed surgical instruments (tools a surgeon used during a surgical procedure) in a shallow tray using a list on a sheet of paper for reference to ensure the tray contained all the required instruments. After CST T placed the surgical instruments in the tray, CST T reviewed the list of required instruments in the tray, folded the sheet of paper, taped a chemical indictor on the paper, and set the paper on top of the instruments. CST T then wrapped the tray and instruments in paper to protect the tray and instruments from contamination during the sterilization process.

- on 12/12/12 at 4:40 PM in the Main OR Central Sterilization Area revealed Central Sterile Supervisor (CSS) U reviewed the contents list of surgical instruments in the shallow instrument tray, and verified the tray contained all the required surgical instruments. CSS U folded the list of required surgical instruments in half, and taped a chemical indicator to the list. CSS U placed the sheets of paper with the chemical indicator on top of the surgical instruments, and wrapped the tray with a sheet of protective paper to protect the instruments from contamination during the sterilization process.

- On 12/12/12 at 1:54 PM, revealed Ambulatory Surgical Center (ASC) staff opened 2 of 2 steam-sterilized trays that contained surgical instruments. Each tray had a list of surgical instruments in the tray, and a chemical indicator taped to the paper. The sheets of paper sat on top of the surgical instruments, and the chemical indicator was sitting facing away from the surgical instruments. The ASC staff checked the chemical indicator showed the contents of the tray had experienced sterilizing conditions (sufficient steam heat and pressure to kill all the bacteria on the instruments) prior to using the instruments on a patient.

- on 12/13/12 at 1:00 PM revealed ASC staff opened a steam sterilized package labeled "ASC Minor OTO Tray #4", that contained multiple surgical instruments. When the ASC staff opened the package, observations revealed a folded list of surgical instruments was sitting on top of the surgical instruments, with a chemical indicator taped to the top of the papers. The ASC staff verified the chemical indicator showed the contents of the tray had experienced sterilizing conditions prior to using the instruments on a patient.

- On 12/13/12 at 10:20 AM, revealed the Main OR staff opened a steam-sterilized package labeled "Central Venous Tray," that contained multiple surgical instruments. When the Main OR staff opened the package, observations revealed a folded list of surgical instruments was sitting on top of the surgical instruments, with a chemical indicator taped to the top of the papers. The Main OR staff verified the chemical indicator showed the contents of the tray had experienced sterilizing conditions prior to using the instruments on a patient.

4. During an interview on 1/8/13 at 4:30 PM, the interim Nurse Manager of Surgical Services stated she previously discussed the practice of placing the chemical indicator on the sheets of papers in the steam-sterilized packages with the Central Sterile Processing staff. She stated she thought the Central Sterile Processing staff had stopped the practice of taping the chemical indicators on top of the paperwork. She thought the Central Sterile Processing staff was instead placing the chemical indicators next to the surgical instruments in the sterilized packages.


5. During an interview on 1/9/13 at 8:50 AM, the Associate Director of Central Sterile Services stated the Central Sterile Technicians had previously placed the chemical indicator on top of the instrument list, which sat on top of the surgical instruments. However, after the surveyor questioned the practice, the facility reviewed the procedure, and determined the Central Sterile Processing staff would place the chemical indicator next to the surgical instruments to better verify the steam actually penetrated to the surgical instruments in the area least accessible to the steam.


III. Based on document review, observation, and staff interview, the facility failed to ensure staff followed the manufacturer's directions for disinfecting liquids in 2 of 2 Operating Rooms (Main OR and ASC) when disinfecting surfaces. The facility identified an average of 77 surgical procedures per day in the Main OR and 31 surgical procedures per day in the ASC.

Failure to follow the manufacturer's directions could result in the staff failing to fully kill all bacteria on a surface, and potentially transfer the bacteria to a patient, causing an infection.

Findings include:

1. Review of the policy "CLEANING AND DISINFECTION OF PATIENT CARE EQUIPMENT, " revised 11/12, revealed in part, "Low-Level disinfection ... Always follow product label for use-dilution and use according to label recommendations.... The contact time for low-level disinfection of non-critical items ... may be up to 10 minutes. Follow the label instructions."

2. Review of the manufacturer's directions for Virex II 256, copyright 2010, revealed in part, "For disinfection, all surfaces must remain wet for 10 minutes."

3. Observations revealed:

- During a tour of the Main OR (Operating Rooms) on 12/12/12 at 11:15 AM Registered Nurse (RN) V assisted the staff to clean OR #16 after a patient's surgery. RN V used Virex II 256 solution (a solution used to kill bacteria) to clean the surgical bed. Immediately after RN V wiped down the surgical bed, and while the solution was still wet, she placed a pillow on the wet surface of the bed. RN V lifted the black foam padding on the surgical table, wiped the lower surface with Virex II 256, and immediately placed the foam padding back on the wet lower surface. When surgical services staff cleaned the floor in OR #16, they only allowed the floor to stay wet for approximately 4 minutes, and before it dried, surgical services staff brought equipment into the room for the next surgery.

- During a tour of the Ambulatory Surgical Center (ASC) on 12/12/12 at 1:45 PM surgical services staff cleaned OR #5 after a patient's surgical procedure finished. The staff cleaned the surgical table by wiping down the black foam pads on the table with Diversey Virex TB solution. The staff placed the black foam pads on the table while the solution was still wet, and failed to allow the solution to stay wet for 3 to10 minutes.


- During a tour of the Main OR on 12/13/12 at 9:30 AM in OR #4 Anesthesia Technician II wiped down the anesthesia machine with Virex II 256 solution. The Anesthesia Technician II wiped down the anesthesia machine's tray, and immediately placed a tube holder, clamps, and tape on the tray while the solution was still wet. At 9:35 AM, the Main OR Advanced Practice Nurse wiped down all of the surgical table's 5 black foam pads with Virex II 256, and immediately set the foam pads on the table while the Virex was still wet.

- during a tour of the Main OR on 12/13/12 at 9:50 AM in OR #2 the Main OR Advanced Practice Nurse wiped down all of the surgical table's 5 black foam pads, immediately placed them on the surgical table before the pad had dried, and she failed to allow the solution to say wet for 10 minutes as required by the manufacturer.

- during a tour of the ASC on 12/13/12 at 1:00 PM in OR #8 revealed Certified Nurses' Aide (CNA) W wiped down the surgical table's black foam pads and arm boards with Diversey Virex TB solution. The solution stayed wet for approximately 20 seconds. CNA W wiped down the pillows, placed the pillows on the surgical table immediately after wiping them down, and while the solution was still wet.

