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Based on staff interviews and document review the hospital's governing body failed to ensure the quality assessment and performance improvement (QAPI) program reflected the complexity of the hospital services related to improved health outcomes, and the prevention and reduction of medical errors. The hospital failed to:

1. Ensure the quality appraisal and performance improvement (QAPI) program implemented after Patient 17's death had measurable indicators or showed evidence of improving health outcomes for the program developed (cross-reference A273).

2. Ensure the governing body, medical staff, and administration, effectively evaluated and/or implemented systems when issues related to physician ordered diets were identified (cross-reference A309).

The cumulative effect of these systemic problems resulted in the inability for the hospital's quality program to monitor QAPI activities in a manner that ensured the nutritional needs of the patients were met in accordance with physicians' orders and acceptable standards of practice.

Based on dietetic services observations, hospital staff interview, and document review, the hospital failed to; ensure dietetic services and nursing services developed a QAPI program that showed measurable improvement in indicators when the quality appraisal and performances improvement (QAPI) program was implemented after Patient 17's death. The program did not have measurable indicators and other quality indicators developed to ensure high risk, high volume physician diet orders were implemented as written.

As a result of the lack of a comprehensive data driven quality program there was no evidence of improvement or identification of all deficiencies in the diet order system.

Findings:

1. Patient 17 was a 23 year-old male with a medical history of arginase deficiency (rare disease resulting in the inability to utilize excess nitrogen leading to elevated ammonia levels in the blood). On 10/15/12 at 6:20 a.m., Patient 17 was transferred from a neighboring hospital due to elevated ammonia levels in the blood and abdominal pain. During the course of hospitalization, Patient 17 was given a meal tray that did not meet the physician ordered therapeutic diet parameters and as a result developed sudden onset altered loss of consciousness, was unarousable, and had labs indicating elevated ammonia in his blood. The patient expired on 10/21/12 (cross reference A629).

2. During food service observations and nutrition care review on 2/12/13 beginning at 10 a.m., it was noted 6 of 11 patients did not receive the correct physician ordered diets (cross reference A629).

3. During food delivery observations on 2/12/13 beginning at 12 p.m., it was noted while dietary staff delivered patient meal trays to the transitional intensive care unit, there was no registered nursing presence during meal delivery.

On 2/12/13 starting at 10:30 a.m., the nutrition quality program including the plan that was initiated after the death of Patient 17, was discussed with the Chief Nursing Officer (CNO), Professional Practice Staff (PP), Director of Dietary (DD), and Registered Dietitian (RD 1). The CNO stated that as a result of Patient 17's death the hospital implemented a "Diet Not Listed" field in the electronic medical record as well as a training handout titled "Tips for entering diet orders" as an education tool for nursing staff and physicians. She also stated it was now the responsibility of nursing staff to deliver all meal trays that were designated as "Specialized Diets" which would include food allergies, isolation trays, late trays and sandwiches. The plan also guided the RNs to check specialized trays against the diet orders before giving them to the patients. Nursing was to log "specialized diet" trays on a tray log when given to the patient.

During an interview on 2/12/13 starting at 11:15 a.m., RD 2 stated she was aware of problems with the physician diet orders and the complications encountered when transferring physician ordered diets to the diet department computer system.

RD 1 was asked at 3:30 p.m., how problem areas were identified and developed for the quality program. She was not able to state how problem areas were identified, unless there was a problem from the whole Dietitian group.

Review of the Patient Nutrition and Food Safety plan dated January 28, 2013 did not contain any measurement standards or data collection to illustrate how this intervention was being assessed for compliance or effectiveness. It was also noted the hospital had not developed a performance improvement activity to evaluate the accuracy of electronic entry of physician ordered diets.

The CNO acknowledged (continuing interview starting 2/12/13 at 10:30 a.m.) there were no measurable indicators developed to ensure the tray delivery of "specialized trays" was effective. In addition, she was not able to state why there was no QAPI plan developed to ensure all diets were accurately and completely transmitted to the Dietary Department.

Review of the Patient Nutrition and Food Safety QAPI program dated January 28, 2013, included nutrition screening, patient dysphagia assessment, admitting units with "diet not listed", food safety and food from home. While the hospital included these issues as part of the QAPI program they were not internally identified; rather they were identified during a hospital recertification survey. Review of a hospital document titled "Statement of Deficiencies" dated 9/28/12 revealed these findings (six areas) were part of a plan of correction. While the hospital included action plans for the areas, as part of the QAPI program, the department did not identify measurement standards, develop methods for data collection, or perform analysis to validate the effectiveness of any of the interventions.

During interview with RD 1 on 2/12/13 at 3:30 p.m., RD 1 acknowledged in the past they had looked at the physician orders for accuracy, but were not doing any quality data collection or analysis to compare physician ordered diets to the diet list to ensure accuracy or completeness. She stated she was not aware how physician ordered diets were entered into the electronic medical system by nursing, and there was no coordination with nursing services to ensure accurate input.

