HospitalInspections.org

Based on dietary management staff interview and departmental document review, the hospital failed to ensure that the Dietary Management Staff (DMS) position, responsible for day to day operations and supervision of dietetic services, met applicable state certification requirements.

The failure to ensure qualified management staff for the day to day operations of the dietetic services can result in deficient practices that can negatively impact patients' health status.

Findings:

California Code of Regulations, Title 22, Division 5, Chapter 1, Article 3 specifies Dietetic Services Staff qualifications. The regulatory requirements for dietetic services specify that if a Registered Dietitian (RD) is not employed with responsibility for dietetic services, defined as the provision of safe, satisfying, nutritional food for patients, a full time person who has completed a dietetic supervisor's training program shall be employed to be responsible for the operation of the food service.

In an interview on 5/10/16 beginning at 10 am, the DMS was introduced as the position responsible for the day to day operations and supervision of food service workers. The Registered Dietitian (RD) was also introduced as an Interim Director for the Department. It was noted that both of these positions were part of a contracted service.

In an interview on 5/10/16 beginning at 10 am with the RD, she stated until recently she was employed as a clinical dietitian; however recently stepped in as the Interim Director for the Department. She stated she continued to provide clinical care 1-2 days per week depending on the need. She also stated DMS was responsible for the daily management and supervision of food service operations. She described her role as RD in food service as completing test tray audits, patient rounding audits, and monthly quality assurance audits that included evaluation of production, cleanliness, equipment evaluation and reviewing operational logs.

Review of the hospital position description, titled, "Chef Manager," dated 2/16, described this position as the person who coordinated activities of food production staff and other kitchen workers ensuring a high quality, efficient and profitable food service department. The position qualifications were described as the possession of a Bachelors or Associate Arts degree; however did not delineate the area of study with respect to educational requirements. The position description did not include State mandated educational requirements.

Review of DMS's personnel file revealed that he did not have education and/or certification in accordance with State regulatory requirements.

Review of the hospital document, titled, "Nutrition/Food Service Agreement," dated 4/14/16, revealed "The Management of...shall be responsible along with Behavioral Health... and... Administration to recruit and select a qualified Nutrition Services Operations Manager to assume day to day managerial responsibilities ..." Review of undated hospital departmental document titled, "SNMH [Sierra Nevada Memorial Hospital] Organizational Chart" confirmed the DMS was the direct supervisor for all staff with the exception of the RD and Diet Office staff. The Hospital document titled, "Statement of Work for Food Management Services" dated 6/17/16, revealed the vendor agreed to develop, implement and maintain a food program in accordance with applicable standards.

Based on staff interview and record/document review, the hospital's Governing Body (GB) failed to effectively govern the hospital and ensure compliance with federal regulations, as evidenced by:

1. The GB failed to ensure that contracted services had provided services which were safe, effective and permitted the hospital to comply with all applicable conditions of participation. Refer to A 83 and A 84.

2. The GB failed to ensure the provision of safe and effective food and nutrition services. Refer to A 618, A 619, A 621, A 629, A 630, A 631, A 701, and A 724.

3. The GB failed to ensure an effective, active system wide infection control program and surveillance for prevention, control, and investigation of infections and communicable diseases. Refer to A 747 and A 749.

4. The GB failed to ensure the hospital had developed, implemented and maintained an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. Refer to A 263, A 273, and A 308.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of services was in compliance with the statutorily mandated Condition of Participation for Governing Body.

Based on interview and record review, the hospital failed to ensure that contract services were assessed to identify quality and performance problems, implement appropriate corrective or improvement activities, and to ensure the monitoring and sustainability of those corrective or improvement activities to ensure that each contract service complied with all applicable conditions of participation and nationally accepted standards. The contractor for Nutrition and Food Service evaluated services, but this evaluation was not analyzed nor a corrective action plan implemented for the findings of non-compliance. This evaluation was not shared with the Quality and Patient Safety Committee or the Quality Committee of the Board.

This failure resulted in persistent non-compliance with condition of participation for Food and Dietetic Services and placed patients at risk of foodborne illnesses. The failure to adequately evaluate contract performance can result in deficient practices that can negatively impact patients' health status.

Findings:

During food production observations on 5/10/16 beginning at 9:35 am, 6/13/16 beginning at 10:55 a.m., and 6/14/16 beginning at 8:30 a.m., deficient practices were noted in the areas of safe food handling, provision of meals in accordance with standards of practice, and comprehensive evaluation of patient menus. Refer to A 618, A 629, A 749 and A 749.

On 6/13/16 at 4:30 pm, the Nutrition and Food Service Manager (NFSM) stated that management of the department was contracted and the staff were employees of the hospital. NFSM stated she performed evaluations of the food service quality on a monthly basis but these reports were not shared with the Quality and Patient Safety Committee or the Quality Committee of the Board. Refer to A 273 for further details.

On 6/14/16, the Quality Plan was reviewed and did not include any direction for how contract services were evaluated (Refer to A 84 for further information). The hospital list of contracts indicated that there were 311 contracts with 147 patient care contracts.

On 6/14/16 at 8:30 am, the Governing Body (GB) minutes were reviewed for the last seven months with Administrative (Admin) Staff C. The GB minutes included many detailed reports of publicly reported quality and patient satisfaction measures each month. Departmental performance measures were limited to a rotating biannual (once every 6 months) review at the Quality Committee of the Board (GB). The minutes of the Quality Committee of the Board were present in the GB minutes on the consent agenda and included brief details as to the performance of all departmental measures including contract services. These minutes did not contain analysis and action plans for the identified measures. In a concurrent interview, Admin Staff C confirmed that the GB only reviewed publicly reported data in detail and the minutes did not include analysis or action plans for measures not meeting performance goals.

On 6/14/16 at 11 am, Admin Staff C reported that she creates a GB report grid that once a year in July summarizes the patient care contract performance as acceptable or not for the Board to review. The grid had a heading titled, "Performance Measures Evaluated" and had four sub categories under the heading; "Timeliness of Service, Effectiveness of Services, Appropriateness of Service and Other." The grid did not have any evaluation of compliance with applicable federal conditions of participation and nationally accepted standards. Admin Staff C stated annually she has the "business" owner (a manager with knowledge of contract) of each contract reviewed contract performance and then marks whether they met or did not meet performance expectations. When asked for an example, a dialysis contract review for the upcoming July meeting was reviewed. The evaluation noted several areas of performance that were "not met" and many that were noted as "met". The evaluation grid for the GB review indicated the dialysis performance was marked as "met". Included in the "not met" items for the dialysis contract were issues with the storage of additives and concentrates, hand hygiene problems, pre-procedure assessment, vascular access standards, clinical practice procedures, equipment disinfection for isolation patients, and personal protective equipment not worn. Admin Staff C reported she reported "met" on this grid because that was what the majority of the items measured had stated. Admin Staff C acknowledged that the GB would not be aware of the issues with any of the contracts based on the information in this report. Admin Staff C acknowledged that there was no analysis of the data or action plans for improvement on the GB report for any of the contract services. Admin Staff C further acknowledged that the hospital GB did not have a mechanism in place to ensure that contract services were in compliance with all conditions of participation and nationally accepted standards.

Based on interview and record review, the hospital failed to have an effective mechanism for the Board to provide oversight that ensured the services provided under contract are provided in a safe and effective manner.

This failure resulted in persistent non-compliance with Food and Dietetic Services and had the potential for other contract services to be provided that are not compliant with quality and patient safety standards. This could result in patients' health being negatively impacted.

