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Based on observation, staff interview, and document review, the hospital failed to employ a registered dietitian who provided guidance to the supervisor and staff of the dietetic service, approved all menus, and participated in developing and revising dietetic policies and procedures. Registered Dietitian as specified in the California Code of Regulations, Title 22, Division 5, Chapter 1. State requirements at Section 70275(a) and Health and Safety Code at 1265.4, specify registered dietitian shall be employed full-time, or part-time, providing guidance to the supervisor and staff of the dietetic service, approval of all menus, participation and revision of dietetic policies and procedures. This standard was not met as evidenced by:

Findings:

During the validation survey from 12/5/11 to 12/7/2011 the Nutrition Services organization was reviewed. The hospital director of food services stated on 12/6/11 at 8:45 a.m., that she was a dietary service supervisor (DSS). She stated she had been employed for 8 years as director of the food service.

On 12/5/11 at 4:00 p.m., the hospital Food Services organization charts and Director of Food Services job description were reviewed. The DSS job description stated the DSS was responsible for the management of the food service operation and was a full time employee. The DSS was the Dietary Service Supervisor as stated in the California Code of Regulations. The organization chart reflected the DSS reported directly to the assistant director of operations and support services. The organization chart outlined that the three registered dietitians (RD) on staff reported directly to the DSS.

On 12/6/11 at 3:15 p.m., the DSS's personnel file was reviewed and confirmed the DSS had a certificate from a community college for Dietetic Service Supervisor.

Registered dietitian 2 (RD 2) stated on 12/6/11 at 9:10 a.m., that she was a full time employee and there were three registered dietitians on staff. She stated the dietitians' responsibilities were clinical and they participated in some patient tray evaluations and menu review. She stated they did not provide guidance to the DSS and food service staff, or develop or revise policies and procedures for the food service department.

Review of the Registered Dietitian's job description on 12/6/11 at 9:10 a.m., listed only clinical nutrition care responsibilities. The job description did not have a provision for the oversight and guidance to the DSS (Director of Food Service) for the operation of the food service.

The hospital failed to ensure that the registered dietitian provided guidance to the supervisor and staff of the dietetic service, approved all menus, and participated and revised dietetic policies and procedures.

Based on observation, staff interview and administrative document review, the governing body failed to ensure there was safe and effective implementation of the patient food service when the Chief executive officer (CEO) allowed the director of food service (DSS) to manage the entire hospital food service without guidance from the registered dietitian with findings of, 1) poor infection control practices in the kitchen which placed the patients at risk of food-borne illness and cross-contamination and, 2) the therapeutic diet manual failed to ensure therapeutic diets were served as ordered by the physician.

Findings:

1. On 12/5/11 at 9:50 a.m., the cool down log was reviewed. The cool down log is used to ensure foods cooked ahead of service are cooled within specific time frames to prevent growth of pathogenic bacteria. The log had entries for roast beef cooked and cooled on 11/1/11, 11/7/11, and 11/28/11. The temperatures were recorded but there was no notation of the time the temperatures were taken. The form, "Cool Down Log" was from another organization that noted at the bottom, "RD for Healthcare" and did not reflect the hospital's cool down policy.

Cook 1 stated on 12/5/11 at 10:00 a.m. that he had an in-service on cooling food this year. He was unable to state the specific temperatures required in specific time frame. He stated food was to cool to 70 degrees Fahrenheit (F) or 40 degrees F in 2 hours with a total of 4 hours to below 40 degrees F. He stated he had not cooked any roast beef in December.

There was no documentation of proper cooling of roast beef or any other food prepared during December. There was potential for food prepared ahead of service and requiring cooling but was not documented. This places patients at risk of food borne illness when the document is not completed.

Review of the policy, "Food Preparation and Service Procedures" required cooling from 140 degrees F to 70 degrees F within 2 hours and from 70 degrees to 40 degrees F in an additional 4 hours.

2. Review of the diet manual and the Food Service policies and procedures signature pages on 12/5/11 at 4:00 p.m., a revealed registered dietitian did not review the food service policies and procedures or the diet manual. Signature pages were signed by the dietary director and management including physician director.

Interview with RD 2 on 12/6/11 at 9:10 a.m., confirmed she and the other registered dietitians were not involved in the development and review of the food service policies and procedures. She confirmed they had not signed the review and approval pages for the policies and procedures or the diet manual.

On 12/6/11 at 2:00 p.m., the CEO and assistant administrator of operations and support services were interviewed. The CEO stated he agreed there were serious and substantial issues regarding the Food and Dietetic Services. The CEO acknowledged he knew there were problems that required addressing when the organizational structure did not include the registered dietitian providing guidance to the DSS. The CEO stated he was the individual in administration who was responsible for the Food and Dietetic Department.

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 department when:

1. There was no analysis or tracking of issues to evaluate services when those services were provided by a DSS and without oversight of the registered dietitian. There were breaks in infection control that could result in patients developing food-borne illness when there was inadequate handwashing by staff serving ready-to-eat food, and equipment not able to accommodate sanitizing large sheet pans (Reference A267 and A276).

2. The QAPI program did not measure, analyze or track the food safety findings which included cross-contamination due to the cook not washing hands between glove use, cook knowledge and demonstration of cool down procedures to prevent food-borne patient illness, inadequate sanitizing of the sheet pans, failure to have nutritional analysis the menu, and adequate detailed emergency disaster food plan (cross reference A618, and A621, and A749). The cumulative effect of the systemic problems resulted in the hospital's failure to meet compliance with a hospital-wide Quality Assurance/Performance Improvement program.

Based on observation, staff interview, and document review, the hospital failed to measure, analyze, and track the services provided by Department of Dietary to address cross-contamination by serving ready to eat food without adequate hand-washing, food safety procedures for cooling food, equipment sanitization and cleaning, and food storage. There was no disaster plan that included water and food menus to meet patient requirements. The failure to measure, analyze, and track the deficient practices in the dietary department would allow the failures to continue.

Findings:

1. On 12/5/11 starting at 9:50 a.m. the three compartment sink was observed. One food service staff was washing large sheet pans, then dipping one end, and then turning and dipping the other end into the sanitizer compartment of the sink. The three compartment sink was one large washing sink, a rinse sink and a sanitizing sink. The rinse and sanitizing sections were not of sufficient size to totally immerse the large sheet pans in the rinse water or the sanitizing solution.

The head cook acknowledged the rinse sink and the sanitizing sink sections were too small to allow for the large sheet pans to be fully immersed.

2. On 12/6/11 at 11:15 a.m., the emergency food plan was reviewed and the emergency food was observed. The emergency food was stored in the old kitchen and consisted of entree items of tuna, peanut butter, canned chili, corned beef, canned chicken, canned ravioli, as well as canned beans and cheese sauces.

