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Based on observation, interviews, clinical record and administrative document review, the facility failed to have a governing body which took full legal responsibility for developing, implementing, and monitoring policies and procedures (P&Ps) when:

1) The governing body failed to implement P&Ps to ensure sterility (a term referring to any process that eliminates or kills all forms of life, including microbial) of steam sterilized surgical instrumentation when staff in Central Processing (CP - the area of the hospital responsible for the packaging, processing, and sterilizing surgical instrumentation) did not open and unclamp surgical instrumentation in order to allow steam to come in contact with instruments' surface, which is necessary for sterilization to occur; and the staff providing oversight to CP staff did not recognize closed and clamped instrumentation as a problem (refer to A747 and A749).

2) The governing body failed to monitor and oversee infection control practices; and P&Ps meant to ensure patients' safety by providing a safe and sanitary environment which included maintaining sterility of surgical instruments; effectively cleaning and disinfecting shared patient equipment and the hospital environment, conforming to surgical attire and traffic patterns in all surgical areas; screening and providing medical staff immunizations; ice machine maintenance; disaster food; et al (refer to A747 and A749).

3) Failed to have a quality program containing mechanisms to ensure there were actions taken to address data indicators that did not meet performance measure thresholds or identified opportunities for improvement. The governing body failed to take actions to address data quality indicators related to the prevention and reduction of medical errors, surgical site infections (SSI), and Clostridium difficile (C. diff -bacterium causing infectious diarrhea) that presented as trends that needed improvement. These failures had the potential for adverse patient outcomes due to persistent patient safety issues (refer to A263, A273 and A283).

The cumulative effects of these systemic problems resulted in the Hospitals' inability to ensure the provision of quality health care in a safe environment.

Based on staff interview and administrative document review, the hospital failed to ensure contracted services were provided in accordance with Medicare conditions of participation when there was no evidence of a monitoring process to evaluate quality and performance problems.

This failure resulted in the potential for problems with the contracted services to go unidentified.

Findings:

On 10/17/14 at 11:10 a.m. the hospital's contract with Stericycle for bio-hazardous waste removal was reviewed. The review revealed no evidence of objective performance measures related to the quality, infection control, and safety of services provided under the contract.

On 10/17/14 at 11:20 a.m., VP/COO confirmed there were no objective performance measures in the contract although there was broad language that Stericycle would provide services in a safe manner consistent with the Joint Commission of Hospital Accreditation standards. VP/COO acknowledged there was no documented evidence the hospital was monitoring the provision of the Stericycle services to ensure the quality and safety of the services performed and to identify any areas that require improvement.

Based on staff interview, clinical record and administrative document review, the hospital failed to ensure than an ongoing, hospital-wide, data driven quality assessment and performance improvement (QAPI) program was maintained when:

1. An effective systems for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel in accordance with Hospital policy and nationally recognized infection control guidelines had not been developed (Refer to A283 and A747).

2. There was no ongoing quality appraisal and performance improvement program that addressed the complexity and scope of Food and Dietetic Services (Refer to A273 and A618).

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on staff interview and document review the hospital failed to have an ongoing quality appraisal and performance improvement program that addressed the complexity and scope of Food and Dietetic Services when the performance improvement program for did not include a component for the evaluation of patient's nutritional status taking into account the patient's medical diagnosis.
This failure resulted in the potential for the hospital to be unable to measure, track and improve Patient's health outcomes related to clinical nutrition care.

Findings:

On 10/15/14 at 3:15 p.m., in a concurrent interview and document review, the Quality Appraisal and Performance Improvement (QAPI) data for food and nutrition services was reviewed with the Director of Food and Environmental Services (DFEVS) and the Clinical Nutrition Manager (CNM). The 2014 Performance Improvement (PI) data Food and Dietetic Services related to test trays and temperature checks for the kitchen and café refrigerators and freezers, as well as the salad bar. The CNM stated that at this time she did not have any clinical nutrition care PI data that she was monitoring. Clinical nutrition care is the evaluation of the patient's nutritional status taking into account the patient's medical diagnosis. There was no indication the hospital developed a QAPI program that identified opportunities for patient outcome in relationship to clinical nutrition care.

On 10/15/14 at 4:30 p.m. an interview was conducted with Interim Director of Quality Services regarding QAPI. The Interim Director of Quality Services stated each department lets Quality know their preferences and in the past they have had discussions between the departments and Quality, however, since she is just interim, she is not aware of those past discussions.

The hospital document titled "Performance Improvement Plan FY15", for fiscal year 2014 - 2015, indicated the purpose of the plan was to "ensure that the Governing Body, medical staff, and professional service staff demonstrate a consistent endeavor to deliver safe, effective, and optimal patient care and services in an environment of minimal risk". It was also noted that the scope of the plan was to encompass organization wide activities related to quality control, quality assessment and performance improvement. The document did not include identification of activities that may lead to improvement in the performance of the clinical nutrition care for the department.

Based on staff interview and administrative document review the hospital failed to identify and implement actions for performance improvement when Clostridium Difficile (C-Diff - a bacteria which causes infectious diarrhea) infection and surgical site infection rates increased significantly from the previous year and the hospital Quality Management Committee took no action.

The lack of hospital documented response to significant increases in rates of infections (in SSIs and C-Diff) placed all hospital patients at increased risk for exposure to serious life-threatening infectious agents and illness.


Findings:

The Hospital's program evaluation dated Fiscal Year (FY) 2014, was reviewed. The evaluation revealed the Clostridium Difficile (C-Diff) rate at year end was 12.67, which represented an almost 50% increase from the previous FY. The year rate of Surgical Site infections (SSIs) was 22%, which represented an 18% increase from the last FY.

A review of the Hospital's Quality Management Committee Minutes for the following dates was conducted: 8/28/14, 5/22/14, and 2/27/14. There was no documentation of recommendations or actions to respond to the surveillance reports that showed increasing rates of SSI's and C-Diff. In the area on the report form reserved for actions and recommendations, the statement "Report accepted" was the only thing documented opposite the Infection Control Surveillance information on all three committee meeting dates.

On 10/17/14 at 12:05 p.m., an interview with Admin Staff D was conducted. She acknowledged the purpose of having the multi-disciplinary team on the quality committee was for them to actively participate in the analysis of information, and provide input/support for recommendations and actions, and evaluate the efficacy of any interventions put in place. Admin Staff D stated there were a lot of questions, discussion and recommendations made in response to the infection control surveillance reports throughout 2014, but none of it was captured on the committee minutes. Admin Staff D stated the group had looked at the SSI's and could not identify any trends, such as type of surgery, room, physician, etc. Admin Staff D was asked if more work would have been done if there had been documenting and evaluation of actions and progress that clearly identified increasing rates of SSI and C-Diff. Admin Staff D stated, "I would have drilled down more."

On 10/16/14 at 1:40 p.m., during an interview, the Director of Surgery (DS) stated she was aware the hospital's surgical site infection rate had increased from the previous year. DS stated, "I thought it had increased a teeny bit, but there was no pattern identified." DS stated she was not aware SSIs had increased 18% from the previous fiscal year. DS indicated she would have had more conversations about this topic with the hospital's Infection Control Nurse if she had known the increase was 18%.

Based on observation, staff interview and record review the hospital failed to ensure that policies and procedures for safe and effective medication use were developed and implemented when:
1) The Insulin (to control blood sugars) IV drip (infused directly through the vein) protocol was entered incorrectly into the electronic system. This failure had the potential of exposing patients to uncontrolled blood sugars causing complications including cardiovascular disease and kidney damage.
2) The Pharmacy failed to clarify duplicate orders for 3 of 30 patients (Patient's 3, 18 and 19). This had the potential of exposing patients to duplicate therapies causing adverse effects including liver problems caused by excess acetaminophen (used for pain).
3) A Physician order for insulin was edited in the electronic system by a nurse thereby changing the original order and keeping the original date. The edition done by the nurse was not cosigned by the physician. This failure had the potential of not being able to detect medication errors.
4) The Pharmacy failed to clarify an incorrect dose of propofol with the physician and the electronic system equated G (standard abbreviation for grams) into mcg (micrograms). This failure had the potential of exposing patients to medication errors.

Findings:

1) Review of Patient (Pt) 20's clinical record indicated that she was admitted to the facility on 9/23/14 and her physician orders dated 9/28/14 included an IV insulin drip. The electronic administration criteria on the physician order for the insulin IV drip indicated a protocol to calculate the rate of insulin drip based on blood glucose (BS) and a multiplier value ranging from 0.01 to 0.04. The administration criteria indicated:
"Initial Infusion Rate: (Blood glucose - 60) x 0.03 (multiplier) = units/hr (hour).
Subsequent rate adjustments: [If blood glucose is]
Greater than 180 mg/dL (milligrams per deciliter): (Blood glucose - 60) x 0.04 = units/hr
110-180 mg/dL: (Blood glucose - 60) x 0.03 = units/hr
80-109 mg/dL: (Blood glucose - 60) x 0.02 = units/hr
65-79 mg/dL: (Blood glucose - 60) x 0.01 = units/hr. "

Review of Pt. 20's vital signs sheets dated 9/28/14 indicated the following blood sugars (BS) and rates of insulin:
- 12 p.m., BS 265, initial insulin rate 6.2 units/hr, correct per above criteria [(265-60) x0.03=6.15]
- 1 p.m., BS 312, insulin rate 10.1 units/hr, correct per above criteria [(312-60) x0.04=10.08].
- 2 p.m. BS 253, insulin rate 9.7 units/hr, incorrect per above criteria [(253-60) x0.04=7.72].
- 3 p.m. BS 251, insulin rate 11.5 units/hr, incorrect per above criteria [(251-60) x0.04 =7.64].
- 4 p.m. BS 215, insulin rate 10.9 units/hr, incorrect per above criteria [(215-60) x0.04 = 6.2].
-5 p.m. BS 168, insulin rate 7.6 units/hr, incorrect per above criteria [(168-60) x 0.03 = 3.24].
-6 p.m. BS 151, insulin rate 6.4 units/hr, incorrect per above criteria [(151-60) x 0.03 = 2.73].

During an interview on 10/15/14 at 11:15 a.m., the ICU director (ICUD) stated that the insulin protocol listed in the administration criteria was incorrect and Pt. 20 was administered insulin based on a different protocol titled "ICU IV Insulin Order." ICUD acknowledged that the protocol "ICU IV Insulin Order" was not part of Pt. 20's clinical record.