4. During an interview at the time of the 12/13/12 at 1:00 PM observations, the Medical Director of the ASC, who was present during the observations, stated he trained the staff the Diversey Virex TB solution needed to stay wet for 3 minutes. The Medical Director acknowledged the solution did not normally stay wet for 3 minutes, and the staff didn't place additional solution to keep the surface wet for 3 minutes.


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IV. Based on observation, document review and staff interviews, the hospital dietary staff failed to maintain sanitary practices during meal service. The Senior Associate Director of Director of Patient Services reported dietary staff provided approximately 1200 patient meals daily.

Failure to maintain sanitary practices during meal service could potentially result in food contamination, including but not limited to, foodborne illness.

Findings include:

1. Observation of meal service on 12/4/12 from 12:00 PM to 12:25 PM, showed Staff B, cook, Staff C, cook and Staff D, food worker were stationed on the hot end of the production side of patient meal service. Observed the staff handle a variety of equipment with gloved hands, including but not limited to, a cooking timer, serving utensils, plates, plate covers, tray tickets and equipment handles (microwave, oven, refrigerator, freezer, etc) in addition to multiple food items, including but not limited to, hamburger and hot dog buns, sliced turkey, sliced cheese, grilled chicken breast, sliced bread, turkey sausage links, french fries, hamburger patties, grilled sandwiches and single serve cans. Observation showed Staff C removed gloves once after handling turkey slices but failed to wash hands before donning clean gloves. Staff B and Staff C wore the same pair of gloves during the entire observation period. During the same observation period, Staff E and Staff F, food workers, were stationed on the cold end of the production side. Staff E and Staff F wore the same pair of gloves during the entire observation period and repeatedly opened refrigerator units to obtain containers of various food items and handle multiple food items with gloved hands, including but not limited to, sliced bread, sliced cheese, lettuce, pickles, onions, ham and turkey slices.

2. Observation of meal service on 12/5/12 from 7:50 AM to 8:20 AM, showed Staff B, Staff C, Staff F and Staff H, cook, were stationed on the hot end of the production side of patient meal service. In addition, Staff G, a foodservice supervisor, assisted the front line staff. Observed the staff handle a variety of equipment with gloved hands, including but not limited to, serving utensils, plates, plate covers, tray tickets and equipment handles (microwave, oven, refrigerator, freezer, etc) in addition to multiple food items, including but not limited to, bacon, pancakes, french toast, cheese, omelets, english muffins, cheese, bread, lettuce tomatoes and sliced ham. At 8:05 AM, observed Staff G remove gloves and don a clean pair, but failed to perform hand hygiene in between the change. At 8:10 AM, observed Staff F remove gloves and don a fresh pair, but failed to perform hand hygiene in between the change. At 8:15 AM, observed Staff B leave the area and return with 2 packages of plastic lids. Staff B failed to remove his gloves and perform hand hygiene before returning to meal service and continued to handle food and equipment with the same pair of gloves. At 8:17 AM, observed Staff B remove the lid from his drink cup, refill the cup, replace the lid (with a straw), rub his nose with one hand and return to the meal service with the same pair of gloves. Observed Staff B touch his apron with gloved hands multiple times throughout the observation period. Staff B and Staff C wore the same pair of gloves throughout the entire observation period.

During an interview on 12/5/12 at 8:19 AM, Staff B reported he was trained to wear gloves during meal service and would often wear two pairs of gloves, which helped provide extra protection when handling the hot plates and then if he had to handled something like raw meat, he could remove one pair and still have a pair on. Staff B further reported is was not necessary to wash his hands when putting on a new pair of gloves.

During an interview on 12/5/12 at 8:50 AM, Staff F reported she was trained to wear gloves all the time and needed to change them when she changed jobs, for example if she made a sandwich then her gloves needed to be changed before starting a new task. Staff F further reported that it was not necessary to wash her hands when putting on a new pair of gloves.

During an interview on 12/5/12 at 2:00 PM, Staff J food service supervisor, reported dietary staff are trained to wear gloves while working in the meal service area and to wash their hands before beginning work. He further reported staff are trained to change gloves when moving to a different job, for example if they move from the grill to a different area, gloves need to be changed.

During an interview on 12/5/12 at 2:10 PM, Staff K food service supervisor, reported new dietary staff are trained to wash their hands at the start of work, wear gloves at all times and change gloves when they touch something that is not clean. He further reported staff use the clear plastic gloves to handle raw meat and can put them over the blue gloves, then remove the clear ones when soiled and continue to work.

During an interview

No Description Available

Tag No.: A0442

Based on document review, observations, and staff interviews, the facility failed to protect all confidential information from unauthorized access in 5 of 29 out patient areas reviewed (Image Management, Digestive Disease Procedure Unit, PET CT, Bone Density Workroom, and Sleep Study).

The facility reported approximately 1000 ERCP (Endoscopic Retrograde Cholangio-Pancreatography - a diagnostic procedure used to examine diseases of the liver, bile ducts, and pancreas) procedures performed per year and approximately 10 Fluoroscopy (an x-ray procedure that produces visual examination of a part of the body or function of an organ) procedures performed per month in the Digestive Disease Procedures Unit.

The facility reported approximately 80 PET CT (Positron Emission Tomography and Computed Tomography - A specialized imaging technique to produce a three-dimensional colored image of those substances functioning within the body along with CT - an imaging technique that can reveal some soft-tissue and other structures of the body that can not be seen in conventional x-rays) procedures performed per day.

The facility reported approximately 150 Bone Density procedures performed per month.

The facility reported approximately 40 Sleep Study procedures performed per week.

Failure to secure medical records against unauthorized access could result in identity theft, theft of financial/insurance information, or unauthorized disclosure of personal medical information.

Findings include:

1. Review of facility policy/procedure titled "Confidentiality of Patient Information", dated July 10, 2012, found it stated, in part, ". . . No UIHC [University of Iowa Hospitals and Clinics] staff member will access patient data, either by means of the electronic medical record systems or the paper medical record, which is not required for the performance of his/her duties. All patient medical information, whether contained in the electronic medical record systems, the paper medical record, or obtained by any other means, must be treated as private and confidential. . . ."

2. An observation during a tour of the Image Management area on 12/12/12 at 3:50 PM, with Image Management Manager, revealed approximately 10 master file envelopes stored on an open shelving unit that contained confidential patient medical information.

