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Based on the number and nature of deficiencies cited, the facility failed to be in compliance with the Condition of Participation of Governing Body. Specifically, the governing body allowed the facility, identified as Hospital A, to comingle space with a separately certified hospital, Hospital B, in a manner that did not permit either hospital to comply with all applicable conditions of participation.

The failures resulted in the co-mingling of patient services, physical space, and personnel with Hospital B, creating confusion for patients and visitors for both the facility and Hospital B. Additionally, the failures resulted in opportunities that affect health outcomes, patient safety, and quality of care being overlooked by the quality department and governing body and resulted in an increased risk of negative patient outcomes.

Cross-reference:

A-0083 - 482.12(e) Standard: Governing Body: Contracted Services - The governing body must be responsible for services furnished in the hospital whether or not they are furnished under contracts. The governing body must ensure that a contractor of services (including one for shared services and joint ventures) furnishes services that permit the hospital to comply with all applicable conditions of participation and standards for the contracted services. The governing body failed to ensure contracted services were provided in a manner which allowed the hospital to comply with applicable conditions of participation and standards of care. These failures resulted in opportunities that affect health outcomes, patient safety, and quality of care being overlooked and resulted in an increased risk of negative patient outcomes. Further, the failures did not permit the hospital to comply with all applicable conditions of participation and standards for the contracted services.

Findings:

Based on observations, interviews and document reviews, the governing body did not maintain separate hospital space and services in a manner that permitted the facility to comply with all applicable conditions of participation.

The failure resulted in the comingling of patient services, physical space, and personnel with a separately certified facility, Hospital B, creating confusion for patients and visitors for both the facility and Hospital B.

1. The facility comingled space with a separately certified hospital (Hospital B).

a) Review of the facility's first floor level floor plan revealed facility space surrounded Hospital B's patient service areas (pharmacy).

b) An interview was conducted with Hospital B's Plant Services Coordinator (PSC A) on 03/17/16 at 8:10 a.m. PSC A stated the facility owned hospital space that surrounded Hospital B's space on the first floor of the facility.

c) On 03/17/16 at 8:15 a.m., a tour of the medical records department and Hospital B's pharmacy was conducted with PSC A and the Regulatory Manager (Manager #22). Observation revealed the surveyors passed Hospital B's pharmacy while proceeding to Hospital A's outpatient wound care clinic and the medical records department, which processed medical records for both the facility and Hospital B. Observation of the sign on the door of the medical records department revealed both the facility's name and Hospital B's name directly above the words "Medical Records," along with the operating hours of 8:00 a.m. to 4:00 p.m.

An interview was conducted with Manager #22 during the tour. S/he stated patients of both the facility, Hospital A, and of Hospital B could come downstairs to the medical records department that serviced both the facilities and request medical records from whichever facility they had received services from.

d) During the same tour, observation revealed walking through a corridor that contained Hospital B's pharmacy in order to get to the facility's outpatient Transitional Care Clinic and outpatient Intravenous (IV) Infusion Center.

e) According to the floor plan provided by Hospital B's PSC A on 03/17/16 at 8:18 a.m., the "CT" room was a part of Hospital B's space.

An interview was conducted during the tour on 03/17/16 at 8:33 a.m. with Hospital A's Registered Nurse #45 (RN) while s/he was restocking items in the CT room used for the outpatient Transitional Care Clinic. S/he stated the CT room was used to see the facility's Transitional Care Clinic patients.

f) Further observation during the same tour revealed the outside entrance of the facility's outpatient Transitional Care Clinic had signage on the automatic sliding doors that read "Transitional Care Clinic" (for the facility, Hospital A) and Hospital B "East Entrance." Upon entering the automatic sliding doors Patient Access Representative (Representative #44) stated s/he was responsible for registering patients for the Transitional Care Clinic for the facility and Hospital B, but only Hospital B patients on Wednesday from 8:00 a.m. to 11:00 a.m., on a first come, first served basis. Representative #44 stated s/he registered patients for the Transitional Care Clinic of the facility at all other times.

g) Observation during the tour revealed signage for Hospital B's Patient Bill of Rights placed above a seating area for facility patients who were registering for the facility's Transitional Care Clinic.

Based on observations, interviews and document reviews, the governing body failed to ensure contracted services were provided in a manner which allowed the hospital to comply with applicable conditions of participation and standards of care.

These failures resulted in opportunities that affect health outcomes, patient safety, and quality of care being overlooked and resulted in an increased risk of negative patient outcomes. Further, the failures did not permit the hospital to comply with all applicable conditions of participation and standards for the contracted services.

Findings:

1. The governing body failed to ensure the quality department monitored all contracted departments and services and demonstrated evidence of an ongoing Quality Assessment and Performance Improvement (QAPI) program related to all contracted services.

a) The Director of Quality (DQ #2) was interviewed on 03/22/16 at 11:25 a.m. DQ #2 provided copies of the Board of Trustees Meetings for meetings held on 02/11/16, 12/10/15, 10/08/15, and 08/13/15. Review of the Board of Trustees Meeting records showed no evidence of discussion or approval of data, collection frequency, or details for quality monitoring and indicators for contracted services the hospital received from outside parties. Further, the documents did not show improvement actions were recommended or evaluated for all contracted services.

