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Based on the onsite validation survey, completed May 2 and 3, 2017, the facility failed to comply with the regulations set forth for Life Safety and, therefore, deficiencies were cited under Life Safety Code tags K0232, K0311, K0321, K0345, K0347, K0351, K0353, K0363, K0372 See survey event ID #S5T421 for full details of the cited deficiencies.

Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.42, INFECTION CONTROL, was out of compliance.

A-0749 - Standard: The infection control officer or officers must develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel. Based on observations, interviews and document review, the facility failed to maintain appropriate infection control processes and follow infection control standards in multiple areas throughout the hospital, including hand hygiene, the care and maintenance of central lines, cleaning/disinfection of surgical supplies, equipment and operating rooms and in the areas of food storage. These failures created the potential for transmission of health care acquired infections to patients receiving care in the facility.

Based on observations, interviews and document review, the facility failed to maintain appropriate infection control processes and follow infection control standards in multiple areas throughout the hospital, including hand hygiene, the care and maintenance of central lines, cleaning/disinfection of surgical supplies, equipment and operating rooms and in the areas of food storage.

These failures created the potential for transmission of health care acquired infections to patients receiving care in the facility.

FINDINGS

POLICY

According to the policy, Sterile Processing Procedures, one of the measures for preventing surgical site infections is to provide surgical items that are free of contamination at the time of use. This can be accomplished by subjecting them to cleaning and decontamination, followed by a sterilization process. Pre-cleaning, decontamination, and sterilization processes will be performed in alignment with manufacturer instructions for use and follow evidence based guidelines.

For instrument cleaning and decontamination, refer to the manufacturer's instructions/guidelines for instrument specific care instructions prior to proceeding.

According to the policy, Infection Control, hand hygiene should occur before and after each patient contact, after touching blood, body fluids, secretions, excretions and contaminated items (whether or not gloves are worn), after removing gloves and when performing numerous tasks and procedures on the same patient to prevent cross-contamination of different body sites.

According to the policy Hand Hygiene, the primary purpose of routine hand hygiene is the removal of dirt and transient contaminants acquired while providing patient care or by contact with environmental sources. Hand hygiene is the single most important process for interrupting the transmission of organisms from person-to-person, and preventing healthcare-acquired infections. The World Health Organization outlines "Five Moments for Hand Hygiene" as before touching a patient, before clean or aseptic procedures, after body fluid exposure risk, after touching a patient, and after touching patient surroundings. [Hand Hygiene should be done] before performing invasive procedures such as starting an IV (intravenous) or manipulation of indwelling devices, before handling medication and clean equipment such as patient charts, computer monitors, keyboards and mouse, IV pumps. When moving hands from a contaminated body site to a clean site during patient care. Before putting on gloves and after removing your gloves.

According to the policy, IV- Central Line, IV catheter care includes scrubbing the hub for 15 seconds prior to each assess with an alcohol wipe/antiseptic wipe, unless a disinfectant cap is used.

According to the policy, Safe Injection Practices, prior to entering any vial, bag bottle or IV port, swab the access stopper with alcohol for 15 seconds to remove microbial contamination and debris. Even if a cap or cover shields the access port, these ports are not sterile and can be heavily contaminated. Prior to medication preparation and medication administration, always use hand hygiene and aseptic technique.

According to the policy and procedure, Central Line Insertion Bundles, the purpose of the policy was to implement evidence-based practices to prevent central line-associated bloodstream infections. All lines placed will utilize hand hand hygiene, full barrier precautions, including full drape, sterile gown, hat, eye protections, sterile gloves and mask. Hand hygiene should be done if hands are soiled or if contamination is suspected and after removing gloves.

According to the policy, Food Safety, product storage label required: name of product, date of preparation, and/or use by date.

REFERENCE

According to Steris Prolystica Enzymatic Cleaner Ultra Concentrate manufacturer's instructions, the cleaner may be automatically dispensed at 1/40-1/10 ounces per gallon (0.2 ml-0.8 ml per liter). Consult the manufacture's recommended reprocessing instructions to determine any additional procedures necessary to clean their particular medical device. This is a complete product. Do not add other chemicals, such as bleach or detergents. Added chemicals may destroy the effectiveness of this product.

According to the EndWrist Instruments reprocessing wall chart, water and a pH-neutral enzymatic cleaner should be used.