Based on staff interview and document review, the hospital failed to ensure the governing body, medical staff, and administration fully implemented a measurable quality assurance and performance improvement (QAPI) program, based on the scope of the problem, that included measurable outcomes, data collection, analysis reported to governing body. This failure to accurately collect and analyze data as it related to the nutrition care of the patients prevented the hospital from identifying opportunities for improvement. It further allowed the deficient practices to continue without remediation.

Findings:

The purpose of a comprehensive performance improvement plan is to ensure services provided are safe, effective, patient-centered, timely, efficient and equitable. An effective plan focuses on areas that significantly impact critical clinical processes, clinical outcomes, key business results, facility core functions and the primary needs of patients. Identified issues would be handled through the appropriate hospital committees such as medical staff and governing body. An effective program would provide and evaluate quantitative and qualitative data, in order to provide safe health care. QAPI principles identify and focus on functions that are important to the patient; assess the hospital's performance with objectives, relevant measures, and defined data elements; demonstrate continuous improvement; and will evaluate all pertinent systems in relationship to patient care activities (ruralhealth.und.edu).

On 2/12/13 starting at 8:45 a.m., the CNO explained the quality program in relationship to patient nutrition/safety was developed by herself as the Interim Chief Executive Officer in conjunction with nursing, clinical nutrition, and quality improvement staff. She also stated the results of the implemented plan were reviewed at medical executive and governing body committee meetings. There was no indication either of the committees identified the lack of quality measurement data. It was also noted these committees did not identify the departments had not comprehensively analyzed the internal systems between nursing and dietetic services, such as the inaccuracy of diet order transcription and lack of consistent nursing oversight in the delivery of specialized diets to ensure patient safety (cross-reference A619, A628, A629, and A631).

Based on observation, interview and record review, the hospital's nursing service failed to accurately assess the patient's medical condition and failed to provide adequate supervision to ensure Patient 17 received the therapeutic diet ordered by the physician. The failures resulted in Patient 17 inadvertently receiving and consuming a meal restricted for his medical condition (arginase deficiency). Patient 17 had a rapid decline in his medical condition after receiving the incorrect diet.

Findings:

1. The nursing assessment of Patient 17 was incorrect. Patient 17's primary nurse (RN A)
incorrectly stated the patient was being treated for pneumonia (lung infection) when he was being treated for an elevated ammonia level.

2. Nursing failed to verify if the correct diet order was entered in the dietary computer system for Patient 17.

3. Nursing failed to ensure Patient 17 received a protein restricted diet.

The cumulative effect of the deficiencies resulted in the nursing services failure to ensure Patient 17 received the therapeutic diet as ordered by his physician resulting in the patient's rapid decline in medical condition. Patient 17 required intensive care and was removed from life support by the family due to poor prognosis. The patient expired soon after (see A395).

Based on observation, interview, and record review nursing failed to supervise and evaluate the nursing care provided for three of 17 sampled patients (1, 3, and 17). Patient 17 incorrectly received and consumed a restricted high protein meal instead of a regular protein-restricted diet of 4 grams per day. The errors caused Patient 17's medical condition to severely deteriorate. Nursing failed to implement seizure precautions per hospital protocol for Patients 1 and 3.

Findings:

1. Review of Patient 17's medical record on 11/8/12 indicated Patient 17 was a 23 year old male with a medical history of arginase deficiency (rare disease resulting in inability to utilize excess nitrogen properly leading to elevated ammonia levels in the blood). Due to Patient 17's medical history, Patient 17 was on a protein restricted diet (ammonia in the body forms when protein is broken down in the intestines). Patient 1 exhibited behaviors which required a one-to-one sitter (a caregiver present) at all times during the hospitalization.

On 11/8/12 at 10 a.m. review of Patient 17's inpatient admission form dated 10/15/12 indicated the patient's diagnoses included "elevated pneumonia" and nausea.

On 2/12/13 at 4 p.m. review of Patient 17's "History and Physical" notes completed by Physician 1 (MD 1) dated 10/15/12 at 6:20 a.m. indicated Patient 17 was transferred from a neighboring hospital due to complaints of abdominal pain. Patient 17 had a history of arginase deficiency, with an elevated ammonia level of 152 on admission. Patient 17 was a full code (life saving measures to be performed in an event of a cardiac or respiratory arrest). The note further indicated Patient 17 required a special diet, and to keep Patient 17 "NPO" (have nothing by mouth) until his "special food" arrived.

On 2/12/13 at 4:15 a.m. review of Physician 2's (MD 2) orders dated 10/16/12 at 8:15 a.m. indicated to advance Patient 17's diet order to a liquid diet for the morning meal (the liquid diet included his medication mixed in the liquid formula) and if the patient tolerated the morning meal, the diet could be advanced "to regular protein-restricted diet of 4 grams per day".

