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Based on observation, interview and document review, the governing body of the hospital failed to ensure the contracted service at the Bistro furnished services that permit the hospital to comply with all applicable conditions of participation and standards including acceptable standards of practice for food service for the operation of the contracted service. The hospital failed to ensure services provided under contract identified quality and performance problems and implemented appropriate corrective action or improvement activities. This is a potential for cross-contamination and food borne illness when the standards of practice of safe food service established by the FDA (Food and Drug Administration) Food Code 2009 are not followed.

Findings:

On 8/7/13 starting at 10:00 a.m., the Bistro Food Service was reviewed. The Bistro was a contracted food service at the Mountain View campus preparing and serving sandwiches, coffee and yogurt. The owner operator stated they prepared the sandwiches, including panini, tuna salad and egg salad, on the premises.

1. There were two plastic blender bases next to the handwashing sink and contaminated by overspray from staff washing hands. Also stored close to the handwashing sink were coffee preparation metal pitchers with potential for overspray of dirty handwashing overspray. The standard of practice is to maintain clean and sanitized dishware from cross contamination of handwashing overspray (Food Code 2009).

2. The owner operator stated the blender bases used to prepare drinks were rinsed in the handwashing sink. The standard of practice is to use the handwashing sink for handwashing only and all dishware is washed, rinsed and sanitized in a designated ware washing sink (Food Code 2009).

3. The temperator for one pint yogurt from the grab and go refrigerated case was 52 degrees Fahrenheit (F). The standard of practice is to maintain all potentially hazardous food (PHF, food capable of supporting growth for pathogenic micro-organism) at 41 degrees F or below. PHF food in the danger zone of 41 degrees to 135 degrees F can be a source of food-borne illness.

4. Bread to make panini sandwiches was next to the ware washing sink which was full of dirt dishes waiting to be washed. Bistro food service Staff 1 stated this was the food preparation area as well as the area to wash the dirty dishware.

5. In the refrigerator were containers of blue cheese and fruit with no date when placed for service.

6. Bistro food service Staff 1 stated they made tuna salad and egg salad and did not have a process to ensure it was cooled to 41 degrees F after preparation to ensure safe food temperatures. Standard of practice is to cool and monitor potentially hazardous food following preparation to ensure they are cooled to 41 degrees F in four hours (Food Code 2009).

7. The owner operator stated the bin ice machine was serviced by a commercial refrigeration company on 6/18/13. Review of the invoice showed a statement "Preventative Maintenance" but did not specify the procedure of cleaning and sanitizing to ensure the manufacturer's directions were followed. This is a potential the ice machine was not cleaned and sanitized to prevent growth of pathogenic micro-organisms.

Interview with the infection control practitioner (IFC 1) concurrently during the inspection stated she did not know what oversight Infection Control Department had for the Bistro. The infection control practitioner (ICP 1) acknowledged the numerous observations of deficient practice were a risk for food-borne illness. ICP1 stated that they did not see the County Inspection Report.

Interview with the director of Nutrition Services (DNS) concurrently stated their department was not involved in providing oversight to the Bistro operation and acknowledged the unsafe practices observed were of concern and a potential for food-borne illness.

Review of the Food Program Official Inspection Report dated 2/18/2013 showed deficiencies in food properly labeled and milk at 48 degrees F and in the danger zone to grow pathogenic micro-organisms.

The Bistro contract dated April 1, 2009 for Hospital Retail Space lease was reviewed. The contract did not ensure the operation complied with acceptable standards of practice for food service operation. There were no provisions for hospital oversight to ensure services provided under contract identified quality and performance problems and implemented appropriate corrective action or improvement activities.

During interview on 8/8/13 at 1:00 p.m., the hospital administrator stated this was a leased retail space and the hospital did not have any oversight of the food service or quality and performance standards.

Based on observation, staff interview, and document review, the hospital failed to maintain an effective ongoing hospital wide data driven quality assessment program involving the Dietary Services and Infection control when:

1. There was no analysis or tracking of issues to evaluate scope of Food Services, including failure to develop an effective quality appraisal and performance approval program. The Nutrition, Dietetics, and Infection Control quality improvement programs (QAPI) failed to measure, analyze or track quality indicators in the food department including food safety, nutrient analysis, hospital diet manual, and physician diet orders. There were breaks in infection control that could result in patients developing food-borne illness when there was lack of staff knowledge, and adequate documentation of safe food cool down procedures. Breast milk was not stored at the correct temperatures, and ice machines were not sanitized with the specified sodium hydrochlorite solution (cross reference A618, A620, A629, A630, A631, and A749).

2. The quality program failed to include indicators relative to the scope of the food and nutrition services that identified opportunities for improvement (cross reference A630, A631, and A749).

