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Based on observation, interview, and record review, the hospital failed to implement a hospital wide Quality Assurance and Performance Improvement (QAPI) program as evidenced by:

The hospital failed to develop, collect, monitor, and analyze hospital wide QAPI projects. (Refer A-0273, A-0283)

The cumulative effect of the hospital's failure to implement and maintain a hospital wide QAPI system to ensure a safe environment for patients by providing quality assurance and process improvement oversight resulted in a failure to comply with the Condition of Participation for QAPI.

Based on observation, interview, and record review, the facility failed to ensure specific program data requirements were met when the hospital failed to provide evidence of a Quality Assessment Performance Improvement (QAPI) program. This failure placed the patients at risk for negative healthcare outcomes when:

1 The dietetic service department does not have a process in place to identify new performance improvement (PI) projects and does not participate in QAPI committee meetings.

2. The dietetic services Department including Director of Food and Nutrition services (DFNS) and the Registered Dietitian (RD), did not identify current quality/infection control issues as PI projects.

3. The Registered Dietitian (RD) had a limited role in providing supervision over the food service operations.

These failures had the potential to cause food borne illness (caused by food contaminated with bacteria, viruses, parasites or toxins) and affect all patient's health and wellbeing.

Findings:

1. During an interview on 7/20/21, at 10:46 AM, with the DFNS, the DFNS stated, one current PI projects for the food and nutrition department was to monitor used towels left unattended in the kitchen. DFNS stated the second PI project was verification the physicians reviewed the RD dietary recommendations and wrote the order if indicated. DFNS stated, the current PI projects were presented to the QAPI committee and have not changed for "years." The DFNS stated, she had not identified other PI projects or quality indicators in the Food and Nutrition department. The DFNS stated, she and the RDs do not attend the QAPI committee meetings.

During an interview on 7/22/21, at 9:42 AM, with the Quality and Risk Analyst (QRA), the QRA verified the DFNS and the RDs do not attend QAPI committee meetings. The QRA stated, the DFNS is to bring QAPI projects to her and she will present them to QAPI. The QRA verified Food and Nutrition department's current PI projects were to monitor used towels left unattended in the kitchen and verify the physicians reviewed the RD dietary recommendations and wrote the order if indicated. The QRA stated the DFNS has internal audits she does within the food service operation such as plate waste (food coming back to the kitchen on meal trays), diabetic snacks being provided, and complementary trays (meal trays for guests), but the data is not presented to the QAPI committee meetings for data analysis.

During a review of the facility's policy and procedure (P&P) titled, "Quality Assessment Performance Improvement (QAPI) Program", (undated), the P&P indicated, "Summary/Intent; The governing body shall be responsible for a hospital-wide QAPI program that reflects all hospital departments and services. . . This is accomplished through an interdisciplinary and collaborative approach to designing, measuring, assessing, and improving healthcare processes and outcomes. The QAPI plan includes, "Ensure that the QAPI program reflects the complexity of the hospital's organization and services. . .Each Hospital Department will have a QAPI Plan, which will include the following: Identification of Improvement Opportunities and Plans for Improvement, Identification of Ongoing Quality Assurance Indicators as needed . . . Data will be collected, assessed and reported quarterly."

2. During an interview on 7/20/21, at 9:13 AM, with DFNS, Nutritional Services Supervisor (NSS), and Cook 1. Cook 1 was asked how does she check to ensure food is cooked thoroughly and is safe to eat. Cook 1 stated she used a thermometer to check the temperature and looked for 135 degrees F (Fahrenheit-unit of measure) to 155 degrees F. The DFNS and NSS agreed that turkey is cooked thoroughly and safe to eat when the internal temperature of the turkey reached 135 degrees F to 155 degrees F.

During a concurrent interview and record review on 7/20/21 at 9:46 AM, with DFNS and NSS, "Safe Cooling Log" (SCL), dated 1/1/21 through 6/21/21 were reviewed. The SCL indicated 13 of 43 entries on the SCL during that time, indicated the turkey and roast beef were not cooled down safely. The DFNS verified the findings and confirmed that turkey and roast beef were on patient menus. The DFNS and NSS confirmed they were unaware unsafe cooling practices of time and temperature control foods (TCS) foods occurred.

During a concurrent interview and record review on 7/20/21 at 12 PM, with DFNS and NSS, the "Roast Turkey" recipe was reviewed. The Roast Turkey recipe indicated, "Bake until internal temperature reaches 165 degrees F for 15 seconds." DFNS and NSS verified the information.

During a review of the facility's P&P titled, "Procedure: HACCP [Hazard Analysis and Critical Care Points]/Infection Control", dated 9/22/20, the P&P indicated, "Potentially hazardous food items are cooked to at least the following safe internal cooking temperature and held for at least 15 seconds: All poultry minimum internal temperature 165 degrees F."

During an interview on 7/20/21, at 11:02 AM, with DFNS and maintenance employee (ME), in the kitchen, ME stated he was responsible for cleaning the facilities ice-machines. ME stated he uses Nickel-Safe Ice Machine Cleaner to clean and sanitize the inside of the ice-machine as the product circulated through the internal components of the ice-machine.

During a concurrent interview and record review on 7/20/21 at 11:05 AM, with DFNS. The Ice-machine manufacturers guidelines were reviewed. The ice-machine's manufacturer's guidelines indicated, "1. Cleaning Procedure; 1) Dilute . . . of recommended cleaner. . . 2. Sanitizing Procedure - Following Cleaning Procedure; 1) Dilute a 5.25% sodium hydrochloride solution [chlorine bleach] with warm water. Add. . . sanitizer to 3 gal.[gallons-unit of measure] of water." DFNS verified the information. DFNS verified the ice-machine manufacturer's guidelines were not followed and acknowledged the ice-machines were not sanitized.

