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Based on observation, interview, and record review, the facility's governing body failed to exercise responsibility for and control over the hospital's conduct in a manner sufficient to ensure compliance with the Centers for Medicare & Medicaid Services (CMS) conditions of participation for hospitals.

1. The governing body failed to provide a hospital wide infection control program to conduct effective surveillance that would prevent the transmission of food borne infections in the dietary department (Cross Reference A 264).


2. The governing body failed to ensure that contracted services were provided with effective oversight (Cross Reference A622, A629 A630, A701, A749).


3. The hospital failed to ensure that contracted services. (Cross Reference A622, A629 A630, A701, A749).

4. The hospital failed to ensure the development and implementation of a performance improvement program within Food and Nutrition Services that reflected operational processes within the department.

5. The failure to have a policy and procedure for monitoring humidity in the surgical suites, the facility's failure to monitor humidity in three of four operating rooms, and the facility's incapability of adjusting humidity levels in two of four surgical suite locations that increased the risk of infection in surgical wound sites. (Cross Reference A749).

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment.

Based on food service observations, dietary staff interview and dietary document review the governing body failed to ensure that contracted services were provided by a Registered Dietitian to ensure that oversight of the department processes were executed in a manner that complied with conditions of participation for quality assurance/performance improvement (QAPI), infection control and dietetic services.

Findings:

Review of the hospitals' contract for food service management was reviewed on 6/15/11 beginning at approximately 9 am. The contract was initially entered into on 10/4/2010 which described the roles and responsibilities of the contractor. According to the document titled "Management Agreement: and dated 9/30/11 the contracted service had the "exclusive right to manage and operate Services for Client's patients, employees, visitors and guests at the Premesis." (sic) The management agreement also specificed that the contractor would conduct weekly tray assessments and quarterly patient surveys.

The hospital document titled "Exhibit C Nutrition Services" dated 9/30/11 noted that the contractor would provide a Director to work in the Nutrition Services.

In an interview on 6/15/11 at 10:45 am, Administrative Staff J was asked to describe the scope of the contracted food service. On 6/15/11 at approximately 1 pm, he presented the surveyor with an analysis. He stated that the scope of the contract was to provide patient and cafeteria food service as well as catering for special events. He also stated the only contracted employee was DMS A whose responsibility was to oversee the nutrition services department. AS J also stated that it would be the responsibility of the CEO to review contracted services and that contracts would not be reviewed until one-year after the implementation date.

Review of DMS A's personnel file revealed that she was not a RD. There was no indication that the contract provided a RD to provide day to day oversight of foodservice operations. Comprehensive review of the hospital position description for the RD and the contracted vendor agreement revealed that the hospital did not implement a mechanism for day to day guidance, by an RD, for food service activities (Cross Reference A621).

Review of food handling practices revealed that staff practices including thawing of meats, cooldown of meats and food storage practices were not in compliance with good food safety guidelines (Cross Reference A749).

The governing body failed to ensure that the dietary department developed and participated in a hospital wide QAPI program that focused on the identification of quality and performance problems (Cross Reference A264)

Review of disaster meal planning revealed there was an inadequate food supply to meet the nutritional needs of patients and staff that would be required for patient care in a disaster (Cross Reference A701).

Staff knowledge was inadequate in terms of monitoring food temperatures utilizing water as the method for thawing (Cross Reference A622).

Based on hospital administrative and dietary staff interview and administrative and dietary document review the hospital failed to ensure there was a hospital wide QAPI program that included nutrition and food services as evidenced by:

1. The failure to ensure development of an effective program, that identified opportunities for improvement, in food services and clinical nutrition care (Cross Reference 264).

The cumulative effect of these systemic problems resulted in the hospitals' failure to meet statutorily mandated compliance with the Condition of Participation for Quality Assurance Performance Improvement.

Based on interview and document review the hospital failed to have an ongoing quality appraisal and performance improvement program that addressed the complexity and scope of Food and Dietetic Services.

Findings:

In an interview on 6/15/11 at 10:10 a.m., the surveyor asked Licensed Staff A how the hospital ensured development of departmental improvement programs. She stated that that the committee did not make decisions on the types of activities, rather would rely on departmental leaders to choose the activities.

On 6/15/11 at 3:00 pm, in a concurrent interview and document review the quality appraisal and performance improvement (QAPI) data for food and nutrition services was reviewed with DMS A, Registered Dietitian B and Licensed Staff A who actively participated in the hospitals' performance improvement program. The performance improvement (PI) data for 2010, noted that the PI activities for clinical nutrition care data focused on the whether or not the physician ordered diets were reflective of a nutrition diagnosis. The 2010 PI data related to food service pertained to patient meal satisfaction, which evaluated the temperature and quality of the food. The food service data also included dietary departmental checklists which consisted of hospital safety rounds, county food facility inspection resports and kitchen inspections. It was noted that all measured parameters for nutrition care and food services reflected an acceptable threshold for the department. There was no identification of opportunities for performance improvement activities related to food and nutrition services from 2005-2010.