During an interview on 12/12/12 at 3:50 PM, the Image Management Manager stated the master file envelopes contained confidential patient medical information and was available to housekeeping staff that cleaned the area two times per week, after imaging staff have left the area. The Image Management Manager further stated the housekeeping staff have a key to the Image Management area and can access the confidential patient information when Image Management staff were not in the area.

- An observation during a tour of the Digestive Diseases Procedure Unit on 12/20/12 at 8:30 AM, with the Digestive Diseases Clinic Nurse Manager, revealed a log book in the ERCP room, stored unsecured on top of a counter with patient names and procedures from 6/2012 to present (approximately 500 patient names).

- An observation during a tour of the Digestive Diseases Procedure Unit on 12/20/12 at 8:45 AM, with the Digestive Diseases Clinic Nurse Manager, revealed in the Fluoroscopy room a log book stored unsecured on top of a counter with patient names, date of birth, and procedures from January 2010 to present (approximately 340 patient names).

During an interview on 12/20/12 at 8:30 AM and 8:45 AM, the Digestive Diseases Clinic Nurse Manager stated the ERCP and Fluoroscopy log books are stored unsecured in the respective areas. The Digestive Diseases Clinic Nurse Manager further reported housekeeping staff accessed the ERCP and Fluoroscopy areas, to clean, after staff had left the area for the day.

- An observation during tour of the PET/CT area on 12/26/12 at 2:45 PM, with Medical Physicist B, revealed 1 binder stored unsecured in an unlocked cupboard in the preparation room that contained approximately 200 patient names and procedures for one year.

During an interview on 12/26/12 at 2:45 PM, Medical Physicist B stated the housekeeping staff accessed the PET/CT preparation room, to clean, after staff had left the area for the day. Medical Physicist B acknowledged the binder that contained confidential patient information was stored in an unlocked cupboard.

- An observation during tour of the Bone Density Workroom on 1/2/13 at 1:45 PM, with Staff R, Senior Imaging Technician, revealed unsecured confidential patient information stored as follows:

one month of papers that contained patient information stored in an open stack-type file container on a desk (approximately 150 patient's information)

Binders that contained patient information, from 1998 to present, stored in 4 - 30 inch open shelving unit and 4 - 36 inch open shelving unit.

During an interview on 1/2/13 at 1:45 PM, Staff R, Senior Imaging Technician, stated the housekeeping staff had their own key and accessed the Bone Density Workroom area, to clean, after staff had left the area for the day. Staff R acknowledged the binders contained confidential patient information were stored in an unlocked cupboard and available to housekeeping staff who did not have the need to know the confidential patient information.

- An observation during tour of the Sleep Study area on 1/7/13 at 2:15 PM, with the Sleep Lab Coordinator, revealed an unlocked 6 shelf cabinet in the utility room that contained patient information from 1/2003 - 8/2007.

During an interview on 1/7/13 at 2:15 PM, the Sleep Lab Coordinator acknowledged the patient information stored in an unlocked cabinet, in the utility room, was unsecured and available to housekeeping staff who cleaned the area after staff had left for the day. The Sleep Lab Coordinator further stated the utility room was locked with a keypad and housekeeping staff had the code to unlock the keypad to enter the utility room.

CONTENT OF RECORD: INFORMED CONSENT

Tag No.: A0466

Based on review of facility policies, medical records, and staff interviews, the facility staff failed to ensure patients and/or their representatives signed an informed consent for a hemodialysis procedure/treatment and/or CRRT (Continuous Renal Replacement Therapy) prior to receiving the treatment.

Failure to have a patient and/or their representative sign an informed consent could potentially allow a patient to receive a treatment without understanding risks and benefits of a hemodialysis or CRRT treatment and/or any alternative therapies available.

The hospital reported an inpatient hemodialysis census of 4 at the time of the survey. Findings for 4 of 4 inpatients (Patient #'s 1, 2, 3, and 4) and 2 of 2 patient's closed medical records reviewed (Patient #'s 5 and 6) that received hemodialysis and/or CRRT treatments without documentation of a signed informed consent include:

1. The hospital had a policy titled "ETHICS, RIGHTS, and RESPONSIBILITIES-PATIENT RIGHTS" Subject/Title "PROTOCOL FOR DOCUMENTATION OF INFORMED CONSENT", RJ-PR-05.07, Revision Date September 2010, which stated in part, "...Purpose...To provide an outline to ensure proper documentation of the information concerning the medical necessity, possible risks, and known alternatives provided to patients prior to the initiation of care...D. Major therapeutic and diagnostic interventions and procedures with known material risks..."

2. Review of the medical record for hemodialysis Patient #1 showed an order on 11/27/12 for a hemodialysis treatment/procedure to occur on 11/28//12. Review of the treatment flowsheet showed initiation of the hemodialysis treatment on 11/28/12 at 9:25 AM. Further review of the Patient's medical record failed to include an informed consent for a hemodialysis treatment signed by the Patient and/or patient representative prior to the hemodialysis treatment and failed to show documentation of discussion regarding the risks, benefits, alternatives, and consequences regarding hemodialysis.

- Review of the medical record for hemodialysis Patient #2 showed on 11/27/12 a hemodialysis treatment/procedure initiated at 3:50 AM. Further review of the Patient's medical record failed to include an informed consent for a hemodialysis treatment signed by the Patient and/or patient representative prior to the hemodialysis treatment and failed to show documentation of discussion regarding the risks, benefits, alternatives, and consequences regarding hemodialysis.

- Review of the medical record for Patient #3 showed an order on 12/4/12 for a CRRT treatment to occur on 12/4/12. Review of the treatment flowsheet showed initiation of the CRRT treatment on 12/4/12 at 1:14 PM. Further review of the Patient's medical record failed to include an informed consent for the CRRT treatment signed by the Patient and/or patient representative prior to the initiation of the CRRT treatment and failed to show documentation of discussion regarding the risks, benefits, alternatives, and consequences regarding CRRT.

- Review of the medical record for Patient #4 showed the patient admitted to the hospital on 12/3/12 and received hemodialysis on 12/4/12 at 2:55 PM. However, further review of the medical record failed to show documentation of informed consent to receive hemodialysis and failed to show documentation of discussion regarding the risks, benefits, alternatives, and consequences regarding hemodialysis.

- Review of the closed medical record for Patient #5 showed the patient admitted to the hospital on 12/2/12 and received a hemodialysis treatment on 12/4/12 at 2:30 PM. However, review of the medical record failed to show documentation of informed consent to receive hemodialysis and failed to show documentation of discussion regarding the risks, benefits, alternatives, and consequences regarding hemodialysis.

