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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 hospital failed to identify poor infection control practices in the kitchen which placed patients at risk of food borne illness and cross contamination.

Findings:

On 6/4/12 beginning at 0930 hours, it was determined that the Food Services Manager had not 1) identified, developed or implemented a comprehensive monitoring system to ensure that previously cooked/prepared potentially hazardous foods were handled in a safe and effective manner to minimize the risk of food borne illness; 2) identified, developed or implemented a monitoring system to ensure time/temperature control of foods in the cafeteria; 3) prepared and/or stored food in a sanitary manner; 4) ensured effective sanitation of surfaces and food production equipment (Cross Reference A749, Findings 1-6), and 5) developed a comprehensive performance improvement program for the food services department that effectively addressed operational procedures surrounding safe food handling practices.

On 6/6/12 beginning at 1330 hours, the Chief Executive Officer, members of the hospital's performance improvement committee and governing body were interviewed. The surveyor asked how the hospital ensured dietetic services were delivered in a safe and effective manner. The Director of Quality stated reports that were submitted by the department would regularly be reviewed by the committee. In an interview on 6/7/12 beginning at 1100 hours with the Food Service Manager (FSM), the food service department's performance improvement activities were reviewed. It was noted that while the food service department developed indicators such as taking tray line temperatures, for performance improvement, the indicators were consistently at 100% during the previous 12 months. There was no indication the hospital effectively evaluated the safety of food services relative to the scope of the department.

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

Findings:

During the survey from 6/4-6/7/12 deficient practices related to 1) safe and sanitary food services operations (Cross Reference A749), and 2) ensuring patient nutritional needs were met (Cross Reference A630) were identified.

In an interview on 6/6/12 beginning at 1330 hours with the hospital's performance improvement committee, the surveyor asked how the hospital ensured that performance improvement activities reflected the depth and scope of services being provided. In particular, those related to dietetic services. The Director of Quality stated reports submitted by the department would regularly be reviewed by the committee. In an interview on 6/7/12 beginning at 1100 hours, with the Food Service Manager (FSM) and the Clinical Operations Manager (COM), they presented their performance improvement activities. It was noted that while the food service department developed indicators such as taking tray line temperatures, for performance improvement, the indicators were consistently at 100% during the previous 12 months. The FSM also acknowledged that at this time, the food service department's activities did not show opportunities for improvement, rather were primarily monitoring activities.

It was also noted there was no performance improvement activities related to the hospital's food production operational procedures. In particular, activities related to food safety and/or sanitation. There was no indication these departments identified that the information submitted by Food and Nutrition Services did not systematically identify opportunities for improvement, rather reflected monitoring of elements that demonstrated a satisfactory level of performance.

Based on medical record review, nursing, Registered Dietitian and administrative staff interview, the facility failed to ensure the development of comprehensive nutrition care plans for three of three patients (Patients 50, 51 and 52) who were seen by a Dietetic Technician, Registered, and were identified through the nutrition screening process to be at moderate nutritional risk. Failure to develop interdisciplinary care plans related to nutritional risk may result in lack of implementation of identified nutrition interventions further compromising the medical and nutritional status of at-risk patients.

Findings:

1. Dietetic Technicians, Registered (DTR) are paraprofessional staff members, who under the direct supervision of a Registered Dietitian, may assist in the implementation or monitoring of medical nutrition therapy.

During patient medical record review, it was noted that for three of three patients (Patients 50, 51, and 52) seen by the Dietetic Technician, Registered (DTR), there was no development of nutrition care plans for these patients who were identified to be at moderate nutritional risk.

a. Patient 50 was admitted with pelvic pain and an unstageable pressure ulcer as well as complaints of nausea and vomiting. The DTR noted that the patient was consuming 40-100% of her meals and she needed help in eating because she did not have much control over hand/arm movements. There was no development of a nutrition care plan despite identified issues with decreased intake and difficulty in eating.

In an interview on 6/5/12 beginning at 1030 hours with the Clinical Operations Manager (COM), she stated it would not be within the scope of practice of the DTR to develop care plans as this would require the ability to assess patients. She also stated the RD's did not review the work of the DTR unless they were prompted to do so, nor would they come back through and develop care plans for those patients unless prompted to do so. The COM also stated that the RD's did not review the DTR's work to determine whether or not a care plan was necessary.

In a concurrent interview with RN 20, she stated that nursing services would rely on clinical nutrition care staff to develop patient care plans related to identified nutrition risks. The RN stated it would be unlikely the nursing staff would routinely develop specific measurable care plans based on dietary interventions. She also stated during the nursing admission assessment, the admitting nurse would select a standardized primary care plan based on admission diagnosis. RN 20 also stated there was the ability to add additional standardized care plans based on need that could also be modified to better fit individual patient needs.

b. Patient 52 was admitted with a diagnosis of a hip fracture. A monitoring visit completed by the DTR revealed the patient had poor dietary intake and would like to try milk shakes in an effort to increase caloric intake. While there were care plans developed for his orthopedic injury, intravenous lines, and medication reconciliation among others, there was no developed care plan for the patient's poor dietary intake, or an evaluation of the effectiveness of nutrition interventions.

c. Patient 51 who was admitted following a fall, with additional admission diagnoses of diabetes and high blood pressure, was also identified at moderate nutritional risk. The patient's intake was identified as being fair; however, there was no development of a nutritional care plan relevant to the patient being identified at moderate nutritional risk.

In an interview on 6/5/12 at 1100 hours with the CNM, she stated she was told by the quality standards committee it was not necessary to develop patient care plans for patients at moderate nutritional risk. In an interview on 6/7/12 at 1000 hours with the Director of Quality, she stated that information was not accurate. The hospital expected all patients identified with care planning needs receive a comprehensive care plan, including those at moderate nutritional risk, resulting in ineffective oversight by the Registered Dietitians who provided the direct supervision of the paraprofessional.

Hospital position description titled "Clinical Dietitian Senior" dated 8/08 noted it was the responsibility of the Registered Dietitian (RD) to "Develop MNT [medical nutrition therapy] Plan of Care in collaboration with other healthcare professionals..." indicating that since the RD was the responsible party for the immediate supervision of the DTR (California Business and Professions Code §2586(d)(1) the responsibility of care planning would be the responsibility of the RD. It was also noted the RD position description did not include the responsibility of DTR supervision as part of daily duties.