In a concurrent interview with DMS A, RD B and Licensed Staff A they acknowledged that the reported activities were reflective of monitoring activities rather than activities for which there would be opportunities for improvement. There was no documentation provided to ensure the QAPI program was developed to fully evaluate the outcomes of processes within hospital food service. There was no indication that the hospital developed a QAPI program the identified opportunities for patient outcome in relationship to clinical nutrition care.

Review on 6/15/11 at 3:45 pm, of hospital document titled "Performance Improvement Program 2011" noted that the purpose of the plan was to be "used by each employee...to continually...improve the processes they perform..." It was also noted that the scope of the plan was to encompass all departments within the organization. While the food and nutrition department was collecting data, there was no identification of activities that may lead improvement in the performance of the department.

Based on interview, medical record review, and document review, the hospital failed to ensure that all medical record entries are legible in 2 of 18 medical records, potentially resulting in situations where staff could be unaware of important medical information.

Findings:

On 6/7/11 and 6/8/11, review of 18 medical records demonstrated that parts of the admission history and physical (H&P) examnation reports of Patients 16 and 17 were illegible. In both cases, the listings under "co-existing conditions", "medications", "allergies", and "HEENT" were illegible.

During an interview on 6/8/11 at 2:30 pm, Licensed Staff A acknowledged that she could not decipher the hand-written entries in the records of Patients 16 and 17.

On 6/8/11, review of the hospital's medical staff rules and regulations of 3/24/11 demonstrated that "all entries in the medical record must be legible (illegible entries shall be deemed as non-documentation)."

Based on observation, interview and document review the hospital failed to ensure that 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).

2. Ensure comprehensive disaster planning (Cross Reference A701)

3. Develop performance improvement activities that reflected the scope and nature of the services (Cross Reference A264).

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

5. Ensure the development of comprehensive policies and procedures that reflected the scope and nature of services (Cross Reference A 619, A620, A749)

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

Based on food services observations, dietary staff interview and dietary document review the hospital failed to ensure an effective organizational processes as evidenced by the lack of foodservice procedures relative to the scope and nature of the departments' activities. Failure to develop comprehensive guidance for food handling procedures that resulted in unsafe food handling practices putting patients at risk for foodborne illness, further compromising clinical status.

Findings:

1. During food service observations beginning on 6/13/11 at approximately 1:30 pm, issues surrounding the handling of PHF's were identified (Cross Reference 749). In an interview on 6/14/11 beginning at 9:05 am, the surveyor asked DMS A to describe the basis for safe food handling guidance. She stated that she utilized California Code of Regulations, Title 22. The California Code of Regulations, Title 22, Social Security Division, Chapter 5 are regulatory requirements that govern facilities. They do not delineate operating policies and procedures (California Department of Public Health, 2011). The surveyor also asked DMS A to provide a procedure that described the process of thawing meats under water. Concurrent review of the hospitals' policy and procedure manual as well as the contracted food service vendors' policies revealed there was no guidance for this process.

Review of the hospital document titled "Nutritional Services Department ...Policies and Procedures Manual" updated 2/10 revealed that while the department had some policies related to food procurement, receiving, storage and handling the policies did not consistently provide staff guidance. Examples included a policy titled " Food Procurement " dated 11/09. The purpose of this policy was to promote proper infection control. It also noted that the policy would follow specific safe food handling practices, including Hazard Analysis Critical Control Program (HACCP); however no procedures were developed. There was no indication that the hospital developed an effective organizational structure including procedural guidance relative to the scope and nature of food services.

Based on food production observations, dietary staff interview and dietary document review the hospital failed to ensure the Director of Food Service provided effective oversight 1) lack of effective monitoring of time/temperature control of potentially hazardous foods and 2) maintenance of disaster supplies.

Failure to ensure implementation of existing policies and development of policies and systems relative to the scope of food services may put patients at risk for foodborne illness, further compromising clinical status and in severe instances may result in death.

Findings:

1. During food storage observations on 6/13/11 beginning at 2 pm, it was noted that in the walk-in refrigerator there were 2 plastic tubs of raw salmon labeled 6/16 that were fully thawed. It was also noted that there was a cooked deli-turkey roll. Fish and turkey are considered potentially hazardous foods (PHF). PHF's are defined as those foods capable of supporting bacterial growth associated with foodborne illness. Safe food handling practices would ensure that PHF's are maintained under safe food preparation/storage temperatures, defined as 41-135?F. Food handling practices would also ensure that if PHF's are held outside of this temperature range, it would be not be for greater than 4 hours cumulatively, prior to cooking/consumption (Food Code, 2009). Foodservice observations from 6/13-6/14/11 revealed concerns associated with safe food handling practices (Cross Reference A749).