During an interview on 7/20/21, at 11:45 AM, with RD 1, RD 1 stated, her role within the foodservice operation was to provide audits over trayline to monitor accuracy of therapeutic diets, and check temperatures. RD 1 stated, on occasion, she would check dating and labeling of food storage. RD 1 stated, the only formal form she completed for foodservice operation was titled, "Food and Nutrition Services Test Tray Evaluation." RD 1 verified she did not have a role in the foodservice operations that entailed safe food handling and sanitation.

During a concurrent observation and interview on 7/20/21, at 11:34 AM, with RD 1, in the kitchen, RD 1 reviewed Patient 12's meal tray and the patient diet card indicated, "Diet; Cardiac Low chol [cholesterol]". RD 1 observed a slice of white bread on Patient 12's lunch meal tray. RD 1 stated a slice of wheat bread should have been served.

During a review of the facility's P&P titled, "Procedure: HACCP [Hazard Analysis and Critical Care Points]/Infection Control", Revision Date 9/22/20, the P&P indicated, "VII. Dishwashing Machine Operation ...B.5. Hand washing is important for the crew in the dish room if one person is loading dirty dishes and also removing clean dishes from racks."

3. During an interview on 7/20/21, at 2:15 PM, with DFNS, DFNS verified the hospital dietitian's role within the food service operation was limited to oversight over trayline and the dietitians were not utilized to provide oversight over safe food handling, and sanitation.

During a review of the facility's P&P titled, "Procedure: HACCP [Hazard Analysis and Critical Care Points]/Infection Control", dated 9/22/20, the P&P indicated, "Procedure: Compliance - Key Elements. . .E. The team members have their specific responsibilities to the HACCP program: . .2. Dietitian - Patient trayline temperature log."

During a review of the facility's job description titled, "Dietitian", dated 3/27/2008, the dietitian job description indicated, "Job Title: Dietitian, Reports to: Director of Dietary. . .General Duties: Plan and delivery nutritional care to patients according to the Physicians diagnoses. . .Screens newly admitted patients to identify those at nutritional risk. Train Nursing and Nutritional Personnel in special diets. Exercises independent judgement under the general supervision of the Food Service Manager."

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Based on observation, interview, and record review, the facility failed to ensure performance improvement (PI) projects were identified hospital wide and presented to the Quality Assessment Performance Improvement (QAPI) program committee. This failure placed the patients at risk for negative healthcare outcomes.

Findings:

During a concurrent interview and record review on 7/22/21, at 1:50 PM, the facility QAPI meeting minutes were reviewed for 7/14/20, 9/15/20, 10/13/20, 11/20/20, 1/12/21, 2/9/21, 4/1/21, 5/12/21, 6/16/21. The QAPI meeting minutes indicated no PI projects or data was presented at the QAPI meetings. Quality Improvement Risk Manager (QRA) verified the information. QRA stated the facility does not currently have a system in place to develop and identify PI projects hospital wide. The departments may have PI projects within the department but the data is not brought to the QAPI committee meetings. QRA was unable to provide QAPI committee sign in sheets for QAPI meetings for July 2020 to May 2021. QRA stated no PI data from the facility departments or facility services has been presented to the QAPI committee meetings for the past 12 months.

During review of the facility's policy and procedure (P&P) titled, "FACILITY POLICY; 2021 QUALITY ASSESSMENT AND PERFORMED IMPROVEMENT (QAPI) PLAN, (undated), the P&P indicated, "The leadership of the hospital establishes this Quality Improvement plan. . . The organizational Performance department staff provides. . .direction for performance and process improvement activities throughout the network of hospitals, clinics, and other out patient services. . .The CB (community board) approves the QAPI plan. . .The QPMC (quality performance monitoring committee-QAPI) shall strive to ensure that there is measurable improvement in indicators with demonstrated link to improved health care outcomes. . . The QPMC shall oversee measurement, and shall analyze and track performance improvement measures. . .The QPMC shall approve the specific indicators used. . .data collection. However, individual departments and services will measure other aspects of performance."

Based on interview and record review, the facility failed to ensure Medical Staff followed the bylaws, as evidenced by the Hospital's failure to have a system in place to ensure provisional Medical Staff (physicians and allied health on probationary period) were observed and reviewed according to Medical Staff bylaws. (Refer to A-0339)

The cumulative effect of this systemic problem resulted in the hospital's failure to deliver care in compliance with the Condition of Participation for Medical Staff.

Based on interview and administrative record review, the facility's failed to implement provisions of the medical staff bylaws when seven of 10 sampled Provisional Medical Staff members (Medical Doctor [MD] 1, Nurse Practitioner [NP], Physician Assistant [PA], MD 4, MD 5, MD 6, and MD 7) did not undergo direct observation, performance evaluations or receive consultations by Medical Staff monitors. This failure had the potential to result in the hospital being unable to ensure the provision of quality health care in a safe environment.

Findings:

During a review of Medical Staff credential file (MSCF), on 7/26/21, at 2 PM, with Credentialing Assistant (CA), PA's MSFC, dated 1/29/21, was reviewed. The MSFC indicated PA was approved for initial appointment to Allied health Professional staff on 2/1/21, expiration of Appointment 1/31/22. PA's "Appointment Recommendations" document, undated, was also reviewed. MD 2's,(Chair of the Department of Surgery), MD 3, (Chair of the Medical Executive Committee) and Community Board Member (CBM) indicated PA was "Qualified for 1 year appointment to the Provisional with Proctors. Assigned proctor was blank. CA was unable to provide documentation PA had been proctored or had an evaluation of his performance by Medical Staff.