Based on observation and interview the hospital failed to ensure appropriate staff were advised regarding the shortage of a medication for the emergency crash carts, a policy and procedure was developed regarding steps to be taken related to the medication shortage, and medications and biologicals were stored per manufacturers' recommendations to ensure safe patient care. This could potentially result in emergency medications not being available when needed.

Findings:

1. During observation of the Rehabilitations Unit's emergency crash cart on
6/4/12 at 1500 hours, a notification was found taped to the outside of the emergency medication kit in the crash carts showing Procainamide (used to treat irregular heart rhythms) was not available in the medication kits. The note read "Procainamide short...please call Rx at 3950 when needed." The medication list for the emergency medication kit showed it was to contain three Procainamide 100 mg/10 ml vials.

During an interview with Pharmacist 2 on 6/7/12 at 1400 hours, he stated there was a shortage of the drug Procainamide, shipments were sporadic, the supply was unpredictable, and when the medications were received, they expired soon after receipt. When asked if the nurses and physicians were made aware of the shortage he stated "no." He also stated the staff were told the Procainamide was not in the supply kits due to the shortage when they came to the pharmacy to pick up new supply kits for the crash carts. He also acknowledged this information was not discussed by the Pharmacy and Therapeutics or Medication committees, and a P&P had not been developed to cover what actions would be taken until the availability of this medication became stable. Pharmacist 2 stated the hospital did have Procainamide vials kept in the medication containers taken to each code by a Pharmacist.

2. During observation of the outpatient endoscopy unit on 6/4/12, the temperature logs for the medication refrigerator showed entries for April and May that were not in the required temperature range for medications of 36 to 46 degrees F (Fahrenheit). The log for April showed on April 1, the temperature was 47 degrees. On April 21 and 22 the log showed temperatures of 36 and 47 degrees F with no documentation to show which temperature was correct. On May 4, 6, 11, 12, 19, 20, 26, 27, 28, and 30, the documented temperatures were from 47 to 52 degrees F. The action plan area on the temperature logs showed the only action plan done related to the out of range temperatures was on 5/30/12. The action plan was to adjust the temperature.

On 6/5/12 at 1415 hours, a follow-up visit and interview was done with RN 4 regarding the temperature logs. RN 4 stated the outpatient unit was not connected to the hospital's central refrigerator monitoring. The outpatient facility was responsible for checking and recording the temperatures on a daily basis. The outpatient facility was only open five days a week. When asked how the refrigerator temperatures were recorded for the weekends, RN 4 showed how the electronic thermometer memory could be accessed to show the temperatures for Saturday and Sunday. The temperature documentation was discussed with RN 4. The logs showed dots and check marks were used, and some entries had more than one entry with no documentation to show which temperature was correct. RN 4 stated she was aware of these issues and was working to correct them.

3. On 6/5/12 at 1415 hours, it was also observed the endoscopy unit had a laboratory refrigerator containing two different biologicals (test kits). The packaging of the biologicals showed they were to be refrigerated at a temperature range of 36 to 46 degrees F. When asked to see the temperature logs for the laboratory refrigerator, RN 4 stated they did not record the temperatures for this refrigerator. When asked how they could ensure the biologicals were maintained per the manufacturers' temperature recommendations, there was no response.

Based on observation, record review and staff interview, the hospital failed to update the list of medications in the code box contained in two of 10 crash carts checked. Failure to keep accurate and current records of medications can potentialy result in an inability to detect drug loss and/or diversion.

Findings:

On 6/4/12 at 1030 hours, during the initial ICU tour conducted with the ICU Director, the two crash carts in ICU were inspected.

The list of medications hanging on top of the crash cart was reviewed against the medication contents of the pharmacy code box. The Adenosine (medication to slow down fast heart rates) in the IV form of 6mg/2ml was listed as three vials while the code box contained 6 vials. The Amiodarone (medication to regulate irregular heart beats) in the IV form of 150mg/vial was listed as five vials but the code box contained only three vials. The Amiodarone IV in the form of 450mg/vial was listed as three vials but the code box contained only two vials. Further review of the list showed Vasopressin (medication to increase heart rate and blood pressure) was listed as six vials but the code box contained only two vials.

On 6/4/12 at 1100 hours, the ICU Director acknowledged the list of medications on the crash carts was not updated. She stated the code box were replaced by pharmacy each time the box was opened. The nurses were not required to verify the correct number of vials in the code box anymore but understood the pharmacist's accountability with regard to the accurate number of medications in every unit.

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

1. Provide organized dietetic services as evidenced by findings of unsafe food handling practices and supervision of the dietary department. Cross Reference A620, A749.

2. Ensure the nutritional needs of patients were met as evidenced by the lack of a comprehensive nutritional analysis of regular and therapeutic menus. Cross Reference A630.

3. Develop performance improvement activities that reflected the scope and nature of the services, and identified opportunities for improvement. Cross Reference A267.

4. Ensure safe and effective food storage/production practices. Cross Reference A749.

5. Ensure the Registered Dietitian position description reflected supervisory responsibility for the paraprofessional Dietetic Technicians, Registered as outlined in California Business and Professions Code. Cross Reference A167.

The cumulative effect of these systemic problems resulted in the inability of the hospital's food and nutrition services to direct and staff in a manner to ensure the nutritional needs of the patients' were met in accordance with practitioners' orders and acceptable standards of practice. The system problems resulted in the hospital's inability to meet the Condition of Participation for Food and Dietetic Services.

Based on food storage and food production observations, dietary staff interview and dietary document review, the hospital failed to ensure the Food and Dietetic Service Manager effectively developed written procedures, according to standards of practice for operational processes. Failure to develop standardized procedures may result in patients being exposed to foodborne illness and cross contamination which may further compromise medical status.

Findings:

1. During several interviews with the Food Service Manager (FSM) from 6/4-6/7/12, observations were made that reflected lack of oversight of food service operations. During the interviews conducted with the FSM, she indicated that while she bore the ultimate responsibility of food service operations, she managed the day to day food service operations through the use of the Chef and front line supervisors. She also stated that she was responsible for coordinating and scheduling meetings for other departments as well as accounting functions within the department.

The FSM was not aware that, although there was the development of a cool down monitoring procedure, the staff were not consistently implementing the system, and were not following the proper cooling methods to ensure food was prepared in a safe manner. Food storage and production activities revealed deficient practices that were not identified prior to the survey; for example, storing raw meat in direct proximity to ready to eat foods.