Review of the "ICU IV Insulin Order" indicated that for subsequent rate adjustments, if blood glucose is greater than 180 mg/dL to keep increasing the multiplier by 0.01. For example for Pt. 20 at 2 p.m. with a BS 253, the insulin rate should be based on (BS - 60) x multiplier of 0.01 more than the previous multiplier (0.04) used, therefore (253-60) x 0.05=9.7 units/hr, which is what Pt. 20 received.

The ICU manager stated that the protocol in the administration criteria was entered incorrectly and kept the multipliers at fixed values ranging from 0.01 to 0.04 only. The ICU manager stated that pharmacy was responsible for adding the administration criteria into the electronic system.

During an interview on 10/15/14 at 12:45 p.m., the Director of Pharmacy (DPS) stated that the "ICU IV Insulin protocol" was used to enter into electronic administration criteria by the IT consultant pharmacist and the DPS verified the information. The DPS stated that he was not aware if the electronic administration criterion was reviewed by any nursing or medical staff.

During an interview on 10/16/14 at 8:45 a.m. the CMO (chief medical officer) stated that a group including 5 or 6 medical staff was reviewing all paper order sets and their entry into the electronic environment and they must have missed the errors in the IV insulin drip protocol entry.

2a) Review of Pt. 18's clinical record indicated that she was admitted to the facility on 10/9/14 with an admitting diagnosis of pregnancy.
Review of Pt. 18's active physician orders dated 10/9/14 included the following narcotic pain medications:
-Hydrocodone/acetaminophen 5/325 mg (milligrams), 1 tablet every 3 hours as needed for pain rating 1-3 (on a pain scale of 1 to 10, 10 being the most severe pain).
-Hydrocodone/acetaminophen 5/325 mg, 2 tablets every 3 hours as needed for pain rating 4-5.
-Acetaminophen/codeine 300/30 mg, 1 tablet every 3 hours as needed for pain rating 4-6.
-Acetaminophen/codeine 300/30 mg, 2 tablets every 3 hours as needed for a pain rating 7-10.
During an interview on 10/14/14 at 3:50 p.m., the DPS stated that the above four orders were initiated from two different order sets. The DPS stated pharmacy should have discontinued one order set for pain medications before entering the second one.
Lexicomp, a nationally recognized drug database indicated "Acetaminophen has been associated with acute liver failure, at times resulting in liver transplant and death. Hepatotoxicity is usually associated with excessive acetaminophen intake and often involves more than one product that contains acetaminophen."
Review of facility policy "Physician (Licensed Independent Practitioner (LIP)) Orders" dated 8/14 indicated "The Pharmacists will review all new and discontinued LIP orders."

2b) Review of Pt.19's clinical record indicated that she was admitted to the facility on 10/7/14. Pt. 19's physician orders that were active simultaneously included:
- Acetaminophen 650 mg every 3 hours as needed for fever or mild to moderate pain dated 10/7/14 and discontinued 10/10/14.
- Acetaminophen 650 mg every 3 hours as needed for fever or mild to moderate pain dated 10/8/14 and discontinued 10/10/14.
- Acetaminophen/codeine 300/30 mg, 2 tablets every 4 hours as needed for mild to moderate pain.
During an interview on 10/14/14 at 3:50 p.m., the DPS acknowledged the duplicate acetaminophen orders and stated that pharmacist should have discontinued one of them.

2c) Review of Patient 3's clinical record indicated that he was admitted to the facility on 10/7/14. Pt. 3's physician orders that were active simultaneously included:
- Acetaminophen 650 mg every 3 hours as needed for headache or temperature above 101 Fahrenheit (measure of temperature) dated 10/7/14.
- Acetaminophen 500 mg by mouth every 4 hours as needed for pain dated 10/9/14.
On 10/15/14 at 9:30 a.m., during an interview, DPS acknowledged the duplicate acetaminophen orders and stated a pharmacist should have called the physician to get one of the acetaminophen orders discontinued.

2d) Review of Patient 3's physician orders indicated the following simultaneously active orders:
- Percocet 10/325 mg (oxycodone with acetaminophen a narcotic for pain) 1 tablet by mouth every 4 hours as needed for pain rated 7 - 10 on the pain scale, dated 10/10/14 .
- Percocet 10/325 mg 2 tablets by mouth every 4 hours as needed for severe pain (A level of 7 - 10 on the pain scale is considered severe pain), dated 10/12/14.
On 10/15/14 at 9:30 a.m., during an interview, the DPS acknowledged that a similar pain scale was used for both orders of Percocet. DPS stated a pharmacist should have called the physician to clarify these orders.

3) Review of Pt. 17's clinical record indicated that she was admitted to the facility on 10/12/14 with a diagnosis of diabetic ketoacidosis (DKA, a serious complication of diabetes that occurs when the body produces high levels of blood acids called ketones).
Review of Pt. 17's physician orders indicated an order, dated 10/12/14 at 10 p.m., for IV Insulin drip with "Ordered Rate: 2.5 units/hr." Review of Pt. 17's vital sign sheets dated 10/12/14 indicated that Pt. 17 received insulin at a rate of 6.8 to 5 units/hr. Pt. 17 did not receive 2.5 units/hr until 10/13/14 after 5 p.m.

During an interview on 10/15/14 at 10:30 a.m., the ICUD stated that Pt. 17 was receiving insulin drip per facility DKA protocol from 10/12/14 till 10/13/14 at 5 p.m. The ICUD stated that the order for the insulin rate was edited to 2.5 units/hr on 10/13/14 at 5:20 p.m. by a nurse based on read back order from physician.

During an interview on 10/15/14 at 12:45 p.m., the DOP confirmed that Pt. 17's insulin drip order was edited from "per DKA protocol" to "2.5 units/hr" on 10/13/14 at 5:20 p.m. but the order retained the original date of 10/12/14. The DPS confirmed that this issue was identified at the previous survey and stated that the plan of correction was to discontinue previous orders and copy and edit new rates as new orders. The DPS stated that a nurse had edited the order and pharmacy verified it without discontinuing and creating a new order with the new rate.
Review of email document dated 9/5/14 provided by the DPS addressing the above issue with his staff indicated "When an order populated for us to review an IV order that the physician has entered a rate change on, we need to copy and edit the order and adjust the rate to what was ordered."
During an interview on 10/16/14 at 9:45 a.m., the DPS stated that the rate change read back order edited by the nurse on 10/13/14 at 5:20 p.m. was still not cosigned by the physician.
Review of facility policy "Physician (Licensed Independent Practitioner (LIP)) Orders", dated 8/14, indicated "All orders must be complete - entering required information in all fields and must include date, time and e-signature of the LIP... Telephone and verbal orders will be e-signed by the LIP within twenty-four (24) hours of their submission."

4) On 10/14/14 at 8 a.m., registered nurse (RN) 5 was observed administering medications to Pt. 11. A 100 ml (milliliter) vial of propofol (a sedative-hypnotic agent for use in the induction and maintenance of anesthesia or sedation) was being administered to Pt. 11 at a rate of 17.2 ml/hr.
Review of Pt. 11's physician order for propofol, dated 10/14/14, indicated "Propofol 1000 mg/100 ml... Ordered Rate: 5 G /KG/MIN."
Review of the manufacturer packet insert for propofol indicated, initiation of sedation should begin at 5 mcg (microgram)/kg/min.
The International System of Units abbreviation for the gram is g.
During an interview on 10/14/14 at 3:50 p.m., the DPS stated that propofol should be ordered in mcg/kg/min and pharmacy should have questioned the rate of 5 g/kg/min. DPS stated that the electronic system had calculated the rate correctly as "g" in the system, equated to "mcg."

Based on observation, interview, and document review, the hospital failed to ensure that dietary services met the needs of all patients as evidenced by failure to:
1. Develop performance improvement activities that accurately reflected the scope and nature of the services. (Refer to A273)
2. Ensure safe and effective food storage/production practices. (Refer to A749)
3. Ensure there was a fulltime Director of Food and Nutrition who was responsible for the daily management of the department and who assured policies and procedures were maintained . (Refer to A620)
4. Ensure disaster food supplies were adequate. (Refer to A701)

The cumulative effect of these systemic problems resulted in the inability of the hospitals' food and nutrition services to ensure that the nutritional needs of patients' were met in accordance with practitioners' orders and acceptable standards of practice.

Based on observation, staff interviews, and record review the hospital failed ensure there was a fulltime Director of Food and Nutrition who was responsible for the daily management of the department and who assured policies and procedures were maintained when:

1) The Director of Food and Nutrition Services was also, concurrently, the Director of Environmental services;

2) There were deficiencies found in safe food handling, proper cooling of food to prevent the growth of germs, food storage, refrigeration, and sanitation (refer to A749 );

3) The Dietetic Departments' performance improvement program did not address the complexity and scope of Food and Dietetic Services when the program did not include a component for the evaluation of patient's nutritional status taking into account the patient's medical diagnosis (refer to A273)

4) The Disaster food supplies (food reserved for use in the event of a disaster) were not adequate to meet the hospitals' disaster menu (refer to A701).

The Hospitals' failure to ensure there was a fulltime Director of Food and Nutrition Services to provide adequate oversight resulted in the potential for growth of microorganisms (germs) in food, the inability to measure, track and improve Patient's health outcomes related to clinical nutrition care, and the potential for not having adequate food supplies in the event of a disaster.

Findings:

1) On 10/13/14 at 12:30 p.m., the DFEVS was introduced as the director of food services and environmental services who worked for a contract food service company. The DFEVS stated she was a Registered Dietitian (RD). The DFEVS acknowledged if she was over two departments she would not be full time as just the Director of Food Services.

Review of the credential verification for the Director of Food and Environmental Services (DFEVS) indicated she was a Registered Dietitian through the period ending 8/31/15.

Review of the hospital organization chart revised 6/20/14 indicated the DFEVS was a contracted employee and was a General Manager over both the Food and Nutritional Services and the Environmental Services departments.