During a review of MSCF, on 7/26/21, at 2 PM, with CA, NP's MSFC, dated 6/25/20 was reviewed. The MSFC indicated NP was was approved for reappointment to Allied health Professional staff on 7/1/20. CA was unable to provide documentation PA had been proctored or had an evaluation of his performance by Medical Staff.

During a review of MSCF, on 7/26/21, at 2 PM, with CA, MD 1's MSCF was reviewed. The MSFC indicated MD 1's initial Medical Staff appointment was 4/1/18. A facility letter dated 3/31/21 was reviewed. The facility letter indicated MD 1 was approved for reappointment to Medical Staff as Professional staff with proctors on 3/1/21. CA was unable to provide documentation MD 1 had been proctored or had an evaluation of his performance by Medical Staff.

During an interview, on 7/26/21, at 2:30 PM, with Chief Medical Officer/Director of Emergency Department (CMOED) and MSD, CMOED stated the provisional staff in the ED have not been proctored. MSD stated, the Department Directors are aware of the provisional Medical Staff proctoring requirement as they recommend appointments and reappointments for Medical Staff and Allied Health for their departments.



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During a concurrent interview and record review, on 7/26/21, at 2:14 PM with MSD, the Credential File for MD 4 was reviewed. The Initial Appointment Letter (IAL), dated 2/27/2020, indicated, ". . . you were approved for initial appointment to the Medical Staff membership. . . , Staff status: Provisional with Proctors, Appointment Date March 1, 2020, Expiration of Appointment February 28, 2021." The IAL further indicated, ". . .Medical Staff Bylaws, Section 5.3, the quality of your work will be monitored by your proctoring physician as noted below. It will be your responsibility to contact your proctor and make arrangements to satisfy the stipulations of your appointment." The Reappointment Letter (RAL), dated 2/26/2021, indicated ". . .you were approved for reappointment of Medical Staff membership and clinical privileges. . . Staff status: Provisional with Proctors, Reappointment Date March 1, 2021, Expiration of Reappointment February 28, 2022." MSD verified both letters, and stated MD 4 was still on Provisional status with proctoring. MSD stated "Just a list of cases [different procedures], but no proctoring. No proctoring was done."

During an interview, on 7/26/21, at 2:52 PM, with MSD, MSD stated there has been no accountability over Medical Staff. MSD stated Ongoing Professional Performance Evaluation (OPPE-Medical Staff monitor performance, behavior, and professionalism) has not been done for Medical Staff for 3 years. Medical staff peer review has been limited to complaints.

During a concurrent interview and record review, on 7/26/21, at 3 PM, with MSD, the Credential File for MD 5 was reviewed. The RAL, dated 3/28/2019, indicated, ". . . you were approved for reappointment to the Medical Staff membership. . . , Staff status: Provisional with Proctors, Appointment Date April 1, 2019, Expiration of Appointment March 31, 2020." The RAL further indicated, ". . .Medical Staff Bylaws, Section 5.3, the quality of your work will be monitored by your proctoring physician as noted below. It is your responsibility to contact a qualified proctor and make arrangements to satisfy the stipulations of your appointment. . ." The RAL, dated 3/26/2020, indicated ". . .you were approved for reappointment of Medical Staff membership and clinical privileges. . . Staff status: Provisional with Proctors, Reappointment Date April 1, 2020, Expiration of Reappointment March 31, 2021. The RAL further indicated, "It will be your responsibility to contact your proctor to make arrangements to satisfy the stipulations of your appointment." The third RAL dated 3/31/2021, indicated "Staff status: Provisional with Proctor, Reappointment Date: April 1, 2021, Expiration of Reappointment: March 21, 2022." MSD confirmed all three letters indicated MD 5 was provisional with proctoring, and no proctoring was done. MSD stated, "We won't find proctoring in the file."

During a concurrent interview and record review, on 7/26/21, at 3:16 PM, with MSD, the Credential File for MD 6 was reviewed. The IAL, dated 3/26/2021, indicated MD 6 was approved for Medical Staff membership. The IAL indicated "Staff Status: Provisional with Proctors, Appointment Date: March 1, 2021, Expiration of Appointment: February 28, 2022. The IAL further indicated, ". . .and the Medical Staff Bylaws, Section 5.3, the quality of their work will be monitored by the proctoring physician." MSD stated, "There's no proctoring."

During a concurrent interview and record review, on 7/26/21, at 3:45 PM, with MSD, the Credential File for MD 7 was reviewed. The IAL, dated 1/29/21, indicated MD 7 was approved for Medical Staff membership. The IAL indicated, "Staff Status: Provisional with Proctors, Appointment Date: February 1, 2021, Expiration of Appointment: January 31, 2022." The IAL further indicated, ". . . the Medical Staff Bylaws, Section 5.3, the quality of their work will be monitored by the proctoring physician." MSD stated "There was no proctoring done."

During a review of the facility's "Medical Staff Bylaws" dated 4/19, the MSB indicated, "OBSERVATION OF PROVISIONAL STAFF MEMBER - FPPE [focused professional performance evaluation]. Each Provisional Staff member shall undergo a period of observation by designated monitors. . .The purpose of observation shall be to evaluate the (1) proficiency in the exercise of Clinical Privileges. . . Observation of Provisional Staff Members shall follow. . .format that Medical Staff deems appropriate . . .to adequately evaluate the Provisional Staff member including, but not limited to, concurrent or retrospective chart review, mandatory consultation, and/or direct observation. Focused Professional Performance Evaluation (FPPE) must be utilized. . . Appropriate records shall be maintained. The results of the FPPE shalt be reviewed by the Department Chair. Based on the review by the Department Chair, s/he shall recommend advancement or further FPPE based on findings. . .A member shall remain in the Provisional staff for a minimum of six (6) months, unless that status is extended by the Medical Executive Committee for up to twenty-four (24) months upon a determine of good cause.

