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Based on interview and record review, the hospital did not have an effective governing body that carried out the functions required by a governing body when the hospital:



1. Failed to ensure that key opportunities for improvement were identified and preventative actions implemented, pertaining to the food service operations and clinical nutrition services within the Food and Nutrition Department. (Cross Reference A-0620 #1-12; A-0749 #1-6; A-0628 #'s 1-4; A-0630 #'s 1-3)

2. Failed to ensure safe food handling and sanitation practices within the food service operations at both Hospital A and Hospital B. (Cross Reference A-0620 #'s 1-12, A-0749 #'s 1-6)

3. The Food and Dietetic Services department was not effectively integrated into the hospital-wide Quality Assessment and Performance Improvement program to address the complexity and scope of the Food and Dietetic Services department. (Cross-Reference A-0273 #1, A-0263)

4. The designated Director of Food & Nutrition Services was not able to serve in a full-time position capacity to oversee daily management of the foodservice operation at Hospital A as his day to day responsibilities encompassed primarily an administrative role.
(Cross-Reference A-0620 #'s 1-10)

The cumulative effect of these problems resulted in the hospital's failure to deliver care in compliance with the Condition of Participation for Governing Body.

Based on observation, interview, record and document review, the hospital did not ensure that the quality assessment and performance improvement (QAPI) program developed, implemented and maintained an effective, ongoing, hospital-wide, data-driven program that incorporated the Food and Dietetic Services department. In addition, an audit process that was developed as part of a plan of correction in response to a federal complaint validation survey did not contain pertinent elements.



1. Failed to ensure that the QAPI program integrated Food and Dietetic Services to reflect the complexity and scope of the department to ensure safe food handling of potentially hazardous foods. In addition, the hospital failed to ensure that systems were in place that would have identified inadequacies in services that had the potential to negatively impact the nutritional status of medically fragile patients.
(Cross-Reference A-308; A-0273 #1)

2. Failed to ensure that key opportunities for improvement were identified and preventative actions implemented, pertaining to the food service operations and clinical nutrition services within the Food and Nutrition Department. (Cross Reference A-0620 #1-12; A-0749 #1-6; A-0628 #'s 1-4; A-0630 #'s 1-3)

3. The designated Director of Food & Nutrition Services was not able to serve in a full-time position capacity to oversee daily management of the foodservice operation at Hospital A as his day to day responsibilities encompassed primarily an administrative role.
(Cross Reference A-0620 #'s 1-12)

4. Failed to ensure safe food handling and sanitation practices within the food service operations at both Hospital A and Hospital B. (Cross Reference A-0620 #'s 1-12, A-0749 #'s 1-6)

5. Failed to ensure that nutritional consults were performed by the Registered Dietitian in the Neonatal Intensive Care Unit (NICU) in accordance with the hospital policy and procedure (Hospital A). (Cross Reference A-0621 #'s 1, 2, 3, 4, 5, and 6)

6. Failed to ensure that therapeutic diet orders met the nutritional needs of three patients who were identified as at nutritional risk due to the lack of a nutritional assessment by the registered dietitian. In addition, the hospital's screening system to identify patients who were at nutritional risk was not effective at capturing the nutritionally high risk patients in a timely manner to ensure the menus based on the diet orders met the needs of the patients (Hospital A and Hospital B). Failed to ensure the development of a comprehensive menu to meet the nutritional needs of patients who did not self-select their own meals, at Hospital B.
(Cross Reference A-0628 #'s 1-4)

7. The hospital failed to ensure that the patient menus for regular and therapeutic diets met the recommended dietary allowances and orders of the practitioner responsible for the care of the patient to ensure patients nutritional needs were met. Dietary staff preparing patient meals lacked guidance on the quantity of menu items to serve to be in accordance with the physician's order. (Cross Reference A-0630 #'s 1-3)

8. Hospital A and B failed to ensure that the audit tool used in their QAPI process collected pertinent data to help determine the accuracy of the hospital's audit process, for all inpatient units that were required to perform weekly audits related to staffing for the month of February 2013. The hospital's audit process was their method of ensuring that all inpatient units in the hospital were in compliance with their Nursing Plan for the Provision of (patient) Care. The audit process was part of their Plan of Correction pertaining to a federal complaint validation survey conducted in December 2012. (Cross Reference A-273 #2)


The cumulative effect of these systemic practices and issues resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Quality Assessment and Performance Improvement.

Based on administrative and dietary staff interview, dietary department document review, the hospital failed to have an ongoing quality assessment and performance improvement (QAPI) program that addressed the complexity and scope of Food and Dietetic Services which resulted in a failure to identify issues in safe food handling practices, food storage and sanitation, all of which could result in food borne illnesses. In addition, departmental staff failed to recognize inadequacies in services that could lead to unmet patient nutritional needs.

Lastly, Hospital A and B failed to ensure that the audit tool used in their QAPI process collected pertinent data to help determine the accuracy of the hospital's audit process, for all inpatient units that were required to perform weekly audits related to staffing for the month of February 2013. The hospital's audit process was their method of ensuring that all inpatient units in the hospital were in compliance with their Nursing Plan for the Provision of (patient) Care. The audit process was part of their Plan of Correction pertaining to a federal complaint validation survey conducted in December 2012.

Findings:
1. An interview on 3/13/13 at 10:00 A.M., with the hospital's quality assurance team was conducted. They were asked to describe how the hospital ensured that performance improvement activities reflected the depth and scope of departmental functions. The quality assurance team discussed a project referred to as the diabetic glycemic index that involved timing of the delivery of meals for the diabetic patients as it related to nursing provisions for diabetic care. That was one project that was identified by the quality assurance team that had measurable objectives with performance improvement indicators for patient safety. The other projects were primarily based on Press-Ganey patient satisfaction scores with the meal service.
Issues identified during the course of the survey were discussed with the quality assurance team and it included; unsafe food handling of potentially hazardous foods, lack of a system to ensure that nutritional needs of patients were met due to lack of comprehensive nutrition assessments to ensure that therapeutic diet's ordered met patient needs, lack of nutrition consults being performed in the neonatal intensive care unit in accordance with hospital policy, lack of menu nutrient analysis to ensure that the patient menus met the recommended dietary allowances and were in accordance with physican's orders, lack of menu development at Hospital B for those patients who did not self-select, and insufficient nutrition screening system to identify high nutritional risk patients to ensure timely assessments and interventions by the registered dietitians. The quality assurance team acknowledged that there was not a system in place, nor did communication between departments occur, in order for the hospital to have identified the above concerns prior to a survey, in order to have a mechanism to resolve the issues for the benefit of patients health and safety.
On 3/7/13 beginning at 11:00 A.M., the food and nutrition departments' performance improvement activities were reviewed. In a concurrent interview and dietary document review with the Food Service Director (FSD) and Clinical Nutrition Manager (CNM) revealed that the dietary department was performing food production quality improvement projects on 1) new moms' celebration meals; snacks for the post-partum floor; pureed soup process; budget expectations for diabetic snacks; and options for the pureed menus. Similarly the department was completing clinical projects that included development of continuing education presentations for hospital staff; best practices meetings for the Registered Dietitians; nutrition care charting templates; in-services with the Diabetes Initiative Committee and monthly journal clubs.
While the department identified issues that were of concern to the operational processes the department did not fully identify how these concerns would improve the health outcomes for patients nor was the department able to demonstrate measurable improvements in the departments systems. It was also noted that while the department identified concerns related to trayline activities there were no performance improvement activities related to safe food handling practices, evaluation of the menu system to ensure physicians' orders and/or the nutritional needs of patients were met.
In an interview on 3/7/13 beginning at 11:00 A.M., the FSD and the CNM acknowledged that while the department developed concerns the departments' performance improvement plan did not fully meet the operational concepts of a performance improvement plan.

Review of hospital document titled "Performance Improvement Policy 6.1", dated 10/5/07, revealed that the purpose of the plan was to "identify opportunities for improving care and services." Hospital policy titled "Performance Improvement 6.2" guided staff that the hospital's performance improvement plan was to 1) find a process to improve based on the hospitals defined tem dimensions of performance; 2) organize to improve and select a team with the process knowledge; 3) clarify and define the process; 4) understand the process and develop measures; 4) set key performance objectives; 5) plan the improvement and data collection; 5) do the improvement and data collection 6) check the results of the implementation; and 7) act to hold the gain and continue the improvement.




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2. A review of the hospital's "Staffing Monitoring Tool" audits were conducted for all inpatient units in Hospital A and B from 3/5/13 to 3/12/13. The hospital's "Staffing Monitoring Tool" required the auditor to review the following items: "Review the prior two shifts. Is the break form complete; Were ratios maintained at all times; If no, were actions documented; Was the chain of command needed; Ask 4 nurses the following questions. Do you know what to do when you need more staff; Do you know where to find your unit's staff guidelines; Total census for both shifts; Were all patients grasped (the hospital's patient classification/acuity tool used to quickly and appropriately predict the amount of total nursing care hours required by each patient each shift per unit) for the past 2 shifts; Enter total number grasped." However, the tool did not require the auditor to document the date and time the audit was performed, dates of the break forms and grasp score sheets that were used to collect that required data needed to complete the Staffing Monitoring Tool. In addition, the tool did not require the auditor to document the names of the staff that were interviewed and any corrective actions taken, if any for identified noncompliance during the staffing audits.

An interview was conducted with the Director of Regulatory Affairs (DRA) on 3/5/13 at 11:28 A.M. The DRA explained that the staffing audits were conducted weekly in the month of February 2013. He stated that the data was collected by the nurse managers or their designee. He explained that once the data was collected, the data was placed into a central database called the "I-Share". He stated that a report was generated to show each unit's compliance with all the criterias listed on the "Staffing Monitoring Tool". He further explained that the data collected and reported by each unit was then compiled into another report to show each of the Tool's criterias (i.e. completion of break forms, chain command verbalized, grasp scores completed, etc...) and the hospital's overall percentage of compliance listed and separated by weeks (i.e. week of 2/4/13, 2/11/13, 2/18/13 and 2/25/13).

The hospital's Staffing Monitoring Tool dated with each week that an audit was to be performed (i.e. week of 2/4/13, 2/11/13, 2/18/13 and 2/25/13) was reviewed to validate the accuracy of the unit's staffing audits and their reported data. The following demonstrates the inability to determine the accuracy of the hospital's monitoring/auditing process and reported data:

A review of the surgical intensive care unit (SICU) grasp scores from 2/19/13 to 2/25/13 was reviewed on 3/8/13 at 9:40 A.M. The grasp scores indicated that 3 grasp scores were missed; 1 grasp score for the day shift on 2/21/13, 1 grasp score for the day shift on 2/23/13, and 1 grasp score for the night shift on 2/24/13.

Further review of the SICU audits indicated that the Staffing Monitoring Tool for the week of 2/25/13 had 35 of 36 grasp scores that were completed. However, the accuracy of the data could not be validated because the date of the staffing and grasp form used to complete the audit tool was not documented.

From 3/5/13 to 3/12/13, multiple nurse managers and/or assistant managers from inpatient units were interviewed. They all stated that they were not required to document when the audit was performed, the staff they interviewed and the corrective action taken, if any for noncompliance identified during the audits.

A review of the Family Maternity Care Center (FMCC) grasp scores from 2/19/13 to 2/25/13 was reviewed on 3/8/13 at 1:45 P.M. The grasp scores indicated that 12 grasp scores were missed; 1 grasp score for the night shift on 2/21/13, 5 grasp scores for the night shift on 2/23/13, and 6 grasp scores for the night shift on 2/24/13.

Further review of the FMCC audits indicated that the Staffing Monitoring Tool for the week of 2/25/13 had 29 of 29 grasp scores that were completed. However, the accuracy of the data could not be validated because the date of the staffing and grasp form used to complete the audit tool was not documented.