The cumulative effect of these systemic problems resulted in the inability of the hospital's food and nutrition services to direct and staff in such a manner to ensure that the nutritional needs of the patients were met with practitioners' orders and acceptable standards of practice.

Based on administrative and dietary staff interview, and dietary department document review, the governing body failed to have an ongoing quality appraisal and performance improvement program that addressed the complexity and scope of the food service which resulted in failure to identify issues in safe food handling practices, food storage and sanitation, which could result in food-borne illness.

Findings:

During the survey from 8/5 to 8/8/2013 deficient practices related to; 1) safe and sanitary food services operation (cross-reference to A620 and A749); 2) ensuring patient nutritional needs were met (cross-reference A621, A629 and A630, A631).

In interviews on 8/6/13 beginning at 2:20 p.m., with the Los Gatos Food Service manager and on 8/8/13 at 9:30 a.m., with the Mountain View clinical nutrition manager and nutrition services director, the quality program for the food service and clinical nutrition department was reviewed.
Findings:

1. Los Gatos and Mountain View Food Service QAPI program consisted of quality monitoring for temperature logs completeness, nutrition and safety audits, and patient tray study and product expiration dates. The Los Gatos sanitation audit was at 96 percent. The nutrition manager at Los Gatos stated they had had these same quality measures for the last 4 years and had made progress but had not added any other quality indicators, just the same ones from the previous years.

2. Mountain View also had the same goals and stated the temperature log and patient tray studies were completed but no percentage compliance was recorded. The sanitation audit was at 96 percent.

3. Review of the clinical goals included new goals for total parenteral nutrition (TPN, feeding through a vein) orders at Mountain View and timeliness of nutrition assessments at Los Gatos.

Review of the goals for FY 2014 listed the same food service goals for another year. The Mountain View clinical manager concurrently and stated they had added monitor for late trays.

There was no QAPI program to address the quality of nutrition assessments, nutrient adequacy of menus, safe storage of breast milk, diet manual meeting needs of staff and clinical dietitians.

Based on staff interview and medical record review, the hospital staff failed to follow the hospital policy and procedures related to the use of a fentanyl patch (a potent long-acting narcotic pain medicine applied to the skin) for one of 6 patients (Patient 93). The staff continued the patient's home fentanyl patch when the policy stipulated to remove the home patch and apply a new hospital dispensed patch when there was an order to do so. The integrity, storage condition, expiration status, etc. of the home patch cannot be guaranteed if used.

Findings:

The hospital's policy and procedures on "FENTANYL TRANSDERMAL PATCHES, USE OF," dated 2/12, indicated the following under Policy and Procedures:

"1. Patients who are admitted to an inpatient unit with a fentanyl TDP (transdermal patch) in place shall have that patch removed once the physician has written orders for a new pain management plan or to replace the TDP with a hospital dispensed fentanyl TDP."

On 8/7/13 at 1:10 p.m., a review of Patient 93's medical record was conducted with the Quality Manager, the director of pharmacy (DOP), and the pharmacy manager (PMGR 2). The medication reconciliation record reflected the patient had been on fentanyl 50 mcg/hr (micrograms/hour) patch every 3 days prior to admission. Upon admission on 7/11/13, she had a physician order for fentanyl 50 mcg/hr patch to be applied every 3 days. The pharmacy dispensing record and the medication administration record showed a new patch was placed on 7/14/13 and 7/17/13, but not on the day it was ordered (7/11/13). The medical record documented a fentanyl patch was in place between 7/11/13 to 7/13/13, indicating the staff continued the patient's home patch until a new hospital dispensed patch was placed on 7/14/13. The Quality Manager and the DOP said, according to the hospital policy, the staff was to remove the patient's home patch and replace it with a new hospital dispensed patch when there was an existing order. They agreed the staff did not follow the hospital policy and procedures.

Based on observation, interview, and record review, the hospital failed to store medications within the temperature range specified on the manufacturer's packaging, to maintain drug integrity, stability, and effectiveness, for two of two medication freezers. The failure had the potential to expose patients to the ineffective treatment of serious infections due to the use of expired and/or less than labeled strength medications.

Findings:

During a visit to the pharmacy on 8/5/13 at 12:10 p.m. with the director of pharmacy (DOP) and the pharmacy clinical manager (PCM), one medication freezer (Freezer 1) was identified. The DOP said the freezer had been out of service for some time and all medications were transferred to a back-up freezer (Freezer 2). The DOP said the hospital facilities (engineering department) was responsible of monitoring temperatures of medication refrigerators and freezers in the pharmacy.