During a review of the facility's "MANUAL FOR: Ongoing Professional Performance Evaluation (OPPE) and Focused Professional performance Evaluation (FPPE) Peer Review", (Manual) undated, the Manual indicated, the purpose of OPPE and FPPE is to provide a continuous monitoring system to evaluate clinical privilege-specific competence's granted medical staff members and allied health professionals at initial and reappointment time. . .6. through the OPPE process, the Medical Staff. . . monitors Practitioner's clinical performance, behavior, and professionalism. . . important indicators of quality and patient safety. 7. Peer Review Committee - Each medical Staff Department that makes judgments regarding the appropriateness of an individual Practitioner's clinical performance, behavior, and/or professionalism."

Based on interview and record review, the facility failed to develop and implement nutrition management care plans for six of 36 sampled patients (Patient 1, Patient 2, Patient 8, Patient 14, Patient 21, and Patient 30). This failure had the potential for patients to not receive appropriate and adequate nutrition and care.

Findings:

During a review of Patient 1's "ANIA" by RD 1, dated 7/19/21, The ANIA, indicated, Patient 1 had "Increased Nutritional Needs."

During a concurrent interview and record review on 7/20/21, at 1:55 PM, with QARN, Patient 1's "history and physical" (H&P), dated 7/18/21 was reviewed. The H&P indicated, Patient 1 was seven days post op cholecystectomy (removal of gallbladder), and had stress induced hyperglycemia. QARN verified the information. QARN was unable to provide documentation a nutrition management care plan was implemented. QARN stated Patient 1 should have had a nutritional care plan initiated.

During a review of Patient 2's "Patient information" (PI) record, undated, the PI record indicated, Patient 2 was admitted on 7/16/21.

During a review of Patient 2's "Adult Nutrition Initial Assessment/Plan" (ANIA) by Registered Dietitian (RD) 1, dated 7/17/21, The ANIA, indicated, Patient 2 had "Increased Nutritional Needs. . . Low Protein Calorie Malnutrition Potential... and/or Nutritional Complications."

During a concurrent interview and record review on 7/20/21, at 2:07 PM, with Registered Nurse (RN) 1, Patient 2's Physician "Orders" (PO), dated 7/17/21, were reviewed. The PO indicated, Diet "Diabetic/Consistent Carb Diet" (CCHO-goal to eat same amount of carbohydrates daily). RN 1 verified the information. RN 1 was unable to provide documentation a nutrition management care plan was implemented. RN 1 stated Patient 2 should have had a nutrition care plans (a detailed plan of interventions/actions to support a patient to achieve nutritional goals) initiated due to his CCHO diet.

During a review of Patient 21's "PI" record, undated, the PI record indicated, Patient 21 was admitted on 7/20/21 at 5:34 AM.

During a concurrent interview and record review on 7/21/21, at 2:30 PM, with RD 2, Patient 21's "H&P", dated 7/20/21 was reviewed. The H&P indicated, Patient 21's physician impression (physician's initial opinion) included gestational diabetes mellitus (pregnancy related increased blood sugar). RD 2 verified the information. RD 2 stated she does not go to the obstetric department to complete nutritional assessments. RD 2 was unable to provide a nutrition management care plan for Patient 21. RD 2 stated Patient 21 should have had a nutrition care plan started by nursing due to gestational diabetes. RD 2 stated her diet recommendation for Patient 21 would have been a CCHO diet. RD 2 stated RD's do not participate in the development, goals or outcome of the nutritional management care plans, nursing is responsible.

During a review of Patient 8's "PI" record, undated, the PI record indicated, Patient 8 was admitted on 7/17/21.

During a review of Patient 8's "ANIA" by RD 1, dated 7/18/21, The ANIA, indicated, "Nutritional Diagnosis Altered nutrition related to multiple medical problems. . . abnormal lab values and medical diagnosis."

During a concurrent interview and record review on 7/21/21, at 3:10 PM, with Quality Analyst Registered Nurse (QARN), Patient 8's "H&P", dated 7/17/21, was reviewed. The H&P indicated, Patient 8's physician's impression included sepsis and hyperglycemia. During a review of Patient 8's "Order Summary" (OS), dated 7/17/21, the OS indicated, "Diabetic/Consistent Carb Diet." QARN verified the information. QARN was unable to provide a nutrition management care plan for Patient 8. QARN stated a nutrition management care plan should have been initiated upon admission for Patient 8.

During a review of Patient 30's "PI" record, undated, the PI record indicated, Patient 30 was admitted on 6/30/21.

During a concurrent interview and record review on 7/22/21, at 11:11 AM, with QA 2, Patient 30's "H&P", dated 6/30/21, was reviewed. The H&P indicated, Patient 30's diagnosis included gestational diabetes. Patient 30's PO, dated 7/1/21, was reviewed. The PO indicated a consult to the nutritionist was ordered with a comment lactating or pregnant. QA 2 was unable to provide documentation of a nutritional consult was obtained. QA 2 was unable to provide a nutrition management care plan for Patient 30.

During a review of Patient 14's "PI" record, undated, the PI record indicated, Patient 14 was admitted on 6/7/21.

During a concurrent interview and record review on 7/22/21, at 11:20 AM, with QA 2, Patient 14's "H&P", dated 6/17/21, was reviewed. The H&P indicated, Patient 14's problem list included gestational diabetes. Patient 14' s' PO, dated 6/7/21, was reviewed. The PO indicated a nutritionist consultation was ordered with a comment of lactating or pregnant. QA 2 was unable to provide documentation of a nutritional consult was obtained. QA 2 was unable to provide a nutrition management care plan for Patient 14.