On 3/13/13 at 9:30 A.M., a QAPI meeting was conducted. During the meeting, the Director of Nursing Quality (DNQ) acknowledged that the hospital's Staffing Monitoring Tool did not require the auditor to document pertinent information such as the audit date and time, names of staff interviewed, corrective action taken, if any when a noncompliance was identified to determine the accuracy of the auditing process and the reported data.

Based on observation, interview and record review, the hospital failed to ensure that the Quality Assessment and Performance Improvement (QAPI) program incorporated the Food and Dietetic Services to reflect the complexity and scope of the department to ensure safe food handling of potentially hazardous foods. The hospital failed to ensure systems were in place that would have identified and improved inadequacies in services that had the potential to negatively impact the nutritional status of medically fragile patients.

Findings:

On 3/13/13 at 10:00 A.M., the quality assurance and program improvement (QAPI) staff acknowledged that neither the neonatal intensive care unit (NICU), nor the food and nutrition department had reported to the QAPI team that nutritional consults were not being done for the neonatal patients in accordance with hospital policy.


During the course of the survey there were extensive unsafe food handling and unsanitary practices that were occurring within the foodservice operations at both Hospital A and Hospital B. In addition, there were systems issues identified by the survey team that would impede nutrition care for patients that were not identified by the quality assurance team, as there was no mechanism in place in which deficit practices would have been recognized.


On 3/13/13 at 11:05 A.M., during an interview with the governing body, the governing body acknowledged that the identified issues as cross-referenced below had not been identified by hospital staff, and reported to governing body. A governing body member stated, "If we had known we would have fixed it immediately."

Based on interview and document review, Hospital B failed to ensure that licensed staff had current competencies to provide Intravenous (IV) Conscious Sedation to patients, for 7 of 8 Registered Nurses (RNs) in the Procedural Unit of Hospital B's Cancer Center.

Findings:

1. A general observation tour of the Procedural Unit (PU) of Hospital B's Cancer Center was conducted with the Registered Nurse Manager (RNM/PU) on 3/11/13 at 8:30 A.M. The RNM/PU stated that procedures performed in the unit are either done under Local Anesthesia (the injection of anesthesia to a specific area of the body) or with Intravenous Conscious Sedation (a drug induced depression of consciousness). The RNM/PU further explained that about 20 percent of the units procedures were performed under IV Conscious Sedation.

Three Registered Nurses (RN 26, RN 27, RN 28) ) were scheduled to work in the Procedural Unit on 3/11/13. Of the 43 procedures scheduled for 3/11/13, one of the procedures was planned to be done with IV Conscious Sedation. A review of the three RNs skills competency file was conducted on 3/11/13 at 8:55 A.M. RN 26 last documented evidence of training in IV Conscious Sedation was dated 11/3/09. RN 27's IV Conscious Sedation Training was last conducted in the year 2000 when she was an RN in the Surgical Intensive Care Unit (SICU). And, RN 28's last documented evidence of training in IV Conscious Sedation was 2/19/10.

An interview was conducted with RN 27 on 3/11/13 at 9:10 A.M. RN 27 stated that she last completed IV Conscious Sedation training when she worked in SICU in 2000. RN 27 stated that she was told that she only had to complete the training once.

A review of the hospital's policy and procedure, entitled "Sedation for Procedures" and dated 4/19/12, indicated that personnel were required to complete a conscious sedation course within six months of hire. The policy further indicated that successful completion of a sedation test was required every two years. Three other policies, all entitled "Sedation Policy" and dated 8/20/09, 1/15/09 and 11/17/11, had different competency requirements. All of the other three policies and procedures indicated that for RNs to perform conscious sedation they were required to complete a "Sedation Self-Examination - repeated annually."

An interview was conducted with the Director of Regulatory Affairs (DRA) on 3/11/13 at 2:40 P.M. The DRA stated that the Procedural unit of Hospital B's Cancer Center had performed 137 sedation cases in the fiscal year 2013, or 17 sedation cases per month. In the fiscal year of 2012, the Procedure Unit performed 306 sedation cases, in total, or 25.5 sedation cases per month.

A second interview was conducted with the RNM/PU on 3/12/13 at 8:25 A.M. The RNM/PU acknowledged that seven of the eight RNs that worked in the Procedural Unit did not have current competency skills in IV conscious sedation.

The one patient scheduled to have a procedure with IV Conscious Sedation was done under a local anesthetic.

Based on interview and record review, Hospital B failed to ensure that 1 of 48 sampled patients (Patient 21) was weighed, as ordered by his physician, during the first three days of his hospital admission.

Findings:

Patient 21 was admitted to Hospital B on 3/4/13 for treatment of back pain according to the Admission Face sheet. A review of Patient 21's medical record was conducted on 3/7/13 at 8:30 A.M. There was a physician's order, written on 3/4/13 at 9:30 P.M., for "Weight Q (every) 48 H (hours)".

An interview was conducted with Patient 21 on 3/7/13 at 8:55 A.M. Patient 21 stated that the last time that he was weighed was two to three weeks ago.

An interview and concurrent record review was conducted with Patient 21's registered Nurse (RN 21) on 3/7/13 at 9:30 A.M. It was documented in Patient 21's medical record that he arrived in Hospital B's Emergency Department (ED) at 3:00 P.M. on 3/4/13. It was documented in Patient 21's ED record that his "stated weight was 150 (pounds)." After reviewing the physician's orders, RN 21 stated that Patient 21 should have been weighed on 3/6/13. There was no documented evidence in Patient 21's medical record that he had ever been weighed since his admission on 3/4/13.

Based on interview, record and document review, Hospital B failed to ensure that 1 of 64 sampled patient's (Patient 18) pain medication was administered in accordance with the physician's order.

Findings:

Patient 18 was admitted to Hospital B on 2/27/13 for treatment of a tumor of the pelvis and hip according to the Admission Facesheet. A review of Patient 18's medical record was conducted on 3/6/13 at 1:30 P.M. On 2/27/13, Patient 18's physician wrote the following orders for pain medication:

Hydromorphone (Dilaudid-a narcotic analgesic) 0.5 mg. (milligrams) intravenous every 4 hours prn (as required) for moderate pain (Pain Score 4-6)

Oxycodone (Roxicodone-a narcotic analgesic) 10 mg. oral every 3 hours prn for severe pain (Pain Score 7-10)

According to Patient 18's Medication Administration Record (MAR), on 3/6/13, Patient 18 received Dilaudid 0.5 mg. intravenously at 12:24 A.M., 4:03 A.M., 8:36 A.M. and 1:32 P.M. However, according to the nurse's pain assessment, Patient 18's pain score (prior to the administration of the Dilaudid) was as follows:

12:24 A.M. Pain Score = 8
4:03 A.M. Pain Score = 7
8:36 A.M. Pain Score = 10
1:32 A.M. Pain Score = 9

Therefore, according to the physician's orders, Patient 18 should have received Oxycodone 10 mg. tablet orally.

A review of the hospital's policy and procedure, entitled Patient Treatment and Medication Orders and dated 2/6/13, "Medications and treatments should be administered as ordered by prescribers."

An interview was conducted with the nursing unit Registered Nurse Manager (RNM) on 3/6/13 at 2:00 P.M. The RNM acknowledged that the four doses of Dilaudid, that were administered to Patient 18 on 3/6/13, were not in accordance with the physician's order for pain medication.

Based on observation, interview and record review, Hospital A failed to implement a policy and procedure to ensure that multiple orders for the same indication were written to include the priority of which anti-nausea drug to use first and under what conditions, for 1 of 64 sampled patients (Patient 56).

Findings:

During a medication pass audit on 3/5/13 at 2:17 P.M., Patient 56 was observed receiving a dose of ondansetron (Zofran, a drug for nausea and vomiting) 4 mg (milligrams) by mouth.

Patient 56 was admitted to Hospital A on 3/4/13 with cyclic vomiting syndrome per the History and Physical, dated 3/4/13.

The record was jointly reviewed with the Director of Pharmacy (DOP), Pharmacist (RPh 56) and Pharmacist (RPh 57) on 3/5/13. The following medications for nausea and vomiting were ordered by Physician (MD 56):

Routine:
1. Ondansetron (Zofran) disintegrating table 4 mg every 8 hours (around the clock PO (by mouth).

PRN (Only as needed):

1. Promethazine (Phenergan) tablets 25 mg, one tablet every 6 hours as need for nausea/vomiting. Administration Instructions: Use first if tolerating PO (by mouth).

2. Promethazine 12.5 mg in sodium chloride 0.9% in 50 ml (milliliters) IVPB (Intravenous by Piggyback infusion) every 6 hours prn for nausea/vomiting at 100 ml/hr (milliliters per hour) over 30 minutes. Administration Instructions: Use third if IV Zofran ineffective.

3. Ondansetron (Zofran) injection 4 mg IV (direct injection into a vein), every 6 hours prn for nausea/vomiting. Administration Instructions: None.

In the set of "PRN" orders, the ondansetron injection 4 mg IV had no administration instructions, and it was not clear in what sequence the Zofran IV should be used in relation to the other medications.

The hospital's Policy and Procedure MCP 321.3 III, E, 4, b, entitled "Therapeutic Duplication of Orders" approved by the hospital on 2/6/13 were reviewed. The policy indicated, "Multiple orders for the same indication without a priority of which to use first and under what conditions are unacceptable. The order requires clarification of conditions under which each would be preferentially used."

Further, Policy and Procedure MCP 321.3 III, C, entitled "Pharmacist Responsibilities", indicated that the pharmacist responsibilities include, "1. Provide oversight for medication administration orders; and, 4. "Review the patient medication profile for potential drug interactions, real or potential allergies, correct dosages based on patient-specific parameters, duplication of therapy, and appropriateness relative to the plan of treatment. Evaluate variation from the organization's criteria for use and correct, clarify and document when necessary."

Registered Nurse (RN 56) was interviewed and acknowledged that the orders were unclear, and that she would normally call the doctor to get clarification before selecting a prn drug for nausea and vomiting.

DOP, RPh 56, and RPh 57 were jointly interviewed. They acknowledged that administration instructions for ondansetron IV were not included in the PRN order, and the sequence with which the PRN orders should have been selected, was not clear. They also acknowledged that the orders, as written, were not in compliance with the hospital's policy.

Based on observation, interview and record review, the hospital failed to ensure organized dietary services were provided, as evidenced by:
1. The designated Director of Food & Nutrition Services was not able to serve in a full-time position capacity to oversee daily management of the foodservice operation at Hospital A as his day to day responsibilities encompassed primarily an administrative role.
(Cross Reference A-0620 #'s 1-12)
2. Failed to ensure safe food handling and sanitation practices within the foodservice operations at both Hospital A and Hospital B. (Cross Reference A-0620 #'s 1-12, A-0749 #'s 1-6)
3. Failed to ensure that nutritional consults were performed by the Registered Dietitian in the Neonatal Intensive Care Unit (NICU) in accordance with the hospital policy and procedure (Hospital A). (Cross Reference A-0621 #'s 1-6)
4. Failed to ensure that therapeutic diet orders met the nutritional needs of three patients who were identified as at nutritional risk due to the lack of a nutritional assessment by the registered dietitian. In addition, the hospital's screening system to identify patients who were at nutritional risk was not effective at capturing the nutritionally high risk patients in a timely manner to ensure the menus based on the diet orders met the needs of the patients (Hospital A and Hospital B). Failed to ensure the development of a comprehensive menu to meet the nutritional needs of patients who did not self-select their own meals, at Hospital B.
(Cross Reference A-0628 #'s 1-4)
5. The hospital failed to ensure that the patient menus for regular and therapeutic diets met the recommended dietary allowances and orders of the practitioner responsible for the care of the patient to ensure patients nutritional needs were met. Dietary staff preparing patient meals lacked guidance on the quantity of menu items to serve to be in accordance with the physician's order. (Cross Reference A-0630 #'s 1-3)
6. The Food and Dietetic Services department was not effectively integrated into the hospital-wide Quality Assessment and Performance Improvement program to address the complexity and scope of the Food and Dietetic Services department. (Cross-Reference A-0273 #1, A-0263)
The cumulative effects of these systematic problems resulted in the hospital's inability to ensure the provision of dietetic services for the health and safety needs of patients in compliance with the Condition of Participation for Food and Dietetic Services.