On 8/6/13 at 11:20 a.m., a visit was made to the facilities department with the DOP and PCM. In the presence of the facilities manager, a review of the electronic temperature monitoring system revealed Freezers 1 and 2 had two different sets of temperature parameters. Freezer 1 had been set from -30?C (negative 30 degrees Celsius) to -10?C. Freezer 2 had been set from -34.4 to -12.2?C. The DOP and PCM could not explain why the freezers had two different temperature parameter settings, when they were used to store the same medications/products. The facilities manager said these settings had been set for at least two years. The facilities record showed medications were transferred from Freezer 1 to Freezer 2 on 8/2/13. A one-month (7/2/13-8/2/13) average reading for Freezer 1 was requested. It had an average reading of -12.4?C.

On 8/6/13 at 11:45 a.m., the medication contents in Freezer 2 were observed with the DOP and PCM. Freezer 2 contained numerous counts of Baxter's (manufacturer) frozen antibiotics (Zosyn, vancomycin, cefazolin, and ceftriaxone). The storage instructions on these antibiotics indicated to store them "at or below -20?C." Thus, any temperatures above -20?C (such as -19?C) would not meet the temperature requirement specified by the manufacturer. The DOP and PCM agreed the current freezer temperature settings (the upper range above -19.9 ?C) for Freezers 1 and 2 did not meet Baxter's storage specification.

The hospital's policy on "MEDICATION STORAGE TEMPERATURE MONITORING," dated 11/12, indicated the medication storage temperature for the freezer was "below -10 degrees C." During an interview on 8/6/13 at 4:30 p.m., the DOP acknowledged the policy needed to be changed to meet the manufacturer's storage specification.

Based on interview and record review, the hospital failed to ensure the provision for safe and effective use of fentanyl patches (a potent long-acting narcotic pain medicine applied to the skin) for 1 of 6 patients (Patient 99). The hospital failed to develop dosing guidelines for these patches and the pharmacy failed to question the dosing titrations outside of the manufacturer's dosing guidelines. The failure had the potential to result in adverse outcomes (such as an overdose) for patients.

Findings:

Patient 99 was admitted to the hospital with diagnoses including abdominal pain, diverticulitis (an intestinal disorder), and pancreatic cancer. On 8/8/13 at 12:45 p.m., a review of Patient 99's clinical record with the director of pharmacy (DOP) and the pharmacy clinical manager (PCM), revealed the patient had a physician order for fentanyl 25 mcg/hr (the patch delivers 25 micrograms/hour) patch to be placed once every 72 hours on 7/30/13 at 6 p.m. (she did not have fentanyl patch use prior to admission). Approximately 14 hours later, on 7/31/13 at 8:13 a.m., the order was increased to fentanyl 50 mcg/hr every 72 hours. Two days later, on 8/2/13 at 8:59 a.m., the order was increased to fentanyl 75 mcg/hr every 72 hours. The medication administration record showed the respective fentanyl patches were applied shortly after they were ordered.

To date, the Full US Prescribing Information (revised 7/12) for this medication documents the initial (first time) dose may be increased after 3 days based on the daily dose of supplemental opioid medications required by the patient on the second or third day of the initial application. The manufacturer further documents that "it may take up to 6 days for fentanyl levels to reach equilibrium on a new dose. Therefore, evaluate patients for further titration after no less than two 3-day applications before any further increase in dosage is made." In other words, the patient should wear the new higher dose through two cycles of 72 hours each (6 days) before further dosage increases are made.

During the review above, the DOP and PCM acknowledged Patient 99's fentanyl patch dose increases were too fast (initial dose increase happened 14 hours, instead of 3 days, after initial application; and the second dose increase happened 2 days, instead of 6 days, after the first dose increase). There was no evidence a pharmacist had called the physician regarding the dosage titration outside of the manufacturer's guidelines. The DOP and PCM said the hospital's current policy and procedures for fentanyl patch use did not address dosing guidelines.

Based on observation, interview, and document review, the hospital failed to ensure intravenous (IV) medication labeling was performed consistent with hospital procedures to ensure safe use. The beyond-use date (BUD, date beyond which medication cannot be stored) assignment on batch compounded products was not consistent with the hospital developed procedures. This may affect the stability and sterility of the compounded products. The labeling requirement was also inconsistent.

Findings:

1. During the visit to the pharmacy's IV Room on 8/5/13 at 10:30 a.m., Pharmacist 1 was asked to explain the process for IV compounding and beyond-use dating for IV compounded products. Pharmacist 1 provided the Compounded Sterile Preparations (CSP) Sheet, dated 11/30/09. He explained the pharmacy staff used this CSP Sheet to assign the BUD for each medication after they were compounded. He explained the information (such as BUD, storage instructions) on the CSP Sheet was derived from the manufacturer's specifications, USP <797> (set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP)), and/or established literature.