During a review of the facility's policy and procedure (P&P) titled, "Plan of Care", dated 10/20, the P&P indicated, "DEVELOPMENT OF THE PLAN OF CARE 1. The data collected in the initial assessment will be utilized to establish the plan of care for the patient. . .each service will develop a plan of care. . .Each service is responsible for the implementation of the department specific plan of care."

During a review of the Hospital's policy and procedure (P&P) titled, "Standards of Care for Acute and Critical Care Nursing Practice", dated 10/20, the P&P indicated, "The nurses caring for the . . .patient develops a plan of care. The plan is individualized to reflect the patient's characteristics and needs. The plan is developed collaboratively with the team, which consists of patient, family, and healthcare providers."

Based on observation, interview and record review, the hospital failed to ensure an organized food and nutrition services as evidenced by:

1. The director of food and dietetic services (DFNS) was not a full-time position which limited her ability to assist the Dietitian in the overall operation of dietetic services. (Refer A-0619)

2. The Registered Dietitians (RD 1 and RD 2) did not fulfill their duties and responsibilities to dietetic services. (Refer A-0620)

3. The therapeutic diet (meal plan that controls the intake of certain foods or nutrients) order for a CCHO (consistent carbohydrate for diabetes care) diet was not provided to eight of 22 patients (Patient 2, Patient 6, Patient 9, Patient 10, Patient 12, Patient 14, Patient 19, and Patient 20) in accordance with the physician's diet order and as guided by the hospital's diet manual. (Refer A-0629)

4. Lack of menus developed for prescribed therapeutic diet orders were provided in accordance with physician orders and as guided in the diet manual. (Refer A-0631)

The cumulative effect of these systemic 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 interview and record review, the facility failed to ensure the organization of the dietetic services when:

1 The director of food and dietetic services (DFNS) was not a full-time position which limited her ability to assist the Dietitian in the overall operation of dietetic services.

2. The position for the Registered Dietitian (RD) had a limited role in providing supervision over the food service operations.

These failures had the potential to place the patients at an increased risk for foodborne illness, and unmet nutritional needs. (Cross-Reference: A-0620, A-0629, A-0631)

Findings:

1. During an interview on 7/20/21, at 10 AM, with DFNS and nutritional services supervisor (NSS) , in the kitchen, DFNS stated she was the director of food and nutrition services and the director of materials management and worked a forty-hour work week. DFNS acknowledged she was not full-time in the capacity of director of food and nutrition services position and stated that is why she has a NSS to assist her in the oversite of the department. NSS stated he was not a certified dietary manager (CDM) but was planning to start the CDM program in the fall.

During a review of the facility's organization chart (OC), undated, the OC indicated, "[name of DFNS] Director Supply Chain & Nutritional Services."

During a review of the facility's job description titled, "Director of Dietary" (DOD), dated 2/16, the DOD job description indicated, "Job Title: Director of Dietary, Reports to: CFO [chief financial officer], Primary Purpose: The primary purpose of your job position is to assist the Dietitian in planning, developing and directing the overall operation of the Dietary in accordance with the Federal, State. . . and other local standards, guidelines, and regulations governing our facility to assure that quality diet and menu are provided on a daily basis and that the Dietary Department is maintained in a safe, clean, and in sanitary manner. Department Specific Duties: Responsible in planning, developing, organizing, implementing, evaluating, and directing the Dietary Department, its programs, and activities."

During a review of the facility's job description titled, "Supervisor, Nutritional Services" (NSS), dated 10/20, the NSS job description indicated, "Provides supervision for the department's production line staff."

2. During an interview on 7/20/21, at 11:45 AM, with Registered Dietitian (RD) 1, RD 1 stated, her role within the foodservice operation was to provide audits over trayline (system of food preparation) to monitor accuracy of therapeutic diets (meal plan that controls the intake of certain food or nutrients), and check temperatures. RD 1 stated, on occasion, she would check dating and labeling of food storage. RD 1 stated, the only formal form she completed for foodservice operation was titled, "Food and Nutrition Services Test Tray Evaluation." RD 1 verified she did not have a role in the foodservice operations that entailed safe food handling and sanitation.

During an interview on 7/20/21, at 2:15 PM, with DFNS, DFNS verified the hospital dietitian's role within the foodservice operation was limited to oversight over trayline and the dietitians were not utilized to provide oversight over safe food handling and sanitation.

During a review of the facility's policy and procedure (P&P) titled, "Procedure: HACCP [Hazard Analysis and Critical Care Points]/Infection Control", dated 9/20, the P&P indicated, "Procedure: Compliance - Key Elements. . .E. The team members have their specific responsibilities to the HACCP program: . .2. Dietitian - Patient trayline temperature log."

During a review of the facility's job description titled, "Dietitian", dated 3/08, the dietitian job description indicated, "Job Title: Dietitian, Reports to: Director of Dietary. . .General Duties: Plan and delivery nutritional care to patients according to the Physicians diagnoses. Performs as a member of the multidisciplinary care team, screens newly admitted patients to identify those at nutritional risk. Train Nursing and Nutritional Personnel in special diets. Exercises independent judgement under the general supervision of the Food Service Manager."

Based on observation, interview, and record review, the facility failed to follow dietetic services guidelines and policy and procedures were not implemented when:

1. The director of food and dietetic services (DFNS) was not employed full-time.

2. Two of two Registered Dietitians (RD 1 and RD 2), were not fulfilling their duties and responsibilities to dietetic services.

