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1900 HOSPITAL BLVD

GAINESVILLE, TX 76240

CONTENT OF RECORD: FINAL DIAGNOSIS

Tag No.: A0469

Based on a review of documentation and interview, the facility failed to ensure that medical records were completed within 30 calendar days following discharge.

Findings included:

In an interview with Staff #6, HIM Director, the afternoon of 5/19/16, she stated that the medical record completion delinquency rate for the most recent month, April 2016, was 13%. Staff #6 provided a document which stated, "Delinquency Rate for April 13%".

UNUSABLE DRUGS NOT USED

Tag No.: A0505

Based on observation, review of documentation, and interviews with facility staff, the facility failed to make outdated drugs unavailable for patient use as expired medications were found in the PACU malignant hyperthermia cart which potentially could have resulted in unsafe or ineffective medications being used in patient care.

The findings were:

The facility policy entitled "Drug Inventory Control" #1729565 dated 10/13 reflected in part "All drug storage areas within the hospital will be inspected monthly by the Pharmacy Department ...Expired, damaged and/or contaminated medications will be removed from drug storage areas within the hospital during the Pharmacy inspection and will be returned to the Pharmacy Department for proper disposal."

During a tour of the surgery department on the afternoon of 5/16/16, the following expired medications were found in the PACU malignant hyperthermia cart available for use in patient care: 50% dextrose injection, 0.5 mg/ml, 50 ml, expired 4/16; 20% Intravenous fat emulsion, 500 ml bag, expired 4/16.

In an interview with the CNO, staff #2 during the tour on the afternoon of 5/16/16, staff #2 agreed the above listed medications were expired.

DIRECTOR OF DIETARY SERVICES

Tag No.: A0620

Based on observation during a tour of the facility with hospital staff, the facility failed to provide a sanitary environment for the preparation, service and storage of food.

Findings were:

During a tour of the kitchen area at approximately 8:10 am on 5/18/16 with Staff #5 and Staff #2, the following was observed:
1. The container for bulk rice was labeled with an expiration date of 4/10/16.
2. The Hydrion test strips for testing sanitizing solution used to clean food preparation surfaces in the kitchen expired on 10/15/15.
3. The trash receptacle next to the hand washing sink had a non-functioning foot pedal leaving no means to open the trash receptacle without touching it.
4. The mixer was greasy and there were dried food and splatters adhered to the surfaces indicating a need for cleaning and creating a risk for contamination.
5. In the clean dish storage area, there were 5 metal bowls available for use in food preparation which were stored with the bowl up. There were food crumbs in the bowls and the bowls were in need of cleaning.
6. The kitchen utensils (spatulas, large spoons, ice cream scoops, for example) were stored in 4 large buckets. The buckets were dirty, with a greasy substance and crumbs and debris observed in the bottom of the buckets. There was an ice cream scoop which had a dried substance which appeared to be food in the bowl of the scoop. There was a rubber spatula which was damaged with tears and a small chunk of rubber missing, revealing a black substance in the tear.
7. There was a large plastic tray containing lids for pots available for use in food preparation. The lids were in need of cleaning, as there was a greasy substance on the lids and a substance which appeared to be dried food. The interior of the plastic storage tray was in need of cleaning, as there was a greasy substance on the tray and crumbs and debris were observed in the bottom of the tray.
8. In the clean dish storage area, there was a large salt dispenser/container which was covered in a greasy substance and was located next to clean dishes available for use.
9. Review of the "Dishmachine Temperature Log" for the month of May, 2016 revealed that the log was not maintained for the Dinner column for the following dates: 5/1, 5/2, 5/3, 5/4/, 5/5, 5/9, 5/10, 5/11, 5/12, 5/13, 5/16. The wash column and the final rinse temperature columns were left blank (no documented evidence of anything written in the space) for the Dinner cycle and there was no means to determine that temperatures were sufficient to clean and sanitize the dishes washed on those dates.

Review of facility policy, "Storage of Pots, Dishes, Flatware, Utensils" Policy #F107 stated, in part, "Store all pots, glasses, and cups in an inverted position on a clean storage surface."

The above findings were confirmed in an interview during the tour the morning of 5/18/16 with Staff #5, Kitchen Manager, and Staff #2, Chief Executive Officer.






29934

Based on observation, review of documentation and interviews with facility staff, the facility failed to properly store patient food items as a patient food refrigerator in cardiac rehab did not have the temperature monitored in accordance with facility policy and potentially could have caused food items to be stored at an unsafe temperature.