Based on observation, interview, record review and dietary document review, the hospital failed to ensure that the Food Service Director (FSD) was functionally acting in a full-time position to be responsible for daily management of the dietary services at Hospital A. At Hospital A, the FSD failed to ensure safe food handling and sanitary conditions as evidenced by; 1) A potentially hazardous food was not cooled down to ensure food safety, 2) A clean utility cart with food storage bins and containers were pushed directly against boxes that contained raw meat located in the thaw box refrigeration, 3) There lacked a thaw date monitoring system to ensure that a frozen juice product was used within 14 days of thawing per manufacturer's guidelines, 4) Food items stored in the refrigerator, freezer and dry storage room were either undated as to when opened, not sealed or both. In addition, inside a walk-in refrigerator contained 11 packages of expired tofu, 5) There were opened sauces and jam that were stored continuously at room temperature but should have been refrigerated after opening per manufacturer,6) A cardboard box that contained frozen vegetables came in direct contact with other frozen vegetables that were being served to patients,7) A utility cart that held the patient dishes that were used for a dinner meal contained a large surface area of brown liquid, and broken chips from a plate, 8) The hoods over the stove range were black and had grease build-up, and 9) There were overall uncleanliness concerns at most workstations throughout the kitchen, in addition to cracked tiles along baseboards.
At Hospital B, Dietary Management Staff 1 (DMS 1), failed to ensure a safe and sanitary environment as evidenced by 10) Lack of a system for dietary staff to identify what dishes were already cleaned and what dishes needed to be washed. Dietary staff stored dirty dishes with food debris on a cart pushed directly up against the racks that held the clean dishes throughout the day until they were able to be washed. Thirty-six meal trays were in disrepair as they were discolored and chipped.
In addition, Hospital B failed to ensure that the FSD provided effective oversight into the departmental operational processes as evidenced by 11) failure to store foods in accordance with manufacturers' guidance and 12) develop procedures to ensure time/temperature control for food safety utilizing water as a method to thaw raw meat.
Failure to ensure safe food handling and sanitation practices had the potential for risk of foodborne illness further compromising the health status of medically fragile patients.
Findings:
At Hospital A:
1. On 3/5/13 at 11:08 A.M., inside the cook-chill walk-in refrigerator, there was large pan of cooked three-cheese pasta bake dated 3/4/13. Chef 62 confirmed that the 3/4/13 date meant that the three-cheese pasta bake was cooked on that day.
Review of the hospital's Blast Chiller Temperature Log indicated that the three-cheese pasta bake began the cooling down process at 12:00 P.M. at 170 degrees Fahrenheit (F). The temperature of the three-cheese pasta bake was not checked again until three hours later, at 3:00 P.M.
According to the directions on the top of the Blast Chiller Temperature Log, "Cooling/time safe range for meat items: Under 70 degrees [F] under 2 hours & 40 degrees [F] or under in under 4 hours."
Excessive time for cooling of potentially hazardous foods (time/temperature control for safety foods) has been consistently identified as one of the leading contributing factors to foodborne illness. If the initial cooling to 70?F took 3 hours, the food safety hazards may not be adequately controlled. (FDA Food Code 2009: Annex 3 - Public Health Reasons/Administrative Guidelines - Chapter 3, Food 3-501.14 Cooling)
According to the review of the Blast Chiller Temperature Log for 3/4/13 and 3/5/13, there were 24 items logged as needing to be cooled down and 9 of the items logged had not contained completed documentation in accordance with the directions on the log to ensure food safety. On 3/5/13 at 11:25 A.M., the FSD and Chef 62 acknowledged that dietary staff was not consistently following hospital policy and procedure for cooling down of potentially hazardous foods.
2. On 3/5/13 at 10:28 A.M., inside a walk-in refrigerator identified as the "thaw box", was a utility cart that contained clean food storage bins, containers, and dishes that was pushed directly against a shelving unit that contained boxes of raw meat.
The Purchasing Coordinator (PC 63) had not known why the utility cart was there. The FSD who was present at the same time stated, "That shouldn't be in here." The FSD acknowledged that there was a potential for cross-contamination.
The hospital's policy and procedure entitled Cleaning and Sanitizing General Equipment and Utensils (Policy 7.4; reviewed 2/1/11) indicated, "Policy: Regular, effective cleaning and sanitizing of equipment, utensils and work or dining surfaces minimize the probability of contaminating food during preparation, storage, service and the transmission of disease organisms to consumers and employees. Purpose: Effective cleaning will remove soil and prevent the accumulation of food residues which may decompose or support the rapid development of food poisoning organism or toxins ..., work surfaces, counters, utensils-thoroughly cleaned and rinsed following contact with raw or uncooked meat and other potentially hazardous foods."
3. On 3/5/13 at 10:35 A.M., inside walk-in refrigerator 1, there were 31 cases, with 70 individual portion sized cartons per case, of juice with manufacturer's guidelines on the cartons that indicated "Keep Frozen", and "Best when used within 14 days of thawing." There was an orange sticker with various dates on the boxes.
PC 63 stated that the juices come in frozen and are placed in the freezer and given an orange sticker with the receiving date. PC 63 stated that the boxes of juices were currently in the refrigerator to thaw. When PC 63 was shown the manufacturer's guidelines on the box, he stated that he would not be able to state how long the cases of juice had been thawing in the refrigerator. The FSD was present during the observation and interview, and acknowledged that there was not a monitoring system in place to ensure the juices were used in accordance with manufacturer's guidelines.
The hospital's policy and procedure entitled Labeling of Food Deliveries (Policy 3.10; reviewed 2/1/2011) indicated, "Labels are to be placed on all products with date of preparation, date received, and/or date defrosted."
4. On 3/5/13 at 10:29 A.M., inside walk-in refrigerator 1, was an opened, uncovered ham hock that was exposed to air and potential contaminants. The ham hock was not dated when opened. Inside the same refrigerator was a box of snap peas that were uncovered and had chunks of ice directly on the peas, and not dated when opened. There was a bag of opened cheese tortellini, and a bag of dinner roles that were not dated once opened.
On 3/5/13 at 10:50 A.M., in the dry food storage room, was a large bag of flour that was not covered which exposed the flour to potential contaminants. The PC 63 and FSD acknowledged that the bag of flour should have been sealed.
The FSD verified that it was his expectation for foods to be dated once opened to ensure the products are used in accordance with the hospital's shelf-life policy, or per manufacturer's guidelines. The dietary policy and procedure manual lacked clear direction to dietary staff on the shelf life of commonly used and ordered items that the hospital utilized for food production. Such as, at the cook's spice rack was a dark corn syrup with an open date of 6/20/12. When asked how long the product could be used once opened, Chef 62 and the FSD was unable to answer.
On 3/5/13 at 10:40 A.M., inside a walk-in refrigerator identified as the "IR Box", was a box of Tofu that contained 11 packages of the tofu, unopened. The outside box contained an orange sticker that indicated "1/11/13." The inside of the box, on each individual package of tofu was a date from the manufacturer that indicated "Expires February 21, 2013."
At that time PC 63 was inside the walk-in refrigerator and was directly asked if the tofu was ok to serve to patients. PC 63 looked at the orange receiving sticker and noted that the tofu had not been opened, and stated, "Yes." PC 63 was then asked to look at the date on the individual container of unopened tofu. PC 63 acknowledged that the tofu had expired and should have been thrown out.
The hospital's policy and procedure entitled Labeling of Food Deliveries (Policy 3.10; reviewed 2/1/2011) indicated, "The shelf life of each product ... will be disposed of if it passes the expiration date."
On 3/5/13 at 11:15 A.M., the FSD stated that the Purchase Coordinator position was delegated the task to ensure sanitary and safe conditions with food storage.
According to the Purchase Coordinator's job description (undated), "Maintains sanitary storage areas that are compliant with State, Federal and Local codes using FIFO [First in, First out] system to reduce waste ..., has thorough knowledge of HACCP [Hazard Analysis Critical Control Point] and maintains compliance in areas."
5. On 3/5/13 at 10:48 A.M., inside the kitchen at the cook's spice rack were items that were stored at room temperature continuously until the item ran out per Chef 62. On the spice rack was an opened bottle of BBQ sauce, not dated as to when opened. On the bottle of BBQ sauce was manufacturer's directions to "refrigerate after opening."
There was an opened bottle of soy sauce, dated 2/27/13 when opened, with manufacturer's directions to "refrigerate after opening."
There was an opened bottle of jam, that was not dated as to when opened, with manufacturer's directions to "refrigerate after opening."
The FSD was present during the observation and acknowledged that the manufacturer's guidelines were not being followed to ensure food quality and food safety.
6. On 3/5/13 at 1:23 P.M., during observation of dinner trayline, a dietary staff brought the original shipping cardboard box that contained a blue bag of frozen vegetables. Dietary staff set the cardboard box on the foodservice counter at trayline. The dietary staff proceeded to tip the cardboard box and held it directly against the serving container and filled it up with the frozen vegetables.
The FSD was present during the above observation and stated that was an unsanitary food handling practice, and had the potential for cross-contamination of the food. Delivery boxes could contain microbes and dust.
The hospital's policy and procedure entitled Cleaning and Sanitizing General Equipment and Utensils (Policy 7.4, reviewed 2/2/11) indicated, "Regular, effective cleaning and sanitizing of equipment, utensils and work or dining surfaces minimize the probability of contaminating food during preparation, storage, service and the transmission of disease organisms to consumers and employees."
7. On 3/5/13 at 1:43 P.M., during observation of dinner trayline, a dietary employee (DE 64) brought over a dish holding cart to trayline for the dinner meal service that contained a stack of white dishes.
The dish holding cart contained a large surface area of a brown colored liquid substance on the bottom, along with a large area of broken white pieces from a plate.
On 3/5/13 at 1:45 P.M., DE 64 observed the dish holding cart and verified that he had brought the cart to the trayline to be used for the dinner meal service.
The FSD observed dish holding cart and acknowledged that serving patient meals on dishes that were obtained from a non-clean cart was not a sanitary practice.
The hospital's policy and procedure entitled Cleaning and Sanitizing General Equipment and Utensils (Policy 7.4; reviewed 2/1/11) indicated, "Policy: Regular, effective cleaning and sanitizing of equipment, utensils and work or dining surfaces minimize the probability of contaminating food during preparation, storage, service and the transmission of disease organisms to consumers and employees. Purpose: Effective cleaning will remove soil and prevent the accumulation of food residues which may decompose or support the rapid development of food poisoning organism or toxins ..."
8. On 3/5/13 at 1:10 P.M., the hood over the stove range was black and had visible grease build-up. Cook 65 was asked who was responsible for cleaning of the hoods. Cook 65 stated, "I don't do any of that. People from the outside come in to do that. There should be a sticker that indicates the last time it was done."
The hospital's policy and procedure entitled Cleaning and Sanitizing General Equipment and Utensils (Policy 7.4; reviewed 2/1/11) indicated, "C. HOODS; Hoods should be cleaned with a solution of Foaming Oven Cleaner and warm water every week. Polish with stainless steel polish."
9. On 3/5/13 at 10:20 A.M., near a hand washing sink was cracked tiles along the baseboard which was identified by the FSD. The FSD reported the cracked tiles along with other kitchen floor issues to facilities on 2/8/13, and remained in need of repair.
On 3/5/13 at 10:41 A.M., the shelving in the walk-in refrigerator identified as "IR Box" had debris build-up.
On 3/5/13 at 2:00 P.M., a general walk through to observe cleanliness was conducted with the FSD and Chef 62. The shelves located by the ice-machine in the kitchen had hard covered plastic covering the shelves. The hard covering was discolored with brown markings, and some had deep chipped crevices which did not lend to a smooth surface to be cleaned and sanitized.
Along side a wall was shelves that contained bins. Inside the bins were food particles, and general debris that held the clean cooking utensils. Chef 62 acknowledged that the bins were not clean, and stated, "More in-servicing could be done."
The hospital's policy and procedure entitled Food Storage (Policy 3.2; reviewed 2/1/11) indicated, "All food items and supply must be stored on clean shelves and or approved storage racks ..."
The hospital's policy and procedure entitled Pest Control (Policy 7.26; reviewed 2/1/11) indicated, "A set of sanitary work rules combined with preventative maintenance will help to eliminate problems with food pest in your unit ..., Food Preparation Areas: Food often lodges in floor, wall and counter joints creating natural "nests" for insects.
At Hospital B:
10. On 3/6/13 at 10:08 A.M., inside the kitchen there was a dish holding cart that was located at the area of the clean side of the dishmachine room. The top four to five dishes had thick dried food debris on them. The Clinical Nutrition Manager, registered dietitian who reported to have oversight responsibilities over the foodservice operation stated, "Those are clean dishes. Clearly, they are not clean however."
The dietary employee that was currently washing dishes (DE 66) was shown the plates that had the dry food debris, and she stated, "These are dirty." She pointed to the dish holding cart, and stated, " Sometimes staff bring dirty dishes to that side."
At that time, DMS 1 observed where the same mentioned above dish holding cart was located. DMS 1 observed the dish holding cart and acknowledged that the designated holding cart for clean and sanitized dishes was dirty from food debris, and acknowledged that there was dried food build up on the plates. DMS 1 stated, "I didn't know that dirty dishes were brought to the clean side."
Just a few minutes later, a dietary employee (DE 67) brought in dirty foodservice equipment and utensils to the clean side of the dishmachine room on a large utility cart and pushed it directly against the shelving that contained the sanitized foodservice equipment, such as plates and bins. One minute later, DE 68 brought in dirty dishes through the clean side of the dishmachine room. At that time, the ongoing daily practice of dietary staff bringing in dirty dishes to the clean side of the dishmachine room which contributed to confusion as to what dishes were waiting to be cleaned was observed by DMS 1.
On 3/6/13 at 10:20 A.M., DE 67 went to the dirty side of the 3-compartment sink and pulled down the spray nozzle to wet a cloth. Just inches below the cloth was a large surface area of leftover food from patients plates that had been scraped from the dishes. As DE 67 was wetting the cloth the splash off the leftover food was splashing and spraying around the area.
DE 67 proceeded to take that cloth and used it on the surface of a food utility cart. DE 67 was asked to explain what he was doing, and he stated, "Oh, there was crumbs on the cart so I wiped them off." DE 67 proceeded to carry on to his next duty, without washing his hands. The FSD was present for all of the above observations and acknowledged that staff appeared unaware of the unsanitary and unsafe food handling and foodservice equipment handling practices that were occurring. The FSD acknowledged that there was an overall unawareness amongst dietary staff of concerns with cross-contamination, and potential outcomes that could occur to the medically fragile patients.
On 3/6/13 at 10:35 A.M., there were 36 meal trays that were discolored, chipped and cracked. The FSD observed the trays and acknowledged that they needed to be replaced.
The hospital's policy and procedure entitled Standards of Sanitation and Hygiene (Policy 6.3, reviewed 2/1/11) indicated, "Employees wash their hands:...after ...cleaning or handling dirty dishes or equipment ..."
The hospital's policy and procedure entitled Food Production (Policy 4.3, reviewed 2/1/11) indicated, "The importance of the food service personnel and their role in obtaining high quality food cannot be overemphasized ..., 8. Develop awareness and adhere to sanitation procedures and good personal hygiene practices, 9. Maintain a positive attitude and a sense of commitment and responsibility toward food production ..."
The hospital's policy and procedure entitled Ware Washing (Policy 7.21;last reviewed 2/2/11) indicated, "Clean dishes must not be placed in dirty racks ..., If any items are not clean they should be rewashed."
The hospital's policy and procedure entitled Cleaning and Sanitizing General Equipment and Utensils (Policy 7.4; reviewed 2/1/11) indicated, "Purpose: Effective cleaning will remove soil and prevent accumulation of food residues which may decompose or support the rapid development of food poisoning organisms or toxins. Application of effective sanitizing procedures destroys those disease or organisms either through tableware such as glasses, cups and flatware or indirectly through the food."
According to the hospital's job description for the Director of Food and Nutrition Services (FSD), "Responsibilities include oversight of all functions including: patient meal service, catering, cafeteria operations, coffee carts, retail sites, food procurement, food preparation and storage, sanitation, safety, equipment maintenance, maintenance of cost records on a variety of indicators and the hiring and training of personnel ...Provides guidance and direction in dietary planning to include standard and therapeutic diets."