During that same interview, DQ #2 stated getting quality data from contracted services had been a struggle for the facility, and the quality department did not monitor up to fifty percent of contracted services that provided clinical care in the facility. DQ #2 stated s/he spoke with hospital leadership after the start of the survey to get additional resources for monitoring contracted services so the facility could monitor 100% of the clinical care contracted services the facility used.

Specifically, DQ #2 stated the quality department did not monitor or have a Quality Assessment Performance Improvement (QAPI) project for the contracted service that provided kitchen staff and all patient meals for the facility. S/he stated the facility had only been monitoring patient satisfaction surveys, which indicated how patients felt about the food choices that were offered at the facility.

b) An interview was conducted with the Chief Financial Officer (CFO #8) on 03/22/16 at 3:27 p.m. CFO #8 stated s/he reported to the Chief Executive Officer and attended the majority of the Governing Body meetings. CFO #8 stated s/he did not recall quality monitoring for contracted services being discussed at Governing Body meetings, and s/he believed the facility was not monitoring all contracted services because the facility did not have an all encompassing list of contracted services that the hospital used.

CFO #8 stated the Governing Board had been informed that all contracted services related to clinical care provided under contract or arrangement needed to be monitored for quality once it was discovered after the start of the survey. (Cross Reference 0308).

c) The failure to monitor kitchen contracted services resulted in the facility having no standard process for labeling, monitoring and disposing of expired food items and created the potential for patients to receive food that was expired and unsafe.

According to the Sodexo Food Product Shelf-Life Guideline, spices are shelf stable for 6 months, frozen solid muscle meat is shelf stable in freezer for up to 6 months and 3 to 4 days in refrigerator storage, and cream cheese is shelf stable for 2 weeks in refrigerator storage.

i) During a tour of the kitchen on 03/08/16, at 8:15 a.m., Executive Chef (EC) #1 was interviewed. S/he stated the date on produce was the date the box was received. Staff were trained to go by sight and smell and to check with EC #1 before produce was discarded.

EC #1 stated the kitchen staff followed the Sodexo Food Product Shelf-Life Guideline. According to EC #1, spices were usable for 1 year if opened, frozen marinated meat remained good for 1 year, and cream cheese was considered appropriate to use up to 6 months. These statements were in contrast to the Sodexo guidelines noted above.

ii) An interview with Cook #27 was conducted on 03/09/16, at 10:10 a.m. S/he explained the dates on produce boxes were the use-by dates and produce was not to be used past the date on the label. This was in contrast to the statements provided by EC #1. Cook #27 reported working in the kitchen for 8 years.

iii) An interview was conducted on 03/10/16, at 09:09 a.m., with Food/Dietetic Director (FDD) #25. FDD #25 stated frontline staff were trained to go by sight, smell, and feel to determine produce freshness. Produce should have been discarded within 2 days of being cut, and the produce box should have been dated with the date it was cut.

Further contradicting the interview with EC #1 and Cook #28, FDD #25 stated, frontline staff should have been trained to know the date on produce was the day the produce was cut. S/he further stated food received that was not labeled should be set aside and the vender should be notified for clarification.

iv) A tour of the facility's kitchen was conducted on 03/08/16, at 8:15 a.m., with EC #1 and FDD # 25. The following concerns were noted:

Expired items present in the kitchen included: a box of celery labeled 01/30, a box of leeks labeled 02/13, an opened box of lettuce labeled 03/02, a bag of chopped red onions labeled 02/27, a bag of chopped and peeled eggplant labeled 02/13, pepper spice labeled 06/2010, and marinated pork in freezer labeled 05/14.

5 - 3 pound tubs of cream cheese not labeled to indicate the expiration date.

v) On 03/22/16, at 11:42 a.m., an interview with Infection Prevention Manager (IPM) #10 was conducted. S/he stated the IPMs did not have policies or a specific checklist to monitor infection control in the kitchen. S/he would review Sodexo policies and trust the employees of the kitchen followed these policies. IPM #10 further stated s/he was present for the annual inspection with Safety Manager (SM) #13, and relied on SM #13 to conduct follow-ups if any issues were present.

vi) On 03/22/16 1:40 p.m., an interview with SM #13 was conducted. S/he provided an Annual Inspection Environment Tour checklist for the St. Anthony Hospital Patient Nutrition and Kitchen on 02/10/16 and 02/11/15. The inspections both noted concerns of food storage, expired food items, and food items not labeled. SM #13 stated s/he expected the contracted kitchen staff to handle the concerns. S/he further stated these were typical findings and a revisit or re-inspection was not warranted.

viii) An interview with Director of Quality (DQ) #2 was conducted 03/22/16 at 11:26 a.m. S/he stated the facility did not conduct any monitoring of the kitchen contracted company, Sodexo, by the quality department. (Cross Reference 0749)

Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.13, PATIENT'S RIGHTS, was out of compliance.

A-0144 - Standard: The patient has the right to receive care in a safe setting. The facility failed to ensure patient safety by neglecting to verify medications and supplies stored in code blue carts were immediately available and safe for patient use. Further, the facility failed to ensure staff had immediate access to patients who were locked in a patient care room. The failure created the potential for emergency equipment and medications needed for emergency situations to be unavailable. This failure also created a potential delay in accessing patients who were in a locked patient care room.

