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LOS BANOS, CA 93635

DATA COLLECTION & ANALYSIS

Tag No.: A0273

Based on staff interview and administrative document review, the hospital failed to ensure an ongoing quality appraisal and performance improvement program that shows measurable improvement in indicators for which there is evidence that it will improve health outcomes when the quality appraisal and performance improvement (QAPI) program implemented an ongoing data based measurable indicators or show evidence of improving health outcomes for the program developed.

This failure resulted in the potential to compromise patient health and the potential to miss the opportunity to improve patient health outcomes.


Findings:

On 4/23/13 at 2:00 p.m., during a concurrent interview and review of the Food and Dietary Services quality appraisal and performance improvement plan, the Corporate Registered Dietitian (CRD) and Dietary Service Supervisor (DSS), stated there was no formal food service quality appraisal performance improvement program in place. There were no identified measurable indicators for the food service department to ensure meals were correctly served, recipes were followed, or to ensure staff followed sanitation procedures. In review of the clinical nutrition program, the CRD stated they looked at accuracy of the diet order in the second quarter and had identified a future program for patient malnutrition but there were no benchmarks or formal program in place at this time to identify or measure clinical nutrition performance improvement. The RD confirmed they had not evaluated the high risk, high volume dietary and food service areas to identify concerns and develop a program.

On 4/23/13 at 2:00 p.m., during an interview with the quality committee, QM 1 and CRD stated that the quality program was developed for core measures and patient care indicators. The departments identified specific areas for quality program but there were no quality or performance improvement program reviewed for the Dietary Department for the high risk high volume areas.

NURSING CARE PLAN

Tag No.: A0396

Based on staff interviews and clinical record review the hospital failed to ensure a multidisciplinary care plan was developed to include individual and measurable goals for 2 of 24 patients (Patient 17 and Patient 16).

This failure had the potential to compromise the medical care of the patients 16 and 17.

Findings:

On 4/ 24/13 during a clinical record review, Patient 17 was noted to have been admitted on 4/18/13 with a diagnosis of hypertension (high blood pressure), urinary tract infection, lipidemia (excess fat cells in the blood), and impaired glucose (blood sugar). The RD assessment dated 4/19/13 noted the goal was to monitor weight status, hydration, and calories. Review of the multidisciplinary plan of care showed there was no nutritional care plan.

On 4/24/13 during a clinical record review, Patient 16 was noted to have been admitted on 4/22/13 with a new diagnosis of Diabetes Mellitus. Patient 16's multidisciplinary plan of care indicated no nutritional care plan had been entered to address the nutrition plan for Diabetes Mellitus diagnosis.

On 4/24/13 at 10:00 a.m., during concurrent interviews, RD 1 stated he did not enter his nutrition recommendations or nutrition plan of care into the multidisciplinary care plan. CRD stated that she had not reviewed the multidisciplinary care plans with the clinical dietitian and there was no monitoring of nutrition assessments or multidisciplinary medical nutrition therapy plan of care.

The hospitals' policy and procedure titled "Plan for Provision of Care", revised 3/13, indicated "All aspects of nutrition care are interdisciplinary and collaborative to optimize the effectiveness of medical treatment."

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on observation, staff interview and record review, the hospital failed to ensure that medications were administered in accordance with physician's orders, hospital policies and procedures, and accepted standards of practice as evidenced by:

1. Patient 1 was administered 2 doses of Protonix (a medication for the management of gastrointestinal disorders) within 11 hours when the medication was ordered by the physician to be administered every 24 hours. In addition, the vial top of Protonix was not properly disinfected prior to the insertion of a needle into the vial to reconstitute the medication for administration on 4/23/13.

2. The hospital medication storage policy and procedure was not consistently implemented when Patient 2's medications were not immediately administered after removal from Pyxis, an automated dispensing cabinet, and were kept in Registered Nurse 5's (RN 5) pockets while RN 5 was administering medication to another patient.

3. Patient 3 did not receive the complete dose of Protonix 40 mg (milligrams, unit for weight) when Registered Nurse 6 (RN 6) did not withdraw the full dose of the medication from the medication vial prior to administration. In addition, Patient 3's IV line was not flushed with normal saline before and after the administration of Protonix as ordered by the physician.

This failure resulted in the potential for harm to patients due to inappropriate dosing and exposure to infectious agents.