On 12/6/11 at 11:15 a.m., review of the emergency menu in policy, "Emergency Feeding Disaster Plan" dated July 2011, showed a generalized menu for breakfast and lunch or dinner. The entree foods listed on this menu were tuna salad, turkey sandwich. The Disaster Emergency Menu for 1500 to 1800 calories (not dated) listed day one through day 3. The foods listed on this emergency menu included meat sandwich, canned veg salad, tuna sandwich and chili.

There was no emergency disaster menu that used the disaster food stored in the emergency food storage room. There was no policy or procedure that specified where the emergency food was stored or how to access or transport this food.

The existing emergency menus were unclear on when to use the perishable foods and when to use the nonperishable foods. The menus were not clear on how to prepare and serve therapeutic restricted diets like renal and consistence modified.

Review of the hospital-wide emergency management plan dated 7/11 stated "96 hour self-sufficient food." There was no further explanation of the "96 hour food." The Emergency Operation Plan revised 7/11 did not incorporate any food service or water plan delineated in this document.

3. On 12/5/11 starting at 9:50 a.m., the cool down log was reviewed. The cool down log is used to ensure foods cooked ahead of service are cooled within specific time frames to prevent growth of pathogenic bacteria. The log showed entries for roast beef cooked and cooled on 11/1/11, 11/7/11, and 11/28/11. The temperatures were recorded but there was no notation of the time the temperatures were taken to ensure they were within designated times. The form, "Cool Down Log" was also from another organization identified at the bottom as "RD for Healthcare" and did not reflect the hospital's cool down policy.

Cook 1 stated on 12/5/11 at 10:00 a.m., that he had an in-service on cooling food this year. He was unable to state the specific temperatures required in a specific time frame. He stated the food was to cool to 70 degrees Fahrenheit (F) or 40 degrees F in 2 hours with a total of 4 hours to below 40 degrees F. He stated he had not cooked any roast beef in December.

There was no documentation of proper cooling of roast beef or any other food prepared during December. There was potential for food prepared ahead of service and requiring cooling but was not documented. This places patients at risk of food-borne illness when the document is not completed.

Review of the policy, "Food Preparation and Service Procedures" required cooling from 140 degrees F to 70 degrees F within 2 hours and from 70 degrees to 40 degrees F in an additional 4 hours.

4. On 12/5/11 starting at 11:30 a.m., trayline (patient meal service) was observed. Cook 1 had gloved hands to handle bread for lunch sandwiches, going directly to refrigerator and microwave handles and returning to food serving and changed gloves. There was no handwashing before the new gloves were put on. The DSS directed Cook 1 to wash his hands and then put on gloves.

Review of the policy IC-609 Plastic Gloves dated July 2011 on 12/7/11 at 2: p.m., stated "to prevent cross contamination and transmission of disease carrying organisms hands are washed before putting on gloves."

5. On 12/5/11 at 9:50 a.m., the table mounted can opener was observed with visible metal shavings on the space behind the blade. Cook 1 stated he would notify the lead cook if the blade needed changing but he had not notified the lead cook to have the blade changed to prevent metal shavings from falling into patient food as cans were opened with the dull can opener blade.

6. On 12/5/11 at 9:50 a.m., the following items were observed in the walk-in refrigerator and freezer:

a. One container identified as egg salad was not labeled with the date of preparation.

b. Two packages of frozen chicken were not labeled with a date when they were placed in the freezer.

7. On 12/5/11 at 9:50 a.m., the three door, reach in refrigerator had gaskets on all three doors that were broken and torn. The two door, roll in refrigerator's left door had a door gasket that was torn. The lead cook acknowledged these needed to be replaced.

8. On 12/5/11 at 9:50 a.m., the kitchen's bin ice machine was observed to have significant black substance on the inner walls of the upper ice making section. Engineer 1 stated the machine was cleaned and sanitized with a quaternary sanitizer. He could not state why there was black substance or film on the interior of the ice making section.

On 12/6/11 at 10:00 a.m., Engineer 2 stated the hospital had 8 shoot type ice machines, one kitchen bin ice machine, one in ICU and a cafe soda ice machine. He stated he was responsible for cleaning the hospital ice machines quarterly. He stated he got the food grade sanitizing solution from the kitchen and identified as a quaternary ammonia sanitizer.

Review of the ice machine manufacturers' directions for each type of ice machine revealed the sanitizing was to use a chlorine bleach solution. Engineer 1 acknowledged he did not know this was required.

Review of the policy, "Sanitation of Ice and Ice Machines IC-230 revised 4/11 stated to use an "EPA registered disinfectant recommended by the manufacturer of the ice machine."

9. On 12/5/11 starting at 9:50 a.m., the stacked ovens had black residue of the bottom of the rack oven section and side walls and the racks also had heavy black residue. The head cook stated the ovens needed to be cleaned.

10. On 12/5/11 at 2:15 p.m. the patient nourishment and breast milk refrigerators were observed on the pediatric floor. Both refrigerator logs had temperature ranges of 35 degrees F to 45 degrees F. The patient nourishment refrigerator contained fresh milk cartons and had a temperature of 44 degrees F.

The temperature logs posted on the refrigerator were not referenced for food temperatures. The temperatures were The FDA Food Code 2009 specifies food held in refrigeration is a 41 degrees F or below. The temperatures at above 41 degrees F promote growth of pathogenic microorganisms and cause serious food-borne illness.

Based on observation, staff interview and document review, the hospital failed to ensure implementation of a comprehensive Dietary Service Quality Assurance Performance Program (QAPI) that included indicators relative to the current scope of service as evidenced by the lack of activities surrounding identified food service issues for the past 12 months.

Findings:

On 12/7/11 at 3:00 p.m., the dietary service supervisor (DSS) was asked to discuss the Quality Assurance Performance Program (QAPI). She confirmed the QAPI program did not measure, analyze or track the food safety findings which included cross-contamination due to the cook not washing hands between glove use, cook knowledge and demonstration of cool down procedures to prevent food-borne patient illness, adequate sanitizing of the sheet pans, failure to have nutritional analysis of the menu, and adequate detailed emergency disaster food plan. The DSS was not able to discuss the method used to identify problems or develop an effective QAPI program.

The QAPI plan for the dietary was reviewed on 12/7/11 and it was limited to a patient satisfaction survey, tray quality and meal accuracy.