A-0168 - Standard: The use of restraint or seclusion must be in accordance with the order of a physician or other licensed independent practitioner who is responsible for the care of the patient as specified under §481.12(c) and authorized to order restraint or seclusion by hospital policy in accordance with State law. The facility failed to ensure an order was obtained from a physician or Licensed Independent Practitioner (LIP) prior to the initiation of physical restraints. The failure created the potential for an unsafe patient care environment in which the responsible attending physicians or practitioners were not aware of patients' medical needs and current health status.

Based on observations, interviews, and document review, the facility failed to ensure patient safety by neglecting to verify medications and supplies stored in code blue carts were immediately available and safe for patient use. Further, the facility failed to ensure staff had immediate access to patients who were locked in a patient care room.

This failure created the potential for emergency equipment and medications needed for emergency situations to be unavailable. This failure also created a potential delay in accessing patients who were in a locked patient care room.

FINDINGS:

POLICY

According to Code Blue Cart Maintenance, the equipment on the outside of the cart, and the integrity of the locks, will be checked once daily by designated unit associates.

1. The facility did not conduct routine equipment and lock safety checks on code blue carts.

a) On 03/07/16 at 11:07 a.m., a tour of the 4th floor medical surgical unit was conducted with the Director of Acute Care Services (Director #33). Director #33 confirmed there were 2 code blue carts located on the unit and that the charge nurse was responsible for conducting a daily assessment of the equipment and lock and documenting its completion on the checklist located on each cart. Observation of the Code Blue Cart and Supplies Checklist for each code blue cart on the unit revealed the following dates were missing documentation that a checklist had been completed:

Code Cart A was missing documentation on 03/02/16 and 03/06/16.
Code Cart B was missing documentation on 03/02/16.

b) Document review of the February 2016 Code Blue Cart and Supplies Checklist for both code carts located on the 4th floor medical surgical unit revealed both code blue carts were missing documentation that a check had been completed on 02/29/16.

c) On 03/10/16 at 10:49 a.m., an interview was conducted with the 4th Floor Charge Nurse (RN #20). RN #20 described the process of performing a daily check on the code blue carts, which included checking for expiration dates and running a safety test on the defibrillator on the carts. RN #20 explained it was important to check code carts daily to ensure the equipment, supplies and medications were working and not expired if needed in an emergency situation. RN #20 recalled working on one of the days documentation was missing and stated s/he probably had forgotten to document that a checklist had been completed.

2. The facility did not ensure immediate access was available to patients and family members located in a locked patient care room.

a) On 03/09/16 at 10:00 a.m., a tour of the Infusion Clinic was conducted with a Registered Nurse employed at the clinic (RN #34). Observation of the patient care rooms revealed the door to access Exam Room #1 was locked. RN #34 stated Patient #39 and his/her spouse were currently inside Exam Room #1. RN #34 stated a copy of the key to Exam Room #1 was stored in the unit.

b) On 03/09/16 at 10:10 a.m., an interview with the Director of Acute Care Services (Director #33) was conducted. Director #33 stated the facility's expectation would be to not have patients receiving care in a locked room.

Based on interviews and document review, the facility failed to ensure an order was obtained from a physician or Licensed Independent Practitioner (LIP) prior to the initiation of physical restraints in 4 of 15 medical records reviewed of patients with documented use of physical restraints (Patient's #1, #12, #16, and #35).

This failure created the potential for an unsafe patient care environment in which the responsible attending physicians or practitioners were not aware of patients' medical needs and current health status.

FINDINGS:

POLICY

According to Restraint: Non-Behavioral, each episode of restraint or seclusion requires an order by a physician or other LIP primarily responsible for the patient's ongoing care. If LIP responsible for the care of the patient is not available to initiate the order, qualified staff may initiate restraint based on assessment but notify a practitioner immediately, within a few minutes to obtain a telephone or verbal order. The order for restraint must be time-limited, not to extend past midnight the next calendar day.

According to Behavioral Restraint or Seclusion, each episode of restraint or seclusion requires an order by a LIP or clinical psychologist, who is primarily responsible for the patient's ongoing care. If the LIP or psychologist who is responsible for the care of the patient is not available to initiate an order, qualified staff may initiate restraint based on assessment. The qualified staff member will notify a practitioner immediately, within a few minutes, to obtain a telephone or verbal order. Behavioral restraint and seclusion orders may be renewed for a maximum of 24 consecutive hours.

1. The facility did not ensure restraint orders were obtained prior to or immediately after placing patients in physical restraints.

a) Electronic medical records of 15 patients with documented use of physical restraints were reviewed with the Nurse Manager of Clinical Informatics (Registered Nurse, RN #18), the Nurse Clinical Informatics Coordinator (RN #19), and the Regulatory Program Manager (Manager #22). The following discrepancies were revealed:

i) Review of the Patient's Plan of Care, dated 02/27/16, revealed Patient #1 was in non-behavioral physical restraints on 02/27/16 at 8:00 p.m.; however, there was no order for restraints until 02/28/16 at 7:48 a.m. (11 hours and 48 minutes after the restraints had been initiated). This was in contrast to the policy which stated to notify a practitioner immediately, within a few minutes, to obtain an order.

ii) Review of the Emergency Department (ED) Transfer Report, dated 09/18/15, revealed Patient #12 was placed in behavioral soft wrist and soft ankle physical restraints on 09/18/15 at 7:05 a.m., leather restraints at 7:20 a.m., and a chest restraint at 7:25 a.m.; however, there was no order for any type of physical restraint.

iii) Review of the Discharge Summary, dated 12/02/15 to 12/05/15, revealed Patient #16 was placed in non-behavioral soft wrist restraints on 12/02/15 at 8:00 p.m. Non-behavioral restraint assessments were documented every two hours from 12/02/15 at 8:00 p.m. to 12/05/15 at 2:00 p.m.

