The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ADVENTIST HEALTH DELANO 1401 GARCES HIGHWAY DELANO, CA 93215 Sept. 3, 2015
VIOLATION: SAFETY FOR PATIENTS AND PERSONNEL Tag No: A0536
Based on observation, interview, and record review, the hospital failed to ensure an x-ray technician wore appropriate protective attire. This failure had the potential to expose staff to high levels of radiation.

Findings:

During an observation on 9/1/15, at 10:21 AM, the X-ray Technician (XT) was in Room 355 providing an x-ray procedure for Patient 1. The XT stood approximately two feet from Patient 1's bed wearing no lead apron during the x-ray procedure.

During an interview with the XT on 9/1/15, at 10:30 AM, he stated the hospital's process was for all x-ray technicians to wear a lead apron during x-ray procedures. He stated he should have worn a lead apron while providing the x-ray procedure for Patient 1, but was more concerned in getting the x-ray procedure done.

The hospital policy and procedure titled "Radiation Protection" dated, 3/20/14, indicated, "If it is necessary to be in the room during exposure, be sure to wear a protective devices-lead aprons, gloves, shields. A lead apron is always worn during the exposure of portable exams."
VIOLATION: PHARMACY ADMINISTRATION Tag No: A0491
Based on observation, interview, and record review, the hospital failed to date fluids placed in a warming cabinet. This failure had the potential for staff to use expired and unsafe fluid solutions.

Findings:

During a concurrent observation and interview with with the Director of Intensive Care Unit (Dir ICU) and Outpatient Charge Nurse (OCN), on 8/31/15, at 9:15 AM, in the Outpatient department, a warming cabinet contained 3 bags of 1 liter of Normal Saline with no date. The OCN confirmed the findings and stated, "We usually have a date... The date must have rubbed off."

The hospital policy and procedure titled "Blanket and Fluid Warming Cabinet" reviewed dated 7/2008, indicated, "IV fluids must be dated and used within 14 days of being placed inside the warming cabinet."

The 2015 Association of periOperative Registered Nurses (AORN), Guideline for Minimally Invasive Surgery, Recommendation II, indicated, "b.1.Fluids kept in a warming cabinet should be labeled with an expiration date... Placing the warming expiration date on the fluid container facilitates communication. Adherence to the manufacturer's instructions for safe temperature ranges will provide stability of the solutions being stored."
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on observation, interview, and record review, the hospital failed to ensure gowns with metal snaps were not stored in the warming unit. This failure had the potential for patients to receive a burn from the heated metal snaps.

Findings:

During an observation on 8/31/15, at 10:15 AM, in the Obstetrics Department, the warming cabinet had two chambers. The lower chamber temperature display indicated 141 degrees. Inside the lower chamber were blankets and five gowns with metal snap closures.

During an interview with Registered Nurse (RN) 3, on 8/31/15 at 10:18 AM, she was asked about the gowns in the warmer. RN 3 stated "We don't normally keep gowns in there... I'll remove them."

The 2015 Association of periOperative Registered Nurses (AORN), Guideline for Minimally Invasive Surgery, Recommendation II, II.c.1. Separate warming cabinets or separate compartments with individual temperature control should be designated for blankets and fluids used for irrigation or distention media.

The hospital policy and procedure titled "Blanket and Fluid Warming Cabinet" draft/undated, indicated "The lower chamber is for blankets and plastic irrigation pour bottles only..."
VIOLATION: NURSING CARE PLAN Tag No: A0396
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

During a review of the electronic medical record for Patient 17, she was admitted through the emergency department on 8/31/15 with a diagnosis of Diverticulosis (small pouches that bulge outward through the colon, or large intestine) and experiencing severe pain at a level of 8-10 with 10 being the worst. There was no care plan for pain in the electronic medical record.

During an interview with Registered Nurse (RN) 4, on 9/2/15, at 3:30 PM, she reviewed the electronic medical record for Patient 17, and was unable to find a care plan for pain. RN 4 stated "She should have one, but it's not here. She's on a lot of pain meds. It should've been done on admission."





Based on interview and record review, the hospital failed to ensure patient health care plans for three of 20 patients (2, 3, and 17) were developed, which had the potential to result in unmet care needs.

Findings:





During a review of the electronic medical record for Patient 2 on 9/2/15, he was admitted on [DATE] with a diagnosis of a malfunctioning peg-tube(feeding tube placed directly through the stomach to provide nutrients) and jaundice (yellowish pigmentation of the skin). Admission assessment indicated Patient 2 had a decubitus ulcer (injury to the skin and/or tissue) on his left and right lateral foot. Morphine (narcotic pain reliever)2 milligram (mg) every 6 hours as needed was ordered for pain and was administered on 8/29/15 at 11:01 PM. There was no care plan for pain found in the electronic medical record.

During a review of the electronic medical record for Patient 3 on 9/2/15, she was admitted on [DATE] with a diagnosis of acute renal failure (sudden loss of the kidney's ability to eliminate excess salt, fluids, waste materials from the blood) and has a history of colon cancer. Patient 3 had a standing pain medication order for: Morphine 2 mg every 4 hours as needed for pain level 8-10, hydromorphone 0.5 mg every 15 minutes, and fentanyl 25 microgram(mcg) every 15 min as needed. The electronic clinical record indicated Patient 3 complained of chest pain on 8/31/15 and was given Hydromophone ( a narcotic medication for pain). There was no care plan for pain found in the electronic medical record.