Based on observation, interviews, and record review, the hospital failed to ensure medications were prepared and administered in accordance with accepted standards of practice and in accordance with the hospital's established protocol and/or policy and procedures, as evidenced by:

1. The failure to ensure emergency department (ED) nurses were adequately trained to draw into syringes correct doses of emergency medications for pediatric patients, when two of four nurses who were tested made errors. Medication errors during medical emergencies would place patients at increased risk to suffer, or fail to recover, as a result of excessive or inadequate doses of emergency medications;

2. The failure to ensure ED nurses were adequately trained to correctly give magnesium sulfate 50%, a medication use in medical emergency to treat pediatric acute nephritis (kidney inflammation), seizures due to magnesium deficiency, and other conditions. Giving undiluted magnesium sulfate to pediatric patients may result unnecessary adverse effects such as irregular heart rhythms, low blood pressure, hypermagnesia intoxication (excessive amount of magnesium in the blood), etc.;

3. The failure of one of four ED nurses to accurately use the Broselow Tape. The Broselow Tape is used during pediatric emergencies, such as during a code, to quickly estimate the patient's weight and determine weight-based drug doses. The correct method of using the tape is by placing the tape in the proper orientation with the red arrow stating "Measure From This End" at the top of the child and aligning the tape to the child's body length, the child's estimate weight is where the sole of the feet meets the tape. Incorrect usage of the Broselow Tape would result in incorrect determination of medication dosages during a medical emergency;

4. The failure to document pain medication administration and pain reassessments on the MAR (medication administration record) for one of three patients (Patient 17) observed during medication pass observation. The failure to document medication administration on the MAR had the potential for the medication to be given again, i.e. by another nurse after shift change, before the next dose was due. The failure to document pain reassessment indicated the lack of assessment for medication effectiveness and potential adverse medication effects;

5. The failure to administer insulin as in accordance with the prescribed insulin infusion protocol, which resulted in administration error, for one of three patients (Patient 25) who were receiving insulin infusion administration;

6. The failure of nursing staff to monitor for vital signs, sedation level, and pain level as in accordance with hospital policy and procedures for two of three patients (Patients 28 and 32) who were receiving intravenous infusion of narcotics delivered by patient controlled analgesia (PCA). PCA is an interactive method of pain management that permits patients to manage their pain by self-administering small amounts of narcotics at frequent intervals by pushing a button upon patient demand.

Findings:

1. At 1:15 p.m. on 12/6/11, an inspection of the pediatric crash cart in the emergency department (ED) was conducted in the presence of the ED director, the pharmacy director, and staff nurse (Staff A). The crash cart contained a Broselow tape for use in emergency situations. The ED director said the Broselow tape would be used to estimate the child's weight (if weight unknown) and to determine weight-based dosages of emergency medications for pediatric patients. He said all ED nurses were PALS (pediatric advanced life support) certified and would attend pediatric codes during medical emergencies.

Two ED staff nurses, Staff I and Staff J, were asked to use the Broselow tape to determine and draw into a syringe the correct amount of atropine (to increase heart rate) needed for the resuscitation of a theoretical pediatric patient of unknown weight. Based on the Broselow Tape, the correct amount for the theoretical patient was 2.1 milliliters (ml). The staff drew up 1.8 ml, the amount needed to be given through the endotracheal tube (via the trachea), which was incorrect. Both staff acknowledged they misread the atropine dose on Broselow tape and drew up the wrong amount of medication.

2. Staff I and Staff J were also asked to calculate the amount of magnesium sulfate 50% needed for the said pediatric patient. After drawn, they said they would give the medication by IV (intravenous) push directly (undiluted). The label on the magnesium sulfate 50% carton read: "Must be diluted prior to IV administration".

During the same ED visit, another ED nurse (Staff L) was asked how she would give magnesium sulfate 50%. She said she would give the medication "straight" [undiluted]by IV push.

Lexi-Comp, a nationally recognized drug information resource, indicates the following for magnesium sulfate 50%: "Magnesium should be diluted to a ?20% solution for I.V. infusion and may be administered I.V. push, IVPB, or continuous I.V. infusion. When giving I.V. push, must dilute first and should not be given any faster than 150 mg/minute."

3. At 1:50 p.m., an ED nurse (Staff K) was asked to demonstrate how to use the Broselow tape for a theoretical pediatric patient of unknown weight. Staff K used the Broselow tape incorrectly by placing the beginning colored section of the tape (instead of the red arrow) as the measurement starting point, thus, overestimated the weight of the theoretical child. The ED director verified that she did not use the Broselow tape correctly.

4. Patient 17's medical record was reviewed with a staff nurse (Staff B) and the supervising nurse (Staff C) at the Medical/Surgical 3 Unit on 12/6/11 at 10:40 a.m. Patient 17 had a physician order for morphine (doses varied depending on pain severity) to be given intravenously (through the vein) every 4 hours as needed for pain.

The computerized nursing note in the patient care system (PCS) indicated a dose of morphine 4 milligrams (mg) was given at 10:30 p.m. on 12/5/11, however, the administration was not documented on the MAR. There was no indication of what pain level the patient was experiencing. Also, there was no documentation of re-assessment after the 10:30 p.m. administration on the MAR. Both Staff B and Staff C said documentation of medication administration and pain initial assessment and re-assessments was to be documented on the MAR and the PCS, according to hospital policy and procedures.

The 12/5/11 MAR also documented a dose of morphine was administered at 6:40 p.m., at which time the patient experienced severe pain (pain score 7 out of 10). Staff B said pain re-assessments were to be done within 15 minutes and two hours post pain medication administration. There was no documented evidence pain re-assessments within the appropriate time frames were conducted for Patient 17 after the 6:40 p.m. administration. Both Staff B and Staff C confirmed the finding.

The hospital's policy and procedures, "PAIN MANAGEMENT POLICY" revised 11/10, indicated, "Levels of pain and the plan of care will be assessed and re-evaluated at appropriate intervals" and "pain/discomfort will be screened/assessed using validated, age-specific tools and documented on the appropriate unit specific form." For intravenous medication administration, the policy indicated to evaluate the pain management intervention after "10-30 minutes" and "reassess in two hours after any pain med."

5. Review of Patient 25's medical record took place on 12/7/11 at 10:15 a.m. with several hospital staff including two intensive care unit staff nurses, Staff D and Staff E. On 11/21/11, the patient had a physician order for blood sugar control through insulin infusion according to the "INSULIN INFUSION PROTOCOL FOR CRITICAL CARE UNIT". Review of the 11/21/11 "DIABETIC RECORD" revealed a nursing staff did not give insulin infusion according to the prescribed protocol, when it indicated to run the infusion at 8 units of insulin/hour, she ran at 7 units/hour instead. There was no physician order to deviate from the protocol and there were no nursing narratives indicating why the nurse deviated from the protocol. Both Staff D and Staff E agreed it was a medication administration error.