Findings:

1. During medication administration observation at 8:35 a.m. on 4/23/13, RN 5 was observed preparing Protonix 40 mg for intravenous administration. RN 5 removed the flip top of the vial and injected 10 ml (milliliters, unit for volume) of sodium chloride 0.9% (a diluent) into the vial for reconstituting. The diaphragm of the vial was not cleaned or disinfected with any agent prior to RN 5 inserting a needle into the vial. The medication was then administered to Patient 1.

The Association for Professionals in Infection Control and Epidemiology published position paper on "Safe injection, infusion, and medication vial practices in health care" dated 2010, indicated that prior to inserting any device into a medication vial, the diaphragm of the vial should be cleansed with friction using sterile 70% isopropyl alcohol,14,17 ethyl alcohol, iodophor,17 or other approved antiseptic swab. The diaphragm should be allowed to dry before inserting any device into the vial.

A review of the physician's order indicated that Patient 1 was ordered Protonix 40 mg intravenously every 24 hours starting at 8:15 p.m. on 4/22/13.

A review of Patient 1's electronic medication administration record (MAR) showed that Patient 1 was administered Protonix 40 mg at 9:57 p.m. on 4/22/13 and 8:31 a.m. on 4/23/13, less than 11 hours apart instead of the every 24 hours as the physicians order required.

A review of the hospitals' standard dosing procedure indicated that for medications ordered to be administered every 24 hours, the first dose should be given when ordered and then repeated every 24 hours.

2. During medication administration observation at 8:45 a.m. on 4/23/13, RN 5 was observed pulling a bag of medications out from her pocket after administering medications to Patient 1. RN 5 stated that the bag of medications were for Patient 2 and she had removed the medications from the Pyxis prior to administering medications to Patient 1.

During an interview at 1:00 p.m. on 4/23/13, the Director of Pharmacy (DOP) stated that medications should not be pre-pulled from Pyxis to reduce the risk of medication errors.

A review of the hospital medication storage policy and procedure indicated that individuals removing medications from Pyxis should proceed directly to the patient for administration without a break in the continuum. In addition, medications and biologicals should not be stored on the person of a health care provider.

3. During medication pass observation at 9:00 a.m. on 4/23/13, Registered 6 (RN 6) was observed reconstituting a vial of Protonix 40 mg powder with approximately 10 ml of sodium chloride 0.9%, withdrawing the medication into a syringe and then administering it to Patient 3 through the patient's intravenous (IV- a tube into a vein to give medications) line. Patient 3's IV line was not flushed before or after the administration of Protonix. There was approximately 3 ml of reconstituted Protonix remaining in the vial. When asked about the remaining medication in the vial, RN 6 stated that she did not know she had not drawn up the full dose of medication from the vial.

A review of the Patient 3's clinical record on 4/23/13 showed that Protonix 40 mg was ordered at 8:50 p.m. on 4/18/13 as follows:

Protonix 40 mg intravenously every 24 hours. Flush line before and after administration.

Intravenous lines should be flushed with saline before and after giving medications IV to avoid contact of incompatible solutions or medications. A review of the manufacturer's product labeling indicated that the intravenous line should be flushed before and after administration of PROTONIX I.V.

PHARMACY ADMINISTRATION

Tag No.: A0491

Based on observation, staff interview and administrative record review, the hospital failed to ensure that the pharmacy was administered in accordance with accepted professional principles when assignment of beyond use (expiration) dates for compounded sterile drugs and environmental monitoring of the compounding area were not performed in accordance with accepted standards of practice.

These failures resulted in the potential for patients to be exposed to contaminated medications.

Findings:

During a concurrent observation and interview at 3:00 p.m. on 4/22/13 with the hospital Director of Pharmacy (DOP), a laminar flow hood was observed in a room. The DOP stated that the room was the IV Room (a room where medications for intravenous use are prepared) of the pharmacy and compounded sterile preparations were prepared in that room inside the laminar flow hood.

Laminar flow test reports dated 1/9/13 and 7/17/12 for the laminar flow hood located in the IV Room were reviewed. The reports indicated the environment inside the laminar flow hood was classified as an ISO 7 environment in the report dated 1/19/13 and as an ISO 5 environment in the report dated 7/17/12. There was no record indicating the IV room environment was tested as part of the inspections. In addition, no environmental monitoring of viable particles (such as bacteria and fungi) was performed to ensure that the compounding environment was maintained within an acceptably low viable particle levels.