3. TCS foods (Time Temperature Control for Safety - food that requires time-temperature control to prevent the growth of bacteria) were not correctly cooled down 13 of 43 times to ensure food safety.

4. Cook 1, the DFNS and the nutritional services supervisor (NSS) were unable to verify the correct internal cooking temperature of poultry.

5. Eight of eight ice-machines in the hospital were not sanitized in accordance with the manufacturer's guidelines.

These deficient practices had the potential to cause foodborne illness to patients and staff.

Findings:

1. During an interview on 7/20/21, at 10 AM, with DFNS and nutritional services supervisor (NSS), DFNS stated she was the director of food and nutrition services and the director of materials management and worked a forty-hour work week. DFNS acknowledged she was not full-time in the capacity of director of food and nutrition services position and stated that is why she had a NSS to assist her in the oversite of the department. NSS stated that he was not a certified dietary manager (CDM).

During a review of the facility's organization chart" (OR), undated, the OR indicated, "[name of DFNS] Director Supply Chain & Nutritional Services."

During a review of the facility's job description titled, "Director of Dietary" (DOD), dated 02/23/2016, the DOD job description indicated, "Job Title: Director of Dietary. . . Primary Purpose: The primary purpose of your job position is to assist the Dietitian in planning, developing and directing the overall operation of the Dietary in accordance with the Federal, State. . . and other local standards, guidelines, and regulations governing our facility to assure that quality diet and menu are provided on a daily basis and that the Dietary Department is maintained in a safe, clean, and in sanitary manner. Department Specific Duties: Responsible in planning, developing, organizing, implementing, evaluating, and directing the Dietary Department, its programs, and activities."

During a review of the facility's job description titled, "Supervisor, Nutritional Services" (NSS), dated 10/20, the NSS job description indicated, "Provides supervision for the department's production line staff."

2. During an interview on 7/20/21, at 11:45 AM, with Registered Dietitian (RD) 1, RD 1 stated, her role within the foodservice operation was to provide audits over trayline (system of food preparation) to monitor accuracy of therapeutic diets (meal plan that controls the intake of certain foods or nutrients), and check temperatures. On occasion, she would check dating and labeling of food storage. RD 1 stated, the only formal form she completed for foodservice operation was titled, "Food and Nutrition Services Test Tray Evaluation."

During an interview on 7/20/21, at 2:15 PM, with DFNS, DFNS verified that the hospital dietitian's role within the foodservice operation was limited to oversight over trayline.

During a review of the facility's policy and procedure (P&P) titled, "Procedure: HACCP [Hazard Analysis and Critical Care Points]/Infection Control", Revision Date 9/22/20, the P&P indicated, "Procedure: Compliance - Key Elements. . . E. The team members have their specific responsibilities to the HACCP program: . .2. Dietitian - Patient trayline temperature log."

During a review of the facility's job description titled, "Dietitian", dated 3/08, the dietitian job description indicated, "Job Title: Dietitian, Reports to: Director of Dietary. . .General Duties: Plan and delivery nutritional care to patients according to the Physicians diagnoses. Performs as a member of the multidisciplinary care team, screens newly admitted patients to identify those at nutritional risk. Train Nursing and Nutritional Personnel in special diets. Exercises independent judgement under the general supervision of the Food Service Manager."

3. During a concurrent observation and interview on 7/20/21, at 9:05 AM, with NSS, in the kitchen, inside the walk-in refrigerator, three pans of cooked turkey, covered and dated, "7/19/21; Use By 7/20" were observed. The NSS stated the turkey was cooked on 7/19/21 and was to be served in the retail cafeteria (for staff and guests) for today's lunch.

During a concurrent interview and record review on 7/20/21, at 9:16 AM, with DFNS, the "Safe Cooling Log" (SCL), dated 7/19/21 was reviewed. The DFNS verified the cooling log for the turkey was incomplete and inaccurate. DFNS stated, "We don't know if it's [turkey] safe." The DFNS instructed the NSS to discard the turkey.

During a concurrent interview and record review on 7/20/21, at 9:20 AM, with Cook 1, the SCL, dated 3/15/21, was reviewed. The SCL indicated temperatures for the turkey were listed 74 degrees F, after 2 hours of the initial cool down process. Cook 1 verified the findings. Cook 1 verified the cooling of the turkey process continued after the temperature of the turkey was 74 degrees, 2 hours after the initial cooling process. Cook 1 was asked if there were any concerns with the documented temperatures on the cool down log for the turkey on 3/15/21, she stated no.

During a concurrent interview and record review on 7/20/21, at 9:20 AM, with DFNS, DFNS verified that Cook 1 should not have continued to cool the turkey on 3/15/21. DFNS stated the turkey is not safe for consumption. DFNS stated Cook 1 should have reheated the turkey to 165 degrees F, and started cooling the turkey again if it had not reached 70 degrees Fahrenheit (F unit of measure) after the 2 hour initial cool down.

During a review of the kitchen's SCL, dated 7/19/21, the SCL indicated, "After 2 hours (Must be 70 degrees or below)" in which that column listed "185 degrees F at 12:30 [PM]. . .After 6 hours (must be 41 degrees F or below) column listed "91 [degrees F]" at 5:30 [PM], under "Corrective Action" was listed "Cut Sliced". The cooling log indicated, "6 hour total cooling time; 135 degrees [F] to 70 degrees [F] in 2 hrs [hours] & 70 degrees F to 41 degrees F in 4 hrs. = 6 hrs. . .Improper Cooling of Hot Foods is the #1 Factor for Rapid Bacterial Growth which causes FOODBORNE ILLNESS!"

