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Based on observation, staff interview, and administrative document review, the hospital failed to employ a Dietetic Service Supervisor (in this facility identified as the Director of Nutrition Services - DNS) 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. State requirements at Section 70275(b) specify that if a dietitian is not employed full-time, a full time person who is a graduate of a state approved course that provides 90 hours of classroom instruction in food supervision shall be employed to be responsible for the operation of food service. The Dietary Service Supervisor who is responsible for the operation of the food service failed to meet this requirement and through the job description failed to meet all the requirments of this Section.

This failure placed patients at risk of not having their nutritional needs met by qualified staff.

Findings:

During the validation survey from 12/20 10 to 12/ 22/10 the Nutrition Services organization was reviewed. The Director of Nutrition Services (DNS) stated that he was a Certified Dietary Manager. He stated that he had been employed for 10 years as Director of Nutrition Services Department.

On 12/20/10 at 1:50 p.m., the hospital Nutrition Services organization charts and Director of Nutrition Services job description was reviewed. The DNS's job description showed he was responsible for the management of the food service operation and was a full time employee. The DNS was the Dietary Service Supervisor as stated in the California Code of Regulations. The organization chart showed the DNS reported directly to the Vice President of Human Relations (DNS). The organization chart showed the three registered dietitians (RD) on staff reported to the DNS.

The Director's job description did not spell out qualifications as outlined in the California Code of Regulations, Title 22, Division 5, Chapter 1 or the Health and Safety Code 1265.4, for the Dietary Service Supervisor who is responsible for the operation of the food service.

On 12/23/12 at 11:00 a.m., the DNS's personnel file was reviewed and confirmed the DNS had a Bachelor's degree in Business Administration. The DNS also presented a Member Profile from the Dietary Managers Association (DMA) dated 12/22/10. This member profile showed that the DNS's certification with the DMA expired 5/31/10. The DNS acknowledged on 12/22/10 at 9:00 a.m., he was not currently a Certified Dietary Manager.

The RD 1 stated on 12/21/10 at 9:00 a.m., she was a full time employee but the dietitian's responsibilities were strictly clinical and did not have oversight of the Nutrition Service. She stated they did not provide guidance to the supervisor and staff for development or revision of the policies and procedures for food service.

Review of the Chief Clinical Registered Dietitian's (RD 1) job description on 12/20/2010 at 1:50 p.m., showed only nutrition care responsibilities with review of trayline and diet office staff. There was no provision for the oversight and guidance for the supervisor (Director of Nutrition Services).

The hospital failed to employ a full time Nutrition Services Director responsible for the hospital food service meeting the State requirements for qualified Dietary Service Supervisor.

Based on observation, staff interview, and administrative document review the governing body failed to ensure that there was safe and effective implementation of the patient food service when the CEO allowed the Certification of the DNS to lapse and poor infection control practices in the kitchen which placed patients at risk of food borne illness and cross contamination for one year.

Findings:

1. On 12/20/10 beginning at 10:30 a.m., the circular ware washing machine was observed. The dish room temperature log was reviewed. The log showed temperature recording for wash and power rinse. The DNS stated that the dish machine had been converted approximately one year ago from a high temperature to a low temperature machine that used a chemical sanitizer. He stated that staff recorded the temperature of the wash and rinse cycles. Review of the logs showed recording of temperatures. The DNS stated that the chemical representative did check the concentration of the sanitizer on his visit each week. The standard of practice would be to record the concentration of the sanitizer each time the dish machine was operated which would be three times per day.

The DNS confirmed that the log had not been modified to record the PPM (parts per million) of the sanitizer.

DNS stated that they did not have documentation of the concentration of the dish machine and could not verify the sanitation of the multiuse dishware including patient plates and utensils for approximately one year.

2. During the initial tour on 12/20/10 beginning at 10:30 a.m., a second issue with the circular dish washing machine was observed. The dish machine was a circular plan with the clean sanitized dishware exiting the final rinse and exposed to the drainage from the dirty dishwater and pans placed on the belt. There was white liquid with food debris including rice on the belt with the clean sanitized dishes that exited the dish machine

3. On 12/23/10 at 10:00 a.m., the CEO was interviewed. He stated that he agreed there were serious and substantial issues regarding the Food and Dietetic Services. The CEO indicated that he communicated with the Director of Human Resources who oversees the Food and Dietetic Services. The CEO acknowledged that he knew there were problems that required addressing. The CEO stated that he was the individual in administration who was responsible for the food and dietetic department.

On 12/23/12 at 11:00 a.m., the DNS's personnel file was reviewed. A member profile showed that the DNS's certification with the DMA expired 5/31/10.

Based on observation, staff interview, and administrative document review, the hospital failed to maintain an effective ongoing, hospital wide data-driven quality assessment program which involved the Department of Nutrition Services when:

1. There was no analysis or tracking of issues to evaluate services when those services were provided by an unqualified Director of Nutrition Services. There were breaks in infection control practices that could result in patients developing food borne illnesses when there was cross contamination of the dishwasher and no measurement of sanitizer concentration. (Refer to A-267, A-276)

2. A QAPI program was not in place in Nutrition Services and there was no documentation reflecting food safety concerns for the past 12 months. (Cross Reference to A-618, and refer to A-620, and A-749)

The cumulative effect of these 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 administrative document review the hospital failed to ensure that they measured, analyzed and tracked the services provided by Nutrition Services to address the cross contamination of the dishwasher, the amount of the sanitizer concentration and maintenance of food safety handling during distribution for the past 12 months. The failure to measure, analyze and track the deficient practices of the Nutrition services would allow the failures to continue.

Findings:

1. During the initial tour on 12/20/10 beginning at 10:30 a.m., the circular ware washing machine was observed. The dish room temperature log was reviewed. The log showed temperature recording for wash and power rinse. On 12/20/10 at 10:30 a.m., the DNS stated that the dish machine had been converted approximately one year ago from a high temperature to a low temperature machine that used a chemical sanitizer. He stated that staff recorded the temperature of the wash and rinse cycles. Review of the logs showed recording of temperatures. The DNS stated that the chemical representative did check the concentration of the sanitizer on his visit each week. The standard of practice would be to record the concentration of the sanitizer each time the dish machine was operated. For this facility it was three times per day.

The DNS confirmed that the log had not been modified to record the PPM (parts per million) of the sanitizer.

DNS stated that they did not have documentation of the concentration of the dish machine and could not verify the sanitation of the multiuse dishware including patient plates and utensils for approximately one year.

There had been no measurement of the sanitizer concentration with no assurance the multiuse dishware was sanitized before service to patient for approximately one year.