- Review of the closed medical record for Patient #6 showed the patient admitted to the hospital on 12/4/12 and received a hemodialysis treatment on 12/5/12 at 10:00 AM. However, review of the medical record failed to show documentation of informed consent to receive hemodialysis and failed to show documentation of discussion regarding the risks, benefits, alternatives, and consequences regarding hemodialysis.

3. During an interview on 12/6/12 at 11:30 AM, the Dialysis Nurse Manager reported the hospital considered hemodialysis treatments as a regular patient treatment and the hospital did not require the patient to sign an informed consent for a hemodialysis and/or CRRT treatment.

-During an interview on 12/10/12 at 3:40 PM with Advanced Practice Nurse and Dialysis Nurse Manager, both acknowledged that the hospital does not require a patient to sign an informed consent prior to receiving a hemodialysis and/or CRRT treatment. The Advanced Practice Nurse agreed the facility's policy lacked clarification concerning informed consent by a patient prior the initiation of a hemodialysis and/or CRRT treatment.

MAINTENANCE OF PHYSICAL PLANT

Tag No.: A0701

I. Based on observation, review of documentation, and staff interview, the facility failed to ensure current safety inspection of 1 of 1 steam sterilizers, used to sterilize all clinic instruments, in the only sterile processing area at the off-site location (Iowa River Landing). The facility reported approximately 4 loads of clinic instruments sterilized per day in the steam sterilizer.

Failure to ensure current safety inspections of the steam-sterilizer could potentially result in the sterilizer failing kill bacteria on clinic instruments and could result in infections to patients. In addition, the lack of safety inspection of the pressure vessel could potentially result in harm to the operator if the steam sterilizer would malfunction.

Findings include:

1. During tour of the sterile processing area on 12/27/12 at 11:45 AM, Staff Q, Central Sterile Supply, stated they were not aware of a boiler certificate for the one steam sterilizer and a certificate of current safety inspection could not be found.

2. During an interview on 1/8/13 at 3:30 PM, the Administrative Vice President for Compliance stated there was not a boiler certificate available to verify current safety inspection for the steam sterilizer at Iowa River Landing and the sterilizer had not been inspected since the clinic began sterilizing instruments on 10/12/12.


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II. Based on observations, document review, and staff interviews the facility failed to maintain hot water temperatures between 110 and 120 degrees Fahrenheit in patient care areas in 2 of 2 off site locations (Iowa River Landing, Institute of Orthopaedics, Sports Medicine, and Rehabilitation). The average monthly volume of patients at the 2 off sites was 11,200.

Failure to maintain water temperatures between 110 and 120 degrees Fahrenheit in patient care areas could potentially result in skin burns.

Findings include:

1. Observation on 12/27/12 at 8:20 AM, with the Iowa River Landing Nurse Manager, revealed the following water temperatures in patient exam rooms:

Exam room 4217 = 124.2 Fahrenheit
Exam room 4264 = 123.6 Fahrenheit
Exam room 3215 = 76.3 Fahrenheit

The Nurse Manager verified the water temperatures.

- Observation on 1/8/13 at 9:19 AM, with the Sports Medicine and Rehabilitation Nurse Manger, revealed the following water temperatures in patient exam rooms:

Exam room I-2 = 135.5 Fahrenheit
Exam room O-2 = 135 Fahrenheit
Exam room W-2 = 136.2 Fahrenheit
Exam room A-3 = 133.9 Fahrenheit

The Nurse Manager verified the water temperatures.

2. According to the Centers for Medicare and Medicaid Services, the acceptable range for water temperature in patient care areas is 110-120 degrees Fahrenheit.

3. Review of the Policy and Procedure titled, Water Supply/Testing, reviewed on 10/12, stated in part. The Manager of Maintenance/Engineering shall establish procedures to ensure that hot water in the University Hospitals and Clinics is temperature set in a range between 120 and 130 Fahrenheit.

4. During an interview on 12/27/12 Staff O, Area Mechanic for Iowa River Landing, at 8:20 AM, reported the hot water temperature was set at 120 Fahrenheit. A follow-up interview at 8:40 AM, with Staff O revealed staff turned the hot water temperature to 110 Fahrenheit.

An additional interview on 1/8/13 at 11:30 AM, the Director of Engineering Services verified that staff at the offsite clinics did not take hot water temperatures.

INFECTION CONTROL PROGRAM

Tag No.: A0749

I. Based on document review, observation, and staff interview, the facility failed to ensure staff performed hand hygiene, in accordance with facility policies and procedures during 16 observations of hand hygiene on 4 of 35 in patient units (Adult Bone Marrow Transplant, 2-JCP, 3-JCP, Intensive Care Unit). The facility identified a current patient census of 590 upon surveyor entrance.

Failure to perform adequate hand hygiene (washing hands or using an alcohol hand cleaner) could result in the spread of an infection between patients.

Findings include:

1. Observation on 12/4/12 beginning at 11:33 AM on the Adult Bone Marrow Transplant unit, 7 Roy Carver South, revealed RN S preparing to perform a stem cell transplant for Patient #12. During the observation, the Patient reported having undergone chemotherapy to prepare for this transplant. Later review of the Patient's medical record showed the Patient received a type of chemotherapy called d-PACE, a high dose chemotherapy that decreases cancer cells and allows stem cells to grow. The stem cells are harvested and frozen until ready to use. Patient #12 was in protective isolation in a private room for patients who need to be isolated because one of the most common side effects of this chemotherapy is risk of infection. Since chemotherapy decreased the patient's cancer cells, it usually also decreases antibodies the patient would need to fight any bacterial infection.

At 11:43 AM, RN S left the Patient's room with gloves on her hands, went into the hall, spoke with the Laboratory person thawing the stem cells, touched a table (a surface that potentially has infectious bacteria present) then returned to Patient #12's room. RN S, without removing the gloves applied hand sanitizer in the palm of her gloved hand and rubbed the hand sanitizer around both gloved hands. Without changing gloves, RN S continued to pick up an IV bag and connect it to the IV tubing without sanitizing the access hub (the place where the IV tubing connects to the bag). At 11:47 RN S left the Patient's room with the same gloves on, went into the medication room, touching the door to open it (a potentially contaminated surface) and returned to the Patient's room without changing gloves or sanitizing her hands. RN S then obtained the Patient's vital signs. At 11:55 AM, still with the same gloves on, RN S left the Patient's room, went to the Nurses' station, back to the Patient's room, applied hand sanitizer over the same gloves, received the bag of stem cells, used the computer (a surface that may potentially have infectious bacteria present) to scan the stem cells and the Patient's armband twice, attached the bag of stem cells to the IV tubing and opened the clamp to deliver the stem cells to the Patient.