On 6/14/11 beginning at 9:05 am, in an interview with Dietary Management Staff A (DMS A) the surveyor asked how the hospital ensured safe food handling practices when staff thawed meat using water. She stated that the hospital did not monitor the time and/or temperature of food if it was thawed under running water. She also stated that to her knowledge there was no policy for thawing foods.

Review of hospital document titled "Job Description/Performance Appraisal" dated 3/30/10 for the Nutrition Services Manager revealed that it was the responsibility of this position to "promote a safe environment of care..."and"...appropriately plans and directs the operations for all feeding facilities of the organization..."

2. During review of disaster preparedness for the food and nutrition department on 6/13/11 at 4:24 pm, it was noted that there were inadequate inventories of disaster food supply. In a concurrent interview with DMS A she acknowleged that she discarded some of the foods because they were expired and had not yet reordered it. She also acknowledged it was within her position description to ensure the daily management of the department, including the maintenance of disaster food supplies. She also stated she had not realized that the supply of powdered milk was inadequate for the expected number of servings (Cross Reference A701).

Based on food production observations, dietary staff interview and dietary document review the hospital failed to ensure the registered dietitian provided effective collaboration for day to day food service activities as evidenced by 1) lack of effective monitoring of time/temperature control of thawed potentially hazardous foods, 2) lack of an effective alternate system to ensure cool down monitoring of potentially hazardous foods that were thawed as part of the cooking process and 3) lack of current specialized training related to safe food handling practices.

Failure to ensure implementation of existing policies and development of policies and systems relative to the scope of foodservices may put patients at risk for foodborne illness, further compromise of clinical status and in severe instances may result in death.


Findings:

1. During foodservice observations beginning on 6/13/11 at approximately 1:30 pm, issues surrounding the handling of PHF's were identified (Cross Reference 749). On 6/15/11 at 12:45 p.m. review of the undated Nutritional Services Organizational Chart provided by the hospital revealed the RD oversight consisted solely of duties related to the clinical care of inpatients. There was no indication that the RD provided day to day oversight for kitchen activities.

The hospital provided a Comprehensive Food Safety Self-Inspection checklist, completed by the RD, dated October 23, 2010, as well as a Food Safety Audit dated 5/15/11, completed by DMS A and co-signed by the registered dietitian. The hospital was unable to provide documentation that the registered dietitian provided comprehensive oversight for the day to day kitchen activities.

In an interview on 6/13/11 at 3:30 p.m. with RD B, the surveyor asked her to describe her involvement in food service. She stated that the hospital recently went to a contracted food service at which point she pulled away from food service oversight. She also stated that the contracted vendor had a registered dietitian that provided DMS A with some guidance but was unsure of the scope. She also stated that if DMS A had a question, she was available for guidance but did not independently provide daily oversight.

Review of the position description/Performance Appraisal for RD B dated 3/25/11 revealed that this positions' responsibilities were listed as clinical duties such as delivering nutritional care in accordance with physicians' orders; assess, plan and administer nutrition care, patient counseling and serve as a resource for development of policies/procedures related to nutritional care. There were no documented responsibilities for RD collaboration with food services or for the assurance that current food handling procedures were followed or that procedures reflective of the nature of food service operations were developed.

3. During an interview on 6/15/11 RD B the surveryor asked her to describe any specialized training she received in relationship to food safety. RD B stated she had not attended any continuing education on food safety "in a long time."

Based on food storage observations and dietary document review the hospital failed to ensure staff was competent in their assigned duties as evidenced by lack of monitoring of potentially hazardous foods during thawing. Failure to ensure staff is competent in their assigned duties may result in practices that place patients at risk for food borne illness. Food borne illness may result in compromise of clinical condition and in severe instances may result in death.

Findings:


During food storage observations on 6/13/11 beginning at 2 pm, it was noted that in the walk-in refrigerator there were 2 plastic tubs of raw salmon labeled 6/16 that were fully thawed and a prepared deli turkey roll. Fish and turkey are considered potentially hazardous foods (PHF). Food storage observations and ensuing investigation revealed that DS G was not thawing PHF's in a safe and effective manner (Cross Reference 749).

Review of hospital document titled "Initial Competency Assessment & Probationary Evaluation Form" dated 5/14/09 noted that under the section titled "Sanitation" recording of food temperatures was a task. It was also noted that the competency would be determined via written/verbal, simulated performance or not assessed due to lack of opportunity. The form also had an area to assess the outcome on a scale of 1-3. While the form was signed off by the preceptor on 6/1-6/5 (no year) there was no indication of how the competency or outcome was determined. There was no additional documentation that DS G was guided on proper thawing techniques.