2a. On 10/13/14, starting at 1 p.m., during the initial tour of the kitchen in the presence of the Director of Food Service & EVS (DFEVS) and the Food Production Manager (FPM), the following items were observed in the walk in refrigerator (Refrigerator #2): Tuna salad, dated 10/13/14, was 57.4 degrees (°) Fahrenheit (F); and egg salad, dated 10/13/14, was 47.3° F. An interview was conducted with the Food Service Worker (FSW) 1. FSW 1 stated she made the salads approximately 15 minutes ago and the ingredients for the tuna salad came from the storeroom. The FSW 1 stated she makes the salads, then puts them in the walk in refrigerator, and doesn't monitor the temperature.

On 10/15/14 at 8:45 a.m., the DFEVS stated the hospital did not have a system (policy and procedure) in place to monitor the temperatures of the cold salads like tuna salad, egg salad, pasta salad, etc. to ensure they reached 41F or less after they were prepared.

According to the FDA Food Code 2013 (3-501.14) Cooling, indicates Potentially hazardous food (time/temperature control for safety food) shall be cooled within 4 hours to 41oF or less if prepared from ingredients at ambient temperature, such as reconstituted foods and canned tuna.
b. On 10/13/14 at 1:10 p.m., a concurrent observation, in the presence of the Dietary Food/Environmental Services Manager (DFEVS) and Food Production Manager (FPM) was conducted. The following food items were observed in a walk in refrigerator (Refrigerator #1): Chicken noodle soup, dated 10/13/14, was 65.1° F; and rice pilaf, dated 10/13/14, was 45° F. Cook 2 was interviewed about these food items. Cook 2 stated he made these items this morning around 9:30 a.m. Cook 2 stated he placed all the items in the blast chiller (type of equipment to cool foods down quickly) and he checked the food after two hours and the food needed to be 70° F, and then after another two hours it would need to be 40° F, or less. Cook 2 stated he documented the temperatures of these foods on the cool down log. Cook 2 stated he puts multiple food items in the blast chiller at the same time and cools them all down together. He stated his practice is just to check one of the food items and just put that temperature down for all of the items. The DFEVS stated this was not the correct practice since different food items can have different density or amounts and could be different temperatures. She stated this was not her expectation of how the cook should be taking temperatures when cooling down foods.

Review of the cooling temperature log dated 10/13/14, showed chicken noodle start time was 9:30 (the documentation was unclear as to whether 8 or 9:30) and initial temperature was 180° F, then time at 9:30, it was documented at 70° F; and 11:15 it was 40° F. The rice pilaf was dated 10/13/14, with a start time of 9:45 a.m., and initial temperature was 180° F; at 10:30 it was 70° F; and at 11:15 it was 40° F. The cooling temperature log indicated to cool hot food to 70° F, or below, within 2 hours; and from 70 to 41 degrees F, or below, within an additional 4 hours. All recorded temperatures for the rice pilaf and the chicken noodle were identical.

Review of manufacturer's directions indicated Use of Food Probes 1) for most accurate results food probes should be used. These need to be properly placed in the center of the thickest part of the product to insure an accurate temperature reading. It also indicated Loading 1) to achieve quickest chill times product should be loaded into pans to a depth of no greater than 2" .2) Products should always be loaded into the shallowest pan possible.3) Chilling of products of greater than 2" depth is often possible within FDA guidelines. However please note that actual chill times are a function of: Start Temperature, Product Density, Product Depth, and Total Load. There was not multiple probes used for the multiple food products in the blast chiller.

c . On 10/13/14 at 1:30 p.m., an observation of the reach in refrigerator (Trayline air curtain #1) was conducted with the Dietary Food/Environmental Services Manager (DFEVS) and Food Production Manager (FPM). There were canned (opened) pears, with a use by date of 10/14/14, that were 53.8° F; and 53.1° F. A concurrent interview was conducted with Food Service Worker (FSW) 3. He stated the pears had been in the refrigerator since the day before.

d. On 10/13/14 starting at 1:35 p.m., an observation was conducted with the Dietary Food/Environmental Services Manager (DFEVS) and Food Production Manager (FPM). The following items were observed in the grill prep area in the café: Chopped chicken that was 46° F; sliced American cheese that was 47.3° F; and white sliced cheese (not labeled) that was 52.7° F. The FPM stated her staff informed her that the temperatures were just taken at 1:30 p.m., and all were okay. When the FPM asked her staff how they took the temperature, the staff placed the thermometer all the way into the food and were uncertain if they touched the bottom of the pan which could be the coldest part of the food. The staff also informed the FPM that she did not take the temperature of the white cheese.

The grill area TCS (Temperature Control Safety) Cold Food Holding log dated 10/13/14, was reviewed. The log indicated the last temperature was taken at 1:30 p.m., and the sliced cheese was 39° F, and the diced chicken was 40° F.

In the deli area, at 1:45 p.m., there was salami dated 10/13 to 10/15/14, that was 47.3° F; provolone cheese that was 47.8° F; and sliced roast beef that was 43.7°F. A concurrent interview was conducted with the FPM who stated the food in the top case of the unit will stay there throughout the night.

The deli area TCS (Temperature Control Safety) Cold Food Holding log was reviewed. The log dated 10/13/14, indicated temperatures were taken at 12 p.m., and the meat was 36° F; and the cheese was 37° F.

On the salad bar at 1:50 p.m., there was pasta salad that was 44.6° F; and sliced ham pieces that were 44.6° F. A concurrent interview was conducted with the FPM. The FPM stated the temperatures are taken for all of the foods in the café every two hours.

Review of the Salad bar Cold Food holding log, dated 10/13/14, indicated the last temperature was taken at 1:25 p.m., and the spinach pasta was 40.1° F. There was no temperature recorded for the ham.
In the display refrigerator (#1) the temperature was 50° F at 2 p.m. The soy milk was 46.9° F and string cheese was 54.5° F. In the display refrigerator (#2) it was 36° F. The hummus dated 10/22/14, was 52.7° F; cream pie dated 10/15/14, was 53.4° F; and the lemon cake dated 10/15/14, was 46.9° F.

In the "grab and go" reach in refrigerator it was 58° F. The Berry parfait (yogurt and berries), dated 10/13/14, was 44.6° F; egg salad sandwich dated 10/14/14, was 47.5° F; and chocolate fat free milk was 45.5° F. In a concurrent interview, with the FPM, she stated the staff will check the thermometers of these units but they do not check the actual food temperatures.

Review of the notes for the TCS Food Cold Holding log indicated to monitor cold foods to make sure they are held at 41° F, or below, before and during the display or service period. When recording the time, associates must initial the product was at the required temperature. If a product is not at the appropriate temperature, then record the corrective action. It indicated temperature taking procedures to take the reading at the center of the pan or at the central core of the meat at least half way inside of the product. It indicated corrective actions for food that has been above 41° F for 2 hours, or less, to rapidly cool the food in less than 4 hours and return it to cold holding; and if a food was above 41° F for more than 2 hours, discard the food and record it.

Review of the hospital policy and procedure titled Food Storage dated 5/10, indicated refrigerated foods shall be maintained at 40° F.

On 10/15/14 at 4:10 p.m. an interview was conducted with the Infection Control Nurse (ICN). The ICN stated she had been doing rounds in the kitchen and café areas at least once a year however she has wanted to increase that frequency but has not been able to do that yet.

e. On 10/13/14 at approximately 3 p.m., during a concurrent observation and interview, the Dietary Food/Environmental Services Manager (DFEVS) and the Food Production Manager (FPM) of the disaster food supply was conducted. In the storage room, there were numerous bottles of floor cleaning chemicals stored next to the disaster food supply. In a concurrent interview, with the DFEVS, she stated the disaster food should not be stored with the chemicals.

Review of the hospital policy and procedure titled Food Storage dated 5/10, indicated pesticides and other toxic substances shall not be stored in the kitchen area or in storeroom used for food and/or food preparation, equipment or utensils. It indicated soaps, detergents, cleaning compounds or similar substances shall not be stored in food storage areas.

f. During an initial tour of Campus 2 kitchen on 10/15/14, starting at 9:30 a.m., with the Food Production Manager (FPM) the three compartment sink (used for washing and sanitizing dishes) was observed with sanitizer in the third compartment. The Food Service Worker (FSW) 4 was asked to check the concentration of the chemical. FSW 4 took out a chemical strip and placed it in the solution for approximately 30 seconds and it read 200 ppm (parts per million) which she stated was good.

Review of the manufacturer's directions on the container for the strips indicated to keep in the solution for 5 seconds. When the test strip was retested holding in the solution for 5 seconds it was only 50 ppm. FSW 4 stated she kept it in longer than 5 seconds and the solution now is not okay and would need to be changed. FSW 4 acknowledged she was not aware that they only needed to keep it in the solution for 5 seconds.

g. On 10/15/14 at 9:45 a.m., during a concurrent observation and interview, the can opener was observed with the FPM at the Outpatient Campus. There were loose metal shavings and a thick dark substance on the blade. FSW 4 stated she was not sure when the last time they replaced the blade was changed but thought maybe it was approximately six months ago. The FPM stated she would put in a work order to get that replaced. The FPM stated they did not have a hospital policy regarding can openers.

According to the 2013 Federal Food and Drug Administration Food Code, Section 4-501.11 Good Repair and Proper Adjustment: "(C) cutting or piercing parts of can openers shall be kept sharp to minimize the creation of metal fragments that can contaminate food when the container is opened." The cutting or piercing parts of can openers may accumulate metal fragments that could lead to food containing foreign objects and, possibly result in consumer injury. (FDA Food Code Annex, 2013). Refer to A749.

3. On 10/15/14 at 3:15 p.m., in a concurrent interview and document review, the Quality Appraisal and Performance Improvement (QAPI) data for food and nutrition services was reviewed with the Director of Food and Environmental Services (DFEVS) and the Clinical Nutrition Manager (CNM). The 2014 Performance Improvement (PI) data Food and Dietetic Services related to test trays and temperature checks for the kitchen and café refrigerators and freezers, as well as the salad bar. The CNM stated that at this time she did not have any clinical nutrition care PI data that she was monitoring. Clinical nutrition care is the evaluation of the patient's nutritional status taking into account the patient's medical diagnosis. There was no indication the hospital developed a QAPI program that identified opportunities for patient outcome in relationship to clinical nutrition care.