A review of the pharmacy compounding record dated 1/21/13 to 3/30/13 showed that 38 compounded sterile preparations were made with beyond use dates assigned ranging from 24 hours to 18 days.

According to United States Pharmacopeia (USP) <797> for Pharmaceutical Compounding - Sterile Preparations, based on the placement of the laminar flow hood in a non-ISO 7 or better environment and the ISO classification of the compounding environment, only immediate use compounded sterile preparations (CSP) or in some cases, CSPs with beyond-use date of less than 12 hours should be prepared using the laminar flow hood in the IV room. In addition, USP <797> indicates that environmental sampling of viable and nonviable particles should be conducted at least every 6 months to ensure that the compounding environment was maintained at an acceptably low viable and nonviable particle levels. The beyond-use dates the hospital pharmacy assigned to their compounded sterile preparations were inconsistent with the USP <797> guidelines to ensure sterility and safety of the compounded sterile preparations.

USP <797> refers to chapter 797 "Pharmaceutical Compounding - Sterile Preparations," in the USP National Formulary. It is the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP). USP 797 describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded.

A review of the hospital policy and procedure dated 9/2009 on drug compounding indicated that it was the policy of the hospital to compound drugs to meet the needs of the patient population following applicable state and federal regulations and standards set forth in USP <797>.

DELIVERY OF DRUGS

Tag No.: A0500

Based on observation, staff interview and administrative document review, the hospital failed to ensure that medication storage areas were routinely inspected by pharmacy staff to ensure proper storage of medications and that no expired or otherwise unusable medications were available for patient use as required by State regulation.

These failures resulted in the potential for patients to be exposed to chemically altered medications.

Findings:

During inspection of various medication storage areas in the hospital between 4/22/13 to 4/24/13, expired or otherwise unusable medications were found in the emergency department, intensive care unit, medical-surgical unit, surgery department, radiology department and the rural clinic (See A 505 for details).

During an inspection of the intensive care unit at approximately 10:30 a.m. on 4/23/13, Registered Nurse 2 stated that the closet where large volume parenterals (medications administered by routes other than the mouth such as through tubing into a vein) were stored was not routinely inspected by pharmacy staff.

A review of the hospital medication area inspection report dated 3/25/13 showed that inspection by pharmacy staff was only conducted in the emergency department, labor and delivery department, medical-surgical unit and the intensive care unit. There was no record the radiology department, the surgery department and the rural clinic was inspected. The Director of Pharmacy acknowledged that not all medication storage areas had been included in the monthly inspection by the pharmacy department.

California Code of Regulations Title 22 Section 70263 (q) (9) stipulates that drugs shall not be kept in stock after the expiration date on the label and no contaminated or deteriorated drugs shall be available for use.

California Code of Regulations Title 22 Section 70263 (q) (10) stipulates that drugs maintained on the nursing unit shall be inspected at least monthly by a pharmacist.

UNUSABLE DRUGS NOT USED

Tag No.: A0505

Based on observation, staff interview and administrative document review, the hospital failed to ensure that outdated, mislabeled, or otherwise unusable drugs were not available for patient use when expired, mislabeled and improperly stored medications were found in Pyxis, automated dispensing cabinets, located in the Emergency Department and the Medical-Surgical Department, the Intensive Care Unit, the Surgery Department, the Radiology Department and the rural clinic.

This failure resulted in the potential for patients to be exposed to chemically altered medications.

Findings:

1. On 4/23/13 at 1:45 p.m., during a concurrent observation and interview in the radiology medication storage room, a partial bottle of Gastrografin 120 milliliters, ml, (for radiographic examination of segments of the gastrointestinal tract) was observed. The Gastrografin bottle label indicated "opened 4/21/13". The radiology technician (RT 1), stated that 30 ml was the average dose used and the remainder was kept for 2 days for potential use.

The manufacturer's label on the Gastrografin container indicated "Single Dose Bottle, discard unused portion."

In a concurrent interview the director of pharmacy DOP, acknowledged that the opened Gastrografin bottle should not be available for use.