During a concurrent interview and record review on 7/20/21, at 9:46 AM, with DFNS and NSS, the SCLs, dated 1/1/21 through 6/21/21 were reviewed. The SCL indicated 13 out of 43 entries on the SCLs during that time, indicated the turkey and roast beef were not cooled down safely. The DFNS verified the findings and confirmed that turkey and roast beef were on patient menus. The DFNS and NSS confirmed unaware unsafe cooling practices of TCS foods occurred.

During review of the "2017 FDA Food Code" (FFC), dated 2017, the FFC indicated, "[A] Cooked time/temperature control for safety food shall be cooled: [1] Within 2 hours from 135 degrees F to 70 degrees F, and [2] Within a total of 6 hours from 135 degrees F to 41 degrees F or less. . .Safe cooling requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of time/temperature control for safety foods has been consistently identified as one of the leading contributing factors to foodborne illness. . .The initial 2-hour cool is a critical element of this cooling process." (3-501.14 Cooling)

During a review of the facility's P&P titled, "Proper Cooling of Cooked Products", dated 7/19, the P&P indicated, "Scope: Dietary Employees (all Cooks), Purpose: To insure a healthy and safe food product for our customer's, Policy: No cooked food product shall be placed in the refrigerator until it has been cooled properly. Safe Cooling Log form is to be used to document and ensure the proper cooling method is followed. Dietary Supervisor will review logs once a week and initial to confirm proper cooling method is being used and logged accordingly, Procedure: . . The product should be cooled to 70 degrees F within 2 hours and from 70 - 41 degrees F in 4 hours a total of cooling time of 6 hours before being placed in the refrigerator."

4. During an interview on 7/20/21, at 9:13 AM, with DFNS, NSS, and Cook 1. Cook 1 was asked how does she check to ensure food is cooked thoroughly and is safe to eat. Cook 1 stated she used a thermometer to check the temperature and looked for 135 degrees F (Fahrenheit-unit of measure) to 155 degrees F. The DFNS and NSS agreed that turkey is cooked thoroughly and safe to eat when the internal temperature of the turkey reached 135 degrees F to 155 degrees F.

During a concurrent interview and record review on 7/20/21, at 12 PM, with DFNS and NSS, the "Roast Turkey" recipe, undated, was reviewed. The Roast Turkey recipe indicated, "Bake until internal temperature reaches 165 degrees F for 15 seconds." DFNS and NSS verified the information.

During a review of the facility's P&P titled, "Procedure: HACCP [Hazard Analysis and Critical Care Points]/Infection Control", dated 9/20, the P&P indicated, "Potentially hazardous food items are cooked to at least the following safe internal cooking temperature and held for at least 15 seconds: All poultry minimum internal temperature 165 degrees F."

5. During a concurrent observation and interview on 7/20/21, at 11:02 AM., with DFNS and maintenance employee (ME), in the kitchen, ME stated he was responsible for cleaning the facilities ice-machines. ME showed the product he used inside the ice-making apparatus of the ice-machine which was a Nickel-Safe Ice Machine Cleaner. ME verified there were no other products used inside the ice-making apparatus (circulated through the ice-machine), except for detergent for the ice-machine bin. ME stated the purpose of the Nickel-Safe Ice Machine Cleaner was to clean and sanitize the inside of the ice-machine as the product circulated through the internal components of the ice-machine. ME stated he used the same process and products for all the facilities ice-machines, which included three Hoshizaki ice machines, and five Follett ice-machines.

During a concurrent interview and record review on 7/20/21, at 11:05 AM, with DFNS. The Ice-machine manufacturers guidelines, revised date 2/27/2009, was reviewed. The ice-machine's manufacturer's guidelines indicated, "1. Cleaning Procedure; 1) Dilute 16 fl. [Fluid]. . .of recommended cleaner Hoshizaki "Scale Away" or "LIME-A-WAY"..., 2. Sanitizing Procedure - Following Cleaning Procedure; 1) Dilute a 5.25% sodium hydrochloride solution [chlorine bleach] with warm water. (Add 1.5 fl. ounce [oz]. (44 ml [milliliter - unit of measure]) of sanitizer to 3 gal.[gallons-unit of measure] of water." DFNS verified the information. DFNS stated she left responsibility to maintain the ice machines to ME because she had given him the manufacturer's guidelines. DFNS verified the ice-machine manufacturer's guidelines were not followed and acknowledged the ice-machines were not sanitized

During a review of Follett ice-machine manufacturer's guidelines, (undated), the Follett ice-machine manufacturer's guidelines indicated a cleaning step with a cleaning solution of "Follett SafeCLEAN", followed by a sanitizing step with "Nu-Calgon IMS-II or IMS-III Sanitizer."

Based on observation, interview, and record review, the facility failed to ensure therapeutic diet (meal plan that controls the intake of certain foods or nutrients) orders are implemented as prescribed and in accordance with the hospital's diet manual for eight of 22 sampled patients (Patient 2, Patient 6, Patient 9, Patient 10, Patient 12, Patient 14,Patient 19, Patient 20). These failures had the potential to compromise the patient's medical and nutritional status.

Findings:

1. During an observation on 7/20/21, at 11:30 AM, in the kitchen, Patient 12's lunch meal tray was observed being placed onto a meal delivery cart.

During a concurrent observation and interview on 7/20/21, at 11:34 AM, with Registered Dietitian (RD) 1, in the kitchen, RD 1 was asked to check Patient 12's meal tray for accuracy as compared to the planned menu. RD 1 reviewed Patient 12's meal tray and the patient diet card. RD 1 stated, the card indicated, "Diet; Cardiac Low chol [cholesterol]." RD 1 stated the therapeutic diet (meal plan that controls the intake of certain foods or nutrients) menu listed as "2000 cal (calorie) Fat/Chol" should have been followed for Patient 12's diet order, which included 1 slice of wheat bread. RD 1 observed a slice of white bread on Patient 12's lunch meal tray and informed dietary staff that a slice of wheat bread should have been served.