6. The preprinted PATIENT CONTROLLED ANALGESIA order sheet indicated to "record respiratory rate, pain/sedation level, and oxygen saturation every 3 hours for duration of PCA therapy." The PCA policy and procedures, revised 11/10, indicated, "patient monitoring will include assessment and documentation of pain level, sedation level, respiratory rate, and oxygen/carbon dioxide saturation."

On 12/7/11 at 11:45 a.m., review of Patient 28's medical record with Staff E and Administrative Staff (Admin) A revealed the patient had a physician order for morphine administration via the PCA on 11/21/11. The computerized "Care Activity - Assessments" record indicated the nursing staff were not consistently documenting the required parameters, such as the pain intensity, sedation level, pulse oximetry, respiratory rate, etc. every 3 hours, as required. For example, there was a 9-hour time lapse between documentation of the required PCA monitoring (11/22/11 at 10:03 to 19:28). Staff E and Admin A acknowledged the documentation was not complete as required.

Similarly, review of Patient 32's medical record with Admin B revealed there was a 10-hour time lapse between documentation of PCA monitoring parameters, between 12/1/11 at 5:35 a.m. to 2:15 p.m. Admin B agreed the documentation was not consistently done as required.

Based on documentation, the medical records department (HIM) was not able to determine the number of patient discharge records not completed within the time frame specified by hospital policy.

Findings:
1. The hospital policy for completion and closing of patient records after discharge was reviewed on 12/6/11. The policy states that medical records not completed, authenticated and signed within fourteen (14) days following the patient's discharge were classified as delinquent.

On 12/6/11 the hospital's medical record department was visited and the department supervisor was interviewed. According to the supervisor there were 570 delinquent records. She could not determine what information in the records was missing, e.g., signature, history and physicals, intraoperative reports, etc. The missing information is needed to determine what previous health assessments existed prior to the patient returning for further care.

2. In addition the Health Information Management policy (#4.0030) dated 11/07, indicated on page 3, physicians that leave delinquent records after being notified of the delinquency on Tuesdays, and do not return to correct the delinquency before the following Monday, will be suspended. The HIM supervisor stated that three physicians were currently suspended. The form provided with this information did not state the physicians were suspended but rather it was titled a "Delinquency Alert." The HIM supervisor was not aware of this and thought they were suspended.

Of the 570 delinquent records, the supervisor could not determine if other physicians met the criteria for suspension as per policy.

It was also noted the medical staff by-laws rules and regulations, reviewed on 12/6/11, referred to a fining mechanism for physicians with delinquent records. This was not addressed in medical record policy.

Failing to develop appropriate policy and procedures and implement existing policy and procedures regarding patient medical records, restricts the hospital's ability to provide quality and consistent patient health care.

Based on staff interview and record review, the hospital failed to ensure patient weight was in the medical record which could jeopardize medical care for one patient (Patient 2).

Findings:

1. Patient 2 was admitted 11/1/11 with diagnoses of mild chronic obstructive pulmonary disease.

Review of the medical record from admission to 11/7/11showed no documentation of weight. The RD assessment dated 11/10/11 showed the admission weight of 63.503 kilograms (140 pounds). The RD nutrition note dated 11/23/11 did not contain a current weight or discuss need for current weight. The nutrition note referenced patient refusing meds, inhaler and meals. The assessment further stated if patient not discharged may require enteral feedings. The nutrition assessment did not identify a nutrition risk. Review of the medical record showed no weight recorded.

RD 1 stated on 11/7/11 at 2:00 p.m., that weights were not regularly obtained on the units, but RDs would request as needed. RD 1 acknowledged the patient's weight was an essential element for complete nutrition assessment. She further acknowledged that monitoring the weigh on this patient would be necessary considering the length of stay and medical condition.

During an interview with nurse manager 1 (NM1) on 11/7/11 at 2:00 p.m., NM1 stated that the hospital did not have a policy specifying when to weigh patients if the patient was hospitalized for a long time.

2. Patient 2 was hospitalized for 36 days with poor oral intake and high nutrition risk status and weight was not monitored on a regular basis to ensure adequate medical care.

There was no system to ensure that staff including RDs, had complete and accurate information to accurately assess patient nutrition status and plan nutrition care.

Based on observation, staff interview, and record review, the hospital failed to ensure drugs were controlled and distributed according to standards of practice, when:

1. There was a lack of close monitoring of the use of the automated dispensing cabinet (Pyxis) override process. Override takes place when an authorized user obtains medication(s) before the pharmacist has a chance to review the physician order for appropriateness, i.e., dose, duration, allergies, drug-interactions, etc. There had been no quality assurance studies to determine the override rate (to determine the extent of the ADC overrides), as in accordance with accepted professional principles (see the Institute for Safe Medication Practice - ISMP- guidelines). Review of the override reports revealed non-emergency medications were also overridden. These failures had potential to result in unsafe medication use practices.

2. The sterile water available in the Malignant Hyperthermia (MH) cart was available in intravenous (through the vein) infusion bags when it was intended for diluting the powder content of Dantrolene before administration. This presented a potential for sterile water to be mistakenly given intravenously, which would lead to patient harm. dantrolene is an emergency medication used for treatment of MH, a potentially fatal medical emergency requiring rapid and effective treatment.

Also, the amount of water contained within the cart was not enough to dilute the contents of Dantrolene should an MH crisis occur.

3. The pharmacists used three different versions of "Drug Storage Area" inspection checklists to conduct monthly unit inspections. Two older versions had the wrong temperature monitoring parameters, 35?F - 56?F(degrees Fahrenheit), instead of the correct 36?F - 46?F. Because the wrong inspection checklist used, a temperature of 50?F at a nursing unit was not identified as out-of-range, and therefore, no corrective action taken, during a unit inspection in October 2011.

Findings:

1. The hospital policy and procedures, "Pyxis and Pyxis Profile medstation, Use of", revised 11/09, indicated, "Medication order for patients on a Profile unit require a pharmacist review before the medication is administered." It allowed for the Pyxis overrides when a delay would cause harm or compromise the patient's clinical status.

On 12/5/11 at 9:45 a.m., during an interview with the pharmacy director, she said the hospital had not had any studies to determine the Pyxis override rates in the hospital.

A 15-day Pyxis override report, from 11/25/11 to 12/5/11, was provided by the pharmacy director. The report was over 150 pages of documented override activities (although not all were true 'overrides'). The report also revealed overrides of non-emergent medications, such as Lantus (a long acting insulin), gabapentin capsules (oral medication to treat neuropathic pain, partial seizures), potassium oral liquid (to supplement low potassium in the blood), sustained-release morphine tablets (long acting), etc. On 12/7/11 at 1 p.m., the pharmacy director agreed those medications should not have been overridden. She said the override amount had been lower than what it used to be (before there was 24/7 pharmacy services, about 2 months ago) but she could not provide information such as what medications were overrideable and what were not.