On 2/12/13 at 11:45 a.m. during an interview with MD 2, he stated Patient 17 was transferred from another hospital with complaints of nausea and high ammonia levels. MD 2 clarified Patient 17 did not have and was never treated for pneumonia. MD 2 stated Patient 17 had a rare disorder (arginase deficiency) requiring the patient to be on a protein restricted diet. Due to Patient 17's arginase deficiency the patient's ammonia blood level was higher than a person without the disease (the range for a person without the disease is 11-35 micrograms per deciliter (mcg/dl) and the range for a person with the disease is 70-100 mcg/dl). MD 2 further stated Patient 17's admitting ammonia level was 123, which was considered elevated but not "grossly" elevated for Patient 17. MD 2 stated Patient 17 was doing well on the morning of 10/16/12 and his diet was slowly advanced as per the patient's prior (pre-hospitalization) medical protocol. After writing the diet orders for Patient 17, MD 2 spoke with Patient 17's primary nurse (RN A) to further explain and clarify Patient 17's orders. MD 2 stated RN A verbalized understanding of Patient 17's new physician orders.

The next morning (10/17/12) while doing patient rounds, MD 2 stated he found Patient 17 in his room "unresponsive". MD 2 stated he was not able to determine how long Patient 17 was unresponsive because the sitter believed the patient was asleep. Upon finding Patient 17 unresponsive measures to protect his airway were initiated. Patient 17 was transferred to the intensive care unit (ICU) for a higher level of care. MD 2 stated Patient 17's ammonia level was rechecked and was severely elevated at 511 mcg/dl. Immediate treatment to reduce Patient 17's ammonia level was initiated. The medical team became aware Patient 17 consumed a high protein diet on 10/16/12. MD 2 stated Patient 17 normally had a protein restricted diet of four grams a day, but on 10/16/12 in addition to his physician ordered diet, Patient 17 consumed a roast beef sandwich which contained 23 grams of protein.

On 11/8/12 at 11 a.m. during an interview with RN A she stated she cared for Patient 17 on the morning of 10/16/12 from 7 a.m. to 3:30 p.m. RN A further stated she was under the impression Patient 17 was being treated for a diagnosis of pneumonia.

On the morning of 10/16/12 at approximately 8:30 a.m., RN A stated MD 2 informed her Patient 17 was going to be placed on a 4 gram protein restricted diet due to having "strange disease", she "had never heard of".

Patient 17's one-to-one sitter was in the room with the patient at all times. RN A stated Patient 17 was also at risk for falls, and the patient kept stating he was hungry. On 10/16/12 at approximately 9:30 a.m., RN A stated she gave Patient 17 a liquid supplement MD 2 had ordered that morning. At 1:30 p.m. RN A stated she returned to Patient 17's room to give him the second liquid supplement. At that time RN A was told by the sitter Patient 17 had tolerated the first liquid supplement and RN A proceeded to administer the second liquid supplement. After administering the second liquid supplement, RN A stated she asked the unit clerk to enter Patient 17's diet order into the computer system as written by MD 2 earlier that morning (if the patient tolerated the morning meal, the diet could be advanced "to regular protein-restricted diet of 4 grams per day").

After an attempt was made by the unit clerk to enter Patient 17's diet order, RN A stated she was informed by the unit clerk the diet ordered for Patient 17 was not an option to select in the computer system database. RN A stated she asked the unit clerk to manually input the diet order into the comment section.

At approximately 3 p.m. before change of shift, RN A stated she returned to Patient 17's room, and the patient stated he was hungry. RN A stated, she asked the sitter if the patient had received his lunch. The sitter responded yes, he had a roast beef sandwich. RN A stated, although she knew Patient 17 was on a protein restricted diet and a roast beef sandwich would not be her first choice, she believed dietary had provided Patient 17 with the correct meal. RN A stated she reported to the oncoming nurse, and informed the oncoming nurse Patient 17 had consumed a roast beef sandwich for lunch.

On 11/8/12 at 11:45 a.m., review of Patient 17's diet order dated 10/16/12 at 1:25 p.m. indicated a regular diet was ordered. In the comment section "Protein - Residual Diet 4G/DAY" (four grams a day) was documented.

On 2/12/13 at 9:15 a.m., during an interview with Nurse B she stated all written physician orders were transcribed (entered into the computer ordering system) by the unit clerks (MUC). Once transcribed, a licensed nurse (either the charge nurse or the bedside nurse) verified and signed off that patient orders written by the physicians were correctly entered by the unit clerk. In addition to the above process, each patient had a multidiscipline care rand (a daily nursing plan of care form) which was continuously updated manually, by either the unit clerk or nurse, to reflect the most recent physician orders and patient condition. The multidiscipline care rand was an important form used by nursing during change of shift report to provide an overall picture of the patient's plan of care to the oncoming nurse. Nursing was responsible to confirm the correct patient information was written on the multidiscipline care rand.

