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Based on observation and Interview, the Dialysis services provided under a contract were not provided in a safe and effective manner.


Based on observation, interview and policy review, the facility failed to ensure that the environment of care for the dialysis unit was maintained in a manner that ensured an acceptable level of safety and well-being of patients, staff and visitors. The facility failed to ensure that supplies were stored in such a manner to ensure their safety (protection against contamination, or deterioration).The hospital failed to ensure that staff were testing equipment properly prior to use.


Observations conducted on 05/25/16 of facility's inpatient dialysis unit with Director of dialysis therapies and rehabilitation, as well as the Quality Director and Director for contracted inpatient service present revealed the following concerns:


Findings included:


Observation of AC 15 at 1010 AM showed machine tested at 0745 that morning. Blood line not in occlusion clamp. BFR at 150. Interview with S95 at 1010 AM stated machine doesn't "necessarily have to have blood line in chamber" to test. S95 also stated ok to run machine at 150 because it was not actually recirculating the system. When surveyor asked S95 what the policy stated he stated that the policy states that blood line is supposed to be in the chamber to test.

Machine AC 15 at 1030 AM - last test was at 0745 that morning. Hanson connectors were not connected and blood line not in blood occlusion clamp. S96 cannulated patient then took machine out of bypass, connected the Hanson, attached transducers, discarded saline from arterial and venous port , attached lines to patient and initiated treatment. Verified with S93 that machine was supposed to have been recirculated prior to initiation of treatment. Neither Hanson connectors or blood line in occlusion clamp for proper testing and recirculation of machine prior to initiation. Also verified that machine had been tested at 0745 AM and treatment started at approx. 1030 which is over 2 hour time and recirculation should have been performed. (per hospital policy).

Drawer 1 (located under "clean" sink on treatment floor): Machine cranks, white clamp, used uptake wands, blue clamps for patient machines.

Drawer 2: Bleach uptake wands (corroded and rust inside), 7 containers used for bleach 2 with no name, and 1 with no HMI labels or solution label. Suction canisters observed in drawer, S95 stated they were used to vinegar machines. Wide open mouth states an uptake wand is placed in the container. Solution remains open to air and particles during uptake of solution.

Review of policy FMS-CS-IC-I-105-OOC5- after prime " place venous bloodline in the occluding clamp below the air detector and close optical detector door ..." Perform test on machine "Hanson connectors must be attached to the machine" "Recirculate the extracorporeal system" " once the extracorporeal system is free of air turn the dialysate flow rate down to 300 ml/min for the remainder of the circulation period until treatment is initiated. Dialyzers primed for longer than two hours must again be recirculated using increased ultrafiltration rate for 5 minutes prior to initiation of patient treatment."

Review of Machine logs for Daily Machine Check Log for dates 5/2/16-5/24/16 of machines identified at A8, AC38, AC15:

Rows to be filled out for log completion:
Top: Date, treatment #, operator initials, and time-Dialysis machine (identifier), Diasafe test (Pass/Fail).
Middle section: Disinfection portion: Machine external cleaning post tx (initial), Vinegar (initial and time), Heat Disinfect (initial and time), Bleach disinfect (initial and time) , Positive result for bleach in machine (>500), negative residual test result for bleach in machine (<0.5), wands-caps-jugs disinfected (yes/no), Positive presence test result for bleach wands-caps and jugs (<0.5). Bottom of log: Meter used (specify ID number of meter)-Operators initials -Meter Cal: conductivity (n/a)

3/3 machine reviewed had incorrect documentation to include missing information of times for disinfection, illegible documentation in boxes for disinfection and dates, inconsistent documentation on each log though each log required same information. Areas not filled in appropriately and either marked through with a line or word "phoenix" documented through several boxes to include one designated for signature. Boxes with "strike through" with no initials to indicate why information was crossed out.

Documentation concerns regarding appropriate machine maintenance reviewed with S93 and Quality Director on 5/25/16.

Based on observations, interview and record review, Facility I campus did not meet the requirement in that outdated drugs were available for patient use in operating room #3 and the medication refrigerator in the post-anesthesia care unit.

Findings included:

During a tour of operating room #3 at Facility I with the Director of Nurses for Perioperative Services on 05/25/2016 at 10:36 a.m., a 1 inch x 2 inch Surgicel SnoW with " expiration date 2016-03 " was observed in a cabinet and available for use.

In an interview on 05/25/2016 at 10:36 a.m., the Director of Nurses for Perioperative Services confirmed that the Surgicel had expired in March of 2016. When asked how often expiration dates are checked, she stated, " We go thru them monthly. "

During a tour of the post-anesthesia care unit at Facility I with the Director of Nurses for Perioperative Services and the Nurse Manager for Perioperative Services on 05/25/2016 at 11:35 a.m., observations of the medication refrigerator revealed outdated medications available for use including two unopened 10 ml vials of Succinylcholine 200 mg (20 mg/ml) both with " expiration date 1 Mar 2016, " one opened 3 ml vial of Humalog 100 units/ml U-100 and one opened 3 ml vial of Humulin R 100 u/ml U-100 with an expiration label affixed with a hand written date for both of " 5/17/16. "

Based on observation, interview, and record review, the facility failed to ensure that food and dietetic services organization requirements were met and in accordance with the facility's policies and Texas Food Establishment Rules (TFER). Specifically, the facility and the Director of Food Nutrition Services (FNS) failed to ensure:


1.) The overall maintenance, cleanliness, and sanitization of the food and nutrition's service areas; floors, wall, ceilings, and equipment were in good repair and; free from dust and debris.

2.) Food intended for patient use was properly stored, labeled, and dated.

3.) Expired food was discarded and not available for use.

4.) The automatic warewashing machine was working properly including the required temperatures.

5.) Sanitizer test strips were available for use and for testing the sanitization of dishes.

6.) Drain board areas were clean and free from contamination.

7.) Temperature logs for equipment and serving foods were completed as required with corrective action noted for temperatures out of range.

8.) Hot water, antibacterial or antimicrobial soap were available at the hand washing sinks for staff preparing and serving food.

9.) Staff were hand washing frequently and changing gloves that were dirty or contaminated.

10.) Dishes that were chipped and/or cracked were removed from use.


This deficient practice could place the Patients and employees at risk of obtaining food borne illnesses and/or infections.

Refer to A620 for evidence of specific findings.

The cumulative effect of these deficient practices resulted in the facility's inability to meet the Condition of Participation for Food and Dietetic Services.


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35755

Based on observation, interview, and record review, the facility failed to ensure that food and dietetic services organization requirements were met and in accordance with the facility's policies and Texas Food Establishment Rules (TFER). Specifically, The Director of Food Nutrition Services (FNS) failed to ensure:


1.) The overall maintenance, cleanliness, and sanitization of the food and nutrition's service areas; floors, wall, ceilings, and equipment were in good repair and; free from dust and debris.

2.) Food intended for patient use was properly stored, labeled, and dated.

3.) Expired food was discarded and not available for use.

4.) The automatic warewashing machine was working properly including the required temperatures.

5.) Sanitizer test strips were available for use and for testing the sanitization of dishes.

6.) Drain board areas were clean and free from contamination.

7.) Temperature logs for equipment and serving foods were completed as required with corrective action noted for temperatures out of range.