In the 7/26/2000 Medication Safety Alert, ISMP wrote: "Administering a drug before a pharmacist has reviewed the order and screened it for safety increases the risk of a medication error, most notably administering drugs to which patients are allergic, at unsafe doses, or with unrecognized food or drug interactions." As a safe practice, the Institute recommended, "Monitor 'override' drugs regularly and consider determining a monthly 'override' rate (# of drugs given before pharmacy review/total # of drugs administered). Reduce the rate over time."

ISMP also recommended, "If automated dispensing cabinets are linked to the pharmacy computer system, establish a restricted list of urgent or emergent drugs that may be available via the "override" feature."

2. On 12/6/11 at 3:40 p.m., an inspection of the MH cart at the operating room (OR) with Staff A and the OR director was conducted. Five bags of 250 milliliter (ml) Sterile Water for Injection were found in the MH cart. The bags, which had the infusion ports, were similar to that of other intravenous infusion solutions such as normal saline 0.9% or dextrose 5% in water. There was a white sticker on each bag, which read: "Must have additive before infusing IV". OR director confirmed the sterile water was intended for reconstituting dantrolene powder only. Having available the IV bag of sterile water had the potential for them to be infused intravenously by mistake, which could lead to patient harm (severe infusion pain, hemolysis). The MH Cart content list indicated "500cc bottles Sterile Water" were to be used for dantrolene dilution.

According to MHAUS (Malignant Hyperthermia Association of the United States), two-1 liter (2,000 milliliters total) of sterile water for injection are needed to reconstitute dantrolene during an MH crisis, should all 36 vials were needed. During the inspection, only five-250 ml (or 1,250 ml) bags of sterile water were available in the MH cart.

3. During the inpatient pharmacy tour on 12/5/11 at 11 a.m., review of the pharmacy unit inspection binder found three versions (1999, 2002, and 2007) of the "Drug Storage Area" inspection checklists were being used by pharmacists for conducting monthly unit inspections. Both the 1999 and 2002 versions had wrong temperature parameters, "35?F - 56?F" (correct medication temperature = 36?F - 46?F), for medication refrigerator monitoring. One inspection sheet revealed a pharmacist used the 2002 version for the unit inspection in October 2011. She noted the temperature was 50?F but because the 2002 version was used, she did not identify it as out of range and did not take corrective action as a result.

Based on observation and staff interview, the hospital failed to ensure medications in one of two adult crash carts in the emergency department (ED) were locked when the cart was in an open area accessible to patients, visitors, and unauthorized personnel. This had the potential for drug loss and/or unauthorized use.

Findings:

On 12/6/11 at 1:15 p.m., during a tour of the ED in the presence of the ED director, one crash cart was observed sealed. However, the top drawer, where emergency medications were stored, was not locked, even though the cart was sealed. The cart was at an open space where it was accessible to anyone within the area including patients, visitors, and facility personnel.

Based on observations, staff interview, and document review, the hospital failed to ensure expired and otherwise unusable medications were removed from the patient care area and not available for patient use.

Findings:

On 12/5/11 at 11:50 a.m., a visit to the Medical/Surgical 2 Unit's medication room with the unit supervisor (Staff F) found an expired intravenous solution which contained folic acid, thiamin, and vitamins (to replenish nutritional deficiencies). It expired 12/1/11. Staff F said the pharmacy was to check unit stock every morning for outdates and should have removed the medication from the medication room.

On 12/5/11 at 1:30 p.m., a visit to the Neonatal Intensive Care Unit (NICU) with the NICU supervisor (Staff G) found two unusable intravenous (IV) solutions in the medication refrigerator: one heparin 500 u nits (premixed in an IV solution, for use to prevent blood clot) which expired 12/4/11, and two gentamycin bags (antibiotic to treat infections) for a patient who was discharged. Staff G agreed they should not be available in the unit.

At 2:30 p.m. on 12/5/11, a visit to the ICU with Staff D found four bags of premixed Cleocin (an antibiotic for treating infections) IV solution in the medication cabinet. The medication was already discontinued the day before. Staff D said the IV bags should have been returned to the pharmacy for disposition.

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

1. Provide organized dietary services that are directed and staffed by adequate qualified personnel when the Director of Dietary was not provided oversight and guidance by the registered dietitian as required (reference A263).

2. Ensure the availability of organized dietary service as evidenced by unsafe serving of ready to eat food when staff failed to wash hands when changing gloves (reference A620).

3. Ensure safe and effective food production practices when the main kitchen failed to ensure an infection control program was in place and when there was a failure to sanitize large food preparation equipment (reference A749).

4. Develop performance improvement activities that reflected the scope and nature of services when identified Dietary Services issues were not analyzed and tracked, and indicators were not identified to ensure the quality assurance and performance program activities were established and when sanitary food handling was not ensured for the past 12 months (reference A267 and A276).

5. Ensure qualified dietitians supervised the nutritional aspects of patient care in a timely manner. This put patients at risk of jeopardizing patient medical care (reference A621).

6. Ensure the therapeutic diets were served a prescribed by the practitioner responsible for the patient with the potential that patient care is compromised (reference A629).

7. Ensure the nutritional needs of the patients were met in accordance with recognized dietary practices when menus were not analyzed to ensure they met Recommended Dietary Allowances or the Dietary Reference Intake (RDI) of the Food and Nutrition Board or the National Research Council (reference A630).

The cumulative effects of these 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 in accordance with the practitioners' orderd and acceptable standards of practice.

Based on food service observation, dietary and clinical staff interview, the hospital failed to ensure safe food handling practices as evidenced by; 1) lack of an effective system to ensure the sanitation of large equipment washed in the three compartment sink (sink containing three compatments for washing, rinsing, and sanitizing dishes, pots, utenisils, and some equipment); 2) disaster food and water plan that would meet the needs of patients and staff and visitors; 3) lack of effective safe food handling practices; 4) lack of effective cleaning/sanitation of hospital ice machines; 5) lack of safe food storage practices; 6) maintaining an effective ongoing QAPI program.

Findings:

1. On 12/5/11 at 9:50 a.m. the three compartment sink was observed. One food service staff was washing large sheet pans, dipping one end and then turning and dipping the other end in the sanitizer compartment of the sink. The three compartment sink was one large washing sink, a rinse sink and a sanitizing sink, The rinse and sanitizing sections were not of sufficient size to totally immerse the large sheet pans in the rinse water or the sanitizing solution.

The head cook acknowledged the rinse sink and the sanitizing sink sections were too small to allow for the large sheet pans to be fully immersed.

2. On 12/6/11 at 11:15 a.m., the emergency food plan was reviewed and the emergency food was observed. The emergency food was stored in the old kitchen and consisted of entree items of tuna, peanut butter, canned chili, corn beef, canned chicken, canned beans and canned ravioli as well as canned beanse and canned cheese sauces.