2. On 4/23/13 at 1:45 p.m. inspection of the radiology medication storage room revealed an opened partial container of Liquid Polibar 1900 ml (diagnostic aid for computed tomography or x-ray examinations of the gastrointestinal tract). The Polibar container had approximately 1000 ml left in it and did not have a use by date.

In a concurrent interview, RT 2 acknowledged that the Polibar had no use by date.

The manufacturer of Polibar recommended storing the remainder in a refrigerator after opening up to 7 days.

3. On 4/23/13 at 2:10 p.m. inspection of the operating room warmer, bottom compartment, revealed 2 bags of intravenous (IV, injected through the vein) solutions, a 1000 ml bag of Lactated Ringers solution (LR, for hydration and electrolytes) and a 50 ml bag of 5% Dextrose (for nutrition and hydration).

The temperature on the warmer display indicated 105?F (Fahrenheit) for the bottom compartment. The bag of L.R. indicated "put in 4/19" and the bag of Dextrose did not have a use by date.

In an interview on 4/23/13 at 2:15 p.m. registered nurse (RN) 4, stated that the LR bag was dated when placed in the warmer and was good for a week.

The facility's policy titled "Medication Storage" dated 3/2011 indicated "IV fluids maybe warmed in the warmer for a period not longer than fourteen days at a temperature not to exceed 104?F."

Review of facility temperature logs for the O.R. warmer bottom compartment indicated that the temperatures for 4/2013 ranged from 106 -110 ?F.

In an interview on 4/24/13 at 12 p.m. quality analyst QM 1, acknowledged that the IV fluids were stored in the warmer at temperatures higher than those listed in facility policy.

4. On 4/23/13 at 10:30 a.m., inspection of the intensive care unit refrigerator revealed a 5 ml opened and used, undated multi dose vial of Tuberculin PPD (purified protein derivative, used to help diagnose tuberculosis infection).

In a concurrent interview RN 2 acknowledged that the Tuberculin PPD vial did not have a use by date.

Review of facility policy "Medication Storage" dated 3/2011 indicated "Multi dose vials will be kept for no more than one month once opened."

The manufacturer recommendations indicated an opened vial should be discarded in 30 days.

5. On 4/22 at 3:45 a.m., an inspection of the emergency department (ED) automatic dispensing cabinet (ADC) revealed a 5 ml oral syringe containing green liquid with no label identifying the content of the syringe. In a concurrent interview, the ED assistant manager RN 1 stated that the green liquid was promethazine (an antihistamine for nausea) and acknowledged that the syringe was unlabeled.

Review of facility policy titled "Labeling Standards" dated 6/12 indicated "all drug containers shall be labeled."

6. On 4/23/13 at 9:45 a.m. inspection of the Med Surg department ADC revealed a neonatal medication tray containing drugs used to treat emergencies. The contents of the medication tray contained 2 expired drugs. The expired drugs were 50% Dextrose (to treat low blood sugar) 50 ml expiration date 4/1/13 (21 days prior to survey) and Atropine (to treat slow heart rate) 0.4 milligrams/ml; two 1 ml vials; expiration date 3/30/13.

In a concurrent interview QM 1 acknowledged that the Dextrose and Atropine were expired and should not have been available for use.

Review of facility policy titled "Medication Storage", dated 3/2011, indicated "Drugs shall not be stored in patient care or pharmacy dispensing areas after the expiration date on the label."

7. During a tour of the rural clinic with the hospital Director of Pharmacy (DOP) at approximately 2:40 p.m. on 4/23/13, the medication storage freezer was inspected. A vial of Varivax (Varicella virus vaccine live) was found in the freezer. On the box of Varivax it indicated that the vaccine should be stored frozen between -58?F and +5?F.

A review of temperature record of the rural clinic medication storage freezer indicated that the temperature had been consistently above 6.3?F for the period between 4/9/13 to 4/23/13. The DOP acknowledged that the identified Varicella vaccine had been improperly stored and was not suitable for patient use.

DIRECTOR OF DIETARY SERVICES

Tag No.: A0620

Based on observation, staff interview and administrative document review, the hospital failed to ensure that the Food and Dietetic Service Director developed and monitored written procedures, according to standards of practice for operational processes as evidenced by failure to ensure:

1) safe food handling practices,

2) emergency food supplies and detailed plan,

3) quality appraisal and performance improvement program for the Food and Nutrition department, (Cross Reference A273)

4) infection control aspects of for preparation (Cross Reference A748).