Review of the Patient Order Summary for Patient #16 revealed non-behavioral restraint orders on 12/02/15 at 7:33 p.m., 12/03/15 at 9:25 a.m., and 12/05/15 at 2:57 p.m. There was no documentation a restraint order was obtained on 12/04/15 or on 12/05/15 prior to 2:57 p.m. This was in contrast to the policy which stated restraint orders must be time-limited, not to extend past midnight the next calendar day.

iv) Review of the Discharge Summary, dated 02/11/16, revealed Patient #35 was placed in non-behavioral soft limb restraints at 10:08 p.m. Non-behavioral restraint assessments were documented every two hours from 02/11/16 at 10:08 p.m. until they were discontinued on 02/12/16 at 3:57 p.m. There was no documentation an order for physical restraints was received.

b) On 03/10/16 at 10:49 a.m., an interview was conducted with the 4th Floor Charge Nurse (RN #20) who stated the facility's expectation was for staff to obtain a doctor's order within the hour of initiation of physical restraints.

c) On 03/09/16 at 3:10 p.m., an interview was conducted with the Psychology Assessment Manager (Manager #5) who stated it would never be acceptable to implement physical restraints without obtaining an order before or immediately after initiation. Manager #5 explained s/he conducted monthly audits of medical records to assess whether or not orders were obtained for patients receiving physical restraints in the Emergency Department (ED). If there were restraint orders missing, Manager #5 stated s/he would discuss the issue with the appropriate practitioner. Manager #5 then stated any findings or trends from the audit would be communicated verbally to the Medical Director of the ED.

d) On 03/09/16 at 3:10 p.m., an interview was conducted with the Medical Director of the ED (Physician #21) who confirmed the facility's expectation was to have a physician order for any restraints implemented. Physician #21 stated s/he was aware of trends of missing physician orders for restraints and there was room for improvement with the issue.

Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.21, QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT PROGRAM, was out of compliance.

A-0308 - Standard: QAPI Governing Body - The hospital's governing body must ensure that the program reflects the complexity of the hospital's organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement). The governing body failed to ensure all departments and services of the hospital, including clinical care provided under contracted or arranged services, were monitored by the quality program. The failure resulted in opportunities that affect health outcomes, patient safety, and quality of care to be overlooked by the quality department and governing body and resulted in an increased risk of negative patient outcomes.

Based on interviews and document reviews, the facility's governing body failed to ensure all departments and services of the hospital, including clinical care provided under contracted or arranged services, were monitored by the facility's quality program.

The failure resulted in opportunities that affect health outcomes, patient safety, and quality of care were overlooked by the quality department and governing body and resulted in an increased risk of negative patient outcomes.

Findings:

1. The facility's governing body failed to ensure the quality department monitored all departments and services and demonstrated evidence of an ongoing Quality Assessment and Performance Improvement (QAPI) program related to all contracted services.

a) The Director of Quality (DQ #2) was interviewed on 03/22/16 at 11:25 a.m. DQ #2 provided copies of the Board of Trustees Meetings for meetings held on 02/11/16, 12/10/15, 10/08/15, and 08/13/15. Review of the Board of Trustees Meeting records from these meetings showed no evidence of discussion or approval of data, collection frequency, or details for quality monitoring and indicators for contracted services the hospital received from outside parties. Further, the documents did not show improvement actions were recommended or evaluated for all contracted services.

During that same interview, DQ #2 stated getting quality data from contracted services had been a struggle for the facility, and the quality department did not monitor up to fifty percent of contracted services that provided clinical care in the facility. DQ #2 stated s/he spoke with hospital leadership after the start of the survey to get additional resources for monitoring contracted services so the facility could monitor 100% of the clinical care contracted services the facility used.

Specifically, DQ #2 stated the quality department did not monitor or have a Quality Assessment Performance Improvement (QAPI) project for the contracted service that provided kitchen staff and all patient meals for the facility. S/he stated the facility had only been monitoring patient satisfaction surveys, which indicated how patients felt about the food choices that were offered at the facility.

The interview with DQ #2 also revealed the following examples of clinical contracts which were not monitored by the facility:

- Stryker Orthopaedics- provided implanted medical products for patient use.
- Martti Translation Services - used for patient interpreter services in the hospital.
- Hill-Rom - provided call lights, beds, and other equipment used for patient care.
- Gown & Gloves Surgical Assisting - provided surgical supplies used for patient care.
- G.E. Medical Systems - provided medical equipment used for patient care.

b) An interview was conducted with the Chief Financial Officer (CFO #8) on 03/22/16 at 3:27 p.m. CFO #8 stated s/he reported to the Chief Executive Officer and attended the majority of the Governing Body meetings. CFO #8 stated s/he did not recall quality monitoring for contracted services being discussed at Governing Body meetings, and s/he believed the facility was not monitoring all contracted services because the facility did not have an all encompassing list of contracted services that the hospital used. CFO #8 stated the Governing Board had been informed that all contracted services related to clinical care provided under contract or arrangement needed to be monitored for quality once it was discovered after the start of the survey.
c) The failure to monitor kitchen contracted services resulted in the facility having no standard process for labeling, monitoring and disposing of expired food items and created the potential for patients to receive food that was expired and unsafe.