During this visit, 5 bags of compounded Vancomycin (an antibiotic) 1,500 mg (milligrams) in 500 ml (milliliters) of D5W (5% dextrose in water) were observed in the pass-through refrigerator. Their labels indicated they were prepared on 7/31/13 and had the assigned expiration date of 8/15/13 (15 days BUD). The CSP Sheet showed they were to have an assigned expiration date of 14 days under refrigeration, not 15 days. Pharm 1 acknowledged the identified Vancomycin bags had the wrong expiration date.

Similarly, the CSP Sheet indicated the batch compounding of azithromycin (an antibiotic) 500 mg in 250 ml of Normal Saline would be assigned an expiration date of 7 days under refrigeration.

A review of the Batch IV Compounding Log for azithromycin 500 mg in 250 ml of Normal Saline prepared on 7/31/13 showed the compounded products were assigned an expiration date of 8/8/13, or 8 days (instead of 7 days), under refrigeration.

On 8/5/13 at 10:45 a.m., the pharmacy operations manager (PMGR 1) acknowledged the identified products had the wrong expiration dates, inconsistent with the pharmacy's established CSP guidelines.

2. During the visit to the Critical Care Unit (CCU) on 8/6/13 at 1:10 p.m. in the presence of the pharmacy director and the CCU director, four compounded IV bags, which had been sent from the pharmacy, were identified. The labels on two of the IV bags did not have a preparation date and time; they both had an expiration date of 8/6/13. It was undeterminable when the products had been prepared or how long they had been stored before being sent to the CCU.

On the same day at 1:30 p.m., PMGR 1 explained that the pharmacy staff just discovered there was a glitch in the pharmacy system, causing some of the labels to come out without the preparation date/fill date. PMGR 1 said there should be a preparation date for each compounded product from the pharmacy.

Based on observation, interview and document review, the hospital failed to ensure dietary services met the needs of all patients as evidenced by failure to:

1. Provide organized dietetic services as a qualified fulltime Dietary Service, and to ensure the Food and Dietetic Service Director developed and monitored written procedure according to standards of practice for operational processes. The Food and Nutrition Director failed to ensure the daily management of the dietary services to ensure safe food handling and sanitation at Mountain View Campus and Los Gatos campus (cross-reference A620, A749).

2. Ensure that a qualified dietitian collaborated with other hospital services such as nursing and social services, and supervised the nutritional aspects of patient care including planning and implementing medical nutrition therapy necessary to meet the nutritional needs of one patient (cross-reference A621).

3. Ensure the regular and therapeutic menus met the nutritional components to meet the current national standards including the RDA (Recommended Dietary Allowances) and DRI (Dietary Recommended Intakes) of the Food and Nutrition Board of the National Research Council (cross reference A630).

4. Ensure a therapeutic diet manual that accurately reflected physician ordered diets and current standards of practice (cross reference A308).

5. Monitor performance improvement activities that reflected the scope and nature of the services and that identified opportunities for improvement (cross reference A308).

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

Based on food storage and food production observations, dietary staff interview and dietary document review, the hospital failed to ensure the Food and Dietetic Service Director developed and monitored written procedures according to standards of practice for operational processes. The Food and Nutrition Director failed to ensure the daily management of the dietary services ensured safe food handling and sanitation at Mountain View Campus and Los Gatos campus as evidenced by: 1) potentially hazardous food not cooled down safely and accurate documentation maintained (cross-reference A749); 2) storing raw chicken with cooked ground chicken; 3) can openers not maintained to prevent cross-contamination with metal shavings not maintained clean and sanitary; 4) storage of disaster canned food and nutritional supplements above the manufacturer's recommended temperatures; 5) food service staff in public area without removing apron; 6) freezer and dry store food not labeled and dated and identified; 7) cross-contamination of food product in dirty dish area; 8) patients' food not labeled and stored properly; 9) no barrier to prevent the overspray from the handwashing sink contaminating the food production area; and 10) no ongoing quality appraisal and performance improvement program (QAPI) that addressed the complexity and scope of the food service which resulted in failure to identify issues in safe food handling practices, food storage and sanitation all of which could result in food-borne illness (cross-reference A308). Failure to develop and implement safe food handling and supervision of food service staff practices and procedures may result in patient being exposed to food borne illness and cross contamination which may further compromise medical status.

Findings:
1. On 8/5/13 starting at 9:15 a.m. in the Mountain View kitchen, walk in refrigerator G, had two pans of cooked turkey pieces labeled cooked 8/4/12, one pan ground chicken dated 8/3, and two pans pasta noodles, dated 7/31/13. There was a pan of egg salad dated "Aug 4."

The executive chef (EC) stated the pasta noodles were not cooled in the blast chiller (super cooling refrigerator) but cooled under running water and placed in the refrigerator.