Although her background is a Registered Dietitian, the quality improvement indicators selected for review did not seem to be those that reflected issues of the department (Cross Reference A749). There was no development of a comprehensive nutritional analysis for the standardized diets within the hospital resulting in the inability to assess whether menus met not only the nutritional needs of patients, but whether or not the therapeutic diets were prepared within the parameters of the physician ordered diets.

The personnel record of the Food Service Director was reviewed. There was no documented evidence that her performance as a director was evaluated since 2005.

2. Random review of selected departmental policies and procedures related to identified deficient practices in dietetic services showed policies did not consistently provide sufficient procedural guidance that reflected current standards of practice, or the department had not developed procedural guidance for all functions.

In an interview with the FSM on 6/4/12 beginning at 0900 hours, she acknowledged the scope of the department would include a wide array of processes, and not all food handling functions were written as procedures:

2a. There was no procedure that provided comprehensive guidance to staff on the proper washing of produce.
2b. There was no policy that reflected the safe cool down of potentially hazardous foods, or a guidance relative to the hospital's menus that identified foods that would be considered capable of supporting bacterial growth associated with foodborne illness.
2c. There was no development of an effective system for time/temperature control of potentially hazardous foods in the cafeteria.
2d. There was no procedure on the proper cleaning of the milkshake machine.
2e. The hospital policy titled "Food Tempering" dated 11/2011 noted the guidance for thawing meat under running water did not fully reflect acceptable standards of practice (Food Code, 2009).
2f. The undated hospital policy titled "Infection Control and Prevention of Food contamination Policies" provided general guidance such as "all ware and food contact surfaces are cleaned and sanitized for use ..." however; there was no procedural guidance on how that would be accomplished. While the document provided a comprehensive overview of processes within the department, procedural guidance was not consistently developed.
2g. There was no procedure on the proper calibration of food thermometers.

3. In an interview with the FSM on 6/7/12 beginning at 1100 hours, and concurrent review of performance indicators beginning in 2011, revealed the dietary department was submitting data on multiple processes within the department (Cross Reference A267). The FSM acknowledged that all of the indicators the department was meeting departmental set thresholds. She also stated within the last several years the department had not identified new issues that may warrant a performance improvement study. It was also noted that while the department was monitoring some food services performance indicators, there was no evaluation of safe food handling systems within the department.

4. During initial tour on 6/4/12 beginning at 0930 hours, it was noted in the walk-in refrigerator across from the loading dock there were 4-1/2 cases of bread and bagels. The thermometer in the refrigerator read 38°F. On the outside of the box the manufacturer's guidance was to "keep frozen." In a concurrent interview with the FSM, she stated that dietary staff routinely stored bread in the refrigerator primarily due to lack of space. Bread quickly becomes stale at refrigerated temperatures of 41°F or below (Federation of Bakers).

Based on tray line observations and dietary staff interview, the hospital failed to ensure the competency of the staff member responsible for taking food temperatures as evidenced by the inability to accurately calibrate food thermometers. Failure to ensure staff competency in this task may result in foods being cooked and/or held at temperatures that support the bacterial growth associated with foodborne illness. Foodborne illness may result in nausea, vomiting and in severe instances in death.

Findings:

On 6/4/12 beginning at 1115 hours, DS (Dietary Staff) 6 was observed taking food temperatures in preparation of the noon tray line. It was noted there was a 20°F difference between the hospital's and surveyor's thermometers. Upon completion of the task, the surveyor requested DS 6 demonstrate the procedure for thermometer calibration. DS 6 obtained a glass of water and ice. It was noted the glass contained approximately 1/3 ice and the remainder was water. Upon thermometer stabilization, DS 6 adjusted the thermometer to 32°F. The standard of practice would be to ensure the ice/water mixture had enough ice to ensure a slushy mixture (University of Nebraska-Cooperative Extension, 2005).

In a concurrent interview, the FSM stated to her knowledge there was not a written procedure for thermometer calibration. Review of the hospital's employee in-service training beginning 6/2011 failed to note any employee training on thermometer calibration.

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

Findings:

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

On 6/6/12 at 0900 hours, the hospital's nutrient analysis for the hospital diets was reviewed. The analysis provided was limited to the regular diet. The analysis consisted of calories, fat, protein cholesterol and sodium. There was no analysis that included daily nutrients, fiber, vitamins or minerals that are specified in the RDA or DRI. There was no analysis of any of the hospital's therapeutic diets.

In a concurrent interview, the FSM stated she had evaluated the menus for calories, protein, fat, cholesterol and sodium. She also acknowledged that in light of the limited analysis it would not be possible to ensure the hospital's developed menus met patient nutritional needs or be possible to ensure the therapeutic menus offered to patients were consistent with the physician ordered diets.

Review on 6/7/12 at 0800 hours, of the department's electronic policy and procedure manual failed to include information related to menu planning. In a follow up interview with the FSM on 6/7/12 at 1300 hours, she confirmed that all of the hospital's policies were electronic and there was none related to ensuring comprehensive evaluation of the nutritional adequacy of patient menus. The menus used were not evaluated to assess whether the menus met the required nutrients or were deficient in nutrients.

2. During tray line observation on 6/4/12 beginning at 1145 hours, it was noted that two patients requested grilled cheese sandwiches as the entrée for the noon meal. The surveyor observed that while the sandwich contained melted cheese it was estimated to be a 1-1.5 ounce serving. In a concurrent interview with the FSM, she stated the noon entrée contained 3 ounces of protein. In a follow up observation on 6/4/12 at 1215 hours, with DS 7, who was preparing additional grilled cheese sandwiches, he stated he put 2 slices of cheese per sandwich. In a review on 6/4/12 at 1330 hours, of the product used, it was noted the 2 slices equaled 1.3 ounces of protein rather than the required 3 ounces. Review of the nutritional analysis document titled "Grilled Cheese Sandwich" dated 3/28/12 revealed the noon entrée consisted of 10 grams of protein in relationship to a 3 ounce protein portion that would be 21 grams.

Based on food storage observations, dietary staff interview and dietary document review, the hospital failed to ensure the comprehensive development of an inventory and established minimum levels of food items to be used in the event of disaster. Failure to develop a system to ensure adequate foods are available in the event of a disaster may result in inadequate food supplies, compromising the medical status of patients and the staffs' ability to care for the patients due to lack of nutrition.