8.) Hot water, antibacterial or antimicrobial soap were available at the hand washing sinks for staff preparing and serving food.

9.) Staff were hand washing frequently and changing gloves that were dirty or contaminated.

10.) Dishes that were chipped and/or cracked were removed from use.


This deficient practice could place the patients and employees at risk of food borne illnesses and/or infections.


Findings included:


Observations conducted on 05/24/16 from 10:15 AM to 12:15 PM of facility A's Food and Nutrition Services (FNS) Kitchen area with the Director of FNS present, the Chief Operations Officer, the Quality Coordinator, and the Director of Facilities Management (FM) present revealed the following:


-Entrance into the kitchen was cracked and falling ceiling tiles observed.

-Dust on the tele tracking device on the ceiling.

-Upon entry into the kitchen there were flies and gnats observed.

-The automatic warewashing dish machine had a red alert that had been silenced from audible alarm and indicated the Final Rinse Temperature was only 91 degrees Fahrenheit. The digital reading on the machine indicated the temperatures were 153 degrees for wash, 163 degrees for rinse, 121 degrees for power wash, and 91 degrees for final rinse. The machine contained a notice that indicated the final temperature rinse must be 180 degrees

F. During observation, FNS employee A indicated the warning for the warewashing dish machine had been alerting since the start of the meal and that it was always alarming, and further stated the audible alarm had not worked in a while.

-The handwashing sink had no hot water and the digital read out from the FNS thermometer indicated the water was only at 74 degrees F. There was no antibacterial or anti-microbial soap available for use. The soap available was a lotion hand soap.

-Holding warmers with designated parameters of 140-160 was reading temperature range of 132 degrees with no intervention.

-The walls where the pots and pans were being washed at the 3 compartment sink had buildup of dust and debris that was large and covered the entire area.

-The drying area used for the pots and pans had white build up. The pans were stacked on top of each other not allowing air-dry.

-There was one trash can that was lined; trash inside with no lid.

-The floor tiles were discolored, had buildup substance, and food spillage throughout.

-Rust observed on metal corners of closet doorway.

- Base board by fridge located across from ice machine had duct tape along edge. Tape was rolling and folding in on itself. Dust and dirt in between wall and tape.

-Dirt and dust accumulated in floor corners and at base of walls throughout the kitchen area. Areas included walkway, dish cleaning area, food preparation area, food storage area, and tray set up area.

-Food shelves had uncovered mushrooms and sausage.

-Staff member observed washing dishes at the 3 compartment sink for pots and pans. The 3rd compartment water for sanitization appeared dirty. Further investigation showed no test strips for disinfectant verification prior to disinfection of dishes. No test strips were available at the designated location. The FNS Director located test strips, and performed test for Surveyor at this time. Strip showed disinfectant not within range initially.

-Food preparation area had a notebook on the counter that was open with a walkie talkie resting on the pages as well as a bag of tortillas, can of sesame oil next to binder was open with no lid over open spout.

-Fan placed on a shelf observed full of dust blowing over the meal preparation area below. Surveyor confirmed with Director that fans were not to be over food.

-Area where dry food and individualized drinks were stored contained a metal sink, Director told surveyor that the sink was not in use. Metal sink had water stains, dust, and debris build up. 2 coffee carafes were inverted on the metal counter. Area around mouth of carafe where it was laying on metal counter showed visible buildup of sediment.

-Ice machine had large amount of dust and debris along vent area. Can labeled " filter monitor " attached to ice machine had white sediment build up and corrosion of metal on canister.

-In hallway beside the ice machine were metal shelves. Top shelf contents of dining room décor, shelf below had box of spoons which were open to air and elements, the spoons were located under the dining room decorations.

- Observation of mustard and mayonnaise bags not labeled next to spoons.

-Refrigerator across from Ice machine contained expired chopped tomatoes according to the food born date. Expired tomatoes verified with Chef.

- A refrigerator had a 2 Gallon metal pot with a liquid dated 05/20/16; but was not labeled to the type of liquid. There was a ½ gallon metal pot with a ladle sticking out that had no label to the type of substance or food inside the pot.

-Food cart located in hallway by ice machine had labeled contents of bacon bits, sunflower seeds, and granola - each food item missing date and time.

-Cart with dishes stacked on each shelf observed between food washing station and tray set up area. Dishes had dust and food sediment on various dishes. Brown liquid observed on dish canister located on bottom shelf of cart. Confirmed with staff in the kitchen that dishes on this rack were clean and to be used for food delivery.

-The metal vents for ventilation were dusty.

-Black food cart outside the refrigerator with food being placed onto for transport had food debris and spillage on the cart.

-Metal cart contained serving dishes that were cracked, separated, and the edges separated.

-The holding warming cart with Rice had a displayed temperature of 71 degrees.

-The refrigerator that had sparkling grape juice could not hardly be opened due to the door tracks had food debris and black spillage in the tracks of the sliding door. In the same area was a metal table; preparation area that surveyor identified brown granular substance on the shelf on metal container the contents labeled as sugar. The covering over top of container was not completely closed, leaving sugar open to air and exposed to particle. On same counter on bottom shelf, brown cardboard boxes were observed with multiple disposable food containers. Boxes were open and damaged on bottom of box. Liquid stains on box on side and bottom. Food containers in boxes were open to air and particle. Dust observed in food containers. The counter top contained food particles.
-Plastic white plastic containers contained food that was not labeled or dated. One container appeared to have granola.

-Staff on tray set up area observed with gloves, touching food, touching trays, touching food storage container then returning to food on the tray. No glove changes or hand hygiene between.

-Opened personal drink located on tray line were staff set up meal trays for patients

-Observation of chill blaster #1 panel error indicator for service needed.
Interview with Director during observation reported that storage area had been out for months and that no food was being stored in this particular blaster. Door opened by surveyor, food rack in storage area with carrots on the rack. Director stated that the chef maintained temperature logs for blaster. Temperature records for Chill blaster #1 requested and never produced for surveyor.


Continuous observations conducted for the two hour duration on 05/24/16 from 10:15 to 12:15 revealed no FNS staff were observed to utilize the handwashing sinks during changes in tasks.


During observations, and interview with the Director of FM at 10:15 AM indicated the facility had been changing out water pumps and that it may have had an effect on the temperatures of the automatic warewashing machine, and hand washing sink.


During an interview on 05/24/16 at 2:30 PM with the Director of FNS confirmed the above observations during walk through. The FNS Director stated he was hired 11/2015 and indicated the FNS quality assurance performance improvement (QAPI) focus was on the "timelines" that food was being served to the patients and the "accuracy" of the trays being served to include all items selected by the patient; with no missing items. The FNS Director stated the patient satisfaction was at "31%" which was not very high due to missing food items, and the food being late. The FNS Director reported his job duties as oversight was of the Chefs, operations, retail, and patient services. He stated he walked around and "glances" at walk in's and coolers. The FNS Director indicated he has had a staff shortage of 20% which has resulted in increased overtime and failure to complete the detailed cleaning schedules as expected. The FNS stated they were supposed to complete detailed cleaning of the walls, ceilings, and vents at least once a month. When the FNS Director was asked about his daily work activities he stated most of his day was spent reviewing emails, in meetings, nurse huddles, and monthly reports. The FNS Director reported monthly reports reviewed were turnover data, performance goals, and employee review. When asked to specify monthly reports if they included infection control, physical plant, or machine maintenance; the FNS Director stated that Chefs were responsible for monthly infection control and physical plant audits. The FNS Director stated that management of temperatures of fridges, freezers, and warmers were monitored by the Chefs.