Review of the cool down log dated August 2013 did not indicate documentation of the ground chicken, turkey or egg salad. EC stated the ground chicken and turkey were blast chilled but acknowledged there was no documentation to ensure the policy was followed. Executive chef stated they did not monitor the cool down temperatures of the egg salad or tuna salad they made at room (ambiant) temperature. EC stated there was no temperature monitoring the cooling of the large quantity of pasta cooled under running water.

Review of the policy titled "Cooling Procedure" stated potentially hazardous food shall be cooled within 4 hours to 41 degrees Fahrenheit (F) or less, if prepared from ingredients at ambient temperature like tuna salad, roasts, meats, poultry, seafood and other potentially hazardous food. Section 11 stated "remove the product from the blast chiller and record the displayed temperature in the log. "

2. The practice of cooling tuna salad or egg salad was discussed at the Los Gatos campus and the manager of Nutrition Services (MNS) stated on 8/6/13 at 9:00 a.m., they did not have a procedure to follow the standard of practice to monitor the cooling to 41 degrees F for the tuna or egg salad products.

3. On 8/5/13 starting at 9:15 a.m. in the Mountain View kitchen, walk in refrigerator G had one pan of cooked ground chicken on the bottom shelf with raw packaged chicken touching, and spilling over the ground chicken pan. The EC stated the cooked ground chicken was on the shelf above and did not know how it was moved to the bottom shelf where it cross-contaminated with the raw chicken product.

The policy titled. "Storage and Food Handling", reviewed 6/20/13, indicated never place cooked food below thawing food.

4. On 8/6/13 starting at 7:30 a.m. at the Los Gatos kitchen, the following were observed:

a. The table mounted can opener had visible small pieces of metal shaving fragments on the ledge behind the blade. The manager of Nutrition Services Los Gatos (MNS) concurrently stated the can openers were discarded when they did not work and did not have knowledge of the dull blade producing metal shavings when opening cans. The MNS stated they did not have a policy to ensure can opener blades were changed when dull to prevent metal shavings. The metal shavings may fall into the food as the can is opened.

b. The ledge behind the blade had a thick layer of black, dried debris. The MNS stated the can opener was washed each day and was not aware of the accumulation of dried food debris on the can opener that was not being cleaned and sanitized with the washing.

5. On 8/6/13 at 2:10 p.m., at the Los Gatos Campus, the disaster food and nutritional supplements were stored in a metal container in the back parking lot. The director of Nutrition Services (DNS) stated they did not have storage room in the building. The DNS acknowledged the storage container was not climate controlled and did not maintain the canned foods and nutritional supplements in a cool and dry place, as stated by the manufacturers' directions.

6. On 8/7/13 at approximately 1:30 p.m. one food service worker was observed in the lobby of the Mountain View campus wearing an apron. The clinical manager stated on 8/8/13 at 1:15 p.m., the department policy was to have food service staff remove aprons before entering the restroom. There was no policy regarding the food service staff wearing their apron, used when preparing and serving food, into a public area and returning to the kitchen to resume food preparation work. This can result in the possible contamination of food.

The policy, "Apron Guidelines" and undated, for Nutrition Services stated aprons must be maintained clean and changed when it is soiled or contaminated. The policy did not further specify potential of contamination when worn in a public area. The food service apron worn while outside the kitchen in a public area and then returned to the kitchen presents a potential for cross-contamination.

7. On 8/6/13 starting at 7:30 a.m., the Los Gatos campus walk in freezer, there was an open package of food with no date opened and no label identifying the contents. The dry storage room contained a large plastic bin of dry white powder dated 8/4/13 with no product identification.

Food Code 2009 requires food that is not readily identifiable be labeled with the name.

The policy titled "Storage and Food Handling Procedures", dated 6/2013 stated "All perishable food prepared or opened by Food Service Department personnel must be labeled as to its identity and dated when it was prepared, opened and must be used by and protected from contamination (covered or sealed)." There was no policy provided to ensure the labeling of dry foods placed into storage bins after opening to ensure accurate identification.

8. On 8/6/13 at 8:45 at the Los Gatos kitchen, Cook 1 was observed dumping excess water from a pan of steamed food in the dirty end of the three compartment sink and then returning the pan to the production area to place the product in a pot for serving. MNS acknowledged the cook should have used a designated food preparation sink to discard the water and not the contaminated dirty washing area.

9. On 8/6/13 at 12:30 p.m., there was one patient's own food in the rehab dining area refrigerator that was not identified with the patient name or the date it was placed in the refrigerator.

Review of the policy "Food Brought in to Patient from Outside", dated 10/12, stated the food not consumed immediately was to be labeled with the patient's name and room number, cover and date, and promptly refrigerate.

The director of Nutrition Services acknowledged concurrently that the unidentified bag was not identified or dated as required for patient safety.

10. One handwashing sink in the Los Gatos kitchen was next to the food preparation area and had dirty handwashing overspray onto food or equipment. There was no barrier to prevent the overspray from the handwashing sink contaminating the food production area.