These failures resulted in the potential for impairment in nutritional services leading to compromised health to patients.

Findings:

1. The following were observed in the kitchen on 4/22/13 starting at 8:30 a.m.:
a. In the kitchen food preparation area, food service worker (FSW) 2 was observed using a paper towel to manually dry utensils that had been cleaned in the dishmachine.
Concurrent interview with the Dietary Service Supervisor (DSS) stated that the staff was not to dry utensils after washing and directed the staff to the correct procedure. She stated that the department used the serve safe standards and the reference provided stated " air dry all items. Never use a towel to dry items. You can recontaminate them. "

b. In the kitchen ' s dry goods storage area, sugar and flour were observed in plastic bins, stored in their original bags inside the bin.
The DSS acknowledged that there was a potential for cross contamination when contaminated exterior bag is allowed to expose the clean contents when the staff access the contents from the original bag.

2. On 4/23/13, starting 8:30 a.m., the following were observed in the kitchen with concurrent interviews with the Corporate Registered Dietician (CRD) and DSS:
a. FSW 3 was observed preparing cantaloupe for food service. She wiped the cantaloupe off with her gloved hands under running water, and then proceeded to slice with a knife. The CRD stated they did not have a policy or staff training that addressed the Food and Drug Administration (FDA) Food Code 2009 standard for "thoroughly" cleaning the cantaloupe's rough netted exterior surface. The CRD acknowledged that the staff should be thoroughly cleaning any debris on the exterior of the cantaloupe before cutting to prevent any cross contamination with microorganisms that could be imbedded in the netting exterior surface.

b. The seven foot long cutting board on the trayline area, across from the grill was observed with numerous deep black colored grooves in the cutting surface.
The DSS stated the cutting board was cleaned each day. She acknowledged that the surface with the deep cuts was not cleanable and needed to be replaced to prevent cross contamination.

c. The kitchen trayline process revealed that temperature of cold-held items was not verified before putting these foods on the patient trays at time of service.
The CRD stated that the temperatures of the cold food should be taken to ensure proper serving temperature. She reviewed the temperature log and noted the log only recorded the hot food temperatures.

3. On 4/24/13 a.m., at 9:00 a.m., the food service kitchen ' s disaster food plan documents were reviewed with DSS and CRD. Review of the documents indicated no instructions regarding what foods to use and for which patient diets (including any needed therapeutic diets), and how many individuals the designated food was intended to cover.
On 4/24/13, at 9:05 a.m., Corporate RD stated the food service kitchen would use a combination of perishable food, food in dry storage, and specially designated disaster food items; CRD acknowledged that this information/instruction was not part of the current disaster food plan document.
The disaster plan did not specify the menu for the therapeutic diets, regular diets and the use of the meals ready to eat (MRE) that they had stored in a back store room.


4. Review of the Food and Dietary Services quality appraisal and performance improvement plan on 4/23/13 at 2:00 p.m., with the CRD and DSS, stated there was no formal food service quality appraisal performance improvement program in place. Cross Reference A276.

QUALIFIED DIETITIAN

Tag No.: A0621

Based on staff interview, and clinical record review, the hospital failed to ensure 1 of 24 patients (Patient 17) received an initial nutrition assessment to ensure medical nutrition therapy addressed all aspects of nutritional care.

This failure placed Patient 17 at risk of not having nutritional needs met and of having her medical condition compromised.

Findings:

A comprehensive nutrition assessment is the evaluation of present nutrition status of an individual enabling the identification of a patient who is malnourished, at risk for developing malnutrition, and treating nutrition related diagnoses for purposes of medical nutrition treatment. The assessment involves assessment of fat stores, protein status, weigh status, diet prescription, medical history and diagnoses, patient height and weight, weight loss and gain, labs values such as albumin to develop a nutrition support plan, medical nutrition therapy and education for patient. Data from the nutrition assessment provide a basis for recommendations and evaluation of support nutrition care. Referenced: Manual of Clinical Dietetics by American Academy of Nutrition and Dietetics.

On 4/23/13 at 9:40 a.m., during concurrent staff interviews and clinical record review, the medical record of Patient 17 was reviewed with the Corporate Registered Dietitian (CRD) and Registered Dietician 1 (RD 1). The medical record indicated, Patient 17 was admitted to hospital on 4/18/13 with diagnosis of hypertension, hyperlipidemia, impaired blood glucose, and dementia. The physician diet orders dated 4/18/13, stated, "Continue pureed diet with thickened liquids."