Findings:

On 6/4/12 beginning at 1515 hours, the hospital's disaster preparedness plan for meal service was reviewed with the FSM. It was noted the hospital had an area that contained 7 cases of entrees such as beef stew in addition to apple sauce and tuna. The FSM also stated the hospital would utilize regularly stored food in the event of a disaster. On 6/5/12 beginning at 0910 hours, in the presence of the Director of the Emergency Operations Center (EOC), she stated that the hospital's plan was to feed a total of 1250 people. Concurrent document review of the prepared disaster supply noted an inventory based on an average daily census of 200 patients, rather than the licensed bed count of 335. The current patient census was also concurrently reviewed. It was noted that approximately 25 percent of the inpatient census were not receiving meal trays, rather were on enteral feeding, which would, at full census, equates to 250 patients receiving meal trays. It was also noted the department did not have a comprehensive par level inventory established that ensured availability adequate food supplies available.

Based on observation, interview, and document review, the hospital failed to maintain the walls of the operating rooms (ORs) to a level that would ensure an acceptable level of safety and quality. Five of the eleven "in use" ORs had holes (full penetration of the inner layer) in the walls from removal/renovation of the emergency lighting. This resulted in the possibility of particles, such as dust, building materials, etc. and micro-organisms such as mold being released into the OR environment. Additionally, a thermometer, last checked and approved by a biomedical engineer on 4/11/12, was found available for patient use in Unit 2-West medication room. The failure to periodically maintain equipment could potentiate inaccurate temperature readings.

Findings:

1. A selected OR case was observed (Patient 28) in OR 8 on 06/05/12 at 1100 hours. This case was a total hip replacement done using laminar air flow. It was noted there was a hole in the OR wall to the right of the entry door (as viewed from inside the OR) which was close to the top of the wall. The hole was through the full thickness of the interior wall board and was about 1 inch in size. There were three wires of different colors protruding from the hole.

The Director of Surgical Services was interviewed 06/05/12 at 1400 hours. She stated the old emergency lights were removed from the ORs and an order put in to Environmental Services to patch the holes left behind. She was unaware that the patching was still not completed approximately two months later at the time the survey was performed.

The Vice President of Facilities was interviewed on 06/06/12 at 1330 hours. He stated the engineering department did not follow through in a timely fashion and that the surgery staff were also partially responsible for not reporting the delay in having all of the holes repaired.

The Infection Control Director was interviewed on 06/06/12 at 1440 hours. She explained that before engineering started the work of removing the emergency lighting from the ORs, they should have filed for an Infection Control Permit. That would have allowed Infection Control Staff to be aware of the work being done and have input as to any infection control issues regarding the work. Since the correct paperwork was not forwarded to Infection Control, she was unaware of the holes or of the work itself being done.

An email document printout entitled "Holes in ceiling from removal of emergency lights," dated 06/05/12 was provided. It listed all 11 ORs currently in use. Two rooms (10 & 11) had no holes. Three rooms had the holes patched (3, 4 and 6). Five rooms had unpatched holes (1, 2, 5, 7, 8 and 9). The remaining holes were patched during the following 24 hours.


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2. On 6/5/12 at 1000 hours, during the initial tour of Unit 2-West accompanied by the Nurse Manager, a thermometer ready for patient use to take temperatures orally, axillary and rectally, was found in the medication room. The biomed sticker stated the thermometer was last checked by a biomedical engineer on 4/11/12. When shown to the Nurse Manager, she took the thermometer away and stated it should not be available for patient use. The hospital issued new thermometers for use.

Based on observation, interview and document review, the hospital failed to provide a sanitary environment as evidence by a failure to:

1. Provide organized dietetic services as evidenced by findings of unsafe food handling practices and supervision of the dietary department. Cross Reference A 620, A749.

2. Ensure safe and effective food storage/production practices. Cross Reference A749.

3. Ensure Infection Control Personnel were aware when emergency lighting was removed from 11 ORs which resulted in a failure of IC personnel to follow the progress of the work and provide oversight to ensure that it was completed in a safe and expeditious manner. Cross Reference A 724, A749.

4. Ensure the dilution of an enzymatic agent followed the manufacturer's instruction. Cross Reference A749, A951.

5. Develop and implement routine maintenance service for sterilizers in the surgical services area and sterilization area. Cross Reference A749, A951.

6. Ensure hand hygiene was performed after a procedure observed. Cross Reference A749, A951.

7. Ensure droplet/contact isolation was maintained. Cross Reference A749.

8. Ensure IV sites/Tube Feedings were dated and timed. Cross Reference A749.

The cumulative effect of these systemic problems resulted in the inability of the hospital to ensure care was provided in a manner that met professional standards and prevented the spread of infection. The system problems resulted in the hospital's inability to meet the Condition of Participation for Infection Control.

Based on observations, staff interview and document review, the hospital failed to ensure the infection control officer provided effective infection control oversight:

In food services when the dietary staff failed to:

1. Develop a comprehensive system to ensure cool down monitoring of potentially hazardous foods.

2. Ensure an effective time/temperature monitoring system for potentially hazardous foods.

3. Ensure effective sanitation of the hospital's ice machines.

4. Ensure proper washing of lettuce.

5. Install an air gap in one food production sink.

6. Store foods in a manner that prevented cross contamination.

7. Ensure effective sanitation of the milkshake machine.

8. Ensure continuous effective sanitation of food production surfaces.

9. Replace cutting boards that were heavily cut and scored.

In other service areas the hospital failed to:

10. Ensure follow up of 2 of 10 random employee TB tests.

In the OR the hospital failed to:

11. Ensure the engineering department complied with the requirement to report to the Infection Control Department all work being done in patient care areas.

12. Ensure the dilution of the enzymatic agent followed the manufacturer's instruction.

13. Develop and implement routine maintenance service for sterilizers in the surgical services area and sterilization area.

14. Ensure hand hygiene was performed by an MD in one of four procedures observed (MD 1)

On the nursing units the hospital failed to:

15. Ensure droplet/contact isolation was maintained for two of two droplet isolation patients observed (Patients 92 and 7)

16. Ensure an IV site was dated and timed for one of five IV sites observed and a tube feeding was timed and dated for one (unsampled patient) of three tube feedings observed.

17. Ensure the nursing unit sinks were clean.

18. Ensure used patient supplies were discarded in appropriate containers.

These failures could potentially develop, transmit and spread hospital acquired infections.