Review of hospital training titled "Safety Fundamentals" dated 12/28/10 and attended by DS G, noted that staff was trained on the identification of PHF's as well as demonstrating "foodborne illness prevention steps at every critical control point"; however there was no descripiton of the concepts taught at the training or that thawing was discussed.

Based on foodservice observations and dietary document review the hospital failed to ensure that all diets were ordered by physicians as evidenced by the development of an "idiosyncratic soft diet" without defined parameters and/or medical staff approval.

Findings:

During review the hospitals therapeutic diet spreadsheet, in conjunction with RD B, for the week of 6/12/11 beginning at 3:30 pm, it was noted that one of the diet columns was labeled as "IS." In a concurrent interview with RD B she stated that this column was for the idiosyncratic diet. She further explained that if the physician ordered a soft diet the speech therapist, the RD and the Dietary Services Supervisor consulted one another and determined the types and/or textures of food that would be given to the patient. She acknowledged that there were no defined parameters on what that diet might entail. She also staed that the physicians' did not use that terminology when ordering diets.

Concurrent review of the hospitals' diet manual, dated 1/11 revealed that there was no approved idiosyncratic diet. RD B acknowledged that this diet was developed within the department and did not have medical staff approval.

Based on medical record review and RD interview the hospital failed to ensure hospital diets met recognized standards as evidenced by the use of diet as tolerated which was not approved diet terminology, for 1 of 8 patients reviewed for nutritional care.

Findings:

Patient 37 was admitted with diagnosis including septic shock and an abdominal wall abscess.

Medical record review was conducted on 6/14/11 beginning at 1:30 pm. Admission diet order dated 6/8/11 was NPO (nothing by mouth).

A follow up diet order dated 6/9/11 was a clear liquid diet and on 6/10/11 the physician ordered as a diet as Tolerated (DAT).

In a concurrent interview with RD B she was asked to describe how the kitchen would interpret the DAT order. She stated that if that order was received in the kitchen it would be interpreted as a regular diet.

Review of the hospitals' diet manual dated 1/11 revealed that DAT was not part of the medical staff approved diets. DAT as not considered to be a valid diet order and would require clarification of the ordering physician prior to implementation as patient diets may require therapeutic diet individualization.

Based on dietary staff interview and dietary document review the hospital failed to ensure comprehensive maintenance of the physical environment as evidenced by 1) inadequate disaster food supplies to meet the needs of patients and staff and 2) ice machine maintenance that did not meet manufacturers' guidance that may result in contaiminated ice and transmission waterborne illness.

Findings:

1. During food storage observations, dietary document review, and interview with DMS A on 6/13/11 beginning at 4:25 pm, the hospitals' disaster meal plan was reviewed. DMS A stated that the hospital was planning for 135 patients and staff. It was noted that the hospital had developed a menu for a total of 4 days, of which 3 of the days consisted of canned supplies. The surveyor conducted a spot check of several items including 1 entree as well as powdered milk. The facility developed menu consisted of 3 cups of powdered milk/day/person for 3 days which would require a total of 1215 servings, or the capacity of 80 gallons of milk. It was noted that the hospital supply was 4.5 gallons. It was also noted that the facility stock for the entree was approximately 35 servings short. DMS A acknowledged the shortage of the staple food supply.

2. On 6/13/11 beginning at 3 pm, the process for hospital ice machine maintenance was reviewed with Facilities Staff (FS) I. FS I described that there were 2 different brands of ice machines and were cleaned and sanitized twice/year. FS I stated that the products used were lime-a-way? and a bleach solution consisting of 2 ounces of bleach to approximately 32 ounces of water.

Review on 6/14/11 at 10 am, of the manufacturers' guidance for each of the ice machines revealed that one of the manufacturers recommended a mixing 7 ounces of Scotsman Ice machine cleaner with 2 liters of warm water followed by a sanitation solution of 1 ounce of bleach with 2 gallons of warm water. Manufacturers' guidance for the second ice machine required Ecolab Mikro-chlor cleaner? in a 2-step process each step requiring different solution strengths. It was also noted that the manufacturer also recommended quarterly cleaning.

Based on observation, interview, and document review the facility failed to: 1) develop and implement safe food storage and food preparation systems to avoid sources and transmission of infections; and 2) maintain the relative humidity levels in their operating rooms that increased the risk of infection in surgical wound sites, as evidenced by:

1. Failure to provide safe/effective dietetic services as evidenced by findings of unsafe thawing of potentially hazardous foods that were then held over for service the following day and unsafe food handling practices (Cross Reference A620 and A749).