A review of the Initial Nutrition Assessment dated 4/19/13 indicated the patient's weight was 101 pounds, height 5 feet 2 inches, with diagnoses of hypertension (HTN), lipidemias, and impaired blood glucose. The patient's meal intake was approximately 40 percent. Labs dated 4/19/13 stated albumin (assesses protein stores and nutritional status) 2.7 mg/dl (normal 3.0 mg/dl), Hemoglobin (blood component) 9.7 g/dl (normal range 12- 15 g/dl), Hematocrit 30.8 percent (normal range 36-47 percent). The plan was to "Continue with present treatment and monitor intake for hydration, calories (kcal), and weight status."

The Initial Nutrition Assessment dated 4/19/13, did not contain an assessment of the patient's estimated needs for calories, protein and fluids, nutrition related medications, poor meal intake, or the below normal lab for albumin, hemoglobin, and hematocrit. The assessment did not address the patient's current weight or weight history. The assessment did not develop a nutrition care plan to address the patient's current nutritional status.

On 4/23/13 at 9:50 a.m., during an interview, the CRD and RD 1 stated they did not have a policy for initial nutrition assessments to direct clinical RD's to an established standard of practice. The CRD stated she was responsible for the clinical staff's supervision and the assessment for Patient 17 was not complete, not adequate, and did not address the medical nutrition therapy based on her multiple nutrition and medical conditions.

DIETS

Tag No.: A0630

Based on staff interview and administrative document review the hospital failed to ensure the nutritional needs of patients were met in accordance with recognized dietary practices when the menus were not analyzed to ensure they met the Recommended Daily Dietary (RDA) allowance or the Dietary Reference Intake (DRI) adopted by the Food and Nutrition Board of the National Research Council of the National Academy of Sciences.

This failure placed patients at risk of not receiving required nutrients thereby compromising their health status.

Findings:

Review of the "nutrient analysis Reference", page 17(a) indicated that analysis results were based on an "average value for males and females 19-70+ years".
On 4/24/13 at 8:40 a.m., during an administrative document review, the hospital census over the past 12 months indicated the following age groups were served by the hospital: "1-3 years, 4-8 years, 9-13 years, 14-18 years, 19-30 years, 31-50 years, and 51-70 years of age."
On 4/24/13 a review of the nutriment analyses for all diets provided by the hospital did not contain data for all age and gender categories outlined in the RDA, or analysis of how the menus met the diet requirement as outlined in the diet manual. The analysis did not contain all of the nutrients provided in the RDA.

On 4/24/13 at 8:45 a.m., during an interview, the Corporate Registered Dietician (CRD) acknowledged the nutrients included in the hospital's menu analysis were the only ones that printed and could not confirm if other nutrient analysis were available. The CRD stated the diet had not been analyzed in reference to the RDA and DRI requirements.

THERAPEUTIC DIET MANUAL

Tag No.: A0631

Based on observation, staff interview, and administrative document review, the hospital failed to have a therapeutic diet manual when included diets did not meet current standards of practice and there was not a comprehensive description of therapeutic diets. A comprehensive description would include the purpose of the diet, indications for the diet, nutritional adequacy of the diet, sample menu plans, and standard of practice references.

This failure resulted in the potential for inaccurate guidance to dietary and hospital staff when following physician ordered diets to meet the nutritional needs of the patients compromising their medical conditions.


Findings:

On 4/24/13 the "Dietary Work Sheet" which listed the physician ordered diets included: "Cardiac, Diabetic, Carbohydrate Controlled, and Renal" diets. A review of the diets generated for patient meal service had these diets: "Low Fat/Low Cholesterol, Limited Concentrated Sweets, and 80 gram protein, 3 gram K (potassium, a mineral), 2 to 3 gram NA (sodium, a mineral)".

A review of the hospital diet manual showed it did not contain an "80 gram protein, 3 gram K (potassium), 2 to 3 gram NA (sodium)" diet. Upon further review, the "Renal Diet" section was found to be only a conceptual (defined as of, or relating to concepts or mental conception; existing in the imagination) guidance of principles for renal diet plans.