Findings:

1. Potentially Hazardous Foods (PHF's) are foods capable of supporting bacterial growth associated with foodborne illness. Safe food handling practices would ensure that time/temperature control parameters were maintained during preparation and storage of PHF's. Meats, soups and grains are classified as PHF's. PHF's that are cooked must be cooled to 70°F within 2 hours and to below 41°F within an additional 4 hours. PHF's that are prepared from ambient room temperature, such as tuna salad, must be cooled to 41°F or below within 4 hours (Food Code, 2009).


During initial tour on 6/4/12 beginning at 0930 hours, it was noted in the walk-in refrigerator there were multiple pans of cooked macaroni and cheese as well as meatloaf. There was also previously cooked pasta, vegetable soup and tuna salad. In a concurrent interview with the FSM, she stated the staff did batch cooking, and did not prepare items on a daily basis, rather prepared menu items 2-3 times/week depending on patient census. All of the observed items were prepared after 6/1/12.

In an interview on 6/4/12 with DS 2 at 1030 hours, he was asked to describe the system for ensuring food safety of the PHF's that were prepared and held for later use. He stated that once items were cooked they would be cooled, during which food temperatures were monitored. Concurrent review of the cool down log revealed there were no monitoring entries for the month of June 2012. Additionally, it was noted the only food items that were monitored were meats. The cool down log did not include time/temperature control monitoring for all PHF's that were prepared. It was also noted for each of the monthly logs, beginning January 2012, there were 6-7 monitoring sheets. The standardized document titled "HACCP Cooling & Reheating Chart" had pre-filled food items that consisted only of meat items. It was also noted, while the document had an area to record the time that the cool down process was started, dietary staff were filling in the food temperature rather than the time.

In a concurrent interview with the FSM, she stated she checked the logs on an intermittent basis. She also stated that if PHF's were cooked every 2-3 days one would expect there would be an average of 12-15 logs on a monthly basis. The FSM acknowledged that dietary staff was not monitoring all PHF's for time/temperature control for food safety.

In an interview on 6/6/12 beginning at 1435 hours with the Infection Control Practitioner (ICP), she was asked to describe how she ensured safe food handling practices. She stated that on a yearly basis the department received an environment of care (EOC) rounds that were conducted by a team that included herself, the Director of Environmental Services, security, and engineering among others. She also stated the team would rely on herself, as the infection control specialist, to identify food safety issues. Review of the EOC rounds on 6/6/12 at 1600 hours, revealed the rounds were limited to assessing safety and security management, life safety, utility and hazardous materials management. There was no documentation of food safety practices.

2a. The standard of practice for cold food holding temperatures are defined as below 41°F (Food Code, 2009). During observation of food production practices on 6/4/12 at 1030 hours, DS 8 was observed mixing Quinoa (a cooked grain product) as the primary ingredient in a salad. During review of food holding practices, in the presence of the FSM, on 6/4/12 beginning at 1425 hours in the cafeteria, the temperature of the Quinoa was 55°F. It was also noted there was a container of tuna that was 43°F. In a previous interview on 6/4/12 at 1030 hours with DS 2, it was determined the facility did not effectively monitor the cool down of all Potentially Hazardous Foods (PHF's-Cross Reference A749, Finding 1). It was also noted, that despite identification the PHF was not monitored for cool down and that the temperature the product was within the food danger zone, the product was not removed from service.

b. To minimize the potential for bacterial growth associated with foodborne illness the standard of practice would be to ensure monitoring of food temperatures over time for food safety. The standard of practice would be to ensure cold foods were held at 41°F or below (Food Code 2009).

During review of food holding practices on 6/4/12 at 1440 hours at the salad bar, the following temperatures were noted: egg salad-47°F; tomatoes-44°F and hard boiled eggs-46°F. In a concurrent interview with the FSM, she was asked to describe the system for monitoring the temperatures of foods while in service. She stated the only time either hot or cold food temperatures were taken was during set up at the beginning of the meal service, which in the case of the salad bar, would be at approximately 1030 hours. There was no temperature monitoring over time. She also stated there was no system to identify how long particular foods were in service or a way to know how long the PHF temperatures were above 41°F.

3. On 6/4/12 beginning at 1050 hours preventive maintenance of the hospital's ice machines was reviewed with ES 2. He stated the preventative maintenance included the flushing of the ice producing mechanism with an ice machine cleaner. He also stated that this was the only chemical that was flushed through the system. Review of the manufacturers' recommendations for the various ice machine brands revealed that in addition to flushing the system with an ice machine cleaner there should also have been the addition of a sanitation step that included a bleach solution with a temperature of 120°F. ES 2 acknowledged that the ice producing mechanism of the machine was currently not being sanitized per manufacturers' recommendations, and he used the same process for all ice machines. Review of undated hospital document titled "Count of Assets by Asset Type" revealed there were 42 ice machines in the hospital.

4. During initial tour on 6/4/12 beginning at 0930 hours, DS 1 was observed preparing lettuce. In a concurrent interview, DS 1 stated the lettuce was cut and placed it in the sink after which it would be rinsed. She also stated this was the usual process. In an interview on 6/4/12 at 1600 hours with the Food Service Manager (FSM), she acknowledged this was the normal process. In a follow up interview on 6/7/12 at 1030 hours, the FSM stated after reviewing standards of practice the lettuce should be washed prior to cutting.

5. During initial tour on 6/4/12 beginning at 0930 hours, it was noted the food production sink near the dry storage area did not have an air gap. In an interview on 6/4/12 with Engineering Staff (ES) 1, he acknowledged there was no air gap. The standard of practice would be to ensure an installation of an air gap between the water supply inlet and the flood level rim of the equipment (Food Code, 2009).

6. During initial tour on 6/4/12 beginning at 0930 hours in the walk-in refrigerator across from the cook's area, it was noted that dietary staff was storing raw fish directly next to cooked chicken. Similarly, in the walk-in refrigerator across from the loading dock, dietary staff was storing raw bacon next to cooked deli meats. In a concurrent interview with the FSM, she stated this was the usual practice. She stated she felt that would be acceptable since the raw and cooked products were next to each other, rather than the raw being stored above the cooked products. It would be the standard of practice to ensure foods would be protected from cross contamination by separating raw animal foods during storage from ready to eat food.

7. During review of dietary equipment cleaning on 6/6/12 beginning at 1600 hours, DS 3 described daily terminal cleaning for the milkshake machine. She described a process that included flushing of the unit with soap and water and rinsing with a sanitizer. She also stated the removal parts would be removed and washed in the food production sink. There was no sanitation step for the removal parts. The standard of practice would be to ensure that all food equipment contact surfaces would be sanitized after cleaning (Food Code, 2009).