During a review of the facility's policy and procedure (P&P) titled, "Procedure: Patient Diet Card", dated 10/20, the P&P indicated, "To provide a procedure for Nutritional Services on completing the form provided for patient diet care. These forms are to be used for all patient diet care."

During a review of the hospital's diet manual, undated, the fat-restricted diet included, "Choose whole grains, such as bread."

During a review of the facility's P&P titled, "Policy: Diet Manual [Therapeutic], dated 9/20, the P&P indicated, "A. The Therapeutic Diet Manual [Nutrition Care Manual] will become the standard for The Nutritional Services Department."

2. During a record review on 7/20/21, at 11:53 AM, Patient 10's patient diet card was reviewed. Patient 10's diet card indicated a diet order of renal dialysis (Dialysis is a treatment for kidney failure that rids your body of unwanted toxins, waste products and excess fluids by filtering your blood) CCHO (Renal Consistent Carbohydrate [CCHO] is a diet for kidney disease and diabetes).

During a review of Patient 10's physician's diet order, dated 7/17/21, the diet order indicated, "Renal Dialysis Consistent Carb [carbohydrate] Diet."

During a concurrent interview and record review on 7/21/21, at 2:50 PM, with RD 2, the hospital's nutrient analysis, undated, of the patient menus for therapeutic diets was reviewed. RD 2 stated the "diabetic" diet was analyzed for an 1,800 calorie per day diabetic diet, but not for that diet to include consistent carbohydrate diet per meal. Patient 10's diet order census list, dated 7/17/21, was reviewed. The diet order census list showed Patient 10's diet order as "Renal Dialysis/Consistent Carb Diet", and Patient 6's diet order as "Diabetic/Consistent Carb Diet; Calories Permitted 1800 cal.[calories per day]." RD 2 stated the nutrient analysis for the diabetic diet was done by another dietitian before her, and was unsure of the date of the nutrient analysis. RD 2 stated that more recently the hospital decided to prescribe CCHO diet orders for diabetes care. RD 2 stated that the hospital's nutrient analysis for the current menus being provided to patients with a physician order for CCHO diet showed that a consistent carbohydrate diet was not being provided to patients in accordance with physician orders, and the hospital's approved diet manual for a CCHO diet. Patient 2, Patient 6, Patient 9, Patient 10, Patient 14, Patient 19, and Patient 20 diet order's were reviewed and indicated CCHO diets were prescribed but were not implemented. The information was verified by RD 2.

During a review of the facility's diet manual, undated, the diet manual indicated, CCHO "Definition: Carbohydrate-controlled diets are often recommended for individuals diagnosed with diabetes, pre-diabetes, or some level of insulin or blood sugar imbalance. . .controlling the amount and type of carbohydrate consumed has been found to be helpful in managing blood sugar. The amount of carbohydrate and available insulin may be the most important factor influencing the body's response after eating and should be considered when developing a patient's eating plan."

During a review of the facility's P&P titled, "Policy: Diet Manual [Therapeutic], dated 9/20, the P&P indicated, "A. The Therapeutic Diet Manual [Nutrition Care Manual] will become the standard for The Nutritional Services Department. Physician's should note that therapeutic diet orders will be complied with according to the standards established in the Diet Manual. B. Therapeutic diet manuals [nutrition care manuals] are to be approved by the Dietitian."

During a review of the facility's job description titled, "Director of Dietary" (DOD), dated 2/16, the DOD job description indicated, "Job Title: Director of Dietary, Review therapeutic and diet plans and menus to assure they are in compliance with the physician's orders."

During a review of the facility's job description titled, "Dietitian", dated 3/08, the Dietitian job description indicated, "Job Title: Dietitian, Plans and evaluates cycle menus for regular and therapeutic diets."


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Based on interview and record review, the facility failed to ensure the facility's diet manual was utilized to ensure accurate menu development for diet orders. This failure had the potential to place patients at risk of not receiving required nutrients thereby compromising medical care.

Findings:

During a concurrent interview and record review on 7/21/21, at 2:50 PM, with Registered Dietitian (RD) 2, The facility's list of routinely ordered therapeutic diets (meal plan that controls the intake of certain foods or nutrients) was reviewed. The list indicated, high fiber and low fiber diets. RD 2 verified the hospital had not developed a high fiber menu or a low fiber menu which included a nutrient analysis to ensure appropriate amount of fiber was provided according to the facility's approved diet manual and in accordance with the physician's order.

During a review of the facility's policy and procedure (P&P) titled, "Policy: Diet Manual (Therapeutic), date 9/20, the P&P indicated, "A. The Therapeutic Diet Manual [Nutrition Care Manual] will become the standard for The Nutritional Services Department. Physician's should note that therapeutic diet orders will be complied with according to the standards established in the Diet Manual. B. Therapeutic diet manuals [nutrition care manuals] are to be approved by the Dietitian."

During a review of the facility's diet manual, undated, the diet manual indicated, high fiber diet "obtain a fiber intake of 25 g [grams-unit of measure] to 35 g per day."

During a review of the facility's diet manual, undated, the diet manual indicated, fiber restricted diet "This diet comprises less than 13 g fiber daily."

During a review of the facility's job description titled, "Director of Dietary", dated 2/16, the job description indicated, "Job Title: Director of Dietary, Review therapeutic and diet plans and menus to assure they are in compliance with the physician's orders."

During a review of the facility's job description titled, "Dietitian", dated 3/08, the job description indicated, "Job Title: Dietitian, Plans and evaluates cycle menus for regular and therapeutic diets."