Findings:

On 6/14/16, the hospital "2016 Performance Improvement /Patient Safety Plan," dated 4/21/16, was reviewed. The purpose of the plan was listed as "To ensure that the Governing Body, medical staff, and professional service staff demonstrate a consistent endeavor to deliver safe, effective, and optimal patient care and services in an environment of minimal risk."

The plan did not address a mechanism for contract service review. The plan did not include a list of indicators for measuring performance.

The minutes of the Quality/Patient Safety Committee were reviewed and did not include contract review but did include review of performance of some of the contracted services. The minutes did not include analysis or action plans for items that were not meeting the target goal.

On 6/14/16 at 10 am, the Director of Quality (DQ) stated she had been in the position since 2/2016 and previous to her appointment, an Interim Director of Quality was in place for two years. The DQ acknowledged that the quality plan and reporting system need some updating. DQ further acknowledged that the mechanism for contract review and assessment was different than the quality assessment processes for other services provided directly by the hospital. When shown the results of an internal evaluation of service in the Food and Nutrition Department, DQ acknowledged the evaluation was not provided to the Quality/Patient Safety Committee. Refer to A 273.

Based on staff interview and document review, the hospital's Governing Body (GB) failed to ensure the hospital had developed, implemented and maintained an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program, as evidenced by:

1. The Quality Assessment and Performance Improvement (QAPI) Program did not contain review of all departments and services, including Contracted Services nor utilize specific Quality Indicators (QI) and/or Performance Indicators (PI) selected to ensure each service was safe, effective and provided services and which facilitated the hospital's compliance with all applicable conditions of participation and standards for the service and care provided.
Refer to A 83, A 84, A 273, and A 308.

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of services was in compliance with the statutorily mandated Condition of Participation for Quality Assessment and Performance Improvement.

Based on observations, Administrative Staff interview, and dietary document review, the hospital failed to ensure an effective performance improvement program for food and nutrition services which accurately reflected the depth and scope of departmental operations. The hospital failed to ensure action plans when issues were identified and to comprehensively incorporate departmental operations into the hospital wide performance improvement program.

Failure to develop a comprehensive program that identified opportunities for improvement may result in compromised outcomes, for a patient census of 69, in relationship to medical and nutritional status.

Findings:

During food production observations on 5/10/16 beginning at 9:35 am, 6/13/16 beginning at 10:55 a.m., and 6/14/16 beginning at 8:30 a.m., deficient practices were noted in the areas of safe food handling, provision of meals in accordance with standards of practice, and comprehensive evaluation of patient menus (Refer to A 629 and A 749 for additional information).

In an interview on 5/10/16 at 11 am with the Registered Dietitian (RD), she was asked to describe the departments' performance improvement program. She stated there were issues with the taste of food. Additionally, there was a long standing problem with the hospitals' menus which was related to staff not following the standardized recipes.

On 5/10/16 beginning at 1 pm, the RD submitted the dietary departments' performance improvement audits. The audits included a monthly food service systems evaluation. In February and March 2016 the contracted service identified issues surrounding cool down of potentially hazardous foods (Refer to A 749); however there was no development of an action plan, nor was the issue moved forward to the performance improvement committee. In a concurrent interview, the RD stated that these documents were internal documents for the contracted vendor and the information was not forwarded to the hospital. The RD also completed tray accuracy checklists, patient rounding forms and test tray evaluations. She stated that while she put the information into a spreadsheet, the information was not analyzed nor provided to the hospital's Director of Quality. The RD stated there was no additional information and/or audits completed by the Department. There were no improvement activities related to the lack of patient satisfaction with respect to the menus or staff not following standardized recipes. There were no performance improvement activities associated with clinical nutrition care.

In an interview on 6/14/16 beginning at 10:10 am with the Chief Nursing Officer, Infection Control Practitioner and Administrative Staff (AS) 7 (Director of Quality), they described the hospitals' performance improvement reporting structure. AS 7 stated that each department was responsible for providing performance improvement activities. AS 7 stated that the dietary department currently was collecting data for Process Improvement Measures (PIMS), a system that was designed to get rapid cycle improvement, of identified issues, within 120 days. AS 7 stated that PIMS audits were associated with topics requiring regulatory compliance; however could also include processes that departments were monitoring. Surveillance activities that fell out of compliance were forwarded to the PIMS committee for oversight. They also stated the hospital developed a SMART (specific, measurable, attainable, realistic and timely) matrix that was intended to facilitate development of action plans. The interview revealed it was hospitals' expectation that Department Managers, in conjunction with the Director of Quality, develop meaningful performance improvement audits.

Review of the Hospital document titled, "FY (fiscal year) 2016 Performance Improvement/Patient Safety Plan" revealed it was the expectation that support services develop improvement projects that impact patient care.

Review of PIMS data submitted by the hospital revealed that the department should be monitoring comprehensive completion of dish machine temperature logs. While this information was submitted to the PIMS committee, there was no analysis of how dish machine log completion, irrespective of a malfunctioning dish machine, would improve the quality and/or safety of patients with respect to dietetic services.

Review of hospital document titled, "Quality/Patient Safety Council Report," dated 2/1/16, revealed that four of the six elements met expected parameters, and therefore, did not require a SMART action plan. Of the two remaining elements, which included temperature recording of the deli refrigeration and labeling/dating of food items utilizing the contracted vendors' label, a SMART action plan was recommended; however the department was not collecting data in relationship to the plan. Similarly there was no evaluation of how the use of a specific label, absent of the presence of expired foods, would contribute to patient safety.

The Hospital position descriptions for the Chef Manager and RD, as well as the statement of work for the contracted vendor, failed to delineate responsibility for the development and maintenance of an effective performance improvement program. Departmental policy, titled, "Performance Improvement," dated 12/11/15, documented, "1. The Director of Food and Nutrition and the Clinical Nutrition Manger take a leadership role in the department's involvement in performance improvement. 2. Nutrition-related performance improvement activities are integrated into the overall organization's performance improvement process..."

Based on interview and record review, the hospital failed to ensure that contract services were assessed to identify quality and performance problems, implement appropriate corrective or improvement activities, and to ensure the monitoring and sustainability of those corrective or improvement activities to ensure that each contract service complied with all applicable conditions of participation and nationally accepted standards. The contractor for Nutrition and Food Service evaluated services but this evaluation was not analyzed nor a corrective action plan implemented for the findings of non-compliance. This evaluation was not shared with the Quality and Patient Safety Committee or the Quality Committee of the Board.

This failure resulted in persistent non-compliance with condition of participation for Food and Dietetic Services and placed patients at risk of foodborne illnesses. The failure to adequately evaluate contract performance can result in deficient practices that can negatively impact patients' health status.

Findings:

During food production observations on 5/10/16 beginning at 9:35 am, 6/13/16 beginning at 10:55 a.m., and 6/14/16 beginning at 8:30 a.m., deficient practices were noted in the areas of safe food handling and storage, provision of meals in accordance with standards of practice, and comprehensive evaluation of patient menus. Refer to A 618, A 629, A 747 and A 749.

On 6/13/16 at 4:30 pm, the Nutrition and Food Service Manager (NFSM) stated that the management of the department was contracted and the staff were employees of the hospital. NFSM stated she performed evaluations of the food service quality on a monthly basis but these reports were not shared with the Quality and Patient Safety Committee or the Quality Committee of the Board (Refer to A 273 for further information).

On 6/14/16, the Quality Plan was reviewed and did not include any direction for how contract services were evaluated (Refer to A 84). The Hospital's list of contracts indicated that there were 311 contracts with 147 patient care contracts.