17065

Hospital B:

11. During initial tour on 3/6/13 beginning at 8:20 A.M., it was noted in the walk-in refrigerator there was a case of thawed sausage, opened 3/4. It was noted that manufacturers' guidelines for the produce were to "keep frozen" with accompanying guidelines "best if thawed 12-36 hours before." Additionally, there was a case of turkey bacon with manufacturers' guidance to "Keep Frozen 0?F or Below." In a concurrent interview with Dietary Management Staff 1 (DMS) she stated that it would be the standard of practice within the facility to store this product in the refrigerator.

12. Safe thawing of potentially hazardous foods, which are defined as those capable of supporting bacterial growth associated with foodborne illness, include the use of complete submersion under running water with the following specified parameters: 1) at a water temperature of 21oC (70oF) or below; 2) with sufficient water velocity to agitate and float off loose particles in an overflow, and 3) for a period of time that does not allow thawed portions of a raw animal food requiring to be above 41oF, for more than 4 hours including: (a) the time the food is exposed to the running water and the time needed for preparation for cooking, or b) the time it takes under refrigeration to lower the food temperature to 41oF.
During general food production observations on 3/6/12 beginning at 8:50 A.M., it was noted that dietary staff was thawing individually wrapped fish under running water. In a concurrent interview with Dietary Staff 4 (DS) the surveyor asked him to describe his process. He stated that he pulled the fish from the freezer placed it in the sink under running water approximately 30 minutes prior. He also stated he would begin preparing the item within the next 30 minutes to be utilized in the cafe for the noon meal. In a concurrent interview with the FSD he stated that since the kitchen had limited refrigerator storage space thawing under running water was done on a regular basis.

Review of hospital policy titled "HACCP Compliance" (Hazard Analysis Critical Control Points) dated 8/6/09 revealed that while the policy guided staff that "products are thawed correctly" there was no guidance on how to accomplish this.

Based on interviews and record reviews, Hospital A failed to ensure that physician's orders for nutrition consults in the Neonatal Intensive Care Nursery (NICU) were performed in accordance with their Food and Nutrition Services Policy and Procedure Manual, for 5 of 5 sampled neonatal patients (31, 32, 33, 34, and 35). Nutrition Consults in the NICU were not completed within 24 hours by the Dietitian in accordance with their policy.

Findings:

1. On 3/8/13 beginning at 9:25 A.M., a tour of the NICU was conducted with the Director of Woman and Infant Services (DWIS) and Charge Nurse (RN 31). Patient 31 was observed in a giraffe bed (specially designed, high-tech warming isolette for critically ill newborns) and was receiving his nutrients through a central line (a long, thin, flexible tube used to give medicines, fluids, nutrients or blood products over a long period of time) in the umbilicus.

A review of Patient 31's medical record was conducted on 3/8/13 at 10:31 A.M. Patient 31 was admitted to Hospital A on 2/26/13 with diagnoses that included extremely low birth weight newborn (less than 500 grams) and respiratory distress per the Admission Note dated 2/26/13. According to a Physician's Order dated 2/26/13, a nutrition consult was ordered for Patient 31. Per the same Order, it indicated that the reason for the consult was due to Patient 31's admission to the NICU. There was no documented evidence to show that the nutrition consult was performed by the Dietitian.

A review of the hospital's policy entitled " Nutrition for the Infant Special Care Center (NICU)", review date of 4/2011 was conducted. The policy indicated that "Nutrition consults are by referral from physicians, nurses, or occupational therapists." Per the policy, it stipulated that "All patients for whom nutrition consults are ordered, are completed by the Dietitian within 24 hours."

An interview and joint record review was conducted with the clinical nurse specialist (CNS 31) on 3/8/13 at 1:24 P.M. She confirmed that there was no documented evidence in Patient 31's medical record to demonstrate that a nutrition consult was performed by the Dietitian.

An interview with the Director of Nutrition (DN 31) was conducted 3/11/13 at 10:32 A.M. DN 31 acknowledged that nutrition consults ordered by the physician in the NICU should have been performed by the Dietitian in accordance with the hospital's policy.

A telephone interview was conducted with the Medical Director of the NICU (Physician 31) on 3/12/13 at 2:37 P.M. Physician 31 acknowledged that the hospital's policy related to Nutrition for the Infant Special Care (NICU) was not followed as evidence by a lack of documented evidence found in medical records to demonstrate that a nutrition consult was performed by the Dietitian.

2. On 3/7/13 at 10:55 A.M., a tour of 4 ISCC (4 Infant Special Care Center - is part of the NICU located on the 4th floor) was conducted with the Director of Woman and Infant Services (DWIS) and the Licensing and Accreditation Principal. Patient 32 was found swaddled in an open crib attached to monitors.

A review of Patient 32's medical records were conducted on 3/8/13 at 1:35 P.M. Patient 32 was admitted to Hospital A on 2/19/13 with a diagnoses that included prematurity, infant of a diabetic mother and hypoglycemia (low blood sugar) per the Admission Note dated 2/19/13. According to a Physician's Order dated 2/19/13, a nutrition consult was ordered for Patient 32. Per the same Order, it indicated that the reason for the consult was due to the admission to the NICU. There was no documented evidence to demonstrate that a nutrition consult was performed by the Dietitian.

A review of the hospital's policy entitled " Nutrition for the Infant Special Care Center (NICU)", review date of 4/2011 was conducted. The policy indicated that "Nutrition consults are by referral from physicians, nurses, or occupational therapists." Per the policy, it stipulated that "All patients for whom nutrition consults are ordered, are completed by the Dietitian within 24 hours."

An interview and joint record review with the clinical nurse specialist (CNS 31) was conducted on 3/8/13 at 1:45 P.M. CNS 31 confirmed that there was no documented evidence in Patient 32's medical record to show that a nutrition consult was performed by the Dietitian, in accordance with the physician's order dated 2/19/13.

An interview with the Director of Nutrition (DN 31) was conducted 3/11/13 at 10:32 A.M. DN 31 acknowledged that nutrition consults ordered by the physician in the NICU should have been performed by the Dietitian in accordance with the hospital's policy.

A telephone interview was conducted with the Medical Director of the NICU (Physician 31) on 3/12/13 at 2:37 P.M. Physician 31 acknowledged that the hospital's policy related to Nutrition for the Infant Special Care (NICU) was not followed as evidence by a lack of documented evidence found in medical records to demonstrate that a nutrition consult was performed by the Dietitian.

3. On 3/8/13 beginning at 9:25 A.M., a tour of the NICU was conducted with the Director of Woman and Infant Services (DWIS) and Charge Nurse (RN 31). General observations were conducted in the "D" nursery of the NICU on 3/8/13 at 9:50 A.M. Patient 33 was found swaddled in an open crib attached to his monitors.

