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Based on observation, record review and interview, the facility failed to ensure products utilized for care and services on patients by staff of contracted service ( hemodialysis) were not passed manufacturer's expiration date and were utilized according to manufacture's specification in 2 of 2 contracted staff observed providing hemodialysis to patients. Staff #s 6 and 7

Findings:
Observation on 12/03/2013 at 12:04 p.m. on the facility's hemodialysis suite revealed the following expired items were observed stored on the cart in the overflow stock room:
One container HiSENSE ultra total chlorine testing strips lot # 062101 which expired 10/13.
One container Serim Guardian blood leak strips expired 11/13.
These strips are utilized to test feed water used on hemodialysis patients for total chlorine and the presence/ absence of blood.

During an interview on 12/03/2013 at 12:04 p.m. with contract dialysis staff nurse #6, he stated that the strips were used to test blood leak and that he should have identified that the blood leak strips were expired.

Review of the manufacture's instruction on the product insert for HiSENSE Ultra Total Chlorine Testing strips directs users as follows:
" SERIM GUARDIAN (Trademark) HiSENSE ULTRA 0.1 (Trademark) Test Strips provide a quick and convenient means for indicating low levels of total chlorine (chloramines/free chlorine) in feed water used to prepare dialysate."
" Do not use a test strip (from an opened or unopened bottle) after the expiration date printed on the bottom of the bottle. "
Review of the manufacture's instruction on the product insert for Serim Guardian blood leak strips directs users as follows:
" Serim GUARDIAN BLOOD LEAK Test Strips provide a rapid method to test dialysate for blood if a dialyzer membrane leak is suspected during the hemodialysis procedure. Do not use a test strip (from an opened or unopened bottle) after the expiration date. "

On 12/03/2013 at 11:46 a.m. Registered Nurse #7) was observed in MICU unit initiating hemodialysis treatment on patient #8.
During an interview on 12/03/2013 at 11:47 a.m. with contract hemodialysis staff #7 the Surveyor asked him how he validated the Conductivity and PH of the dialysate solution. He said he had used the test strip to validate the PH of the dialysate solution. He said he had removed the strip from the container and brought it to the MICU unit to test for the PH of the dialysate solution.

Subsequent observation on 12/03/2013 at 12:05 on the facility's hemodialysis suite, revealed Registered Contract Nurse #6 showed the surveyor a container with strips used for testing PH of dialysate solution ( RPC K100-0117). He stated that there was only one bottle in the building and so it is used between patients on different floors.

Review of the manufacture's instruction on product usage instructs users as follows:
Indications for Use
K100-0117 E-Z Chek® 6.8 - 8.5 pH Test Strips are indicated for use in testing the pH of acid/bicarbonate
dialysate and bicarbonate concentrate. There are no other indications for use.
Directions for Acid/Bicarbonate Dialysate or Bicarbonate Concentrate
1) Remove one strip from the bottle and immediately recap the bottle.
2) Dip the strip into the solution to be tested and move back and forth for one second.
3) Remove the strip and shake off excess liquid. After 10 seconds, compare the strip to the color chart on
the bottle.
4) Match the strip as closely as possible to one of the color scales on the bottle. Read the pH listed above
the matched colors. Colors that are between two scales indicate a pH that is between the two values for
those scales.
Warnings and Cautions
„h Do not touch the indicator pads.
„h Keep all unused test strips in the original bottle.
„h Replace cap immediately/tightly after removing a strip.
„h Do not use test strips from an opened or unopened bottle after expiration date printed on the bottle label.
„h Do not allow the test strip to come in contact with liquids or with work surfaces that may contaminate the strip.
„h Do not leave test strips in areas exposed to vapors of any type.
.

Based on observation, record review and interview, the facility failed to ensure the Food Service Manager managed the dietary services for outdated and mislabeled food supplies, environmental sanitation, and proper use of the dishwashing machine and three compartment sink for sanitation.

Findings include:

Observation on 12/03/13 at 10:40 a.m. with Chef #3 and Clinical Nutrition Manager #4, during initial tour of the kitchen, revealed the following food items improperly labeled or stored:

Cooler #1
1. Molded strawberries
2. Beef base in a container with no use by date or date when opened
3. One (1) bowl of raw chicken labeled " prep 11/21/13 "

Interview with Chef ID #3 at this time, she stated the date was incorrect; it was actually prepped on 12/02/13.