According to the Sodexo Food Product Shelf-Life Guideline, spices are shelf stable for 6 months, frozen solid muscle meat is shelf stable in freezer for up to 6 months and 3 to 4 days in refrigerator storage, and cream cheese is shelf stable for 2 weeks in refrigerator storage.

i) During a tour of the kitchen on 03/08/16, at 8:15 a.m., Executive Chef (EC) #1 was interviewed. S/he stated the date on produce was the date the box was received. Staff were trained to go by sight and smell and to check with EC #1 before produce was discarded.

EC #1 stated the kitchen staff followed the Sodexo Food Product Shelf-Life Guideline. According to EC #1, spices were usable for 1 year if opened, frozen marinated meat remained good for 1 year, and cream cheese was considered appropriate to use up to 6 months. These statements were in contrast to the Sodexo guidelines noted above.

ii) An interview with Cook #27 was conducted on 03/09/16, at 10:10 a.m. S/he explained the dates on produce boxes were the use-by dates and produce was not to be used past the date on the label. This was in contrast to the statements provided by EC #1. Cook #27 reported working in the kitchen for 8 years.

iii) An interview was conducted on 03/10/16, at 09:09 a.m., with Food/Dietetic Director (FDD) #25. FDD #25 stated frontline staff were trained to go by sight, smell, and feel to determine produce freshness. Produce should have been discarded within 2 days of being cut, and the produce box should have been dated with the date it was cut.

Further contradicting the interview with EC #1 and Cook #28, FDD #25 stated, frontline staff should have been trained to know the date on produce was the day the produce was cut. S/he further stated food received that was not labeled should be set aside and the vender should be notified for clarification.

iv) A tour of the facility's kitchen was conducted on 03/08/16, at 8:15 a.m., with EC #1 and FDD # 25. The following concerns were noted:

Expired items present in the kitchen included: a box of celery labeled 01/30, a box of leeks labeled 02/13, an opened box of lettuce labeled 03/02, a bag of chopped red onions labeled 02/27, a bag of chopped and peeled eggplant labeled 02/13, pepper spice labeled 06/2010, and marinated pork in freezer labeled 05/14.

5 - 3 pound tubs of cream cheese not labeled to indicate the expiration date.

v) On 03/22/16, at 11:42 a.m., an interview with Infection Prevention Manager (IPM) #10 was conducted. S/he stated the IPMs did not have policies or a specific checklist to monitor infection control in the kitchen. S/he would review Sodexo policies and trust the employees of the kitchen followed these policies. IPM #10 further stated s/he was present for the annual inspection with Safety Manager (SM) #13, and relied on SM #13 to conduct follow-ups if any issues were present.

vi) On 03/22/16 1:40 p.m., an interview with SM #13 was conducted. S/he provided an Annual Inspection Environment Tour checklist for the St. Anthony Hospital Patient Nutrition and Kitchen on 02/10/16 and 02/11/15. The inspections both noted concerns of food storage, expired food items, and food items not labeled. SM #13 stated s/he expected the contracted kitchen staff to handle the concerns. S/he further stated these were typical findings and a revisit or re-inspection was not warranted.

viii) An interview with Director of Quality (DQ) #2 was conducted 03/22/16 at 11:26 a.m. S/he stated the facility did not conduct any monitoring of the kitchen contracted company, Sodexo, by the quality department. (Cross Reference 0749)

Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.23, NURSING SERVICES was out of compliance.

A-0386 - Standard: Organization - The hospital must have a well-organized service with a plan of administrative authority and delineation of responsibilities for patient care. The director of the nursing service must be a licensed registered nurse. He or she is responsible for the operation of the service, including determining the types and numbers of nursing personnel and staff necessary to provide nursing care for all areas of the hospital. Hospital A provided nursing services to Hospital B when needed for difficult intravenous (IV) access and emergency services. This failure created the potential for delays in patient care and poor patient outcomes. Further, this organization of nursing staff allowed Registered Nurses (RNs) of Hospital A access to treat patients admitted to Hospital B.

A-0395 - Standard: A registered nurse must supervise and evaluate the nursing care for each patient. The facility failed to ensure nursing staff monitored patients after they received high alert intravenous medications and provided patient monitoring when patients were transported outside the ED. This failure created an unsafe patient care environment in which the patient's physiological needs and the patient's response to interventions were not properly monitored.

A-0409 - Standard: Blood transfusions and intravenous medications must be administered in accordance with State law and approved medical staff policies and procedures. The facility failed to ensure nursing staff reassessed a patient after the patient received a high alert cardiac medication that warranted additional nursing assessments. The failure created an unsafe patient care environment in which the patient's physiological needs and the patient's response to interventions were not properly assessed.

Based on interviews and document reviews, the facility (identified as Hospital A) provided nursing services for a separately certified hospital (Hospital B) while the employees concurrently provided services at Hospital A. Specifically, Hospital A employees would respond to Hospital B for patients with difficult intravenous (IV) access and for the provision of emergency services while scheduled and working at Hospital A.