2. During the initial tour on 12/20/10 beginning at 10:30 a.m., the circular dish washing machine was observed. The dish machine was a circular plan with the clean sanitized dishware exiting the final rinse and exposed to the drainage from the dirty dishwater and pans placed on the belt. There was white liquid with food debris including rice on the belt with the clean sanitized dishes that exited the dish machine.

The DNS stated that he was aware that there was the cross contamination of the sanitized dishware.

3. On 12/20/10 starting at 10:30 a.m., during the kitchen tour, there were approximately 6 prune juice pint cartons in the tray line reach-in refrigerator. There was no date on the cartons to indicate their thaw date or when the juice should be discarded. On 12/20/10 at 10:30 a.m., the DNS stated the juice was received frozen and thawed for service. He stated that the thawed juice was to be used in four days. He stated that there was no system to date the thawed juice to ensure it was used as directed by the manufacturer.

4. On 12/20/10 during the initial tour at 11:12 a.m., FS2 was observed at the hand washing sink. FS2 was running his hands under the running water and adding soap and rinsing hands.

DS1 acknowledged that FS2 was not lathering long enough when he was washing his hands.

Review of the policy No 700 titled Infection Control and Department Sanitation showed hand washing was to " 8. Lather up soap ad scrub hands, wrists, and lower arms, 9. Scrub hands with soap for at leash 10 seconds. "

Food Service staff failed to follow policy for proper hand washing technique.

5. On 12/21/10 at 10:11 a.m., observation of the ICU pantry, showed 4 cans of Two Cal HN ( enteral nutritional product) had expiration dates of "1 dec 2010". There was one can Beneprotein (powder protein supplement) open with not dated when opened. The manufacturer's direction on the can stated "shelf stable for 6 months from date opened."

RD 1 acknowledged the products should have been discarded and dated when opened.

6. On 12/21/10 at 11:30 a.m., the trayline was observed. On 12/21/10 at 11:30 a.m., the trayline checker was observed wiping the dome lids that covered the hot food with a white cloth. She stated that the domes were wet and needed to be dried before they were placed on the plate.

a. The domes were put away and stacked wet. This provides a moist environment for the growth of microorganism after the domes finish washing and stored before service.

b. In addition, the domes were not dried at the end of the washing cycle since the dish machine was changed to the low temperature use of a chemical sanitizer and did not generate adequate drying time for the domes.

c. The use of drying cloths is prohibited as a standard of practice as cited in the FDA (Food and Drug Administration) Food Code 2009. The use of a drying cloth can cross contaminate the lids.

Review of the policy No 700 titled Infection Control and Department Sanitation on 12/22/10 showed the "Dishes are allowed to air dry before stacking them in service area or clean dish storage area. Dishes are not stored when wet. Dishes are not towel dried."

7. On 12/21/10 at 11:45 a.m., the patient tray delivery system was observed. The hot-cold tray delivery system required the delivery cart to be plugged in and trays were delivered from the one hall plug location approximately 50 or more feet down patient hallways. Patient trays were placed on an open three shelf small cart with one shelf approximately 4 inches from the floor. The lettuce, bean salad, gelatin salad, and cake were delivered uncovered and exposed to cross contamination during the delivery distance.

Review of the policy No.700 titled Infection Control and Department Sanitation: service Standards E. "All foods being displayed, held, or transported are protected from contamination in clean refrigerators, heat maintenance equipment, or carts, appropriately covered."

The failure to cover the patient food placed the food at risk of cross contamination during delivery.

8. On 12/22/10 at 3:00 p.m., the DNS and RD 1 were asked to discuss the service of the Quality Assurance Performance Improvement (QAPI) program. They confirmed that the QAPI program did not measure, analyze or track the food safety findings which included the cross contamination of the dishwasher, no measurement of sanitizer concentration, and the failure to maintain patient food safety during distribution of foods for the past 12 months.

The QAPI program for dietary was reviewed on 12/22/10. There was an undated patient satisfaction improvements effort that reflected no dates for the past year other than on-going and failed to address the food safety findings.

Based on observation, staff interview, and administrative document review the hospital failed to ensure the implementation of a comprehensive Nutrition Services Quality Assurance Performance Improvement 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:

1. On 12/21/10 at 11:30 a.m., the trayline was observed. The trayline checker was observed on 12/21/10 at 11:30 a.m., wiping the dome lids that covered the hot food with a white cloth. She stated that the domes were wet and needed to be dried before they were placed on the plate.

a. The domes were put away and stacked wet. This provides a moist environment for the growth of microorganism after the domes finish washing and stored before service.

b. In addition, the domes were not dried at the end of the washing cycle since the dish machine was changed to the low temperature use of a chemical sanitizer and did not generate adequate drying time for the domes.

c. The use of drying cloths is prohibited as a standard of practice as cited in the FDA (Food and Drug Administration) Food Code 2009. The use of a drying cloth can cross contaminate the lids.

Review of the policy No 700 titled Infection Control and Department Sanitation on 12/22/10 showed the "Dishes are allowed to air dry before stacking them in service area or clean dish storage area. Dishes are not stored when wet. Dishes are not towel dried."

2. On 12/21/10 at 11:45 a.m., the patient tray delivery system was observed. The hot-cold tray delivery system required the delivery cart to be plugged in and trays were delivered from the one hall plug location approximately 50 or more feet down patient hallways. Patient trays were placed on an open three shelf small cart with one shelf approximately 4 inches from the floor. The lettuce, bean salad, gelatin salad, and cake were delivered uncovered and exposed to cross contamination during the delivery distance.

Review of the policy No.700 titled Infection Control and Department Sanitation: service Standards E. "All foods being displayed, held, or transported are protected from contamination in clean refrigerators, heat maintenance equipment, or carts, appropriately covered."

The failure to cover the patient food placed the food at risk of cross contamination during delivery.

3. On 12/22/10 at 3:00 p.m., the DNS and RD 1 were asked to discuss the services of the QAPI program. They confirmed that the QAPI program did not cover indicators for food safety findings including the cross contamination of the dishwasher, measurement of sanitizer concentration, when dishes were stored wet and dried with a cloth towel, and when there was a failure to cover the patient food which placed the food at risk of cross contamination during delivery.

Significantly, there was no documented QAPI program reflecting the food safety and sanitation of the Nutrition Services. The sanitizer concentration was not monitored to ensure the dishware used by patients was sanitized during each washing and the facility failed to provide documentation for the past 12 months. There was no documentation of indicators being developed to monitor ice machine sanitation including the bin ice machine in the kitchen. There was no documentation of indicators for maintaining the circular dish machine maintained multiuse dishware in sanitary condition.

Based on observation, staff interview, and administrative document review, the facility failed to ensure nursing standards of practice were met when three of three registered nurses failed to correctly draw up pediatric medication doses. The result of this failure had the potential to place pediatric patients at risk of receiving incorrect or inadequate doses of medication.

