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Based on interview and record review, the facility failed to complete needed changes to its requirements regarding updated examinations prior to the survey. The deficient practice delayed an enhancement to patient safety demanded by federal regulations.

Findings:

Review of the medical staff bylaws and rules and regulations presented by the facility indicated that they were effective 9/15/09. Review of the medical staff bylaws indicated, "The Rules and Regulations are incorporated into these Bylaws as if set forth herein." Review of the "Medical Staff Rules and Regulations" indicated that for "Surgical or other invasive diagnostic or therapeutic procedures... If an H&P [medical history and physical examination] was performed more than 24 hours prior to the procedure, an interval update must be done and recorded in the chart prior to surgery or a procedure requiring anesthesia services. An interval update records any changes since the last H&P was performed." Although separate provisions were present requiring an update after admission for all inpatients, there were no provisions requiring an update after registration for outpatient surgeries when the H&P was done within 24 hours prior to the procedure.

Review of a document titled, "PROPOSED AMENDMENTS TO MEDICAL STAFF BYLAWS AND RULES AND REGULATIONS" revealed a note adhered to the document stating "pending approval [changes] to go Thurs. admin MEC' (medical executive committee). The proposed amendments included language requiring an H&P update after registration for outpatient surgeries.

Review of the agenda for the Administrative MEC meeting planned for 1/7/10 indicated that proposed amendments to the medical staff rules and regulations were on the agenda.

In an interview on 1/5/10 at 4:05 p.m., Staff A stated that the facility hadn't done approvals over the holidays because they wanted to have a meaningful approvals process. Staff B stated that the governing body could approve the amendments prior to conclusion of the survey.

20245

Based on food service observation, dietary staff interview, dietary and administrative document review, the hospital failed to:

Findings:

1. Ensure the availability of organized dietetic services that are directed and staff by adequately qualified personnel. (Cross reference A 619, A 620, A 622, A 749)

2. Provide effective cleaning and sanitation of stationary food production surfaces and equipment (Cross reference A 619, A 749)

3. Ensure the nutritional needs of the patients were met (Cross reference A 628, A 630)

The cumulative effects of these systemic problems resulted in the inability of the hospital's food and nutrition services to direct staff in such a manner to ensure a sanitary environment and avoid sources and transmission of infections in food services. Failure to ensure food is stored, prepared and served following science-based sanitary practices has the potential to put critically ill patients at risk for transmission of food borne illness during the course of hospitalization and potentially compromise medical outcome.

Based on food service observations, dietary staff interview, and dietary department document review, the hospital failed to ensure comprehensive organization of the department as evidenced by lack of development of policies and procedures that reflected the depth and breadth of the dietary departmental functions. Failure to ensure that departmental functions met food handling standards of practice might result in unsafe food handling practices and cross contamination of food. Poor food handling practices might result in food borne illness resulting in gastrointestinal illness, further compromising medical status and in severe instances may result in death.

Findings:

1. During food storage observations in the food production area on 1/5/10 beginning at 11 am, it was noted that in refrigerator 2D18 there was a container labeled sun dried tomatoes with an open date of 9/14/09. In a concurrent interview, DMS A was asked the hold time for foods, to which he stated that the general hold time was 3 days; however this product would be retained for up to 6 months. The surveyor then asked if the hospital had guidance for which foods would be held longer than 3 days. He replied that there was no written guidance. The surveyor also asked how he determined that the product was acceptable for use for the 6 month timeframe, to which he replied that he was unsure.

Similarly in a follow up observation in the food production area on 1/5/10 beginning at 3 PM, there were multiple spices that were received from 2005-2007. Additionally, dietary staff was storing dried goods in previously used plastic spice containers. DMS A stated that staff was likely using these containers after they removed the product from the bulk container. He also stated that he was unaware that this was an unacceptable storage practice.

In a concurrent interview, DMS A was asked whose responsibility it was to oversee the storage of foods. He replied that it was his responsibility, and acknowledged there was no comprehensive system for ensuring that spices were discarded after a designated period of time. He also acknowledged that the hospital had no written guidance for the listed items.

Plastic spice containers are classified as single-use containers and are not intended to store multiple products, multiple times (Food Code, 2009). At 3 PM a 1/17/10 review of hospital policy and procedure manual revealed that there was no guidance to dietary staff on the use of proper storage containers for transferring bulk foods to the food production area (Cross Reference A 620). Repeated use of single use containers may result in odors and chemical particles being transferred to stored foods.

2. During observation of food handling practices of potentially hazardous foods (PHF's) on 1/5/10 beginning at 4 PM, it was noted that the hospital utilized blast chillers with probes to monitor the temperatures of PHF's during cooldown. PHF's are defined as those foods that requires time/temperature control for safety (TCS) to limit pathogenic microorganism growth or toxin formation associated with foodborne illness (Food Code, 2009).

In a concurrent interview, Dietary Management Staff A described a process where up to 5 items would be put in the blast chiller at any one time. He further stated that there were 2 probes in each of the two blast chillers; however each chiller had the capacity for up to 3 probes. The surveyor asked how the hospital ensured that the items that did not contain probes were properly cooled. Dietary Management Staff A replied that the items that were not probed were "similar." The surveyor also asked what was meant by similar, after which he pointed at a diagram affixed to the wall. He also stated there was no further guidance for dietary staff to follow.

Review of the hospital policy and procedure manual revealed that there was no procedure developed to ensure proper use of food safety monitoring equipment (Cross Reference A 701 and 749).

3. During initial tour in the dry storage area on 2/5/10 beginning at 10:20 am, it was noted that there was a can of opened protein powder with a scoop in it , resulting in potential cross contamination of the powder. It was also noted that the can had a "Patient 2's" name on it with a physicians' order dated 12/26/09, which guided staff to deliver 1 can of the supplement to the unit every Monday. It was also noted that underneath the current label there was a second label that revealed a physicians' order dated 12/22/09 that also ordered beneprotein (a powdered protein supplement) for Patient 1. Additionally it was noted that there was third patient label, which was illegible, underneath the one for Patient 1.

In a concurrent interview Dietary Management Staff A stated that the current system was for the protein powder to be sent to the unit per the physicians' order. Once opened, the unused supplement would be discarded. He also acknowledged that this can of powder had been sent to the unit and returned to the dry storage area a total of 3 times for 3 different patients. He further stated that all enteral feedings were sent to the nursing units on a daily basis and unopened cans would be returned to the dietary department. He also acknowledged that sending the supplement to the unit for 3 different patients without knowing at which point it had been opened might result in cross contamination of the product. He further acknowledged there was no written policy guiding staff on how to handle patient supplements that might be returned to the kitchen multiple times.

On 1/7/10 at 3 PM, a review of nutrition services department policy and procedure manual revealed that the hospital did not have any guidance for use of powdered protein supplements or enteral feedings for multiple patients.

4. On 1-5-10 at 11:30 a.m. during lunch trayline observations, it was noted that all food was plated in a chilled condition. While reviewing the trayline food temperature log, one food entree, polenta, was observed to be 69.1 degrees. It was also noted that there were greater than 50 servings of the polenta being offered to patients. During a concurrent interview, Dietary Management Staff H (DMS H) stated her job was to take food temperatures before the trayline and the temperature of all the foods was supposed to be "less than 41° F". When asked about the polenta entree, which was observed to have temperature of 69.1°F, DNS H stated, "That was the temperature when tray line started." When asked by the surveyor if there was any action she should take if a food temperature was not less than 41°F, DMS H stated, "No, DMS A does that."