During a concurrent interview and electronic clinical review with the Clinical Analyst (CA), on 9/2/15, 2:04 PM, she reviewed the electronic medical chart for Patient 2 and 3 and was unable to find care plans for pain.

During an interview with the Director of Intensive Care Unit on 9/3/15, at 4:10 PM, she stated pain assessments should be done every shift and patients receiving pain medication should have a pain care plan.

The hospital policy and procedure titled "Nursing Initial Assessment and Reassessment" dated 4/25/11, indicated, "11. A physical assessment will be performed including pain assessment and documented in the EMR. Information from the physical assessment will be used to develop an individualized interdisciplinary plan of care. 13. A plan of care is initiated for each primary care problem identified."
VIOLATION: ORDERS DATED AND SIGNED Tag No: A0454
Based on record review and interview, the hospital failed to have verbal orders signed for two of 20 sampled patients (14, 16) within 48 hours. This failure had the potential to delay or cause inappropriate treatment.

Findings:

During a review of the electronic record for Patient 14, the telephone order written on 7/24/15 at 3:30 PM read, "Discharge planner to arrange for home health to resume care for pt. (patient) upon discharge for wound care." The order was electronically signed by the ordering physician on 8/13/15 at 12:29 PM.

During a review of the electronic record for Patient 16, the telephone order written on 8/27/15 at 9:50 AM read, "Transfer to ICU department under the care of hospitalist... Medication please see Med Reconciliation (list of patient medications)." The order was not authenticated (signed) by the ordering physician.

During an interview with the Quality and Risk Coordinator, on 9/2/15, at 3:10 PM, she stated "The orders should be signed in 48 hours."

The hospital policy and procedure titled "Verbal and Telephone Orders" dated 6/25/14, indicated "All verbal orders and telephone orders shall be signed by the issuing provider or covering provider within 48 hours."

The hospital Medical Staff Rules and Regulations dated 7/31/14, indicated "Verbal Orders: f. Will be countersigned, dated, and timed by the prescriber (original signature) or another practitioner responsible for the care of the patient within 48 hours. Telephone orders: b. All requirements for verbal orders apply to telephone orders."
VIOLATION: FACILITIES Tag No: A0722
Based on observation, interview, and record review, the hospital failed to have an Eyewash Station available and accessible to patient, staff, and visitors. This failure had the potential to cause injury during accident involving chemicals or hazardous materials.

Findings:

During a concurrent interview and observation with the Infection Control Nurse (IC) 1 and Director of Medical Surgical Unit (Dir M/S) on 8/31/15, at 9:50 AM, in the Surgical Pavilion, there was a wall mounted Bottled Eye Wash Station, in the hallway near the Nurse Station. It was noted to be missing both bottles of eyewash, and IC 1 and Dir M/S verified the finding. The Dir M/S stated "It was being changed, and removed because they were expired." The Dir M/S nor IC 1 could not state how long the bottles were missing.

During an interview with Registered Nurse (RN) 1 on 8/31/15, at 9:55 AM, she was asked about the Eye Wash Station, and she stated "I know they had one, but I don't know where I would go to rinse my eyes. I haven't seen it (eye wash station) there in a long while."

During an observation and interview with the Dir M/S on 8/31/15, at 10:07 AM, in the Medical Surgical Department, the Dir M/S was asked where the Eye Wash Station was located. The Dir M/S walked to the Supply Room door, keyed in a code, and opened the door. The Eye Wash Station was on the wall to the back of the room. There were two wheelchairs blocking the path to the Eye Wash Station. The Dir M/S stated "I see this is a problem."

The 2015 Association of periOperative Registered Nurses (AORN), Guideline for a Safe Environment of Care, Part 1 Recommendation IX, IX.i.3. "Eyewash stations should be located so that travel time is no greater than 10 seconds from the location of chemical use or storage, or should be immediately available ..."

The hospital policy and procedure titled "Eye Wash Stations" dated 5/2006, indicated "Purpose: The purpose of the Eye Wash Station Management Plan is to reduce the risk of injury or death of patients, staff, and visitors. Objective: Establish procedures on inspecting eye wash stations, replacing used or expired eye wash bottles. Organization and Responsibility: Individual staff members are responsible... reporting the use of an eye wash station to the Security Department. Ise pf the Eye Was Station management Plan: The following specific locations are required to have Eye Wash Stations: ...Med-Surge...Pavilion..."
VIOLATION: VENTILATION, LIGHT, TEMPERATURE CONTROLS Tag No: A0726
Based on observation, interview, and record review, the hospital failed to:

1. Maintain the temperature and humidity log and follow up on out of range humidity in the Operating Room (OR),

2. Maintain a temperature log for the Patient refrigerator in the Wound Care Center.

These failures had the potential for increase in environmental contaminates in the OR and food being stored at substandard temperature ranges.