This failure created the potential for delays in patient care and poor patient outcomes. Further, this organization of nursing staff allowed Registered Nurses (RNs) from Hospital A access to treat patients admitted to a separately certified hospital, Hospital B.

FINDINGS

POLICY

According to Hospital B's Code Blue policy, Flight for Life staff is to respond to Code Blues unless concurrently responding to a neonatal emergency at Hospital A. Designated staff on the Hospital A/Hospital B Campus will respond to a Code Blue through an overhead page.

1. Hospital A nursing staff responded to emergency services for Hospital B while concurrently working at Hospital A.

a) Review of Hospital B's Rapid Response Team Records, dated 07/14/15 through 02/08/16, revealed 4 of 5 records where Hospital A's House Supervisor (Registered Nurse) responded to a rapid response at the separately certified Hospital B.

Additionally, 3 of 5 rapid response records, for the same time frame, showed the Resource Registered Nurse (RN) from Hospital A responded and assisted with rapid responses and 2 of 5 records showed critical care RNs from Hospital A responded to and assisted with rapid responses at Hospital B while working at Hospital A. As example,

- On 08/03/15 at 3:17 p.m., RN #48 responded to and assisted with a rapid response in Hospital B. Additionally, noted on the record a House Supervisor for Hospital A responded and assisted with the same rapid response.

- On 08/30/15, at 6:57 a.m., RN Administrator #46 and RN #47 responded and assisted with a Code Blue called at Hospital B.

- On 11/06/15, at 4:39 p.m., RN Administrator #46 responded and assisted with a patient having symptoms of a stroke at Hospital B. Also, noted on the record as responding and assisting was a Critical Care RN from Hospital A.

- On 02/08/16, at 6:20 p.m., RN #47 responded and assisted with a rapid response called at Hospital B.

b) An interview with a Clinical Lead (RN C) employed at Hospital B was conducted on 03/15/16, at 12:29 p.m. S/he stated a Resource RN, a House Supervisor, and a Critical Care RN from Hospital A were notified and trained to respond to rapid responses and code blues at Hospital B. RN C stated emergency alerts were paged overhead at both Hospital A and Hospital B and the response team from Hospital A was notified via page for emergencies at Hospital B.

c) An interview with Resource RN #37 on 03/21/16 at 1:33 p.m., and a separate interview with Resource RN #38 on 03/22/16, at 1:00 p.m., revealed that part of Hospital A's orientation included how to respond and assist with Hospital B's emergencies and how to be a resource RN for Hospital B. Hospital B did not provide an orientation for RN #37 or RN #38.

Further, RN #37 and RN #38 stated their employee badge issued by Hospital A provided them access to both Hospital A and the separately certified Hospital B. Both RNs reported they did not report time spent at Hospital B and were never trained to do so. Any services provided for Hospital A and Hospital B were documented together on Hospital A's Resource Nurse Daily Log.

d) On 03/22/16 at 2:10 p.m., Critical Care RN #14 stated Charge RNs working at Hospital A responded to and assisted with rapid responses and codes called at Hospital B. S/he stated Hospital A's initial code responder training included responding to Hospital B's emergent situations. RN #14 stated s/he was not oriented at Hospital B; however, orientation of Hospital A included a tour of Hospital B. Further, s/he stated a rapid response kit containing emergency drugs from Hospital A would be taken and could be used during patient emergencies at Hospital B.

e) On 03/22/16 at 10:00 a.m., an interview the with Administrative Manager (RN #36) was conducted. S/he stated emergency alerts for Hospital B were announced over the speaker system at Hospital A as well as an alert that came over RN #36's pager, provided by Hospital A.

S/he stated part of Hospital A's training was to acknowledge that Hospital B would require Hospital A's nursing services during patient emergent events. RN #36 did not keep track of the time s/he provided services at Hospital B while concurrently working at Hospital A.

f) On 03/15/16, at 3:30 p.m., an interview with Emergency Telephone Operator (ETO) #40 revealed s/he was contacted via phone when Hospital B needed an emergency response. ETO #40 was provided slides of instructions to follow for emergent situations at both Hospital A and Hospital B.

ETO #40 provided the 12 emergent situations and the instructions s/he had been provided for Hospital B. Eleven out of 12 slides instructed ETO #40 to contact staff from Hospital A and have them respond in the event of an emergency in Hospital B.

The list of Hospital A's staff, who were to respond to patient emergencies in Hospital B, included Hospital A's Administrative RN, Hospital A's Code BLUE group, Hospital A's notification group, Hospital A's Code RED group, and Hospital A's Rapid Response Team.

g) During an interview on 03/21/16 at 9:15 a.m., the Vice President of Patient Care Services of Hospital B (VP B) stated Flight for Life RNs (Resource RNs) employed at Hospital A responded to rapid responses and code blues within Hospital B. S/he further stated rapid responses and code blues for Hospital B were announced overhead at both Hospital A and Hospital B.

2. Hospital A nursing staff provided nursing services to Hospital B while simultaneously working for Hospital A.

a) During an interview with RN C, on 03/15/16, at 12:29 p.m., s/he reported Resource RNs employed by Hospital A were trained to help Hospital B (the separately certified hospital) where ever it was needed, including with patients who had difficult venous access for IV placement and blood draws.

b) An interview with Resource RN #37 on 03/21/16 at 1:33 p.m., and a separate interview with Resource RN #38 on 03/22/16, at 1:00 p.m., revealed part of Hospital A's orientation included how to assist Hospital B with patients who had difficult IV access.