At 11:40 a.m. during an interview, Dietary Management Staff A stated he had personally prepared the polenta for trayline by taking it directly out of the freezer and putting it in the oven at "about 350°F for about 18 minutes" and then putting it in the blast chiller "for about 30 minutes" while it was already chilling other food items. He stated he did not take the temperature of the polenta when he removed it from the oven, and did not put a probe in the polenta to record the temperature while it cooled or before trayline. When asked if he noted the time or temperature of the polenta at any point, DMS H stated, "I forgot".

On 1/7/10 at 3:00 p.m., a review of the food and nutrition services department policy and procedure manual revealed the hospital did not have any guidance on use of the chilled trayline and procedures to ensure safe food through control of critical time temperature parameters.

5. On 1/5/10 at 3:00 p.m., during review of sanitation practices, Dietary Staff I (DS I) was observed wiping countertops with a kitchen towel which he had dipped into a clear solution in a red bucket. During a concurrent interview DS 1 stated he was wiping surfaces with "the 146" after he cleaned them with "the 133" cleaner. He stated he changed the solution "every two hours" and the 146 solution was "good right now." When the surveyor asked DS I whether he checked anything about the solution, Dietary Management staff (DMS) J, who was standing nearby, told the surveyor, "Supervisors check the sanitizer, not employees." DMS J stated, "Dietary Management K (DMS K) is here and does that."

During an interview at 3:05 p.m., the surveyor requested DMS K to check the sanitizer solution DS I was using to sanitize work tables. DMS K left and returned with a sanitizer test kit retrieved from "the janitor's closet." DMS K dipped the strip into the solution for a count of two, and then removed the strip. There was no color change. DMS K dipped a second strip in the solution and counted to 20. The strip was dark green. DMS K stated one of her responsibilities was to check the sanitizer concentration but stated she didn't know how to do it unless she read the directions.

The surveyor and supervisor went to the janitor's closet where DMS K read the directions for testing the sanitizer, then dispensed sanitizer into a bucket from a wall dispenser. DMS K dipped a test strip into the solution dispensed from a wall dispenser and counted to 10 per the instructions. DMS K compared the color to the test kit chart and stated, "It's 200 parts- that's good." The surveyor again asked DMS K to check the actual solution DS I had been using and DMS K did so. The strip was observed to be a vivid green color, and when compared to the test kit, the signage on the wall indicated that 500 ppm (parts per million )was an "unacceptable level." When the surveyor asked what "unacceptable" meant, DMS answered, "I don't know . The solution is ok because the dispenser is right. We check the dispenser, not the bucket being used."

At 3:10 p.m., DMS K provided the December, 2009 "Ecolab-Cleaning Agents Concentration Test Log" check log, which revealed the sanitizer was checked one time daily at 8 AM as it was dispensed from the wall dispenser. DMS K also acknowledged there was no additional guidance to ensure the proper strength of the chemical was utilized.

On 1/7/10 at 3 PM, the Ecolab (manufacturer of 146 sanitizer) publication "Technical Digest" was reviewed and revealed the product "must be used within the recommended ppm level."

On 1/7/10 at 3 p.m. a review of the food and nutrition services policy and procedure manual revealed the hospital did not have guidance to ensure that the sanitizer was at an acceptable level when used.

Findings:

1. During observation of food handling practices of potentially hazardous foods (PHF's) on 1/5/10 beginning at 4 pm, it was noted that the facility utilized blast chillers with probes to monitor the temperatures of PHF's during cooldown. PHF's are defined as those foods that requires time/temperature control for safety (TCS) to limit pathogenic microorganism growth or toxin formation associated with foodborne illness (Food Code, 2009).

In a concurrent interview Dietary Management Staff (DMS) A described a process whereby up to 5 items would be put in the blast chiller at any one time. He further stated that there were 2 probes in each of the two blast chillers; however each chiller had the capacity for 3 probes. The surveyor asked how the facility ensured that the items that did not contain probes were properly cooled. DMS A replied that the items that were not probed were "similar." The surveyor also asked what was meant by similar, after which he pointed at a diagram affixed to the wall. He further stated there was no other guidance for staff to utilized.

Review on 1/6/10 at 10 am, of facility documents titled "Batch Record Form" for sampled dates of 12/14/09 and 12/21/09, totaling 3 blast chill cycles revealed that on all of these days there were 4-7 items being cooled. It was also noted that in the 12/14/09 batch the probes were inserted into the minestrone soup and eggs, there were no temperature probes for the cream of wheat or cream of rice. On the second batch dated 12/14/09 there were 6 items placed in the chiller; however the only items that were probed were beef and chicken broth. There was no probing of oatmeal, gravy, turkey or fish. Similarly on 12/21/09 batch the items probed were the navy bean soup and cream of wheat. There was no probing for cream of rice or rice.

Review on 1/6/10 at 4:30 pm, of the manufacturers' recommendations for the blast chiller revealed that while it was possible to group foods to form "batches" it was also noted that the hospital had no specific guidance on determining which foods to batch. The manufacturers' guidance noted that items with higher water content are likely to cool faster than those with relatively lower water content. It was also noted that the average cooling time for the oatmeal was the longest and scrambled eggs the shortest.

Review on 1/7/10 at 9 am, in-service document titled "Blast Chilling for Patient Meal Service" revealed that management staff had not provided guidance on batching foods during cooldown. Similarly, review on 1/7/10 at 9 am, of the departmental policy and procedure manual revealed there was not guidance provided for batching of foods.

Review of hospital document titled "Provider's Plan of Correction" dated 12/15/09 revealed that the hospital had completed a through review of food handling systems and found 100% compliance in the handling of PHF's. There was no documentation that the hospital had fully evaluated manufacturers' recommendations for proper use of the blast chillers to ensure safe handing of PHF's.

Review on 1/7/09 at 3 pm, of the position description for the Director of Food and Nutrition Services, revealed that this was the position whose responsibility it was to "manage programs, operationas activities...trains and evaluates the activities of personnel...to evaluate and implement goals...policies and procedures of the division."

Similarly the position description for the Food Service Manager Administrator noted it was the responsibility of this position was "implements and monitors operating systems to ensure complicance with established protocols."

2. During food storage observations in the food production area on 1/5/10 beginning at 11 am, it was noted that in refrigerator 2D18 there was a container labeled sun dried tomatoes with an open date of 9/14/09. In a concurrent interview with DMS A he was asked the hold time for foods, to which he stated that the general hold time was 3 days; however this product would be retained for up to 6 months. The surveyor then asked if the facility had guidance for which foods would be held longer than 3 days. He replied that there was no written guidance.

3. In a follow up observation in the food production area on 1/5/10 at 3 pm, the following was noted. A container of cloves with a use by date of 2/6/09; dill week with a receipt date of 3/15/05; mustard powder opened 7/08 and sesame seeds with a receipt date of 2008. It was also noted there was Cajun powder, marjoram and gumbo seasoning opened, no date. In a concurrent interview with DMS A, he was asked whose responsibility it was to oversee the storage of foods, to which he replied that it was his responsibility, and acknowledged there was no comprehensive system for ensuring spices were discarded after a designated period of time. He also acknowledged that the hospital had no written guidance for the observed items.