During an interview on 05/24/16 at 5:40 PM with Chef A for FNS stated there were 5 managers and 10 supervisors who were responsible to manage the operation and systems of the FNS. Chef A stated it was the managers and supervisors responsibility to ensure the cleaning was being completed as scheduled and to ensure temperatures of the equipment and food were being completed completely and daily. Chef A stated their staffing was down 20% and they did not have a dedicated cleaning crew to ensure the overall cleanliness of the equipment and physical environment. Chef A stated with the focus being on serving food within a timeline, and ensuring the accuracy of each trey; it has resulted in the cleaning being neglected.


During an interview on 05/25/16 at 8:30 AM with the COO, she stated the FNS Director was a contracted service as well as the upper management of the FNS. The COO stated she had previously met with the FNS Director due to the cleanliness of the overall kitchen environment and the FNS Director assured he would take control and ensure the expectations for sanitation and environment were met as expected. The COO stated she had been working with the FNS Director to accomplish the staffing needed and they were hosting a job fair on this date.


The following facility records and policies were reviewed:

A.) Facility Internal Audits/Inspections:

Review of the Food Safety Audit dated 4/26/2016 revealed the following items were checked, "No."

-Handwashing. Hands Washed frequently and correctly, No

-Gloves changed when they are torn, dirty, or contaminated, No.

-Repeat food safety training for all employees conducted at least annually, No.

-All areas properly ventilated, No.

The documented corrective action plan on page 12 revealed the unsatisfactory condition observed was; "cleanliness, hand washing, changing gloves." The corrective action was to have training and counseling with employees; by 04/30/16.


Review of the Comprehensive Food Safety Self-Inspection dated 02/11/16 completed by the Food Service Director (FSD) revealed the following items were checked, "No."

-All food stocks rotated to avoid spoilage and assure freshness? Manufacture's expiration, "Use By" or "Sell By" dates followed? No.

-All foods prepared in operation are covered and labeled as to contents and date of preparation before placement in refrigerators and freezers? No

-Hand and fingernails clean, fingernails were trimmed, and no polish or artificial fingernails? No.

-Disposable gloves, tongs, or other dispensing devices used properly to handle ready-to-eat food? Disposable gloves changed with each activity or when gloves become torn or contaminated? No

-Washing, rinsing, and sanitizing procedures posted and followed at all potwashing and dishwashing stations in us? No. (Includes correct products, temperatures, procedures, sanitizer concentration and contact time, and dishwashing machine final rinse pressure and proper utensil racking).

-All ceilings and walls in good repair, easily cleanable and free of cracks, holes, and peeling paint? No.

Review of the Kitchen Inspection Checklist dated 02/05/16, completed by the Infection Prevention (IP) RN for facility A revealed the following areas/items were documented as "No" for non-compliance:

-Ready-to-eat, potentially hazardous foods which are stored for more than 24 hours after being processed or opened are dated marked with a 7 day expiration date. "No."

-Chemicals stored away from or below all food and food related supplies. "No."

-Wash and rinse cycle times and temperatures correct. "No."

-All food and single service items are stored at least 6 inches above the floor. "No."

-Floor free from food spillage, silverware, broken glassware, loose mats, torn carpets or other hazards. "No."


Review of the Healthy Work Environment (HWE) Environmental Tour Rounds for the 1st Quarter of 2016 and the 4th Quarter of 2015 revealed in the area of FNS that a "0" was scored which indicated non-compliant in the following areas:

-Floor surfaces and work areas are clean and free of clutter. "0"

-Supplies are stored appropriately and shelving is secure. "0"


B.) Review of the FNS Cleaning Schedules:

Review of the Facility's Cleaning Schedules included 10 designated areas of the kitchen; (veggie, fry, prep, entrée, morning, front house/service/dining area, salad, 1, salad 2, salad 3, and Host/Hostess Cleaning List). There also was a Facilities and Equipment Cleaning Schedule for the month of January. Review of these documented forms for all 10 areas revealed they were incomplete and not consistently reviewed/signed by a supervisor. There were only two veggie master cleaning schedules reported for the month of January and those were incomplete and not signed by a supervisor.


Further review of the Facility's Cleaning Schedules provided by the facility revealed no further documented evidence for 9 of 10 areas of the kitchen: (veggie, fry, prep, entrée, morning, front house/service/dining area, salad 1, salad 2, salad 3, and Facility and Equipment Cleaning Schedule) were provided after January 2016. Repeated requests were made for documented evidence of these cleaning schedules for the FNS.


C.) Dishwashing Machine Temperature Logs:

April 2016 revealed Final Rinse Temperatures were to be between 170-190 degrees F. The documented temperatures for 04/14/16 were "136" for both Lunch and Dinner meals. On 04/15/16 the dinner final rinse temperature was documented with 3 blanks. The bottom of the form had a place for identified issues and corrective action that were blank. On 04/24/16 the final rinse temperature for lunch was documented at 129 and dinner was at 135. On 04/25/16 and 04/29/16 the final rinse temperatures for dinner were starred and indicated, "no value."


D.) Review of the Freezer and Refrigerator Temperature logs:


Review of the Refrigerator Temperature Logs on 05/24/16 for Refrigerator Location "#1" revealed the Temperatures had already been documented for May 25th-31st with the time and employees initials blank. The temperatures were then erased/whited out; but could still be observed.


Review of the Freezer Temperature Log dated May 2016 for Location #1 revealed temperatures were to be at 0 Fahrenheit or below. Documentation indicated on 05/07/16 the temperature was "38" and on 05/08/16 the temperature was "36." There was no documented Corrective Action.


Review of the Freezer and Refrigerator Temperatures on 05/24/16 for May 2016 revealed temperatures were to be checked and recorded once a day. The Temperature sheets revealed the following:

-Freezer Location #10 did not have any temperatures recorded for 05/18/16 through 05/20/16.

-Freezer location #19-1 did not have any temperatures recorded for 05/14/16, 05/15/16, and 05/18/16 through 05/20/16.

-Refrigerator Temperature Log #11 did not have any temperatures recorded for 05/18/16 through 05/20/16.

-Refrigerator Temperature Log #18 did not have temperatures recorded for 05/16/16 through 05/20/16.

-Refrigerator Temperature Log #19 did not have any temperatures recorded for 05/18/16 through 05/20/16.

-Refrigerator Temperature Log #20 did not have any temperatures recorded for 05/18/16 through 05/20/16.

-Refrigerator Temperature Log #23 did not have any temperatures recorded for 05/18/16 through 05/20/16.

-Refrigerator Temperature Log #24 did not have any temperatures recorded for 05/18/16 through 05/20/16.


Freezer Temperature Log for February 2016 revealed Freezer Location #4 was documented on 02/13/16 at 09:30 was "18" and on 02/14/16 at 10:00 was "20" (Fahrenheit assumed) with no Corrective Action/Comments documented in the Comment section. The documented freezer temperatures were to be maintained at 0 to -10 degrees F or (-12 to -18 degrees Celsius).