On 4/24/13, at 3:00 p.m., during an interview, the Corporate Registered Dietician (CRD) acknowledged the diet order terminology did not match the menu system. She acknowledged the menus and diet manual should use consistent terminology and definitions. The CRD stated the diet manual should include all diets regularly ordered by the physicians.

A review of the diet manual determined it did not contain all elements of each routinely ordered diet which would allow the hospital and/or dietary staff to use the document as a comprehensive resource to order and/or prepare the patients diets. The diet manual did not have BRAT diet (pediatric diet), High fiber diet, high potassium diet, vegetarian diet which were listed as hospital diets.

EMERGENCY GAS AND WATER

Tag No.: A0703

Based on staff interview and administrative document review, the hospital failed to provide a detailed plan for an emergency water supply for patients, staff and visitors. This failure has the potential of an inadequate water supply on site in the case of an emergency and could compromise the health of patients, staff and visitors.

Findings:

On 4/24/13 at 1:30 p.m., during a concurrent interview and record review, the disaster water plan was reviewed with the Corporate Registered Dietician (CRD) and the Dietary Service Supervisor (DSS). The CRD stated the plan was based on one gallon of water per person per day. She stated there was some water in 5 gallon containers in the maintenance department and in department offices but, the hospital did not have a written description of the quantity or the locations. The document reviewed with the Corporate RD did not specify how many patients, staff and visitors the hospital planned for or how much water was needed and its source. There was not a detailed plan to ensure adequate water for drinking, meal prep, and hygiene was available or that staff knew the location of the water and how to access it.

The Corporate RD acknowledged the plan for water needed more detail and specific information regarding the quantity of water, the location, and method of access for the licensed capacity of the hospital, staff and visitors needed to be included.

DISPOSAL OF TRASH

Tag No.: A0713

Based on observation and staff interview, the hospital failed to ensure proper storage and disposal of trash when garbage and debris were not properly contained with in receptacles.

This failure had the potential of transmission of communicable disease and odor.

Findings:

On 4/23/2013, at 08:30 a.m., during a concurrent observation and interview, 3 trash dumpster's were noted with lids open. The ground around and under the dumpster's had an accumulation of trash and leaves. The Dietary Service Supervisor (DSS) stated, the trash area was the responsibility of the Engineering or Housekeeping Departments. The DSS stated the Dietary Department brought out their garbage but she did not know the requirement for keeping the lids closed. The DSS confirmed the hospital had failed to maintain the trash storage area and the dumpster's with tight fitting lids.

The Food and Drug Administration, Food Code 2009 indicated, "Waste stored, located, disposed in a 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 so that unsanitary conditions are eliminated."

INFECTION CONTROL PROFESSIONAL

Tag No.: A0748

Based on observation, staff interview, and administrative document review the infection control officer failed to developed and implement policies and procedures for the prevention of infection when:

1) Registered Nurse 5 (RN 5) did not perform hand hygiene in accordance with the hospital policy and procedure upon removal of gloves and after patient contact;

2) Dietary staff did not follow safe food handling guidelines when they handled contaminated items and then handled food without washing hands between items or changing gloves;

3) The kitchen ice machine was not cleaned and sanitized in accordance with Manufacturer's instructions; and

4) Breast milk was not stored in a refrigerator approved for the storage of food.

These failures resulted in the potential for patients to be exposed to infectious organisms.

Findings:

1) During medication administration observation at 8:35 a.m. on 4/23/13, RN 5 was observed wearing protective gloves while administering an intravenous Cipro (an antibiotic). RN 5 stated she had to replace the IV tubing and then removed her gloves and proceeded to the supply room. RN 5 did not perform hand hygiene after removing the vinyl protective gloves. After finishing administering medication to Patient 1, RN 5 removed her gloves. RN 5 then reached in to her pocket to take out the medications that she had prepared for Patient 2. No hand hygiene was performed by RN 5 after her gloves were removed and before she started handling Patient 2's medications. Upon entering into Patient 2's room, RN 5 sanitized her hands with waterless hand sanitizer and put on vinyl protective gloves. After medication administration to Patient 2 was completed, RN 5 removed the gloves and left the patient's room without performing hand hygiene.
The hospital's Infection Control policy and procedure titled "Hand Hygiene" dated 8/12, indicated hand washing resulted in reduction of patient morbidity and mortality from health care acquired infections. The policy also stated that proliferation of microorganisms could happen within the moist environment of gloves. Hand hygiene was indicated for all staff before patient contact, before donning gloves, after patient contact, after removing of gloves and between glove changes. Hand hygiene was a general term that applied to hand washing, antiseptic hand wash, antiseptic hand rub or surgical hand antisepsis.