The above information was confirmed on 2/12/13 at 9:45 a.m., during an interview with Nurse C, on 2/12/13 at 10:15 a.m. with Nurse D, and on 2/12/13 at 10:45 a.m. with Nurse E.

On 2/12/13 at 11:30 p.m. review of Patient 17's diet order written on 10/16/12 by MD 2 for a "protein-restricted diet of 4g/day" indicated nursing signed off on the order, indicating the order was entered correctly into the dietary computer system. However, review of Patient 17's multidiscipline care rand dated 10/16/12 indicated Patient 17 was on a "protein residual diet of 4g/day" and not the correct diet of "protein restricted diet of 4g/day".

On 2/12/13 at 2 p.m. during an interview with the admitting director, he stated the "inpatient admission" form had an incorrect diagnosis for Patient 17. The health service representative (HSR 1) who entered the incorrect diagnosis received the information from the transferring hospital via telephone. HSR 1 (a non-medical employee) mistakenly entered Patient 17's admitting diagnosis as "elevated pneumonia" rather than the correct diagnosis of elevated ammonia.

On 11/8/12 at 12:30 p.m. review of Patient 17's discharge summary completed by Physician 3 indicated "when patient was admitted on October 15th, he was initially kept NPO. As his abdominal pain improved, he was restarted back on his diet with protein restriction on October 16th". Due to an ordering miscommunication Patient 17 received the incorrect diet. Patient 17 received a 20 ounce protein sandwich on October 16, 2012. On October 17, 2012 Patient 17 "developed sudden onset altered loss of consciousness, was unarousable, and had labs notable for elevated ammonia to 511." The note further indicated Patient 17 was intubated for airway protection. Patient 17's condition deteriorated and on October 21, 2012 Patient 17's family made the decision "to extubate patient for comfort measures" (concentrating on the quality of life by reducing the severity of the disease symptoms when the prognosis of death is imminent). Patient 17 expired later that day.

On 2/12/13 at 4:30 a.m. review of Patient 17's "Death Certificate Worksheet" completed by Physician 4, indicated Patient 17's immediate cause of death was cardiorespiratory arrest due to cerebral stroke, due to hyperammonemia (elevated blood ammonia levels), due to arginase deficiency.

Nurse A failed to perform a complete assessment of Patient 17's medical condition. Nursing failed to ensure the correct diet order was transcribed by the unit clerk into the computer system. Nursing failed to supervise meals to ensure Patient 17 was provided a protein restricted diet.

2. On 2/12/13 at 9 a.m. review of Patient 1's medical record indicated the patient was admitted to the hospital on 2/7/13 with a diagnosis of syncope (fainting) and had a physician's order to be on seizure precautions.

On 2/12/13 at 9:15 a.m. during an interview with registered nurse B (RN B) she stated seizure precautions included to pad the side rails of the bed, and have suction and oxygen set up available at bedside.

On 2/12/13 at 9:20 a.m. during an observation of Patient 1's room, nursing padded only two of the four side rails.

On 2/12/13 at 9:25 a.m. review of Patient 3's medical record indicated the patient was admitted to the hospital on 2/2/13 with a diagnosis of syncope (fainting) and had a physician's order to be on seizure precautions.

On 2/12/13 at 9:30 a.m. during an observation of Patient 3's room, nursing did not have a complete suction set at bedside for Patient 3.

On 2/12/13 at 9:45 a.m. during an interview with registered nurse C (RN C, Patient 3's primary nurse), she stated seizure precautions included all side rails to be padded. RN C further stated Patient 3's suction set was not complete.

On 2/12/13 at 10 a.m. review of the hospital's "seizure precautions" standard of care form indicated to pad side rails, and suction equipment must be ready for use.

Based on observation and record review,the hospital failed to keep medication in a secure and locked area.

Findings:

During a tour of 4 East on 2/11/13 at 10:26 a.m., a medication cart was observed unattended and unlocked. The cart was located between Rooms 07 and 09. It contained medication packets labeled with the names of the medications and the names and medical record numbers of two patients.

Another drawer contained needles, lancets (device used to puncture skin) and bottles of saline.

Record review on 2/14/13 at 8:20 a.m., of the hospital policy "Medication Storage" indicated, "All drugs must be kept secured."

Based on observation, interview, and document review, the hospital failed to ensure the Food and Nutrition Services was organized to meet the needs of all patients as follows :

1. Failed to provide an organized and effective food and dietetic services with clinical nutrition management (cross-reference A619).

2. Failed to ensure patients received appropriate meal substitutions (cross-reference A628).

3. Failed to ensure therapeutic diets prescribed by the physicians responsible for the care of the patients were served as ordered (cross-reference A629).