Review of the Form titled Refrigerator Temperature Logs indicated to check and record temperature once a day. Review of the following Refrigerator Temp Logs for April 2016 revealed the following areas temperatures were not being completed once a day:

Doctors Lounge, North

Doctors Lounge, Inside

Doctors Lounge, Outside

Medical Record

Labor and Delivery


Review of the Refrigerator temperature log for April 2016 for the location, "Café Pepsi Cooler 1" reviewed the refrigerator temperatures were to be below 40 degrees F. There was an area for corrective action/comments. The month of April included documentation for 18 of 28 days that documented temperatures above 40 degrees with no corrective action/comments. On 04/19/16 there was a comment that "doors are broken and left open."


Review of the café cooler Coca-Cola mini fridge for April 2016 documented 21 days of "31" days documented for the month of April, a 30 Day month, that temperatures were over 40 degrees.


--Review of the Daily Service & Hazardous Analysis Critical Control Points (HACCP) Records for April 1st-April 5th, 2016 revealed the forms were incomplete. The form included a Cooking Temperature, Holding and Serving Temperature, Cooling Temperature, and Reheating Temperature for each food item for Breakfast, Lunch, Dinner, Mid-Afternoon Feed, and Late Night; as appropriate and designated for items served. The forms did not always include the appropriate temperatures to include the cooking and holding/serving temperatures. The forms did not always include temperatures for all meals on the specified date to include Breakfast, Lunch, Dinner, Mid-Afternoon Feed, and Late Night.


E.) Inservice Training Reviewed:

Review of the "Handwashing" Inservice revealed it was undated and there were only 3 employees who signed the attendance roster from an approximate 120 FNS employees.


Review of the "Cooking Temperatures" Inservice revealed it was undated and there were only 4 employees who signed the attendance roster.


Review of the "Thawing Food" Inservice revealed it was undated and there were only 4 employees who signed the attendance roster.


Review of the "Personal Hygiene" Inservice revealed it was undated and the attendance roster was blank.


Review of the "Safe Off-Site Service" Inservice revealed it was undated and the attendance roster was blank.


Review of the "Using Gloves" Inservice revealed it was undated and the attendance roster was blank.


F.) Facility Policies reviewed:

Review of the policy titled, FNS Hazard Analysis Critical Control Points (HACCP) - Safety Practices for Food Handling dated 04/10/14 revealed Primary work place hazards assessed included the following, in part:

1. Employees: a. Hand washing procedures.

b. Hygiene standards.


3. Flies, roaches, and rodents

6. Receiving and storage of food and supplies.

7. Cleaning and sanitation of equipment, and preparation areas.


8. Storage of Food:

a. Date and label

b. Store foods, chemicals, and paper goods properly.

c. Rotate stock continuously.

d. Record Temperatures daily.


9. Personal Hygiene

a. Hand Washing procedures.

b. Procedures for use of Single-use gloves

c. Health code regulations.


10. A. Establish quality and safety limits by requiring the following:

1. Employee Hygiene Standard

2. Hand Washing procedures.

4. Cleaning of equipment and environment.

5. Techniques to prevent cross-contamination during all steps of receiving, storage preparation and service.

6. Temperatures for preparation, holding, and service.


13. Record Keeping System:

A. Essential records to maintain are:

1. Monitoring of temperatures on all equipment. Take actions as needed.

2. Monitor temperatures throughout the receiving, storage, preparation, and service cycle.

3. Monitor requirements for finished product and serving of the product.


14. Verify that the HACCP System is working:

A. Supervisor meeting (1 per week minimum).

1. Present data collected.

2. Discuss concerns and solutions.


Review of the policy titled, Personnel Health and Hygiene, Safety, Combustible Fuel FNS, effective 04/10/14 revealed the following:


Gloves should be changed frequently, at least when hands make contact with a non-sanitary surfaces including work surfaces, handling raw poultry or meat, picking objects up from floors, garbage, clothing, face, hair, coughing, sneezing, etc. Gloves should also be removed when leafing the immediate food production area, with fresh gloves applied (after hand washing) upon return to the work area.



Handwashing/Sanitizing- Hands should be sanitized with sanitizer gel (applying gel to hands and rubbing until evaporated) or washed with warm water and soap.


Review of the policy titled, Infection Control Plan - FNS, effective 04/10/14 revealed the following, in part: In General,

5. Handwashing is mandatory.

10. Inservice education is conducted by the Director of FNS or under his/her supervision.
Food Storage,

1. The floors, walls, and shelves of the storage areas should be cleaned regularly. Temperatures should be documented daily. The storage areas should be maintained at the following temperatures:

Refrigeration 33-41 degrees F

Freezers 0 to -10 degrees F.

4. All food should be covered to protect food from contamination.

5. Leftovers need to be labeled and dated.


Dishwashing Procedures,

B. The final rinse water should be at least 180 degrees F.


Review of the policy titled, Temperature Log of Refrigerators and Freezer in Kitchen - FNS effective 04/10/14 revealed, "1. The temperature of all refrigerators and freezers will be recorded a minimum of once daily by Food and Nutrition personnel on temperature log forms. Temperatures for the refrigerator should be at or below 41 degrees F and Freezer temperatures should maintain frozen food in solid state."


In accordance with the Texas Food Establishment Rules:

§229.164(o) (5) (B) ... "refrigerated, ready-to-eat, potentially hazardous food prepared and packaged by a food processing plant shall be clearly marked using calendar dates, days of the week, color-coded marks, or other effective means, at the time the original container is opened in a food establishment and if the food is held for more than 24 hours, to indicate the date or day by which the food shall be consumed on the premises, sold, or discarded, based on the temperature and time combinations specified in subparagraph (A) of this paragraph:

(i) the day the original container is opened in the food
establishment shall be counted as Day 1; and

(ii) the day or date marked by the food establishment may not
exceed a manufacturer ' s use-by date if the manufacturer determined the use-by date based on food safety.


§229.164 (r) Labeling.

(1) Food labels.

(A) Food packaged in a food establishment, shall be labeled as specified in
law, including 21 Code of Federal Regulations (CFR) 101, Food Labeling, 9 CFR 317, Labeling, Marking Devices, and Containers, and 9 CFR 381, Subpart N, Labeling and Containers.


§229.165(f) (15) Warewashing machines, temperature measuring devices. A warewashing machine shall be equipped with a temperature measuring device that indicates the temperature of the water:

(A) in each wash and rinse tank


§229.165(k) (4) Warewashing equipment, cleaning frequency. A warewashing machine; the
compartments of sinks, basins, or other receptacles used for washing and rinsing equipment, utensils, or raw foods, or laundering wiping cloths; and drainboards or other equipment used to substitute for drainboards as specified under subsection (g)(3) of this section shall be cleaned:

(A) before use;

(B) throughout the day at a frequency necessary to prevent
recontamination of equipment and utensils and to ensure that the equipment performs its
intended function

(16) Warewashing equipment, determining chemical sanitizer concentration.

Concentration of the sanitizing solution shall be accurately determined by using a test kit or other device.

(l) Utensils and temperature and pressure measuring devices.