On 6/14/16 at 8:30 am, the Governing Body (GB) minutes were reviewed for the last seven months with Administrative (Admin) Staff C. The GB minutes included many detailed reports of publicly reported quality and patient satisfaction measures each month. Departmental performance measures were limited to a rotating biannual (once every 6 months) review at the Quality Committee of the Board (GB). The minutes of the Quality Committee of the Board were present in the GB minutes on the consent agenda and included extremely brief details as to the performance of all departmental measures including contract services. These minutes did not contain analysis and action plans for the identified measures. In a concurrent interview, Admin Staff C confirmed that the GB only reviewed publicly reported data in detail and the minutes did not include analysis or action plans for measures not meeting performance goals.

On 6/14/16 at 11 am, Admin Staff C reported that she creates a GB report grid that once a year in July summarizes the patient care contract performance as acceptable or not for the Board to review. The grid had a heading titled, "Performance Measures Evaluated" and had four sub-categories under the heading "Timeliness of Service, Effectiveness of Services, Appropriateness of Service and Other". Admin Staff C stated she has the "business" owner (a manager with knowledge of contract) of each contract review contract performance and then mark whether they met or did not meet performance expectations. When asked for an example, a dialysis contract review for the upcoming July meeting was reviewed. The evaluation noted several areas of performance that were "not met" and many that were noted as "met". Included in the "not met" items for the dialysis contract were issues with the storage of additives and concentrates, hand hygiene problems, pre-procedure assessment, vascular access standards, clinical practice procedures, equipment disinfection for isolation patients, and personal protective equipment not worn. The evaluation grid for the GB review indicated the dialysis performance was marked as "met". Admin Staff C reported she reported "met" on this grid because that was what the majority of the items measured had stated. Admin Staff C acknowledged that the GB would not be aware of the issues with any of the contracts based on the information in this report. Admin Staff C acknowledged that there was no analysis of the data or action plans for improvement on the GB report for any of the contract services. Admin Staff C further acknowledged that the hospital GB did not have a mechanism in place to ensure that contract services were in compliance with all conditions of participation and nationally accepted standards.

Based on food service observations, dietary staff interview, and dietary document review, the hospital failed to ensure the provision of effective food and nutrition services as evidenced by:

1. Lack of an effective system that monitored time/temperature control and potential cross contamination of foods capable of supporting bacterial growth associated foodborne illness. Refer to A 749, findings 1-6.

2. Lack of development of departmental policies and procedures that reflected the depth and scope of departmental operations and lack of effective oversight of food production activities. Refer to A 619.

3. Lack of menu development and nutritional analysis of diets commonly served to patients. Refer to A 630.

4. Lack of development of a diet manual that reflected the scope of diets routinely ordered by hospital physicians. Refer to A 631.

5. Lack of development of a comprehensive performance improvement program that reflected the depth and scope of food and nutrition services. Refer to Finding A 273.

6. Development of a dietetic services organizational structure that was not consistent with State regulatory requirements. Refer to A 023.

7. A disaster plan that lacked specific implementation information and that did not mirror the nutritional content of the hospitals' diets. Refer to A 701.

8. Nutrition needs and interventions were not included in six of six sampled patients interdisciplinary care plans. Refer to A 621.

9. Ice machines were not maintained according to manufacturer's instructions. Refer to A 724, finding 1.

10. Failure to maintain a refrigerator to avoid ice build up. Refer to A 724, finding 2.

The cumulative effects of these systemic problems resulted in the hospital's inability to provide food and nutrition services in a safe and effective manner in accordance with the statutorily mandated Conditions of Participation for Dietetic Services.

Based on observation, dietary management staff interview, and dietary document review, the hospital failed to ensure effective oversight of the dietary department by the Director of Food Service, the position responsible for the daily management of the department as evidenced by 1) failure to identify the lack of an effective system to monitor cooldown temperatures previously cooked foods; 2) lack of development of a departmental policy and procedure manual that reflected the scope of foodservice operations and 3) the retention of unlabeled, undated and expired food items.

Failure to ensure effective oversight resulted in unsafe food handling practices and activities not in accordance with food service standards of practice. This had the potential to affect the hospital census of 69.

Findings:

1. During initial tour on 5/10/16 beginning at 9:35 am, it was noted the dietary department failed to ensure an effective system for time/temperature cooldown monitoring of previously cooked foods that were capable of supporting bacterial growth associated with foodborne illness (Refer to A 749). In a concurrent interview on 5/10/16 with the Director of Food Services, a Registered Dietitian, she was asked to describe previously identified areas of concern within the department. She stated there was a long standing problem with the taste of food that was related to staff not following the standardized recipes. She was unaware of any other issues.

In a follow up observation on 6/13/16 beginning at 10 am, there were greater than 20 individual cups of chili, dated 5/27 and 5/28/16, in the 2-door freezer.

In a concurrent interview and document review on 6/13/16 beginning at 11:15 am with Dietary Management Staff (DMS), the department's cool down logs were reviewed. The individual cups of chili were not on the log. DMS stated that they were not on the log because they were not cooked, rather the raw ingredients were placed in the paper cups and would be heated in the microwave when needed.

Review of the recipe title "Chili, three bean" guided staff to assemble the ingredients which consisted of beans, onions, garlic and spices, cooking in a stock pot over medium heat, simmering for 30-35 minutes. There was no guidance that raw ingredients could be frozen and reheated in a microwave.

2. During review of dietetic services operations on 5/10/16 beginning at 9:35 a.m., 6/13/16 beginning at 10:55 a.m., and 6/14/16 beginning at 8:30 a.m., multiple issues surrounding effective implementation of dietetic services were identified (Refer to A 630, A 701 and A 749).

Review of the department's policy and procedure manual, approved 4/28/16, revealed that while a department manual was established it did not fully reflect the scope and complexity of the department in particular in relationship to provision of food services. The policies were not specific to the hospitals operation, rather were generic. Examples of approved food service policies included directory of services, infant formula preparation (a service the hospital did not provide), interpretation of nutrition care orders, isolation tray service, nutritional standards of menus and approvals, room service (a service the hospital did not provide) and tray assembly. There were no procedures related to direct food production operations with respect to food safety, storage, sanitation and/or preparation. In an interview on 6/13/16 beginning at 12 p.m., Administrataive Staff 10 acknowledged that the approved policy and procedure manual did not fully reflect the departments' operations.

3. During food storage observation on 5/10/16 at 10:15 am, in refrigerator "L" there was sliced turkey breast, delivered on 4/1/16 with an expiration on 4/28/16. In freezer "M" there were opened boxes of pureed corn and roast port, frozen cookies and facility prepared ice cream cups that were opened and/or prepared with no date. In a concurrent interview with Dietary Management Staff he acknowledged the turkey was expired and the opened/portioned items should have been dated.

Based on interview and record review, the hospital failed to ensure that a qualified dietician provided care planning for nutritional needs on the interdisciplinary care plan for six of six sampled patients reviewed (Patients 1, 2, 3, 4, 5 and 6).

This failure had the potential for a lack of collaboration to meet the patients' nutritional needs and result in a decline in health status.

Findings:

On 6/14/16, Patients 1, 2, 3, 4, 5 and 6's records were reviewed with Administrative (Admin) Nurse A. All six patients were evaluated by a dietician and nutrition services were recommended to meet the needs of these patients. Six of six patient's interdisciplinary care plans did not include nutritional needs or the recommended interventions to improve the patients' nutritional status.