Hospital B did not provide an orientation for RN #37 or RN #38. RN #37 and RN #38 stated the employee badge issued by Hospital A provided them access to both Hospital A and Hospital B. Both RNs reported they did not report time spent at Hospital B and were never trained to do so. Any services provided for Hospital B, while working a shift at Hospital A, were documented together on the Resource Nurse Daily Log.

c) Review of Hospital A's Resource Nurse Daily Log, dated 02/01/16 through 03/21/16, showed multiple instances of Registered Nurses providing services at Hospital B while working at Hospital A. As example,

- On 03/08/16, the Resource RN reported to room 364 in Hospital B to assist with a blood draw.
- On 03/05/16, Hospital A's Resource RN reported to Hospital B to start an IV in room 380.
- On 02/26/16, Hospital A's Resource Nurse Daily Log revealed the day shift resource RN reported to Hospital B for an IV start.
-On 02/25/16, the day shift Resource RN for Hospital A reported to Hospital B for 2 IV starts in rooms 352 and 386.

A review of 49 days of Hospital A's Resource Nurse Daily Log revealed 20 examples when Hospital A's Resource RN reported to Hospital B for RN resource services.

Based on interviews and document review, the facility failed to ensure nursing staff monitored patients after they received high alert intravenous medications and provided patient monitoring when patients were transported outside the ED in 1 of 9 ED records reviewed (Patient #15).

This failure created an unsafe patient care environment in which the patient's physiological needs and the patient's response to interventions were not properly monitored.

FINDINGS:

POLICY

According to Patient Transport, prior to transport a nursing assessment is completed to determine the skill level required for patient transport. Nursing (RN) must accompany during transport when the patient is determined to be unstable.

REFERENCE

According to the Intravenous Medication Reference Chart located in the medication room in the Emergency Room, when Hydralazine Hydrochloride is given intravenously (IV) it is recommended to get a blood pressure and heart rate before administration and every 5 minutes for the first 15 minutes after administration and another 15 minutes with each dose. It is required for the patient to be on a cardiac monitor with registered nurse (RN) supervision on transport.

1. Nursing staff did not assess the patient to determine if s/he was clinically stable to transport to nuclear medicine and magnetic resonance imaging (MRI) without Registered Nurse (RN) supervision.

a) Medical record review of the Emergency Department (ED) Report revealed Patient #15 presented to the ED on 02/20/16 with a chief complaint of a syncopal (fainting) episode and severe back pain. In addition, the ED Report revealed Patient #15's blood pressure was 231/106 at 8:45 a.m. (an ideal blood pressure is below 120/80).

According to the Medication Discharge Summary Report, Patient #15 received 10 milligrams (mg) of Intravenous (IV) Hydralazine (a high alert cardiac IV medication used to decrease blood pressure) at 9:05 a.m. Patient #15 was then transferred to the nuclear medicine department at 9:08 a.m. (3 minutes later). No nursing assessment or vital signs were documented to determine if the patient was unstable and needed to be accompanied by a RN during transport, in accordance with facility policy.

The next documented blood pressure was 193/58 at 10:38 a.m. (1 hour and 53 minutes after the hydralazine was administered). This was in contrast to the reference used by the facility which stated to assess blood pressures every 5 minutes for the first 15 minutes after administration and another 15 minutes with each dose.

According to the ED Transfer Report, at 11:30 a.m., Patient #15 was subsequently sent to the MRI department, as documented by the patient's RN (RN #31), and returned to the ED with a MRI technician at 12:22 p.m. without being accompanied by a RN and on a cardiac monitor.

Documentation from RN #39 on the Code Blue Record revealed the MRI technician told another RN on the unit to come and look at the patient because the patient's family member was concerned and stated the patient didn't look well. Documentation noted the patient was cold, unconscious, and with blue lips which resulted in the immediate initiation of a code blue response and chest compressions at 12:22 p.m. Patient #15 was admitted to the intensive care unit at 2:35 p.m. and was later pronounced dead at 11:06 p.m. on 02/20/16.

b) On 03/22/16 at 1:18 p.m., an interview was conducted with Radiology Technologist #12 (Rad Tech) who explained the decision for a RN to escort patients to imaging services was up to the nursing staff assigned to the patient. Rad Tech #12 stated the expectation was for the nurse to escort a patient to MRI if the patient required cardiac monitoring. S/he stated that during a MRI scan, a patient's blood pressure and oxygen saturation level would be monitored only if a RN accompanied the patient.

c) On 03/22/16 at 11:25 a.m., an interview was conducted with ED RN #31 who recalled caring for Patient #15 on 02/20/16. S/he explained the usual responsibilities of a RN when transporting a patient off of the ED unit and stated it would depend on the patient's destination. Imaging transport staff would check with the RN and tell him/her when the patient would leave and when the patient would return to the unit. If a patient required frequent vital signs or the use of a cardiac monitor, a RN would escort the patient off the unit.

RN #31 confirmed s/he did not escort the patient to either test or place a cardiac monitor on Patient #15 before s/he was transferred off the ED unit on 02/20/16. RN #31 stated s/he did not "feel" Patient #15 needed to be on a cardiac monitor or have a RN escort to the nuclear medicine and MRI department because the patient had been alert and fully able to converse with staff and knew about his/her care prior to leaving the ED unit.