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2. The failure to have a policy and procedure for monitoring humidity in the surgical suites, the facility's failure to monitor humidity in three of four operating rooms, and the facility's incapability of adjusting humidity levels in two of four surgical suite locations that increased the risk of infection in surgical wound sites. (Cross Reference A749).

The cumulative effect of these systemic problems resulted in the inability of the hospitals' infection control program and food and nutrition services to ensure: 1) that food production/storage processes were safely implemented and potentially hazardous foods were monitored in accordance with acceptable standards of practice; and 2) that surgical procedures were performed under conditions that were least likely to promote the growth of organisms in surgical wound sites.

Based on food production observations, dietary staff interview and dietary document review the hospital failed to ensure dietary management staff provided effective oversight into food services as evidenced 1a) lack of effective time/temperature monitoring system for potentially hazardous foods thawed using water.

Failure to ensure effective systems to prevent the transmission of hospital acquired infections, such as foodborne illness, may result in further compromising acutely ill patients' clinical condition and in severe instances may result in death.

The lack of the effective systems to prevent the transmission of hospital acquired infections resulted in an immediate jeopardy situation to the health and safety of patients. An immediate jeopardy was called on 6/14/11 at 11:25 am, related to the lack of effective thawing practices, for potentially hazardous foods, utilizing water as a defrosting method, The immediate jeopardy was not abated prior to survey exit on 6/15/11 at 4:25 pm. The Chief Executive Officer, and the Chief Nursing Officer, the Registered Dietitian and the Dietary Manager were informed on 6/15/11 at 4:25 pm, that the IJ was not abated.

Additional findings not included in the immediate jeopardy as follows:

1b) lack of a comprehensive system to ensure cooldown monitoring of potentially hazardous foods; 1c) storage of foods not following manufacturers' guidance and 1d) lack of an effective system for dating spices.

2. The facility failed to maintain the relative humidity levels in their operating room locations. This was evidenced by the facility's failure to have a policy and procedure for monitoring humidity, the facility's failure to monitor humidity in three of four operating rooms, and the facility's inability to adjust humidity levels in two of four operating room locations. This failure resulted in the potential for an increase in bacterial growth in surgical wounds and subsequent surgical wound site infections.

Findings:

1a. During food storage observations on 6/13/11 beginning at 2 pm, it was noted that in the walk-in refrigerator there were 2 plastic tubs of uncooked, fully thawed salmon, measuring approximately 5 " deep. Fish is considered a potentially hazardous food (PHF). PHF's are foods capable of supporting bacterial growth associated with foodborne illness. Safe food handling practices would ensure that PHF's under refrigeration are maintained below 41?F.

In an interview on 6/13/11 at 2:15 pm, with DMS A the surveyor asked the pull date of the item. DMS A summoned DS G who stated the item was pulled from the freezer earlier in the day. The surveyor asked him to describe why the item was fully thawed. He stated that he thawed it beginning at approximately 1:30 pm under water and completed the process about 2:05 pm. On 6/13/11 at 2:15 pm, the surveyor took the temperature of the salmon, in the presence of DS G, which was 57?F. There was no indication that DS G was concerned that the salmon temperature was above 41?F or that he notified DMS A of the elevated temperature. The standard of practice would be to ensure that cooling be accomplished in accordance with time and temperature criteria by using one or more methods, based on the type of food, such as placing the food in shallow pans, separating into smaller or thinner portions, using rapid cooling equipment adding ice as an ingredient or other effective methods (Food Code, 2009).

The standard of practice for thawing foods utilizing water would be to ensure that thawing items were 1) completely submerged under running water at a water temperature of 70?F or below and 2) for a period of time that does not allow thawed portions of raw animal food requiring cooking, to be above 41?F for more than 4 hours including: a) the amount of time the food is exposed to the running water and b) the time needed for preparation for cooking or the time it takes under refrigeration to lower the food temperature to 41?F (Food Code, 2009).

In an interview on 6/13/11 at 2:15 pm, the surveyor asked DS G to describe the thawing process for the salmon. He stated that approximately 1 hour ago the items was pulled from the freezer and placed in water. Once thawed he put the salmon into 2 bins, wrapped them and put them in the walk-in refrigerator. He further stated the item would be used the following day. The surveyor asked him if any food or water temperatures were taken at any time during the thawing process. He replied that he did take the temperature; however when the surveyor asked what the temperature was he stated "I don't remember." He also stated he did not record the temperature anywhere. The surveyor asked him if there was a procedure or staff guidance on monitoring food temperatures during the thawing process. He stated there were guidelines and directed the surveyor to a document that was posted on the bulletin board adjacent to the stove. He also stated " that ' s how I was trained to do it " and that he had been following this process for about 2 years. Concurrent review of the hospital document titled "Food Product Shelf Life Guideline" dated 11/22/10 revealed that the document did not provide any guidance on thawing food under water; however it did note that fish "Must be thawed under refrigeration ..."