- Observation on 12/4/12 beginning at 11:33 AM, on the Adult Bone Marrow Transplant unit, 7 Roy Carver South, revealed Laboratory Med Technician (MT) KK thawing stem cells for Patient #12's transplant. MT KK was wearing gloves while cleaning the machine used to thaw the stem cells. Without changing gloves or sanitizing hands, MT KK moved the garbage can, moved the computer, and plugged it into an outlet. MT KK continued, without changing gloves or sanitizing hands, to open 7 bottles of sterile water. After opening the first bottle, MT KK pulled the garbage closer to her workstation then, without changing gloves or sanitizing her hands, MT KK opened the rest of the sterile water bottles and poured the sterile water into the warming container of the machine. With the same gloves on MT KK took the empty bottles to the recycle container outside the unit in the soiled hold touching the doors with her gloved hands. MT KK removed the gloves upon return to the unit but did not wash her hands or use hand sanitizer prior to turning on the computer and plugging in the scanner. At 11:49 AM, MT KK, without washing or sanitizing her hands, donned clean gloves, put oven mitts over the gloves to remove the frozen stem cells from the container of liquid nitrogen then placed the stem cells in the warm water, removed the oven mitts, and manipulated the bag with her gloved hand. With the same gloves on, MT KK used the computer. At 12:10 PM, MT KK donned the oven mitt only and removed the second bag of stem cells from the liquid nitrogen. Without donning gloves, MT KK picked up the bag of stem cells and placed them in a bag. Without washing or sanitizing her hands, MT KK donned gloves and put the stem cells in the warm water then used the computer.

- Observation on 12/4/12 at 8:00 AM, on the Adult Bone Marrow Transplant unit, 7 Roy Carver South, revealed RN JJ passing Patient #13's medications who was in protective isolation and scheduled to receive an ATG (an immunosupressant) at 9:00 AM. After obtaining the mediations from the medication room on the unit, RN JJ entered the Patient's room, donned a gown, and applied hand sanitizer to the palm of her hand. RN JJ failed to rub the sanitizer between her fingers and nail beds as required by facility policy. RN JJ donned gloves, touched her hair, glasses, and nose just before putting the blood pressure cuff on the Patient. RN JJ picked up the pulse ox probe (a device applied to the finger that measures the amount of oxygen in the blood) off the floor and, without sanitizing, placed the probe on the Patient's finger.

- Observations on the Respiratory Specialty Care Unit 7 JCP 12/11/12 at 2:00 PM, revealed RN HH providing patient for Patient #13 who was in isolation for Vancomycin-resistant Enterococcus (VRE) in the urine.

VRE is a type of bacteria called enterococci that have developed resistance to many antibiotics especially Vancomycin. VRE, like many bacteria, can be spread from one person to another through casual contact or through contaminated objects. Most often, VRE is spread from the hands of a healthcare giver to a patient in a hospital or other health care setting.
Patient #13 was receiving Continuous Venovenous Hemodialysis (CVVHD) (a way to filter or clean toxins from a person ' s blood when their kidneys are not functioning). RN HH went to the dialysis machine, and removed the effluent (Effluent is the waste products removed from the blood, such as urea, creatinine, potassium, extra fluids, and may contain blood) bag from the machine. RN HH drained the effluent bag into the only sink in the patient's room. While the effluent bag was still draining, RN HH washed her hands in the sink contaminated by the effluent concurrently draining into the same sink. When RN HH washed her hands, she also failed to rub the soap into a lather for 15-seconds and wash all surfaces of her hands and nails as required by the facility's policy on hand hygiene. RN HH turned on the water, wet her hands, applied soap, and rinsed her hands all in less than 10-seconds.

During the same observation, a Fellow physician (A physician who enters a training program in a medical specialty after completing residency) was performing a procedure with a physician instructor. When the Fellow left the room, he removed his gown and gloves and placed them in the garbage, but failed to wash or sanitize his hands before leaving the Patient's room. Staff in the Patient's room did not stop the Fellow and request that he come back to sanitize hands; this surveyor did request the Fellow return and sanitize his hands before moving on to other rooms or tasks.

- Observations on the Respiratory Specialty Care Unit 12/11/12 at approximately 2:45 PM, revealed RN FF entered Patient #11's room to provide care .

Patient #11 was receiving Continuous Venovenous Hemodialysis (CVVHD) (a way to filter or clean toxins from a persons blood when their kidneys are not functioning). While RN FF was in the room, she put on gloves and changed the bag of dialysate (a solution used to help convey impurities from the blood through the filter and into the effluent). RN FF drained what was left in the bag of dialysate she had removed into the sink in the patient's room. As RN FF left the room, she removed her gloves, and washed her hands in the same sink she had used to drain the dialysate a few minutes earlier. RN FF used a potentially contaminated sink to wash her hands, and failed to follow the facility's policy on hand hygiene when she failed to wash the back of her hands and nail beds with soap and water and failed to wash for 15-seconds as required by the facility's policy on hand hygiene.

At 3:00 PM, RN FF went back into Patient 11's room to provide additional care. RN FF used alcohol based hand sanitizer when she entered the room. RN FF failed to rub the alcohol based hand sanitizer onto the back of her hands or nail beds, as required by the facility's policy on hand hygiene. RN FF went to the dialysis machine, and removed the effluent (Effluent is the waste products removed from the blood, such as urea, creatinine, potassium, extra fluids, and may contain blood) bag from the machine. RN FF drained the effluent bag into the sink in the patient's room. While the effluent bag was still draining, RN FF washed her hands in the sink contaminated by the effluent concurrently draining into the same sink. When RN FF washed her hands, she also failed to wash the back of her hands or her nail beds and failed to rub the soap into a lather for 15-seconds as required by the facility's policy on hand hygiene.

While RN FF was providing care to the patient, a resident physician entered the room, assessed the patient, spoke with the patient's spouse, and then left the room without washing his hands or using alcohol based hand rub.

During an interview on 12/11/12 at 3:10 PM, Assistant Nurse Manager GG said staff should wash their hands with soap for at least 30 seconds to 1 minute and should not wash their hands in the same sink where they drain the effluent. Assistant Nurse Manager GG said they should have a separate dedicated sink for draining contaminated fluids such as, the effluent. There was only 1 sink in the Patient's room.