4. During food storage observations on 1/5/10 beginning at 3 pm, it was noted that in the food production area dietary staff was storing sugar in a previously used container labeled "garlic." Similarly staff was storing salt in a container labeled Italian seasoning. In a concurrent interview with DMS A, he stated that staff was likely using these containers after they removed the product from the bulk container. He also stated that he was unaware that this was an unacceptable storage practice.

Plastic spice containers are classified as single-use containers and are not intended to store multiple products, multiple times (Food Code, 2009). Review on 1/7/10 of facility policy and procedure manual, revealed that there was no guidance to dietary staff on the use of proper storage containers for transferring bulk foods to the food production area.

Similarly the position description for the Food Service Manager Administrator noted it was the responsibility of this position was "implements and monitors operating systems to ensure complicance with established protocols."


20245

Based on observation, interview, and document review, the hospital failed to ensure dietary management staff was responsible for daily managment of food service, and had the knowledge to implement procedures to ensure food safety. Dietary Management Staff failed to use the blast chiller following manufacturer's guidance, and failed to develop and implement policies for length of storage for potentially hazardous foods and for re-use of single use food containers. Failure to comprehensively identify system deficiencies may result in food borne illness resulting in gastrointestinal distress and in severe instances may result in death.

Based on observation, interview, and dietary document and records review, the hospital failed to ensure safe food handling. Management staff with responsibility for oversight of food safety had not had their competency assessed in use of food safety equipment and products, and had not trained or checked competencies of dietary staff who daily used the food safety equipment and products. Failure to ensure competency of dietary staff may result in unsafe food handling practices putting patients at risk for foodborne illness. Foodborne illness may result in gastrointestinal distress, further compromising medical status and in severe instances may result in death.

Findings:

1. During observation of food handling practices of potentially hazardous foods (PHF's) on 1/5/10 beginning at 4 pPM it was noted that the hospital utilized blast chillers with probes to monitor the temperatures of PHF's during cooldown. PHF's are defined as those foods that requires time/temperature control for safety (TCS) to limit pathogenic microorganism growth or toxin formation associated with foodborne illness (Food Code, 2009).

In a concurrent interview DMS A described a process whereby up to 5 items would be put in the blast chiller at any one time. He further stated that there were 2 probes in each of the two blast chillers; however each chiller had the capacity for up to 3 probes. The surveyor asked how the hospital ensured that the items that did not contain probes were properly cooled. Dietary Management Staff A replied that the items that were not probed were "similar." The surveyor also asked what was meant by similar, after which he pointed at a diagram affixed to the wall. Additionally the surveyor asked DSM A how this information was implemented during the cooling process. He had no response.

Review on 1/6/10 at 10 am of hospital documents titled "Batch Record Form", for sampled dates of 12/14/09 and 12/21/09 totaling 3 blast chill cycles, revealed that on all of these days there were 4-7 items being cooled. It was also noted that there appeared to be no consistency in which items were monitored. It was also noted that that this system for inconsistently monitoring food items was present for the entire month of 12/09.

Review on 1/6/10 at 4:30 pPM of the manufacturers' recommendations revealed that while it was possible to group foods to form "batches", it also provided specific guidance on determining which foods to batch. The manufacturer's guidance noted that items with higher water content were likely to cool faster than those with a lower water content. It was also noted that the average cooling time for oatmeal was the longest and scrambled eggs the shortest. Additionally it was noted that items such as thicker soups, which would likely be the consistency of gravy, required more cooling time than the scrambled eggs.

Review on 1/7/10 at 9 am of an in-service document titled "Blast Chilling for Patient Meal Service" revealed that management staff had not provided guidance on batching foods during cooldown. Similarly, review on 1/7/10 at 9 am of the departmental policy and procedure manual revealed there was no guidance provided for batching of foods.

A 1/8/10 9 am review of the position description for Dietary Management Staff (DMS) A revealed that this was the person responsible for the overall safe food production activities. Review on 1/7/10 at 9:30 am of the personnel file for DMS A revealed that there were no competencies completed.

In an interview on 1/8/10 at 9:30 am, DMS B stated that department personnel had developed a competency assessment which was very similar to the employee performance evaluation. She further stated the tool was not approved or implemented as it did not provide the opportunity to evaluate competency for specific position duties, rather it was a general evaluation.

Hospital document titled "Providers Plan of Correction" dated 12/15/09 revealed that the hospital would be completing a "competency checklist that will be performed by Director, Food & Nutrition Services for all leadership members." The document also noted that "The Associate Administrator, Support Services will review data...weekly for six weeks to ensure compliance..." There was no evidence that competency or effectivness of the hospitals' plan of correction were evaluated.

2. During observation of food preparation procedures on 1/6/10 at 3 pPM Dietary Staff G was asked how he ensured foods were properly cooked for food safety. He replied that he would use a thermometer. The surveyor then asked how he ensured the thermometer was accurate, to which he replied that the thermometers were regularly calibrated. The surveyor requested Dietary Staff G demonstrate the calibration of the thermometer. Dietary Staff G proceeded by placing ice in a metal 4" x 4" x 6" metal steam pan and added water. The resulting solution was approximately 1" of ice floating on top, and the rest water. He also stated that the desired temperature would be 32°F, and if it was not 32°F he would adjust the thermometer. After Dietary Staff G demonstrated the process, he was instructed by DMS A that the process was incorrect, and proceeded to add additional ice.

A 1/7/10 2 pPMreview of hospital document titled "Thermometer Calibration In-service" revealed that while staff had been presented training, the training was limited only to management staff. There was no evidence that direct line staff, those that were responsible for daily food production activities, were provided training.

Review on 1/7/10 at 3 pPM of hospital document titled "Provider's Plan of Correction" dated 10/15/09 revealed that the hospital "Provided in-service training on use and calibration of digital thermometers for all users." It was also noted that the hospital implemented a thermometer checklist which was performed on each user monthly to verify proper use and care of digital thermometers. There was no documentation that the providers' plan of correction was implemented.

3. During food storage observations on 1/5/10 beginning at 3 pPM it was noted that in the food production area, dietary staff was storing sugar in a previously used container labeled "garlic". Similarly, staff was storing salt in a container labeled Italian seasoning. In a concurrent interview, DMS A stated that staff was likely using these containers after they removed the product from the bulk container. He also stated that he was unaware that this was an unacceptable storage practice.

Plastic spice containers are classified as single-use containers and are not intended to store multiple products, at multiple times (Food Code, 2009). Review on 12/7/09 of the hospital policy and procedure manual, revealed that there was no guidance to dietary staff on the use of proper storage containers for transferring bulk foods to the food production area.

Review on 1/8/10 at 9 am of the position description for DMS A revealed that this position was the person responsible for the overall safe food production activities. Review on 1/7/10 at 9:30 am of the competency file for DMS A revealed that there were no completed competencies.

In an interview on 1/8/10 at 9:30 am, DMS B stated that department personnel had developed a competency assessment which was very similar to the employee performance evaluation. She further stated the use of this tool was not approved or implemented as it did not provide the opportunity to evaluate competency for specific position duties, rather was a general evaluation.