The findings were:

The facility policy "Nursing Unit Stock" #C034 dated 1/16 reflected in part "Catering Associate is responsible for daily temperature monitoring of unit refrigerator(s) on a posted temperature sheet."

During a tour of the cardiac rehab department on the morning of 5/17/16, a patient food refrigerator containing juice products for patient consumption was observed to not have a thermometer inside or a log of the refrigerator temperatures. In an interview with the CNO, staff #2 during the tour on the morning of 5/17/16, staff #2 agreed that the temperature of the food refrigerator was not being monitored.

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

During a tour of the patient care areas the afternoon of 5/17/16 accompanied by Staff #2, the following was observed:
In the med/surg nursing station, there were:
1. Pink lab tubes, quantity of 7, expired 4/2016,
2. Red lab tubes, quantity of 6, expired 3/2016,
3. Blue lab tubes, quantity of 1 expired 1/2016
4. Anaerobic culture collection bottle, quantity of 1 expired 1/2016,
5. Aerobic culture collection bottle, quantity of 1, expired 1/2016.
In the Med/Surg Crash cart, there were:
1. 0.9 NaCl, 100 ml IV bag, expired 4/16
2. D5W, 500 ml IV bag, expired 4/16.
In the Labor and Delivery Suite, in Room 401, the emergency call light cord was wrapped and tied in a knot around the handicap grab bar, rendering it ineffective for a patient experiencing a fall on the floor to summon help in an emergency. The surveyor tugged on the call light cord in the bathroom and, as it was wrapped and tied around the grab bar, the call light could not and did not function.

The above findings were confirmed during the tour the afternoon of 5/17/16 by Staff #2.






29934

Based on observation, review of documentation, and interviews with facility staff, the facility failed to maintain supplies to ensure an acceptable level of safety and quality as expired medical supplies were found available for use in patient care areas. This potentially could have resulted in unsafe or ineffective medical supplies being used in patient care.

The findings were:

The facility policy entitled "Emergency Crash Carts" #1317370 dated 2/15 reflected in part "Nursing will check the crash cart monthly for expired non-pharmaceutical supplies and replace as needed."

During a tour of the facility on the afternoon of 5/16/16 and the morning of 5/17/16, the following medical supplies were found in patient care areas available for use.
1. Found in the PACU difficult intubation cart: ultrasound gel, 20 gm packets, 3 expired 4/15; 21 gauge x 4" insulated needle, expired 8/15; 14 Fr stylet, expired 6/15.
2. Found in the PACU malignant hyperthermia cart: multilumen CVC kit, expired 3/16; radial artery catheterization set, 4 expired 12/15; arterial blood sampler, 3 expired 3/16; red & yellow top lab tubes, 3 expired 11/15; blue top lab tubes, 3 expired 9/15; grey top lab tubes, 2 expired 6/15; green & yellow top lab tubes, 6 expired 12/15; purple top lab tubes, 3 expired 8/15; 16 Fr Foley catheter, expired 1/16.
3. Found in OR #3: collection & preservation swab kit, 2 expired 4/16.
4. Found in OR #4 anesthesia cart: radial artery catheterization set, 3 expired 12/15.
5. Found in OR #4 circulator cart: povidone iodine swabsticks, 1 package expired 11/15.
6. Found in Respiratory Therapy: Cidex test strips, partial jar of 60, expired 4/16.
7. Found in Ultrasound Room #1: 10% buffered formalin specimen transport container, 5 expired 3/14; povidone iodine swabsticks, 2 packages expired 8/15.
8. Found in Ultrasound Room #2: 10% buffered formalin specimen transport container, 2 expired 3/14.
9. Found in the Therapy storage room: Tubigrip support bandage, 2 boxes of 10, expired 3/15; Vac Granufoam dressing, expired 4/16.
10. Found in the Therapy exam room: Betasoft surgical scrub, 8 oz. bottle, 3 expired 6/14.
11. Found in the Therapy OT area: Saline wound wash, 7.1 oz. can, expired 1/16.

In an interview with the CNO, staff #2 during the tours on the afternoon of 5/16/16 and the morning of 5/17/16, staff #2 agreed the above listed supplies were expired.