8. On 6/6/12 beginning at 1610 hours, a review of surface sanitation procedures was conducted. In an interview with DS 4 he described a process that included utilizing a chemical sanitizer. DS 4 demonstrated the testing of quaternary ammonia strength (the sanitizing chemical) using the bucket located in the cook's area. There was no reaction of the test strip which indicated an inadequate chemical strength. DS 4 stated the acceptable range of chemical would be 200-400 parts per million.

In a concurrent interview with DS 5, a cook, he stated he started his shift at 1030 hours. He further stated the morning cook usually filled the bucket with the chemical, which was the bucket he would use throughout his shift which ended at 1900 hours. In a concurrent interview with the FSM, she stated the procedure would be to change out the sanitizer every 2 hours. She further stated while that was the desired procedure, there was no written policy to support that, or was there a mechanism in place to ensure the sanitizer was changed every 2 hours. The standard of practice would be to ensure that sanitizers were effective throughout the period of use (Food Code, 2009).

9. During general food production observations on 6/6/12 beginning at 1620 hours, it was noted that dietary staff used plastic cutting boards. The surface of 6 of the 14 cutting boards were fully covered with multiple cuts and scores which would inhibit the ability of the cutting board to be effectively sanitized. It would be the standard of practice to ensure cutting surfaces were discarded if they were not capable of being resurfaced (Food Code, 2009).

10. On 6/6/12 beginning at 1500 hours, 10 random employee health records were reviewed in the presence of Administrative Staff 1 (AS). It was noted that the Tuberculosis (TB) testing in 2 of 10 records reviewed did not meet the hospital's policy as outlined by AS 1. One employee had two inconclusive chest x-rays, one in 1998 and a second in 2006; while the employee received the yearly TB symptom questionnaires that were negative. AS 1 stated there should have been additional review by a physician to ensure the health status of the employee. The second employee indicated that she had a history of positive TB screening at which point the hospital performed a blood test (Quantiferon Gold) intended to detect the presence of a TB infection. It was noted the 2009 test was negative. In a concurrent interview with AS 1, she stated that upon completion of the blood test, indicating the employee was not exposed to TB, she should have started receiving yearly TB skin testing.


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11. A selected OR case was observed (Patient 28) in OR 8 on 06/05/12 at 1100 hours. This case was a total hip replacement done using laminar air flow. It was noted there was a hole in the OR wall to the right of the entry door (as viewed from inside the OR) which was close to the top of the wall. The hole was through the full thickness of the interior wall board and was about 1 inch in size. There were three wires of different colors protruding from the hole.

The Director of Surgical Services was interviewed 06/05/12 at 14:00. She stated that old emergency lights were removed from the ORs and an order was put in to Environmental Services to patch the holes left behind. She was unaware that the patching was still not completed approximately two months later when the survey was performed.

The Vice President of Facilities was interviewed on 06/06/12 at 13:30. He stated that the engineering department did not follow through in a timely fashion and that the surgery staff were also partially responsible for not reporting the delay in having all of the holes repaired.

The Infection Control Director was interviewed on 06/06/12 at 1440 hours. She explained that before engineering started the work of removing the emergency lighting from the ORs, they should have filed for an Infection Control Permit. That would have allowed Infection Control Staff to be aware of the work being done and have input as to any infection control issues regarding the work. Since the correct paperwork was not forwarded to Infection Control, she was unaware of the holes or of the work itself being done.

An e-mail document printout entitled "Holes in ceiling from removal of emergency lights," dated 06/05/12 was provided. It listed all 11 ORs currently in use. Two rooms (10 & 11) had no holes. Three rooms had the holes patched (3, 4 and 6). Five rooms had unpatched holes (1, 2, 5, 7, 8 and 9). The remaining holes were patched during the following 24 hours.

The emergency lighting was removed/renovated from 11 ORs without knowledge or input from Infection Control (IC) Personnel. Also, IC personnel were not able to follow the progress of the work and provide oversight to ensure that it was completed in a safe and expeditious manner.



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15 b. On 6/4/12 at 0940 hours, during the initial tour of ICU with ICU Director, ICU Rm. 35 was noted to have a sign indicating the patient was in contact and droplet isolation. Per hospital policy, standing less than 3 ft from the patient required a PPE gown, mask and gloves to be worn. However, observation of the dialysis nurse standing in-between the patient and the dialysis machine showed the dialysis nurse was operating the machine with bare hands with the mask hanging on her neck. She donned gloves and mask only when she noted the surveyor was watching.

16a. On 6/5/12 at 1330 hours, during the initial tour of the 5th nursing floor accompanied by Director PR, observation of Patient 11's IV site showed on the IV needle site, where the IV solution was infusing, there no sticker to reveal the date and time the IV needle was inserted and by whom.

When RN 2 was approached, she admitted she forgot to label the IV dressing with the date and time it was inserted including the initial of the person who inserted the IV needle.

16b. Further tour of the Telemetry Unit with Nurse Manager 2 revealed a tube feeding bag in Room 52 with no label when it was hung. When showed to Nurse Manager 2, she called the primary care nurse to label the feeding bag.

17. On 6/4/12 at 1000 hours, while standing in front of the ICU nurse station waiting for the Nurse Manager, the grout between the wash sink and the wall was noted to be brown on the left side and white on the right side. Nurse Manager 2 called housekeeping to show the grout discoloration possibly due to collected dirt. The sink on the other side of the nurse station was also pointed to the Nurse Manager for the same issue.

18. On 6/6/12 at 0950 hours, a tour of the Oncology Unit with Nurse Manager 3 was conducted. Behind the door of the linen room were two dusty, used admission kits, a used disposable Styrofoam cup and a used pillow case. When these items were handed to Nurse Manager 3, she stated "These dirty items do not belong here."


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12. The CDC's Guideline for Disinfection and Sterilization in Healthcare Facilities, dated 2008, reads in part: "cleaning is the removal of foreign material (e.g., soil, and organic material) from objects and is normally accomplished using water with detergents or enzymatic products. Thorough cleaning is required before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes. Enzyme solutions should be used in accordance with manufacturer's instructions, which include proper dilution of the enzymatic detergent and contact with equipment for time specified on the label." Too dilute a solution can result in ineffective cleaning and too concentrated an ezymatic solution can damage instruments/tissue.