Cooler #2
1. Cut up bell peppers with use by date of 12/1/13
2. One (1) large box of mixed salad greens labeled on box by manufacturer "use by 12/01/13"

Cooler #3
1. Plastic bottle of Salsa with a paper label use by date of 11/15/13. The bottle had a use by date of 11/23/13.
2. Plastic bottle of Sweet and Sour sauce with use by date of 11/15/13.
3. Plastic bottle of Szechwan sauce with no use by date or date opened.
4. Bottle of Dijon dressing with no use by date or date opened.
5. Jar of Chipolti sauce with use by date of 5/5/12.
6. One (1) bag of cheese cubes: opened and not dated
7. Two (2) bags of cheese cubes labeled by manufacturer use by "11/24/13"
8. One (1) gallon of mayonnaise, opened not dated
9. One (1) gallon of horseradish, opened not dated

Interview with Chef ID #3 at this time of observation, she stated, "All foods should be dated when opened." She said the gallon jars of mayonnaise and horseradish were good for 30 days after opening.

Record review of the Food & Nutrition Services Expired/Recalled Products P&P dated 11/2015 revealed the following:
" I. POLICY AND GENERAL STATEMENT
Outdated ...nutrition products are not provided to patients ...
To develop a mechanism to ensure the retrieval and safe disposition of expired ...nutrition products.
II. PROCEDURE
...b. Expiration dates are checked prior to each use.
c. Outdated ...products are discarded immediately or returned to the manufacturer for credit ...
e. All ...expired goods are kept in a separate location while awaiting return."

Record review of the Food & Nutrition Services Labeling of Food Supplies dated 6/2013 revealed the following:
" III. PROCEDURE
1. All in-use and stored foods must be labeled with the following information:
Product Name
Preparation or Opening Date
Use By Date

2. All foods must be discarded by the manufacturer's 'Use By/Best Before' Date or the documented 'Use by Date'.

Further observations at this time revealed the following:
Dry storage area
1. Grey plastic storage flat was dirty with grime and dust.
2. Seven wire racks had a build-up of dust and dirt on the lower legs and support ledges.
3. There was a large amount of trash, dirt and grime under approximately 120 feet of stationary wire racks against the wall.
4. There were five white, rolling bins storing grain and sugar that were dirty with dust and dirt. There was a large amount of trash, dirt and grime under the bins.

General Kitchen area
1. The back section of the meat slicer was dirty with dried on food particles.
2. There was a blue food scoop and a clear plastic cup lying on top of granola in a plastic storage bin.
3. There was a clear plastic cup lying on top of sunflower seeds in a plastic storage bin.
4. There was a thick layer of black grime around the holder for the can opener.
5. The mixer had a thick build-up of grime in the crevices of the stand.
6. The top of the rolling rice bin had dirt and grime.
7. There was a thick build-up of black baked on grime on the tilt skillet.
8. There was an accumulation of dirt, grease and grime on the sides and front bottom lip of the warmer.
9. There was a thick accumulation of black, baked on grime on the back of the griddle.

Interview on 12/03/13 at 10:50 a.m. with Chef ID #3 she stated, "The kitchen was terminally cleaned once a week."

Interview on 12/3/13 at 10:55 a.m. with Chef #3, she said scoops should not be kept in the containers.


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Record review of the Food & Nutrition Services Sanitation Program Policy and Procedure (P&P) dated 7/13 revealed the following:
" General Statement
The Food and Nutrition Services Department maintains a sanitation program to maintain a clean, safe, and effective environment of care and to prevent the transmission of disease-carrying organism through food and food contact services.
PROCEDURE
A. The Food Service Director/General Manager monitors cleaning and sanitizing schedules ....See attached cleaning schedule ....
Meat Slicer - Daily
Tilt Skillet - Daily
Deep Fat Fryer - Weekly
Can Opener - Daily
Warming Oven - Weekly
Floors - Daily
Shelving - When needed..."

Record review of the Food & Nutrition Services Can Opener Sanitation P&P dated 11/2015 revealed the following:
" ...C. The base is scrubbed with general purpose cleaner.
D. If the base needs additional cleaning, the base is removed from the mounting and scrubbed with an abrasive pad ... "

Dishwashing Machine/Three Compartment Sink
Observation on 12/5/13 at 10:15 a.m. with Chef #3, Clinical Nutrition Manager #4, and the Food Service Manager #42 of the pots/pans cleaning area revealed a three compartment sink with each section filled. The third sink had quaternary ammonium as the sanitizing agent.

Interview at this time with the dishwasher, staff #43, he said he checked the concentration of sanitizing agent in the third sink three times a day. He then pointed to a log sheet that was posted by the sink.

Further observation on 12/5/13 at 10:20 a.m. of the dishwashing machine revealed there was no obvious sanitizing chemical behind the machine.

Interview at this time with the Food Service Manager #42, he was asked if there were any sanitizing chemicals for the machine. He said, "No." He was asked if the machine was a high temperature machine. He said it was.

Observation at this time revealed a log posted on the wall where temperatures for the machine were written. There were sections for documenting temperatures three times a day. The Rinse section had a minimum of 160 degrees Fahrenheit (F) to a maximum of 200 degrees F. Manager #42 was asked for the dishwashing machine manufacturer's instructions.