On 6/14/16, the hospital policy titled, "Documentation Nursing Process and Multidisciplinary Plan of Care," dated 9/2008, read, "The RD (Registered Dietician)/ Therapist/ Pharmacist has responsibility for the identification of patient problems, expected outcomes, planning and implementing patient care on dietary/ therapy/ medication problems in collaboration with the RN (Registered Nurse)... The RD will Contribute to the Plan of Care following their specialty assessment."

On 6/14/16 at 3:50 pm, Admin Nurse A acknowledged that all six sampled patients did not have evidence of nutritional care on the interdisciplinary care plan.

Based on medical record review, administrative staff interview and dietary department document review, the hospital failed to ensure diet changes were approved by the physician for one of six patients (Patient 1) when the texture of a diet was changed without a physicians' order.

Failure to include the physician in daily patient care activities may result in lack of identification of clinical problems, further compromising the medical and nutritional status of patients.

Findings:

A therapeutic diet is a component of a treatment program for an individual whose health status is impaired or at risk due to disease, injury, or surgery. Therapeutic diets are not defined by the content of what is provided or when it is served, but why the diet is required. Therapeutic diets provide the corresponding treatment that addresses a particular disease or clinical condition, which is manifesting an altered nutritional status by providing the specific nutritional requirements to remedy the alteration (Centers of Medicare/Medicaid Assessment Tool, 2013).

Patient 1 was admitted on 6/7/16 with symptoms including increased weakness, falls and a diagnosis of hyponatremia (low sodium level in the blood). Medical record review was conducted on 6/14/16 beginning at 1:45 pm. The admission diet order, dated 6/7/16, was consistent carbohydrate diet, regular texture. A comprehensive nutrition assessment, completed by the Registered Nurse documented decreased dietary intake and a weight loss, however the amount was unclear. A nutrition services note, dated 6/8/16 and completed by the Registered Dietitian (RD), reiterated the weight loss, lack of teeth and confirmation of the pureed diet order. A follow up note, completed by the RD on 6/10/16, documented nursing services reported Patient 1 was eating well on regular texture. An additional RD note on 6/14/16 documented a change from regular texture to a ground texture. In a concurrent interview with Administrative Staff 10, she stated the change in texture may have been in response to patient request. Review of medical record revealed that there was no physicians order for the change in texture.

Review of dietary services policy and procedure manual, approved 4/28/16, indicated the policy did not provide guidance with respect to alteration in physician ordered diets.

Based on meal distribution observations, dietary staff interview, and dietary document review, the hospital failed to ensure patient nutritional needs were met as evidenced by:

1. Failure to distribute guidance to dietary staff for physician ordered vegetarian diet to 1 of 3 dietary staff responsible for patient meal tray tickets; and

2. Lack of comprehensive development of a nutritional analysis for the hospitals menus.

These failures may result in insufficient nutritional intake which could compromise the medical and nutritional status of the hospital census of 69 patients.

Findings:

1. During meal distribution observation on 6/13/16 beginning at 12 pm, there was one random patient (Patient 7) with a physician ordered renal vegetarian diet (includes only foods from plants and limits the amount of protein, phosphorus, calcium, sodium, and/or potassium to help decrease the amount of waste made by your body, which can help your kidneys work better). The selection that was plated was an egg salad sandwich with vegetables. In an interview on 6/14/16 at 9:30 am with Dietary Staff (DS) 8, she stated that the hospital did not have a pre-selected vegetarian menu in the computerized system, rather when patients had vegetarian diets she would select a meatless entrée. She described that for the noon meal she selected the egg sandwich and for the evening meal the patient received a vegetable salad so the patient would not receive an egg sandwich for two consecutive meals. She also stated she instructed DS 2 to eliminate the beans from the salad since it was a renal diet. Concurrent review of the electronic tray ticket revealed that the patient received egg salad sandwiches for both lunch and dinner, in addition to the vegetable salad. In a concurrent interview with the Registered Dietitian, she stated that there was a vegetarian menu; however it was listed as an "other" diet.

In an interview on 6/14/16 at 11:45 am with DS 2, he described the prepared salad was in accordance with the recipe which included a ¼ cup combination of kidney and garbanzo beans. The purpose of the development of standardized menus would be to ensure that dietetic services were implemented in a method that met the assessed nutritional needs of patients, in accordance with physician ordered diets (National Food Service Management Institute, 2014).

Review of departmental document, titled, "House Diet Nutritional Analysis," dated 3/9/16, revealed that while there was an analysis for a vegetarian diet; DS 8 was unaware of its existence. Additionally, the analysis was not comprehensive rather was limited to calories, protein, fat, carbohydrate in addition to some limited vitamins and minerals. In an interview on 6/14/16 beginning at 3 p.m., with Administrative 10 she acknowledged that the nutritional analysis did not include all the nutrients in accordance with the standard of practice (National Institute of Medicine of the National Academies of Science, 2010).

2. On 6/14/16 beginning at 1 pm, the department's analysis for routinely ordered diets was reviewed. It was noted that while there was a nutritional analysis, it was not comprehensive, rather was limited to calories, protein, fat, carbohydrate in addition to some vitamins and minerals. In a concurrent interview with Administrative Staff (AS) 10, she acknowledged that it would not be possible to evaluate the nutritional adequacy of the menu without the benefit of a comprehensive analysis.

Review of hospital document, titled, "Statement of Work for Food Management Systems," dated 6/17/13, revealed it was the responsibility of the hospital to provide the food management information technology system which would include the development of a nutritional analysis of patient menus.

Based on contract staff interview and dietary department document review, the hospital failed to develop and utilize a diet manual that was specific to the hospital; included diets routinely ordered; provided accurate guidance for ordering and preparing patient meals.

This failure had the potential to result in a lack of consistency and communication concerning the diets among medical, nursing and dietary staff. This failure had the potential to affect the patient census of 69.

Findings:

Diet manuals establish a common language and practice for physicians and other healthcare professionals to use when providing nutrition care to patients. The diet manual includes the purpose and principles of each diet, the meal pattern, the foods allowed and foods to avoid and describes the nutritional adequacy and/or inadequacy of each diet. The diet manual and diets ordered by the hospital should mirror the nutritional care provided by the hospital (California Department of Public Health, 2013).

On 6/14/16 beginning at 3 pm, the hospital presented a manual titled, "Nutrition Care Manual" as the diet manual. The document was reviewed in the presence of Administrative Staff (AS) 10. The cover page, dated 4/28/16, noted that the manual was not fully approved rather was approved only by the Medical Staff Representative and the Registered Dietitian. There was no documentation that the Pharmacy and Therapeutics Committee reviewed and/or approved the document. In a concurrent interview with AS 10 she acknowledged that based on the signatur page of the manual not all of the hospitals' committees had the opportunity to approve the document.

In an interview on 6/13/16 beginning at 12 pm, the Registered Dietitian stated that the hospital offered three levels of meal planning for diabetics; 45, 60 or 75 grams (a metric unit of measure) of carbohydrate per meal. A concurrent review of the undated section that was intended to describe the diabetic diet revealed that the information was limited to patient education materials describing the importance of carbohydrate counting, listed foods have carbohydrates, meal planning tips and label reading tips. The section did not describe how to order carbohydrate controlled diets in the hospital, the three levels of carbohydrate menus available, the nutritional adequacy/inadequacy of the diet, foods to use/avoid or a sample meal pattern that is consistent with the hospital's menu. The bottom of each of the pages noted that the "handout may be duplicated for client education." The format was similar for the remaining diets in the manual. The manual did contain an undated document titled "Cross-walk of Therapeutic Diet Orders and Menus." While this document did provide the purpose of the diet and a brief description, including modifications, it did not comprehensively address the requirements of a diet manual.