Findings:

1. On 12/20/10 at 1:55 p.m., the Director of the Emergency Department (EDD), said registered nurses were expected to accurately draw up doses of pediatric emergency medications during pediatric codes (emergencies). She said they knew how to use the Broselow tape to obtain doses of medications. The Broselow tape was used to measure the length of a pediatric patient and determine the weight based on the length. The Broselow tape provided doses of emergency medications which corresponded to the weights listed on the tape.

On 12/20/10 at 2:05 p.m., RN 13, a registered nurse in the Emergency Department with EDD and Pharmacy Services (PHS) present, was asked to draw into a syringe a dose of atropine (to increase heart rate) from an emergency (code blue) medical cart for a theoretical patient. RN 13 was provided the length of the patient and used the Broselow tape to determine the dose. The Broselow tape showed a dose of 0.17 mg (milligrams) of atropine for the theoretical patient. She drew into a syringe a dose of 0.085 mg which was incorrect. The Broselow tape provided a dose based on a concentration of atropine of 0.1 mg/ml (milliliters). The cart contained a concentration of atropine of 0.05 mg/ml.

On 12/20/10 at 2:25 p.m., RN 1, a registered nurse in the Emergency Department with EDD and PHS present, was asked to draw into a syringe a dose of atropine from an emergency medical cart for a theoretical patient. RN 1 was provided the length of the patient and used the Broselow tape to determine the dose. She drew into a syringe 4.8 ml of atropine, 0.05 mg/ml, or 0.24 mg. The correct dose was 4.2 ml or 0.21mg. She subsequently said she should have drawn 2.1 ml into the syringe. The latter dose would have been correct if the emergency cart had contained an atropine concentration of 0.1 mg/ml which was listed on the Broselow tape.

On 12/20/10 at 2:50 p.m., RN 2, a registered nurse in the Pediatric in-patient area, was interviewed with PHS and PHS 2 present. RN 2 was a charge nurse who was asked if she provided direct patient care. She replied, "yes". She was asked to draw into a syringe from an emergency cart a dose of atropine for a theoretical 17 kg (kilograms) pediatric patient. She drew into a syringe 3.3 ml of atropine, 0.05 mg/ml. The Broselow tape which she used to determine the dose indicated that she should have drawn into a syringe 3.3 ml of atropine, 0.1 mg/ml. RN 2 was subsequently asked to draw into syringe doses of epinephrine and sodium bicarbonate for the 17 kg patient. She used the Broselow tape to determine the dose and drew up 18.5 ml of sodium bicarbonate which was 0.5 mEq (milliequivalents)/ml for a dose of 9.25 mEq. The Broselow tape indicated that she should have drawn into the syringe 16.5 mEq or 33 ml of sodium bicarbonate

The hospital's "Code Blue Policy and Procedure, number 18-14-01" read, "Advanced Cardiac Life Support (ACLS) certified RNs (registered nurses) may initiate Emergency Cardiac Protocols prior to arrival of physician, including defibrillation." Also, "In the event the physician is unable to respond to a Code Blue due to an emergency in the ED (Emergency Department), the ED RN will run the code until a physician arrives" and Nurse #2-RN-ACLS Certified Preferred ... Prepares and administers emergency medications per ACLS protocols until MD arrives."

Personnel records for RN 1, RN 2 and RN 13 indicated that each had an active certification for PALS (Pediatric Advanced Life Support) and ACLS.

Census records for the hospital showed the current pediatric census for in-patients was one, with an average of 1 to 4 patients per day for the previous 6 month period. The Emergency Department showed pediatric patients were seen approximately 1000 per month (approximately 30 pediatric patients per day) for the previous 6 month period. According to the EDD during this time period there were approximately 1 to 6 emergency pediatric events per month.

Based on observation, staff interviews, and administrative document reviews, the hospital failed to provide pharmaceutical services which met the needs of patients when:

1. Three of three Registered Nurses (RN 1, RN 2 and RN 13) in the Emergency Department and Pediatric area of the hospital were unable to accurately draw up into syringes emergency medications for pediatric patients. Because of the hospital's failure to have a system in place to assure that pediatric emergency medications were administered by a professional qualified to do so in a safe and effective manner, Immediate Jeopardy was called on 12/20/10 at 5:05 p.m. with the hospital Director of Patient Services.. (Refer to A 500)

2. Three of three patient area unit inspections were not conducted as required by State regulations in order to prevent the use of outdated and potentially deteriorated drugs and to ensure the availability of emergency drugs. (A 500)

3. Medication discrepancy reports from automated drug dispensing cabinets demonstrated that all medications were not accounted for and potentially indicated that inappropriate medications and doses of medications may have been administered to patients. (A 500)

4. New medication orders were not always reviewed by pharmacists prior to administration to patients when the automated drug dispensing cabinets override function was used an average of approximately 90 times each day. (A 500)

5. Preprinted physicians' orders for medications were unclear and were left to interpretation by health care workers. (A 500)

6. The facility did not limit access to medications to clearly identified persons who required access for patient care. (A 502)

7. Outdated or otherwise unusable drugs and biologicals remained available for patient use. (A 505)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of safe and effective drugs to meet the needs of the hospital patients. Because of the hospital's failure to have a system in place to assure that pediatric emergency medications were administered by a professional qualified to do so in a safe and effective manner, Immediate Jeopardy was called on 12/20/10 at 5:05 p.m. with the hospital Director of Patient Services. (Refer to A 500)

Based on observations, staff interviews, and administrative document reviews, the hospital failed to provide for patient safety in the control and distribution of drugs and biologicals in accordance with facility policies, accepted standards of practice, and Federal and State laws when:

1. Three of three RNs (RN 1, RN 2 and RN 13) in the Emergency Department and Pediatric area of the hospital failed to calculate and draw up into a syringe the correct dose of emergency pediatric medications. Because of the hospital's failure to have a system in place to assure that pediatric emergency medications were administered by a professional qualified to do so in a safe and effective manner, Immediate Jeopardy was called on 12/20/10 at 5:05 p.m. with the hospital Director of Patient Services.

2. Three of three patient area unit inspections were not conducted as required by State regulations. Patient unit inspections were required by State regulations in order to prevent the use of outdated and potentially deteriorated drugs and to ensure the availability of emergency drugs on portable emergency carts. This failure increased patient risk to avoidable adverse effects from medication errors and possible inaccessibility of life saving medications during emergencies.

3. The 840 discrepancies listed on the medication discrepancy report from automated drug dispensing cabinets (Omnicells) for the period between 11/20/10 through 12/20/10 were not completely resolved as required by facility policy. This failure to resolve all discrepancies increased patient risk to avoidable adverse effects from medication errors.