Findings:

During an interview with Registered Nurse (RN) 2, on 9/1/15, at 10:30 AM, she was asked about the temperature and humidity log. RN 2 stated "We take them, but give the numbers to facilities and they keep the log." RN 2 was asked what was done when the numbers were out of range, and she stated "If it's broken they (facilities) fix. We have a dehumidifier for the humidity. We check again in 30 mins, and if it's out after 30 minutes we call them, but we don't write it anywhere."

During a review of the "Daily Rounds Log" the following dates showed that the Humidity in OR's 1, 2, and 3 were out of the 30-60% range, and there was no documentation regarding what was done:

6/22/15: OR 1 67%, OR 2 65%
6/24/15: OR 1 63%, OR 2 65%, OR 3 62%
6/25/15: OR 1 70%, OR 2 68%, OR 3 65%
6/26/15: OR 1 80%, OR 2 76%, OR 3 63%
8/21/15: OR 1 70%, OR 2 78%, OR 3 68%
8/24/15: OR 1 80%, OR 2 72%, OR 3 69%
8/25/15: Log was blank with a note stating "Temps were not taken by surgery"
8/26/15: OR 172 %, OR 2 69%, OR 3 66%
8/28/15: OR 1 68%, OR 2 67%, OR 3 69%
9/1/15: OR 1 69%, OR 2 76%

During an interview with the Facilities Unit Coordinator (FC), on 9/1/15, at 11 AM, he reviewed the "Daily Rounds Log" and verified the days when the humidity was out of range. The FC was asked where they documented what was done when the humidity was out of range, and he stated "We don't write anything down. The department takes care of it... with humidity they use the dehumidifier, but it's not written anywhere." The FC was asked about the column lines title "Check if not normal", and he stated "Well, you can write there."

The hospital policy and procedure titled "Daily Temperature and Humidity Readings" dated 6/19/2013, indicated "...humidity level of 30-60% are to be maintained."

The 2015 Association of periOperative Registered Nurses (AORN), Safe Environment of Care, part II, Recommendation III.c. "Room temperature, humidity, and ventilation must be controlled and monitored." Recommendation III.d. "Monitoring and recording...will assist in verification that minimum recommended parameters are met and maintained and will identify when corrective action needs to be taken."





During a concurrent interview and observation with the Quality and Risk Coordinator (QRC) and Infection Control (IC) 2 on 8/31/15, at 2:57 PM, in the Wound Care Center, a patient refrigerator was found with unlabled and undated foods and fluids that included: two 16 ounce cans of energy drinks in a black plastic bag, three apples, one fluid filled plastic cup, one yogurt, seven cartons of apple juice 4 ounces, plastic bag containing two pears and a can of fruit juice, and three orange juice 11.3 ounce bottles. The patient refrigerator had no temperature log. Both QRC and IC 2 confirmed the findings.

During an interview with the Medical Assistant (MA), on 8/31/15, at 3 PM, she stated all food contained in the refrigerator were for diabetic patients only and did not know who checks the temperature on the patient refrigerator. The MA stated, the building was used for several services including, wound treatment, diabetic treatment, and gastroenterology treatment, and etc...

The hospital policy and procedure titled "Food Unit Refrigerators/Freezers dated 6/25/14, indicated, "A Temperature Record will be posted and used to ensure the refrigerator meets the daily recommended temperature... Temperatures are to be checked daily on all unit refrigerators..."
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observation, interview and record review, the hospital failed to provide an environment to avoid sources and transmission of infections and communicable disease as evidenced by the hospital's failure to have effective systems in place to ensure:

1. Surgical hinged instruments were sterilized in the open position in accordance with nationally accepted infection control standards. (Refer to A 0749)

2. Humidity guidelines and policies were followed for the operating room. (Refer to A 0726 and A 0749)

3. Clean supplies were not stored in the dirty utility room. (Refer to A 0749)

4. Isolation carts (cart that holds supplies for nurses caring for infected patients) were stocked only with required items. (Refer to A 0749)

5. Ice machine was maintained in sanitary condition. (Refer to A 0749)

6. Open and undated food removed from patient refrigerator. (Refer to A 0749)

7. Failure to disinfect glucometer after use. (Refer to A 0749)

8. Failure to disinfect patient equipment after use in isolation room. (Refer to A 0749)

9. Failure to ensure supplies stored appropriately. (Refer to A 0749)

10. Failure to follow hand hygiene procedures. (Refer to A 0749)

11. Failure to dispose of trash in cleaned patient room. (Refer to A 0713 and A 0749)

12. Failure to ensure urinary catheter was below patient bladder. (Refer to A 0749)

13. Failure to ensure isolation signs posted on patient isolation rooms. (Refer to A 0749)

The cumulative effects of these systemic failures resulted in the hospital's inability to ensure a sanitary environment placing patients, staff, and visitors at risk of being exposed to infectious and communicable diseases.