Record review of the dishwashing machine manufacturer's instruction booklet on page 6 under Recommended Minimum Temperatures revealed "NOTE: Refer to the HOT WATER SANITIZING label on the right side of the control box for minimum temperature ratings." There was nothing in the booklet that showed chemicals were to be used for sanitizing.

Observation on 12/6/13 at 8:45 a.m. of the warewashing machine with Food Service Manager #42 revealed the label for the minimum temperature rating was not seen anywhere on the machine. Manager #42 was asked to show how the range from 160 degrees F. to 200 degrees F. was established. By the time of exit on 12/6/13 at 3:00 p.m., Manager #42 had not brought any information.

Further observations and interviews on 12/6/13 at 8:45 a.m. of the three compartment sink revealed dishwasher staff #43 had just refilled all the sinks. There were two containers of quaternary ammonium strips and three containers of chlorine strips in a holder on the wall by the three compartment sink.

Interview with Food Service Manager #42 at this time, he was asked if he used the chlorine strips for anything in the kitchen. He said he did not have anything that used chlorine. He removed the strips. Food Service Manager #42 was asked to check the level of sanitizing fluid in the third sink. The quaternary strip was in the water for 10 seconds as recommended, but it did not change color. The printed instruction sign over the sink noted the level of sanitizing solution should be between 150 and 400 ppm (parts per million). Dishwasher staff #43 said he had already checked the level for that morning and it was alright. Manager #42 saw the quaternary ammonium bottle under the sink was empty. Manager #42 was asked if the third sink should be checked more often than three times a day. He said it should be checked each time the sink was refilled.

Record review of the Food and Nutrition Services' P&P for the three compartment sink washing dated 7/2013 revealed the following:
"III. PROCEDURE
...D. Sanitizer is added to the final sink. Sanitizer test strips are used to monitor the concentration of the sanitizer. These strips are recorded on the sanitizer solution log...
F. Once the pans are washed, they are rinsed in the second sink and then placed into the sanitizer for 2-3 minutes...."

At 9:10 a.m. Manager #42 gave the surveyor a bottle of chlorine and said that was the chemical that was being used in the dish machine.

Interview on 12/6/13 at 10:10 a.m. with Clinical Nutrition Manager #4, she said the dishwashing machine was a low temperature machine and used chlorine to sanitize in the final rinse. She said an outside vender set up the machine to use chlorine in the final rinse, if the machine did not reach 180 degrees F. She verified that they did not record the chlorine concentration when they checked the machine.

Record review of the facility's P&P for Washing Dishes dated November 2012 revealed the following:
"II. PROCEDURE
....G. Dish machine temperatures are taken at each meal period. If a temperature is noted to be out of range the dish room associate notifies the manager immediately and documents a corrective action on the temperature log.
H. Test strips must be utilized....
J. If sanitizer is not being used Final Rinse temperature must be 180."

Record review of the warewashing machine logs revealed the following:
October 2013
Out of 93 readings, 86 were below 180 degrees F. There was no documentation the chlorine level was checked or any corrective action.

November 2013
Out of 90 readings, 84 were below 180 degrees F. There was no documentation the chlorine level was checked or any corrective action.

December 2013
Out of 12 readings, 11 were below 180 degrees F. There was no documentation the chlorine level was checked or any corrective action.

Interview on 12/6/13 at 1:00 p.m. with outside vendor #44 for the dishwashing machine, he said the machine was a high temperature sanitizing machine. He said that the manufacturer's label was in a difficult place on the machine to see. The minimum temperature for the machine was 180 degrees F. He agreed that using the chlorine and the high temperature to sanitize was confusing and a duplication. He was asked if he had contacted the manufacturer of the dish machine before he changed it to use chlorine. He denied he altered the machine. He was asked if the machine could alert staff when the chlorine level was low or out. He said not like it was now. He would have to add something to alert staff. He said he was going to change the machine to a low temperature machine with water to be between 120 and 160 degrees F. and use chlorine. He said that should stop the confusion.
Record review of the Texas Food Establishment Rules (TFER) dated 9/2006 revealed the following:
229.165(f)
"(13) Warewashing (dishwashing) machine, data plate operating specifications. A warewashing machine shall be provided with an easily accessible and readable data plate affixed to the machine by the manufacturer that indicates the machine's design and operating specifications including the: (A) temperatures required for washing, rinsing, and sanitizing;..."
229.165(k)
"(12) Mechanical warewashing equipment, hot water sanitization temperatures.
(A) ....in a mechanical operation, the temperature of the fresh hot water sanitizing rinse as it enters the manifold may not be more than ...(194 degrees Fahrenheit), or less than:...
(ii)...(180 degrees Fahrenheit).