On 10/15/14 at 4:30 p.m. an interview was conducted with Interim Director of Quality Services regarding QAPI. The Interim Director of Quality Services stated each department lets Quality know their preferences and in the past they have had discussions between the departments and Quality, however, since she is just interim, she is not aware of those past discussions.

The hospital document titled "Performance Improvement Plan FY15", for fiscal year 2014 - 2015, indicated the purpose of the plan was to "ensure that the Governing Body, medical staff, and professional service staff demonstrate a consistent endeavor to deliver safe, effective, and optimal patient care and services in an environment of minimal risk". It was also noted that the scope of the plan was to encompass organization wide activities related to quality control, quality assessment and performance improvement. The document did not include identification of activities that may lead to improvement in the performance of the clinical nutrition care for the department. Refer to A273.

4. On 10/13/14 beginning at 3:00 p.m., a concurrent observation and document review of the hospital plan for Disaster for Food Service (untitled) was conducted food service with the Director of Food and Environmental Services (DFEVS) and the Food Production Manager (FPM). Concurrent review of the hospitals' disaster menu noted the plan included the provision to provide 811 meals, three times/day; 2433 meals per 24- hour period for three days. The food was stored in a manner that was difficult to see what items were all there and we would have to review the following day when the person responsible (FSW 7) for stocking these items was working.

On 10/14/14 at 9:20 a.m. the food service for disaster preparedness was reviewed with the Food Service Worker (FSW 7) and with DFEVS. FSW 7 stated he went through the food supplies and there were some expired items and some that they did not have. An observation and random comparison of the hospital developed inventory and available food supplies revealed there was inadequate supplies of items such as hot cereal (3 cases short), peanut butter (10 cases short), ravioli (10 cases short), oyster crackers (4 cases short), vanilla wafers (9 cases short), low salt tuna (2 cases short), puree green beans (1 case short), beef stew (14 cases short), puree pears (2 cases short), ensure (nutrition supplement) (20 cases short), nepro (nutrition supplement specifically designed to help meet the nutritional needs of patients on dialysis) (1 case short), Glucerna (diabetic nutrition supplement) (2 cases short), powdered milk (1 case short), assorted crackers (2 cases short), puree peaches (3 cases short), cheerios (2 cases short), granola cereal (10 cases short) and mayonnaise (5 cases short). Refer A701.

Based on interview and record review, the hospital failed to ensure that the therapeutic diet ordered by the physician, for 1 of 30 patients (Patient 3), was implemented when staff did not ensure Patient 3 received 1800 to 2200 calories and 5 to 7 carbohydrate servings per meal.

This failure resulted in Patient 3 not receiving the calories and carbohydrates required by the therapeutic diet ordered.

Findings:

On 10/15/14, a review of the clinical record for Patient 3 was conducted. Patient 3 was admitted to the hospital on 10/7/14 with a diagnosis of left knee degenerative joint disease. A review of the physician orders dated 10/7/14 indicated an ADA (American Diabetes Association)/carbohydrate controlled diet (diabetic diet).

Review of the hospital Diet Manual indicated the Diabetic Diet provided between 1800 to 2200 calories and 5 to 7 carbohydrate servings per meal.

On 10/15/14 at 12:00 p.m. an interview was conducted with the Clinical Nutrition Manager (CNM) . The CNM stated Patient 3 was on room service, therefore he could order his own food. The CNM acknowledged Patient 3 was on an ADA/carbohydrate diet and he did not order enough carbohydrate servings per meal. The CNM stated she was not aware this was happening with the room service type menu and the diabetic diets. The CNM acknowledged that providing 3 to 4 carbohydrates per meal would be less than 1800 calories per day.

Review of the meal intake records of what the patient ordered dated 10/12/14-10/14/14, showed Patient 3 ordered between 3 and 4 carbohydrate servings per meal. The hospital provided only the food items Patient 3 ordered.

On 10/14/14 at 1:30 p.m., an interview was conducted with FSW 5 and FSW 6 regarding diets and room service. FSW 5 and FSW 6 stated the diabetic diet provides 5 carbohydrate servings for each meal and that the patients have to order that many carbohydrates.

Based on staff interview and record review, the hospital failed to ensure nutritional needs were met in accordance with recognized dietary practices for 3 of 30 patients (Patients 28, 24, and 14) when patients at nutritional risk were not identified in a timely manner.

This failure resulted in the potential for compromising the Patient's clinical status due to nutritional needs not being met.

Findings:

1. Patient 28 was admitted to the hospital on 10/9/14 with diagnoses that included sepsis (potentially fatal whole-body inflammation caused by severe infection) and cellulitis (bacterial skin infection). Review of the physician's orders dated 10/9/14 indicated a regular diet. Review of the medical record indicated the Nutrition Assessment was dated 10/14/14, 5 days after admission.

On 10/15/15 at 2:40 p.m. an interview was conducted with the Clinical Nutrition Manager (CNM). The CNM stated according to hospital policy, the assessment should have been done after 2 days because of the sepsis diagnosis, not 5 days.

Review of the hospital policy and procedure titled, "Continuous Nutrition Monitoring" dated 10/13, indicated a nutrition evaluation (assessment) for all patients identified at potential nutrition risk via the continuous nutrition monitoring be done within two days of identification.

2. Patient 14 was admitted to the hospital on 10/6/14 with diagnoses that included pneumonia (lung infection), Chronic Obstructive Pulmonary Disease (lung disease), and Cerebrovascular accident (stroke). Review of the history and physical dated 10/6/14, indicated the physician's assessment/impression included altered mental status, acute renal failure (rapid decline in kidney function), and possible sepsis. Review of the physician's progress notes dated 10/9/14 indicated Patient 14 had a preliminary report that showed lung cancer. Review of physician's notes dated 10/10/14 indicated stage IV lung cancer. Patient 14's weight dated 10/6/14 was 137.5 pounds, height was 6'0" and body mass index was 18.6. A body mass index (BMI) is a means to measure weight related to height. A BMI of 18.5 or less is considered underweight. Review of the physician's orders dated 10/8/14 indicated a pureed diet. On 10/12/14 physician's orders indicated oral supplements, Pulmocare (nutrition supplement for patients diagnosed with lung disease) three times a day.

Review of the percent eaten (oral intake) by Patient 14, dated 10/7/14, indicated nothing was taken by mouth; 10/8/14 indicated 25% eaten for dinner; 10/11/14 indicated 5% for breakfast, 50% lunch and 25% dinner; 10/12/14 indicated 70% for breakfast, 75% for lunch; and 10/14/14 indicated 20% for breakfast and 10% for lunch. The percent eaten was recorded for 8 of 20 meals reviewed the rest were missing data.

Review of the facility document titled, "Nutrition Assessment" dated 10/11/14, indicated Patient 14 does not like the pureed diet and he is able to swallow his medications. The Registered Dietitian (RD) estimated the patient needs to be 1700 to 1900 calories per day and 70 to 87 grams of protein per day. The RD indicated the patient is underweight and the family is considering hospice care. The RD indicated the patient's nutrition status classification is severely compromised. The RD recommended a swallow evaluation. The RD documented her plan was to follow up with the patient in 1 to 4 days.

Patient 14's clinical record contained no order for a swallow evaluation, and as of 10/14/14 there was no reassessment or follow up by the RD regarding her recommendation.

On 10/14/14 at 4:00 p.m. an interview was conducted with the RD. The RD stated she was not aware of the high risk diagnoses that would have brought her in sooner to see Patient 14 . The RD stated since the hospital has gone to physician order entry in the electronic medical record there is no system for the RD to communicate her recommendations to the physicians, therefore when she tells the nurse it really varies if that information gets passed along to the physician. The RD acknowledged that Patient 14 was high risk, however, they were not aware of his low weight, or other diagnoses that would have brought them in sooner. The RD stated the nurses do not have a formal way to consult the RD in the electronic medical record; there is only a physician consult in there. The RD stated a nursing consult will trigger if their nutrition screen is positive, but that only asks three questions. The RD stated some nurses will verbally tell her if a patient needs a nutrition consult, but that varies on the nurse. The RD acknowledged she should follow up with her recommendations timely, especially since they may not get to the physician. The RD agreed that it would be important for this patient to be able to have his diet upgraded so he could eat more foods he enjoyed.

On 10/14/14 at 3:30 p.m., a review of the hospital policy and procedure titled "Continuous Nutrition Monitoring", dated 10/13, was conducted. It indicated a nutrition evaluation (assessment) for all patients identified at potential nutrition risk via the continuous nutrition monitoring would be done within two days of identification.

3. Patient 24 was admitted to the hospital on 10/9/14 with diagnoses that included bilateral pneumonia and atrial fibrillation with rapid ventricular response (a type of abnormally fast heart rate that may present as a medical emergency). Review of the history and physical dated 10/9/14 indicated the caregiver for Patient 24 reported Patient 24 had a loss of appetite but no nausea or vomiting. The assessment/impression included the patient presented with hypoxemia (low oxygen level in the blood), and acute kidney injury.

Review of the Nutrition Assessment, dated 10/12/14, indicated Patient 24 was eating poorly and had refused breakfast that morning. The Nutrition Assessment, conducted by the RD, indicated the patient was at mild nutrition status and the priority points (the patients nutrition status is determined by the hospital based on points assigned related to weight, weight loss, diagnoses, etc.) did not take into account the patient's poor oral intake. If that had been taken into account, her nutrition risk would have been higher. The RD did recommend Ensure (nutrition supplement) two times a day. The Nutrition assessment indicated the RD would follow up with the patient in 4 to 6 days and was at mild nutrition risk.

On 10/15/14 at 1:15 p.m., an interview was conducted with the CNM. The CNM was not sure why the RD did not take into account the current oral intake but stated the grid (guidelines within the hospitals policy) they use states only if oral intake is poor for greater than two weeks. The CNM acknowledged this did not seem like a current standard of practice but it was what their contract food service company has as the policy. The CNM acknowledged this patient should have had the nutrition needs estimated. The CNM acknowledged the RD intervention for the Ensure was not ordered by the physician and not given to Patient 24. The RD did not return to see if the intervention was implemented.

Based on observation, interview and record review, the hospital failed to ensure the hospital diet manual consistently used, reflected diets routinely ordered by physicians and was in accordance with current national standards when:

1) The hospital diet manual did not accurately reflect physician ordered diets and current standards of practice;
2) The hospital diet manual was not consistently used to develop the hospitals' diets.