4. Failed to ensure the current therapeutic diet manual was approved in accordance with current national standards and included therapeutic diets routinely ordered at the hospital and used as guidance for ordering and preparing diets (cross-reference A631).

5. Failed to ensure the governing body ensured a quality assessment and performance improvement (QAPI) program that reflected the complexity of the hospital services that focused on indicators related to improved health outcomes and the prevention and reduction of medical errors (cross-reference A263, A273, and A309).

The cumulative effect of these systemic problems resulted in the inability for the hospital's food and nutrition service to direct and staff in such a manner to ensure the nutritional needs of the patients were met in accordance with physician orders and acceptable standards of practice.

Based on observation, staff interview and document review, the hospital failed to provide an organized and effective food and dietetic services with clinical nutrition management. The lack of organization and supervision of the dietary department resulted in deficient practices in clinical nutrition assessment, providing meal substitutions, therapeutic diets as ordered by the physician, and a current diet manual meeting the standards of practice.

Findings:

Medical record review was conducted on 2/12/13 beginning at 1:30 p.m. It was noted that 6 of 10 records (60 percent) reviewed for clinical nutrition care had incorrect transmission of physician ordered diets. Patient 17 received excess protein resulting in his death; Patients 9, 12, and 14 received protein restricted diets that were unnecessary; Patients 12, 13, and 14 had calorie restricted diets that were not followed; Patient 13 did not receive the physician ordered cardiac diet; and Patient 11's texture modified diet was more restrictive than the physician ordered (cross-reference A629).

During interview on 2/12/2012 starting at 8:45 a.m., with the Director of Dietary (DD), Registered Dietitian (RD 1), and Facilities Administrator (FA) it was confirmed the Food and Nutrition Department had an organization structure with one director who was responsible for the entire department including the food service and clinical aspects. The FA acknowledged because of the size of the department, this compromised the department's ability to provide effective oversight for the food service and clinical nutrition services required at this large teaching hospital.

During an interview on 2/12/13 starting at 11:15 a.m., RD 2 stated she was aware of problems with the physician diet orders and the complicated transition from the physician order to the diet department computer system.

At 3:30 p.m., RD 1 was asked how problem areas were identified and developed for the quality program and she was not able to state how problems were identified unless it was a problem from the whole Dietitian group. RD 1 stated she was not trained on what the ward clerks entered or how the system had three or more screens required to enter a physician order. She explained there was a default system for the admitting ward clerks to enter diets. The system gave a renal diet a default to a prerenal diet. She stated when this system was used the RD staff was to go to the patient medical record and physician ordered diet and verify which of the renal diets the physician wanted. She stated there was no mechanism for the Dietary Department to know when the default diet was entered and no dietitians were reviewing and correcting. She stated when a physician entered a calorie controlled diet for a renal diet they did not give the calorie control but changed this to a no concentrated sweet diet and did not verify with the physician that this was correct.

Diet manuals establish a common language and practice for physicians and other health care professionals to use when providing nutritional care to patients. For each diet, the diet manual includes the purpose and principles, the meal pattern, the nutritional adequacy of the food, and the foods allowed or not allowed. Diets ordered by the physician must be included in the facility's diet manual.

During review of the hospital diet manual on 2/12/13 beginning at 8:45 a.m., it was noted the diet manual did not effectively describe the physician ordered diets. The Diet Manual terminology was not consistent with the department's computer diet ordering system (CBORD), the hospital's electronic medical record (EMR), or physicians' diet orders. The hospital developed guidance, and other diet order related documents, did not match the Diet Manual and the Diet Manual did not include all the diets ordered by physicians.

In an interview on 2/12/13 beginning at 8:45 a.m., with RD 1 she stated the hospital was in the process of reviewing the diet manual with an outside vendor to be consistent with the hospital's practices. As an example, it was noted the manual did not contain a carbohydrate consistent diet that was specific to the hospital menu, rather contained conceptual guidance of the principles of diabetic meal planning. Similarly, review of the renal, fat controlled, sodium restricted diets, did not use the terminology consistent with the electronic medical record of the CBORD diet ordering software.

A diet manual would ensure inclusion of all of the specific hospital's physician ordered diets; meet the current standards of practice; include a comprehensive description of the therapeutic diets offered by including the purpose of the diet, indications of the diet, nutritional adequacy of the diet and sample meal plans that were consistent with the hospital's menu and scope of hospital clinical care.

While the diet manual had some of the elements, not all elements were present for each routinely ordered hospital diet which would allow for hospital and/or dietary staff to use the document as a comprehensive resource to order and/or prepare patient diets (cross-reference A631).

Based on observation, staff interview, and document review, the hospital failed to ensure patients received appropriate meal substitutions as evidenced by modifying patient diets outside of physician ordered parameters.