Due to the hospital's failure to implement an effective Infection Control Program, the Chief Nursing Officer (CNO) was verbally notified of an Immediate Jeopardy (IJ) situation on 8/31/15 at 12:10 PM. The CNO was informed of the observation, interviews and record reviews with the Infection Control Nurse 1, Registered Nurse 2, and Central Services Tech, related to the processing of surgical hinged instruments in the closed position. A total of 126 peel packs of hinged instruments were found to have been sterilized in the closed position in the Surgical Services Department, Obstetrics, and Emergency Room. The IJ was removed, in the presence of the CNO and Quality Risk Coordinator on 9/1/15 at 11:53 AM, after observations in Central Services of instruments reprocessed in the open position in all departments involved. Immediate action that took place: All peel packs were removed and opened. Instrument spreaders (device used to maintain hinged instruments in open position during sterilization) were borrowed from another facility and ordered for use. Education for all Operating Room/Central Service staff was completed on sterilization process and use of spreaders.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observation, interview, and record review, the hospital's infection control officer failed to develop effective systems for identifying, reporting, investigating, and controlling infections and communicable diseases of patients in accordance with hospital policy and nationally recognized infection control guidelines as evidenced by:

1. Failure to sterilize hinged instruments in an open position in accordance with nationally accepted infection control standards;
2. Failure to ensure humidity guidelines and policies were followed for the operating room;
3. Storing clean supplies in the dirty utility room;
4. Failure to ensure isolation carts (cart that holds supplies for nurses caring for infected patients) were stocked only with required items;
5. Failed to maintain ice machine in sanitary condition;
6. Failed to remove open and undated food from patient refrigerator;
7. Failure to disinfect glucometer after patient use;
8. Failure to disinfect patient equipment after use in isolation room;
9. Failure to ensure supplies were stored appropriately;
10. Failure to ensure urinary catheter was below patient bladder; and,
11. Failure to ensure isolation signs were posted on patient isolation rooms.

The effects of these system problems resulted in the hospital's inability to provide a sanitary environment and placed all patients, staff, and visitors at risk of developing infectious and communicable diseases.

Due to the hospital's failure to implement an effective Infection Control Program, the Chief Nursing Officer (CNO) was verbally notified of an Immediate Jeopardy (IJ) situation on 8/31/15 at 12:10 PM. The CNO was informed of the observations, interviews, and record reviews with Infection Control Nurse (IC) 1, Registered Nurse (RN) 2, and Central Services Tech (CST), related to the processing of surgical hinged instruments in the closed position. A total of 126 peel packs of hinged instruments were found to have been sterilized in the closed position in the Surgical Services Department, Obstetrics, and Emergency Room. The IJ was removed, in the presence of the CNO and Quality Risk Coordinator (QRC) on 9/1/15 at 11:53 AM, after observations in Central Services of instruments reprocessed in open position in all departments involved. Immediate action that took place: All peel packs were removed and opened. Instrument spreaders (device used to maintain hinged instruments in open position during sterilization) were borrowed from another facility and ordered for use. Education for all Operating Room/Central Service staff was completed on sterilization process and use of spreaders.

Findings:

1. During an observation with IC 1, RN 2, and the CST, on 8/31/15, at 10:30 AM, in the Operating Room/Sterile Instrument Area, the following hinged instruments were found to have been sterilized in the closed position:

16 Scissors (used for cutting and dissecting tissue)
16 Needle holders (used to hold the needle when sewing body tissue)
26 Small clamps (used to hold, clamp, or move tissue during surgery)
38 Large clamps
1 Gelpi retractor (used to expand and retract tissues)

The above findings (total of 97 instruments) were verified by IC 1, RN 2, and the CST.

During an interview with the the CST, on 8/31/15, at 10:35 AM, he stated "They were open when I packed them."

During an observation with IC 1 and the Director of Pharmacy (Dir Pharm), on 8/31/15, at 10:45 AM, in the Obstetrics (OB) Department, the following hinged instruments were found to have been sterilized in the closed position:

4 Clamps
2 Scissors
3 Ring forceps (used for grasping and holding)
1 Gelpi

The above findings (total of 10 instruments) were verified by IC 1, Dir Pharm, and the Director of Intensive Care Unit (Dir ICU).

During an observation with the Dir ICU and Dir Pharm, on 8/31/15, at 11 AM, the following hinged instruments were found to have been sterilized in the closed position:

8 Alligator forceps (long forceps with small jaw for compressing and grasping tissue)
6 Forceps (used for grasping and holding tissue)
2 Ring forceps
3 Needle holders

The above findings (total of 19 instruments) were verified by Dir ICU and Dir Pharm.

During an interview with IC 1, on 8/31/15, at 11:25 AM, she was asked about oversight in surgery. IC 1 stated, "Our schedule is every six months, so twice a year." When asked what she looks for in the department, IC 1 stated "Temperature and humidity...check that instrument packs are intact." IC 1 was asked if she looks at hinged instruments being opened or closed, and she stated "No, just intact package."

During an interview with RN 2, on 8/31/15, at 11:35 AM, she said she was the Charge Nurse for Surgery and was covering since the Director of Surgical Services was out. RN 2 was asked if she had any training for Central Department and Instruments, and she stated "No, not here." RN 2 was asked what she checks for when getting instruments for a procedure. RN 2 stated "We check if the packages are intact. We make sure it's (instrument) not clamped, and if it is closed we open through the paper. The CST is supposed to do that."