4. The override mechanism in dispensing of medications from the automated dispensing cabinets (Omnicells) was used by nurses 9929 times (approximately 90 times per day) for the time period between 9/1/10 and 12/20/10. This practice of utilizing the override mechanism in the Omnicells bypassed pharmacy review and approval of new medication orders and did not follow facility policy regarding use of the override mechanism only under immediate or emergent situations for new medication orders. This failure to have pharmacy oversight of new medication orders increased patient risk to avoidable adverse effects from medication errors.

5. Thirteen of nineteen pre-written medication orders reviewed did not follow professional standards of practice from ASHP (American Society of Hospital Pharmacists) guidelines for clarity and specific directions This failure increased patient risk to avoidable adverse effects from medication errors.

Findings:

1. On 12/20/10 at 1:55 p.m., EDD, the Director of the Emergency Department, said registered nurses were expected to accurately draw up doses of pediatric emergency medications during pediatric codes (emergencies). She said they knew how to use the Broselow tape to obtain doses of medications. The Broselow tape was used to measure the length of a pediatric patient and determine the weight based on the length. The Broselow tape provided doses of emergency medications which corresponded to the weights listed on the tape.

On 12/20/10 at 2:05 p.m., RN 13, a registered nurse in the Emergency Department with EDD and PHS present, was asked to draw into a syringe a dose of atropine (to increase heart rate) from an emergency (code blue) medical cart for a theoretical patient. RN 13 was provided the length of the patient and used the Broselow tape to determine the dose. The Broselow tape showed a dose of 0.17 mg (milligrams) of atropine for the theoretical patient. She drew into a syringe a dose of 0.085 mg which was incorrect. The Broselow tape provided a dose based on a concentration of atropine of 0.1 mg/ml (milliliters). The cart contained a concentration of atropine of 0.05 mg/ml.

On 12/20/10 at 2:25 p.m., RN 1, a registered nurse in the Emergency Department with EDD and PHS present, was asked to draw into a syringe a dose of atropine from an emergency medical cart for a theoretical patient. RN 1 was provided the length of the patient and used the Broselow tape to determine the dose. She drew into a syringe 4.8 ml of atropine, 0.05 mg/ml, or 0.24 mg. The correct dose was 4.2 ml or 0.21mg. She subsequently said she should have drawn 2.1 ml into the syringe. The latter dose would have been correct if the emergency cart had contained an atropine concentration of 0.1 mg/ml which was listed on the Broselow tape.

On 12/20/10 at 2:50 p.m., RN 2, a registered nurse in the Pediatric in-patient area, was interviewed with PHS and PHS 2 present. RN 2 was a charge nurse who was asked if she provided direct patient care. She replied, "yes". She was asked to draw into a syringe from an emergency cart a dose of atropine for a theoretical 17 kg (kilograms) pediatric patient. She drew into a syringe 3.3 ml of atropine, 0.05 mg/ml. The Broselow tape which she used to determine the dose indicated that she should have drawn into a syringe 3.3 ml of atropine, 0.1 mg/ml. RN 2 was subsequently asked to draw into syringe doses of epinephrine and sodium bicarbonate for the 17 kg patient. She used the Broselow tape to determine the dose and drew up 18.5 ml of sodium bicarbonate which was 0.5 mEq (milliequivalents)/ml for a dose of 9.25 mEq. The Broselow tape indicated that she should have drawn into the syringe 16.5 mEq or 33 ml of sodium bicarbonate.

The hospital's "Code Blue Policy and Procedure, number 18-14-01" read, "Advanced Cardiac Life Support (ACLS) certified RNs (registered nurses) may initiate Emergency Cardiac Protocols prior to arrival of physician, including defibrillation." Also, "In the event the physician is unable to respond to a Code Blue due to an emergency in the ED (Emergency Department), the ED RN will run the code until a physician arrives" and Nurse #2-RN-ACLS Certified Preferred ... Prepares and administers emergency medications per ACLS protocols until MD arrives."

Personnel records for RN 1, RN 2 and RN 13 indicated that each had an active certification for PALS (Pediatric Advanced Life Support) and ACLS.

Census records for the hospital showed the current pediatric census for in-patients was one, with an average of 1 to 4 patients per day for the previous 6 month period. The Emergency Department showed pediatric patients were seen approximately 1000 per month (approximately 30 pediatric patients per day) for the previous 6 month period. According to the EDD during this time period there were approximately 1 to 6 emergency pediatric events per month.

Immediate Jeopardy was called with the hospital Director of Patient Services on 12/20/10 at 5:05 p.m. An acceptable plan was presented to the survey team and contained the following elements: a) Pharmacy replaced all pediatric atropine carpujects (syringe and needle device) in the code carts to be consistent with the dosage used on the Broselow tape (0.1 mg/ml) - this element had a completion date of 12/20/10; b) electronic message to all affected nurses of the atropine dose change - this element had a completion date of 12/20/10; c) physicians attending pediatric emergency codes to be responsible for calculating emergency medications until all nurses are trained - this element had a completion date of 12/20/10; PALS trained nurses will be educated and trained to calculate pediatric emergency medications associated with the Broselow tape - this element had a completion date of 1/7/11. Immediate Jeopardy was lifted on 12/21/10 at 3:30 p.m. and communicated to the hospital Director of Patient Services.

2. On 12/20/10 at 11 a.m., the patient care area unit inspections binder containing pharmacists' unit inspection reports were reviewed with PHS (Pharmacy Director) and PHS 2 (Pharmacist 2). PHS said unit inspections were carried out monthly by pharmacists. Examination of activities pharmacists carried out during unit inspections included checking and removing expired and deteriorated medications, checking to ensure the presence of hospital approved and unexpired medications in emergency carts, and ensuring correct storage conditions for medications.

The California Code of Regulations (CCR), Title 22 section 70263 required "emergency drug supplies to be inspected by pharmacists every 30 days or less" (f)(3); "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" (q)(9); "drugs maintained on the nursing unit shall be inspected at least monthly by a pharmacist". These requirements by CCR were intended to ensure that patients did not receive expired, deteriorated, and improperly stored medications and that all of the unexpired medications in emergency carts were available for use when emergency medical care was needed.

Inspection records were reviewed for three patient care units for the time period between April 2010 and November 2010. The following were examples of consecutive dates patient care unit area inspections were carried out. The dates of the inspections indicated there were several months when unit inspections were not conducted.

Medical Telemetry (area of hospital to care for patients with heart problems) unit had inspections on 4/6/10, 9/15/10 and 10/29/10; there were no inspection records provided for the months of May 2010, June 2010, July 2010, August 2010, and November 2010.

The Cardiac Care Unit (specialized area of hospital that cares for seriously ill patients with heart problems) had inspections on 8/25/10, 10/21/10 and 11/17/10; no documented evidence was provided for inspections for the months of April 2010, May 2010, June 2010, and July 2010.