Findings:

During patient trayline on 2/12/13 beginning at 11:30 a.m., it was noted the noon meal consisted of a pork cutlet, rice pilaf, carrots and a cookie in addition to beverages. It was also noted there were more than five patients whose patient tray card designated either a dislike or an allergy to pork. It was also noted the tray card for these patients specified the "VMC** " diet. In a concurrent interview with the director of dietary (DD) she stated the VMC diet was essentially the cardiac diet which was restricted in fat and sodium. It was also noted the entree for these diets was a plain chicken breast, steamed rice, carrots and applesauce. In an interview on 2/12/13 at 12:20 p.m., with the diet clerk (DC) she stated it was the standard of practice if a patient did not like a particular item, the VMC items would be substituted. She also acknowledged these substitutions could provide a more restricted diet than the physician ordered diet. It was also noted Patient 18 had a mechanical soft diet order. Concurrent review of the meal selections Patient 18 was given revealed he received a "VMC" baked pork cutlet, VMC rice and VMC gravy all of which were modified in both fat and sodium content. Patient 18's physician ordered diet did not modify the fat or sodium content of the diet, rather ordered only a modification in the texture of the diet.

Based on observations, record reviews, document reviews, and interviews, the hospital failed to ensure staff entering physician therapeutic diet orders into the hospital's electronic medical record computer entry (EMR) were accurate and the Dietary Services Department served meals to patients as ordered, as evidenced by:

Seven of eleven patients reviewed (Patients 17, 9, 11, 12, 13, 14, and 19) did not receive diets as ordered by their physician. These errors directly contributed to Patient 17's death, and had the potential to compromise the nutritional status and medical care for patients receiving therapeutic diets.

Findings:

On 2/12/13 records reviewed for the following patients revealed:

1. Patient 17 was a 23 year old male with a medical history of arginase deficiency (rare disease resulting in inability to utilize excess nitrogen leading to elevated ammonia levels in the blood). On 10/15/12 at 6:20 a.m., he was transferred from a neighboring hospital due to elevated ammonia levels in the blood and abdominal pain.

On 10/16/12 at 8:15 a.m., the physician diet order for Patient 17 was liquid diet for the morning meal. The liquid diet specified for the patient to have his medication mixed in a liquid formula brought from the patient's home. If the patient tolerated the morning meal, the order indicated his diet could be advanced to a "regular protein-restricted diet of 4 grams per day." The diet order entered into the EMR system indicated, "Regular diet" with an order comment, "residual protein 4 grams per day."

The initial admission patient screening for Patient 17 did not trigger a nutrition consultation by the registered dietitian. Because the diet was not entered into EMR when the physician initially ordered it at 8:15 a.m., it did not show up on the Dietary Services Department's computerized diet order printout entitled, "Patient List with Notes."

At 10/16/12 at 1:30 p.m., registered nurse A (RN A) asked the unit clerk to advance the diet order as written by the physician. Subsequently, the Dietary Services Department sent Patient 17 a late lunch tray for a regular diet consisting of a roast beef sandwich that contained 20 grams of protein.

The following day, Patient 17 developed sudden onset altered loss of consciousness, was unarousable, and had labs for elevated ammonia in his blood. The patient expired on 10/21/12.

2. Patient 14 was admitted to the hospital on 2/10/13 with a diagnosis of altered mental status. The physician diet order for Patient 14 was, "1800 ADA, cardiac, renal." The diet entered into EMR indicated, "PRED (pre-dialysis), NCS (no concentrated sweets), cardiac."

During a concurrent observation and interview with the assistant nurse manager (NM 1), at approximately 1:30 p.m., using Patient 14 as an example, NM 1 demonstrated how to enter a physician diet order into the EMR computer system. She was not able to match the diet order as written by the physician to the data entry choices provided by the system. She acknowledged she sometimes had to guess or make judgments about what selections to make.

A review of the Dietary Services Department's computer generated document entitled, "Dietary Clinical Workload Report" indicated the following:

1. On 2/10/13 at 5:45 p.m., Patient 14 was admitted to the hospital,
2. At 12:25 p.m., RN 1 entered the physician's diet order which was, "1800 ADA, cardiac, renal," as PRED (prerenal), NCS (no concentrated sweets), cardiac into EMR.
3. At 12:49 p.m. NM 1 corrected the diet order to CC18 (controlled carbohydrate 1800 calories), NA2 (2 gram sodium), cardiac.

At approximately 1:30 p.m., during a concurrent interview with NM 1, she stated she changed the diet order because she became aware Patient 14 had a pork allergy. She acknowledged that the difference in how the diet orders were entered into the system depended on the opinion of the person entering the diet, because the system did not have selections that matched what the physician ordered.