The hospital position description titled "Center Sterile Technician" dated 3/19/08 indicated "Wraps instrument sets and peel packages according to AORN (Association of periOperative Registered Nurses) and AAMI (Association for the Advancement of Medical Instrumentation) standards."

The hospital policy and procedure titled, "Designation of Responsibility for Central Services", Scope: "Central Services Staff" dated 6/19/13, indicated "The Director of Surgical Services is responsible for the Central Services Department ... This individual will have the skill and knowledge of the sterilization process and follow the standards of the Association of Operating Room Nurses and AAMI. In the absence of the Director of Surgical Services, the Charge Nurse of Surgery will be responsible for the supervision of Central Services."

The hospital policy and procedure titled "Assembling Trays" dated 6/19/13 indicated "All trays are assembled by the Central Services personnel to be used by the emergency room ...OB..."

The hospital policy and procedure titled "Decontamination of Central Services Materials" dated 6/25/14, indicated "1. Instrument, A. Preparation: Open all hinged instruments."

The 2015 Association of periOperative Registered Nurses (AORN), Cleaning and Care of Surgical Instruments and Powered Equipment, Recommendation XII.c. "Instruments with hinges should be opened and those with removable parts should be disassembled when placed in trays designed for sterilization." Recommendation XII.c.1 "Instruments should be kept in the open and unlocked position using instrument stringers, racks, or instrument pegs designed to contain instruments."

2. During an interview with RN 2, on 9/1/15, at 10:30 AM, she was asked about the temperature and humidity log. RN 2 stated "We take them, but give the numbers to facilities (Maintenance department) and they keep the log." RN 2 was asked what was done when the numbers were out of range, and she stated "If it's broken they (facilities) fix it. We have a dehumidifier for the humidity. We check again in 30 mins, and if it's out after 30 minutes we call them, but we don't write it anywhere."

During a review of the "Daily Rounds Log" the following dates showed that Humidity in Operating Room (OR) 1, 2, and 3 to be out of the 30-60% range, and there was no documentation regarding what was done:

6/22/15: OR 1 67%, OR 2 65%
6/24/15: OR 1 63%, OR 2 65%, OR 3 62%
6/25/15: OR 1 70%, OR 2 68%, OR 3 65%
6/26/15: OR 1 80%, OR 2 76%, OR 3 63%
8/21/15: OR 1 70%, OR 2 78%, OR 3 68%
8/24/15: OR 1 80%, OR 2 72%, OR 3 69%
8/25/15: Log was blank with a note stating "Temps were not taken by surgery"
8/26/15: OR 172 %, OR 2 69%, OR 3 66%
8/28/15: OR 1 68%, OR 2 67%, OR 3 69%
9/1/15: OR 1 69%, OR 2 76%

During an interview with the Facilities Unit Coordinator (FC), on 9/1/15, at 11 AM, he reviewed the "Daily Rounds Log" and verified the days when the humidity was out of range. The FC was asked were they documented what was done when the humidity was out of range, and he stated "We don't write anything down. The department takes care of it... with humidity they use the dehumidifier, but it's not written anywhere." The FC was asked about the column lines title "Check if not normal", and he stated "Well, you can write there."

The hospital policy and procedure titled "Daily Temperature and Humidity Readings" dated 6/19/13, indicated "...humidity level of 30-60% are to be maintained."

The 2015 AORN, Safe Environment of Care, part II, Recommendation III.c. "Room temperature, humidity, and ventilation must be controlled and monitored." Recommendation III.d. "Monitoring and recording... will assist in verification that minimum recommended parameters are met and maintained and will identify when corrective action needs to be taken."

3. During an observation on 8/31/15 at 9:25 AM, with IC 1 and the Director of Medical Surgical Unit (Dir M/S), of the Dirty Utility Room, the following clean items were found stored with dirty items:

1 case of multi use paper
2 boxes of black printer ink
11 3-ring binders
5 packages of patient forms
2 boxes of toner cartridges
13 rolls of patient labels
3 bottles of 70% rubbing alcohol
3 packages of mercury spill kits
1 container of red glitter
4 boxes of patient arm bands

During an interview with Dir M/S, on 8/31/15, at 9:30 AM, she stated "These items should not be in here."

4. During an observation on 8/31/15, at 9:45 AM, with IC 1, the isolation carts outside of Rooms 111 and 113 were found to be stocked with non required items. The follow items were found:

Isolation cart for 111-
1 package of Electrocardiogram electrodes (pads to record electrical activity of the heart)
2 rolls of Clear trash bags
1 box of shoe covers

Isolation cart for 113-
8 packages of Alcohol prep pads
1 22 gauge (g) 1 1/4 inch (") intravenous catheter (hollow tube place into vein to administer medication/fluids)
1 20 g 1" intravenous catheter
non-sterile 2 x 2 gauze
1 roll of 2 " paper tape

During an interview the IC 1 on 8/31/15, at 9:50 AM, she stated "There should only be PPE (personal protective equipment) and required stuff inside."

The hospital policy and procedure titled "Transmission Based Isolation (Airborne, Droplet, Contact, Enteric)" dated 4/22/15, indicated "*Isolation carts must contain the following items: Non-sterile gloves, non-sterile gowns, surgical mask, alcohol hand rub, disposable stethoscopes, disinfectant wipes, bleach wipes for C-diff patients, Isolation signs."