A review of Patient 33's medical record was conducted on 3/8/13 at 2:10 P.M. Patient 33 was admitted to Hospital A on 2/25/13 with diagnoses that included late preterm triplet and newborn sepsis observation and evaluation per the Admission Note dated 2/25/13. According to a Physician Order dated 2/25/13, a nutrition consult was ordered for Patient 33. There was no documented evidence to demonstrate that a nutrition consult was performed by the Dietitian.

A review of the hospital's policy entitled " Nutrition for the Infant Special Care Center (NICU)", review date of 4/2011 was conducted. The policy indicated that "Nutrition consults are by referral from physicians, nurses, or occupational therapists." Per the policy, it stipulated that "All patients for whom nutrition consults are ordered, are completed by the Dietitian within 24 hours."

An interview and joint record review with the clinical nurse specialist (CNS 31) was conducted on 3/8/13 at 2:30 P.M. CNS 31 confirmed that there was no documented evidence in Patient 33's medical record to show that a nutrition consult was performed by the Dietitian, in accordance with the physician's order.

An interview with the Director of Nutrition (DN 31) was conducted 3/11/13 at 10:32 A.M. DN 31 acknowledged that nutrition consults ordered by the physician in the NICU should have been performed by the Dietitian in accordance with the hospital's policy.

A telephone interview was conducted with the Medical Director of the NICU (Physician 31) on 3/12/13 at 2:37 P.M. Physician 31 acknowledged that the hospital's policy related to Nutrition for the Infant Special Care (NICU) was not followed as evidence by a lack of documented evidence found in medical records to demonstrate that a nutrition consult was performed by the Dietitian.

4. A review of Patient 34's medical record was conducted on 3/11/13 at 11:07 A.M. Patient 34 was admitted to Hospital A on 1/11/13 with diagnoses that included prematurity and feeding difficulty in infant per the Admission Note dated 1/11/13. According to a Physician's Order dated 1/11/13, a nutrition consult was ordered for Patient 34. There was no documented evidence in the medical record to demonstrate that a nutrition consult was performed by the Dietitian.

A review of the hospital's policy entitled " Nutrition for the Infant Special Care Center (NICU)", review date of 4/2011 was conducted. The policy indicated that "Nutrition consults are by referral from physicians, nurses, or occupational therapists." Per the policy, it stipulated that "All patients for whom nutrition consults are ordered, are completed by the Dietitian within 24 hours."

An interview with the Director of Nutrition (DN 31) was conducted 3/11/13 at 10:32 A.M. DN 31 acknowledged that nutrition consults ordered by the physician in the NICU should have been performed by the Dietitian in accordance with the hospital's policy.

A telephone interview was conducted with the Medical Director of the NICU (Physician 31) on 3/12/13 at 2:37 P.M. Physician 31 acknowledged that the hospital's policy related to Nutrition for the Infant Special Care (NICU) was not followed as evidence by a lack of documented evidence found in medical records to demonstrate that a nutrition consult was performed by the Dietitian.


5. A review of Patient 35's medical record was conducted on 3/11/13 at 2:00 P.M. Patient 35 was admitted to Hospital A on 1/17/13 with diagnoses that included prematurity and congenital gastroschisis (an abdominal wall defect) per the Admission Note dated 1/17/13. According to a Physician's Order dated 1/17/13, a nutrition consult was ordered for Patient 35. There was no documented evidence found in the medical record to demonstrate that a nutrition consult was performed by the Dietitian.

A review of the hospital's policy entitled " Nutrition for the Infant Special Care Center (NICU)", review date of 4/2011 was conducted. The policy indicated that "Nutrition consults are by referral from physicians, nurses, or occupational therapists." Per the policy, it stipulated that "All patients for whom nutrition consults are ordered, are completed by the Dietitian within 24 hours."

An interview with the Director of Nutrition (DN 31) was conducted 3/11/13 at 10:32 A.M. DN 31 acknowledged that nutrition consults ordered by the physician in the NICU should have been performed by the Dietitian in accordance with the hospital's policy.

A telephone interview was conducted with the Medical Director of the NICU (Physician 31) on 3/12/13 at 2:37 P.M. Physician 31 acknowledged that the hospital's policy related to Nutrition for the Infant Special Care (NICU) was not followed as evidence by a lack of documented evidence found in medical records to demonstrate that a nutrition consult was performed by the Dietitian.

Based on observation, interview, record and dietary document review, the hospital failed to ensure that therapeutic diet orders met the nutritional needs, for 3 of 48 sampled patients (Patient 69, Patient 70, and Patient 71) who were identified as at nutritional risk and lacked an assessment of nutritional needs by the Registered Dietitian. In addition, the hospital failed to ensure that their screening system identified patients who were at nutritional risk. Their system was not effective at capturing the nutritionally high risk patients in a timely manner to ensure the menus based on the diet orders met the needs of the patients. Failure to ensure patients nutritional needs are met in a timely manner could impede healing and could negatively impact the health status of medically fragile patients.
In addition, Hospital B failed to ensure the development of a comprehensive menu to meet the nutritional needs of all inpatients as evidenced by the absence of a system to ensure the nutritional adequacy of meals to patients who did not self-select their own meals.

Findings:
1. On 3/7/13 at 2:53 P.M., Patient 69's medical record was reviewed. Patient was admitted to Hospital A on Patient 69's diagnosis included congestive heart failure (CHF - a weakness of the heart that leads to a buildup of fluid in the lungs and surrounding body tissues) and end stage renal disease (ESRD - a progressive loss in kidney function over a period of time) per the history and physical, dated 3/2/13.

On 3/7/13 during the same time of the medical record review, the Clinical Nutrition Manager reviewed the nursing admission assessment done for Patient 69 on 3/3/13. According to the Clinical Nutrition Manager, nursing provided a referral to the registered dietitian (RD) since the admission assessment "triggered" due to Patient 69 had "chronic skin issues." Per the same nursing admission assessment form under "skin integrity" was documentation of "macerated lesion to coccyx ..." The Clinical Nutrition Manager stated that within their nutrition screening identification system there were no further triggers that would have brought Patient 69 to the attention of the RD at time of admission.
On 3/3/13, per the nurse referral, a registered dietitian (RD) wrote a note "acknowledged RN trigger for chronic skin issues". On 3/3/13, the physician prescribed a therapeutic diet order for renal [kidney] diet 80 gram protein daily.
Although the RD addressed the RN referral within 24 hours per hospital policy, the RD failed to assess Patient 69's individualized nutrition needs to ensure that the therapeutic diet order prescribed met the nutritional needs of the patient.
The Clinical Nutrition Manager verified that Patient 69 would have altered nutritional status due to congestive heart failure, ESRD, and a decubitus ulcer that was difficult to stage at the time, among other pertinent diagnosis. It was noted that on 3/3/13 the RD documented "PT [patient] may benefit from Nepro supplement as well". The Clinical Nutrition Manager stated that it was her expectation that a RD would have assessed Patient 69's individualized nutrition needs to ensure the therapeutic diet ordered, and recommendations being provided would have met the patient's nutritional needs. In addition, lack of a patient's individualized nutritional needs was a barrier to communication to the multidisciplinary team to assist in monitoring nutrition care. The Clinical Nutrition Manager verified that based upon Patient 69's height, weight and diagnosis that the therapeutic diet order had not met Patient 69's nutritional needs.
Patient 69's nutritional needs were not assessed by an RD until 3/5/13, despite an RD visit for Patient 69 on 3/3/13. On 3/5/13, an RD assessed Patient 69's nutritional needs at an estimated 2,305 - 2,766 calories per day, and protein at 110 - 120 grams of protein per day. During the same record review, the Clinical Nutrition Manager stated that the hospital's renal menu provided approximately 2,000 calories a day.
When the Clinical Nutrition Manager was asked why one RD assessed the patient's needs, and one RD had not, she stated that she was recent to her management position and that previous guidance to the clinical dietitian's had not been clear for expected hospital practices of the RD's.
The Clinical Dietitian Manager was asked if Patient 69 would have been identified to have been assessed by an RD, if the patient had not had chronic skin issues at time of admission. The Clinical Dietitian Manager stated that the hospital's nutrition screening identification system would have identified Patient 69 for an RD, or DTR (Dietetic Technician, Registered) at day 4 due to the CHF diagnosis. She added that there was not clear direction for determining a nutritional risk factor for ESRD. According to hospital staff the average length of patient stay was 3-5 days.
2. On 3/8/13 at 9:38 A.M., Patient 70's medical record was reviewed. Patient 70 was admitted to Hospital A on 2/24/13 with diagnosis that included sepsis. The nursing assessment at time of admission for Patient 70 triggered the RD due to "chronic skin issues", according to the Clinical Nutrition Manager. Due to the "trigger" and RD would see the patient within 24 hours to assess nutritional needs.
On 2/25/13 an RD documented a note in Patient 70's medical record that indicated "Acknowledged RN trigger for skin issues per RN admission summary." On the same note, the RD noted "sepsis likely r/t UTI [urinary tract infection - an infection of the kidney, ureter, bladder, or urethra] ..., no staged ulcers at this time and PT started on a regular diet. Will monitor PO adequacy/tolerance and assess need for further supplementation. Will assess PT per nutrition policy."