For example, for a physician diet order "renal":
The initial data entry screen in the EMR computer system entitled, "Enter Food and Nutrition Order", provided ten primary "diet type" choices. Until the unit clerk selected one primary diet choice from the list, a diet order was not generated and sent to the Dietary Services Department. Choice Number 8 is "Renal/Liver/Prot" (protein). When Choice Number 8 is selected, a secondary selection screen appears. This second screen has eight sub-categories to choose from:
1. Protein 40 GM (grams) (NA2) (2 gram sodium),
2. Protein 60 GM (NA2),
3. Protein 75 GM (NA2),
4. Protein 100 GM (NA2),
5. Dialysis,
6. Predialysis,
7. Peritoneal Dialysis, and
8. 2 GM sodium.

Up to five additional diets can be selected from the primary screen, for combination diets after the primary diet type is entered.

There was no documentation for clarification by nursing staff for the physician to determine the exact diet the patient required.

Review of the "Tips for entering diet orders" included direction when ordering a renal diet in combination with diabetic or other diets to "Please have the physician clarify the order".

3. Patient 9 was admitted with orthopedic injuries after a fall at home. In an interview on 2/12/13 beginning at 2:30 p.m., with RN 2 she stated during the course of hospitalization the patient experienced some cardiac related issues and was transferred to the rehabilitation unit. Patient 9's admission height was 5 feet 4 inches and weight was 180 (82 kilograms) pounds. On 2/8/13 Patient 9's physician ordered a mechanical soft, cardiac and renal diet which was changed on 2/11/13 at 0830 to NPO (nothing by mouth) for a surgical procedure. On 2/11/13 at 1200 the physician initiated a mechanical soft diet by writing "ok to resume diet mech [mechanical] soft." With the exception of the mechanical soft texture modification there were no additional dietary restrictions ordered.

A medical nutrition follow-up note dated 2/8/13 noted the patient's nutritional needs were estimated at 1600 calories. There was no estimation of Patient 9's protein requirements. As a rough estimate Patient 9's protein needs could range from 0.8-1 grams of protein per kilogram, of body weight, which would have equated to 65-82 grams of protein/day (Academy of Nutrition and Dietetics).

Concurrent review of a hospital document titled "Patient List with Notes" dated 2/11/13, which was the hospital's diet list, revealed the patient was receiving a pre-dialysis diet as well as a cardiac restricted diet in addition to the mechanical soft texture. The document also noted that while the patient had a history of high blood pressure, there was no notation of renal failure. In an interview with the DD she stated a pre-dialysis diet consisted of no more than 40 grams of protein/day, restrictions of sodium potassium and phosphorus as well as fluid restrictions which would not meet Patient 9's estimated nutritional needs.

In a concurrent interview with RN 3 she stated it was likely that nursing unit support staff entered the more restricted diet orders instead of the current physician ordered diet. She also stated the unit clerk should have asked nursing staff to clarify the order. RN 3 also demonstrated how unit clerk staff arrived at the decision to enter a pre-dialysis diet as opposed to a renal diet. RN 3 demonstrated that once a renal diet was selected the drop down screen in the electronic medical record guided staff to choose either a 40, 60, 75, or 100 gram protein restriction in addition to dialysis, pre-dialysis, peritoneal dialysis or a 2 gram sodium restricted diet. She also stated that nursing staff were guided to select the pre-dialysis diet in place of a physician ordered renal diet.

A hospital document titled "Diet Order Implementation" dated 7/2012 guided staff that for a non-specific diet order such as a renal diet, the patient would automatically receive a pre-dialysis diet. It was also noted it would be the responsibility of the Clinical Dietitian to document "in the patients' medical records the type of diets to be used at the moment until corrected diet order is received." There was no documentation in Patient 9's medical record the RD reviewed or assessed the need for a pre-dialysis diet for Patient 9.

In an interview on 2/12/13 beginning at 3 p.m., with RD 1, she was unable to explain neither how the hospital arrived at the decision to classify non-specified renal diets as "pre-dialysis" diets nor how the department ensured the developed system would function effectively and meet patient medical and nutritional needs.

4. Patient 11 was admitted to the hospital on 1/29/13 with diagnoses including urinary tract infection and dehydration and a medical history of dementia and two stage III (full thickness tissue loss) pressure ulcers on his hip. On 2/4/13, the physician ordered diet for Patient 11 was "dysphasia (difficulty swallowing), mechanical soft, regular diet". The diet entered into EMR indicated, "Dysphasia, ground, all liquid."

5. The physician ordered diet for Patient 12 was "1800 ADA (1800 calorie American Diabetic Association), cardiac." The diet entered into EMR indicated, Dial (dialysis), NCS (no concentrated sweets), cardiac.

6. Patient 13 was admitted to the hospital on 2/6/13 with diagnoses that included pneumonia and tuberculosis. The physician ordered diet for Patient 13 was "other: 1800 kcal (kilocalories), cardiac." The diet entered into EMR indicated, "4 carb (carbohydrates), and allergy pork."