5. During a concurrent observation and interview with the Dir M/S and Facilities Maintenance Mechanic (FMM), on 8/31/15, at 10 AM, in the Surgical Pavilion, the Ice Machine was opened by the FMM. The Ice Machine was found to have white residue on the ice chute. The inside was wiped with a white paper towel, and brown/black residue appeared on the paper towel. The FMM was unable to identify the brown/black residue, and stated "It's cleaned every quarter...and scheduled for September."

There was no policy and procedure provided.

6. During an observation with the Dir M/S and IC 1, on 8/31/15, at 9:40 AM, in the Medical Surgical Unit, the patient refrigerator had an opened half pint of 2% milk with no label. The Dir M/S stated "That should be tossed."

During a concurrent interview and observation with the QRC and IC 2 on 8/31/15, at 2:57 PM, in the Wound Care Center, a patient refrigerator was found with unlabeled and undated foods and fluids that included: two 16 ounce cans of energy drinks in a black plastic bag, three apples, one fluid filled plastic cup, one yogurt, seven cartons of apple juice 4 ounces, plastic bag containing two pears and a can of fruit juice, and three orange juice 11.3 ounce bottles. The patient refrigerator had no temperature log. Both the QRC and IC 2 confirmed the findings.

During an interview with the Medical Assistant (MA), on 8/31/15, at 3 PM, she stated all food contained in the refrigerator were for diabetic patients only and did not know who checks the temperature on the patient refrigerator. The MA stated the building was used for several services including, wound treatment, diabetic treatment, and gastroenterology treatment.

The hospital policy and procedure titled "Food Unit Refrigerators/Freezers dated 6/25/14, indicated, "Food assigned to individual patients will be labeled with patient name, room number, and expiration date."

The hospital policy and procedure title "Food Unit Refrigerators/Freezers" dated 6/2/14, indicated "Any product found that is not labeled with a date will be thrown out..."





9. During an observation on 8/31/15, at 3:16 PM, with IC 2 and the Quality and Risk Nurse, inside the "Wound Care Clinic Reception" area (per building map) a cabinet located under a sink contained the following items.

1. One sharps container.
2. Three packages of plastic cups.
3. One roll of trash bags.
4. Six containers of "Sani Clothes" disinfectant cleaner.
5. One case containing a telephone.
6. Forty-one water bottles.
7. One vase.
8. One can of room deodorizer spray.
9. One can of disinfectant spray.
10. One box labeled "Blood Pressure Monitor".

IC 2 looked under the sink and verified the findings. IC 2 stated "Nothing should be stored under the sink."

The hospital policy and procedure titled "Materials Management Safety" dated 4/29/14, indicated, "All equipment and supplies must be properly stored."

10. During an observation on 9/1/15, at 3:36 PM, outside the door of the ICU with IC 1, Patient 18's urine drainage bag (used to store urine) was seen attached to the right side bed frame at the head of the bed (above the level of the bladder). The urine drainage bag contained a yellow liquid.

During a concurrent interview and observation with RN 7, on 9/1/15, at 3:40 PM, she indicated she was in charge of care for Patient 18. RN 7 was asked if the urine drainage bag for Patient 18 was in the correct position, she said "No, it should be there," walking over to the bed and pointing to below the bladder. RN 7 moved the urine drainage bag to the spot she had indicated. A request was made for the hospital's policy and procedure for positioning of a urine drainage bag, none was provided.

BardMedical Patient care guide dated 2010, indicated "Always keep urine bag below the level of the bladder to prevent urine from flowing back into the bladder from the tubing and urine bag. Urine backflow can cause infection. Failure to keep the drainage bag below the level of the bladder and upright can slow emptying of the bladder, causing patient discomfort and potentially increasing the risk of contamination of the collection system. Never hang the drainage bag from the side bedrail."

11. During an observation on, 8/31/15, at 9:24 AM, a yellow isolation cart was observed outside two patient rooms. Both rooms had patients in the beds but no isolation sign posted outside either room to indicate which of the rooms was an isolation room.

During an interview with the Dir Pharm, on 8/31/15, at 9:26 AM, the Dir Pharm could not indicate which room was the isolation room, he stated, "There is usually a sign up that designates (the room)." The Dir Pharm said let me go find out, he returned with RN 5.

During an interview with RN 5, on 8/3/15, at 9:28 AM, standing outside rooms, RN 5 stated one room was an isolation room, "There should be a sign."

The hospital policy and procedure titled "Transmission Based Precautions (Airborne, Droplet, Contact, and Empiric Isolation)" dated 4/22/15, indicated, "Practice of Isolation: 2. Signs, Isolation carts: Place appropriate signs on the patient's door to indicate the type of isolation precaution required for the patient.

The hospital policy and procedure title "Infection Control Plan" dated 4/21/15, indicated "Purpose/Quality Statement: Protect healthcare workers, visitors and others in the healthcare environment. This is accomplished by limiting unprotected exposure to pathogens by using administrative controls, engineering controls, isolation, hand hygiene, barrier precautions including personal protective equipment (PPE)..."