Review of the Hospital's policy titled, "Nutrition Care Manual," dated 12/11/15, revealed that the purpose of the nutrition care manual was to provide a reference of evidence based nutrition information, provide a tool for professional in calculating nutritional assessment formulas, standardization of current principles of nutritional care and to have a current diet manual. The policy did not provide hospital specific information with respect to the provision of dietetic services. In a concurrent interview with AS 10, she stated that the hospital used to have a comprehensive diet manual; however it was likely eliminated by the contracted vendor.

Based on dietary and administrative staff interview and departmental document review, the hospital failed to ensure a well-defined disaster feeding plan that met patient nutritional parameters.

Failure to ensure a disaster plan that could be readily implemented by staff and included foods that would likely be consumed by patients may result in further compromising the medical and nutritional status of a total of 540 patients and staff.

Findings:

On 6/14/16 beginning at 2 pm, the hospital's disaster preparedness plan for nutrition services was reviewed with the Registered Dietitian (RD), Dietary Management Staff and Administrative Staff (AS) 8. In a concurrent interview they stated the plan presented consisted of Phase 1 menu that required non-generator dependent natural gas and a second plan where no generator, power or potable water was available. The RD stated that the hospital plan was for seven days. She further stated that after three days, freeze-dried entrees would be available for patients and ration bars for staff.

An undated/untitled document that described emergency operations, page 18, was reviewed and read, "IV. Sustainability of Operations without External Support" described a self-sufficiency period of 96 hours.

A review of the Nutrition Services policy titled, "Emergency Plan Food and Nutrition," dated 12/11/15, guided staff to utilize the phase 1 plan if there was no safe water, refrigeration or cooking facilities eventually transitioning into the phase 2 plan. Review of the Phase 1 plan included items that required cooking such as rice pasta or potatoes for both lunch and dinner. Similarly, the breakfast meal included cooked eggs. While breakfast could also include yogurt, cottage or string cheese, the facility did not have the full supply of these items. A review of the departmental document titled, "Emergency Pars," dated 7/15, revealed a par level of 288 hard boiled eggs; however the facility planned to feed 540 people. Review of the 3-day menu plan for no utilities included items such as peanut butter or nuts; however there were no serving sizes. Review of the par level indicated 400 servings of peanut butter. There was no inventory listing for nuts. The no utility plan had a notation when the food supply was exhausted to implement the food ration bars. There was no guidance for incorporation of other foods. The main hospital plan did not include the additional parameters, nor did the dietary plan include adequate information for implementation should dietary staff be unavailable. While the no utility plan had a nutritional breakdown for 1 day, the nutritional analysis was not consistent with the menu. As an example, the dinner meal included a granola bar for the starch; however there was no mention of granola bars on the menu. In a concurrent interview with the RD, she stated that the documents presented were the extent of the written plan for dietetic services.

Based on food storage observations, dietary and engineering staff interview, and hospital document review, the facility failed to ensure equipment was maintained as evidenced by:

1. Ice machine maintenance for 13 machines that did not fully follow manufacturer's instructions;

2. Buildup of ice particles in one food storage freezer;

3. One patient refrigerator in the Intensive Critical Care Unit (ICCU) was not maintained in proper functioning order.

Failure to ensure equipment was maintained may result in equipment malfunction that could result in food borne illnesses.

Findings:

1. On 6/13/16 at 11:10 am, ice machine preventive maintenance was reviewed with Engineering Staff (ES) 6. He described a cleaning and sanitation process for machines utilizing two different chemicals. In a concurrent interview with ES 6, he stated the hospital's ice machines were from two different manufacturers; however he followed the same procedure for all machines irrespective of the manufacturer. He also stated that the dietetic services ice machine was the only one from the Follett®.

Review of the chemicals on 6/13/16 at 2 pm, revealed that the cleaning chemical was a phosphoric based product and the sanitizing agent was a chlorine based product.

Review of manufacturers' guidance for the dietetic services ice machine revealed that the ice machine cleaner should be a chlorine rather than a phosphoric acid based product.

2. During review of food storage practices on 5/10/16 beginning at 9:35 am, the walk-in freezer "K" was observed to have a build-up of ice particles on the roof and the blower. In a concurrent interview with Dietary Management Staff (DMS), he stated the issue was not identified by staff.

In a follow up observation on 6/13/16 beginning at 10:30 am, the ice droplets on the roof and blower continued to be present. Water droplets may occur when warm external air mixes with colder air in a freezer (National Science Foundation 2015). In a concurrent interview, the surveyor queried Dietary Staff 11 on whether or not the door was left open for an extended period of time, such as during food deliveries. She stated, "No, the delivery is not until tomorrow."


26611

3. On 6/13/16 at 11:35 am, the ICCU patient food refrigerator was observed to have a three inch build up of ice on the interior ceiling.

In a concurrent interview, Administrative Nurse A acknowledged that this was not acceptable for patient food safety.

Based on observations, interview, and document review, the hospital failed to promote effective infection control practices as evidenced by:

1. The lack of an effective system to monitor time/temperature control of seven of seven previously cooked foods capable of producing foodborne illness. Refer to A 749, findings 1 and 5.

2. Reuse of greater than eight foods that were previously served in the self-serve salad bar. Refer to A 749, finding 2.

3. Lack of a comprehensive procedure for one Registered Nurse to sanitize infant feeding preparation areas. Refer to A 749, finding 3.

4. Lack of immunizations for two of two contracted dietary staff, prior to assuming the position. Refer to A 749, finding 4.

5. Failure to maintain clean food storage areas. Refer to A 749, finding 6.

6. Failure to segregate staff food from patient food. Refer to A 749, finding 7.

7. Failure to observe isolation precautions. Refer to A 749, finding 8.

The cumulative effects of these systemic problems resulted in the hospital's inability to provide a sanitary environment and systems to avoid the sources and transmission of infections, and the prevention of food borne illnesses, in accordance with the statutorily mandated Conditions of Participation for Infection Control Services.

Based on observations, interview, and document review, the hospital failed to ensure systems to prevent the spread of communicable diseases and the incidence of food borne illnesses were implemented as evidenced by:

1. The lack of an effective system to monitor time/temperature control for seven of seven previously cooked foods capable of producing foodborne illness;

2. Reuse of greater than eight foods that were previously served in the self-serve salad bar;

3. Lack of a comprehensive procedure for one Registered Nurse (RN) to sanitize infant feeding preparation areas;

4. Lack of immunizations for two of two contracted dietary staff prior to assuming the position;

5. Inconsistent oversight of temperatures for the storage of patient food in refrigerators;

6. Debris and dried, spilled substances were present in food storage areas;

7. Staff food, a smoothie drink, was stored with patient food; and

8. Physician A and RN B did not observe contact isolation precautions.

These failures have the potential to cause infection and foodborne illnesses that could negatively impact a patient's health status affecting the hospital census of 69.

Findings:

1. Potentially Hazardous Foods (PHF) are those that are capable of supporting bacterial growth associated with foodborne illness. PHF's require time and temperature control through all phases including receiving, storage and food production. It would be the standard to ensure that hot PHF's are consistently monitored and cooled from 135°F (degrees Fahrenheit) to 70°F within 2 hours and to 41°F or less in an additional 4 hours, a maximum total of 6 hours. Similarly, foods that are prepared from room temperature ingredients shall be monitored to ensure temperatures decrease to 41°F or below within 4 hours of preparation (Food Code 2013).

a. During initial tour on 5/10/16 beginning at 9:35 am, in the 2-door freezer adjacent to the food production area, there were two packages of previously cooked turkey, weighing approximately three pounds, each dated 4/28 and 5/6/16 respectively. Similarly, there were packages of previously cooked meatballs and pot roast (dated 5/2/16); roast beef (dated 4/20/16); meatloaf (dated 5/6/16) and flank steak (dated 4/26/16). In a concurrent interview with Dietary Management Staff (DMS), he stated these items were left over from either patient meal service or the café serving line and would be utilized at an ensuing meal or as part of a recipe, such as soup.