Review on 1/7/10 at 3 pPM of position description titled "Food Service Manager Administrator" revealed that it was the duties of this position to have through knowledge of the principles and pproceduresof modern institutional food service operations...including production, storage and ssanitation The position description also noted that the position required the "Ability to: Analyze ssituationsaccurately and implement effective solutions."

Hospital document titled "Provider's Plan of Correction" dated 12/15/09 revealed that the hospital would be completing a "competency checklist that will be performed by Director, Food & Nutrition Services for all leadership members." The document also noted that "The Associate Administrator, Support Services will review data...weekly for six weeks to ensure compliance..." There was no evidence that competency or effectivness of the hospital's plan of correction was evaluated.

4. On 1/6/10 at 3:00 p.m. Dietary Staff I (DS I) was observed wiping countertops with a kitchen towel which he had dipped into a clear
solution in a red bucket. During an interview DS 1 stated he was wiping surfaces with "the 146" after he cleaned them with "the 133" cleaner. He stated he changed the solution "every two hours" and the 146 solution was "good right now." When the surveyor asked DS 1 whether he checked anything about the solution, Dietary Management staff (DMS) J, who was standing nearby, told the surveyor "supervisors check the sanitizer, not employees." DMS J stated "Dietary MManagementK (DMS K) is here and does that."

During an interview at 3:05 p.m., the surveyor requested DMS K to check the sanitizer solution DS I was using to sanitize work tables. DMS K
left and returned with a sanitizer test kit retrieved from "the janitor's closet." . DMS K dipped the strip into the solution for a count of two, and then removed the strip. There was no color change. DMS K dipped a second strip in the solution and counted to 20; the strip was dark green. DMS 3 stated one of her eresponsibilitieswas to check the sanitizer concentration but stated she didn't know how to do it unless she read the directions. The surveyor and supervisor went to the janitor's closet where DMS K read the directions to test the sanitizer, then dispensed sanitizer into a bucket from a wall dispenser. DMS K dipped a test strip into the solution dispensed from a wall dispense and counted to 10 per the instructions. DMS K compared the color to the test kit chart and stated "It's 200 parts- that's good." The surveyor again asked DMS K to check the actual solution DS I had been using and DMS K did so. The strip was observed to be a vivid green color,
and when compared to the test kit, 500 ppm (parts per million). The signage on the wall revealed the vivid green color was an "unacceptable level." When the surveyor asked what "unacceptable" meant, DMS K stated "I don't know . The solution is "ok" because the dispenser is right. We check the dispenser, not the bucket."

DMS K provided the December, 2009 "Ecolab-Cleaning Agents Concentration Test Log" check log which revealed the sanitizer was checked daily at 8 AM as dispensed from the wall dispenser, but was never checked when in use.
On 1/7/10 at 3:00 p.m., review of the Ecolab (manufacturer of 146" sanitizer) publication "Technical Digest" revealed the product "must be used within the recommended ppm level."

On 1/6/10 at 5:00 p.m. review of the HHospitaldocument "Plan of Correction" dated 12/15/09, revealed the Hospital IInfectionControl Officer conducted training with dietary staff on ....proper cleaning and sanitizing methods.

Review on 1/8/10 of the position description for Dietary Management Staff (DMS) A revealed that this was the person responsible for the overall safe food production activities. Review on 1/7/10 at 9:30 am, of the personnel file for DMS A revealed that there were no competencies completed.

During review of the personnel records for DS I, DMS J, and DMS K on 1/7/10 at 9:30 a.m., it was revealed these staff had not had their competencies evaluated on the use of the sanitizer.

Based on observation, interview and document review, the hospital failed to ensure the patient menu met the needs of greater than 100 critically ill patients, as evidenced by the fact that non-nutritionally equivalent menu items were substituted for missing food items, menu items did not provide the amount of protein as required by the menu, and patient food preferences were not followed. Failure to meet the nutritional needs of patients may result in decreased nutritional status and weight loss, further compromising their medical status.

Findings:

1. On 1/6/10 at 11:30 a.m. during lunch grayline observations, it was noted that "polenta" was being served in place of "spinach quiche" on the non-select menu.
At 11:35 a.m., Clinical Nutrition Staff AF stated, "I talked it over with Dietary Management Staff A and he thought that would be good. It's not really a nutritionally equivalent substitution."

On 1/7/09, CNS AF provided the nutritional analysis of the two menu items. The spinach quiche provided 11 grams of high biological value protein (protein containing all the essential amino acids), and the polenta provided only four grams total protein.

During review of hospital policies and procedures on 1/7/09 at 9:00 a.m., it was revealed the hospital had no policies and procedures for menu standards and food substitution policies.


17065

2. During observation of trayline on 1/6/10 beginning at 11 am, it was noted that patients with regular diets were offered a breaded veal patty. It was also noted that residents with a mechanical soft diet were offered a 3 ounce, unbreaded beef patty, which was of similar size. The surveyor requested that dietary staff remove the breading off of one veal patty. The veal patty was weighed, noting a final edible protein portion of 2.25 ounces. A second veal patty was weighed noting similar results.

Review on 1/6/10 at 11:30 am of manufacturer's specifications for the veal patty revealed that the serving size, including breading, had a weight of 4 ounces. It was also noted that the protein content, per the manufacturer's specifications, of the 4-ounce portion was 14.44 grams, which equated to slightly greater than a 2-ounce edible protein portion. A 1-ounce portion of meat equates to 7 grams of protein (USDA National Nutrient Database, 2010). Similarly it was also noted that per the manufacturer's specifications the chopped veal patty was also less than 3 ounces of protein as specified on the therapeutic spreadsheet, rather equated to 2.37 ounces of edible protein.

In an interview on 1/7/10 at 2 PM, Clinical Nutrition Staff F was asked to describe the menu development process. She stated that the current menu has been in existence for greater than 13 years. She also stated that it was the responsibility of DMS A to develop new recipes/items and provide the Registered Dietitian (RD) with the nutrient content. She also stated that it was the responsibility of the RD to analyze the appropriateness of the item and to approve it for compliance and allergies. There was no documentation that the hospital had evaluated the particular product being ordered to ensure that the manufacturer's specifications met menu planning needs.

Review on 1/7/10 at 3 PM of hospital policy and procedure titled "Purchasing" revealed that the hospital participated in a purchasing consortium. The policy also noted that food service management members participated in the product selection. There was no documentation that the hospital performed a product evaluation to ensure selected items met menu planning specifications.

Review on 1/7/10 at 3 PM of position description titled "Food Service Manager Administrator" revealed that it was the responsibility of this position to assist in formulating menus and implementing portion sizes. The position description also noted that the position required the "Ability to: Analyze situations accurately and implement effective solutions."

3. During plating of the noon meal on 1/6/10 beginning at 10 am, it was noted that tray card food preferences were not being followed. It was noted for Patient 3, the physician's diet order was a "no concentrated sweets" diet. It was also observed that on the tray card there was highlighted guidance to place two veal patties on the tray. Dietary staff placed one veal patty on the plate.

Similarly it was noted that Patient 4 had a physician ordered mechanical soft diet. It was also noted that the area indicating "large portion" was highlighted. The meal portion that was placed in the cart was the same as those with regular portions.

In a concurrent interview with Dietary Staff G the surveyor asked the purpose of the highlights on the meal tickets, to which he replied that it indicated that dietary staff should pay particular attention to the highlighted areas.