The Progressive Care Unit (generalized area of hospital for care of patients) had inspections on 4/6/10, 5/31/10 and 10/21/10. No documented evidence for inspections was provided for the months of June 2010. July 2010, August 2010, September 2010 and November 2010.

On 12/20/10 at 11 a.m., during an interview, PHS and PHS 2 confirmed that the required monthly inspections were missed for the above named units.

3. On 12/21/10 the discrepancy report from the automated drug dispensing machines (Omnicells) for the period between 11/20/10 through 12/20/10 was reviewed with PHS (Director of Pharmacy). The discrepancy report listed 840 discrepancies, for an average of 27 discrepancies per day.

On 12/20/10 at 11 am, during an interview, the PHS stated Omnicells were located in patient care areas throughout the hospital. The Omnicells were connected to the hospital computer system. Pharmacists reviewed prescribers' written medication orders which were scanned into the hospital computer system on patient care units by nurses and clerks. These scanned orders subsequently showed up on computers in the pharmacy. Pharmacists reviewed new medication orders for important patient safety factors which included drug-drug interactions, appropriateness of the medication, correct dose, potential medication errors, and adverse effects. Pharmacists subsequently allowed nurses to obtain medications for new orders from the Omnicells after they approved the order. The approval process was communicated to the Omnicell by pharmacists via the computer which connected the pharmacy and the Omnicells.

Discrepancies occurred when the number of doses of a particular medication in the Omnicell did not match the number which was listed in the computer. Nurses were to indicate in the computer the number of doses they were going to remove. Discrepancies could have indicated, for example, that more than one dose was removed and administered to a patient in error, drug diversion had occurred, the nurse did not correctly list the number of doses removed (that is, incorrect count) in the computer, or too few doses were removed and possibly administered to a patient in error.

On 12/20/10 11:30 a.m. the PHS stated the pharmacy staff did not follow-up to determine the disposition of discrepancies which were not controlled drugs. The PHS indicated that there were not enough personnel in the Pharmacy Department to determine the reasons for all of the discrepancies. The PHS stated pharmacy personnel followed-up on controlled drug discrepancies only and resolved them. Controlled drugs included narcotic type pain medications, sedatives and stimulants. Of the total number of discrepancies, the estimate for controlled drugs was less than 25 per cent. Review of the discrepancy list with PHS included the following additional medication types: antibiotics (medications to treat infections), diabetes medications, vaccines, iron, anticoagulants (decrease blood clotting), heart medications, and blood pressure medications. Each of these types of medications could cause adverse reactions if given in error.

4. The Omnicell discrepancy and override reports for 9/1/10 through 12/20/10 were reviewed with PHS. The report documented 9929 overrides during this period, for an average of approximately 90 overrides per day. Overrides occurred when a nurse was able to remove and administer a medication from an Omnicell for a prescriber ' s new medication order before a pharmacist had reviewed and approved the order. Examples of medication overrides listed on the report included vaccines, narcotic type pain medications, heart and blood pressure medications, intravenous solutions, diuretics (increase urine flow), sedatives, drugs affecting the birthing process (delivery of babies from mothers ), local anesthetics (pain control), paralyzing agents (muscle relaxants) and hydrocortisone type medications.

On 3:45 p.m. on 12/21/10 the PHS stated overrides should only occur in emergency type situations when the medication was needed before a pharmacist could review the new medications order.

PHS was asked to provide policies and procedures regarding Omnicell overrides on 12/20/10 at 1:20 p.m. He provided "Automated Dispensing System, number 62-3302-01" which read "... a select number of medications will be allowed in immediate or emergent situations. Medications will include narcotic analgesics, antiemetics, cardiac medications and other medications that will be mutually agreed upon, by nursing and pharmacy." The policy and procedures did not list either the patient care units or the specific drugs which were allowed on override. Overrides from Omnicells placed patients at increased risk from potentially avoidable adverse effects of medications and medication errors. This could occur as a result of administration of medications to patients before pharmacists' had reviewed the new orders to help ensure patient safety.

5. On 12/21/10 at 11 a.m., 19 preprinted medication orders were reviewed with PHS (Director of Pharmacy) and PHS 2 (Pharmacist 2). PHS and PHS 2 confirmed that 13 of the 19 nineteen preprinted orders contained instruction which were unclear and/or unambiguous. Examples of unclear instructions included:

"Rule Out Myocardial Infarction Order Set": "Sinus bradycardia with signs of decreased output, peripheral hypoperfusion, or frequent PVCs". None of the terms (sinus bradycardia, decreased output, hypoperfusion, PVCs) had parameters listed in the order set.

"Post-Cesarean Section Clinical Pathway Orders": "Mild Pain" was not defined and the terms "minimal bleeding" and "excessive bleeding" listed no parameters. This order set had "Give Methylergonovine (for bleeding after birth) 0.2 mg intramuscular one time prn (as needed for) bleeding". No explanation or parameters were set for " bleeding " .

"Argatroban Order Set": "Monitor patient for the possibility of hypersensitivity to argatroban". The order set did not identify the signs and symptoms to observe for hypersensitivity reactions. Argatroban is an anticoagulant which is used to prevent clotting and may prolong bleeding. Included in this order set, "If INR is subtherapeutic, restart argatroban and repeat the next day." The INR (International Normalized Ratio) is a laboratory test to determine how long it takes for blood clotting to occur and is used to monitor the use of some anticoagulants. The order set did not define the term "subtherapeutic".

"Gynecology Post-Op": "O2 per Nasal Cannula to maintain SpO2 at 94%." O2 was oxygen administration and SpO2 was oxygen saturation in the blood. The orders did not explain how to adjust the rate of oxygen administration to achieve an oxygen saturation of 94%.

Review of ASHP guidelines on preventing medication errors in hospitals written in American Journal of Hospital Pharmacists 1993; 50:305-14 stated under " ...Recommendation for Prescribers ...5. Care should be taken to ensure that the intent of medication orders is clear and unambiguous. Prescribers should a. Write out instructions rather than using non-standard or ambiguous abbreviations... b. Do not use vague instructions, such as ' take as directed, ' ... c. Specify exact dosage strengths ... "

Based on observation and staff interview, the hospital failed to keep all medications in a secure area and failed to limit access of medications to clearly identified health care workers. These failures increased the risk of unauthorized use and administration of medications.

Findings:

On 12/20/10 at 11:25 a.m., a medication waste container was observed in Operating Room 5 with RN 19 (Registered Nurse 19), PHS (Director of Pharmacy), and PHS 2 (Pharmacist 2) present.. The medication waste container included many partially used containers of potentially dangerous drugs including propofol (a strong sedative). The container top had an opening from which these partially used medications could be extracted. RN 19 said ancillary staff and non-licensed staff had access to the room as they cleaned up after surgery. RN 19 indicated that these ancillary and non-licensed staff should not have access to medications. She said no licensed staff who were authorized to have access to the medications were in the room at the same time during clean up.