INFECTION PREVENTION CONTROL ABX STEWARDSHIP

Tag No.: A0747

Based on review of documents, observation, and interview, the facility failed to provide a sanitary environment for patient care, as hinged surgical instruments were found available for use that had been processed in the closed and/or clamped position which potentially could have resulted in inadequate sterilization of these instruments. Immediate use (flash) sterilization processing was used to process the instruments for 79% of the cataract surgery cases performed at the facility in the first quarter of 2016 which potentially could have resulted in inadequate sterilization of these instruments. The Cidex glutaraldehyde solution used to disinfect the endovaginal ultrasound probe was not checked with test strips as recommended by the manufacturer which potentially could have resulted in inadequate disinfection of the probe. There were also dust, drips on equipment and items available for use in patient care, unwrapped laryngoscope blades, insufficient external door seals, expired infant formula, tears in vinyl coverings, contaminated boxes stored next to patient supplies and other areas in need of cleaning.

Cross refer to:

CFR 482.42(a) Infection Control Officer(s) A0748
CFR 482.42(a)(1) Infection Control Program A0749

INFECTION CONTROL PROFESSIONAL

Tag No.: A0748

Based on observation, review of documentation and interviews with facility staff, the facility failed to effectively develop and implement infection control policies as demonstrated by the following. Hinged surgical instruments were found available for use that had been processed in the closed and/or clamped position which potentially could have resulted in inadequate sterilization of these instruments. Immediate use (flash) sterilization processing was used to process the instruments for 79% of the cataract surgery cases performed at the facility in the first quarter of 2016 which potentially could have resulted in inadequate sterilization of these instruments. The Cidex glutaraldehyde solution used to disinfect the endovaginal ultrasound probe was not checked with test strips as recommended by the manufacturer which potentially could have resulted in inadequate disinfection of the probe.

The findings were:

The Centers for Disease Control (CDC) article entitled Guideline for Sterilization and Disinfection in Healthcare Facilities dated 11/2008 reflected in part "Once items are cleaned, dried, and inspected, those requiring sterilization must be wrapped or placed in rigid containers and should be arranged in instrument trays/baskets according to the guidelines provided by the AAMI and other professional organizations. These guidelines state that hinged instruments should be opened ... Flash sterilization is a modification of conventional steam sterilization (either gravity, prevacuum, or steam-flush pressure-pulse) in which the flashed item is placed in an open tray or is placed in a specially designed, covered, rigid container to allow for rapid penetration of steam. Historically, it is not recommended as a routine sterilization method because of the lack of timely biological indicators to monitor performance, absence of protective packaging following sterilization, possibility for contamination of processed items during transportation to the operating rooms, and the sterilization cycle parameters (i.e., time, temperature, pressure) are minimal ...Flash sterilization should not be used for reasons of convenience, as an alternative to purchasing additional instrument sets, or to save time."

Cidex Product Literature reflected in part "To ensure each CIDEX® Solution efficiently destroys microorganisms, the minimum effective concentration (MEC) required for high-level disinfection should be tested with the appropriate CIDEX® Test Strip prior to each usage. CIDEX® Activated Glutaraldehyde Solution may be used or reused for up to a maximum of 14 days provided the required condition of activated glutaraldehyde concentration and temperature exist based upon monitoring described in the Instructions for Use. Do not rely solely on days in use."

During a tour of the surgery department on the afternoon of 5/16/16, the following hinged surgical instruments that had been processed in peel packs were observed to be in the closed and/or clamped position: sponge forceps, 3 sets; tenotomy scissors; suture scissors; and potts scissors. In an interview with the surgery director, staff #18 during the tour on the afternoon of 5/16/16, staff #18 agreed the above listed instruments were in the closed and/or clamped position.

During a tour of the surgery department on the afternoon of 5/16/16, the flash sterilization log was reviewed and a large number of immediate use (flash) sterilization runs of cataract instruments were observed. In an interview with the surgery director, staff #18 during the tour on the afternoon of 5/16/16, staff #18 was asked for statistics regarding the number of immediate use sterilizations of cataract trays and the number of cataract cases done. Staff #18 provided the following statistics: January 2016, 17 immediate use sterilizations out of 21 cataract cases or 81%; February 2016, 38 immediate use sterilizations out of 48 cataract cases or 79%; March 2016, 42 immediate use sterilizations out of 54 cataract cases or 78%. Staff #18 stated the facility did not have enough cataract instrument trays to perform the normal sterilization process with the number of cataract cases being done per day.