These failures resulted in the potential for inaccurate guidance to dietary and hospital staff when following physician ordered diets and not meeting the nutritional needs of patients, further compromising medical status.

Findings:

1. During an observation of the meal service on 10/14/14 at approximately 12:30 p.m., it was noted there were patients receiving American Diabetes Association (ADA) diet/Carbohydrate controlled, cardiac diet, mechanical soft, pureed diet, soft/bland/low residue, sodium controlled diet and renal (kidney) diet.

On 10/15/14 at 10:10 a.m., a concurrent record review and interview with the Clinical Nutrition Manager (CNM) regarding the hospital's therapeutic diet manual was conducted. Upon review of the 2013 diet manual, it showed the definition of cardiac diet was called a Fat Controlled diet. It indicated that to order the diet in the electronic medical record (EMR), it was called Fat Controlled. However, the instructions in the diet manual were not consistent with what was available in the EMR. When looking on the EMR, it showed there was no diet that could be ordered called Fat Controlled. There was a diet called Cardiac.

The Diet manual contained a Diabetic Diet, however, it gave a range that the diet would provide between 1800 to 2200 calories and 5 to 7 carbohydrate servings per meal. On 10/14/14 at 1:30 p.m. an interview was conducted with food service worker (FSW) 5 and FSW 6 regarding diets and room service. FSW 5 and FSW 6 stated the diabetic diet provides 5 carbohydrate servings for each meal.

Further review of the 2013 Diet Manual showed there were the following diets: Cardiac, Clear Liquid, Diabetic, Full Liquid, Hepatic (Liver), Renal (kidney), Mechanical Soft, Protein Controlled, Lactose controlled (a diet that avoids or limits milk and milk products or any foods prepared with milk), and neutropenic (low immune system). Further review of the electronic medical record indicated there was a renal diet that could be ordered but not a hepatic renal diet. There was nothing in the diet manual for the puree diet, pediatric diets for age, gestational diabetic diet, or soft/bland/low residue diet which could be ordered by the physicians at the hospital.

Review of the hospital policy and procedure titled "Diet Manual" dated 5/10, indicated the nutrition care practices are standardized and a current diet manual recommended by the dietitian and approved per protocol shall be used as the basis for diet orders and for planning of modified diets. It indicated the diet manual is the department's mechanism to standardize nutrition care throughout the organization.

2. On 10/13/14, at 3:00 p.m., during an inspection of the disaster food supply, it was noted that peanut butter was planned to be served to patients prescribed puree diets, for two of the three days at breakfast.

On 10/15/14, at 10:10 a.m., an interview was conducted with the CNM and Director of Food and Environmental Services (DFEVS) regarding if peanut butter was allowed for puree diets. The CNM stated she was unsure. The DFEVS stated she did not think it would be allowed. When asked to see what was allowed and not allowed in the puree diet it was discovered the hospital did not have anything for the puree diet in the hospital's Diet Manual. The CNM stated they also had a Nutrition Care Manual on the hospital intranet. Inspection of the puree diet information in the facility Nutrition Care Manual revealed that peanut butter is not allowed unless it is incorporated into foods and pureed.

Based on observation, staff interview, and record review, the hospital failed to ensure the hospital environment was maintained in a manner to assure patient safety when:

1. Food supplies planned for use in a disaster were not adequate to meet the hospital developed plan.

2. Disaster food did not include a provision for recommendations for patients prescribed puree diets.

3. Canned water for use in a disaster was not stored according to the manufacturer's directions.

These failures resulted in the potential for the hospital not being able to assure the safety and well being of patients.


Findings:

1. A review of the hospitals' Disaster Menu indicated the plan included the provision to provide 811 meals, three times/day; 2433 meals per 24 hour period for three days.

On 10/14/14 at 9:20 a.m., the food service for disaster preparedness was reviewed with the Food Service Worker (FSW 7). FSW 7 stated he went through the food supplies and there were some expired items and some items they did not have. A random comparison of the hospital developed inventory and available food supplies found there was inadequate supplies of items such as hot cereal (3 cases short), peanut butter (10 cases short), ravioli (10 cases short), oyster crackers (4 cases short), vanilla wafers (9 cases short), low salt tuna (2 cases short), pureed green beans (1 case short), beef stew (14 cases short), pureed pears (2 cases short), Ensure (nutrition supplement) (20 cases short), Nepro (nutrition supplement for Patients with kidney disease) (1 case short), Glucerna (diabetic nutrition supplement) (2 cases short), powdered milk (1 case short), assorted crackers (2 cases short), pureed peaches (3 cases short), cheerios (2 cases short), granola cereal (10 cases short) and mayonnaise (5 cases short).

2. On 10/13/14, at 3 p.m., during an inspection of the disaster food supply with the Director of Food and Environmental Services (DFEVS) and the Food Production Manager (FPM), it was noted, on the Disaster Menu, that peanut butter was planned to be served to patients prescribed puree diets, for two of the three days at breakfast.

On 10/15/14, at 10:10 a.m. an interview was conducted with the CNM and Director of Food and Environmental Services (DFEVS) regarding if peanut butter was allowed for puree diets. The CNM stated she was unsure. The DFEVS stated she did not think it would be allowed. When asked to see what was allowed and not allowed in the puree diet it was discovered the hospital did not have anything for the puree diet in the hospital's Diet Manual. The CNM stated they also had a Nutrition Care Manual on the hospital intranet. Inspection of the puree diet information in the facility Nutrition Care Manual revealed that peanut butter is not allowed unless it is incorporated into other foods and pureed.

During the course of the survey there were two patients that were prescribed puree diets.

3. On 10/13/14 at approximately 3:30 p.m., an observation of canned water, for use in the event of a disaster, was conducted with the DFEVS and FPM. There were 4 pallets of canned water stored on the dock area directly in the sun. Review of the label on the can of water indicated the water should be stored in a cool dry place. According to the Accuweather website, the temperature in Merced on 10/13/14 was 95 degrees Fahrenheit (F).

Based on observation, staff interview and review of hospital documents, the hospital failed to maintain the food service equipment in a manner to ensure an acceptable level of safety and quality when:
1. Three of three walk-in freezers (hospital and Campus 2), and three reach-in refrigerators in the kitchen and café were not maintained.
2. The ice machine at the cancer care center was not maintained according to manufacturer's guidelines.

These failures resulted in the potential for the growth if infectious organisms (bacteria, mold) in food not maintained at the proper temperature, in ice from the ice machine not properly maintained and in a fall risk due to ice build-up on the floor.
Findings:
1.a. During the initial kitchen tour on 10/13/14 starting at 12:45 p.m., a joint observation was conducted with the Director of Food and Environmental Services (DFEVS) and the Food Production Manager (FPM). The walk-in freezer (Freezer #2) had ice buildup around the sides and base of both of the doors that led into the freezer. A concurrent interview was conducted with the FPM; she stated she was not aware this freezer had problems with ice before now.
b. On 10/13/14 at 1:05 p.m. the walk-in freezer (Freezer #1) was observed with ice buildup around the pipe connected to the condenser and condensation buildup on the ceiling behind the condenser. There was also (approximately 3 inches wide and 12 inches long) ice built up under the condenser on the floor. A concurrent interview conducted at this time with the FPM stated they have had problems with ice building up in this freezer before.
Review of the work order request dated 9/11/13 showed the request had been submitted to the maintenance department. No records were provided by the maintenance department to show when this was resolved.
c. On 10/13/14 at 1:30 p.m., a joint observation of the reach-in refrigerator (Tray line air curtain #1) was conducted with the DFEVS and FPM. There were canned (opened) pears that were dated with a use by date of 10/14/14 were 53.8° F and 53.1° F. A concurrent interview was conducted with FSW 3. He stated the pears had been in the refrigerator since the day before. The DFEVS stated this unit stays open during the meal service, however, if working properly the food should still remain cold.

The hospital's policy and procedure titled "Food Storage", dated 5/10, indicated refrigerated foods shall be maintained at 40° Fahrenheit (F).

d. On 10/13/14, in the display refrigerator in the café (#1) the temperature was 50° F at 2:00 p.m. The soy milk was 46.9° F and string cheese was 54.5° F. The FPM stated she was not aware there was a temperature problem with this and would need to put in a work order.

The hospital's policy and procedure titled "Food Storage", dated 5/10, indicated refrigerated foods shall be maintained at 40° Fahrenheit (F).

e. On 10/13/14, in the grab and go reach in refrigerator it was 58° F at 2:15 p.m. The Berry parfait (yogurt and berries) dated 10/13/14 was 44.6° F, egg salad sandwich dated 10/14/14 was 47.5° F, and chocolate fat free milk was 45.5° F. In a concurrent interview with the FPM, she stated the staff will check the thermometers of these units but they do not check the actual food temperatures. The FPM stated she was aware this unit had problems in the past keeping food cold enough.

The hospital's policy and procedure titled "Food Storage", dated 5/10, indicated refrigerated foods shall be maintained at 40° Fahrenheit (F).

f. On 10/15/14 at 9:32 a.m. during a joint observation with the FPM at the Campus 2 kitchen, the walk-in freezer was observed to have ice buildup under the condenser. FSW 4 stated the ice will build up from time to time. The FPM stated they would put a work order in for that.

On 10/14/14 at 10:10 a.m. an interview was conducted with Engineer 7. Engineer 7 stated the walk-in freezer #2 needed new gaskets and freezer #1 has problems with warming up and then condensation and ice will build up. He stated they have talked about doing some different things to help prevent ice from building up on the floor but they have not figured it out yet. Engineer 7 stated the tray line reach-in refrigerator has been freezing up at the top and that is why it is not working properly. He stated they would need to fix those units.

2. On 10/17/14 at 8:55 a.m., during a tour of the outpatient cancer treatment center (OCTC), the treatment center's ice machine and an annual ice machine cleaning log were observed. The cleaning log was divided into the twelve months of the year, and had room for four weekly entries each month. There was only one entry on the log dated 10/8/14.


On 10/17/14 at 10:40 a.m., during concurrent interview and review of the OCTC's ice machine cleaning log, the Dietary Food/Environmental Services Manager (DFEVS) stated, "It's not a question of whether it was done or not. It wasn't documented and it wasn't done." The DFEVS stated she did not know why it wasn't noticed before; pointing to the area of January through September which was completely blank. The DFEVS stated disciplinary action was pending due to the lack of oversight provided which allowed it to go unnoticed for so long.