On 12/20/10 at 1:30 p.m., PHS said the hospital did not have a policy and procedure describing which hospital staff could have access to medications in the Operating Rooms area. On 12/22/10 at 8:15 a.m., PHS said the entire hospital did not have a policy and procedures describing who could have access to medications in the facility.

Review of Patient Safety & Quality Healthcare (published by The Joint Commission) in the July-August 2008 on-line issue under "Medication Storage" stated in part "...An Element of Performance ...addresses the security of a drug between the time it is dispensed and when it is administered to the patient. Written policies must define what constitutes security and list personnel with authorized access to medications. All controlled substances must be locked and other medications stored safely, with disposition by the end of each shift. Attention should also be paid to anesthesia kits, delivery to patient care and procedural units and other areas, and processes in which medications are not immediately placed into secure storage areas after being delivered by the pharmacy."

Based on observation and administrative document review, the hospital failed to not make available outdated drugs from patient use when:

1. Expiration dates were not correctly identified and written down for medications.
2. Expired drugs were not removed from possible usage areas.

These failures increased the risk of administration of outdated medications to patients and possible avoidable adverse effects of medications.

Findings:

On 12/20/10 at 11:20 a.m., the anesthesiology cart in Operating Room 5 was inspected with PHS (Director of Pharmacy) and PHS 2 (Pharmacist 2). Two containers of Nimbex injection (muscle relaxing drug), 2 milligrams (mg)/milliliter (ml), 10 ml, were observed in the cart at room temperature. Hand written by hospital staff on the container was an expiration date of 1/14/11. However, the manufacturer's printed instructions on the container read: "refrigerate (36 - 46 degrees Fahrenheit). Upon removal from refrigeration to room temperature, use within 21 days". There were 25 days remaining from 12/20/10 to 1/14/11 and, therefore, the hospital hand written expiration dating was incorrect. The integrity of the product was not guaranteed by the manufacturer for more than 21 days outside refrigeration of 36 - 46 degrees Fahrenheit. The United States Food and Drug Administration (FDA) approved the 21 day dating which was printed on the container by the manufacturer.

The anesthesiology cart in Operating Room 5 also contained Esmolol, 100 mg/10 ml which was opened and may have previously been used but was not dated to denote with the date it was opened. On 12/20/10 at 11:25 a.m., PHS said the hospital policy was to place an expiration date of 28 days from the time of opening on opened multidose containers. Hospital policy and procedures, "Infection Control and Aseptic Technique, 62-2801-01" read, "Multiple dose vials shall be dated with expiration date when opened and discarded in 28 days."

On 12/2010 at 11:35 a.m., the portable emergency cart in the Operating Rooms area was inspected with PHS and RN 4. The expiration dating listed on the outside cover of the cart by the pharmacy was 6/1/11. However, the expiration dating placed by the pharmacy on a plastic cover enclosing most of the medications read 4/1/11.

On 12/22/10 at 8:06 a.m., two containers of chlorhexidine oral rinse (antiseptic mouth wash), which was repackaged by pharmacy personnel, was found in the pharmacy and was labeled with an expiration date of 12/5/10.

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

1. Provide organized dietetic services as evidenced by finding of significant unsafe dishware handling practices when there was a lack of an effective system to ensure the monitoring of the chemical sanitation of mulituse dishware. (Reference: A 620).

2. Ensure the availability of organized dietary services that are directed and staffed by adequate qualified personnel when the Director of Nutrition Services failed to maintain a current certification with the Dietary Manager Association. (Reference A 23).

3. Ensure the patient diets are prescribed by the physician when 2 of 4 patients (Patient 1 and 2) received diets other than as prescribed by a physician. (Reference A 629).

5. Ensure safe and effective food production practices when the main kitchen failure to ensure an infection control program was in place and when there was a failure to maintain sanitized ice machines in the hospital. (Cross Reference A 747and refer to A 749).

6. Develop performance improvement activities that reflected the scope and nature of services when identified Nutrition Services issues that were not analyzed and tracked and indicators were not identified to ensure quality assurance and performance improvement activities were established and when the sanitation of dishware was not ensured for the past 12 months. (Reference A 267 and A 276).

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

Based on observation, dietary and clinical staff interview, and administrative document review the hospital failed to ensure the Director of Nutrition Services (DNS) demonstrated responsibility for daily management of the dietary services when safe food handling practices were not implemented as evidenced by:
1. the lack of an effective system to ensure the monitoring of the sanitation of multiuse dish ware,
2. a disaster water plan that would not meet the needs of patients,
3. the lack of effective protection against cross contamination during delivery of patient meals,
4. the lack of effective cleaning/sanitation of hospital ice machines,
5. the lack of safe food storage practices,
6. the failure to maintain established policies and procedures that reflect the practices of the service,
7. the failure to maintain an ongoing Quality Assurance Performance Improvement (QAPI) program in nutritional services.

These failures placed patients at risk of developing food borne illnesses.

Findings:

1a. During the initial tour on 12/20/10 beginning at 10:30 a.m., the circular ware (type of dishware washing unit) washing machine was observed. The dish room temperature log was reviewed. The log showed temperature recordings for wash and power rinse. On 12/20/10 at 10:30 a.m., the Director Nutrition Services (DNS) stated that the dish machine had been converted approximately one year ago from a high temperature to a low temperature machine that used a chemical sanitizer. He stated that staff recorded the temperature of the wash and rinse cycles. Review of the logs showed recordings of temperatures. The DNS stated that the chemical representative did check the concentration of the sanitizer on his visit each week. There was no recording of the concentration of the sanitizer when the dish machine was operated three times per day. The standard of practice would be to record the concentration of the sanitizer each time the dish machine was operated.

The DNS confirmed that the log had not been modified to record the PPM (parts per million) of the sanitizer.

DNS stated that they did not have documentation of the concentration of the dish machine and could not verify the sanitation of the multiuse dishware including patient plates and utensils for approximately one year.

There had been no measurement of the sanitizer concentration with no assurance the multiuse dishware was sanitized before service to patients for one year.

1b. On 12/20/10 at 10:30 a.m., the circular dish washing machine was observed. The dish machine was a circular plan with the clean sanitized dishware exiting the final rinse and exposed to the drainage from the dirty dishwater and pans placed on the belt. There was white liquid with food debris including rice on the belt intermixed with the clean sanitized dishes that exited the dish machine.

The Director Nutrition Services stated that he was aware that there was the cross contamination of the sanitized dishware.