During food production observation on 5/10/16 at 10:20 am, Dietary Staff (DS) 1 was cutting a cooked post roast. She stated the roast was used on patient tray line on 5/9 with leftover meat being used for soup. She further stated that she is usually the evening cook. She described a process whereby the meats which were cooked for dinner were routinely placed in the refrigerator or freezer and where then wrapped prior to leaving at 6 pm She also stated that she did not monitor cool down temperatures as there was "not enough time" prior to the end of her shift. She stated that the only employees after 6 pm, were staff responsible for dishes and evening cleaning.

In an interview and concurrent document review of a departmental document, titled, "Cooling Temperature Log," dated 3/25 through 5/6/16, on 5/10/16 at 10:30 am, with Dietary Management Staff (DMS) and the Registered Dietitian (RD), they both acknowledged that none of the observed items were monitored in accordance with the hospital guidance printed on the form. The guidance printed on the form was consistent with the standard of practice. It was also noted that the flank steak, dated 4/26/16, was monitored beginning at 1:26 pm with a recorded temperature of 147°F. The ensuing temperature was recorded at 4:20 pm (3 hours after the initial value was taken) with a temperature of 19°F. It was also noted that the values were entered with a standard black-in pen. At some point after the initial time entry of 4:20 pm, the document was altered with a black felt tip marker changing the time to 3:20 pm. There were two associate initials for the two temperatures recorded in black pen ink. There was no associate initial or notation at the time the document was altered. It was also noted that the ensuing entry, dated 4/27/16, for turkey was entered with a black felt tip marker.

Review of the departmental document titled, "Cooling Temperature Log" from 6/25/15 - 5/6/16 revealed 50 entries for 10-1/2 months. It was also noted that there were multiple entries that were taken after 6 pm, despite that the evening cook shift ended at 6 pm. The DMS stated he was the position responsible for supervision of dietary staff. He also stated he was the position responsible for reviewing the documents, and while he reviewed the documents, and noted there were issues with cool down monitoring he had not addressed the issue with staff nor independently recorded cool down temperatures of items in an attempt to verify accuracy of recorded values. The RD concurrently acknowledged issues with temperature monitoring.

Review of assessments completed by the vendor responsible for oversight of dietetic departmental operations from 11/2015 through 3/2016 revealed that in February and March 2016, the evaluation revealed there were issues with cooling foods; however there was no developed action plan.

b. In an interview on 6/14/16 beginning at 11:55 am with Dietary Staff 3 (the position responsible for cold food production activities) was asked to describe the preparation of tuna salad. He stated that the ingredients were obtained from the dry storage area and mixed according to a recipe. He further stated upon completion the item was labeled, dated, and placed in the refrigerator. When asked if there was temperature monitoring after the item was placed in the refrigerator, he stated there was not.

In an interview and concurrent document review with the RD on 6/14/16 at 12 p.m., review of the "Cooling Temperature Log" from 6/1-6/11/16, she confirmed there was no monitoring of food prepared from ingredients at ambient room temperature. The RD stated she had not thought about the necessity to monitor these foods. It was also noted that the cooling log did not provide guidance for foods prepared from room temperature ingredients.

While the hospital had a cool down monitoring form, review of departmental policy and procedure manual, approved 4/26/16, revealed there was no written approved policy/procedure associated with cool down of PHF's. Review of standardized recipe titled, "Tuna Salad" was limited to ingredients, assembly instructions and serving temperature. With the exception of covering and chilling, there was no additional guidance to food production staff with respect to food safety.

c. On 6/13/16 beginning at 11:20 am, in an interview with Dietary Staff 4, he stated he was responsible for serving the hot entrée items in the café. He further stated that if items were leftover, they would be taken back to the kitchen for reuse. He described the process as covering the item, labeling and dating and placing it in the refrigerator. He stated there were no other process steps after the item was in the refrigerator.

In a follow up observation on 6/13/16 beginning at 2:40 pm, it was noted the café items were removed. There were no observed leftover items. In a concurrent interview with Dietary Management Staff, the surveyor asked him to demonstrate the presence of a time/temperature monitoring example of café foods. He stated that the crab cakes on 6/2/16 would have been a café item. It was noted that temperature monitoring was not complete; rather the temperature of the item was documented at 149°F at 2:15 pm. There were no other documented temperatures.

Hospital document titled, "Infection Prevention & Control Plan 2016," described the purpose of the plan as the implementation of a program that encompassed all departments. Hospital infection prevention committee meeting notes, dated 11/20/15, noted environment of care rounds were completed in the dietary department; however the rounds were limited to housekeeping issues. There were no identified issues surrounding food safety.

2. It would be the standard of practice that food, after being served and in the presence of a consumer and that is unused by the consumer, may not be offered as food for human consumption (Food Code, 2013).

On 6/13/16 beginning at 11:20 am, set up of cafeteria items was observed. In a concurrent interview with Dietary Staff (DS) 3, he described the process whereby food temperatures were taken at the beginning of set up and again at 1-1:30 pm shortly after which the café items would be removed from service. In a follow up observation on 6/13/16 at 2:40 pm, DS 3 was observed breaking down the salad bar. He was removing greater than 8 the partially used items from service, covering and dating them. He further stated that on the following day he would place fresh items in new serving containers and place the leftover, partially used items on top of the fresh items. He further stated that partially used items could be held up to a maximum of three days.

Review of the departmental policy and procedure manual, dated 4/26/16, failed to reveal any procedures associated with café operations.

3. The standard of practice would be to ensure infant feeding procedures are completed utilizing aseptic technique. Prior to feeding preparation, all work surfaces must be cleaned with an antibacterial sanitizing solution that is appropriate for food contact surfaces. The solution should be wiped off with an individual paper towel from a dispenser (Infant Feedings: Guidelines for Preparation of Human Milk and Formula in Health Care Facilities, 2011).

On 6/13/16 beginning at 3:15 am, infant feeding practices were reviewed with Registered Nurse (RN) 5. She described a process for labeling and dating infant breast milk that was stored in a refrigerator within the unit. She also stated that on rare occasions, the addition of fortifiers and/or modifiers for breast milk was ordered. RN 5 stated that process would happen on a plastic tray on top of the medication cart. She further stated that the plastic tray would be cleaned with a disinfectant product after which the breast milk was mixed on top of the plastic tray. It was noted that the plastic tray was open, on top of the medication cart adjacent to a sharps container with a second plastic container inside the tray. It was also noted that the product used for sanitation of the preparation tray was labeled as not being conducive to use on food contact surfaces.

Review of hospital clinical procedure, titled, "Breast Milk Collection" last approved on 4/2009, noted, "...strict hygiene needs to be practiced during the collection, storage and preparation of human milk for hospitalized infants ..." The clinical procedure did not include guidance for the fortification of infant feeding.

4. On 6/14/16 beginning at 10 am, contracted vendor human resource records were reviewed in the presence of the Registered Dietitian (RD). Review of the files for the RD and Dietary Management Staff revealed that with the exception of tuberculosis screening, there was no other health information in the file. In a concurrent interview with the RD, a contract employee, she stated she was not asked to provide any health related information to the contracted vendor.