According to the Emerel Multi-Surface Creme Cleanser, the cleanser is a mild acid, mild abrasive formula.

According to the facility's Central Line Insertion Checklist, the critical bundle elements are hand hygiene, use of full barrier precautions, maximal sterile barriers and aseptic technique.

According to the Association of periOperative Registered Nurses (AORN), Guidelines for Perioperative Practice, 2015:

Recommendation II.d. (page 13), Floors should be mopped with damp or wet mops. Dry methods of environmental cleaning (i.e., dusting, sweeping) should not be used in semi-restricted and restricted areas.

Recommendation VIII (page 624), Surgical instrument, cleaning product, and cleaning equipment manufacturers' validated, written IFU (Instructions for Use) should be reviewed for compatibility during selection and followed during use of cleaning products and equipment for cleaning and decontaminating surgical instruments.

Recommendation VIII.c (page 625), The cleaning product manufacturer's written IFU should be followed for concentration and dilution. Using the product in the concentration recommended by the manufacturer's written IFU helps to ensure consistent and accurate cleaning chemistry.

1. The facility staff who were responsible for the disinfection of surgical instruments failed to follow standard infection control guidelines and the manufacturers' instructions for use of enzymatic detergent in the pre-cleaning of surgical instruments.

a) An observation was conducted on 04/05/17 at 12:20 p.m. in the Sterile Processing decontamination room. Sterile Processing Technician (SPT) #5 and SPT #6 pre-cleaned contaminated surgical instruments used on a patient during a robotic procedure. During the observation, both SPTs added additional enzymatic detergent from an unlabeled squeeze bottle located near the sink, to a blue tub which was already filled with a pre-measured amount of enzymatic detergent and water. SPT #5 stated the enzymatic detergent in the bottle was not diluted with water. Additionally, SPT #5 injected the cannulated instrument with the full concentration enzymatic detergent from the squeeze bottle. This was in contrast to manufacture's instructions which stated, the cleaner may be automatically dispensed at 1/40-1/10 ounces per gallon of water (0.2 ml-0.8 ml per liter).

While the instruments soaked in the enzymatic detergent, both SPT's were observed scrubbing the end of the instruments with a white liquid. SPT #5 stated the cleanser was used to remove the dry blood from the ends of the surgical instrument and was only used on the robotic instruments. The facility provided the Emerel cleanser manufacture's instructions which did not show any evidence the product was approved to use on the surgical instruments. Additionally, according to Steris, the Prolystica enzymatic cleaner should not have any other chemicals added to the detergent and indicated added chemicals may destroy the effectiveness of this product.

Both SPTs rinsed, and re-submerged the instruments in the enzymatic detergent, after scrubbing with the Emerel cleanser, then repeated the process again.

At 1:07 p.m., during the same observation, SPT #5 had to change the blue tub when the water became contaminated. After s/he emptied the blue tub, SPT #5 filled the tub with water, then dispensed the enzymatic detergent from the automated dispenser located on the wall. Prior to filling with water, the surgical instruments were already in the tub. Because of the weight of the instruments, there was an unknown volume of water. When asked about the volume of water, SPT #5 stated s/he usually filled up the tub prior to instruments being placed in the bin to achieve an exact measurement. SPT #5 stated s/he was trying to get the surgical instrument case done.

c) An interview was conducted on 04/06/17 at 8:27 a.m., with SPT #5. After review of the observation conducted on 04/05/17, SPT #5 stated s/he did not believe the higher concentration of enzymatic detergent would impact the surgical instruments. SPT #5 stated s/he did not know how much of the enzymatic detergent was used when adding the additional amount of enzymatic detergent from the squeeze bottle, to the water. S/he stated the use of the bottle had been in place for the past year.

d) An interview was conducted on 04/06/17 at 12:24 p.m., with the Director of Perioperative Services (Director #4) and the Sterile Processing Supervisor (Supervisor #13). Director #4 stated the Perioperative department, which included Sterile Processing, followed AORN guidelines for sterile processing. S/he stated the enzymatic detergent needed to be diluted appropriately and the bottle could only be used if it was diluted according to manufacture's instructions. S/he then stated if the tub was filled with water while there were instruments in the tub, the dilution ratio would be inaccurate.

During the same interview, both Director #4 and Supervisor #13 were asked if the facility could provide evidence the Emerel cleanser was approved to be used on surgical instruments. Director #4 stated the use of the cleanser had not been approved for and was not indicated on any policy.