7. During a concurrent interview and observation in the Med-Surgical Unit with RN 9 on 9/1/15, at 11:18 AM, she indicated she had two patients requiring blood sugar checks (a test where a health care provider pricks a fingertip with a needle, then places a drop of fresh blood onto a test strip, which is then placed into a blood glucose meter). RN 9 proceeded to enter Room 112 and performed a bedside blood glucose fingerstick on Patient 4. After finishing the test, RN 9 exited out of Patient 4's room and entered Room 114 without disinfecting the used glucometer.

During an interview with RN 9 on 9/1/15, at 11:40 AM, she stated all glucometers were disinfected after each patient use. RN 9 made no comment when asked why the glucometer was not disinfected after using it on Patient 4 and entering Room 114.

During an interview with the Quality Assurance/Quality Control (QA/QC) Supervisor Specialist, on 9/3/15, at 12:59 PM, she indicated the hospital practice for disinfecting the glucometer was for staff to disinfect before and after each patient use and when visible blood is seen.

The hospital policy and procedure titled "StatStrip POC GLE Nova Meter-Waived (name brand for the glucometer)" dated 1/20/15, indicated, "The stat strip meter should be disinfected: ..After every patient."

8. During a concurrent interview and observation with RN 8, in the Intensive Care Unit (ICU), on 9/1/15, at 9:15 AM, a "Contact Precautions" sign was posted outside of a patient room. The sign included pictures as well as check marks indicating what proper personnel protective equipment must be worn prior to entering the room and how to clean equipment brought into the room. "Clean Equipment with Hospital Approved Cleaner 1. Quat or Sani-wipes 2. Followed by BLEACH." RN 8 stated Patient 2 had Methicillin-resistant Staphylococcus (bacterial infection).

On 9/1/15, at 9:20 AM, RN 8, was observed entering Patient 2's room with a portable computer containing clip boards and loose papers. After administering medication and providing care for Patient 2, RN 8 exited out of the room with the portable computer without cleaning and/or disinfecting the portable computer.

During an interview with RN 8 on 9/1/15, at 9:40 AM, she stated the portable computer was used for several patients through out the day. RN 8 confirmed she did not disinfect the portable computer after exiting Patient 2's room. RN 8 stated, "We are supposed to wipe it down."

During an interview with IC 2 on 9/3/15, at 12:54 PM, she stated equipment such as the portable computers were to be wiped down with the hospital approved wipes before leaving an isolation room.

The hospital policy and procedure titled "Transmission Based Isolation (Airborne, Droplet, Contact, Enteric), dated 4/22/15, indicated, "Avoid sharing of equipment, but if unavoidable, ensure that reusable equipment is appropriately disinfected between patients."

The hospital policy and procedure titled "Disinfection & Sterilization" dated 9/2011, indicated, "Non-critical: The item will come in contact with intact skin; requires low-level disinfection. Examples: Bedrails, floors and furniture, beside tables and computers on wheels... Non-Critical items should be disinfected: After contact with a patient or environmental surfaces of a patient in isolation."
VIOLATION: SURGICAL SERVICES Tag No: A0940
Based on observation, interview, and record review, it was determined the hospital did not meet the Conditions of Participation (COP) for Surgical Services as evidenced by:

1. Failure to sterilize hinged instruments (used in surgery or medical procedures for grasping and holding objects) in an open position per policy. (Refer to A 0951)

2. Failure to ensure humidity guidelines and policies were followed for the Operating Room (OR). (Refer to A 0951)

3. Failure to follow policy and procedure for flash sterilization. (Refer to A 0951)

The cumulative effects of these failures had the potential for staff to use unsterile instruments and an OR with increased environmental contaminates.
VIOLATION: OPERATING ROOM POLICIES Tag No: A0951
Based on observation, interview, and record review the hospital failed to:

1. Sterilize hinged instruments in an open position per policy;
2. Ensure humidity guidelines and policies were followed for the Operating Room (OR); and,
3. Follow policy and procedure for flash sterilization.

These failures had the potential for staff to use un-sterile instruments and OR with increased environmental contaminates.

Findings:

During an observation with Infection Control (IC) 1, Registered Nurse (RN) 2, and Central Services Technician (CST), on 8/31/15, at 10:30 AM, in the OR/Sterile Instrument Area, the following hinged instruments were found to have been sterilized in the closed position:

16 Scissors (used for cutting and dissecting tissue)
16 Needle holders (used to hold the needle when sewing body tissue)
26 Small clamps (used to hold, clamp, or move tissue during surgery)
38 Large clamps
1 Gelpi retractor (used to expand and retract tissues)

The above findings (total of 97 instruments) were verified by IC 1, RN 2, and the CST.

During an interview with the CST, on 8/31/15, at 10:35 AM, he stated "They were open when I packed them."

During an observation with IC 1 and the Director of Pharmacy (Dir Pharm), on 8/31/15, at 10:45 AM, in the Obstetrics (OB) Department, the following hinged instruments were found to have been sterilized in the closed position:

4 Clamps
2 Scissors
3 Ring forceps (used for grasping and holding)
1 Gelpi

The above findings (total of 10 instruments) were verified by IC 1, Dir Pharm, and the Director of Intensive Care Unit (Dir ICU).