On 6/4/12 at 1116 hours, GI Tech 1 was observed processing dirty endoscopes (an endoscope is a device with a light attached that is used to look inside a body cavity or organ). During interview GI Tech 1 stated she mixed 4-5 pumps (one pump equals one ounce) of the enzymatic product added to an uncertain amount of water. GI Tech 1 stated she had been away from work for a while and had just returned to work and she was not sure how to mix the new product. A review of the manufacturer's instruction showed for manual cleaning, add 1-2 ounces of the product to one gallon of water.

13. According to the AORN's Perioperative Standards and Recommended Practices, 2010 edition, under Recommended Practices for Sterilization in the Perioperative Practice Setting, the manufacturer's written instruction for operating steam sterilizers should be followed; quality control programs that enhance personnel performance and monitor sterilization efficacy are established to promote patient and employee safety; preventive maintenance on sterilizers should be performed by qualified personnel on a scheduled basis (periodic inspections, maintenance, and replacement of components subject to wear, help maintain proper functioning of sterilizers); inspection and cleaning should be performed as outlined in the manufacturer's written instructions and maintenance records should be kept for each sterilizer.

On 6/6/12 at 1020 hours, the SPD service area was toured with the Director of Surgical Services and the Manager of Sterile Processing (SP). Three autoclaves used for processing/sterilization of the surgical instruments were observed in the department. The autoclaves had heavy brown stains and scaling. The middle autoclave had heavy dust and debris accumulated on the door side and the areas where the doors closed/interlocked had a brown oil-like liquid running down the interlocked areas. A concurrent interview with the Manager of SP revealed the autoclaves had annual preventative maintainance service and cleaning by contracted services. The Manager of SP was aware the autoclaves should have routine maintenance done more often than annually; however, there were no actions initiated. The Manager of SP stated the autoclaves had not received the required maintenance services because it was too much work to shut down and restart the autoclaves. The Manager of SP further stated there were six more autoclaves located in the operating room suits and outpatient surgical center all serviced by the SPD that also had not received routine maintenance.

A review of the manufacturers' operation manuals for the sterilizers showed autoclaves required individualized routine maintenance schedules and bimonthly inspection. The routine maintenance should include daily, weekly, quarterly maintenance.

14. According to the CDC's Guideline for Hand Hygiene in Health-Care Settings, dated October 25, 2002, handwashing/hand hygeine are indicated before and after removing gloves.
According to the AORN's Perioperative Standards and Recommended Practices, 2011 Edition, under Recommended Practices for Hand Hygiene in the Perioperative Setting, hand hygiene should be performed before putting gloves on and after removing gloves or other personal protective equipment.

On 6/4/12 at 1055 hours, during an observation of a colonoscopy procedure, MD 1 was observed gowned and gloved preceding a procedure. MD 1 terminated the procedure, passed the contaminated endoscopy to a RN, removed gloves and started electronic documentation. There was no hand hygiene observed.


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15 a. Review of the hospital's P&P "Isolation Precaution Guideline Overview," effective 10/1/2008, defined droplet transmission of infectious agents as respiratory droplets that occur when an infected person coughs, sneezes or is suctioned and the infectious agent/droplet can be transmitted by direct or indirect contact. The hospital described PPE (Personal Protective Equipment) for a patient in droplet isolation as gloves, a gown and a mask. PPE acts a barrier between the organism and transmission of the organism.

On 6/5/12 at 1055 hours RN 3 was observed caring for Patient 92. The patient was in Droplet Isolation. The RN was wearing PPE and was in close contact with the patient. During the RN's patient care an in-house cell phone rang and the RN reached into her pocket with a gloved hand and answered the phone and then replaced the phone in her pocket without disinfecting the phone. The nurse broke the protective barrier and contaminated the phone. During an interview immediately after leaving the room, the RN stated the patient was in isolation for possible MRSA in the sputum. Methicillin-resistant Staphylococcus aureus is a type of staph bacteria that does not respond to some antibiotics that are commonly used to treat staph infections.

Based on interview and hospital document review, the hospital failed to ensure patients' families would be approached by a designated requestor when one of eight nurses surveyed (RN 1) stated they would approach the family regarding organ donation. This could potentially result in a failure to obtain organ/tissue donation.

Findings:

According to the hospital's P&P "Donation After Cardiac Death" revised 4/2011, approaching the legal next of kin regarding organ/tissue donation shall rest with the Organ Procedure Organization.

On 6/4/12 at 1515 hours, RN 1 was asked what occurred when a patient died related to organ/tissue donation and the RN responded that she would ask the family if they were interested in organ donation.

Based on record review and interview, the hospital failed to ensure surgical services met the needs of the patients:

1. A "Time Out" was not done effectively for one of five sampled patients (Patient 43). This resulted in the patient returning for a second pain management procedure.

2. The hospital failed to ensure hand hygiene was performed by one MD in one of four procedures observed.

3. The hospital failed to ensure the dilution of an enzymatic agent followed the manufacturer's instruction.

4. The hospital failed to develop and implement a routine maintenance service for sterilizers in the surgical services area and sterilization area.

5. The hospital failed to ensure Infection Control Personnel were aware when the emergency lighting was removed/renovated from 11 ORs which resulted in a failure of IC personnel to follow the progress of the work and provide oversight to ensure that it was completed in a safe and expeditious manner.

These failures could potentially result in an unsafe surgical environment for patients.

Findings:

1. On 4/12/12, the Department received a hospital reported adverse event. The report stated on 3/28/12 Patient 43 was consented for a right side thoracic nerve pain management procedure. The procedure was completed and the patient was discharged to home. Upon discovery of the wrong side procedure the following day, the procedural physician disclosed to the patient and family what had occurred.

The hospital's P&P titled Universal Protocol to Prevent Wrong Person/ Procedure: Site/Side Operations Or Procedures, revision 3, effective date 2/8/12, a policy statement showed prior to initiation of any surgical or invasive procedure, each of the three components of the "Time Out/Universal Protocol" will be followed and documented as appropriate prior to initiation of the procedure, the Pre-operative/invasive Procedure Verification Process will be followed and documented. Verification will include: verify the correct site/side. The P&P showed in the Points to Emphasize all members of the procedural team will be actively engaged in the "Time Out." The team must stop all activities and acknowledge the component of the "Time Out".

Patient 43's medical record was reviewed on 6/5/12. The physician's order and patient signed consent were for T7 to T10 (Thoracic Spine) Radiofrequency Ablation Under Fluoroscopy with Sedation right side. Radio frequency ablation (RFA) is a medical procedure where part of the electrical conduction system of tissue is ablated (removed) using the heat generated from high frequency alternating current. Fluoroscopy shows continuous x-ray pictures on a monitor.