Upon exit of survey, the facility could not provide evidence the Emerel cleanser was appropriate for use on the surgical instruments during the pre-cleaning and decontamination process and would be removed from the facility.

2. The facility failed to ensure patient care staff performed hand hygiene and glove change according to established infection control guidelines.

a) On 04/03/17, 04/04/17 and 04/05/17 observations were conducted in multiple areas of the facility. There were multiple hand hygiene and glove change breaches. As example,

i) On 04/05/17 at 12:20 p.m., SPT #5 and SPT #6 were observed pre-cleaning surgical instruments used on a patient who had a bloodborne infectious disease. Both SPTs scrubbed the instruments which were submerged in a tub of enzymatic detergent. During the observation, the door bell rung which was located at the entrance of the decontamination room. SPT #5 walked to the paper towel dispenser with her/his contaminated gloves and proceeded to touch the door handle with a paper towel. SPT #5 did not remove her/his contaminated gloves according to the policy. After SPT #5 opened the door and contaminated the handle, 2 OR staff members at separate times removed their gloves, performed hand hygiene, then touched the contaminated door handle. Neither staff member was aware of the contamination.

ii) On 04/03/17 at 9:50 a.m., a medication administration observation was conducted. RN #1, while wearing gloves, administered 2 IV medications through Patient #1's Peripherally Inserted Central Catheter (PICC), a tube that is inserted into a vein, and threaded into the tip of the heart. After administration, RN #1 discarded the contaminated syringes, alcohol wipes and the medication vials. While still wearing the same contaminated gloves, RN #1 prepared an IV antibiotic. S/he inserted the IV tubing into the medication bag. RN #1 did not remove his/her gloves which were used to discard supplies off the bedside table or perform hand hygiene before s/he prepared the IV tubing and medication. RN #1 connected the tubing to the patients PICC line and began the administration.

iii) On 04/04/17 at 11:35 a.m., observations of the preoperative area were conducted. Anesthesiologist #12 was observed entering room #3 of a pediatric patient. On entry into the room, the anesthesiologist did not perform hand hygiene, which according to facility policy, was the single most important process for interrupting the transmission of organisms from person-to-person and preventing healthcare-acquired infections. Anesthesiologist #12 touched the patient's hand, then proceeded to leave and return 2 more times to the patient's room. During the entire observation no hand hygiene was observed.

iv) On 04/05/17 at 11:45 a.m., a surgery case tracer was attempted. RN #7 was observed in the Day Surgery Unit preparing a patient for surgery. RN #7 used a temporal thermometer to obtain the patient's temperature. After s/he used the thermometer on the patient's forehead, RN #7 exited room #4 and used a phone located at the nursing station to call the patient's surgeon. No hand hygiene was performed when the nurse exited the room. RN #7 then entered the room to recheck the patient's temperature and exited the room again without performing hand hygiene and made a second call to the surgeon.

b) An interview was conducted on 04/06/17 at 8:27 a.m., with SPT #5 who stated gloves were considered contaminated after handling dirty surgical instruments. After review of the observations conducted on 04/05/17, SPT #5 stated the use of a paper towel to open the door to the hallway was a general practice in the department. SPT #5 stated s/he had seen other staff members touch the door handle with a paper towel.

c) On 04/06/17 at 10:23 a.m., an interview was conducted with Anesthesiologist #12 and the Chief Medical Officer (CMO #14). Anesthesiologist #12 stated when s/he began employment at the facility, s/he did not receive hand hygiene training. CMO #14 stated the training process changed after Physician #12 started at the facility.

d) An interview was conducted on 04/06/17 at 12:00 p.m. with RN #7 who worked in the Day Surgery Unit. RN #7 stated s/he should have done hand hygiene upon exiting and entering the patient's room on 04/05/17. S/he stated the risk of not washing hands was the spread of infection and cross-contamination between patients and staff. RN #7 was aware of the facility policy and stated s/he was focused on calling the patient's surgeon about the patient's elevated temperature.

e) On 04/06/17 at 12:24 p.m., an interview was conducted with Director #4 and Supervisor #13. Director #4 stated paper towels were not an effective barrier to prevent cross contamination and should not be used to open doors in the decontamination room. S/he stated staff members were expected to remove gloves and perform hand hygiene according to policy.