In an interview on 6/14/16 beginning at 10 am with the Infection Control Practitioner (ICP), Chief Nursing Officer, Administrative Staff 7, and the Director of Quality, they stated that the hospital had a full time registered nurse responsible for employee health, which reported to a regional director at another hospital. They also stated that the regional office was responsible for ensuring employee health information was current and complete and would make the assumption that the contracted vendor would have been responsible to provide health information to the regional representative.

Hospital procedure, titled, "Immunization Policy," dated 10/11, indicated that vaccination will be given as recommended by the Centers for Disease Control and would include verification of measles, mumps and rubeola (a form of measles) immunity; chicken pox screening; tetanus (an infection characterized by muscle spasms), diphtheria (a bacterial infection) and pertussis (whooping cough) screening; annual flu vaccinations and Hepatitis B (a liver infection caused by a virus) screening.

As of 6/14/16, the hospital was unable to provide screening for dietetic services contract management staff, in accordance with hospital policy.

Review of hospital document, titled, "Statement of Work for Food Management Services," dated 6/17/13, revealed it was the responsibility of the contracted vendor to provide system service employee physicals.



26611

5. On 6/13/16, during an observational tour starting at 9:40 am, the temperatures of patient food refrigerators were not monitored daily as follows:

a. At 11:35 am, Intensive Critical Care Unit (ICCU) refrigerator had no evidence of monitoring on 6/6, 6/2, and 6/12/16.

In concurrent interviews, Administrative (Admin) Nurse A acknowledged the above findings.

b. At 11:45 am, Outpatient Surgery Recovery Unit (includes the post anesthesia care area where patients recover immediately after surgery) had no evidence of monitoring on 6/4 and 6/5/16.

Admin Nurse A stated the Outpatient Surgery Unit was not open on weekends and so monitoring did not occur.

On 6/13/16, the surgical logs were reviewed. The logs indicated that unscheduled surgeries did occur on the weekends.

On 6/13/16 at 11:40 the Post Anesthesia Unit Supervisor confirmed patients come to her unit even on weekends.

c. At 11:55 am, the Emergency Department (ED) had no evidence of monitoring on 6/1 and 6/2/16.

d. At 11:30 am, the Women Infants and Children's Unit (WICU) had no evidence of monitoring and did not have a thermometer in the refrigerator.

On 6/13/16 at 4:30 pm, Dietary Supervisor A stated the Nutrition and Food Service Department was responsible for monitoring the inpatient refrigerators' temperatures (ICCU and WICU) and the Nursing Staff were responsible for monitoring the outpatient departments (Outpatient Surgery and ED).

On 6/13/16, the hospital policy, titled, "Meal Service and Feedings," dated 4/2015, read, "The Food and Nutrition Services Department is responsible for daily temperature monitoring of the unit refrigerators and freezers on a posted temperature sheet...."

In concurrent interviews, Admin Nurse A acknowledged the above findings.

e. At 11:35 am, the ICCU refrigerator temperature log for 6/2016 indicated that the temperature was out of normal temperature range (35 to 40 degrees) at 41 degrees (red zone). No actions were noted on the form for this elevated temperature. The form included instructions "Any temperatures in the RED zone needs immediate attention. Remove food from refrigerator if the temperature is out of range greater than one hour or if perishable food temperature check yields food that is greater than 40 degrees." The form contained instruction of who to notify on weekdays and weekends.

In a concurrent interview, Admin Nurse A acknowledged the above finding.

f. On 6/14/16 at 9:40 am, the ED large locked ED refrigerator was observed. The thermometer indicated that the refrigerator was 30 degrees (safe range 35-40 degrees).

In a concurrent interview, Admin Nurse A acknowledged the above finding.

6. Pantry and refrigerator drawers containing food items and utensils in the Med Telemetry Unit and the ICCU were dirty with debris and dried spilled substances.

On 6/13/16, the hospital policy titled, "Meal Service and Feedings," dated 4/2015, read, "The Food and Nutrition Services Department is responsible for the cleaning and sanitation of the pantry refrigerator." The policy did not include instructions for the the pantry drawers.

On 6/13/16 at 4:30 pm, the Nutrition and Food Service Manager stated she was not clear who was responsible for the cleaning of pantry drawers.

7. On 6/13/16, the ED refrigerator at the nursing station contained a green smoothie bottle with the expiration date of 6/6/16.

In a concurrent interview, Admin Nurse A acknowledged the above finding.

On 6/13/16 at 4:30 pm, Nutrition and Food Service Manager stated that smoothie drink was not a food service item and was most likely staff food.

On 6/13/16, the hospital policy titled, "Meal Service and Feedings," dated 4/2015, read, "Nursing is responsible for ensuring that only patient food is stored in the unit refrigerators..."

8. a. On 6/14/16 at 10:55 am, during a tour of the ICCU, Physician A was seen going from one patient room to another without performing hand hygiene. Physician A entered Room 9 which had a posted sign for contact precautions (procedure to prevent the transmission of microorganisms from direct and indirect contact). Physician A moved close to talk with Patient 6 and his clothing touched the over bed table. A nurse was present in Room 9 and alerted the physician to the surveyor's presence. Physician A proceeded to don the protective gown and gloves that were required.

The hospital policy titled, "Standard Precautions and Isolation," dated 9/11/15, read, "Clean hands with hospital-supplied soap or alcohol-based hand cleanser before caring for a patient and after contact with ANYTHING in the patient room....Healthcare Workers (HCWs) Caring for Patients on Contact Precautions Must: 1. Put on gloves and a disposable gown prior to entering the patient's room when direct contact with the patient and or the patient's environment is anticipated..."

In a concurrent interview, Admin Nurse A acknowledged that Physician A was not following the proper hand hygiene and isolation precautions for Patient 6.

8. b. On 6/14/16 at 10:45 am, Registered Nurse (RN) B was observed in a Med Tele Unit room that had a contact precautions sign posted. RN B appeared to be exiting the room and had gown and gloves removed. In response to a patient request, she picked up the pen and wrote a note on the communications board. RN B sanitized her hands and exited the room. In a concurrent interview, RN B confirmed that she was asked to write something on the board after she had removed her gloves. RN B further acknowledged she should have worn gloves to touch environmental surfaces while in a contact precautions room. In a concurrent interview, Admin Nurse A acknowledged that RN B should have been wearing gloves when touching environmental surfaces while in a contact precautions room.

Based on food storage observations, dietary and engineering staff interview, and hospital document review, the facility failed to ensure equipment was maintained as evidenced by:

1. Ice machine maintenance for 13 machines that did not fully follow manufacturer's instructions;

2. Buildup of ice particles in one food storage freezer;

3. One patient refrigerator in the Intensive Critical Care Unit (ICCU) was not maintained in proper functioning order.

Failure to ensure equipment was maintained may result in equipment malfunction that could result in food borne illnesses.

Findings:

1. On 6/13/16 at 11:10 am, ice machine preventive maintenance was reviewed with Engineering Staff (ES) 6. He described a cleaning and sanitation process for machines utilizing two different chemicals. In a concurrent interview with ES 6, he stated the hospital's ice machines were from two different manufacturers; however he followed the same procedure for all machines irrespective of the manufacturer. He also stated that the dietetic services ice machine was the only one from the Follett®.

Review of the chemicals on 6/13/16 at 2 pm, revealed that the cleaning chemical was a phosphoric based product and the sanitizing agent was a chlorine based product.

Review of manufacturers' guidance for the dietetic services ice machine revealed that the ice machine cleaner should be a chlorine rather than a phosphoric acid based product.