In an interview on 6/13/11 at 3:30 pm, with the Registered Dietitian (RD) the surveyor asked her to describe her involvement in food service. She stated that the hospital recently went to a contracted food service at which point she stated that she pulled away from foodservice oversight. She stated her oversight consisted of periodically completing a food safety inspection. She also stated if DMS A identified a problem she would ask for guidance and that the contracted vendor had a Registered Dietitian that also provided guidance to DMS A. The hospital document titled, "Job Description ...Registered Dietitian" dated 3/25/11 revealed that this position reported to DMS A. It was also noted that the job summary for this position was to plan and deliver nutritional care of patients. There was no indication that the RD, the position with specialized knowledge and training in food service, was assigned responsibility for the oversight of food services. The role of the RD in food service would be to ensure effective food handling processes as well as adherence to sanitation and safety standards. Review of the undated departmental organizational chart noted that the RD provided only "clinical oversight" to the cooks and diet aides. There was no indication that the hospital gave the RD clear authority for comprehensive foodservice oversight.

In a follow up observation on 6/13/11 at 4:45 pm, (3 hours after the thawing process started) the salmon temperature was 53?F. A follow up observation on 6/13/11 at 5:20 pm (3.75 hours after the thawing process was started) noted the salmon temperature was 52?F. At no time during the observation period was the temperature of the thawed item below 41?F nor were there observed interventions to facilitate a more effective cooling method such as separating the food into smaller quantities or placing it in the freezer. The standard of practice would be to ensure that raw PHF's are maintained under time/temperature control during food handling/storage. Time/temperature maintenance would ensure cold PHF's are not held above 41?F for greater than 4 hours cumulatively, including the amount of time required for thawing as well as cooking (Food Code, 2009). The hospital failed to ensure an effective system for time/temperature monitoring during the observed thawing process. It was also noted that while staff were staff in the kitchen while the surveyor took multiple temperatures dietary staff did not seek recognize any potential concerns.

On 6/14/11 beginning at 9:05 am, in an interview the surveyor presented DMS A with the observed salmon temperatures and time frames in which they were taken and asked DMS A if these temperatures were acceptable. She stated that since the items were in the refrigerator she was "confident that residents would not get sick." The surveyor asked DMS A to describe the basis for this information. She stated that she utilized California Code of Regulations, Title 22. The California Code of Regulations, Title 22, Social Security Division, Chapter 5 are regulatory requirements that govern facilities. They do not delineate operating policies and/or procedures (California Department of Public Health, 2011). DMS A stated that the hospital did not monitor the time and/or temperature of food during thawing; that there was no policy for thawing foods, and that there was no guidance for staff to follow. DMS A did not recognize or express any concern that there was no temperature monitoring during the thawing process nor did she acknowledged that there should have been a system to monitor time/temperature control during the process; or offer any additional steps that should have been implemented to facilitate cooling.

Review on 6/14/11 at 10 am, of the departments' policy and procedure manual updated 2/10 confirmed there was no procedure for thawing of foods using water. The dietary staff was unable to demonstrate the understanding of safe thawing using water and there were no observed interventions to facilitate rapid cooling of the salmon. The item was served to patients for lunch on 6/14/11.

In an interview on 6/15/11 at 10:45 am, with Administrative Staff J was asked to describe the scope of the contracted food service. On 6/15/11 at approximately 1 pm, he presented the surveyor with an analysis. The analysis indicated that the contracted vendor was responsible for operating patient and cafeteria services as well as special functions. He also stated the only contracted employee was a director to work in the nutrition services department. Review of DMS A's personnel file revealed that she possessed a certificate in food service operations; however was not a RD. There was no indication that the contract provided a RD to provide day to day oversight of foodservice operations. Comprehensive review of both hospital position description for the RD and contracted vendor agreements indicated that there was no RD responsibility for foodservice operations

During an on site visit on 6/24/11 at 3:15 p.m., review of documents indicated that the RD job description was amended to include oversight of kitchen procedures. The procedure for thawing frozen foods was revised and a log for recording temperatures and the process was developed. A lesson plan for training staff was created and six of the 17 staff currently working in the kitchen were trained on the new policy. The dietary manager stated that the six not yet trained would be trained prior to working their next shift. During observation at 3:30 p.m., the kitchen staff on duty demonstrated competency by thawing shrimp for the evening meal.

At 4:15 p.m. on 6/24/11, the Chief Nursing Officer, the Registered Dietitian and the Dietary Manager were informed that the IJ was abated.