During an observation with the Dir ICU and Dir Pharm, in the Intensive Care Area on 8/31/15, at 11 AM, the following hinged instruments were found to have been sterilized in the closed position:

8 Alligator forceps (long forcep with small jaw for compressing and grasping tissue)
6 Forceps (used for grasping and holding tissue)
2 Ring forceps
3 Needle holders

The above findings (total of 19 instruments) were verified by Dir ICU and Dir Pharm.

During an interview with IC 1, on 8/31/15, at 11:25 AM, she was asked about oversight in surgery. IC 1 stated "Our schedule is every six months, so twice a year." When asked what she looks for in the department, IC 1 stated "Temperature and humidity... check that instrument packs are intact." IC 1 was asked if she looks at hinged instruments being opened or closed, and she stated "No, just intact packages."

During an interview with RN 2, on 8/31/15, at 11:35 AM, she stated she was the Charge Nurse for Surgery. RN 2 was asked if she had any training for processing instruments, and she stated "No, not here." RN 2 was asked what she checks for when getting instruments for a procedure. RN 2 stated "We check if the packages are intact. We make sure it's (instrument) not clamped, and if it is closed we open through the paper. The CST is supposed to do that."

The hospital position description titled "Center Sterile Technician" dated 3/19/08 indicated "Wraps instrument sets and peel packages according to AORN and AAMI standards."

The hospital policy and procedure titled "Designation of Responsibility for Central Services", Scope: "Central Services Staff" dated 6/19/13, indicated "The Director of Surgical Services is responsible for the Central Services Department ... This individual will have the skill and knowledge of the sterilization process and follow the standards of the Association of Operating Room Nurses and AAMI. In the absence of the Director of Surgical Services, the Charge Nurse of Surgery will be responsible for the supervision of Central Services."

The hospital policy and procedure titled "Assembling Trays" dated 6/19/13 indicated "All trays are assembled by the Central Services personnel to be used by the emergency room ...OB..."

The hospital policy and procedure titled "Decontamination of Central Services Materials" dated 6/25/14, indicated "1. Instrument, A. Preparation: Open all hinged instruments."

The 2015 Association of periOperative Registered Nurses (AORN), Cleaning and Care of Surgical Instruments and Powered Equipment, Recommendation XII.c. "Instruments with hinges should be opened and those with removable parts should be disassembled when placed in trays designed for sterilization." Recommendation XII.c.1 "Instruments should be kept in the open and unlocked position using instrument stringers, racks, or instrument pegs designed to contain instruments."

2. During an interview with RN 2, on 9/1/15, at 10:30 AM, she was asked about the temperature and humidity log. RN 2 stated "We take them, but give the numbers to facilities and they keep the log." RN 2 was asked what was done when the numbers were out of range, and she stated "If it's broken they (facilities) fix. We have a dehumidifier for the humidity. We check again in 30 mins, and if it's out after 30 minutes we call them, but we don't write it anywhere."

During a review of the "Daily Rounds Log" the following dates showed that Humidity in the OR 1, 2, and 3 to be out of the acceptable 30-60% range. There was no documentation regarding what was done to correct the out of range humidity:

6/22/15: OR 1 67%, OR 2 65%
6/24/15: OR 1 63%, OR 2 65%, OR 3 62%
6/25/15: OR 1 70%, OR 2 68%, OR 3 65%
6/26/15: OR 1 80%, OR 2 76%, OR 3 63%
8/21/15: OR 1 70%, OR 2 78%, OR 3 68%
8/24/15: OR 1 80%, OR 2 72%, OR 3 69%
8/25/15: Log was blank with a note stating "Temps were not taken by surgery"
8/26/15: OR 172 %, OR 2 69%, OR 3 66%
8/28/15: OR 1 68%, OR 2 67%, OR 3 69%
9/1/15: OR 1 69%, OR 2 76%

During an interview with the Facilities Unit Coordinator (FC), on 9/1/15, at 11 AM, he reviewed the "Daily Rounds Log" and verified the days when the humidity was out of range. The FC was asked where they documented what was done when the humidity was out of range, and he stated "We don't write anything down. The department takes care of it... with humidity they use the dehumidifier, but it's not written anywhere." The FC was asked about the column lines title "Check if not normal", and he stated "Well, you can write there."

The hospital policy and procedure titled "Daily Temperature and Humidity Readings" dated 6/19/13, indicated "...humidity level of 30-60% are to be maintained."

The 2015 AORN, Safe Environment of Care, part II, Recommendation III.c. "Room temperature, humidity, and ventilation must be controlled and monitored." Recommendation III.d. "Monitoring and recording... will assist in verification that minimum recommended parameters are met and maintained and will identify when corrective action needs to be taken."

3. During an interview with the CST, on 9/1/15, at 10:55 AM, the "Flash Log" from 1/2014 to 8/2015 was reviewed. The strips from each flash sterilization load did not have the operator name, operator initials, or patient information. The CST stated "I guess I forgot that part."

The hospital policy and procedure titled "Flash Sterilization and System IE" dated 6/19/13, indicated "Documentation in log must include date, item(s) sterilized, exposure time, patient identification information, load number, and initials of staff member."