- Observations during a tour on 12/5/12 at 2:00 PM on the 2-JCP Pediatric Unit revealed 2 of 2 Resident physicians (a physician who is undergoing advanced training in a specialty area of study) walked out of room 24-1, and failed to perform hand hygiene after leaving the room.

During an interview at the time of the observations, the Assistant Nurse Manager for 2-JCP stated all staff members exiting a room needed to perform hand hygiene when they left the room.

Review of the policy "HAND HYGIENE", revised 3/11, revealed in part, "Perform [hand hygiene] with an alcohol-based hand rub: 1. Before and after contact with patients and their environment, ... After removing gloves, because hands may be contaminated during or after glove removal."

- Observations on 12/11/12 at 9:00 AM, in the Medical Psychiatric Unit, revealed Registered Nurse (RN) X entered Patient #7's room, and administered Patient #7's morning medications. RN X washed her hands with soap and water prior to administering the medications. After administering the medications, RN A washed her hands again with soap and water. During both observations, RN X failed to wash the back of her hands and nail beds, as required by the facility's policy on hand hygiene.

- Observations on 12/6/12 at 8:20 AM, in the Bone Marrow Transplant Unit, revealed RN Y administering medications to a patient. RN Y used alcohol based hand sanitizer to cleanse her hands prior to administering the medications. When RN Y left the patient's room, she again used alcohol based hand sanitizer to cleanse her hands. During both observations RN Y failed to rub the alcohol based hand sanitizer onto the back of her hands and nail beds, as required by the facility's policy on hand hygiene.

- Observations on 12/6/12 at 8:35 AM, in the Bone Marrow Transplant Unit, revealed RN Z administering Patient #8's morning medications. Patient #8's morning medications included 2 Intravenous (directly into a vein) medications. RN Z used alcohol based hand sanitizer to cleanse her hands prior to administering the medications. When RN Z left Patient #8's room, she again used alcohol based hand sanitizer to cleanse her hands. During both observations RN Z failed to rub the alcohol based hand sanitizer onto the back of her hands and nail beds, as required by the facility's policy on hand hygiene.

- Observations on 12/6/12 at 9:55 AM, in the 3-JCP unit, revealed RN AA administering Patient #9's morning medications. RN AA used alcohol based hand sanitizer to cleanse her hands prior to administering the medications. When RN AA left the room, she again used alcohol based hand sanitizer to cleanse her hands. During both observations RN AA failed to rub the alcohol based hand sanitizer onto the back of her hands and nail beds, as required by the facility's policy on hand hygiene.

- Observations on 12/6/12 at approximately 10:05 AM, in the 3-JCP unit, revealed RN AA administering Patient #10's morning medications. RN AA used alcohol based hand sanitizer to cleanse her hands prior to administering the medications. When RN AA left the room, she again used alcohol based hand sanitizer to cleanse her hands. During both observations of RN AA failed to rub the alcohol based hand sanitizer onto the back of her hands and nail beds, as required by the facility's policy on hand hygiene.

- Observations on 12/5/12 at approximately 2:00 PM, in the 2-JCP unit, revealed Certified Nursing Assistant (CNA) BB cleaning a patient room after the patient was discharged. While CNA BB was cleaning the room, she received a message on her hospital issued cell phone. CNA BB reached into her pocket with the gloves she was wearing while cleaning the room, and picked up the cell phone. CNA BB read the message, and returned the phone to her pocket while wearing the dirty gloves she used to clean the room. CNA BB failed to cleanse her hands prior to, or after, using the cell phone. CNA BB also failed to follow the facility's policy on hand hygiene by failing to remove her gloves prior to using the cell phone, and then cleanse her hands prior to returning to a task involving soiled objects.

- Observations on 12/5/12 at 3:10 PM, in the 2-JCP unit, revealed Housekeeper CC was cleaning room 22 after a patient was discharged. After Housekeeper CC finished cleaning the room, she removed the gloves she was wearing, and cleansed her hands with alcohol based hand sanitizer. Housekeeper CC failed to rub the alcohol based hand sanitizer on the back of her hands and her nail beds, as required by the facility policy on hand hygiene.

- Observations on 12/5/12 at approximately 3:30 PM, in the 2-JCP unit, revealed a CNA entered room 31 (where the patient was on contact isolation protocols, which required staff to wash their hands after leaving the room and wear a disposable gown when they entered the room). The CNA provided care to the patient, and then left the room. After the CNA removed her gloves, she used alcohol based hand sanitizer. The CNA failed to rub the alcohol based hand sanitizer on the back of her hands and nail beds, as required by the facility's policy on hand hygiene.

- Observations on 12/5/12 at approximately 4:00 PM, in the 2-JCP unit, revealed RN DD entered room 2376, and drew blood from the patient. The patient in room 2376 required contact isolation protocols. RN DD wore gloves and a disposable gown. RN DD reached under her disposable gown, grabbed a pen from her pocket, labeled the blood specimen, and returned the potentially contaminated pen to her pocket. As RN DD left the room, she washed her hands. When RN DD washed her hands, she failed to wash the back of her hands and nail beds, as required by the facility's policy on hand hygiene.

- Observations on 12/5/12 at 4:40 PM, in the 2-JCP unit, revealed RN EE entered room 2367, and assessed the patient. After RN EE assessed the patient, she left the room, and used alcohol based hand sanitizer to cleanse her hands. When RN EE used the alcohol based hand sanitizer, she failed to rub the alcohol based hand sanitizer onto the back of her hands and nail beds, as required by the facility's policy on hand hygiene. While RN EE was assessing the patient, Physician C entered the room, and assessed the patient. When Physician C left the room, he used the alcohol based hand sanitizer to cleanse his hands. Physician C failed to rub the alcohol based hand sanitizer onto the back of his hands and nail beds, as required by the facility's policy on hand hygiene.


2. Review of the policy "HAND HYGIENE" revised 3/11, revealed in part.

Perform hand antisepsis with an alcohol-based hand rub before and after contact with patients and their environment. Before putting on sterile gloves, when inserting a central line, and before inserting indwelling urinary catheters, peripheral vascular catheters, or other invasive devices that do not require a surgical procedure. If moving from a contaminated body site to a clean body site during patient care. After removing gloves, because hands may be contaminated during or after glove removal.

Perform hand hygiene with plain soap and water or an antimicrobial soap and water when caring for any patient with diarrhea, hands are visibly dirty or contaminated with blood and/or body fluids, before eating, and after using the restroom.