11. There was no QAPI program to address the quality of nutrition assessments, nutrient adequacy of menus, safe storage of breast milk, diet manual meeting needs of staff and clinical dietitians, and food safety practices of cool down of hot and ambient temperature foods (cross-reference A308).

Based on document review and staff interview, the hospital failed to ensure the qualified dietitian supervised the nutritional aspects of the service, including making necessary recommendations to meet the nutritional needs of one patient (65).

Findings:

Patient 65 was admitted 7/24/13 with diagnoses of supervision of other normal pregnancy. Patient 65 was on a regular diet and her medications included a stool softener (treatment for constipation).

A nutrition review by the registered dietitian (RD) dated 7/26/13 indicated referral by registered nurse (RN) with patient complaint of no BM (bowel movement) since admission. Nutritional assessment of constipation documented and RD reviewed methods of increasing fiber intake with patient. The assessment stated to continue the regular diet and modify snacks per patient request.

Review of the policy "Nutrition Screening and Assessment" dated 8/12 indicated, "the nutrition assessment will include evaluation of factors which may affect nutrient selection, intake, digestion ... ".

There was no evaluation of the patient's current fiber intake or requirements during pregnancy or recommendations to the physician for diet modifications or other interventions to address the constipation.

Based on staff interview and document review, the hospital failed to ensure therapeutic diets, including the nutritional supplements, were prescribed by the practitioners responsible for the care of patients. This had the potential of compromising patient medical care.

Findings:

On 8/5/13 starting at 10:00 a.m., the El Camino - Los Gatos Nutrition Orders List was reviewed. On the list were patients with orders, "RD (Registered Dietitian) may order supplements PRN."

The chief clinical dietitian stated on 8/5/13 at 2:00 p.m., the hospital had a policy that the physician diet order could include an order for "supplements to be given by Clinical Dietitian to implement an oral nutritional supplement based on nutritional assessment and identified nutritional risk." She stated the registered dietitians (RDs) had entered orders in the patient medical records for supplements since the policy was started in 10/2012.

Review of the policy "Nutrition Services Department Oral Nutrition" supplements dated 7/12 indicated the Medical Executive and Board of Directors approvals on 9/20/12 and 10/20/12 respectively.

The nutrition clinical manager stated she thought if the physician wrote the order for the RD to order the oral nutritional supplements, it was okay.

The medical director and chief excecutive officer were interviewed on 8/8/13 at 10:30 a.m. The medical director stated he thought RDs ordering the oral nutritional supplements was a reasonable thing to do. He acknowledged he was not aware regulations required the physician to order the therapeutic diet, which included the nutritional supplement, based on medical need.

A therapeutic diet is defined as a physician ordered diet as part of treatment for a disease or clinical condition, or to eliminate, decrease, or increase specific nutrients in the diet. This is also called Medical Nutrition Therapy. This would include the use of nutritional supplements as part of the physician diet order to increase calories or other disease specific medical nutrition requirements.

Based on dietary document review, and staff interview, the hospital failed to ensure standard menus were analyzed for the nutritional components to meet the current national standards including the RDA (Recommended Dietary Allowances) and the DRI (Dietary Reference Intake) of the Food and Nutrition Board of the National research Council. This has the potential for the patient in the hospital not to receive adequate nutrition or meet the established recommended dietary allowances of all nutrients.

Findings:

The DRI/RDA consists of nutrient based references whose purpose is to plan diets for individuals, focusing on optimizing health status, disease prevention and ensuring consumption of nutrients in adequate amounts. The provisions of the Dietary Reference Intakes, which include the Recommended Dietary Allowances (RDAs), Adequate Intake, and Acceptable Macro and Micronutrient distribution ranges, developed by the Food and Nutrition Board under the auspices of the Institute of Medicine are used to evaluate the nutritional adequacy of patient menus.

On 8/5/13 at the Mountain View campus, starting at 1:00 p.m., the hospital nutrient analysis for the regular and therapeutic menus was requested. The clinical nutrition manager brought data spread sheets of diet analysis. The nutrient analysis data did not have all of the specified nutrients such as iodine and biotin. There was no complete analysis of the nutrition data provided for the therapeutic diets at the Mountain View campus. This analysis would include comparison of the RDA and DRI requirements for age and gender for each diet category to ensure the menus served met the diet specifications for restrictions, or met the required nutrients.

On 8/6/13 starting at 8:30 a.m., the nutrition services manager at Los Gatos stated Los Gatos did not have a full nutrient analysis of their hospital menus. They had only looked at the basic four food groups and did not have a computerized analysis of all of the nutrients. They did not have the CBORD (nutrition computer menu and analysis system) used at Mountain View and did not have the capability to do a nutrient analysis of their menus.