f) On 04/06/17 at 2:22 p.m., an interview was conducted with the Chief Nursing Officer (CNO #15) who stated the risk to patients when staff members did not follow infection control guidelines, would be unwanted outcomes, infections and potential harm to patients. S/he stated staff were expected to follow these polices.

g) On 04/06/07 at 11:46 a.m., an interview was conducted with the Director of Epidemiology (Director #3). Director #3 stated the facility followed the Centers for Disease Control and Prevention (CDC) for hand hygiene. Director #3 stated in the sterile processing department, hand hygiene should be done when handling infectious disease instruments in order to protect the spread of infection to staff members and patients. S/he stated a paper towel was not considered a barrier to prevent cross contamination between contaminated gloves and a door knob. Staff members should never go from a dirty task to a clean task without hand hygiene.

Director #3 stated all staff members were expected to follow the facility's hand hygiene guidelines.

3. Nursing staff failed to follow aseptic and sterile technique during central line placement.

a) On 04/05/17 at 3:55 p.m., an observation of a sterile central line placement, in a patient with an impaired immune system, was observed. RN #8 and RN #9, both trained in central line placement and made up the facility's central line placement team, stated central line placement was a sterile procedure. RN #8 removed the sterile gown from the sterile line placement pack and placed the gown on a chair in the patient's room, which was considered a dirty surface. RN #9 then picked up and put on the now non-sterile gown, donned sterile gloves and performed the central line placement. RN #9 did not perform hand hygiene after picking up the gown from the contaminated chair and prior to donning the sterile gloves to perform the sterile procedure.

b) On 04/06/17 at 9:08 a.m., an interview was conducted with RN #8, who stated sterile technique was important to prevent infection in patients. RN #8 indicated in prior central line placement procedures, the sterile gown had been placed on a sterile towel to maintain sterility, but this was not the current practice. S/he was unsure why the sterile towel was no longer used. RN #8 was unable to ensure the sterile gown placed on the patient's chair maintained sterility and identified it could have been an infection control risk.

c) On 04/06/17 at 11:46 a.m., an interview was conducted with Director #3 who was in charge of the facility's infection control program. Director #3 stated central line placement was considered a sterile procedure and a patient's chair was considered dirty. Director #3 identified a sterile gown placed on a patient's chair would be considered improper sterile technique and the gown was no longer sterile.

On review of the facilities central line insertion checklist instructions, maximal sterile barriers and aseptic technique were to be used, including a sterile gown, sterile gloves and a large drape.

4. Facility staff failed to follow safe injection practices in 3 of 5 medication observations. Nursing staff did not disinfect the rubber septum on medication vials and IV ports according to infection control guidelines.

a) On 04/03/17 at 9:50 a.m., a medication observation was conducted in the Intensive Care Unit (ICU). RN #1 prepared IV medications to be administered to Patient #1. RN #1 removed the plastic cap from the IV Lasix (a diuretic) medication vial, pierced the rubber septum with a needle and a syringe, then proceeded to draw up the medication. RN #1 did not disinfect the rubber septum after s/he removed the plastic cap. RN #1 administered the IV medication via the patient's PICC line. RN #1 repeated the same steps when s/he administered IV Pepcid (an antihistamine).

Furthermore, RN #1 did not scrub the PICC line IV administration ports for the required 15 seconds according to the policy. RN #1 scrubbed the port with alcohol for 2 seconds prior to administering the IV medication into the patients venous access. This was in contrast to the policy.

b) On 04/04/17 at 9:40 a.m., a medication observation was conducted on the 4th floor Ortho/Neuro unit. RN #2 prepared IV solumederol (a steroid) to be administered to Patient #14 through her/his IV catheter. RN #2 removed the plastic cap from the IV medication vial and pierced the rubber septum with a needle and syringe. RN #2 then diluted the medication with normal saline and administered it through the patient IV access. The rubber septum was not disinfected with alcohol prior to being pierced with needle and syringe.

c) An observation of a sterile surgical procedure was conducted on 04/06/17 at 7:27 a.m. the Director of Perioperative Services (Director #4) was observed preparing a vial of Marcaine, a local anesthesia which was injected in a patient's surgical incision for pain control. Director #4 removed the plastic cap from the medication vial, pierced the rubber septum with a needle, drew up the medication in a syringe and administered the medication onto the sterile field. The rubber septum was not disinfected prior to administration which according to facility policy should be swabbed, with alcohol for 15 seconds, prior to entering the rubber septum to help prevent the transmission of infections.