Review of the emergency menu in policy, "Emergency Feeding Disaster Plan" dated July 2011, on 12/6/11 at 11:15 a.m., had a generalized menu for breakfast and lunch or dinner. The entree foods listed on this menu were tuna salad, turkey sandwich. The Disaster Emergency Menu for 1500 to 1800 calories (not dated) listed day one through day 3. The foods listed on this emergency menu included meat sandwich, canned veg salad, tuna sandwich and chili.

There was no emergency disaster menu that used the disaster food stored in the emergency food storage room. There was no policy or procedure that specified where the emergency food was stored or how to access or transport this food.

The existing emergency menus were unclear on when to use the perishable foods and when to use the nonperishable foods. The menus were not clear on how to prepare and serve therapeutic restricted diets like renal and consistence modified.

Review of the hospital-wide emergency management plan dated 7/11 stated "96 hour self-sufficient food." There was no further explanation of the "96 hour food." The Emergency Operation Plan revised 7/11 did not incorporate any food service or water plan delineated in this document.

3. On 12/5/11 starting at 9:50 a.m., the cool down log was reviewed. The cool down log is used to ensure foods cooked ahead of service are cooled within specific time frames to prevent growth of pathogenic (disease-causing) bacteria. The log showed entries for roast beef cooked and cooled on 11/1/11, 11/7/11, and 11/28/11. The temperatures were recorded but there was no notation of the time the temperatures were taken to ensure they were within designated times. The form, "Cool Down Log was also from another organization identified at the bottom as "RD for Healthcare" and did not reflect the hospital's cool down policy.

Cook 1 stated on 12/5/11 at 10:00 a.m., he had an in-service on cooling food this year. He was unable to state the specific temperatures required in specific time frame. He stated the food was to cool to 70 degrees Fahrenheit (F) or 40 degrees F in 2 hours with a total of 4 hours to below 40 degrees F. He stated he had not cooked any roast beef in December.

There was no documentation of proper cooling of roast beef or any other food prepared during December. There was a potential for food prepared ahead of service and requiring cooling but was not documented. This places patients at risk of food-borne illness when the document is not completed.

Review of the policy, "Food Preparation and Service Procedures" required cooling from 140 degrees F to 70 degrees F within 2 hours and from 70 degrees to 40 degrees F in an additional 4 hours.

4. On 12/5/11 at 11:30 a.m., trayline (patient meal service) was observed. Cook 1 was observed with gloved hands handling bread for lunch sandwiches, going directly to the refrigerator and microwave handles and returning to food serving and changed gloves. There was no handwashing before the new gloves were put on. The DSS directed Cook 1 to wash his hands and then put on gloves.

Review of the policy IC-609 Plastic Gloves dated July 2011 on 12/7/11 at 2 p.m., stated "to prevent cross contamination and transmission of disease carrying organisms hands are washed before putting on gloves."

5. On 12/5/11 at 9:50 a.m., the table mounted can opener was observed with visible metal shaving on the space behind the blade. Cook 1 stated he would notify the lead cook if the blade needed changing but he had not notified the lead cook to have the blade changed to prevent metal shaving from falling into patient food as cans were opened with the dull can opener blade.

6. On 12/5/11 starting at 9:50 a.m., the following items were observed in the walk-in refrigerator and freezer:

a. One container identified as egg salad was not labeled with the date of preparation.
b. Two packages of frozen chicken were not labeled with a date when they were placed in the freezer.

7. On 12 5/11 starting at 9:50 a.m. , the three door, reach in refrigerator had gaskets on all three doors that were broken and torn, and the two door roll in refrigerator one left door had a door gasket that was torn. The lead cook acknowledged these needed to be replaced.

8. On 12/5/11 starting at 9:50 a.m., the bin ice machine in the kitchen was observed to have significant black substance on the inner walls of the upper ice making section. Engineer 1 stated the machine was cleaned and sanitized with a quaternary sanitizer. He could not state why there was black substance or film on the interior of the ice making section.

On 12/6/11 at 10:00 a.m., Engineer 2 stated the hospital had 8 shoot type ice machines, one kitchen bin ice machine, one in ICU and a cafe soda ice machine. He stated he was responsible for cleaning the hospital ice machines quarterly. He stated he got the food grade sanitizing solution from the kitchen and identified as a quaternary ammonia sanitizer.

Review of the ice machine manufacturers' directions for each type of ice machine revealed the sanitizing was to use a chlorine bleach solution. Engineer 1 acknowledged he did not know this was required.

Review of the policy, "Sanitation of Ice and Ice Machines IC-230" revised 4/11 stated to use an "EPA registered disinfectant recommended by the manufacturer of the ice machine."

9. On 12/5/11 starting at 9:50 a.m., the stacked ovens had black residue on the bottom of the rack oven section and side walls and racks also had heavy black residue. The head cook stated the ovens needed to be cleaned.

10. On 12/5/11 at 2:15 p.m. the patient nourishment and breast milk refrigerators were observed on the pediatric floor. Both refrigerator logs had temperature ranges of 35 degrees F to 45 degrees F. The patient nourishment refrigerator containing fresh milk cartons had a temperature of 44 degrees F.

The temperature logs posted on the refrigerator were not referenced for food temperatures. The temperatures were The FDA Food Code 2009 specifies food held in refrigeration is a 41 degrees F or below. The temperatures at above 41 degrees F promote growth of pathogenic micro-organisms and cause serious food borne illness.

11. On 12/7/11 at 3:00 p.m., the DSS (Director Services Supervisor) was asked to discuss the Quality Assurance Performance Program (QAPI). She confirmed the QAPI program did not measure, analyze or track the food safety findings which included cross-contamination of the cook not washing hands between glove use, cook knowledge and demonstration of cool down procedures to prevent food-borne patient illness, not adequate sanitizing of the sheet pans, failure to have nutritional analysis the menu, and adequate detailed emergency disaster food plan. The DSS was not able to discuss the method used to identify problems or develop an effective QAPI program.

The QAPI plan for the dietary was reviewed on 12/7/11 was limited to a patient satisfaction survey, tray quality and meal accuracy.

Based on medical record review and staff interview the hospital failed to ensure qualified dietitians supervised the nutritional aspects of patient care in a timely manner. This put the patients at risk of jeopardizing patient medical care.

Findings:

1. Patient 3 was admitted 11/20/11 with diagnoses of primary cardiac arrest. Record review on 12/7/11 at 2:00 p.m. showed a physician order for nutritional consultation dated 11/29/11. Review of medical record did not show a nutrition consult.