In an interview with Dietary Management Staff H on 1/6/10 at 11:35 am, the surveyor asked if the hospital performed any trayline accuracy studies, to which she replied that it was the responsibility of the "06" position to ensure the trays were accurate. She also stated that she did not know if any data was collected to determine areas that may require additional training.

A follow up observation of the meal cart on 1/6/10, at 11:45 am, revealed that there were no additional items given to patient. In a concurrent interview, Clinical Nutrition Staff F stated that patients with large portions should have been given a pre-packaged sandwich in addition to the meal tray. She further stated that the department chose to put sandwiches on trays since there was a limited amount of food that could be placed on a patient tray due to constraints of the re-thermalization unit. The surveyor also asked if the hospital had evaluated the acceptability to patients of providing a sandwich in place of larger portions of the hot entree, to which she replied they had not.

Based on observation, interview, and document review, the hospital failed to ensure physician diet orders were followed, as evidenced by failure to: 1) follow nursing procedures in serving food to a patient with "aspiration precautions," (Patient 5); 2) failure to follow physician's orders to "weigh every other day, (Patient 7), (Patient 7 lost 10 kilograms (22 pounds) in nineteen days), and 3) not providing the volume of enteral formula orders per physicians order for Patient 2 who had a documented 19 pound weight loss. These practices put these critically ill patients at further risk of poor outcome during their hospitalization.

Findings:

1. Patient 5 had diagnoses including altered mental status. On 1-6-10 at 12:05 p.m. during lunch meal, dietary staff was observed leaving a tray on the cart after passing all other patient trays. During a concurrent interview, Licensed Staff M (LS M) stated the tray was not passed because there was a paper on the tray that read "Aspiration Alert." LS M took the tray from the cart and brought it to the Patient 5, who was sitting up in his room, in bed, with his feet hanging over the side and back facing the hallway. LS M then disappeared. When the surveyor left the hallway six minutes later, Patient 5 was still eating in his room. During an interview, Nurse Management Staff Q stated "The licensed nurse should have stayed with the patient, or should have had a CNA (certified nursing assistant) come stay with the patient while she was eating."

On 1/6/09 the hospital provided the policy "Swallowing Precautions for Dysphagia Patients" as the nursing policy/procedure to be followed for a patient with aspiration alert. The policy included the procedure "Nursing shall assist with feeding of patient and /or observe patient while eating for signs of aspiration."

2. Patient 7 had diagnoses that included subdural hematoma (intra-cranial bleeding, blood collecting over the brain) and was admitted on 12/17/09 and weighed 73.1 kilograms (kg). Upon admission, the physician ordered Patient 7 to have "weights every other day" and a "Regular" diet.

On 1/7/10 commencing at 9:30 a.m. during medical record review, it was revealed Patient 7 had been determined to be at "low nutrition risk" when admitted, and had not been seen by the food and nutrition department, following their procedures, until 12-23-09 when Dietary Staff N completed a "Comprehensive Nutrition Screen" and determined the patient was at "moderate nutrition risk" and noted "suggest Ensure supplements." The nutrition screen revealed the patient had not been weighed since admission. On 12/30/09 Dietary Staff N again charted "No new weight" and "moderate risk". On 1/5/10 Patient 7 was weighed by nursing for the first time following admission, and was noted to weigh 63 kg., a 10 kg (22 pounds) weight loss in 19 days since admission. On 1/6/10 Clinical Nutrition Staff O completed an "Initial Nutrition Assessment" and noted the 10 kg weight loss, and recommended "(change supplement) to Ensure Plus (product provides 1.5 Calories per milliliter.)

On 1/7/10 at 11:00 a.m. during an interview, CNS O stated she assessed the patient when the weight loss was noted, but that Patient 7 was not at "high risk" until there was a weight loss. CNS O acknowledged Patient 7 had not been weighed every other day as ordered by the physician, and that she might have assessed the patient before the 22 pound weight loss occurred if there had been weights following the physician's order. During a concurrent interview, Nursing Management Staff R stated the unit where the patient was did "critical care" and wouldn't routinely pay attention to an order regarding weighing patients. NMS R acknowledged the order for weights every other had not been followed, and the physician had not been notified of the failure to follow the order nor the weight loss when it was noted on 1/5/10. NMS R stated "That's something the registered dietitian looks at."

During a review of the "Provider Plan of Correction" for survey completed 10/08/09, pg. 70 B, it was revealed the hospital reported it had corrected deficient practice regarding nurse failure to weigh patients following physician's orders. The POC reported established monitoring of clinical nutrition charts, including compliance with weight orders, that was completed on 12/9/09. The hospital had identified "Monitoring will continue with 5 random charts reviewed weekly in each service level x 1 month. The POC Page 70 A noted "Specified the need for nursing to document rationale if weights...were not recorded as ordered."


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3. Patient 2 was admitted after being found unconscious. Observation of the patient on 1/7/10 at 10:55 am, revealed that the patient continued to be unconscious and was lying in bed. It was also noted that he was being fed via enteral feeding (a feeding tube placed externally into the stomach through a small surgical incision).

An observation of the tube feeding revealed that the feeding was hung at 6 am and the enteral pump was running at a rate of 65 cc's/hour. Concurrently the surveyor requested that Nursing Staff J display the function that indicated the volume of feeding that had been delivered. The volume was noted to be 1116 cc's. It was also noted that the remaining amount of feeding in the open system bag was slightly less than 200 cc's.

Nursing Staff J was asked to describe the process for delivering open system enteral feedings. She stated that nursing staff should be putting in the amount of feeding required for 8 hours in the bag. At the end of 8 hours any extra feeding and the feeding bag were discarded. She also stated that based on the amount of feeding currently left in the bag the previous nurse likely added only 2 cans of enteral feeding which would not be enough for the full 8-hour shift. The surveyor also asked Nursing Staff J the policy of clearing the enteral feeding pump, to which she replied that the pump should be cleared every 8 hours and the amount of feeding should have been recorded in the patient's medical record. The surveyor asked how the hospital was able to ensure the physician's order for Patient 2 's feeding was accurately delivered, to which she acknowledged that it would not be possible to tell in this situation. Nursing Staff J also stated that all tube feedings would be delivered over a 24-hour period. The surveyor also asked whether or not there was a mechanism for "make up", as feedings are turned off for personal care or medical procedures to which she replied there was not.

Medical Record review was conducted on 1/7/10 from 9:30-11 am.
Physician's diet order dated 12/18/09 noted an order for enteral feeding with Promote at a rate of 65 cc's/hour. A physician's order dated 12/21/09 decreased the feeding rate to 50 cc's/hour. A follow up order dated 12/26/09 increased the rate back to 65 cc's/hour where it remained.

Review of tube feeding administration beginning on 1/2/10 revealed that the physician's orders of 1,560 cc's of feeding in a 24-hour period were not met for 5 of the 5 days reviewed.

Review of Patient 2's weight noted an admission weight on 12/17/09 of 136 pounds. It was also noted that through the course of hospitalization Patients' weights had fluctuated up and down with a final weight of 115 pounds on 1/5/10. Review of Input/Output (I/O) records from 1/3/ - 1/6/10 revealed that the patient had a positive fluid balance ranging from 215-775 cc's of fluid per 24/hour period. It was also noted that Patient 2 was receiving various doses of diuretics beginning on 12/20/09. In addition, the physician ordered weights revealed there was a weight loss of 19 pounds despite a positive fluid balance.