There was no documentation the RD or the patient's physician were notified to clarify the order.

Based on document review and interviews, the hospital failed to ensure an approved current therapeutic diet manual that included diets routinely ordered at the hospital and was used as guidance for ordering and preparing diets, as evidenced by:

1. Diet Manual diet names and titles did not match the terminology used by the Dietary Services Department's computer diet ordering system (CBORD), the hospital's electronic medical record (EMR), or physicians' diet orders.

2. Tip Sheets and other diet order related documents did not match the Diet Manual.

3. The Diet Manual did not include all the diets ordered by physicians.

These failures had the potential to compromise the nutritional status and medical treatment of patients.

Findings:

1. On 2/12/13, starting at 8:45 a.m., the Registered Dietitian (RD 1), Director of Dietary (DD), and Professional Practice staff (PP 1) reviewed the hospital's diet ordering practices and documents, and the terminology in the Diet Manual. RD 1 acknowledged the diet manual diets did not match those used in the hospital's computer systems. For example:

The hospital Diet Manual Section I: Diets for Renal Disease listed several categories for renal disease diets that included the following:
a. Acute. Protein level 0.6-0.8 grams of protein per kilogram ideal body weight, 1-2 grams sodium per day.
b. Pre-Dialysis. Protein level 0.55-0.6 grams of protein per kilogram ideal body weight, sodium varies from 1-3 grams per day, to no added salt.
c. Nephrotic Syndrome (a collection of symptoms such as swelling, and protein in the urine due to poor kidney function) Protein level 0.8-1.0 grams per kilogram ideal body weight, sodium 1 gram per day.
d. Hemo-dialysis (a treatment to filter waste from the blood). Protein level 1.2-1.4 grams per kilogram ideal body weight, sodium 1-3 grams per day.
e. Peritoneal dialysis (a treatment to filter waste from the blood). Protein level 1.2-1.5 grams per kilogram ideal body weight, sodium 2-4 grams per day.

In addition, the Diet Manual recommended monitoring phosphorus, potassium, water and calcium levels, increasing fiber, providing a daily multiple vitamin and mineral supplement.

The EMR computer system allowed the user to select a combination Renal/Liver/Protein diet. Once selected, the system opened a subsection under this diet category. The user was prompted to select one of the following eight diets:
a. Protein 40 GM (grams) (NA2) (2 grams sodium)
b. Protein 60 GM (NA2)
c. Protein 75 GM (NA2)
d. Protein 100 GM (NA2)
e. Dialysis
f. Predialysis
g. Peritoneal dialysis
h. 2 gram sodium

For these same Diets the Dietary Services Department's CBORD system coded these diets as:
a. PR40 (40 grams protein)
b. PR60
c. PR75
d. PR100
e. DIAL
f. PRED
g. PDIA
h. NA2

Since the terminology between these systems did not match, a chart was developed entitled, "EMR Diet List and Cbord Codes 02072013".

The hospital diet manual, EMR computer charting system, and Dietary Services Department's CBORD system did not match, using the same terminology and descriptions.

A review of the hospital Diet Manual showed it did not include the diet "ADA".

On 2/12/13 starting at 8:45 a.m. during an interview with the DD, she acknowledged there were multiple areas where the Diet Manual and the ordering systems did not match, and would need revision. She acknowledged the diet manual used by the hospital must match the diets ordered by physicians.

2. On 2/12/13 starting at 8:45 a.m., during an interview with the Acting Clinical Dietitian Manager (RD 1) and the DD, RD 1 stated multiple documents were created to assist physicians and hospital staff to understand the diet ordering system as part of the Diet Manual. These documents include the following:
a. Tips for Entering Diet Orders.
b. Description of Hospital Diets
c. EMR Diet List and Cbord Codes
d. Diet Order Implementation
e. Non Specific Diet Order Default Guidelines

During a concurrent interview with the Chief Nursing Operator (CNO) and PP 1, they stated the document entitled "Tips for Entering Diet Orders" was developed in response to Patient 17 receiving the wrong diet.

RD 1 was not able to explain how the multiple levels of this document were validated to ensure the physician diet order was correct through the system.

3. A review of the "Tips for Entering Diet Orders" document indicated it included diets not included in the Diet Manual. For example, under the subsection "Where to find the correct diet type" 02 Regular/Soft, a diet called CRAM (Complex Carbohydrates, Rice and Milk) was listed, however, this diet could not be found in the Diet Manual.

In the subsection "Diet Not Listed" diets for "aminoacidopathies (protein inborn errors of metabolism), organic acidemias (inborn errors of metabolism) were included. None of the diets listed could be found in the Diet Manual.

The CNO in a concurrent interview stated there had been no validation of how these multiple systems were coordinated and evaluated.