Procedures for hand hygiene

When using alcohol based waterless hand rubs be sure hands are not dirty. If hands are dirty wash first. Apply a thumbnail-sized amount of alcohol based hand rub to hands. Spread gel or foam all over hands; pay attention to the palms, backside of hands, fingers, fingertips, between fingers, and nail beds. Rub the gel or foam into hands until dry (approximately 12-30 seconds). After many uses, the hand rub may cause hands to feel 'sticky', at this point, wash hands with soap and water.

When washing hands only use warm water, wet hands, use enough soap to achieve a rich lather, rub soap into a lather for at least 15 seconds. Rub all areas of the fingers including fingertips, nail beds, palms, back and sides of hands, rinse hands well and dry with paper towels.

II. Based on document review, observation, and staff interview, the facility failed to ensure staff correctly placed the chemical indicator in packages sterilized at the facility in 2 of 2 sterile processing areas (Main OR and Ambulatory Surgery Center). The facility identified an average of 77 surgical procedures performed per day in the Main Operating Rooms, and 31 surgical procedures performed per day in the Ambulatory Surgical Center.

Failure to place the chemical indicators in the recommended location could potentially result in a false positive reading for sterility, and staff could potentially use a contaminated instrument on a patient, potentially resulting in the patient developing an infection.

Findings include:

1. Review of the policy "Assembly and Packaging," revised 9/09, revealed in part, "A chemical indicator is placed in the center of all packs and instrument trays and [sic] the tray is then wrapped."

2. Review of the undated manufacturer's directions for the chemical indicators (a mechanical device to show steam penetrated into the package undergoing sterilization using steam for heat and pressure to kill all the bacteria on the tools) revealed in part, "Place a ... steam chemical indicator in each pack ... to be steam sterilized in an area determined to be the least accessible to steam penetration."

3. Observations revealed:

- on 12/12/12 at 3:10 PM in the Ambulatory Surgical Center (ASC) revealed Central Sterile Technician (CST) T placed surgical instruments (tools a surgeon used during a surgical procedure) in a shallow tray using a list on a sheet of paper for reference to ensure the tray contained all the required instruments. After CST T placed the surgical instruments in the tray, CST T reviewed the list of required instruments in the tray, folded the sheet of paper, taped a chemical indictor on the paper, and set the paper on top of the instruments. CST T then wrapped the tray and instruments in paper to protect the tray and instruments from contamination during the sterilization process.

- on 12/12/12 at 4:40 PM in the Main OR Central Sterilization Area revealed Central Sterile Supervisor (CSS) U reviewed the contents list of surgical instruments in the shallow instrument tray, and verified the tray contained all the required surgical instruments. CSS U folded the list of required surgical instruments in half, and taped a chemical indicator to the list. CSS U placed the sheets of paper with the chemical indicator on top of the surgical instruments, and wrapped the tray with a sheet of protective paper to protect the instruments from contamination during the sterilization process.

- On 12/12/12 at 1:54 PM, revealed Ambulatory Surgical Center (ASC) staff opened 2 of 2 steam-sterilized trays that contained surgical instruments. Each tray had a list of surgical instruments in the tray, and a chemical indicator taped to the paper. The sheets of paper sat on top of the surgical instruments, and the chemical indicator was sitting facing away from the surgical instruments. The ASC staff checked the chemical indicator showed the contents of the tray had experienced sterilizing conditions (sufficient steam heat and pressure to kill all the bacteria on the instruments) prior to using the instruments on a patient.

- on 12/13/12 at 1:00 PM revealed ASC staff opened a steam sterilized package labeled "ASC Minor OTO Tray #4", that contained multiple surgical instruments. When the ASC staff opened the package, observations revealed a folded list of surgical instruments was sitting on top of the surgical instruments, with a chemical indicator taped to the top of the papers. The ASC staff verified the chemical indicator showed the contents of the tray had experienced sterilizing conditions prior to using the instruments on a patient.

- On 12/13/12 at 10:20 AM, revealed the Main OR staff opened a steam-sterilized package labeled "Central Venous Tray," that contained multiple surgical instruments. When the Main OR staff opened the package, observations revealed a folded list of surgical instruments was sitting on top of the surgical instruments, with a chemical indicator taped to the top of the papers. The Main OR staff verified the chemical indicator showed the contents of the tray had experienced sterilizing conditions prior to using the instruments on a patient.

4. During an interview on 1/8/13 at 4:30 PM, the interim Nurse Manager of Surgical Services stated she previously discussed the practice of placing the chemical indicator on the sheets of papers in the steam-sterilized packages with the Central Sterile Processing staff. She stated she thought the Central Sterile Processing staff had stopped the practice of taping the chemical indicators on top of the paperwork. She thought the Central Sterile Processing staff was instead placing the chemical indicators next to the surgical instruments in the sterilized packages.


5. During an interview on 1/9/13 at 8:50 AM, the Associate Director of Central Sterile Services stated the Central Sterile Technicians had previously placed the chemical indicator on top of the instrument list, which sat on top of the surgical instruments. However, after the surveyor questioned the practice, the facility reviewed the procedure, and determined the Central Sterile Processing staff would place the chemical indicator next to the surgical instruments to better verify the steam actually penetrated to the surgical instruments in the area least accessible to the steam.


III. Based on document review, observation, and staff interview, the facility failed to ensure staff followed the manufacturer's directions for disinfecting liquids in 2 of 2 Operating Rooms (Main OR and ASC) when disinfecting surfaces. The facility identified an average of 77 surgical procedures per day in the Main OR and 31 surgical procedures per day in the ASC.

Failure to follow the manufacturer's directions could result in the staff failing to fully kill all bacteria on a surface, and potentially transfer the bacteria to a patient, causing an infection.

Findings include:

1. Review of the policy "CLEANING AND DISINFECTION OF PATIENT CARE EQUIPMENT, " revised 11/12, revealed in part, "Low-Level disinfection ... Always follow product label for use-dilution and use according to label recommendations.... The contact time for low-level disinfection of non-critical items ... may be up to 10 minutes. Follow the label instructions."

2. Review of the manufacturer's directions for Virex II 256, copyright 2010, revealed in part, "For disinfection, all surfaces must remain wet for 10 minutes."