A comprehensive nutrition assessment dated 1/5/10 and completed by the Registered Dietitian (RD) noted that the tube feeding was at the goal rate and that the rate would meet the estimated nutritional needs of the patient. The assessment also noted that the average intake for the previous 4 days was below the physician ordered volume of feeding. The assessment additionally noted that the diuretic was discontinued. The RD also documented a weight loss of 19 pounds over the previous 6 days, attributing the change to fluid loss. However there was no indication that the RD had reviewed or assessed I/O records which documented a positive fluid balance. It was also noted there were no recommended changes in tube feeding delivery to ensure the physician's orders were met. Additionally there was no documentation that there was further assessment of the weight loss.

On 1/7/10 at 2 PM, review of hospital policy titled "Enteral Tubes for Feeding/Medication Administration" guided staff "For continuous ...put enough formula into the container to feed the patient for 8 hours." The policy also guided staff to "Follow provider's order regarding type of feeding ...For continuous feeding, the use of pump is mandatory in order to ensure accurate flow control..."

Based on food service observations, dietary staff interview and dietary document review the hospital failed to ensure comprehensive maintenance of equipment of two blast chillers in the dietary department as evidenced by the absence of food temperature monitoring probes.

Findings:

During observation of food handling practices of potentially hazardous foods (PHF's) on 1/5/10 beginning at 4 PM, it was noted that the hospital utilized blast chillers with probes to monitor the temperatures of PHF's during cooldown. PHF's are defined as those foods that requires time/temperature control for safety (TCS) to limit pathogenic microorganism growth or toxin formation associated with foodborne illness (Food Code, 2009).

In a concurrent interview, DMS A described a process whereby up to 5 items would be put in the blast chiller at any one time. He further stated that there were 2 probes in each of the two blast chillers; however each chiller had the capacity for up to 3 probes. The surveyor asked how the hospital ensured that the items that did not contain probes were properly cooled. DMS A replied that the items that were not probed were "similar." The surveyor also asked what was meant by "similar", after which he pointed at a diagram affixed to the wall. The surveyor inquired why the hospital was not utilizing the full capacity of the chiller by providing 3 probes for each unit. DMS A stated that the hospital had ordered some probes but others broke. He also stated that there were additional probes being ordered.

In an interview on 1/6/10 at 3 PM, with Dietary Staff D he was asked to describe the process for cooling down PHF's utilizing the blast chiller. He stated that if he had items such as oatmeal and scrambled eggs and gravy he would probe the oatmeal and scrambled eggs but not the gravy. In an interview on 1/6/10 at 3:10 PM, with Dietary Staff E he stated that would never put in more than 2 items since the unit had only 2 probes.

Review on 1/6/10 at 10 am, of hospital documents titled "Batch Record Form" for sampled dates of 12/14/09 and 12/21/09, totaling 3 blast chill cycles revealed that on all of these days there were 4-7 items being cooled. It was also noted that in the 12/14/09 batch the probes were inserted into the minestrone soup and eggs, there were no temperature probes for the cream of wheat or cream of rice. On the second batch dated 12/14/09 there were 6 items placed in the chiller; however the only items that were probed were beef and chicken broth. There was no probing of oatmeal, gravy, turkey or fish. Similarly on 12/21/09 batch the items probed were the navy bean soup and cream of wheat. There was no probing for cream of rice or rice.

On 1/7/10 at 3:30 PM, a review of hospital document titled "Purchase Order" noted that on 12/10/09, the hospital received an additional 3 probes for the blast chiller. However there was no documentation of additional purchase orders to replace probes that became non-functional.

Review of hospital document titled "Provider's Plan of Correction" dated 12/15/09 revealed that the hospital had completed a through review of food handling systems and found 100% compliance in the handling of PHF's. There was no documentation that the hospital had fully evaluated manufacturer's recommendations for use of the blast chillers.

20245

Based on food service observations, dietary staff interview, dietary and administrative document review, the hospital failed to:

1. Ensure the availability of organized dietetic services that were directed and staffed by adequately qualified personnel (A 619, A 620, A 622, A 749)

2. Provide organized dietetic services as evidenced by findings of unsafe food handling practices as evidenced by lack of effective monitoring of potentially hazardous foods (A 619, A 749)

3. Provide effective and safe cleaning and sanitation of stationary food production surfaces and equipment (A 749)

4. Ensure the presence of adequate plumbing to minimize the cross contamination during food production activities (A 749)

The cumulative effects 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 a sanitary environment and avoid sources and transmission of infections in food services. Failure to ensure acceptable standards of practice may put patients at risk for transmission of a food borne illness during the course of hospitalization.

Based on observation, interview, and document review, the hospital failed to store, prepare and serve food using safe, science based food handling techniques and products, as evidenced by:

a. The food was not heated, cooled, and held for service following safe time-temperature guidelines.
b. Sanitizer concentrations utilized on food contact surfaces was at an unacceptably high level.
c. Foodstuffs were not stored following manufacturer's guidelines, and the foods were available for use in patient food service.
d. Patient food trays were uncleanable, and had ragged fibrous shreds protruding from worn edges that were no longer glossy and coated with a cleanable surface. e. The hospital infection control oversight failed to implement timely checking of sanitizer used for cleaning and sanitizing stationary food equipment and surfaces.
f. A single opened can of food supplement was sent to multiple patients on multiple occasions, and provided for cross contamination and adulteration as the can was out of sight of staff
g. The blast chiller was not used following manufacturer's guidelines,
h. Kitchen sinks did not have air gaps, that would prevent contamination during a back-flow situation, and
i. The hospital ice machines were not sanitized with chemicals/concentration following manufacturer's guidance.

These practices put all patients at risk of food-borne illness, which can cause nausea, vomiting, and diarrhea further compromising the medical status of patients and and in severe instances may result in death.

Findings:

1. On 1-5-10 at 11:30 a.m. during lunch trayline observations, it was noted all food was plated in a chilled condition. While reviewing the trayline food temperature log, one food entree, polenta, was observed to be 69.1 degrees. During a concurrent interview, Dietary Management Staff H (DMS H) stated her job was to take food temperatures before the trayline and the temperature of all the foods was supposed to be "less than 41° F". When asked about the entree, polenta, which was observed to have a temperature of 69.1°F, DMS K stated "That was the temperature when tray line started." When asked by the surveyor if there was any action she should take if a food temperature was not less than 41°F, DMS H stated, "No, DMS A does that." At 11:40 a.m. during an interview, Dietary Management Staff A stated he had personally prepared the Polenta for trayline by taking it directly out of the freezer and putting it in the oven "about 350°F for about 18 minutes" and then putting it in the blast chiller "for about 30 minutes" while it was already chilling other food items. He stated he did not take the temperature of the polenta when he removed it from the oven, and did not put a probe in the polenta to record the temperature while it cooled or before trayline. When asked if he noted the time or temperature of the polenta at any point, DMS A stated "I forgot".

On 17/10 a.m. during a review of hospital training documents for DMS A, DMS H, and DMS K, it was that revealed none of the staff had been evaluated for competency in time-temperature monitoring of food items during the preparation and serving process.