2) On 4/24/12 at 8:15 a.m., during an observation, Food Service Worker (FSW) 4 was observed preparing burritos with gloved hands and handling kitchen equipment and then food (tortillas) without washing hands and changing gloves when contaminated.

On 4/23/13, at 8:45 a.m., during an observation of breakfast preparation in the foodservice kitchen, Cook 2 was observed wearing 1 disposable plastic glove on one hand, and during course of breakfast preparation activities. She was observed touching food and non-food surfaces, such as refrigerator handles, in between preparing and serving food items for patients. The cook was observed handling tortillas for breakfast burritos with the contaminated gloved hand. Cook 2 did not perform handwashing procedures in-between touching food and other surfaces.

Corporate Registered Dietician (CRD) acknowledged concurrently that the food service staff was not practicing safe food handling when they changed from food preparation and handled contaminated kitchen equipment such as refrigerator handles and did not wash hands and change gloves as required in the Serve Safe Manual they used as standard of practice.

3) On 4/22/13 at 3:00 p.m., during a concurrent observation and interview, the kitchen ice machine was observed. The maintenance repair technician (MRT) stated that the 4 facility ice machines were cleaned with a nickel safe (descaling chemical) and then flushed with 5 gallons of hot water on a regular preventative maintenance (PM) schedule. He stated this was the only chemical he used and emphasized he rinsed with hot water. He stated that he did not have chlorine bleach and did not use any sanitizer step.


Review of the ice machine PMs for the kitchen, medical-surgical unit, and maternity unit, dated 2/1/2013, 11/17/2012, 12/20/2012 respectively, indicated the directions were to follow the manufacturers guidelines.

The manufacturer's guideline indicated an additional sanitizing procedure using a solution of 5.25 percent sodium hypochlorite solution (chlorine bleach) to the internal components.

The hospital's policy and procedure titled "Cleaning Ice Machine" dated 5/12, indicated the environmental services cleaning of the exterior of the ice machines. Review of the Ice Machine Maintenance policy revised 3/12, indicated the "Ice machines located throughout the facility 1. Cleaned with phosphoric acid solution every 3 months ... " There were no further directions to sanitize the ice machines with the manufacturer's directed chlorine bleach solution.

Interview on 4/23/2013 at 2:00 p.m., the Infection Control Nurse acknowledged the ice machines were not sanitized according to as manufacturer's guidelines. She stated the infection control committee had developed a policy that included for the ice machines to follow manufacturer's directions. She stated that she had not reviewed the procedure with the engineering department and did not know that the refrigeration engineer was not sanitizing the ice machines with the required chlorine bleach solution.

4) On 4/23/13 at 10:30 a.m., a storage unit labeled "breast milk freezer" was observed in the newborn nursery unit. Thermometer reading of 34 degrees Fahrenheit (F). was noted from device inside the unit. Temperature log on top of unit was titled "refrigerator/freezer log".

On 4/23/13 at 10:35 a.m., interview with NICU supervisor RN in newborn nursery about the storage unit; She was not able to state whether unit was designated as a refrigerator or a freezer.

On 4/23/13 at 3:30 p.m. document review of product manual for storage unit indicated that unit was a non-commercial wine/beverage cooler. Excerpt from page 8 of product manual, under "Optimizing Performance", indicated " Do not store perishable food in your appliance. The unit's interior temperature may not be low enough to prevent spoilage."

On 4/23/13 at 3:40 p.m., the Infection Control (IC) RN stated she was not aware of the purchase of the breast milk storage unit but stated that she should have been notified and the procedure for purchasing equipment included a committee review. She acknowledged that there was no committee review of this purchase. She acknowledged that she was not aware of the limitations of the storage unit to maintain safe and required temperatures for the breast milk. She stated this presented a serious infection control problem that could affect the safety of the breast milk stored for use in the infant care unit.


The hospital's policy titled "Breastfeeding" reviewed 2/12 stated guidelines for storing expressed breast milk for use in the hospital required refrigeration at 32 to 39 degrees F.