The provision of the DRI which include the RDAs Adequate Intake and Acceptable macronutrient Distribution Range developed by the Food And Nutrition Board under the aegis of the Institute of Medicine, are used to evaluate nutritional adequacy of patient menus.

Based on observation, interview, and document review, the hospital failed to have a therapeutic manual that accurately reflected physician ordered diets and current standards of practice. Lack of a current and comprehensive diet manual that reflects hospital-developed diets may result in inaccurate guidance to dietary and hospital staff when following physician ordered diets to meet the nutritional need of the patient and further compromising patient medical status.

Findings:

The nutrition services manager (NSM) at Los Gatos on 8/6/13 starting at 4:00 p.m. stated both the Mountain View and Los Gatos campuses used the (Academy of Nutrition and Dietetics) Care Manual (NCM) for their diet manual. This manual was online (computer based) for all staff, and information was of a general nature for disease states, not specific to the diet orders of the hospital. The NCM was divided into five sections including diseases/conditions, meal plans, and references.

Review of the NCM determined it did not specifically list the hospital diets, but gave general information regarding the disease states. There was no adequacy section specific to the hospital menus and their specific nutrient content, and comparison to the RDAs (Recommended Dietary Allowance) and DRIs (Dietary Recommended Intakes). The NCM was a broad reference manual and not specific to the hospital diets.

The hospital diet manual should ensure the diets offered meet the current standard of practice and included a comprehensive description of the therapeutic diets offered by including the purpose of the diet, the indication for the diet, nutritional adequacy of the diet, and sample menu plans consistent with the hospital's menu and current standard of practice references.

Based on observation and staff interview, the hospital failed to ensure proper storage of trash, with the potential of transmission of communicable disease or odor.

Findings:

On 8/5/13 starting at 08:30 a.m., the trash compactor area at the Mountain View campus was observed. The ground around and under the compactor had an accumulation of trash and black dried substance under the entire length of the approximately 20 foot long compactor. The area had a foul smell.

Review of the policy titled "Environmental Services" policies and procedures, "Infection Control Policy Procedures Solid Waste Disposal", reviewed 8/12, summary was to remove solid waste from the facility on a regular basis. The solid waste compactor was emptied three times per week, or as needed. The compactor was cleaned before being returned to the hospital. There was not a procedure to clean the area around and below the compactor.

The infection control practitioner (ICP 1) on 8/5/12 at approximately 2:00 pm., acknowledged the policy was incomplete and did not give direction to staff to maintain the trash area clean.

According to the Food and Drug Administration(FDA) Food Code 2009, waste stored, located, and disposed in a sanitary manner will not permit the transmission of communicable disease or odor, create a nuisance or provide a breeding place for or food source for insects, rodents and vermin (various small animals or insects, such as rats or cockroaches, that are destructive, and injurious to health). Outside receptacles must be constructed with tight fitting lids to prevent the scattering of the garbage and refuse by birds, the breeding of flies, or the entry of rodents. Thorough and proper cleaning of garbage storage areas and receptacles is necessary so unsanitary conditions are eliminated.

Based on observation, interview, and document review, the hospital's Infection Prevention program failed to develop an effective system for identifying unsafe food handling practices that involve; 1) cool down of potentially hazardous food; 2) storage of raw poultry with cooked product; 3) identify a system to ensure the engineering staff at Mountain View and Los Gatos used the sanitizing products as specified by the ice machine manufacturers; 4) infection control review and involvement with the coffee cart operated by the hospital volunteers and 5) storage of breast milk.

Failure to clean and sanitize ice machines could potentially place patients at risk of infection. Failure to cook and cool food could place patients at risk of food-borne illness. Failure of the infection control committee to plan and review the high risk and high volume food service department has the potential of food borne illness and compromised patient care.

Findings:

1. The Food and Drug Administration (FDA) Food Code 2009, requires potentially hazardous food to be cooled from 135 degrees Fahrenheit (F) to 70 degrees in 2 hours, and 70 degrees to 41 degrees in additional 4 hours. The Mountain View kitchen utilized a blast chilling refrigerator (rapid cooling equipment). Products found on 8/5/13 starting at 8:30 a.m. at the Mountain View campus for ground chicken, turkey pieces and pasta noodles were not documented on the cooling log.

Tuna salad and egg salad products were also available on the Los Gatos and the Mountain View campuses and there was no policy or practice to cool from ambient temperature of 70 degrees F to 41 in 4 hours or less. The dietary food supervisor (DFS) explained on 8/5/13 at 8:30 a.m. the tuna is made from refrigerated ingredients but they do not verify the safe temperature, and just place in the refrigerator.

Review of the Nutrition Services Sanitation Audit worksheet used by the Food Service Department and the Infection Control Practitioners for review did not include observation of the cooling of potentially hazardous food from 135 degrees F or the ambient temperature cooling of tuna as an element of their sanitation monitoring.