On 10/17/14 at 11:10 a.m., during a telephone conversation, Engineer 8 stated, "There is no preventative maintenance for the ice machine in the OCTC. One guy said he remembers doing [providing maintenance for] it once three and a half years ago."


On 10/17/14 at 11:30 a.m., at the OCTC, Engineer 8 was unable to easily open the cabinet below the ice machine to turn the water off. Several calls were made, and multiple keys were tried unsuccessfully. The water to the ice machine was ultimately shut off, and the front and top panels of the machine were removed. Engineer 8 stated scale [Limescale is the hard, off-white, chalky mineral and calcium deposits] was present on the ice chute and dust was on the inside of the cover and all surfaces behind the cover the ice machine. It needs cleaned and sanitized even when you can't see it [scale and dust]. There was an air filter on the side of the machine beneath printing that indicated, "Clean twice a month." Engineer 8 stated, "It probably hasn't been done in a very long time. The last service was in 2011. This machine just fell off the radar."

On 10/17/14 at 11:40 a.m., during an interview, EVS Assistant Manager (EVSAM) stated in the first week of October she saw the OCTC ice machine cleaning chart and noticed it was totally blank. EVSAM stated she was responsible to provide oversight to EVS Tech that was supposed to be doing the weekly cleaning and was not. The EVSAM stated, "We cleaned it together on 10/8/14. There was significant Calcium deposits in the tray. Some is still left, only so much would come off. [EVS Tech's name] admitted she hadn't been cleaning the ice machine. She said she did not know it was one of her duties. She knew how, she just wasn't doing it."

Review of the OCTC's ice maker manufacturer's instruction manual, issued 11/15/13, provided by the facility, indicated, "...the maintenance schedule below is a guideline. More frequent maintenance may be required depending on water quality, the appliance's environment, and local sanitation regulations. ...Every 2 Weeks - Air Filter - Inspect. Wash with warm water and neutral cleaner if dirty. Monthly - External Water Filters - Check for proper pressure and change if necessary. - Appliance Exterior - Wipe down with a clean, soft cloth. Use a damp cloth containing a neutral cleaner to wipe off oil or dirt build up. Clean any chlorine staining (rust colored spots) using a non-abrasive cleanser. Every 6 Months - Ice maker and Storage Bin - Clean and sanitize per the cleaning and sanitizing instructions provided in this manual... Cleaning and Sanitizing Instructions - The appliance must be cleaned and sanitized at least twice a year. More frequent cleaning and sanitizing may be required in some conditions..."

Based on observation, staff interview, and record reviews the hospital failed to provide an environment which avoided sources and transmission of infections and communicable disease when the hospital failed to have effective systems in place to ensure:

1. Hinged and ratcheted instruments were sterilized in the unlocked and open position in accordance with nationally accepted infection control standards (Refer to A749, item 1).

2. Sharps were handled in a safe manner (Refer to A749, item 2).

3. A functional and sanitary environment for the provision of surgical services so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area (cross reference - Refer to A749, item 3a-c).

4. Staff were screened for vaccine preventable diseases in accordance with nationally accepted infection control standards (Refer to A749, item 4).

5. High level disinfected endoscopes were processed in an environment where contamination would not likely occur (Refer to A749, item 5).

6. Physicians consistently documented daily the necessity for continuing central lines (tubing inserted into a large vein for administration of medications) in their patients (Refer to A749, item 6).

7. Staff members were trained and competent to ensure the outpatient endoscopy procedure room was effectively disinfected (Refer to A749, item 7).

8. Food handling, cooling, storage, refrigeration, sanitation, and food and water disaster preparedness were safe practices per the hospital's policy and procedures (P&Ps), manufacturer's recommendations, and the 2013 Food Code (refer to A749 ).

9. An ice machine in the hospital's outpatient cancer treatment center (OCTC) was cleaned and sanitized per manufacturer's recommendations. (refer to A749).

The cumulative effects of these systemic problems resulted in the hospital's inability to provide infection control services and care in a safe and effective manner in accordance with the statutorily-mandated Condition for Coverage for Infection Control Services.

Based on observation, staff interview, and document review, the hospital's infection control officer failed to develop effective systems for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel in accordance with Hospital policy and nationally recognized infection control guidelines as evidenced by the failure to ensure:

1. Hinged and ratcheted (having teeth to allow motion in only one direction) surgical instruments were sterilized in the open position. An Immediate Jeopardy (IJ) was called on 10/13/14 at 5:05 p.m., when surgical instruments were discovered having gone through the sterilization process in the closed and locked position.

2. Sharps (any item having corners, edges, or projections capable of cutting or piercing the skin) were handled in a safe manner

3. A functional and sanitary environment for the provision of surgical services so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area when:

a. Staff were trained and competent to effectively disinfect the perioperative environment.

b. Restricted areas and traffic patterns in the GI procedure areas were identified and implemented in accordance with nationally accepted standards of practice.

c. The hospital staff wore commercially laundered surgical attire in the GI procedure area in accordance with nationally accepted standards of practice.

4. Medical staff (Physicians and Nurse Practitioners) were screened for vaccine preventable diseases in accordance with nationally accepted infection control standards.

5. High level disinfection processes (a process where all microorganisms, such as bacteria except possibly spores, are killed) of endoscopes were not occurring in close proximity to decontamination processes with potential for cross contamination.

6. Physicians consistently documented daily the necessity for continuing (keeping) patient central lines (tubing inserted into a large vein for administration of medications).

7. Staff members were trained and competent to ensure the outpatient endoscopy procedure room was effectively disinfected (Refer to 0749, item 7).

8. Policy and procedures were developed for monitoring ambient (room temperature) and cold salads prepared in advance with no temperature monitoring system.

9. Unsafe food handling practices were identified which involved cool down of potentially hazardous food and proper temperatures of cold food items.

10. Unsafe storage temperatures of food and beverages in the cafeteria refrigerator were identified.

11. Disaster foods (foods intended to be used should a disaster occur) were not stored next to chemicals.

12. Food service staff followed manufacturer's directions for a chemical solution.

13. Food service equipment was not worn and in need of replacement.

14. The ice machine at the cancer care center was maintained according to manufacturer's guidelines resulting in the potential for growth of microorganisms (bacteria, mold).
These failures resulted in the hospital's inability to provide infection control services and care in a safe and effective manner.

Findings:

1. During the initial tour of the central processing (CP) area on 10/13/14 at 12:40 p.m., the Central Processing Supervisor (CPS) was observed placing surgical instruments into a metal tray to be sterilized. CPS placed two surgical instruments called "verbugge" (which is a hinged and ratcheted instrument used as a bone-holding clamp) in the tray with the instruments positioned in the closed and locked position. In a concurrent interview, CPS was asked why he packaged instruments in the closed and locked position. CPS stated, "If I unlock them they fall apart." CPS was asked about the training he had received to learn how to properly position instruments for sterilization. CPS stated he had taken an online course prior to beginning to work in the area and had received training on the job. CPS stated there had not been any in-services training provided on packaging/positioning instruments or competency evaluations of his instrument packaging skills provided to him since he began working in this position in 12/2013.

On 10/13/14 at 2:15 p.m., a minor procedure tray (surgical tray used in procedures that are less complicated) was opened and inspected in the sterile supply room (a room where sterilized supplies are kept prior to use) known as the "Pack Room" located in the perioperative suite. Four (4) hinged surgical instruments known as towel clips were observed in the tray in the closed and locked position. In a concurrent interview, the Surgical Services Clinical Manager (CM) 3 explained these instrument clips were used to secure sterile towels together that were used in the sterile field and that the instruments were sterilized in the closed and locked position for safety reasons because the instrument tips were sharp. CM 3 stated that staff members were taught to position these instruments in the locked position for sterilization. CM 3 stated probably all trays contained towel clips in the locked position. CM 3 acknowledged that all trays with towel clips, which included most trays, would need to be pulled from all hospital and outpatient settings, and be reprocessed, and sterilized.

On 10/13/14 at 2:30 p.m., six sterilized minor bone trays (trays prepared with surgical instruments used for bone surgery) were opened and inspected in the Pack Room. The two surgical instruments called "verbugge" were observed to be in the locked and closed position in all six trays. In a concurrent interview, CM 3 acknowledged the instruments were in the locked and closed position and all these trays in all hospital and outpatient settings needed to be pulled, reprocessed, and sterilized.

On 10/13/14 at 5:05 p.m., an Immediate Jeopardy (IJ- a situation in which the hospital's noncompliance with one or more requirements of licensure has caused, or is likely to cause, serious injury or death to a patient) was called when surgical instruments were discovered having gone through the sterilization process in the closed and locked position. This positioning potentially interfered with the sterilization process which placed the instruments at risk for not being sterile. This practice placed surgical patients at risk for serious life threatening infections and an IJ was called with the Hospital President (HP), the Manager of Risk/Quality ((Admin Staff D), the Vice President/Chief Nursing Officer ((VP/CNO), the Regulatory Compliance Manager ((RC) and the Vice President Medical Affairs (CMO).

On 10/13/14 at 6:30 p.m., during an interview with a Technician (2) from the Operating Room (OR) in the central processing area, OR 2 stated she had been inspecting sterile instrument packages and found that all ratcheted instruments sterilized in peel packs had been found in the locked position and all were being pulled from all hospital and outpatient settings and being reprocessed and sterilized.

On 10/14/14 at 7:50 a.m., OR 1 was observed opening a minor bone tray located on the sterile field in an operating room in preparation for surgery. After inspecting the tray, OR 1 announced the two verbugges situated in the tray were positioned in the closed and locked position. OR 1 held up one of the verbugges so the surveyor could see it was locked. The instrument tray was then removed from the operating room.