(1) Good repair and calibration





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35755

Based on observation, interview, and record review, the facility failed to ensure:


1.) The dialysis unit maintained an environment that provides an acceptable level of safety and well-being of patients, staff and visitors.


2.) Supplies were stored in such a manner to ensure their safety (protection against contamination, or deterioration).The hospital failed to ensure that staff were testing equipment properly prior to use.


Specifically, observations conducted on 05/25/16 of facility C's inpatient dialysis unit with Director of dialysis therapies and rehabilitation, as well as the Quality Director and Director for contracted inpatient service present revealed the following:


3.) Facility A failed to meet the requirement in that a leaking Steris washer in the decontamination room had no signage to identify that it had been removed from service.


Findings included:


1.) Observation of AC 15 at 1010 showed machine tested at 0745 that morning. Blood line not in occlusion clamp. BFR at 150. Interview at 1010 AM with S95 stated machine doesn't "necessarily have to have blood line in chamber" to test. S95 also stated ok to run machine at 150 because it was not actually recirculating the system. When surveyor asked S95 what the policy stated he stated that the policy states that blood line is supposed to be in the chamber to test.

Machine AC 15 at 1030 AM - last test was at 0745 that morning. Hanson connectorss were not connected and blood line not in blood occlusion clamp. S96 cannulated patient then took machine out of bypass, connected Hanson, attached transducers, discarded saline from arterial and venous port , attached lines to patient and initiated treatment. Verified with S93 that machine was supposed to have been recirculated prior to initiation of treatment. Neither Hanson connectors or blood line in occlusion clamp for proper testing and recirculation of machine prior to initiation. Also verified that machine had been tested at 0745 and treatment started at approx. 1030 which is over 2 hour time and recirculation should have been performed. (per hospital policy)

Drawer 1 (located under "clean" sink on treatment floor): Machine cranks, white clamp, used uptake wands, blue clamps for patient machines.

Drawer 2: Bleach uptake wands (corroded and rust inside), 7 containers used for bleach - 2 with no name and 1 with no HMI labels or solution label. Suction canisters observed in drawer, S95 stated they were used to vinegar machines. Wide open mouth states an uptake wand is placed in the container. Solution remains open to air and particles during uptake of solution.

Review of policy FMS-CS-IC-I-105-OOC5- after prime "place venous bloodline in the occluding clamp below the air detector and close optical detector door ..." Perform test on machine "Hanson connectors must be attached to the machine" "Recirculate the extracorporeal system" "once the extracorporeal system is free of air turn the dialysate flow rate down to 300 ml/min for the remainder of the circulation period until treatment is initiated. "Dialyzers primed for longer than two hours must again be recirculated using increased ultrafiltration rate for 5 minutes prior to initiation of patient treatment."

Review of Machine logs for Daily Machine Check Log for dates 5/2/16-5/24/16 of machines identified at A8, AC38, AC15:

Rows to be filled out for log completion:

Top: Date, treatment #, operator initials, and time-Dialysis machine (identifier), Diasafe test (Pass/Fail).

Middle section: Disinfection portion: Machine external cleaning post tx (initial), Vinegar (initial and time), Heat Disinfect (initial and time), Bleach disinfect (initial and time) , Positive result for bleach in machine (>500), negative residual test result for bleach in machine (<0.5), wands-caps-jugs disinfected (yes/no), Positive presence test result for bleach wands-caps and jugs (<0.5). Bottom of log: Meter used (specify ID number of meter)-Operators initials -Meter Cal: conductivity (n/a)

3/3 machine reviews had incorrect documentation to include missing information of times for disinfection, illegible documentation in boxes for disinfection and dates, inconsistent documentation on each log though each log required same information. Areas not filled in appropriately and either marked through with a line or word "phoenix" documented through several boxes to include one designated for signature. Boxes with "strike throu" with no initials to indicate why information was crossed out.

Documentation concerns reviewed with S93 and Quality Director on 5/25/16.



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2.) During a tour of the decontamination room in the surgical area at Facility A on 05/23/2016 at 11:45 a.m., a leaking Steris washer was observed with a wet towel on the floor in front of it with no signage to identify that it had been removed from service which placed staff at risk for use of unsafe leaking equipment that needed repair.

In an interview on 05/23/2016 at 11:45 a.m., the Assistant Manager of Perioperative Services confirmed the above findings and stated, "The door is loose and has to be replaced, we put a work order in and we are waiting on parts." When asked about the lack of signage, the Assistant Manager of Perioperative Services stated, "We usually put up a sign, we had one up but I don't know what happened to it," and at 11:48 a.m., "He's making a sign now."

Review in part, of the objectives of the safety management plan in the hospital's procedure #7740 and entitled, "Environment of Care (EOC) Management Plan 2014-2015," on 05/26/2016 revealed, "The hospital identifies safety risks associated with the environment of care that could affect patients, staff, and others entering the hospital's facilities, and takes action to minimize or eliminate the identified safety risks."

Based on observation, interview, and record review the facility failed to provide a clean, sanitary, and safe environment to avoid sources and transmission of infections and communicable diseases. Specifically, observations of the facility revealed the following:

1.) The Food Nutrition Services (FNS) kitchen area of Facility A and Facility B were unsanitary and unsafe in order to avoid the transmission of infection and communicable diseases.

2.) The refrigerator at the post-anesthesia care unit and; the medication refrigerator of the emergency department at Facility I were unsanitary with spillage and debris present.

3.) The Dialysis Unit of Facility C was unsanitary and unsafe in order to avoid the transmission of infection and communicable diseases.


These deficient practices placed the patients' health and safety at risk for the transmission of infections and/or communicable diseases.

The cumulative effect of these deficient practices resulted in the facility's inability to meet the Condition of Participation for Infection Control.

Findings included:

1.) FNS of Facility A

Observations conducted on 05/24/16 from 10:15 AM to 12:15 PM of facility A's Food and Nutrition Services (FNS) Kitchen area with the Director of FNS present, the Chief Operations Officer, the Quality Coordinator, and the Director of Facilities Management (FM) present revealed the following concerns:

-Entrance into the kitchen cracked and falling ceiling tiles observed.
-Dust on the tele tracking device on the ceiling.
-Upon entry into the kitchen there were flies and gnats observed.
-The automatic warewashing dish machine had a red alert that had been silenced from audible alarm; and indicated the Final Rinse Temperature was only 91 degrees Fahrenheit. The digital reading on the machine indicated the temperatures were 153 degrees for wash, 163 degrees for rinse, 121 degrees for power wash, and 91 degrees for final rinse. The machine contained a notice that indicated the final temperature rinse must be 180 degrees F. During observation, FNS employee A indicated the warning for the warewashing dish machine had been alerting since the start of the meal and that it was always alarming; and further stated the audible alarm had not worked in a while.
-The handwashing sink had no hot water and the digital read out from the FNS thermometer indicated the water was only at 74 degrees F. There was no antibacterial or anti-microbial soap available for use. The soap available was a lotion hand soap.
-Holding warmers with designated parameters of 140-160 was reading temperature range of 132 degrees with no intervention.
-The walls were the pots and pans were being washed at the 3 compartment sink had buildup of dust and debris that was large and covered the entire area.
-The drying area used for the pots and pans had white build up. The pans were stacked on top of each other not allowing air-dry.
-There was one trash can that was lined; trash inside with no lid.
-The floor tiles were discolored, had buildup substance, and food spillage throughout.
-Rust observed on metal corners of closet doorway.
- Base board by fridge located across from ice machine had duct tape along edge. Tape was rolling and folding in on itself. Dust and dirt in between wall and tape.
-Dirt and dust accumulated in floor corners and at base of walls throughout the kitchen area. Areas included walkway, dish cleaning area, food preparation area, food storage area, and tray set up area.
-Food shelves had uncovered mushrooms and sausage.
-Staff member observed washing dishes at the 3 compartment sink for pots and pans. The 3rd compartment water for sanitization appeared dirty. Further investigation showed no test strips for disinfectant verification prior to disinfection of dishes. No test strips were available at the designated location. The FNS Director located test strips, and performed test for Surveyor at this time. Strip showed disinfectant not within range initially.
-Food preparation area had a notebook on the counter that was open with a walkie talkie resting on the pages as well as a bag of tortillas, can of sesame oil next to binder was open with no lid over open spout.
-Fan placed on a shelf observed full of dust blowing over the meal preparation area below. Surveyor confirmed with Director that fans were not to be over food.
-Area where dry food and individualized drinks were stored contained a metal sink, Director told surveyor that the sink was not in use. Metal sink had water stains, dust, and debris build up. 2 coffee carafes were inverted on the metal counter. Area around mouth of carafe where it was laying on metal counter showed visible buildup of sediment.
-Ice machine had large amount of dust and debris along vent area. Can labeled " filter monitor " attached to ice machine had white sediment build up and corrosion of metal on canister.
-In hallway beside the ice machine were metal shelves. Top shelf contents of dining room décor, shelf below had box of spoons which were open to air and elements, the spoons were located under the dining room decorations.
-Refrigerator across from Ice machine contained expired chopped tomatoes according to the food born date. Expired tomatoes verified with Chef.
-Cart with dishes stacked on each shelf observed between food washing station and tray set up area. Dishes had dust and food sediment on various dishes. Brown liquid observed on dish canister located on bottom shelf of cart. Confirmed with staff in the kitchen that dishes on this rack were clean and to be used for food delivery.
-The metal vents for ventilation were dusty.
-Black food cart outside the refrigerator with food being placed onto for transport had food debris and spillage on the cart.
-Metal cart contained serving dishes that were cracked, separated, and the edges separated.
-The holding warming cart with Rice had a displayed temperature of 71 degrees.
-The refrigerator that had sparkling grape juice could not hardly be opened due to the door tracks had food debris and black spillage in the tracks of the sliding door. In the same area was a metal table; preparation area that surveyor identified brown granular substance on the shelf on metal container the contents labeled as sugar. The covering over top of container was not completely closed, leaving sugar open to air and exposed to particle. On same counter on bottom shelf, brown cardboard boxes were observed with multiple disposable food containers. Boxes were open and damaged on bottom of box. Liquid stains on box on side and bottom. Food containers in boxes were open to air and particle. Dust observed in food containers. The counter top contained food particles.
-Staff on tray set up area observed with gloves, touching food, touching trays, touching food storage container then returning to food on the tray. No glove changes or hand hygiene between.
-Opened personal drink located on tray line were staff set up meal trays for patients
-Observation of chill blaster #1 panel error indicator for service needed.
Interview with Director during observation reported that storage area had been out for months and that no food was being stored in this particular blaster. Door opened by surveyor, food rack in storage area with carrots on the rack. Director stated that the chef maintained temperature logs for blaster. Temperature records for Chill blaster #1 requested and never produced for surveyor.

Continuous observations conducted for the two hour duration on 05/24/16 from 10:15 to 12:15 revealed no FNS staff were observed to utilize the handwashing sinks during changes in tasks.

During observations, and interview with the Director of FM at 10:15 AM indicated the facility had been changing out water pumps and that it may have had an effect on the temperatures of the automatic warewashing machine, and hand washing sink.

2.) FNS Of Facility B:
- Observation of the kitchen area on 5/25/16 between 10:45 am and 11:50 am revealed the following:

- A large industrial steam oven which was leaking large amounts of water directly on to the tile floor. As a result, there was approximately 1 inch of standing water in the area encompassing the stove, oven and food prep tables.

- Unidentified black and brown debris were noted inside the sugar storage bin.

- Staff had placed the food scoop, handle down inside the flour storage bin.

- food debris, dust, grease, and paper were found underneath the stove.

- In the dishwashing area where the 3 compartment and dishwasher were kept, a large amount of black material was observed which resembled mold.

- The area to the right of the ice machine, next to the 3 compartment sink, the floor had large accumulations of food debris, white build-up, and black mold like substance.

- In the walk-in freezer, there was dirt, dust, and food debris on the walls and ceiling.

- The air conditioning vents throughout the kitchen were covered in a black mold like substance.


During an interview on 05/24/16 at 2:30 PM with the Director of FNS at facility A confirmed the above observations during walk through. The FNS Director stated he was hired 11/2015 and indicted the FNS quality assurance performance improvement (QAPI) focus was on the "timelines" that food was being served to the patients and the "accuracy" of the trays being served to include all items selected by the patient; with no missing items. The FNS Director stated the patient satisfaction was at "31%" which was not very high due to missing food items, and the food being late. The FNS Director reported his job duties as oversight was of the Chefs, operations, retail, and patient services. He stated he walked around and " glances " at walk in ' s and coolers. The FNS Director indicated he has had a staff shortage of 20% which has resulted in increased overtime and failure to complete the detailed cleaning schedules as expected. The FNS stated they were supposed to complete detailed cleaning of the walls, ceilings, and vents at least once a month. When the FNS Director was asked about his daily work activities he stated most of his day was spent reviewing emails, in meetings, nurse huddles, and monthly reports. The FNS Director reported monthly reports reviewed were turnover data, performance goals, and employee review. When asked to specify monthly reports if they included infection control, physical plant, or machine maintenance; the FNS Director stated that Chefs were responsible for monthly infection control and physical plant audits. The FNS Director stated that management of temperatures of fridges, freezers, and warmers were monitored by the Chefs.

During an interview on 05/24/16 at 5:40 PM with Chef A for FNS at facility A stated there were 5 managers and 10 supervisors who were responsible to manage the operation and systems of the FNS. Chef A stated it was the managers and supervisors responsibility to ensure the cleaning was being completed as scheduled and to ensure temperatures of the equipment and food were being completed completely and daily. Chef A stated their staffing was down 20% and they did not have a dedicated cleaning crew to ensure the overall cleanliness of the equipment and physical environment. Chef A stated with the focus being on serving food within a timeline, and ensuring the accuracy of each trey; it has resulted in the cleaning being neglected.

During an interview on 05/25/16 at 8:30 AM with the COO, she stated the FNS Director was a contracted service as well as the upper management of the FNS. The COO stated she had previously met with the FNS Director due to the cleanliness of the overall kitchen environment and the FNS Director assured he would take control and ensure the expectations for sanitation and environment were met as expected. The COO stated she had been working with the FNS Director to accomplish the staffing needed and they were hosting a job fair on this date.