At that time, the RD failed to assess Patient 70's individualized nutrition needs. The Clinical Nutrition Manager verified that a condition of sepsis was an indicator that the patient had altered nutrition status that should have been assessed. The Clinical Nutrition Manager then assessed what Patient 70's needs would have been at that time. The Clinical Nutrition Manager stated that Patient 70's assessed estimated nutritional needs were 2,670 - 3,115 calories a day, and 133 - 178 grams of protein a day. The Clinical Nutrition Manager stated that the hospital's regular diet menu provided approximately 2,000 calories per day, and 100 grams of protein per day. The diet order prescribed had not met the assessed nutritional needs.
In addition, the RD that addressed the RN trigger for skin issues on 2/25/13 had not assigned a nutrition risk level that would have guided the follow up visit in terms of by whom, an RD or DTR, and in what time frame.
The next nutrition intervention that was done was on 3/1/13 by a DTR. When asked how the patient came to the attention of the DTR, the Clinical Nutrition Manager stated, "An RD must have given it to her." At the time of the DTR visit, the patient's diet order was NPO [nothing by mouth], and had been since 2/27/13, 2-3 days. The Clinical Nutrition Manager stated that at that time there continued to be lack of a nutrition risk factor assigned that would have dictated time period for follow up and by whom.
The next nutrition intervention was not until 3/7/13 after the patient had a status of NPO/sip water for 8 days. At that time, Patient 70 was "reassessed at severe nutrition risk" by an RD.
The Clinical Nutrition Manager verified that the hospital's nutrition screening system to identify nutritionally high risk patients needed to be updated and revised. According to the nutrition risk categories a condition of sepsis would have triggered an assessment by an RD within 24 hours, only if the patient with sepsis was in the ICU (intensive care unit). The Clinical Nutrition Manager verified that the policy (Policy 14.10) was not supported by literature reviews and standards of practice. In addition, the Clinical Nutrition Manager acknowledged that the RD should have assessed the patient's nutritional needs on the first visit, on 2/25/13 to have provided the multidisciplinary team with the information that the diet ordered had not met assessed needs, and should have provided nutritional recommendations at that time. Further, the Clinical Nutrition Manager stated that the RD failed to assign an appropriate nutrition risk factor on 2/25/13, and if she had done so it would not have been followed up by a DTR which was driving the other follow up date to be 5 -7 days apart.
3. On 3/8/13 at 11:00 A.M., Patient 71's medical record was reviewed. Patient 71 was admitted to the hospital on 2/25/13 with diagnosis that included congestive heart failure (CHF - a weakness of the heart that leads to a buildup of fluid in the lungs and surrounding body tissues).
On 2/25/13 per the nursing assessment admission note, Patient 71 was identified as with heart failure as one of the conditions under the "Hospital Problem List." There were no nursing triggers to RD based on the hospital's criteria related to the "Nutritional Status" questions, and the skin integrity area.
On 2/28/13 an RD completed an "Initial Nutrition Assessment" for Patient 71. According to the Clinical Nutrition Manager, Patient 71 was brought to the attention of the RD via the Nutritional Assessment policy's diet education schedule for CHF on admit day 3.
Per the physician's daily progress notes, dated 2/28/13, Patient 71 was newly diagnosed with diabetes.
The Initial Nutrition Assessment, dated 2/28/13, indicated that Patient 71 was on a cardiac, carbohydrate limited diet, and fluid restriction of 1.5 L. The nutrition assessment lacked an assessment of Patient 71's individual nutrition needs in order to determine if the therapeutic diet ordered met patient 71's nutritional needs, and to communicate to the interdisciplinary team the nutritional needs for Patient 71. The RD noted "Pt offered snacks in between meals and preferences obtained."
On 3/4/13, an RD completed a "quick nutrition note" in response to "acknowledged nutrition consult re poor nutrition and low prealbumin." There continued to be no assessment of Patient 71's individualized nutrition needs by an RD. The RD noted, "Pt has not been receiving his snacks."
During this same record review, the Clinical Nutrition Manager calculated Patient 71's estimated nutritional needs to be 2,015 - 2,200 calories a day, and 109 grams of protein per day. The Clinical Nutrition Manager estimated that the hospital's menu for a carbohydrate limited diet provided 1,800 calories a day. She was unable to verify how much protein the carbohydrate limited, cardiac diet provided as the hospital's menus as she stated the nutrient analysis was not sufficiently completed. The Clinical Nutrition Manager verified that Patient 71 had not been receiving adequate nutrition from the therapeutic diet order to meet his needs since he was admitted to the hospital 6 - 7 days ago. There was no documentation to the physician responsible for the care of the patient that the prescribed therapeutic diet order was not meeting patient's needs, as the RD never completed a comprehensive nutrition assessment for Patient 71.
According to the hospital's job description for Inpatient Registered Dietitian, "...this position collaborates with healthcare team to provide medical nutrition therapy to pediatric/adolescent, adult, and geriatric patients. Identifies patients at various nutrition risk levels based on criteria outlined by department. Assesses nutrition needs and identifies nutrient requirements with regard to age and disease-specific needs of patients. Develops and implements nutrition care plan for all assigned patients ..., continuously evaluates and monitors the effectiveness and outcomes of medical nutrition therapy intervention."
The hospital's policy and procedure entitled Nutritional Assessment (Policy 14.10; reviewed 4/2011) indicated, "A Nutritional Assessment will be documented by the clinical staff in the medical record for patients found to be at Nutritional Risk ..., Responsibilities; ...Review diet order for appropriateness to diagnosis, tolerance, adherence, and current medical status ..., the following methods are used to assess patients' weight status and determine calorie, protein, and fluid requirements ..., The goal amount of calories, protein and fluid shall be determined by a reasonable estimate of patients' metabolic requirements."




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4. Hospital B

On 3/6/13 beginning at 10:15 A.M., the plating of lunch meals was observed. It was noted that there were a variety of standardized diets that included regular, carbohydrate limited, renal and heart healthy. In an interview on 3/6/13 beginning at 10:40 A.M., with DMS 1 she was asked to describe the menu selection system. She stated that patients were given the opportunity to self-select meals; however if the patient did not select their own meals dietary staff would circle the entree item to be given. It was also noted that there appeared to be no consistency in the food choices that were made by dietary staff on behalf of the patient.

In a concurrent interview the surveyor asked DMS 1 to describe the process when patients did not select their meal choices. She stated that staff working the different trayline sections would randomly select the entree as well as side dishes and beverages. The surveyor also asked with this system how the hospital ensured that patient nutritional needs were met based on trayline staffs' selections and the physician ordered diet. She stated that the hospital did not have a defined non-select menu; however did have an undated/unapproved document that guided staff on foods that were not allowed on specific diets such as renal and heart healthy diets. She also acknowledged that without standardized menus it would not be possible to determine if the foods provided to patients would meet their nutritional needs.

Based on observation, interview and record review, the hospital failed to ensure that nutrition care plans were detailed to reflect specific nutrition interventions that were planned for patients to address an identified nutritional concern in accordance with hospital policy, for 2 of 48 sampled patients (Patient 71, Patient 72). Lack of specific individualized nutrition care plans is a barrier to the multidisciplinary healthcare team responsible for monitoring the dietary and nutritional intake status of patients. In addition, health care team members are not consistently completing documentation of a patient's nutritional intake from all nutritional sources which is a barrier to nutritional assessment, and monitoring of nutrition, to ensure the patient's nutritional needs are being met.
The hospital failed to ensure that the patient menus for regular and therapeutic diets met the recommended dietary allowances and orders of the practitioner responsible for the care of the patient to ensure patients nutritional needs were met. Dietary staff preparing patient meals lacked guidance on the quantity of menu items to serve to be in accordance with the physician's order.
Hospital A failed to show consistent documentation to ensure that ordered nutritional supplements were consistently offered and provided to 1 of 48 sampled patients (Patient 1). In addition, Hospital B failed to ensure that 1 of 48 sampled patients (Patient 21) received a dietary supplement that was labeled and contained instructions for use.

Findings:
1. On 3/8/13 at 11:00 A.M. at Hospital A, Patient 71's medical record was reviewed. Patient 71 was admitted to the hospital on 2/25/13 with diagnosis that included congestive heart failure (CHF - a weakness of the heart that leads to a buildup of fluid in the lungs and surrounding body tissues).
Per the physician's daily progress notes, dated 2/28/13, Patient 71 was newly diagnosed with diabetes.
The Initial Nutrition Assessment, dated 2/28/13, indicated that Patient 71 was on a cardiac, carbohydrate limited diet, and fluid restriction of 1.5 L (liters). The nutrition assessment lacked an assessment of Patient 71's individual nutrition needs in order to determine if the therapeutic diet ordered met patient 71's nutritional needs, and to communicate to the interdisciplinary team the nutritional needs for Patient 71. The RD noted "Pt offered snacks in between meals and preferences obtained."
On 3/4/13, an RD completed a "quick nutrition note "in response to" acknowledged nutrition consult re poor nutrition and low prealbumin." There continued to be no assessment of Patient 71's individualized nutrition needs by an RD. The RD noted, "Pt has not been receiving his snacks."
At that time, the nutrition care plan for Patient 71 was reviewed. The nutrition care plan indicated, "1. Review clinical nutrition screening report for level of nutrition risk (ONGOING), 2. Collaborate with dietitian on optimal nutritional requirements, patient preferences and educational needs (ONGOING), and 3. Provide and encourage nutritional supplements/snacks (ONGOING)." According to the Clinical Nutrition Manager the patient should have been receiving an AM snack of 1 canned fruit cup (4 ounces), and a PM (evening) snack of graham crackers and peanut butter. The care plan was not specific to the actual intervention that was planned which creates a barrier to a team member following up with the patient on the snacks, and encouraging them to the patient. Four days later the patient had not been receiving snacks as planned with the patient by the RD.
During this same record review, the Clinical Nutrition Manager calculated Patient 71's estimated nutritional needs to be 2,015 - 2,200 calories a day, and 109 grams of protein per day. The Clinical Nutrition Manager estimated that the hospital's menu for a carbohydrate limited diet provided 1,800 calories a day. She was unable to verify how much protein the carbohydrate limited, cardiac diet provided as the hospital's menus as she stated the nutrient analysis was not sufficiently completed. The Clinical Nutrition Manager verified that Patient 71 had not been receiving adequate nutrition from the therapeutic diet order to meet his needs since he was admitted to the hospital 6-7 days ago. There was no documentation to the physician responsible for the care of the patient that the prescribed therapeutic diet order was not meeting patient's needs, as the RD never completed a comprehensive nutrition assessment for Patient 71.
On 3/4/13 Glucerna (an oral nutrition supplement) was ordered three times a day as entered by the RD per the hospital's definitions of "hospital-specific diet order regimens". Under Carbohydrate Limited Diet Indications it included a definition of "Foods included : A well balanced diet that includes all food groups. May include oral supplements for patients that consume < 100% estimated needs which included Glucerna, per the policy and procedure Aspects of Clinical Nutrition (Policy 15.1, reviewed 4/2011)."
Review of the "LDA" screen that had a line item labeled as "Diet Supplements" and "Supplement-Intake (mL - milliliters)" was left blank on 3/4/13, and 3/7/13.
Review of the nutrition care plan remained the same as indicated above. There was no documentation that a specific oral nutrition supplement, Glucerna TID was being provided to Patient 71 per the care plan, and at what time of the day (with meals or between meals). Multidisciplinary team members who coordinate care of related diabetic medicine with meals need to have specific details on nutritional interventions being provided, and to the timing of such nourishments.
On 3/8/13 at 11:15 A.M., the Clinical Nutrition Manager acknowledged that the RDs were supposed to list specific nutrition interventions being provided to a patient on the nutrition care plan. The Clinical Nutrition Manager stated that it was a problem with the electronic medical record as "we cannot free text on the care plan."
2. On 3/11/13 at 11:30 A.M., Patient 72's medical record was reviewed. Patient 72 was admitted to Hospital B on 1/4/13 with a diagnosis that included status post liver transplantation 11/12/11.
According to Patient 72's medical record he received ensure plus with meals, at least since 1/10/13. On 1/17/13, the RD documented, "Continues to drink Ensures. Encouraged at least 2x daily ..."
A review of the LDA screen lacked a line item that should have been present entitled "Supplements; diet supplements; supplement-Intake (mL)." The Clinical Nutrition Manager verified that nursing or dietary should have generated a line item in the electronic medical record in order to have monitored the nutrition intervention of the oral nutrition supplement. The Clinical Nutrition Manager was asked to pull up the multidisciplinary nutrition care plan for Patient 72, and stated, "There is no nutrition care plan. No one selected a nutrition care plan for him."
According to the hospital's job description for Inpatient Registered Dietitian," ... this position collaborates with healthcare team to provide medical nutrition therapy to pediatric/adolescent, adult, and geriatric patients. Identifies patients at various nutrition risk levels based on criteria outlined by department. Assesses nutrition needs and identifies nutrient requirements with regard to age and disease-specific needs of patients. Develops and implements nutrition care plan for all assigned patients ..., continuously evaluates and monitors the effectiveness and outcomes of medical nutrition therapy intervention."
The hospital's policy and procedure entitled Nutrition Care Plan (Policy 14.9; reviewed 4/2011) indicated, "Policy: The Nutritional Care Plan consists of identification of nutritional problems, the provision of nutritional intervention activities and the evaluation of nutritional care. A multidisciplinary Nutrition Care Plan with measurable goals and actions are developed for all patients/residents determined to be nutritionally compromised. Purpose: To define and delineate the process for the provision of nutritional care, and to outline the components of the nutritional care plan. To facilitate consistent high quality standards of care by the clinical nutrition staff and other staff responsible for the care of patient/resident. To establish standards by which clinical nutrition care is measured. 6. The nutritional care plan is documented in the on-line (EPIC) plan of care, including the nutrition related problem, expected outcome, and planned intervention ...,9. Only the Registered Dietitian (and Registered Nurse) may develop a nutrition care plan."
3. On 3/5/13 at 2:00 P.M., observation of dinner trayline was observed. DE 3 was preparing a dinner plate for a "renal" diet according to a tray ticket. DE 3 stated it was for a renal diet in case a late tray was ordered. He placed a 4 ounce piece of chicken that was weighed on the dinner plate for the renal diet.
On 3/6/13 at 1:00 P.M., the Clinical Nutrition Manager was asked what the hospital's parameters were for a "renal diet." She stated that when a physician ordered a renal diet without specifying any parameters that it meant "60 gram protein, 2 gram sodium, 2 gram potassium, and low phosphorous." When she was asked what low phosphorous criteria was she stated, "800 milligram phosphorous." She was asked who determined that low phosphorous meant 800 mg of phosphorous at the hospital, and she stated, "It was determined by the food and nutrition department."
According to the hospital's policy 14.8 entitled Diet Orders, there was a renal diet for 60 gm protein, 2 gm sodium, 2 gm potassium, and low phosphorus. There was no criteria listed as what constituted low phosphorus as determined by the physician's at the hospital as diet orders are physician driven since physician's are responsible for the care of the patient.
The Clinical Nutrition Manager was asked for the patient menu nutrient analysis that was provided to patients when a physician ordered a renal diet. The Clinical Nutrition Manager stated that the hospital did not have a nutrient analysis to demonstrate that the patient menu for a renal diet was in accordance with physician's orders. The Clinical Nutrition Manager acknowledged that lack of a nutrient analysis also created lack of guidance to dietary staff preparing the patient meals at trayline. The Clinical Nutrition Manager acknowledged that 4 ounces of chicken at lunch, and 4 ounces of protein at dinner without having a system to take into account other protein in the renal diet that was provided likely exceeded the therapeutic diet order for a "renal diet."
At that time the Clinical Nutrition Manager stated that the hospital had not conducted a nutrient analysis for any of the therapeutic diet orders to ensure that the menus provided to patients met the nutritional needs of the patients, and were in accordance with physician orders.
Further, the Clinical Nutrition Manager verified that the hospital had not conducted a comprehensive nutrient analysis for patient menus on a regular diet, or on any of the therapeutic diets to ensure the recommended dietary allowances, and dietary reference intakes were met in accordance with the Food and Nutrition Board of the National Research Council in order to meet the nutritional needs of the patients.