On 10/16/14 at 8:45 a.m., the IJ was abated (lifted) and the hospital administration was notified when all Plans of Action to address the findings that led to the IJ were completed. The following hospital staff were present: the Hospital President (HP), the Vice President/Chief Operating Officer (VP/COO), the Manager of Risk/Quality (Admin Staff D), the Vice President/Chief Nursing Officer (VP/CNO), the Regulatory Compliance Manager (RC), Infection Control Nurse (ICN), and the Vice President Medical Affairs (CMO). The Hospital's Plan of Action included: the process of opening surgical sets and packages; and ensuring surgical instruments were unlocked, unclamped, opened, repackaged, and reprocessed. The hospital brought in a qualified person who provided training and oversight to CP staff. Training, mentoring, monitoring, and skill competency checks were initiated. A method to ensure staff continued to check, monitor, validate, and audit instruments were sterilized in the opened and unclamped position was developed and implemented. Efforts were made to inform surgeons and gain their cooperation in the event of potential delays resulting from staff now acting on their obligation to reject closed/clamped instruments on the grounds that their sterility could not be ensured.

On 10/16/14 at 1:45 p.m., during an interview, the Director of Surgery (DS) stated the problem identified with staff sterilizing surgical instruments in the closed and locked position was ultimately her responsibility. DS indicated she should have checked surgical trays for correct instrument position and not relied solely on her staff. DS stated she was familiar with national sterilization guidelines and knew that it was not acceptable to sterilize hinged and ratcheted instruments in a closed and locked position. DS stated it was a mistake to not go back and check all staff for competency on an annual basis to ensure everyone knew the basics of sterile processing. DS stated that staff also needed more specific ongoing in-service training along with annual competency checks that looked in detail at processing skills.

The Hospital's policy titled "Instruments, Scope and Power Equipment, Care of," dated 10/12, was reviewed. The policy indicated, "Instruments with removable parts should be disassembled and placed in storage trays or canisters designed for sterilization ...Ring handled instruments are to be secured in a manner that allows the box lock to remain in the open position ...Delicate and sharp instruments are to be protected according to the manufacturer's instructions. If wrapped in a peel [a pouch used to sterilize a single item] must have a "plastic blunt tip cover" to prevent package perforation and subsequent contamination."

The 2014 Perioperative Standards and Recommended Practices published by the Association of Operating Room Nurses (AORN) was reviewed. AORN standards indicated, "Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces and instruments with hinges should be opened..."

2. On 10/14/14 at 9:20 a.m., the Anesthesiologist (A) 1 was observed recapping a syringe with needle attached using both her hands. In a concurrent interview, A 1 stated she should have recapped the needle by using the one-handed scoop (scooping the cap up with the needle using one hand) technique to prevent needle sticks.

The 2014 Perioperative Standards and Recommended Practices published by the Association of Operating Room Nurses (AORN) was reviewed. Recommendation XIVg.4. under the section titled "Medication Safety" provided direction that, "Perioperative team members should demonstrate competency related to safe injection practices including, but not limited to, complying with sharps safety measures ..."

The 2014 Perioperative Standards and Recommended Practices published by AORN was reviewed. Recommendation III.h.1 under the section titled "Sharps Safety" indicated, "Needles should not be recapped. When a safe needle device is not available and recapping is required, a one-handed scooping recapping technique must be used. Two-handed recapping of hypodermic needles is associated with an increased incidence of injuries."

3a. On 10/14/14 at 6:40 a.m., the Environmental Services (EVS) 1 was observed cleaning Operating Room (OR) 6. EVS 1 was using a cloth, dipped in a bleach solution called Activate, attached to a mop handle to wipe the ceiling surface. EVS 1 completed half the ceiling using the same damp cloth. When she reached the midpoint of the ceiling, the cloth was dry and no moisture was being applied to the ceiling.

On 10/14/14 at 6:45 a.m., Clinical Manager (CM) 3 stated the housekeeper was trying to clean OR 6's ceiling with a cloth that had become dry with use, and asked if she could intervene. She then instructed EVS 1 to get another cleaning cloth and dip it into the bleach solution and clean those portions of the ceiling that were not moist.

A review of the manufacturer's technical information sheet for the Environmental Protection Agency (EPA) registered one-step hospital disinfectant called "Activate" was conducted. The technical information sheet indicated the product was highly effective against a broad spectrum of pathogens (germs) when used as directed. The instructions indicated that to be effective the product solution needed to be in contact with the surface thoroughly wet for four (4) minutes.

3b. On 10/15/14 at 8:15 a.m., the endoscopy procedure area (referred to as the GI area) was observed. The GI area contained a recovery area (area where patients recover from surgery), procedure room, and an area where equipment was cleaned and disinfected. When entering the GI area, there were no signs which indicated "authorized personnel only" or "surgical attire required".

On 10/15/14 at 8:20 a.m., an interview with Clinical Manager (CM) 3 was conducted. CM 3 was asked about the traffic patterns in the GI area. CM 3 stated the GI area was not considered a surgical area, therefore there were no restrictions or requirements alerting personnel that traffic and the type of attire required were restricted. CM 3 stated the types of procedures performed in the GI area included colonoscopy (a procedure that visually examines the large intestine with a long, flexible instrument, or probe); Esophagogastroduodenoscopy (EGD - upper endoscopy, a procedure that visually examines the swallowing tube, stomach, and the first portion of small intestine with a long, flexible instrument, or probe); biopsy (a procedure to obtain body tissue for microscopic examination), and peg insertion (the placement of a tube in the stomach through the abdomen through which nutrition can be given).

On 10/15/14 at 10:15 a.m, the Infection Control Nurse (ICN) stated endoscopy procedures performed in the outpatient GI center were billed as surgical procedures. The ICN stated the hospital followed the Association of Operating Room Nurses (AORN) standards for all surgical procedures.

A review was conducted of the definition of surgery developed by the American College of Surgeons, dated 4/2007, and adopted by the Centers for Medicare and Medicaid (CMS) in regulations. Surgery was defined as "... altering the human body by the incision or destruction of tissues and is part of the practice of medicine. Surgery is also the diagnostic or therapeutic treatment of conditions or diseases processes by any instruments causing localized alteration or transposition of live human tissue which include lasers, ultrasound, ionizing radiation, scalpels, probes, and needles..ll of these surgical procedures are invasive, including those that are performed with lasers, and the risks of any surgical intervention are not eliminated by using a light knife or laser in place of a metal knife or scalpel."

Review of The Perioperative Standards and Recommended Practices published by the AORN, 2014 edition indicated "Traffic patterns should be designed to facilitate movement of patients and personnel into, through, and out of defined areas within the surgical suite. Signs should clearly indicate the appropriate environmental controls and surgical attire required. The semi-restricted area includes the peripheral support areas of the surgical suite. It has storage areas for clean and sterile supplies, work areas for storage and processing of instruments, scrub sink areas, and corridors leading to the restricted areas of the surgical suite. Traffic in this area is limited to authorized personnel and patients. The restricted area includes operating rooms, procedure rooms, and the clean core area. "

3c. On 10/15/14 at 8:20 a.m., during an interview, Clinical Manager (CM) 3 was asked about the use of surgical attire in the GI area. CM 3 stated the GI area was not considered a surgical area, therefore staff wore home laundered scrubs and did not have to cover their hair in the hallway outside the GI procedure room.

On 10/15/14 at 10:15 a.m., the Infection Control Nurse (ICN) stated endoscopy procedures performed in the outpatient GI center were billed as surgical procedures. The ICN stated the hospital followed Association of Operating Room Nurses (AORN) standards for all surgical procedures.

Review of the hospital's policy titled, "Attire, Surgical," dated 3/13, indicated, "All individuals who enter the restricted and semi-restricted areas of the surgical suite will wear commercially laundered surgical attire provided by the hospital and proper hair covering, shoes and or shoe coverings/booties...Disposable caps are to be worn to confine hair and scalp skin and all possible head and facial hair, including bangs, sideburns, and neckline...All individuals entering the operating room should wear a surgical mask when open supplies and equipment are present and/or during any procedure must wear a mask."

Review of the 2014 Association of Operating Room Nurses (AORN) Perioperative Standards and Recommended Practices, under Recommended Practices for Surgical Attire, indicated, "Clean surgical attire, including shoes, head covering, and all individuals who enter the semirestricted and restricted areas of the surgical suite should wear freshly laundered surgical attire intended for use only within the surgical suite. Persons entering the semirestricted or restricted areas of the surgical suite for a brief time for a specific purpose should cover all head and facial hair and should don [put on] either freshly laundered surgical attire; single-use attire, or a single-use jumpsuit designed to completely cover outside apparel. All individuals who enter the semirestricted or restricted areas should wear freshly laundered attire that is laundered at a health care-accredited laundry facility or disposable surgical attire provided by the facility and intended for use within the perioperative setting. All individuals entering the restricted areas should wear a mask when open sterile supplies and equipment are present."

4. On 10/17/14 at 9.a.m., a medical record review was conducted for four medical staff members: three physicians (MD) 1, 2, and 3; and one nurse practioner (NP) 1. The status of immunity for measles, mumps, and rubella (a highly contagious viral infection) were unknown for two of the four medical staff members reviewed (MD 1 and MD 2). There was also no documented evidence that the hepatitis B immunization had been offered to MD 2.

On 10/17/14 at 9:05 a.m., during an interview, Director of Medical Staff Admin (DSA) stated, "Our policy is to track participating providers for tuberculosis and the rest of the immunizations are voluntary..." DSA was asked what nationally accepted infection control guidelines she based that policy on and DSA stated she [DSA] didn't know.

According to the Centers for Disease Control (CDC) - the nationally recognized source for Health Care Provider (HCP) immunizations, the 2011 Morbidity and Mortality Report (MMWR) MMWR. 2011;60 (RR07):1-45 "Healthcare workers (HCP) include physicians, dental professionals administrative staff, and...The guidelines recommend any facility or organization that provides direct patient care to formulate a comprehensive vaccination policy for all HCP...To ensure that all HCP are up to date with respect to recommended vaccines, facilities should review HCP vaccination and immunity status at the time of hire and on a regular basis (that is, at least annually) with consideration of offering needed vaccines, if necessary, in conjunction with routine annual disease-prevention measures (for example, influenza vaccination or tuberculin testing)...On the basis of documented nosocomial [hospital acquired] transmission, HCP are considered to be at substantial risk for acquiring or transmitting hepatitis B, influenza, measles, mumps, rubella, pertussis, and varicella (also known as chicken pox)." CDC provides detailed recommendations for these vaccinations in the MMWR document cited at the beginning of this paragraph.