The following facility records and policies were reviewed:
A.) Facility Internal Audits/Inspections:

Review of the Food Safety Audit dated 4/26/2016 revealed the following items were checked, "No."
-Handwashing. Hands Washed frequently and correctly, No
-Gloves changed when they are torn, dirty, or contaminated, No.
-Repeat food safety training for all employees conducted at least annually, No.
-All areas properly ventilated, No.
The documented corrective action plan on page 12 revealed the unsatisfactory condition observed was; "cleanliness, hand washing, changing gloves." The corrective action was to have training and counseling with employees; by 04/30/16.

Review of the Comprehensive Food Safety Self-Inspection dated 02/11/16 completed by the Food Service Director (FSD) revealed the following items were checked, "No."
-All food stocks rotated to avoid spoilage and assure freshness? Manufacture's expiration, "Use By" or "Sell By" dates followed? No.
-All foods prepared in operation are covered and labeled as to contents and date of preparation before placement in refrigerators and freezers?
-Hand and fingernails clean, fingernails were trimmed, and no polish or artificial fingernails? No.
-Disposable gloves, tongs, or other dispensing devices used properly to handle ready-to-eat food? Disposable gloves changed with each activity or when gloves become torn or contaminated? No
-Washing, rinsing, and sanitizing procedures posted and followed at all potwashing and dishwashing stations in us? No. (Includes correct products, temperatures, procedures, sanitizer concentration and contact time, and dishwashing machine final rinse pressure and proper utensil racking).
-All ceilings and walls in good repair, easily cleanable and free of cracks, holes, and peeling paint? No.

Review of the Kitchen Inspection Checklist dated 02/05/16, completed by the Infection Prevention (IP) RN for facility A revealed the following areas/items were documented as "No" for non-compliance:
-Ready-to-eat, potentially hazardous foods which are stored for more than 24 hours after being processed or opened are dated marked with a 7 day expiration date. "No."
-Chemicals stored away from or below all food and food related supplies. "No."
-Wash and rinse cycle times and temperatures correct. "No."
-All food and single service items are stored at least 6 inches above the floor. "No."
-Floor free from food spillage, silverware, broken glassware, loose mats, torn carpets or other hazards. "No."

Review of the Healthy Work Environment (HWE) Environmental Tour Rounds for the 1st Quarter of 2016 and the 4th Quarter of 2015 revealed in the area of FNS that a "0" was scored which indicated non-compliant in the following areas:
-Floor surfaces and work areas are clean and free of clutter. "0"
-Supplies are stored appropriately and shelving is secure. "0"

B.) Review of the FNS Cleaning Schedules:

Review of the Facility's Cleaning Schedules included 10 designated areas of the kitchen; (veggie, fry, prep, entrée, morning, front house/service/dining area, salad, 1, salad 2, salad 3, and Host/Hostess Cleaning List). There also was a Facilities and Equipment Cleaning Schedule for the month of January. Review of these documented forms for all 10 areas revealed they were incomplete and not consistently reviewed/signed by a supervisor. There were only two veggie master cleaning schedules reported for the month of January and those were incomplete and not signed by a supervisor.

Further review of the Facility's Cleaning Schedules provided by the facility revealed no further documented evidence for 9 of 10 areas of the kitchen: (veggie, fry, prep, entrée, morning, front house/service/dining area, salad 1, salad 2, salad 3, and Facility and Equipment Cleaning Schedule) were provided after January 2016. Repeated requests were made for documented evidence of these cleaning schedules for the FNS.

C.) Dishwashing Machine Temperature Logs:

April 2016 revealed Final Rinse Temperatures were to be between 170-190 degrees F. The documented temperatures for 04/14/16 were "136" for both Lunch and Dinner meals. On 04/15/16 the dinner final rinse temperature was documented with 3 blanks. The bottom of the form had a place for identified issues and corrective action that were blank. On 04/24/16 the final rinse temperature for lunch was documented at 129 and dinner was at 135. On 04/25/16 and 04/29/16 the final rinse temperatures for dinner were starred and indicated, "no value."

D.) Review of the Freezer and Refrigerator Temperature logs:

Review of the Freezer Temperature Log dated May 2016 for Location #1 revealed temperatures were to be at 0 Fahrenheit or below. Documentation indicated on 05/07/16 the temperature was "38" and on 05/08/16 the temperature was "36." There was no documented Corrective Action.

Freezer Temperature Log for February 2016 revealed Freezer Location #4 was documented on 02/13/16 at 09:30 was "18" and on 02/14/16 at 10:00 was "20" (Fahrenheit assumed) with no Corrective Action/Comments documented in the Comment section. The documented freezer temperatures were to be maintained at 0 to -10 degrees F or (-12 to -18 degrees Celsius).

Review of the Refrigerator temperature log for April 2016 for the location, "Café Pepsi Cooler 1" reviewed the refrigerator temperatures were to be below 40 degrees F. There was an area for corrective action/comments. The month of April included documentation for 18 of 28 days that documented temperatures above 40 degrees with no corrective action/comments. On 04/19/16 there was a comment that "doors are broken and left open."

Review of the café cooler Coca-Cola mini fridge for April 2016 documented 21 days of "31" days documented for the month of April, a 30 Day month, that temperatures were over 40 degrees.

--Review of the Daily Service & Hazardous Analysis Critical Control Points (HACCP) Records for April 1st-April 5th, 2016 revealed the forms were incomplete. The form included a Cooking Temperature, Holding and Serving Temperature, Cooling Temperature, and Reheating Temperature for each food item for Breakfast, Lunch, Dinner, Mid-Afternoon Feed, and Late Night; as appropriate and designated for items served. The forms did not always include the appropriate temperatures to include the cooking and holding/serving temperatures. The forms did not always include temperatures for all meals on the specified date to include Breakfast, Lunch, Dinner, Mid-Afternoon Feed, and Late Night.

E.) Inservice Training Reviewed:
Review of the "Handwashing" Inservice revealed it was undated and there were only 3 employees who signed the attendance roster from an approximate 120 FNS employees.

Review of the "Cooking Temperatures" Inservice revealed it was undated and there were only 4 employees who signed the attendance roster.

Review of the "Thawing Food" Inservice revealed it was undated and there were only 4 employees who signed the attendance roster.

Review of the "Personal Hygiene" Inservice revealed it was undated and the attendance roster was blank.

Review of the "Safe Off-Site Service" Inservice revealed it was undated and the attendance roster was blank.

Review of the "Using Gloves" Inservice revealed it was undated and the attendance roster was blank.

F.) Facility Policies reviewed:

Review of the policy titled, FNS Hazard Analysis Critical Control Points (HACCP) - Safety Practices for Food Handling dated 04/10/14 revealed Primary work place hazards assessed included the following, in part:
1. Employees: a. Hand washing procedures.
b. Hygiene standards.
3. Flies, roaches, and rodents
6. Receiving and storage of food and supplies.
6. Cleaning and sanitation of equipment, and preparation areas.
8. Storage of Food:
a. Date and label
b. Store foods, chemicals, and paper goods properly.
c. Rotate stock continuously.
d. Record Temperatures daily.
9. Personal Hygiene
a. Hand Washing procedures.
b. Procedures for use of Single-use gloves
c. Health code regulations.
10. A. Establish quality and safety limits by requiring the following:
1. Employee Hygiene Standard
2. Hand Washing procedures.
4. Cleaning of equipment and environment.
5. Techniques to prevent cross-contamination during all steps of receiving, storage preparation and service.
6. Temperatures for preparation, holding, and service.
13. Record Keeping System:
A. Essential records to maintain are:
1. Monitoring of temperatures on all equipment. Take actions as needed.
2. Monitor temperatures throughout the receiving, storage, preparation, and service cycle.
3. Monitor requirements for finished product and serving of the product.
14. Verify that the HACCP System is working:
A. Supervisor meeting (1 per week minimum).
1. Present data collected.
2. Discuss concerns and solutions.