d) An interview was conducted with RN #2 on 04/06/17 at 10:43 a.m. RN #2 stated the top of an IV medication vial should be disinfected for 15 seconds and was stated s/he was aware s/he did not follow procedure during the observation on 04/04/17. RN #2 stated the rubber septum on medication vials should be disinfected with alcohol when the plastic cap was removed. S/he also reported IV ports on PICC and central lines should be disinfected with alcohol for 15 seconds and if not done, bacteria could be introduced into the patient's intravenous access.

e) An interview was conducted on 04/06/17 at 11:46 a.m., with Director #3. Director #3 stated once the cap was removed from an IV medication vial, the rubber septum should be disinfected to prevent contamination of bacteria.

f) An interview was conducted on 04/06/17 at 12:24 p.m., with Director #4. After review of the observation conducted earlier the same day Director #4 stated if the medication vial was brand new, the rubber septum did not need to be disinfected, which contradicted facility policy.



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5. The facility failed to ensure food was identifiable, labeled, and dated with expiration or use by dates. Additionally, the facility failed to ensure food was discarded after the expiration date or use by date.

a) On 04/03/17 at 11:35 a.m., a tour was conducted of the kitchen with the Head Chef (Chef # 10), who was in charge of patient food for the facility. On observation of the kitchen, multiple food items were observed improperly stored and handled including expired food and/or items without the label, which according to the Food Safety policy, was required to determine the expiration date.

Example of expired food still located in the facility:

-1 tub of pepperoni, which label had indicated it was expired 4 days prior to the survey. Chef #10 was unable to state if patients had been given the expired food.
-3 bags along with 4 tubs of lettuce with discoloration and no label to indicate the expiration date was observed in the refrigerator.
-1 tub of red peppers which had expired 04/01/17 located in the food preparation area refrigerator.
-1 tub of muffins which had expired on 04/02/17

Examples of food with no label to indicate expiration:

-20 bags of bread
-1 tub of cucumbers
-1 tub of squash
-1 angel food cake
-1 package of croissants
-1 tub of strawberries
-1 bag of bagels
-1 bag of green beans
-1 bag of English muffins
-1 bag of French fries located in the refrigerator
-1 bag of spinach
-1 tub of salad dressing

Chef #10 was unable to ensure food items without a label were not expired and food with expired labels had not been served to patients.

b) On 04/06/17 at 1:19 p.m., an interview was conducted with the Director of Nutritional Services (Director # 11) who was in charge of all kitchen staff. S/he stated the expectation was all items in the kitchen were labeled appropriately with expiration dates and if items were expired, it was thrown away. S/he stated this was done to protect patients, potentially compromised with medical issues, from becoming sick from expired food.

c) On 04/06/17 at 11:46 a.m., an interview was conducted with Director #3. Director #3 stated microorganisms grew fast once food was expired and could infect patients and staff which created an infection control risk.

6. The facility failed to ensure environmental cleaning equipment used in the operating room did not create an infection control risk.

a) On 04/06/17 at 12:18 p.m., a tour of the Operating Room (OR) was conducted with Director #3, who was in charge of infection control for the facility. Director #3 stated the facility followed AORN guidelines. On tour a broom and dustpan were observed next to the sink located between OR #5 and 6. When asked what the broom was for, Director #3 stated it was used to sweep up debris from the floor in the operating rooms. Director #3 stated s/he was unsure if it was an infection control risk.

OR staff members were then observed using the broom to clean debris, including possible bone fragments from a patient from the floor in OR #6. OR staff then returned the broom next to the sink located between OR #5 and 6. Director #3 stated s/he was unable to ensure the broom was properly cleaned to maintain sterility for the operating rooms. On the same tour 1 other broom was noted to be present in the OR area.

b) On 04/06/17 at 12:24 p.m., an interview was conducted with Director #4 and Supervisor #13. Director #4 stated the brooms used in the OR were used to remove bone pieces from orthopedic procedures. Director #4 stated s/he did not see the process as an infection control risk. However, this was in contrast to AORN recommendations.

c.) On 4/07/17 at 5:15 p.m., a second interview was conducted with Director #3. S/he stated all brooms had been removed from the operating rooms due to brooms being an infection control risk.