5. On 10/13/14 at 12 p.m., in the Hospital Gastrointestinal (GI) Lab decontamination room, a sink where dirty endoscopes were cleaned and decontaminated was observed. The sink was located within approximately one foot of where high level disinfection of endoscopes occurred. In a concurrent interview, the Respiratory Therapist (RT) stated there was potential on a busy day for a clean scope to be removed from the machine where it was disinfected and be in in close proximity to the sink where dirty scopes were being cleaned. RT stated there was potential for the disinfected scope to become contaminated in this situation.

On 10/15/14 at 8:15 a.m., in the Hospital Gastrointestinal (GI) Lab decontamination room, a sink was observed, where dirty endoscopes were cleaned and decontaminated. The sink was located within approximately one foot of where endoscopes were high level disinfected. The Outpatient Center Endoscopy Technician (T) 4 stated the dirty endoscopes were being cleaned in close proximity to where the highly disinfected scopes were being high level disinfected and then moved into storage. T 4 stated there was potential for aerosols (liquid or solid particles released into the air) generated from the scope cleaning process contaminating the disinfected scope.

The Hospital's Policy titled, "Instruments, Scope and Power Equipment, Care of," dated 10/12, which included instructions related to cleaning and disinfecting endoscopes, was reviewed. The policy did not address the need to separate decontamination processes from areas where high level decontamination and clean endoscopes are handled.

A review of the 2014 Association of Operating Room Nurses (AORN) Standards and Recommended Practices, under Recommended Practices for Cleaning and Processing Flexible Endoscopes and Endoscope Accessories was conducted. The AORN standards indicated: "Flexible endoscopes should be decontaminated in an area physically separated from locations where clean items are handled and patient care activities are performed. Physical separation of decontamination areas from areas where clean items are handled minimizes the risk of cross-contamination. Cross-contamination can result when soiled items are placed in close proximity to clean items or placed on surfaces upon which clean items are later placed. Aerosols created during cleaning can also cause cross-contamination. The decontamination area should be physically separated from clean patient care areas and include a door. This area should contain, but not be limited to: sinks to manually clean flexible endoscopes, hand-washing facilities, eyewash station, automated equipment consistent with the types of flexible endoscopes to be decontaminated, adapters and accessories to connect the flexible endoscopes with cleaning equipment and utilities, leak testing equipment, low-pressure air, closed storage facilities, and proper ventilation. The design of the decontamination area facilitates the safe and effective decontamination of flexible endoscopes and accessories. Appropriate equipment and utilities facilitate desired infection control practices."

6. On 10/15/14 at 2:05 p.m., Patient 11's Central Vascular Access Device Need Assessment form was reviewed. The documentation indicated the central line was inserted on 10/14/14. On 10/15/14, the physician entered his initials and the time, but the area of the form where the reason(s) for continued need would go was left blank. In a concurrent interview, Registered Nurse (RN) 5 stated the physician did not document the reason for continued need for the central line.

On 10/15/14 at 2:20 p.m., Patient 21's Central Vascular Access Device Need Assessment form was reviewed. The patient's physician had documented the rationale for continuing the central line on 10/4/14 through 10/9/14. In a concurrent interview, RN 4 confirmed the patient still had a central line and the physician had not performed daily documentation to support the continued necessity of the line from 10/10/14 through 10/15/14.

Review of California Senate Bill 739, dated September 28, 2006, was conducted. The Bill requires physicians to perform a daily assessment and document daily the necessity of their patients' central lines.

7. On 10/17/14 at 8 a.m., during concurrent observation and interview, the Interim Clinical Manager of Outpatient Endoscopy (CMOE) was asked how staff clean the endoscopy procedure room between patients. She pulled out a container of quaternary ammonium (widely used disinfectant) based wipes, and stated they wiped down the tables with them between patients. The label of the product did not indicate effective disinfection for C- difficile (C-diff a bacteria). The CMOE stated she was unaware the product did not work for C-diff and said a product that would kill C- Diff was needed. The CMOE stated there was no policy/procedure for cleaning rooms between patients.

The Centers for Disease Control and Prevention (CDC), an organization recognized for providing nationally accepted infection control guidelines, was accessed online at: "http://www.cdc.gov/hai/organisms/cdiff/cdiff_faqs_hcp.html#a4" and "http://www.cdc.gov/hai/organisms/cdiff/cdiff_faqs_hcp.html". The CDC provided the following information related to cleaning an environment where C-diff could be present: "Consider using an Environmental Protection Agency (EPA) -registered disinfectant with a sporicidal [spore/fungus killing] claim for environmental surface disinfection after cleaning in accordance with label instructions; generic sources of hypochlorite (e.g., household chlorine bleach) also may be appropriately diluted and used. (Note: Standard EPA-registered hospital disinfectants are not effective against Clostridium difficile spores) Hypochlorite-based disinfectants may be most effective in preventing Clostridium difficile transmission in units with high endemic [regularly found among particular people or in a certain area] rates of Clostridium difficile infection."

8. On 10/13/14, starting at 1 p.m., during the initial tour of the kitchen in the presence of the Director of Food Service & Environmental Services (DFEVS) and the Food Production Manager (FPM), the following items were observed in the walk-in refrigerator (Refrigerator #2): Tuna salad, dated 10/13/14, was 57.4 degrees (°) Fahrenheit (F); and egg salad, dated 10/13/14, was 47.3° degrees F. An interview was conducted with the Food Service Worker (FSW) 1. FSW 1 stated she made the salads approximately 15 minutes ago and the ingredients for the tuna salad came from the storeroom. The FSW 1 stated she makes the salads, then puts them in the walk-in refrigerator, and doesn't monitor the temperature.

On 10/15/15 at 8:45 a.m., the DFEVS stated the hospital did not have a system (policy and procedure) in place to monitor the temperatures of the cold salads like tuna salad, egg salad, pasta salad, etc., to ensure they reached 41° F or less after they were prepared.

The FDA Food Code 2013 (3-501.14) Cooling, indicated Potentially hazardous food (time/temperature control for food safety) shall be cooled within 4 hours to 41° F or less if prepared from ingredients at ambient temperature, such as reconstituted foods and canned tuna.

On 10/15/14 at 4:10 p.m., an interview was conducted with the Infection Control Nurse (ICN). The ICN stated she had been doing rounds in the kitchen and café areas at least once a year, however, she has wanted to increase that frequency but has not been able to do that yet.

9. On 10/13/14 at 1:10 p.m., a concurrent observation, in the presence of the Dietary Food/Environmental Services Manager (DFEVS) and Food Production Manager (FPM) was conducted. The following food items were observed in a walk-in refrigerator (Refrigerator #1): Chicken noodle soup, dated 10/13/14, was 65.1 degrees (°) Fahrenheit (F); and rice pilaf, dated 10/13/14, was 45° F. Cook 2 was interviewed about these food items. Cook 2 stated he made these items this morning around 9:30 a.m. Cook 2 stated he placed all the items in the blast chiller (type of equipment to cool foods down quickly) and he checked the food after two hours and the food needed to be 70° F, and then after another two hours it would need to be 40° F, or less. Cook 2 stated he documented the temperatures of these foods on the cool down log. Cook 2 stated he puts multiple food items in the blast chiller at the same time and cools them all down together. He stated his practice is just to check one of the food items and just put that temperature down for all of the items. The DFEVS stated this was not the correct practice since different food items can have different density or amounts and could be different temperatures. She stated this was not her expectation of how the cook should be taking temperatures when cooling down foods.

A review of the "cooling temperature log", dated 10/13/14, with temperatures recorded by Cook 2 ( who previously stated he only recorded the temperature of one food item and put that temperature down for all food items), indicated chicken noodle start time was 9:30 (the documentation was unclear as to whether 8 or 9:30) and initial temperature was 180° F, then time at 9:30, it was documented at 70° F; and 11:15 it was 40° F. The rice pilaf was dated 10/13/14, with a start time of 9:45 a.m., and initial temperature was 180° F; at 10:30 it was 70° F; and at 11:15 it was 40° F. The cooling temperature log indicated to cool hot food to 70° F, or below, within 2 hours; and from 70 to 41 degrees F, or below, within an additional 4 hours. All recorded temperatures for the rice pilaf and the chicken noodle were identical.

The FDA Food Code 2013 (3-501.14) Cooling, indicated Potentially hazardous food (time/temperature control for food safety due to the potential for growth of disease causing germs) shall be cooled within 4 hours to 41° F or less if prepared from ingredients at ambient temperature....

On 10/15/14 at 4:10 p.m., an interview was conducted with the Infection Control Nurse (ICN). The ICN stated she had been doing rounds in the kitchen and café areas at least once a year, however she has wanted to increase that frequency but has not been able to do that yet.

10a. On 10/13/14 at 1:30 p.m., an observation of the reach-in refrigerator (Trayline air curtain #1) was conducted with the Dietary Food/Environmental Services Manager (DFEVS) and Food Production Manager (FPM). There were canned (opened) pears, with a use by date of 10/14/14, that were 53.8 degrees (°) Fahrenheit (F); and 53.1° F. A concurrent interview was conducted with Food Service Worker (FSW) 3. He stated the pears had been in the refrigerator since the day before.

Review of the hospital policy and procedure titled Food Storage dated 5/10, indicated refrigerated foods shall be maintained at 40° F.

b. On 10/13/14 starting at 1:35 p.m., an observation was conducted with the Dietary Food/Environmental Services Manager (DFEVS) and Food Production Manager (FPM). The following items were observed in the grill prep area in the café: Chopped chicken that was 46 degrees (°) Fahrenheit (F); sliced American cheese that was 47.3° F; and white sliced cheese (not labeled) that was 52.7° F. The FPM stated her staff informed her the temperatures were just taken at 1:30 p.m., and all were okay. When the FPM asked her staff how they took the temperature, the staff placed the thermometer all the way into the food and were uncertain if they touched the bottom of the pan which could be the coldest part of the food. The staff also informed the FPM that she did not take the temperature of the white cheese.

The grill area TCS (Temperature Control Safety) Cold Food Holding log dated 10/13/14, was reviewed. The log indicated the last temperature was taken at 1:30 p.m., and the sliced cheese was 39° F, and the diced chicken was 40° F.

In the deli area, at 1:45 p.m., there was salami dated 10/13-10/15/14, that was 47.3° F; provolone cheese that was 47.8° F; and sliced roast bee