Based on observation, interview and record review the facility failed to have systems in place: 1)to ensure high touch partition curtains in patient rooms were cleaned;

2) Staff failed to use proper aseptic technique when preparing intravenous medication for administration; and

(3) Failed to wash their hands after removing used gloves and prior to handling clean equipment..

This failed practice had the potential for the spread of infection to staff and patients. Citing random observations on three (3)of five(5 patient care units.Unit 6, Infusion Unit and the Medical Intensive Care Unit.

Findings:

Observation on Medical/ Surgical Unit (6) on 12/4/2013 at 1:30 PM eight (8) occupied patient rooms had curtains drawn across the entrance to the rooms.

Observation in the Infusion Unit on 12/5/2013 at 11:23 am revealed six(6) occupied patient bays with drawn curtains across the entrances. Staff, patient and family members on the units at time of observation were handling the curtain several times while entering and exiting the patient bays and rooms. The curtains were high touch areas.

During an interview on 12/4/2013 at 2:15 pm on Unit 6 with Staff (#38) Housekeeping regarding cleaning of the curtains at the entrance to patient rooms she stated the curtains were inspected and if they were soiled they would be reported to her supervisor, she stated she did not know what the next step was.

During an interview on 12/4/2013 at 2:25 pm with the Nurse Manager (#40) on Unit (6) she stated there were no protocols for cleaning the curtains in patient rooms. She stated the curtains were not routinely changed when a patient is discharged from a room unless the patient was on isolation.

During an interview on 12/5/2013 at 11: 35 am with theNurse Manager(#39) on the Infusion Unit regarding cleaning of the curtains at the entrance of the patient bays, she stated there was no cleaning schedule for the curtains ,she believes the curtains would be taken down if they were visibly soiled.
when asked how long the curtains were up the Manager stated the curtains had been up since August 2012 when the unit was first opened and were never removed.

During an interview on 12/5/2013 at 1:40 pm with the infection control director(#26) she stated there were no policies for cleaning the curtains used in patient rooms. She stated this was an area that was not previously identified as a potential infection source and will be looked at going forward.

Observation on the Infusion Unit on 12/5/2013 at 11:40 am revealed Staff (# 27) Registered Nurse was preparing intravenous Dexamethasone for administration. The Staff did not clean the port of the medication vial prior to withdrawing the medication , she then injected the medication into two separate 10 cc syringes of normal saline without cleaning the hubs of the syringes or change the needle.

Review of the facility's Infection Control Policy dated 7/17/2013 titled "steps common to all methods or intravenous medication administration'',documented the following information:

'Cleanse all ports on medication vials and IV systems with alcohol swab and allow to dry."

During an interview on 12/5/2013 at 2:10 pm with Staff (# 41) Infection Control Nurse she stated in-services would be done to re-educate the staff.


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Contract RN#7
On 12/03/2013 at 11:46 a.m. contract registered nurse #7 was observed in the medical intensive care unit cannulating patient # 8. The patient had a vascular access to her left arm. During the process the nurse donned a pair of gloves which he secured from a box of gloves stored on the wall near the hand washing sink. After cannulating the patient's vascular access, the nurse removed his contaminated gloves. He then proceeded to the box of clean gloves stored on the wall and picked up a new pair of gloves which he donned. The nurse did not wash/ clean his contaminated hands after removing the contaminated gloves.
Registered nurse #7 donned a new pair of gloves connected the patient's external blood line to the vascular access and initiated hemodialysis treatment on the patient. After initiating the treatment, registered nurse #8 removed his contaminated gloves, and walked over to the treatment sheet which he stored on top of the dialysis machine . He did not wash/ clean his hands in between connecting the patient ' s blood line and handling the patient's treatment sheet.

Interview on 12/03/2013 at 11:48 a.m. with registered nurse #7, the Surveyor informed him that he did not wash/ clean his hands in between cannulating, connecting the blood line, removing his contaminated gloves and handling the patient 's treatment sheet with his contaminated. He stated " Even with clean gloves.

Review of the facility's hemodialysis contracted policy and procedure ( policy # 7-03-02) directed staff as follows : " Hands will be washed upon entering the hospital /facility, prior to gloving, after removal of gloves between patients, after contaminated machines contact, between patients before touching clean areas such as counters tops, supply carts or medication carts and at the close of business day prior to going home. "

Staff #24
On 12/04/2013 at 9:15 a.m. during tour of the facility's endoscopy suite, Endoscopy Technician #24 walked into the decontaminated room of the suite holding a contaminated blue container with contaminated scope. She was wearing a pair of gloves. The technician placed the contaminated container with the scope on the dirty counter. She then used her contaminated gloved hands to retrieve a clean container to take to the endoscopy suite. She did not remove her gloves and wash/ clean her contaminated hands before handling the clean container.
The Facility's Nurse Manager was present in the hallway, the Surveyor notified him of her observation.