During a tour of the imaging department on the morning of 5/17/16, a Cidex container was observed in ultrasound room #1 which had an ultrasound machine with an endovaginal probe. The ultrasound tech, staff #15 was asked if the Cidex solution was used to disinfect the endovaginal probe and staff #15 stated it was. Staff #15 was asked if the concentration of the Cidex was being checked with test strips before use and staff #15 stated the Cidex was not being tested.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observation and interview, it was determined that the facility failed to provide a sanitary environment in all areas of the hospital as there were dust, drips in equipment and items available for use in patient care, unwrapped laryngoscope blades, insufficient external door seals, expired infant formula, tears in vinyl coverings, contaminated boxes stored next to patient supplies and other areas in need of cleaning.

Findings included:

During a tour of the facility the afternoon of 5/17/16 accompanied by Staff #2, the following was observed:
1. The glucometer cases (3) in the Med/Surg nurses station, the Women's services nurses station, and the Emergency Department were dirty and in need of cleaning as there were dust, dirt, and drips inside the case where the glucometer, lancets, gauze, controls, and alcohol preps were stored. This presents a risk of cross contamination.
2. There were laryngoscope blades which were stored unwrapped or had not been packaged and stored in a way to prevent contamination. It could not be determined that the laryngoscope blades had been processed by sterilization or high level disinfection in accordance with current standards of practice. Unwrapped laryngoscope blades were found in the Med/Surg crash cart and in Women's Services.
3. The ICU supply room floor was in need of cleaning as there were observed raised fluffs of dust and other debris on the floor.
4. The external doors on the north side of the facility and in the materials management supply storage department had insufficient door seals or weather stripping, leaving a gap between the doors and the frame with outside light visible seen from inside the building. The lack of weather stripping or seals prevents a risk for contamination from the weather and the entry of insects, rodents, and other environmental contaminants such as dust and debris.
5. A labor and delivery patient bed in LDR room 2, available for patient use, per Staff #2, was observed by the surveyor. There were 3 dried reddish drips observed on the bed, which were easily removed by the surveyor with an alcohol prep pad. This indicated the equipment had not been thoroughly cleaned or disinfected. This presents a risk for cross contamination. There was a layer of dust on horizontal surfaces, including patient care equipment and a dirty tape/sticker residue observed on equipment in the room.
6. In LDR room 3, there was a bottle of Similac Advance infant formula, 2 fluid ounces, available for patient use which expired 1/Jan/2016. There was a layer of dust on high and low horizontal surfaces, including patient care equipment.
7. In the C-Section OR in Women's Services, available for use in patient care, there was a dried, dark reddish streak approximately 1 1/8 inches long on one of the delivery bed stirrups. This reddish area was easily removed with an alcohol prep pad by the surveyor, indicating the equipment had not been thoroughly cleaned or disinfected.
8. In the C-Section OR in Women's Services, there were 2 scissors observed which had been sterilized in the closed position, therefore not all surfaces were exposed to the sterilizing agent preventing effective sterilization.
9. In the C-Section OR in Women's Services, available for use in patient care, the OR table arm board had 5 tears in the vinyl covering. The tears on the upholstery exposed the porous material beneath the vinyl covering. This porous material cannot be adequately cleaned or disinfected between patients, and could harbor pathogens.
10. In the Newborn Nursery, 3 out of 3 infant cribs had mattresses which were old and the vinyl covering was cracked, with tears and holes. One mattress had a seam which had unraveled approximately 8 inches, leaving the internal porous foam exposed, which was stained. This porous material cannot be adequately cleaned or disinfected between patients, and could harbor pathogens, presenting a risk for cross contamination.
11. In the Emergency Department, there was a contaminated external shipping box stored on the shelves in the Clean Utility Room with patient care supplies, available for patient use, including catheters, gauze, vaginal speculums, and bed pans. Storing patient use items in contact with a contaminated external shipping box/container, makes cross contamination likely.
12. In the Emergency Department Triage room, there were 2 large dirty external shipping boxes stored on the Ebola Cart, in a patient care area with other supplies for use in an emergency. "External shipping containers have been exposed to unknown and potentially high microbial contamination. Also, shipping cartons, especially those made of corrugated material, serve as generators of and reservoirs for dust." (AAMI ST46-Section 5.2 Receiving items)
13. In the Emergency Department Clean Utility room and in the Supply room, the floor was in need of cleaning as there were black spots and dust and debris on the floor. There was a dirty broom with raised fluffs of dust clinging to the broom which was leaned up against the wall next to the shelves storing patient supplies.
The above findings were confirmed during the tour of the facility the afternoon of 5/17/16 with Staff #2, Chief Nursing Officer.