2. During the review of the disaster preparedness plan on 12/20/10 at 12:00 p.m., the food and water supply was evaluated. The hospital Emergency Operation plan showed potable water was planned for 72 hours and included bottled water that was available at materials management. The plan did not delineate the number of patients and staff included in the plan. There was no amount of water to be available for the 72 hour plan.

Assistant Vice President of Quality (AVPQ) on 12/20/10 at 12:00 p.m., confirmed the disaster plan did not specify the number of patients and staff the plan served. She stated that there was potable water in the Distinct/Part Skilled Nursing Facility (D/P SNF) building but was unable to verify how much was planned to cover the licensed capacity of the hospital and the D/P SNF. The plan identified 215 gallons of bottled water in the hospital's emergency food and water storage. She was asked what quantity of water per person per day would be planned and acknowledged that the plan did not specify.

3. On 12/21/10 at 11:45 a.m., the patient tray delivery system was observed. The hot-cold tray delivery system required the delivery cart to be plugged in and trays were delivered from the one hall plug location approximately 50 or more feet down patient hallways. Patient trays were placed on an open three shelf small cart with one shelf approximately 4 inches from the floor. The lettuce, bean salad, gelatin salad, and cake were delivered uncovered and exposed to cross contamination during the delivery distance.

Review of the policy No.700 titled Infection Control and Department Sanitation: service Standards E. " All foods being displayed, held, or transported are protected from contamination in clean refrigerators, heat maintenance equipment, or carts, appropriately covered. "

This put patient food at risk of cross contamination during delivery.

4. On 12/21/10 at 1:30 p.m., and throughout the survey, the cleaning and sanitizing of the hospital's 20 ice machines were investigated. The ice machines were located hospital wide in medical units, kitchens and cafeterias and used for patients and the public.

On 12/21/10 at 10:11 a.m., the Intensive Care Unit (ICU) pantry shoot ice machine was observed. The two clear plastic shoots had visible buildup of white substance on the inside. Staff confirmed the presence of white substance with a paper towel wiped on the inside of the tubes. The staff stated that the exterior was cleaned by dietary staff and the ice making part was maintained by facility's engineer (E1).

During the meeting with E1 on 12/21/10 at 1:30 p.m., the preventative maintenance for all hospital ice machines was reviewed. There were 20 ice machines. E1 stated the ice machines were on a preventative maintenance plan and were cleaned every six months when he washed all the parts with a nickel safe ice machine cleaner to remove the hard water build-up. He stated that "the parts were clean enough and he did not use a product to sanitize the ice machines during the scheduled preventive maintenance."

Review of the manufacturer's manuals showed specific requirements for cleaning and sanitizing the internal parts of the ice machines. They specified following the cleaning, the sanitizing procedure was to use a 5.25 percent sodium Hypochlorite solution. The E1 confirmed that the hospital was not following the manufacturer's recommendations.

5a. During the initial kitchen tour on 12/20/10 at 10:30 a.m., three gallon containers of ready-to-eat fruit were stored under raw thawing meat and on a shelf with dried red residue.

The Director Nutrition Services acknowledged on 12/20/10 at 10:30 a.m., the ready to eat food should not be stored on or below the shelves used for thawing raw meat.

On 12/20/10 at 10:30 a.m., review of the policy No 503- titled Production Control stated " Items to be thawed under refrigeration must be thawed in the following top-to-bottom order to ensure that cross contamination does not occur: Cooked and ready to eat food (top shelf) and raw foods below. "

5b. On 12/20/10 starting at 10:30 a.m., during the kitchen tour, there were approximately 6 prune juice pint cartons in the tray line reach-in refrigerator. There was no date on the cartons to indicate their thaw date or when the juice should be discarded. On 12/20/10 at 10:30 a.m., the Director Nutrition Services stated the juice was received frozen and thawed for service. He stated that the thawed juice was to be used in four days. He stated that there was no system to date the thawed juice to ensure it was used as directed by the manufacturer.

5c. On 12/21/10 at 10:11 a.m., observation of the Intensive Care Unit (ICU) pantry, showed 4 cans of Two Cal HN (nutritional product) had expiration dates of " 1 dec 2010 " There was one can Beneprotein (powder protein supplement) open with not dated when opened. The manufacturer's direction on the can stated "shelf stable for 6 months from date opened."

Registered Dietician 1 acknowledged the products should have been discarded and dated when opened.

6a. On 12/21/10 during the initial tour at 11:12 a.m., Food Service Worker 2 (FS 2) was observed at the hand washing sink. FS2 was running his hands under the running water and adding soap and rinsing hands.

Dietary Staff 1 acknowledged that FS2 was not lathering long enough when he was washing his hands.

Review of the policy No 700 titled Infection Control and Department Sanitation showed hand washing was to "8. Lather up soap ad scrub hands, wrists, and lower arms, 9. Scrub hands with soap for at least 10 seconds."

Food Service staff failed to follow policy for proper hand washing technique.

6b. On 12/21/10 at 11:30 a.m., the trayline (method used to distribute food to patients) was observed. The trayline checker was observed on 12/21/10 at 11:30 a.m., wiping the dome lids that covered the hot food with a white cloth. She stated that the domes were wet and needed to be dried before they were placed on the plate. The domes were put away and stacked wet. This provided a moist environment for the growth of microorganism after the domes finished washing and stored before service. In addition, the domes were not dried at the end of the washing cycle since the dish machine was changed to the low temperature use of a chemical sanitizer and did not generate adequate drying time for the domes.

The use of drying cloths was prohibited as a standard of practice as cited in the FDA (Food and Drug Administration) Food Code 2009. The use of a drying cloth could cross contaminate the lids.

Review of the policy No 700 titled Infection Control and Department Sanitation on 12/22/10 at 10:00 a.m., showed the "Dishes are allowed to air dry before stacking them in service area or clean dish storage area. Dishes are not stored when wet. Dishes are not towel dried."

7. On 12/22/10 at 3:00 p.m., the Director Nutrition Services and Registered Dietician 1 were asked to discuss the service of the Quality Assurance Performance Improvement (QAPI) program. They confirmed that the QAPI program did not measure, analyze or track the food safety findings which included the cross contamination of the dishwasher, no measurement of sanitizer concentration, and the failure to maintain patient food safety during distribution of foods for the past 12 months.

The QAPI program for dietary was reviewed on 12/22/10. There was an undated patient satisfaction improvements effort that reflected no dates for the past year other than "on-going" and failed to address the food safety findings.

Based on staff interview and clinical record and administrative document review the hospital failed to ensure therapeutic diets were prescribed by the practitioners for the care of 2 of 4 patients reviewed for nutrition parameters. (Patients 1 and 2).

Failure to provide the therapeutic diets as prescribed by the practitioners placed the patients at risk of receiving a diet that did not meet their nutritional needs.