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4. A tour of Hospital A's 11 West unit was conducted with the unit charge nurse on 3/5/13 at 2:00 P.M.

On 3/5/13 at 2:20 P.M., Patient 1's medical record was reviewed. Patient 1 was admitted to Hospital A on 2/20/13 with diagnoses that included end stage liver disease per the History and Physical, dated 2/20/13.

A review of the physician's order sheet indicated that an order for Milkshake 650 kcal (kilocalorie) and 25 g (grams) protein twice daily was ordered on 2/27/13 at 1:30 P.M. Per the record, an order for Glucerna Shake 5 times daily was ordered on 3/2/13 at 2:00 P.M.

A review of Patient 1's flowsheet showed no documentation that the ordered milkshake was being offered or provided to the patient since 2/27/13, when it was originally ordered. In addition, the ordered Glucerna Shake was not consistently documented on the flowsheet to show that it was being offered or provided to the patient 5 times daily as ordered by the physician.

A joint record review and interview with registered nurse (RN) 1 was conducted on 3/5/13 at 3:00 P.M. RN 1 acknowledged there was a lack of documented evidence that the nutritional supplements were consistently offered and provided to Patient 1 as ordered by the physician.





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5. Patient 21 was admitted to Hospital B on 3/4/13 for treatment of back pain according to the Admission Face sheet. A review of Patient 21's medical record was conducted on 3/7/13 at 8:30 A.M. There was a physician's order, written on 3/5/13 at 1:08 P.M., for Beneprotein (a concentrated instant protein powder) three times a day before meals.

An interview and observations were conducted with Patient 21 on 3/6/13 at 8:55 A.M. Patient 21 was observed eating breakfast while in his hospital bed. Hand written on Patient 21's breakfast menu was "Beneprotein". On Patient 21's breakfast tray was a 5 ounce clear plastic container with a lid. The plastic container contained about 2 ounces of a tan powder. However, there was no label on the container to indicate what the powder was. And, there were no instructions on the container with direction for use of the product. Patient 21 stated that he had never seen the powder on his tray before and he did not know what it was or what to do with it. Patient 21 thought that the powder might be coffee creamer.

An interview was conducted with Patient 21's registered Nurse (RN 21) on 3/7/13 at 9:05 A.M. RN 1 looked at the container of tan powder and stated that she did not know what it was or what to do with it. RN 21 called the dietary department. The dietary department confirmed that the tan powder was Beneprotein.

On 3/7/13 at 9:10 A.M., an interview was conducted with the Director of Nursing (DON). The DON acknowledged that the powdery substance should have been labeled and contained instructions for use.

An interview was conducted with the Patient Services Manager (PSM) of the Dietary Department on 3/7/13 ar 11:00 A.M. The PSM stated that the Dietary Department ran out of labeled packets of Beneprotein. The PSM further stated that she was not aware that unlabeled clear plastic containers of Beneprotein were being placed on patient's meal trays.

Based on interview and record review, the hospital failed to ensure that the hospital's diet manual provided clear parameters for routine therapeutic diet orders prescribed by practitioners responsible for the care of patients, therefore the information was not available to all medical, nursing and food service personnel. The hospital failed to ensure that the hospital's designated diet manual was reviewed and approved annually by the Pharmacy and Therapeutics, Medical Director, and Dietitian in accordance with hospital policy and procedure. A non-customized diet manual which did not reflect how the hospital prepared and implemented physician's diet orders had the potential for miscommunication from multidisciplinary team members to the patient and had the potential for misinterpretations by staff of a physician's diet order.
Findings:
On 3/5/13 at 2:00 P.M., observation of dinner trayline was observed. DE 3 was preparing a dinner plate for a "renal" diet according to a tray ticket.
On 3/6/13 at 1:00 P.M., the Clinical Nutrition Manager was asked what the hospital's parameters were for a "renal diet." She stated that when a physician ordered a renal diet without specifying any parameters that it meant "60 gram protein, 2 gram sodium, 2 gram potassium, and low phosphorous." The Clinical Nutrition Manager acknowledged that the parameters for low phosphorous were not taken to the medical executive committee in order for the criteria for low phosphorous to be physician-driven. The Clinical Nutrition Manager acknowledged that without defined parameters for therapeutic diets it would impede menu development to ensure the menu provided to patients were in accordance with physician's orders.
On 3/8/13 at 11:00 A.M. at hospital A, Patient 71's medical record was reviewed. Patient 71 was admitted to the hospital on 2/25/13 with diagnosis that included congestive heart failure (CHF - a weakness of the heart that leads to a buildup of fluid in the lungs and surrounding body tissues).
Per the physician's daily progress notes, dated 2/28/13, Patient 71 was newly diagnosed with diabetes.
The Initial Nutrition Assessment, dated 2/28/13, indicated that Patient 71 was on a cardiac, carbohydrate limited diet, and fluid restriction of 1.5 L (liters).
During this same record review, the Clinical Nutrition Manager calculated Patient 71's estimated nutritional needs to be 2,015 - 2,200 calories a day, and 109 grams of protein per day. The Clinical Nutrition Manager estimated that the hospital's menu for a carbohydrate limited diet provided 1,800 calories a day. She was unable to verify exactly how many calories and how much protein the carbohydrate limited, cardiac diet menus provided as the hospital's menus had not been nutritionally analyzed. At that time the Clinical Nutrition Manager stated that the hospital had not conducted a nutrient analysis for any of the therapeutic diet orders to ensure that the menus provided to patients met the nutritional needs of the patients, and were in accordance with physician orders. The diet manual lacked specific patient menu nutrient analysis so that physician's would have an understanding that included how many calories and protein would be provided to a patient when ordering regular or therapeutic diets, and if the hospital patient menu were deficit in any recommended dietary allowances due to potential limits of a therapeutic diet.
The Clinical Nutrition Manager stated that all of the hospital's diets needed to be reviewed to ensure they entailed clear physician drive parameters, that the patient menus met the therapeutic diet orders, and that the hospital's diet manual would serve the purpose as a communication tool as to what a patient would receive nutritionally when various diets were ordered at the hospital. The Clinical Nutrition Manager acknowledged that the diet manual should contain information based on a complete nutrient analysis for a patient menu that was actually utilized at the hospital.
On 3/6/13 at 1:05 P.M., the FSD, the Clinical Nutrition Manager, and the Director of Facilities & Hospitality Services stated that the medical staff were not involved in the last review and approval of the hospital ' s diet manual, last reviewed on 2/24/13.
The hospital's policy and procedure entitled Nutrition Care Manual (Policy 15.2; reviewed 4/2011) indicated, "Policy: The Food and Nutrition Services Department uses the current edition of the Nutrition Care Manual ..., Purpose: ...To serve as a method of communication among physicians, nurses and dietitians regarding the types and amounts of foods served to patients..., To standardize the application of current principles of nutrition care ...,Procedure: The Nutrition Care Manual is approved by the Pharmacy and Therapeutics, Medical Director, Director of Food & Nutrition and Clinical Nutrition Manager. An approval form is completed with all required signatures ...The Nutrition Care Manual is reviewed and approved annually."
According to the hospital's job description for the Director of Food and Nutrition Services, "Responsibilities include ...Provides guidance and direction in dietary planning to include standard and therapeutic diets."

Based on observation, interview, record and document review, the hospital failed to ensure safe effective food handling systems were maintained, as evidenced by 1) extended holding of raw chicken under refrigeration; 2) lack of an effective system to monitor time/temperature control of cooked foods; 3) lack of a system to clean and/or sanitize the bag in a box connectors for soda syrup and juices; 4) lack of a sanitation process for large pieces of food production equipment, 5) kitchen areas that were not clean, 6) General uncleanliness, unsafe food handling practice and poor sanitary condition in both foodservice operations at Hospital A and Hospital B were identified which had the potential to result in foodborne illness in the immunocompromised patients.
In addtion, Hospital A failed to ensure that the hospital's own policy and procedure related to infection control was followed when two visitors were observed not wearing personal protective equipment inside a room identified as requiring contact precaution. Hospital B failed to ensure that the Paraffin Pan located in the Occupational Therapy Gym was routinely cleaned according to manufacturer's instructions. In addition, the horizontal surface of a treatment table located in the Occupational Therapy Gym was not disinfected after 1 of 48 sampled patients (Patient 26) was fitted for a finger splint. Lastly, Hospital B failed to ensure that licensed staff were current with their annual tuberculosis testing, as required by the hospital policy, for 1 of 15 employee personnel files reviewed (Registered Nurse - RN 26).

Findings:

Hospital B:

1. United States Department of Agriculture (USDA) guidelines for storage of whole cuts of meat and poultry are 3-5 days under refrigeration (USDA, 2013).

During an initial kitchen tour on 3/6/13 beginning at 8:20 A.M., the following was noted in the walk-in refrigerator:

a. There were 2 cases of thawed chicken that were undated; however there was a packing date of 2/21/13. It was also noted that the chicken was in a plastic bag within a box, it did not appear to have been packaged in a reduced oxygen manner. Packing foods in a reduced oxygen environment allows for increased holding time for raw meats (Food Code, 2009). In a concurrent interview with Dietary Management Staff 1 (DMS 1) she stated that the item was received fresh and was delivered on delivered 3/5/13. She also stated that the meat would be utilized within the next several days.

In an interview on 3/6/13 at 1:00 P.M., with the Food Service Director (FSD) he was asked to provide manufacturers' storage guidelines for the raw meat. In a follow up interview on 3/7/13 at 11:00 A.M., the FSD stated that to his knowledge the raw chicken was not packaged in a manner to extend the hold time past USDA guidelines for thawed poultry.

Review of hospital document titled "Storage and Defrosting of Meats, Fish and Poultry", dated 10/5/07, revealed that while the policy guided staff on storage procedures it did not address food storage timeframes for food safety of meats, fish or poultry.