2. Patient 4 was admitted 11/25/11 with diagnoses of end stage renal disease with dialysis. Medical record reviewed on 12/7/11 at 2:00 p.m. Admission nutrition assessment dated 11/26/11 stated patient at moderate nutritional risk.

Nutritional Care Guidelines stated moderate risk patient rescreened every 7 days and assessed as needed. Registered dietitian 2 (RD 2) was giving patient education on 12/7/11. There was no documentation of rescreening in 7 days.

RD 2 stated the RDs were short staffed as one RD was on medical leave.

3. Patient 2 was admitted 11/1/11. The RD initial assessment was dated 11/10/11. The patient was seen 9 days after admission and not at the minimum of 7 days for screening or assessment.

The RD nutrition note dated 11/23/11 was 13 days later and not at the rescreening time frame of 7 days. The nutrition note referenced patient refusing meds, inhaler and meals. The assessment further stated if patient not discharged may require enteral feedings. The nutrition assessment did not identify a nutrition risk.

Patient 2 was hospitalized for 36 days with poor oral intake and RD follow-up did not meet stated time frames.

3. On 12/7/11 at 3:00 p.m. the assistant administrator was interviewed. She stated the RD was on medical leave starting 10/31/11 until 1/3/12. She stated an RD was hired per diem starting on 11/16/11. The per diem RD was covering clinic assignments.

Review of the dietary department work schedule starting on 11/19/11 to 12/16/11 showed RD 1 scheduled for 5 days and RD 2 scheduled for 11 days. The schedule did not reflect a per diem RD on the acute hospital schedule. The administrator or DSS did not speak to the requirement for scheduling the RDs to meet acuity of the hospital patients.

The delayed RD coverage put patients at risk of not meeting nutritional needs.

Based on observation, staff interview and document review the hospital failed to ensure the therapeutic diets were served as prescribed by the practitioner responsible for the patient with the potential that patient care is compromised.

Findings:

On 12/5/11 starting at 11:30 a.m. the trayline (patient meal service) was observed:

1. The regular menu specified 3 ounce serving of roast beef. The 1800 and 2000 calorie diets specified 2 ounce serving of roast beef and gestational diabetic diet was 3 ounce serving of roast beef.

Cook 1 was observed placing an unmeasured amount of roast beef on three regular trays; one gestational diabetic diet tray, and one 2400 calorie diet. Cook 1 was asked how he knew the serving size of the roast beef and he stated, "I guess I need a scale."

The DSS acknowledged the meat should be weighed to ensure the specified portion.

2. A 2000 calorie diabetic diet was served 2 ounces (weighed on scale) of enchilada casserole. The menu specified a casserole serving that included 2 ounces of turkey. Cook 1 stated he made the casserole with 18 ounces of turkey for 6 servings and had been making this recipe for 5 years.

Review of the Enchilada Casserole recipe on 12/5/11 at 12:00 p.m., had a 2x4 inch serving size when 8 servings were prepared. There was no recipe for 6 servings and there was no direction on how to serve the casserole to ensure the 2 ounces of turkey was provided for the therapeutic diet.

Review of the policy, "Food Preparation and Service Procedures" on 12/7/11 at 2:00 p.m., stated, "All food prepared for patient meal service and for the cafeteria will be prepared using standardized recipes and production."

Based on observation, staff interview, and document review, the hospital failed to ensure the nutritional needs of the patients were met in accordance with recognized dietary practices when menus were not analyzed to ensure they met Recommended Dietary Allowances or the Dietary Reference Intake (RDI) of the Food and Nutrition Board or the National Research Council. This put patients at risk of menus not providing required nutrients and compromising medical care.

Findings:

Registered dietitian 1 (RD 1) was asked for the nutrient analysis of the menus. She stated that nutritional analysis of the menus was based on serving of fruit, vegetables, milk and protein. The document, "Dietary: Adequacy of Menus Part IB" dated 1/15/11 and signed by RD 1 was reviewed. The form showed menus meet RDA by meeting the following standards by looking at vitamin C and vitamin A foods. The menu evaluated was regular. The form was for Long Term Care Facilities regulation and did not reflect the acute hospital regulation.

Review of the policy TX-921 Patient Menus with Menu Approval Letter reviewed July 2011, showed the following menus offered: Regular, Soft. Bland, low sodium, low cholesterol, Cardiac, Low Sodium/Renal, Diabetic, calorie controlled. Also observed during the survey were diets for pediatric for age and high fiber pediatric diet. The policy stated "All menus are planned to meet Recommended Daily dietary Allowances."

There was not quantifiable analysis of the sodium, calories, cholesterol, soft/bland or fiber or pediatric menus. This analysis only looked at limited nutrients like vitamin C fruit, vegetables including vitamin A sources, protein and fat, and did not analyze for the extensive nutrition listing in the Recommended Dietary allowances for zinc, fiber, energy, protein, vitamin K, calcium, Folate, B12, Magnesium, Iron, and Selenium.

There was no complete analysis to ensure the quantifiable amounts of all nutrients were provided for the therapeutic diets including, pregnancy, pediatric, renal restricted, and sodium restricted.

Based on observation, staff interview and document review the hospital failed to have a current therapeutic diet manual approved by the dietitian and medical staff and readily available to medical, nursing, and food service personnel when the adult and pediatric diet manual was a generalized guide and was not specific to the diets prescribed at the hospital. There was no reference for physician or nurses to evaluate the hospital provided diets. The diet manual was not approved by the dietitian and although the online manual was approved by medical staff it did not contain specifics on the diets that were prescribed.

Findings:

On 12/5/11 at 2:15 p.m. a Registered nurse (RN) on the pediatric floor was asked to find information on the pediatric high fiber diet prescribed to Patient 1. The RN stated she would call the RD or the Dietary Department. She accessed the online Nutrition Care Manual but was not able to provide diet parameters for this specific diet order that included the amount of fiber the diet was to provide.

There was no information for the "pediatric high fiber diet."

RD 1 stated the hospital had the online Nutrition care manual for adults and the online care manual for pediatrics.

Review of the 5/17/11 at 10:00 a.m., computer entry diet list showed diets ordered included: ADA, Renal, High fiber diet, high potassium diet, high residue diet, low residue diet, psych intensive care diet.

ADA diet manual 5 edition states "there is no longer one "ADA diet" (small) meal plan based on a strict distribution of nutrient." Diet terminology in current American Dietetic Manuals is based on carbohydrate distribution and termed consistent carbohydrate diet.

The Care Manual (eatright.org) is a generalized reference resource that covers all aspects of nutrition management but does not clearly outline specific diets as ordered in the hospital.

The Care Manual failed to identify diet terminology and the specific values assigned to each diet as prescribed and was not readily available to the medical staff and nursing personnel when ordering or referencing a patient's diet.