Review of the policy titled, Personnel Health and Hygiene, Safety, Combustible Fuel FNS, effective 04/10/14 revealed the following:
Gloves should be changed frequently, at least when hands make contact with a non-sanitary surfaces including work surfaces, handling raw poultry or meat, picking objects up from floors, garbage, clothing, face, hair, coughing, sneezing, etc. Gloves should also be removed when leafing the immediate food production area, with fresh gloves applied (after hand washing) upon return to the work area.
Handwashing/Sanitizing- Hands should be sanitized with sanitizer gel (applying gel to hands and rubbing until evaporated) or washed with warm water and soap.

Review of the policy titled, Infection Control Plan - FNS, effective 04/10/14 revealed the following, in part: In General,
5. Handwashing is mandatory.
10. Inservice education is conducted by the Director of FNS or under his/her supervision.
Food Storage,
1. The floors, walls, and shelves of the storage areas should be cleaned regularly. Temperatures should be documented daily. The storage areas should be maintained at the following temperatures:
Refrigeration 33-41 degrees F
Freezers 0 to -10 degrees F.
4. All food should be covered to protect food from contamination.
5. Leftovers need to be labeled and dated.
Dishwashing Procedures,
B. The final rinse water should be at least 180 degrees F.

Review of the policy titled, Temperature Log of Refrigerators and Freezer in Kitchen - FNS effective 04/10/14 revealed, "1. The temperature of all refrigerators and freezers will be recorded a minimum of once daily by Food and Nutrition personnel on temperature log forms. Temperatures for the refrigerator should be at or below 41 degrees F and Freezer temperatures should maintain frozen food in solid state."

2.) During a tour of the post-anesthesia care unit at Facility I campus with the Director of Nurses for Perioperative Services and the Nurse Manager for Perioperative Services on 05/25/2016 at 11:45 a.m., observations of the medication refrigerator below the ice machine revealed brown spillage/dried drippings on the upper and lower rack of the door and bottom shelf.
In an interview on 05/25/2016 at 11:45 a.m., the Nurse Manager for Perioperative Services confirmed the above findings and stated, " It may be from the ice machine but we had it fixed. "
During a tour of the emergency department at Facility I campus with the Night Supervisor on 05/25/2016 at 1:58 p.m., observation of the medication refrigerator that required access via the automatic dispensing cabinet revealed a black hair and dusty debris on the bottom shelf.
In an interview on 05/25/2016 at 1:58 p.m., the Night Supervisor confirmed the above findings.

3.) Dialysis of Facility C

Observations conducted on 05/25/16 of facility C's inpatient dialysis unit with Director of dialysis therapies and rehab as well as the Quality Director and Director for contracted inpatient service present revealed the following concerns:

- S96 inappropriately wiping access with alcohol then touching access prior to cannulation
- one sink on treatment floor not designated as clean or dirty. Staff (S) verbalized sink was "clean"
- S94 dumping contaminated saline bag from patient machine into "clean" sink
- Sink not wiped down with disinfectant after saline from contaminated bag poured into sink.
- Gloves not changed between machine and patient
- Lack of hand hygiene after removal of gloves and new gloves donned
- Gloves used to touch machine were then used to touch patient charts and other equipment such as thermometers.
- No observation of disinfection of equipment (thermometer) between patients or disinfection of patient belongings (charts) after being touched with contaminated gloves.
- Blood on sharps container 2/3 observed
- Rust on sharps container 1/3
- Blood soaked gauze in regular waste can next to biohazard container
- S94 observed to have acrylic nails
-clean supplies for future patient on counter behind machine with patient receiving dialysis. Supplies in backsplash area
- acid jug on treatment floor
- "Clean sink with rust under cabinet and on towel dispenser
- Thermometer used on patient placed on rounding table on paperwork by chart. No disinfection of thermometer performed.
-Machine AC 35 with blood in transducer
- Cabinets with supplies to include bleach containers with corrosion, basin used for vinegar with sediment on them.

Interview with S95 regarding disinfection of outside of machine, it was stated by RN that Gray topped sani-wipes were used to disinfect the dialysis machine. S93 verified that machines were to be wiped down with bleach after use, Quality Director verified that gray wipes being used were alcohol based.
Interview with S93 it was verified that infection control policy states staff should use handsanitizer after glove removal. Additionally confirmed that gloves were to be changed when going from machine to patient, or from patient to equipment.
Interview with S93 and S95 it was stated that the one sink on dialysis treatment floor was designated as " Clean " . Stated that contaminated saline was to be dumped in drains located in dialysis area. Verified that sink was not labeled as "Clean" or "Dirty".
Per S95, when asked if staff wiped down mobile sharps containers between patients S95 stated " no " that "housekeeping did". Surveyor questioned S95 about frequency that housekeeping would be wiping down sharps S95 stated "probably daily".
Interview with S95 regarding where biohazardous waste should be disposed, he stated that trash can was for normal waste only, biohazard bins for biohazard waste to include materials with blood.
At approx 1015 clean supplies observed in backsplash area. Interview with S95 stated backsplash was clean, S93 confirmed backsplash area behind machine was " dirty " and clean supplies should not be stored there.
Review of policies:
Policy FMS-CS-IC-II-155-090A " if a handwashing sink becomes contaminated, the sink shall be disinfected with 1:100 bleach solution ... "
Policy FMS-CS-IC-II-155-110A " After use all equipment and supplies must be considered as potentially blood contaminated, and should be separated, handled with caution and either disinfected or discarded. " " Alcohol products shall not be used to disinfect large environmental surfaces " " All work surfaces shall be cleaned and disinfected with 1:100 bleach " . " Externally disinfect the dialysis machine with 1:100 bleach solutions after each dialysis treatment. " " Change transducer protectors between each treatment and immediately if soiled with blood or other fluid ... "





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During a tour of the post-anesthesia care unit at Facility I with the Director of Nurses for Perioperative Services and the Nurse Manager for Perioperative Services on 05/25/2016 at 11:45 a.m., observations of the medication refrigerator below the ice machine revealed brown spillage/dried drippings on the upper and lower rack of the door and bottom shelf.
In an interview on 05/25/2016 at 11:45 a.m., the Nurse Manager for Perioperative Services confirmed the above findings and stated, " It may be from the ice machine but we had it fixed. "
During a tour of the emergency department at Facility I with the Night Supervisor on 05/25/2016 at 1:58 p.m., observation of the medication refrigerator that required access via the automatic dispensing cabinet revealed a black hair and dusty debris on the bottom shelf.
In an interview on 05/25/2016 at 1:58 p.m., the Night Supervisor confirmed the above findings.