1b. During food storage observations on 6/13/11 beginning at 2 pm, it was noted that in the walk-in refrigerator there was a prepared deli-turkey roll that was 52?F. A follow up observation on 6/13/11 at 4:40 pm, noted that the turkey was 48?F (a decrease of 3 degrees). A final observation on 6/13/11 at 5:15 pm (3 hours after the initial temperature was taken) noted the turkey was 48?F. The temperatures of the item during the 3 hour observation period dropped 4?F. The standard of practice would be to ensure that PHF's are maintained under time/temperature control during food preparation/storage. Time/temperature maintenance would ensure that PHF's are not held in the food danger zone, defined as between 41-135?F for greater than 4 hours cumulatively (Food Code, 2009).

On 6/14/11 beginning at 9:05 am, DMS A was asked to take the temperature of the turkey. It was noted that the turkey was no longer in the refrigerator. In a concurrent interview with DMS A she stated that it appeared that the cook had already cut the turkey into small cubes for the salad bar where it would be served.

The surveyor presented DMS A with the observed time/temperatures of the heated deli turkey roll from 6/13/11 and asked if these temperatures were acceptable. She stated that since the items were in the refrigerator she was "confident that residents would not get sick" from eating the salmon. The surveyor asked DMS A to describe the basis for this guidance. She stated that she utilized California Code of Regulations, Title 22. The California Code of Regulations, Title 22, Social Security Division, Chapter 5 are regulatory requirements that govern facilities. They do not delineate operating policies and procedures (California Department of Public Health, 2011).

In an interview on 6/14/11 at 9:20 am, with DS H the surveyor asked her to describe how the turkey was cooked. She stated that she thought she may have needed extra turkey on 6/13/11, all of which was frozen. She stated she placed the fully frozen turkey in the oven in a 300?F oven to thaw it on 6/13/11 at approximately 9 am and was removed at 10:30 or 11 am after which she put the uncovered item in the refrigerator and asked the evening cook to cover it later in the day. She also stated that she cooked the meat to a temperature of 165?F; however did not record the temperature. She further stated that she did not ask the evening cook to record any temperatures either. The surveyor asked why there was a thin slice missing from the end. She stated that she sliced the item to see if it was cooked. The surveyor completed a review of the timeline which noted that the DS H stated that at approximately 11 am the temperature of the meat was 165?F. The surveyor took a temperature on 6/13/11 at 2:15 pm (3.25 hours after it was removed from the oven) and noted a temperature of 52?F. A follow up turkey temperature taken on 6/13/11 at 4:40 pm, was 48?F and at 5:15 pm, was 47?F. DMS A was unable to provide an explanation as how the temperature of the item dropped 113?F in slightly over 3 hours; however dropped only 4 degrees in an additional 3 hours while continuously being in the walk-in refrigerator.

Hospital policy titled "Two Stage Cooling of Food" dated 11/09 guided staff that foods must be cooled from 140?F to 70?F within two hours and from 70?F to below 41?F or lower within four hours. The procedure also guided staff to check the temperature every half hour for the first two hours and every hour for the last 4 hours to make sure it is cooling properly. DS H failed to follow departmental procedures.

In an interview on 6/14/11 beginning at 3:05 pm, with Infection Control Staff U she was asked to describe her departments' involvement in Food and Dietetic Services. She stated that twice each year she completed safety rounds that included reviewing physical plant temperature logs, cleanliness, storage of supplies, hand hygiene, use of hair covers and employee safety hazards. She also stated that she would provide education to dietary staff if DMS A identified any needs. She further stated that she would rely on DMS A to identify concerns within the department

1c. Between 9:05 a.m.-10:00 a.m., on 6/14/11 in the walk in refrigerator there was a full case of thawed French Breadsticks dated by hospital staff "opened 6/4/11" and Exp(ire) 1/18/12. The box had manufacturer's label "Keep Frozen." The hospital was asked to provide manufacturer's guidance regarding refrigerated shelf life, and that revealed two weeks when thawed and storage in freezer or room temperature only. Additionally there were 4 sealed containers of thawed Hummus in manufacturer's package labeled "Keep Frozen." The staff had labeled the packed "Use by 7/20/11." The surveyor requested the hospital provide manufacturer's guidance as to the shelf life once thawed. The hospital reported the manufacturer guidance was the product would be used within 14 days when thawed.

1d. During food storage observations on 6/13/11 beginning at 2:30 pm, it was noted that greater than 20 containers of opened spices were opened and undated. It was also noted that items such as nutmeg was delivered 11/09; cinnamon sticks- delivered 2/08; sesame seeds delivered 4/08 and chives delivered 4/10.

Hospital document titled "Food Product shelf Life Guideline" dated 11/22/10 guided staff that spices could be held up to 6 months and would be best if used within 3 months. Hospital document titled "Comprehensive Food Safety Self-Inspection:October 23, 2010" noted in the column labeled "Unsatisfactory Condition" noted that "all products are not dated to ensure first in, first out."