2. During review of food storage practices on 5/10/16 beginning at 9:35 am, the walk-in freezer "K" was observed to have a build-up of ice particles on the roof and the blower. In a concurrent interview with Dietary Management Staff (DMS), he stated the issue was not identified by staff.

In a follow up observation on 6/13/16 beginning at 10:30 am, the ice droplets on the roof and blower continued to be present. Water droplets may occur when warm external air mixes with colder air in a freezer (National Science Foundation 2015). In a concurrent interview, the surveyor queried Dietary Staff 11 on whether or not the door was left open for an extended period of time, such as during food deliveries. She stated, "No, the delivery is not until tomorrow."


26611

3. On 6/13/16 at 11:35 am, the ICCU patient food refrigerator was observed to have a three inch build up of ice on the interior ceiling.

In a concurrent interview, Administrative Nurse A acknowledged that this was not acceptable for patient food safety.

Based on observations, interview, and document review, the hospital failed to ensure systems to prevent the spread of communicable diseases and the incidence of food borne illnesses were implemented as evidenced by:

1. The lack of an effective system to monitor time/temperature control for seven of seven previously cooked foods capable of producing foodborne illness;

2. Reuse of greater than eight foods that were previously served in the self-serve salad bar;

3. Lack of a comprehensive procedure for one Registered Nurse (RN) to sanitize infant feeding preparation areas;

4. Lack of immunizations for two of two contracted dietary staff prior to assuming the position;

5. Inconsistent oversight of temperatures for the storage of patient food in refrigerators;

6. Debris and dried, spilled substances were present in food storage areas;

7. Staff food, a smoothie drink, was stored with patient food; and

8. Physician A and RN B did not observe contact isolation precautions.

These failures have the potential to cause infection and foodborne illnesses that could negatively impact a patient's health status affecting the hospital census of 69.

Findings:

1. Potentially Hazardous Foods (PHF) are those that are capable of supporting bacterial growth associated with foodborne illness. PHF's require time and temperature control through all phases including receiving, storage and food production. It would be the standard to ensure that hot PHF's are consistently monitored and cooled from 135°F (degrees Fahrenheit) to 70°F within 2 hours and to 41°F or less in an additional 4 hours, a maximum total of 6 hours. Similarly, foods that are prepared from room temperature ingredients shall be monitored to ensure temperatures decrease to 41°F or below within 4 hours of preparation (Food Code 2013).

a. During initial tour on 5/10/16 beginning at 9:35 am, in the 2-door freezer adjacent to the food production area, there were two packages of previously cooked turkey, weighing approximately three pounds, each dated 4/28 and 5/6/16 respectively. Similarly, there were packages of previously cooked meatballs and pot roast (dated 5/2/16); roast beef (dated 4/20/16); meatloaf (dated 5/6/16) and flank steak (dated 4/26/16). In a concurrent interview with Dietary Management Staff (DMS), he stated these items were left over from either patient meal service or the café serving line and would be utilized at an ensuing meal or as part of a recipe, such as soup.

During food production observation on 5/10/16 at 10:20 am, Dietary Staff (DS) 1 was cutting a cooked post roast. She stated the roast was used on patient tray line on 5/9 with leftover meat being used for soup. She further stated that she is usually the evening cook. She described a process whereby the meats which were cooked for dinner were routinely placed in the refrigerator or freezer and where then wrapped prior to leaving at 6 pm She also stated that she did not monitor cool down temperatures as there was "not enough time" prior to the end of her shift. She stated that the only employees after 6 pm, were staff responsible for dishes and evening cleaning.

In an interview and concurrent document review of a departmental document, titled, "Cooling Temperature Log," dated 3/25 through 5/6/16, on 5/10/16 at 10:30 am, with Dietary Management Staff (DMS) and the Registered Dietitian (RD), they both acknowledged that none of the observed items were monitored in accordance with the hospital guidance printed on the form. The guidance printed on the form was consistent with the standard of practice. It was also noted that the flank steak, dated 4/26/16, was monitored beginning at 1:26 pm with a recorded temperature of 147°F. The ensuing temperature was recorded at 4:20 pm (3 hours after the initial value was taken) with a temperature of 19°F. It was also noted that the values were entered with a standard black-in pen. At some point after the initial time entry of 4:20 pm, the document was altered with a black felt tip marker changing the time to 3:20 pm. There were two associate initials for the two temperatures recorded in black pen ink. There was no associate initial or notation at the time the document was altered. It was also noted that the ensuing entry, dated 4/27/16, for turkey was entered with a black felt tip marker.

Review of the departmental document titled, "Cooling Temperature Log" from 6/25/15 - 5/6/16 revealed 50 entries for 10-1/2 months. It was also noted that there were multiple entries that were taken after 6 pm, despite that the evening cook shift ended at 6 pm. The DMS stated he was the position responsible for supervision of dietary staff. He also stated he was the position responsible for reviewing the documents, and while he reviewed the documents, and noted there were issues with cool down monitoring he had not addressed the issue with staff nor independently recorded cool down temperatures of items in an attempt to verify accuracy of recorded values. The RD concurrently acknowledged issues with temperature monitoring.

Review of assessments completed by the vendor responsible for oversight of dietetic departmental operations from 11/2015 through 3/2016 revealed that in February and March 2016, the evaluation revealed there were issues with cooling foods; however there was no developed action plan.

b. In an interview on 6/14/16 beginning at 11:55 am with Dietary Staff 3 (the position responsible for cold food production activities) was asked to describe the preparation of tuna salad. He stated that the ingredients were obtained from the dry storage area and mixed according to a recipe. He further stated upon completion the item was labeled, dated, and placed in the refrigerator. When asked if there was temperature monitoring after the item was placed in the refrigerator, he stated there was not.

In an interview and concurrent document review with the RD on 6/14/16 at 12 p.m., review of the "Cooling Temperature Log" from 6/1-6/11/16, she confirmed there was no monitoring of food prepared from ingredients at ambient room temperature. The RD stated she had not thought about the necessity to monitor these foods. It was also noted that the cooling log did not provide guidance for foods prepared from room temperature ingredients.

While the hospital had a cool down monitoring form, review of departmental policy and procedure manual, approved 4/26/16, revealed there was no written approved policy/procedure associated with cool down of PHF's. Review of standardized recipe titled, "Tuna Salad" was limited to ingredients, assembly instructions and serving temperature. With the exception of covering and chilling, there was no additional guidance to food production staff with respect to food safety.

c. On 6/13/16 beginning at 11:20 am, in an interview with Dietary Staff 4, he stated he was responsible for serving the hot entrée items in the café. He further stated that if items were leftover, they would be taken back to the kitchen for reuse. He described the process as covering the item, labeling and dating and placing it in the refrigerator. He stated there were no other process steps after the item was in the refrigerator.

In a follow up observation on 6/13/16 beginning at 2:40 pm, it was noted the café items were removed. There were no observed leftover items. In a concurrent interview with Dietary Management Staff, the surveyor asked him to demonstrate the presence of a time/temperature monitoring example of café foods. He stated that the crab cakes on 6/2/16 would have been a café item. It was noted that temperature monitoring was not complete; rather the temperature of the item was documented at 149°F at 2:15 pm. There were no other documented temperatures.

Hospital document titled, "Infection Prevention & Control Plan 2016," described the purpose of the plan as the implementation of a program that encompassed all departments. Hospital infection prevention committee meeting notes, dated 11/20/15, noted environment of care rounds were completed in the dietary department; however the rounds were limited to housekeeping issues