Review of the policy titled TX-934 diet Orders stated "Diet prescriptions should be consistent with terminology used in the diet manual."

Based on observation, staff interview, and document review the hospital failed to ensure detailed plan for emergency water for the licensed capacity of the hospital, employees and visitors.

Findings:

On 12/6/11 at 11:15 a.m., the emergency/disaster water supply and plan was reviewed. There were approximately 950 gallons of 16 ounce bottled water in the "trailer."

This water was designated for patient drinking in emergency/disaster and also rotated using the vending program. Since this water stock was depleted and then restocked each month, there was no system to ensure the par level of drinking emergency/disaster water was maintained at 950 gallons for patients and quantity not identified by the plan for staff and visitors.

The building used to store the emergency/disaster water was not in the licensed hospital building and would need to be moved to secure and approved food storage area in the hospital.

In addition, the policy EC-327 Emergency Paper and Water Provision stated the emergency water was to be used for patient and staff drinking. The amount of water was based on 2 gallons per day per patient bed for a three day minimum. That amount was doubled.

There was no emergency/disaster water stored for staff drinking. The director of food service (DSS) was not able to state the quantity of water that was specified in the policy. There was water allocated for the dietary department.

There was no plan for drinking water for visitors. There was no quantity of drinking water specified for the staff. There was no plan for emergency/disaster water for other patient uses.

Based on documentation and interview, not all patient care equipment was checked for safety prior to use.

Findings:

1. On 12/7/11 the hospital bio-medical department was visited and the biomedical engineer was interviewed. A review of the department's inventory of equipment indicated that some equipment was loaned to other facilities, e.g., pulse oximeter, light phototherapy, syringe pumps.

Although engineering was aware that equipment may be loaned, there was no system in place or policy directing staff on tracking the equipment's return.

2. Further review of the equipment log revealed that some patient care equipment was missing. The policy stated the department manager is notified of the missing piece of equipment. If the equipment cannot be located the department manager is again notified. There is no process or time line as to what occurs if the equipment is never found.

3. During a tour of the facility on 12/5/11 a warming unit used to heat disposable towelettes was located in the pediatric unit. The warm towelettes were used on infants for hygiene. There was no evidence the heating unit was checked for safety by hospital engineering or that annual preventive maintenance was performed. Engineering staff stated they did not know the warming unit was being used in the hospital.

Based on observation, staff interview, and document review, the hospital failed to ensure the infection control officer developed a system for identifying potential for food-borne illness in the dietary department when, 1) ten to 12 ice machines were not sanitized according to the manufacturers' recommendations and were not cleaned according to the policies approved by the infection control committee; 2) failed to ensure dietary staff used handwashing when changing gloves when serving ready-to-eat food.

Findings:

1. On 12/5/11 starting at 9:50 a.m., the kitchen bin ice machine was observed to have significant black substance on the inner walls of the upper ice making section. Engineer 1 stated the machine was cleaned and sanitized with a quaternary sanitizer. He could not state why there was black substance or film on the interior of the ice making section.

On 12/6/11 at 10:00 a.m., Engineer 2 stated the hospital had 8 shoot type ice machines, one kitchen bin ice machine, one in ICU and a cafe soda ice machine, He stated he was responsible for cleaning the hospital ice machines quarterly. He stated he got the food grade sanitizing solution from the kitchen and identified as a quaternary ammonia sanitizer.

Review of the ice machine manufacturers' directions for each type of ice machine revealed the sanitizing was to use a chlorine bleach solution. Engineer 1 acknowledged he did not know this was required.

Review of the policy, "Sanitation of Ice and Ice Machines IC-230" revised 4/11 stated to use an "EPA registered disinfectant recommended by the manufacturer of the ice machine."

2. On 12/5/11 starting at 11:30 a.m., trayline (patient meal service) was observed. Cook 1 with gloved hands handling bread for lunch sandwiches, going directly to refrigerator and microwave handles and returning to food serving and changed gloves. There was no handwashing before the new gloves were put on. The DSS directed Cook 1 to wash his hands and then put on gloves.

Review of the policy IC-609 Plastic Gloves dated July 2011 on 12/7/11 at 2: 00 p.m., stated "to prevent cross contamination and transmission of disease carrying organisms hands are washed before putting on gloves."

On 12/6/11 at 10:00 a.m., was interviewed regarding the infection control oversight of the dietary department. She stated she was involved in environment of care rounds and did some in-services for food service staff on hand hygiene. She stated this was 6 months ago but remembered the ovens needed cleaning and the department was told of the rounds findings. She stated she was not aware of the FDA Food Code or the HACCP (Hazard Analysis Critical Control Point Program). This program is a systematic preventive approach to food safety that addresses physical, chemical, and biological hazards as a means of prevention rather than finished product inspection. HACCP is used in the food industry to identify potential food safety hazards, so that key actions can be taken to reduce or eliminate the risk of the hazards being realized (FDA Food Code 2009).

3. Review of the Infection Prevention and Control Plan for 2011-2012 showed there were no specific goals directed for the dietary department to ensure compliance with food safety requirements and prevent potential for food-borne illness to the hospital patients, staff and visitors.

Based on observation, interview and record review the hospital failed to review and revise discharge instructions when significant changes in anti-diabetic medications were made for one (37) of eight sampled patients.

Findings:

Patient 37 was admitted from the emergency room with diagnoses including acute gallstone pancreatitis, diabetes mellitus, hypertension and exacerbation of asthma.

On 12/2/11 a surgery consultation was obtained, but no surgery was scheduled pending Patient 37 becoming more medically optimized for a cholecystectomy. Review of the clinical record indicated the treatment plan included antibiotic and steroid therapy with an insulin sliding scale to cover the increased blood sugars from the steroids.

On 12/5/11, physician's orders indicated Patient 37 would be discharged home on a steroid inhaler with a gradual taper and blood pressure medications. There were no orders indicating Patient 37's oral anti-diabetic medications.

When the clinical record was reviewed with the unit supervisor on 12/5/11 at 1:45 p.m., she stated the physician maintained the discontinue oral anti-diabetic medication, Patient 37 would be seen by the primary care physician on 12/8/11.

During an interview with licensed nurse 11 (LC 11) on 12/6/11 at 9:35 a.m., and 11:15 a.m. she stated she had provided Patient 37 with medication handout instructions for the inhaler and the blood pressure medications. She stated she assessed Patient 37's understanding of the proper use of the glucometer but did not provide written discharge aftercare instructions on the importance of continued blood sugar monitoring or when to notify the primary care physician for out of range results.

The hospital failed to reassess Patient 37's diabetic discharge aftercare needs when discharge orders indicated continued use of a steroid inhaler and discontinued oral anti-diabetic medications.