2. Cooked ground chicken was observed on 8/5/13 starting at 8:30 a.m., in the Mountain View kitchen. It had the potential of cross-contamination with raw chicken packaging touching and located above the ground cooked chicken pan placed on the bottom shelf.

3. On 8/6/13 starting at 10:00 a.m. at Los Gatos and 8/813 at 10:00 a.m. at Mountain View the manufacturer's directions for sanitizing the hospitals' ice machines were reviewed. Chief Engineer 1 stated Mountain View had approximately 40 ice machines. The manufacturer specifies a household bleach (200 part per million (ppm) of 5.25% sodium hypochlorite). Both the bleach products used at Los Gatos and Mountain View were a 6.1% concentration of sodium hypochlorite.

a. Review on 8/6/13 starting at 8:30 a.m., the Los Gatos ice machine preventive maintenance directions did not include direction for the sanitizing solution preparation. The preventative maintenance was not as detailed as the Mountain View and did not ensure the procedure met the manufacturer's directions.

b. Review on 8/8/13 at Mountain View indicated preventive maintenance directions specified the concentration of the sanitizing solution to be 200 ppm sodium hydrochlorite. Chief Engineer 1 stated the engineering staff did not verify the concentration stated in the procedure and could not verify the measurements of 1 ounce food grade bleach and 2 gallons of water met the 200 ppm (part per million) concentration.

4. On 8/8/13 at 10:00 a.m., the coffee cart operated by the hospital volunteer services was observed in the hospital lobby area:

a. Volunteer 1 was using the designated handwashing sink to wet a cloth to use in the sanitizer bucket and volunteer 2 used the designated handwashing sink to discard liquid in preparation of washing. There was no preparation sink to use.

b. Volunteer 1 was making a sanitizing solution from a quaternary ammonia concentrate and stated one pump was used. The volunteers did not test the concentration to ensure the manufacturer's concentration of 200 ppm was met. Volunteer 2 stated she used one small pump of sanitizer for the dish sanitizing pan.

There was no documentation for the concentration of the sanitizer to ensure 200 ppm and effective sanitation of surfaces and dishware.

Review of "Coffee Cart Staff Procedures", not dated, indicated in the cleaning directions, "all utensils are to be washed in hot soapy water, rinsed in hot clean water, and soaked in the sanitizer solution. Rinse each item thoroughly in the "hand" sink ."

Food Code 2009 specifies designated handwashing sinks for handwashing only. In addition, there were no directions for the mixing of the sanitizer for dishwashing or cleaning to meet the manufacturer's directions of 200 parts per million for the quaternary ammonia sanitizer the volunteers were using.

5. Breast milk storage was reviewed at the Los Gatos campus on 8/6/13 starting at 8:30 a.m., and Mountain View on 8/7/13 at 9:30 a.m.

a. At Los Gatos NICU (neonatal intensive care unit) one breast milk storage refrigerator log was observed 8/6/13 at 2:45 p.m. The refrigerator temperature read 36 degrees Fahrenheit (F). The breast milk refrigerator temperature log dated August 2013 stated acceptable temperatures range of 36 degrees F to 46 degrees F.

The "Breast Milk Storage" policy dated 6/09 specified the refrigerator should be maintained at 32 to 39 degrees F. Review of breast milk storage logs from February 2013 to August 2013 indicated refrigerator temperatures exceeded the 39 degree F temperature range approximately 4 times each month. The logs used were dated "revised 7/20/2006".

ICP 1 stated concurrently she did not know when infection control reviewed the NICU, and acknowledged the temperature logs had never been evaluated to ensure they reflected the temperatures as specified in the policy. The NICU manager was not aware of the temperature range in the policy.

b. The Mountain View breast milk freezers and refrigerators were on a central temperature monitoring system. Review of the three month graph dated 5/7/13 to 8/8/13 for NICU Bay 1 milk freezer reading in C (Centigrade). The log indicated a line starting at minus 20 degrees C (0 degrees Fahrenheit) and above. The temperature range was set between minus 30 degrees and minus ten degrees C and not at the required minus 20 degrees C or below as required in the policy.

The "Breast Milk Storage" policy dated 6/09 specified the freezer temperatures should be maintained at or below minus 20 degrees C (zero degrees F).

The NICU Manager at Mountain View stated she did not know why the temperature tracking was consistently above the required temperature.

On 8/7/13 at 1:00 p.m., the quality manager reported the Facilities Department is responsible for the hospital-wide temperature monitoring system and they had set the temperature parameters incorrectly on the NICU freezer. She acknowledged that neither infection control staff nor the NICU manager had verified the temperature ranges that were set by Facilities Department and only responded to call when the system was out of range.