2. On 1/5/10 at 3:00 p.m. Dietary Staff I (DS I) was observed wiping countertops with a kitchen towel which he had dipped into a clear solution in a red bucket. During an interview DS 1 stated he was wiping surfaces with "the 146" after he cleaned them with "the 133" cleaner. He stated he changed the solution "every two hours" and the 146 solution was "good right now." When the surveyor asked DS 1 whether he checked anything about the solution, Dietary Management staff (DMS) J, who was standing nearby, told the surveyor, "Supervisors check the sanitizer, not employees." DMS J stated "Dietary Management K (DMS K) is here and does that."
During an interview at 3:05 p.m., the surveyor requested DMS K check the sanitizer solution DS I was using to sanitize work tables. DMS K left and returned with a sanitizer test kit retrieved from "the janitor's closet." DMS K dipped the strip into the solution for a count of two, and then removed the strip. There was no color change. DMS K dipped a second strip in the solution and counted to 20; the strip was dark green.
DMS 3 stated one of her responsibilities' was to check the sanitizer concentration but stated she didn't know how to do it unless she read the directions. The surveyor and supervisor went to the janitor's closet where DMS K read the directions to test the sanitizer, then dispensed sanitizer into a bucket from a wall dispenser. DMS K dipped a test strip into the solution dispensed from a wall dispense and counted to 10 per the instructions. DMS K compared the color to the test kit chart and stated, "It's 200 parts- that's good." The surveyor again asked DMS K to check the actual solution DS I had been using and DMS K did so. The strip was observed to be a vivid green color, and when compared to the test kit, 500 ppm (parts per million). The signage on the wall revealed the vivid green color was an "unacceptable level." When the surveyor asked what "unacceptable" meant, DMS K stated "I don't know. The solution is "ok" because the dispenser is right. We check the dispenser, not the bucket."

DMS K provided the December, 2009 "Ecolab-Cleaning Agents Concentration Test Log" check log", which revealed the sanitizer was checked daily at 8 AM as dispensed from the wall dispenser. It was never checked when in use. On 1/7/10 the Ecolab (manufacturer of 146 sanitizer) publication "Technical Digest" was reviewed. It indicated the product "must be used within the recommended ppm level."

On 1//7/10 during review of the staff training documents, it was revealed competency of staff to use sanitizer effectively at an acceptable level, had not been assessed.

On 1-6-10 at 9:00 a.m. the hospital provided an undated Cleaning Procedure for Stainless Steel Counters and Work Areas that specified "Disinfectant 146" needs to be refreshed frequently, and the "Safety Rule" to "Use the correct dilution of chemical."

Review of facility document titled "Provider's Plan of Correction" dated 12/15/09 revealed that the hospital Infection Control Officer had conducted training with Dietary staff on safe food handling and monitoring of potentially hazardous foods and proper cleaning and sanitizing methods. The Infection Control Officer....visually inspects the kitchen monthly for cleanliness and interviews staff.

During an interview on 1/7/10 at 9:30 a.m., Hospital Management Staff P (Infection Control) stated the hospital had determined to follow a "less frequent monitoring check for food equipment sanitizers- "not like we would do in the operating room" to determine whether the cleaning/sanitizing steps were effective. She stated "We thought we would do less and then see if that was enough, rather than more and cut back (in frequency of monitoring)."

Review of the monitoring schedule revealed the sanitizer was checked at the point of dispensing just one time a day at "8 AM Before Breakfast Break" but never at point of use. During review of the December 2009 "Ecolab-Cleaning Agents Concentration Test Log" revealed the sanitizer had been checked on six of Thirteen days in December, and three of five days in January.

The hospital provided an inservice given on October 22, 2009 to "2606 Senior Food Service Workers". DS I and DMS K were not on the signature page for attendance. The hospital provided Kitchen Equipment Cleaning & Sanitizing Guidelines, hand dated 11/13/09 with signatures on it. DMS K had not signed. The hospital provided personnel files with employee evaluations. Review of the files revealed dietary management staff and dietary staff had not been evaluated for competency in testing concentration of sanitizer.

3. On 1/510 at 10:45 a.m. during initial kitchen observations, the following was observed in the walk-in refrigerator #2D23:
a. A cased of Hilltop Hearth Hamburger Buns dated "Opened 1/4, Use by 1/12." The printed manufacturers handling instructions on the box directed "Thaw at room temperature, good for 5 days when thawed. Do Not Refrigerate." During a concurrent interview, Dietary Management Staff L stated the hospital always kept their bread in the refrigerator. He acknowledged the manufacturer's handling guidelines were not followed.
b. Undated bags of wheat bread, white bread, and English muffins, out of the original box. When the surveyor asked DMS L what the storage length of time was, DMS L stated, "It doesn't stay here very long. The hospital provided the 11/10/09 Sanitation/Infection Control Policy and Procedures for Food Preparation that revealed, "All items not in their original packages are covered, labeled, and dated.
c. An opened one-half gallon container of Cross Valley Farms Deli Tuna Salad, dated "opened on 12/31/09." When the surveyor asked Dietary Management Staff L how long the opened item was good for, he stated, "It doesn't stay here very long." The hospital provided the 10/20/07 Leftover Policy that specified "After 48 hours, opened food items are disposed of."

4. On 1/5/10 at 11:30 a.m. during kitchen observations, the fiberglass/plastic patient food trays were observed to be frayed and "shredded" with the appearance of having been roughly cut with a pair of dull scissors. The corners were easily pulled apart and individual filaments separated with unknown fibrous looking debris attached. The heavily frayed edges no longer had intact glazed cleanable surfaces. DMS J acknowledged the trays were not cleanable in that condition.

During a review of the hospital nutrition services policies and procedure manual on 1/7/10 at 9:00 a.m., it was revealed there were no policies or procedures that would ensure food contact surfaces would be "cleanable" at all times as required by the State (2007 California Retail Food Code) and federal food codes(2005 Food Code).


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5. During initial tour in the dry storage area on 1/5/10 beginning at 10:20 am, it was noted that there was a can of opened protein powder, with a scoop in it. It was also noted that the can had a Patient 2's name on it with a physician's order dated 12/26/09 which guided staff to deliver 1 can of the supplement to the unit every Monday. It was also noted that underneath the current label there was a second label that revealed a physician's order dated 12/22/09 that also ordered Beneprotein for Patient 1. Additionally it was noted that there was a third patient label, which was illegible, underneath the one for Patient 1.

In a concurrent interview, DMS A stated that the current system for the protein powder would be sent to the unit per the physician's order and once opened, the unused supplement would be discarded. He also acknowledged that the can of powder had been sent to the unit and returned to the dry storage area a total of 3 times for 3 different patients.

Medical record review on 1/6/10 at 9:30 am, for Patient 2 confirmed the presence of a physician's order, dated 12/21/09, for Beneprotein three times/day to be added to an enteral feeding.

Review on 12/7/09 of nutrition services department policy and procedure manual, revealed that the hospital did not have any guidance for use of powdered protein supplements for multiple patients.

6. During observation of food handling practices of potentially hazardous foods (PHF's) on 1/5/10 beginning at 4 PM, it was noted that the facility utilized blast chillers with probes to monitor the temperatures of PHF's during cooldown. PHF's are defined as those foods that requires time/temperature control for safety (TCS) to limit pathogenic microorganism growth or toxin formation associated with foodborne illness (Food Code, 2009).