2. Time/temperature control for food safety would include cooldown monitoring of potentially hazardous foods (PHF). PHF's are those foods capable of supporting bacterial growth associated with foodborne illness (Food Code, 2009). Cooldown monitoring would ensure that cooked potentially hazardous shall be cooled: 1) within 2 hours from 135?F to 70?F; and within an additional 4 hours from 70?F to 41?F) or less (Food Code, 2009).
During food storage observations on 3/6/13 beginning at 9:40 A.M., it was noted that there was chicken salad in a refrigerator in the catering area. In a concurrent interview with Dietary Staff 1 (DS) she was asked to describe the production process for this item. She stated that on 3/5/13 she cooked the chicken. Once the chicken was complete she deboned it after which she prepared the chicken salad. She further stated that upon completion of the item she would put it in the refrigerator. The surveyor also asked her to describe how she ensured that the food would be safe to use for multiple days. She stated that she was aware of time/temperature control monitoring for foods that were cooked and saved; however this item was not monitored. She further stated that there used to be a log for this purpose however it was no longer in existence. It was also noted that DS 2 was preparing a pasta salad from recently cooked pasta. She also stated that this item would not be monitored for time/temperature control and once the item was prepared it would be refrigerated until use.

In a follow up interview on 3/l7/13 beginning at 9:00 A.M., with the FSD he stated that cooldown monitoring at Campus B was discontinued approximately 2 years ago; however the reason for the discontinuance was unclear.

In an interview on 3/7/13 beginning at 10:00 A.M., with Infection Control Committee Members 1 and 2, they stated that infection control staff conducted audits of departments minimally every 2 months. In addition they Environment of Care Committee, which was an interdisciplinary audit process was also conducted. They also stated that they would rely on departmental management staff to identify infection control issues within their own departments in addition to reports from outside entities such as the County Health Department.

Review of departmental documents titled "Food Safety and Sanitation Audit", dated 10/12 and 11/12, revealed that each of the audits noted that proper cooling methods were utilized and that temperature logs were reviewed. In an interview on 3/7/13 beginning at 9:30 A.M., with the FSD he acknowledged that the results audit tool did not accurately reflect the operational systems within the department in light of the absence of any cooling logs.

Review of hospital documents dated 12/5/12, 1/4/13 and 2/7/13 that were reflective of the infection control rounds of the dietary department at Hospital B revealed that while there was review of some safe food handling concepts such as cross contamination during preparation, holding temperatures, hand hygiene, equipment operations and kitchen cleanliness there was no review of time/temperature control concepts for food safety.

3. During general food production observations on 3/6/13 at 9:00 A.M., it was noted there was a rack of greater than 5 bag in a box of soda syrup that had plastic connectors. In a concurrent interview with DMS 2 he stated that at the time the syrup box was empty would remove the connector from the box are reconnect to a new box of syrup. The surveyor asked whether or not there was any regular cleaning of the connector, he stated there was not. Manufacturers' guidance for the syrup connectors recommends a weekly cleaning/sanitizing of the connectors with a manufacturer specific chlorine sanitizer.

4. During general food production observations on 3/6/13 beginning at 9:30 A.M., Dietary Staff 3 was asked to describe the cleaning process for the large steam kettle and the griddle. She described a process whereby the equipment would be cleaned with detergent and rinsed with water. The surveyor asked whether there were any additional processes that would be complete prior to putting the equipment back into use. She stated there was not.
It would be the standard of practice to ensure that all food production equipment would be sanitized in one of the following methods: a) hot water operations by immersion for at least 30 seconds; b) hot water mechanical operations by being cycled through equipment that is set to achieve a surface temperature 160?F as measured by an irreversible registering temperature indicator; or c) the application of sanitizing chemicals by immersion, manual swabbing, brushing, or pressure spraying methods.
Hospital document titled "Cleaning and Sanitizing General Equipment and Utensils", dated 10/5/07, revealed that the hospital developed procedure did not include a sanitation procedure, consistent with the standard of practice, to ensure effective sanitation of large equipment.
5. During general kitchen observations on 3/6/13 beginning at 9:30 A.M., it was noted there were issues with overall cleanliness in food storage areas. It was noted in the dry storage area the racks were covered with a grey dust-like material. Additionally it was noted that the vents above the refrigerators. Similarly in the food storage area that was previously the departments loading dock it was noted that that there was crumpled trash in the corners and that the floors were not clean.
Review of undated hospital document titled "Thornton Kitchen Cleaning Schedule" revealed that it was the responsibility of various staff members for cleaning duties. The document assigned a sweeping and mopping of only the general kitchen areas. It did not include any of the ancillary food storage areas. It was also noted that on a monthly basis all floors and wall were to be cleaned by "assigned staff "; however it was unclear who the assigned staff would be to clean the floors of the food storage area. It was noted that the wire racks or vents were not listed on any cleaning schedule.
Review of hospital documents dated 12/5/12, 1/4/13 and 2/7/13 that were reflective of the infection control rounds of the dietary department at Hospital B revealed that on each of the reports the committee identified issues related to kitchen cleanliness.




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6. During the course of the survey, at Hospital A, the following were identified: Potentially hazardous food were not consistently cooled down to ensure food safety, clean foodservice equipment was stored on a utility cart in the raw meat thaw box, a frozen juice item was not monitored to ensure used within 14 days once thawed per manufacturer's guidelines, the hoods over the stove range were black with grease build up and had the potential to contaminate food being cooked on the stove range below the hood, therewere overall uncleanliness concerns among workstations and storage units for clean equipment.

Review of the infection control program rounds in the kitchen at Hospital A showed that the program had identified several of the same issues on repeat visits that were not resolved. According to a report that was provided to the FSD by the infection prevention program, dated 12/5/12, it was identified during that time that "clean dishes have visible dust and debris, and floor has several missing tiles; not a cleanable surface, among other items that were identified."

According to an infection control program report, dated 1/31/13, of an audit in the kitchen at Hospital A, some of the items identified included, "floor has chips and cracks rendering it a non-cleanable surface, "open dried food items were not stored in air tight containers." Those items listed above were unresolved by the Food and Nutrition Department, and by facilities as the cracked floor had been reported to that department by two other departments within the hospital.

At Hospital B, there was not a system in place at the 3-compartment sink and dishmachine area to ensure that cross-contamination of dirty with clean would not occur. There was no direct oversight and guidance provied to the dietary staff when this practice was occurring routinely.

The hospital had not ensure that the foodservice operations at both Hospital A and Hospital B operated in a safe food handling and sanitary manner.


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7. A tour of the unit 6 East was conducted with the unit charge nurse on 3/7/13 at 10:50 A.M. At 10:58 A.M., a visitor was observed sitting on a chair at the foot of Patient 3's bed. At the same time, a visitor was also observed assisting Patient 2 at the bedside. Both visitors were not wearing gowns and gloves. A signage was posted outside Patient 2 and 3's room indicating that the patients were place on "Contact Precaution".

An interview with registered nurse (RN) 2, the nurse assigned to Patient 2, was conducted on 3/7/13 at 11:00 A.M. RN 2 stated that Patient 2's visitor (Visitor 1) was already informed in the past regarding the use of personal protective equipment (PPE). However, when Visitor 1 was interviewed, Visitor 1 indicated that she was given 2 conflicting instructions by the nurses. Visitor 1 stated that she had been instructed by some nurses to wear PPE. But according to Visitor 1, she was also informed by other nurses that she did not need to wear PPE because she was the patient's wife.

An interview with Patient 3's visitor (Visitor 2) was conducted on 3/7/13 at 11:05 A.M. Visitor 2 stated that he had been in the patient's room since last night and saw nurses wearing the gown and gloves. However, Visitor 2 stated that nobody instructed him to wear a gown and gloves.

A interview with RN 3 was conducted on 3/7/13 at 11:15 A.M. RN 3 stated that he did not see Visitor 2 inside Patient 3's room.

Patient 2's medical record was reviewed on 3/7/13 at 3:00 P.M. A review of the physician's order, dated 2/25/13 at 1:22 P.M., indicated that Patient 2 was placed on contact precaution due to MRSA (methicillin resistant staphylococcus aureus - a bacterium responsible for several difficult-to-treat infections in humans) in the nares.

Patient 3's medical record was reviewed on 3/7/13 at 3:10 P.M. A review of the physician's order, dated 3/3/13 at 10:35 P.M., indicated that Patient 3 was placed on contact precaution due to MRSA in the nares.

The hospital's policy and procedure titled Contact Precautions was reviewed on 3/7/13 at 3:30 P.M. The policy indicated that, "Visitors shall wear gloves and gowns when entering room."

During the infection control meeting conducted on 3/12/13 at 3:00 P.M., the Infection Control Practitioner (ICP) stated that it was the hospital's policy that visitors wear PPE when entering a patient room that was on isolation precaution. The ICP stated that the visitors of Patient 2 and 3 should have followed the hospital's policy and wore the PPE prior to going inside the patients' room.









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8. A general observation tour of the Occupational Therapy Gym at Hospital B was conducted with the Manager of Physical Therapy and Occupational Therapy (MPT/OT) on 3/7/13 at 11:30 A.M. A review of the operating instructions from the manufacturer of the Paraffin Pan indicated to "Clean the unit after every 40 treatments, when the paraffin is no longer clear, or whenever sediment accumulates on the bottom." The MPT/OT stated that when the Paraffin Pan is cleaned it is documented on the Treatment Log. However, there was no documentation evidence on the Paraffin Pan Treatment Log that the pan had ever been cleaned. The first treatment entered on the log was dated 11/4/10. On 5/23/11, the 40th treatment had been documented on the Treatment Log. On 3/7/13 at 11:45 A.M., the MPT/OT acknowledged that there was no documented evidence that the Paraffin Pan had been cleaned after the 40th treatment on 5/23/13.

9. A general observation tour of the Occupational Therapy Gym at Hospital B was conducted with the Manager of Physical Therapy and Occupational Therapy (MPT/OT) on 3/7/13 at 11:30 A.M. A patient (Patient 26) was observed at a treatment table with his wife and an Occupational Therapist (OT). According to the MPT/OT, Patient 26 had surgery about a week prior for a malignant tumor of the right little finger. Patient 26 was in the Occupational Therapy Gym to be fitted for a finger splint. Multiple fittings of the finger splint were done until the OT was satisfied with the fit. The OT escorted Patient 26 and his wife out of the OT Gym. The OT never returned to the OT Gym and the treatment table was never disinfected after Patient 26 was fitted for his finger splint.

A review of the hospital's policy and procedure , entitled "Cleaning of Surface Areas - Examination Rooms and equipment Between Patients in Ambulatory Care" and dated 8/11, indicated that "to ensure that examination rooms and equipment is cleaned between patients...Wash the...examination/procedure table...with EPA (Environmental Protection Agency) approved hospital grade disinfectant."

An interview was conducted with the MPT/OT on 3/7/13 at 12:10 P.M. The MPT/OT acknowledged that it was not acceptable that that treatment table was not disinfected after Patient 26 was fitted for a finger splint.

10. A review of a random sampling of hospital employees personnel files was conducted on 3/13/13 at 9:10 A.M. There was documentation in the personnel file of Registered Nurse (RN 26) that the last time she had been tested for tuberculosis was 4/14/11.

A review of the hospital's policy and procedure, entitled "Aerosol Transmissible Disease (ATD) Standards/Tuberculosis (TB) Control Plan" and dated 1/9/13, indicated that "An annual test for TB infection will be a requirement for all the HCWs (Health Care Workers)..."

A verbal message was given to the surveyor by the Administrative Analyst on 3/13/13 at 12:05 P.M. The message was that the Registered Nurse Manager of the Procedural Unit of Hospital B's Cancer Center acknowledged that RN 26 had not been tested for tuberculosis in April of 2012 as required by hospital policy and procedure. The RNM/PU acknowledged that RN 26 was last tested for TB on 4/14/11.