3. Observations revealed:

- During a tour of the Main OR (Operating Rooms) on 12/12/12 at 11:15 AM Registered Nurse (RN) V assisted the staff to clean OR #16 after a patient's surgery. RN V used Virex II 256 solution (a solution used to kill bacteria) to clean the surgical bed. Immediately after RN V wiped down the surgical bed, and while the solution was still wet, she placed a pillow on the wet surface of the bed. RN V lifted the black foam padding on the surgical table, wiped the lower surface with Virex II 256, and immediately placed the foam padding back on the wet lower surface. When surgical services staff cleaned the floor in OR #16, they only allowed the floor to stay wet for approximately 4 minutes, and before it dried, surgical services staff brought equipment into the room for the next surgery.

- During a tour of the Ambulatory Surgical Center (ASC) on 12/12/12 at 1:45 PM surgical services staff cleaned OR #5 after a patient's surgical procedure finished. The staff cleaned the surgical table by wiping down the black foam pads on the table with Diversey Virex TB solution. The staff placed the black foam pads on the table while the solution was still wet, and failed to allow the solution to stay wet for 3 to10 minutes.


- During a tour of the Main OR on 12/13/12 at 9:30 AM in OR #4 Anesthesia Technician II wiped down the anesthesia machine with Virex II 256 solution. The Anesthesia Technician II wiped down the anesthesia machine's tray, and immediately placed a tube holder, clamps, and tape on the tray while the solution was still wet. At 9:35 AM, the Main OR Advanced Practice Nurse wiped down all of the surgical table's 5 black foam pads with Virex II 256, and immediately set the foam pads on the table while the Virex was still wet.

- during a tour of the Main OR on 12/13/12 at 9:50 AM in OR #2 the Main OR Advanced Practice Nurse wiped down all of the surgical table's 5 black foam pads, immediately placed them on the surgical table before the pad had dried, and she failed to allow the solution to say wet for 10 minutes as required by the manufacturer.

- during a tour of the ASC on 12/13/12 at 1:00 PM in OR #8 revealed Certified Nurses' Aide (CNA) W wiped down the surgical table's black foam pads and arm boards with Diversey Virex TB solution. The solution stayed wet for approximately 20 seconds. CNA W wiped down the pillows, placed the pillows on the surgical table immediately after wiping them down, and while the solution was still wet.

4. During an interview at the time of the 12/13/12 at 1:00 PM observations, the Medical Director of the ASC, who was present during the observations, stated he trained the staff the Diversey Virex TB solution needed to stay wet for 3 minutes. The Medical Director acknowledged the solution did not normally stay wet for 3 minutes, and the staff didn't place additional solution to keep the surface wet for 3 minutes.


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IV. Based on observation, document review and staff interviews, the hospital dietary staff failed to maintain sanitary practices during meal service. The Senior Associate Director of Director of Patient Services reported dietary staff provided approximately 1200 patient meals daily.

Failure to maintain sanitary practices during meal service could potentially result in food contamination, including but not limited to, foodborne illness.

Findings include:

1. Observation of meal service on 12/4/12 from 12:00 PM to 12:25 PM, showed Staff B, cook, Staff C, cook and Staff D, food worker were stationed on the hot end of the production side of patient meal service. Observed the staff handle a variety of equipment with gloved hands, including but not limited to, a cooking timer, serving utensils, plates, plate covers, tray tickets and equipment handles (microwave, oven, refrigerator, freezer, etc) in addition to multiple food items, including but not limited to, hamburger and hot dog buns, sliced turkey, sliced cheese, grilled chicken breast, sliced bread, turkey sausage links, french fries, hamburger patties, grilled sandwiches and single serve cans. Observation showed Staff C removed gloves once after handling turkey slices but failed to wash hands before donning clean gloves. Staff B and Staff C wore the same pair of gloves during the entire observation period. During the same observation period, Staff E and Staff F, food workers, were stationed on the cold end of the production side. Staff E and Staff F wore the same pair of gloves during the entire observation period and repeatedly opened refrigerator units to obtain containers of various food items and handle multiple food items with gloved hands, including but not limited to, sliced bread, sliced cheese, lettuce, pickles, onions, ham and turkey slices.

2. Observation of meal service on 12/5/12 from 7:50 AM to 8:20 AM, showed Staff B, Staff C, Staff F and Staff H, cook, were stationed on the hot end of the production side of patient meal service. In addition, Staff G, a foodservice supervisor, assisted the front line staff. Observed the staff handle a variety of equipment with gloved hands, including but not limited to, serving utensils, plates, plate covers, tray tickets and equipment handles (microwave, oven, refrigerator, freezer, etc) in addition to multiple food items, including but not limited to, bacon, pancakes, french toast, cheese, omelets, english muffins, cheese, bread, lettuce tomatoes and sliced ham. At 8:05 AM, observed Staff G remove gloves and don a clean pair, but failed to perform hand hygiene in between the change. At 8:10 AM, observed Staff F remove gloves and don a fresh pair, but failed to perform hand hygiene in between the change. At 8:15 AM, observed Staff B leave the area and return with 2 packages of plastic lids. Staff B failed to remove his gloves and perform hand hygiene before returning to meal service and continued to handle food and equipment with the same pair of gloves. At 8:17 AM, observed Staff B remove the lid from his drink cup, refill the cup, replace the lid (with a straw), rub his nose with one hand and return to the meal service with the same pair of gloves. Observed Staff B touch his apron with gloved hands multiple times throughout the observation period. Staff B and Staff C wore the same pair of gloves throughout the entire observation period.

During an interview on 12/5/12 at 8:19 AM, Staff B reported he was trained to wear gloves during meal service and would often wear two pairs of gloves, which helped provide extra protection when handling the hot plates and then if he had to handled something like raw meat, he could remove one pair and still have a pair on. Staff B further reported is was not necessary to wash his hands when putting on a new pair of gloves.

During an interview on 12/5/12 at 8:50 AM, Staff F reported she was trained to wear gloves all the time and needed to change them when she changed jobs, for example if she made a sandwich then her gloves needed to be changed before starting a new task. Staff F further reported that it was not necessary to wash her hands when putting on a new pair of gloves.

During an interview on 12/5/12 at 2:00 PM, Staff J food service supervisor, reported dietary staff are trained to wear gloves while working in the meal service area and to wash their hands before beginning work. He further reported staff are trained to change gloves when moving to a different job, for example if they move from the grill to a different area, gloves need to be changed.

During an interview on 12/5/12 at 2:10 PM, Staff K food service supervisor, reported new dietary staff are trained to wash their hands at the start of work, wear gloves at all times and change gloves when they touch something that is not clean. He further reported staff use the clear plastic gloves to handle raw meat and can put them over the blue gloves, then remove the clear ones when soiled and continue to work.

During an interview