In a concurrent interview, DMS A described a process whereby up to 5 items would be put in the blast chiller at any one time. He further stated that there were 2 probes in each of the two blast chillers; however each chiller had the capacity for up to 3 probes. The surveyor asked how the facility ensured that the items that did not contain probes were properly cooled. Dietary Management Staff A replied that the items that were not probed were "similar." The surveyor also asked what was meant by similar, after which he pointed at a diagram affixed to the wall.

In an interview on 1/6/10 at 3 PM, Dietary Staff D was asked to describe the process for cooling down PHF's utilizing the blast chiller. He stated that if he had items such as oatmeal and scrambled eggs and gravy he would probe the oatmeal and scrambled eggs but not the gravy. In an interview on 1/6/09 at 3:10 PM, with Dietary Staff E he stated that would never put in more than 2 items since the unit had only 2 probes.

Review on 1/6/10 at 10 am, of facility documents titled "Batch Record Form" for sampled dates of 12/14/09 and 12/21/09, totaling 3 blast chill cycles revealed that on all of these days there were 4-7 items being cooled. It was also noted that in the 12/14/09 batch the probes were inserted into the minestrone soup and eggs, there were no temperature probes for the cream of wheat or cream of rice. On the second batch dated 12/14/09 there were 6 items placed in the chiller; however the only items that were probed were beef and chicken broth. There was no probing of oatmeal, gravy, turkey or fish. Similarly on 12/21/09 the batch items probed were the navy bean soup and cream of wheat. There was no probing for cream of rice or rice.

Review on 1/6/10 at 4:30 PM, of the manufacturer's recommendations for the blast chiller noted that while it was possible to group foods to form "batches", it was also noted that there was specific guidance on determining which foods to batch. The manufacturer's guidance noted that items with higher water content are likely to cool faster than those with relatively lower water content. It was also noted that the average cooling time for the oatmeal was the longest and scrambled eggs was the shortest. Additionally it was noted that items such as thicker soups, which would likely be the consistency of gravy, required more cooling time than the scrambled eggs.

Review of facility document titled "Provider's Plan of Correction" dated 12/15/09 revealed that the hospital had completed a thorough review of food handling systems and found 100% compliance in the handling of PHF's. There was no documentation that the hospital had fully evaluated manufacturer's recommendations for use of the blast chillers. There was no documentation that the hospital had developed and implemented an effective plan to ensure all PHF's were monitored for time/temperature control for safety.

7. During general kitchen observation on 1/5/10 beginning at 11 am, it was noted that none of the food production sinks had air gaps, instead had direct plumbing into the waste water system. It was noted that there were remnants of food stuff in the food production sink located in the food production area as well as the sinks adjacent to the large walk in freezers.
In a concurrent interview the surveyor asked Dietary Management Staff B the purpose of the sinks adjacent to the walk-in refrigerators. She replied that this was the area where patient nourishments would be prepared. The surveyor asked if this was the area where items such as whole fruits would be washed, to which she replied "yes."

In a follow up interview on 1/6/10 beginning at 9:30 am, Maintenance Supervisor C was asked to describe how the hospital ensured that there was an air gap in food production sinks. He stated that he was aware of the lack of air gaps identified on 10/8/09 during a previous survey; however he stated he was unsure of what an air gap in a food production area would look like. He further stated he believed that the food production sinks did have adequate air gaps. Maintenance Supervisor C described his concept of the air gap was the space between where the water faucet ends and the top rim of the sink begins. The purpose of an air gap is to provide a break in waste water plumbing to prevent non-potable water from flowing back into the potable water supply, causing contamination of food production equipment. The standard of practice in food production sinks would be to ensure installation of the plumbing system, by providing an air gap, to prevent backflow of a solid, liquid, or gas contaminant at each point of use at the food establishment (Food Code, 2009).

Review of facility document titled "Provider's Plan of Correction" and dated 12/15/09 revealed that "The Infection Control Officer has now observed that adequate plumbing is maintained in the food preparation area."

8. On 1/6/10 beginning at 9:00 a.m. an interview and observations were conducted with Maintenance Supervisor (MS) C regarding the process for cleaning and sanitizing the hospital ice machines. During the interview it was revealed the hospital did not follow the manufacturer's guidance for type and concentration of sanitizer. The manufacturer's guidance required a 200 ppm (parts per million) sodium hypochlorite/warm water solution. The product used by MS C was ammonium chloride and ethyl alcohol. During a concurrent interview, MS C acknowledged the sanitizer was incorrect.

Review of the 12/15/09 facility document titled "Provider's Plan of Correction" revealed "The Facility Services Department has changed the preventive maintenance....All preventive maintenance tasks are per the recommendations of the manufacturer."


14545

Based on interview and record review, the facility failed to implement specific surgical privileges for its surgery and ophthalmology departments prior to the survey. More specific privileges were still in draft form and had not yet been agreed to. The deficient practice delayed a change which was needed in order for the facility to be able to grant only those surgical privileges for which it had determined that the provider had current competence.

Findings:

In an interview on 1/5/10 between 10:28 a.m. and 10:57 a.m., Staff D stated that he had encountered some resistance from the department chairs to the concept of enumerating specific surgical privileges and that he would like to see the surveyor guidance regarding specific surgical privileges in order to be able to persuade them that specific surgical privileges were a requirement.

Review of Practitioner 1's credentials file indicated that he had been appointed to the facility's medical staff on 10/20/09. Practitioner 1's general surgery core privileges included "Preoperative, operative and post-operative care of patients of all patients [sic] with diseases of the alimentary tract, abdomen, breast, head and neck, endocrine system, vascular system, and soft tissues..."

Review of the Surgical Council on Resident Education's (SCORE) General Surgery Residency Patient Care Curriculum Outline (http://home.absurgery.org/xfer/patientcareoutline09-10.pdf) indicated for each of the organ systems included in Practitioner 1's core privilege, there were surgical procedures which were complex and were "Not consistently performed by general surgeons in training and not typically performed in general surgery practice." The outline further indicated that completion of a general surgery residency did not necessarily imply competence in the procedures listed as being complex.

Review of Practitioner 5's credentials file indicated that he had been appointed to the facility's medical staff on 12/15/09. Review of Practitioner 5's general ophthalmology core privileges indicated that they included "surgical management off [sic] disorders and abnormalities affecting the eye, ocular adnexa, visual system and related systems..."

In an interview on 1/5/10 at 1:24 p.m., Staff C stated that Practitioner 1's privileges were done before the latest revisions. She stated that the latest draft of the surgery privileges was created "last week" and had been calendared for consideration by the medical executive committee (MEC) "this week" and consideration by the governing body "next Tuesday". In an interview on 1/5/10 at 1:49 p.m., Staff C stated that Practitioner 5's privileges had been completed in October and so were not yet the revised version.

Review of the agenda for the "ADMINISTRATIVE MEC MEETING JANUARY 7, 2010" indicated that "Review and Approval of Revised Privilege Lists" for the "Surgery Service" and the "Ophthalmology Service" was on the agenda.

In an interview on 1/5/10 at 4:05 p.m., Staff A stated that the facility hadn't done approvals over the holidays because they wanted to have a meaningful approvals process. Staff B stated that the governing body could approve changes prior to conclusion of the survey.