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2. During record review, on 6/7/11 at 1:45 p.m., the facility's humidity logs for the locations where patients had major surgical procedures were requested. The facility had three operating rooms and one labor and delivery room. The facility was able to locate humidity logs for the labor and delivery room but not for the three operating rooms. The humidity was logged for the labor and delivery room by labor and delivery staff. No humidity logs were available prior to January 2011.

During an interview on 6/7/11 at 2:31 p.m., Licensed Staff R stated that the Surgery Department did not monitor humidity levels in the operating rooms. Licensed Staff R indicated that she believed engineering staff monitored the humidity levels. Licensed Staff R indicated that the facility did not have an adopted policy or procedure for monitoring humidity levels in their operation rooms.

During interview on 6/7/11 at 2:52 p.m., Engineering Staff S stated that engineering staff did not monitor humidity levels in the operation rooms.

During observation on 6/7/11 at 3:03 p.m., of the Surgery Department all three operating rooms had wall mounted hygrometers that displayed the relative humidity levels at their respective locations. Operating room 1 had a relative humidity of 86 percent. Operating room 2 had a relative humidity of 88 percent. Operating room 3 had a relative humidity level of 59 percent.

On 6/8/11 at 9:01 a.m., the labor and delivery room was observed. The labor and delivery room had a wall mounted hygrometer displaying the relative humidity level at that location. The relative humidity was 72 percent.

On 6/8/11 at 2:35 p.m., Licensed Staff T was interviewed. Licensed Staff T stated that labor and delivery staff observed the humidity levels daily. Licensed Staff T stated that the relative humidity should be within the range of 45 to 60 percent and that if humidity was observed to be outside the 45 to 60 percent range then labor and delivery staff would contact the Engineering Department to adjust.

During an interview on 6/8/11 at 2:40 p.m., Engineering Staff S stated that there was no way to adjust humidity levels in the labor and delivery room or operating room 3. Engineering Staff S stated that new air handling units were installed on 6/4/11 for operating rooms 1 and 2 and that the new air handling units could adjust humidity levels in those two operating rooms. Engineering Staff S indicated that prior to the new air handling units, there was no way to adjust relative humidity levels in operating rooms 1 and 2. Engineering Staff S indicated that there was no way for the facility to maintain the relative humidity at any specified range.

During an interview on 6/8/11 at 10:00 a.m., Infection Control Staff U stated that she was unaware that the humidity in the operating rooms was not being monitored. Staff Control Staff U stated that in 2008 the maintenance department was assigned to monitor the operating room humidity. Infection Control Staff U presented log sheets that indicated with a check mark that the humidity had been observed by the maintenance staff but there were no specific humidity numbers logged, and no record of the operating room staff being made aware of times when the humidity was above the acceptable range. Infection Control Staff U acknowledged that there was no policy defining the process for monitoring the humidity, who should be responsible for monitoring it, what the safe range was, and what to do if the humidity was out side of the accepted range.

Based on medical record review, and document review, the hospital failed to ensure that a medical history and physical (H&P) examination was completed and documented no more than 30 days prior to surgery in 4 of 18 cases reviewed, potentially placing patients at risk for untoward outcomes.

Findings:

Review of the medical records of 18 surgical cases on 6/7/11 and 6/8/11 demonstrated:
1) The records of Patients 14 and 18 contained H&P examination reports of services that had been performed more than 30 days prior to admission for surgery. Patient 14's H&P was performed 36 days prior to surgery. Patient 18's H&P was performed 37 days prior to surgery.
2) The records of Patients 16 and 17 contained H&P reports that did not include all of the elements required by the hospital's bylaws and by the regulations. The H&P reports were absent present illness details, relevant past medical and surgical history, current medications and medication allergies, psychosocial history, physical examination specific to the operative procedure, and planned course of action.

On 6/8/11, review of the hospital's medical staff bylaws, dated 3/24/11, demonstrated that the following parameters are required to meet the standards of an "abbreviated H&P" for outpatient surgery: chief complaint, details of present illness, relevant past medical and surgical history (including current medications and medication allergies), relevant past psycho-social history, relevant physical examination of the body systems pertinent to the operative procedure (including at a minimum an appropriate assessment of the patient's cardiorespiratory status), a statement on the conclusions or impressions drawn from the history and physical examination, and a statement on the planned course of action.

On 6/8/11, review of the hospital's 3/24/11 medical staff rules and regulations demonstrated that when the H&P is not on the medical record prior to surgery, the procedure shall be postponed until the H&P has been recorded. The bylaws definition of an adequate H&P was not included in the rules and regulations. As a result, Patients 14, 16, 17, and 18 were inappropriately admitted to the operating room.