Findings:

1. Patient 1's medical record was reviewed on 12/21/10 at 10:30 a.m. Patient 1 was admitted 12/5/10 with diagnoses of abdominal pain, hyponatremia, and hyperkalemia. The physician's diet order dated 12/14/10 was for a "low K+ " (low potassium) diet.

Review of the diet sheet on 12/21/10 at 10:30 a.m., showed the diet was a "renal, 2 gram sodium, 2 gram potassium, and low phosphorus diet."

RD 1 stated on 12/21/10 at 10:30 a.m., that the computer input for the diets did not include a "Low Potassium diet." The nursing unit staff would have input for the "renal, 2 gram sodium, 2 gram potassium, and low phosphorus." The diet office staff would note the "low potassium" order in the note section but the diet would be served with all of the renal restrictions including 2 gram sodium and protein restrictions. She acknowledged the computer input diet order that was served to Patient 1 was not the diet as ordered by the physician.

Review of the medical record showed no documentation that the RD or nursing staff contacted the physician to verify the diet order.

2. Patient 2's medical record was reviewed on 12/21/10 at 11:15 a.m. Patient 2 was admitted on 12/9/10 with among other diagnosis anemia and malnutrition.

A Registered Dietician (RD) assessment dated 12/11/10 stated Patient 2 was a high nutrition risk and the physician diet order was a regular with high protein shakes with meals dated 12/9/10.

A review of the RD's note dated 12/15/10, showed the diet order as a regular diet with milkshakes at 10:00 a.m., 2:00 p.m. and with meals.

Review of physician orders showed no physician order for milkshakes at 10:00 a.m. and 2:00 p.m.

On 12/21/10 at 10:00 a.m., RD 1 stated the RD would have called the diet office to add the additional supplement and not get a physician order. She stated that there were no diet manual provisions approved by the medical staff to modify a patient's diet based on established patient parameters.

The policy titled "Medical Nutrition therapy communications" stated "Physician: identifies patients at nutrition risk; effective treatment plan; writes nutrition prescription orders, i.e., diet supplements, enteral nutrition; ..."

Based on observation, staff interview, and document review, the hospital failed to ensure its infection control program was designed and implemented to prevent sources of infectious organisms when the infection control program failed to include:
1. Evaluation of safe food handling practices in the main kitchen for the prior twelve months as pertained to the circular ware washing machine and the circular dish washing machine. (Refer to A 749)
2. Maintaining 20 - 25 sanitized hospital ice machines according to the manufacturer's recommendations for the past six months. (Refer to A 749)

The cumulative effect of these systemic problems resulted in the hospitals inability to ensure a safe and sanitary environment and put ill and medically compromised patients at risk of cross contamination and food borne illness.

Based on observation, staff interview, and administrative document review, the hospital failed to ensure the infection control officer developed a system for identifying potential food borne illnesses in the dietary department when:

1. 20 - 25 ice machines were not cleaned and sanitized according to the manufacturer's recommendations and were not cleaned according to the policies approved by the infection control committee oversight.

2. The hospital failed to ensure the dishwashing equipment sanitized the multiuse patient wares and the circular dish machine operated in a manner to intermix dirty rinse water with food particles onto clean dishware.

These failures placed patients at risk for food borne illnesses.

Findings:

1. On 12/21/10 at 10:11 a.m., and throughout the survey, the cleaning and sanitizing of the hospital's 20- 25 ice machines were investigated. The ice machines were located hospital wide in medical units, kitchens and cafeterias and used for patients and the public. The ICU pantry shoot ice machine was observed. The two clear plastic shoots had visible buildup of white substance on inside. Staff confirmed the presence of white substance with a paper towel wiped on the inside of the tubes. The staff stated that the exterior was cleaned by dietary staff and the ice making part was maintained by facilities.

During the meeting with Engineer 1(E1) on 12/21/10 at 1:30 p.m., the preventative maintenance for all hospital ice machines was reviewed. There were 20 - 25 ice machines. E1 stated the ice machines were on a preventative maintenance plan and were cleaned every six months when he washed all the parts with a nickel safe ice machine cleaner to remove the hard water build-up. He stated that "the parts were clean enough and he did not use a product to sanitize the ice machines during the scheduled preventive maintenance."

Review of the manufacturer's manuals showed specific requirements for cleaning and sanitizing the internal parts of the ice machines. They specified following the cleaning, the sanitizing procedure was to use a 5.25 percent sodium Hypochlorite solution. The E1 confirmed that the hospital was not following the manufacturer's recommendations.

2. During the initial tour on 12/20/10 beginning at 10:30 a.m., the circular ware washing machine was observed. The dish room temperature log was reviewed. The log showed temperature recording for wash and power rinse. The Director of Nutrition Services (DNS) stated that the dish machine had been converted approximately one year ago from a high temperature to a low temperature machine that used a chemical sanitizer. He stated that staff recorded the temperature of the wash and rinse cycles. Review of the logs showed recording of temperatures. The DNS stated that the chemical representative did check the concentration of the sanitizer on his visit each week. There was no recording of the concentration of the sanitizer when the dish machine was operated three times per day that would be the standard of practice.

The DNS confirmed that the log had not been modified to record the PPM (parts per million) of the sanitizer.

DNS stated that they did not have documentation of the concentration of the dish machine and could not verify the sanitation of the multiuse dishware including patient plates and utensils for approximately one year.

There had been no measurement of the sanitizer concentration with no assurance the multiuse dishware was sanitized before service to patient.

3. In addition, during the initial tour on 12/20/10 beginning at 10:30 a.m., the circular ware washing machine was observed. The dish machine was a circular plan with the clean sanitized dishware exiting the final rinse and exposed to the drainage from the dirty dishwater and pans placed on the belt. There was white liquid with food debris including rice on the belt with the clean sanitized dishes exited the dish machine.

On 12/20/10 at 10:30 a.m., the Director of Nutrition Services (DNS) stated that the staff had placed the dirty pans on the dish belt with liquid and food debris in them and this was the white liquid and food debris observed. The DNS stated that he was aware that there was cross contamination of the sanitized dishware.

4. On 12/21/10 at 2:20 p.m., the infection control preventionist was interviewed regarding the infection control oversight of the nutrition department. She stated that the Department policies were developed with the Title 22 regulations and she did informal rounds in the kitchen about once a year but there was no documentation or formal procedures to ensure the hospital maintained a sanitary environment which included review of the ice machine cleaning and sanitizing practices. She stated that she was aware of the cross contamination potential of the circular dishwashing machine but had not overseen the implementation of preventative measurements while a new machine was purchased.

5. Review of the infection control program (No.34-01-01) on 12/21/10 showed the program was to provide an effective hospital wide program for the surveillance, prevention and control of infections. There was no specific plan that addressed the techniques for food sanitation included in the infection control policy.