On 6/5/12 at 1500 hours during an interview, the Manager of the Surgical Center (MSC) stated Patient 43 came to the Outpatient Surgery on 3/28/12. The hospital investigation of the event showed the Procedural Physician, MD 2, did the side marking on the patient following the hospital's policy. The surgical team took the patient to the procedure room and started to prepare the patient. The surgical sterile drapes covered the mark that was put by the physician. The procedural Time Out was conducted and the procedure proceeded without the team's knowledge the wrong side was been done. The surgical team included three RNs, a radiology technician and a surgical technician. The MSC further stated during the procedure, Patient 43 did not receive any of the sedatives and was awake and aware. Patient 43 went home with family after the procedure. The family member noted the small dressing that covered the infection side was on the wrong side of the patient's problem side. The family member called the outpatient surgical center and the center initiated an investigation immediately.

2. According to the CDC's Guideline for hand Hygiene in Health-Care Settings, dated October 25, 2002, hand washing and hand hygiene are indicated: Decontaminate hands after removing gloves.

According to the AORN's Perioperative Standards and Recommended Practices, 2011 Edition, under Recommended Practices for Hand Hygiene in the Perioperative Setting, hand hygiene should be performed before putting gloves on and after removing gloves or other personal protective equipment.

On 6/4/12 at 1055 hours, during an observation of a colonoscopy procedure, MD 1 was observed gowned and gloved preceding a procedure. MD 1 terminated the procedure, passed the contaminated endoscopy to a RN, removed gloves and started electronic documentation. There was no hand hygiene was observed.

3. The CDC's Guideline for Disinfection and Sterilization in Healthcare Facilities, dated 2008, reads in part: "cleaning is the removal of foreign material (e.g., soil, and organic material) from objects and is normally accomplished using water with detergents or enzymatic products. Thorough cleaning is required before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes. Enzyme solutions should be used in accordance with manufacturer's instructions, which include proper dilution of the enzymatic detergent and contact with equipment for time specified on the label." Too dilute a solution can result in ineffective cleaning and too concentrated an enzymatic solution can damage instruments/tissue.

On 6/4/12 at 1116 hours, GI Tech 1 was observed processing dirty endoscopes (an endoscope is a device with a light attached that is used to look inside a body cavity or organ). During interview GI Tech 1 stated she mixed 4-5 pumps (one pump equals one ounce) of the enzymatic product added to uncertain amount of water. GI Tech 1 stated she had been away from work for a while and had just returned to work and she was not sure how to mix the new product. A review of the manufacturer's instruction showed for manual cleaning use, add 1-2 ounces of the product to one gallon of water.

On 6/4/12 at 1116 hours, GI Tech 1 was observed processing dirty endoscopic tubes. During interview GI Tech 1 stated she mixed 4-5 pumps (one pump equals one ounce) of the enzymatic product added to uncertain amount of water. GI Tech 1 stated she had been away from work for a while and had just returned to work, she was not sure how to mix the new product. A review of the manufacturer's instruction showed for manual cleaning use, add 1-2 ounces of the product to one gallon of water.

4. According to the AORN's Perioperative Standards and Recommended Practices, 2010 edition, under Recommended Practices for Sterilization in the Perioperative Practice Setting, the manufacturer's written instruction for operating steam sterilizers should be followed; quality control programs that enhance personnel performance and monitor sterilization efficacy are established to promote patient and employee safety; preventive maintenance on sterilizers should be performed by qualified personnel on a scheduled basis (periodic inspections, maintenance, and replacement of components subject to wear, help maintain proper functioning of sterilizers); inspection and cleaning should be performed as outlined in the manufacturer's written instructions; and maintenance records should be kept for each sterilizer.

On 6/6/12 at 1020 hours, the SPD service area was toured with the Director of Surgical Services and the Manager of Sterile Processing (SP). Three autoclaves used for processing/sterilization of surgical instruments were observed. The autoclaves were observed with heavy brown stains and scaling. The middle autoclave had heavy dust and debris accumulated on the door side and the areas where the doors closed/interlocked had a brown oil-like liquid running down the interlocked areas. A concurrent interview with the Manager SP revealed the autoclaves had annual preventative maintenance service and cleaning by a contracted service. The Manager was aware the autoclaves should have routine maintenance done more often than annually; however, there were no actions initiated. The Manager stated the autoclaves had not received the required maintenance services because it was too much work to shut down and restart the autoclaves. The Manager further stated there were six more autoclaves located in the operating room suits and outpatient surgical center all serviced by the SPD that also had not received routine maintenance.

A review of the manufacturer's operation manuals for the sterilizers showed autoclaves required individualized routine maintenance schedule and bimonthly inspection. The routine maintenance should include a daily, weekly, quarterly maintenance.


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5. A selected OR case was observed (Patient 28) in OR 8 on 06/05/12 at 1100 hours. This case was a total hip replacement done using laminar air flow. It was noted there was a hole in the OR wall to the right of the entry door (as viewed from inside the OR) which was close to the top of the wall. The hole was through the full thickness of the interior wall board and was about 1 inch in size. There were three wires of different colors protruding from the hole.

The Director of Surgical Services was interviewed 06/05/12 at 1400 hours. She stated the old emergency lights were removed from the ORs and an order put in to Environmental Services to patch the holes left behind. She was unaware that the patching was still not completed approximately two months later at the time the survey was performed.

The Vice President of Facilities was interviewed on 06/06/12 at 1330 hours. He stated the engineering department did not follow through in a timely fashion and that the surgery staff was also partially responsible for not reporting the delay in having all of the holes repaired.

The Infection Control Director was interviewed on 06/06/12 at 1440 hours. She explained that before engineering started the work of removing the emergency lighting from the ORs, they should have filed for an Infection Control Permit. That would have allowed Infection Control Staff to be aware of the work being done and have input as to any infection control issues regarding the work. Since the correct paperwork was not forwarded to Infection Control, she was unaware of the holes or of the work itself being done.

An e-mail document printout entitled "Holes in ceiling from removal of emergency lights," dated 06/05/12 was provided. It listed all 11 ORs currently in use. Two rooms (10 & 11) had no holes. Three rooms had the holes patched (3, 4 and 6). Five rooms had unpatched holes (1, 2, 5, 7, 8 and 9). The remaining holes were patched during the following 24 hours.