This was in contrast to the facility's reference which stated to use a cardiac monitor and nursing supervision after administering IV Hydralazine. RN #31 reported s/he was not familiar with the facility's reference chart pertaining to administering high alert medications.

d) On 03/10/16 at 4:44 p.m., an interview was conducted with the ED RN Manager (RN #7). During the interview, documents were requested and received regarding guidance nursing staff were expected to use during the administration of high alert IV medications. The documents included the Intravenous Medication Reference Chart, which stated it was required for the patient to be on a cardiac monitor with registered nurse (RN) supervision during transport.

e) On 03/22/15 at 4:15 p.m. an interview was conducted with the Chief Nursing Officer (CNO #15) who stated the expectation was for staff to follow policies pertaining to transport of patients off of the patient care unit.

Based on interviews and document review, the facility failed to ensure nursing staff reassessed a patient after the patient received a high alert cardiac medication that warranted additional nursing assessments in 1 of 9 emergency department (ED) records reviewed (Patient #15).

This failure created an unsafe patient care environment in which the patient's physiological needs and the patient's response to interventions were not properly assessed.

FINDINGS:

POLICY

According to Medication Administration, Monitoring and Documentation, Clinicians who administer medications should have the following information available and be knowledgeable about: Potential harmful effects of the drug, Technique for administration, and assessments.

With medication monitoring, assess for and address side effects, intolerances and adverse drug reactions. In particular, monitor the patient's response to the first dose of a new medication.

REFERENCE

According to the Intravenous Medication Reference Chart located in the medication room in the Emergency room, when Hydralazine Hydrochloride is given intravenously (IV) it is recommended to get a blood pressure and heart rate before administration and every 5 minutes for the first 15 minutes after administration and another 15 minutes after. It is required for the patient to be on a cardiac monitor with registered nurse (RN) supervision on transport.

1. The Registered Nurse (RN) did not perform an assessment and reassessment of the patient's blood pressure after administration of IV Hydralazine according to facility approved policy and guidelines.

a) Medical record review of the Emergency Department (ED) Report revealed Patient #15 presented to the ED on 02/20/16 with a chief complaint of a syncopal (fainting) episode and severe back pain. In addition, the ED Report revealed Patient #15's blood pressure was 231/106 at 8:45 a.m. (an ideal blood pressure is below 120/80).

According to the Medication Discharge Summary Report, Patient #15 received 10 milligrams (mg) of Intravenous (IV) Hydralazine (a high alert cardiac IV medication used to decrease blood pressure) at 9:05 a.m. Patient #15 was then transferred to the nuclear medicine department at 9:08 a.m. (3 minutes later). No nursing assessment or vital signs were documented after the administration of the Hydralazine and prior to the patient leaving the ED.

The next documented blood pressure was 193/58 at 10:38 a.m. (1 hour and 33 minutes after the hydralazine was administered). This was in contrast to the reference used by the facility which stated to assess blood pressures every 5 minutes for the first 15 minutes after administration and another 15 minutes with each dose.

b) On 03/22/16 at 11:25 a.m., an interview was conducted with Emergency Department (ED) Registered Nurse (RN) #31 who stated, when administering cardiac high-alert medications, s/he would stay in the room with the patient to see if the medication was working correctly. In addition, s/he would keep the patient on a cardiac monitor so s/he could assess the patient from the nurses' station. RN #31 stated s/he would monitor the patient to assess for an unsafe drop in blood pressure.

During the same interview, a medical record review was conducted for Patient #15. RN #31 confirmed s/he took care of Patient #15 on 02/20/16 and the patient had a blood pressure of 231/106 at 8:45 a.m. RN #31 also stated s/he administered Hydralazine at 9:05 a.m. and that no subsequent blood pressures were taken until 10:38 a.m.

RN #31 stated s/he did not "feel" Patient #15 needed to be on a cardiac monitor or have a RN escort to nuclear medicine because the patient had been alert and fully able to converse with staff and knew about his/her care prior to leaving the ED unit. RN #31 stated s/he was not sure if there was a specific policy regarding administration and assessment of high alert IV medications. After reviewing the facility's reference chart regarding IV Hydralazine administration and assessment, RN #31 stated s/he would usually stay with patients and assess their vital signs every 5 to 10 minutes after administering IV Hydralazine.

c) On 03/10/16 at 4:25 p.m., an interview was conducted with ED RN #6 who reported when administering IV Hydralazine, s/he would reassess the patient's blood pressure within 5 minutes after administration and would expect the patient to be put on a cardiac monitor.

d) On 3/22/16 at 2:42 p.m., an interview was conducted with the ED Physician (Physician #35) who explained the facility's expectation would be for the nurse to monitor the blood pressure frequently if a patient had a blood pressure of 231/106 and received IV Hydralazine in an attempt to lower the blood pressure.

e) On 03/22/16 at 4:15 p.m., an interview was conducted with the Chief Nursing Officer (CNO #15), who stated the expectation for IV medications was to use resources available such as guidelines, policies and the pharmacy department.

Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.24, MEDICAL RECORD SERVICES, was out of compliance.

A-0441 - Standard: The hospital must have a procedure for ensuring the confidentiality of patient records. The facility allowed staff to access, process, and store medical records containing Protected Health Information (PHI) from a separately certified facility in their medical records department. The failure allowed unauthorized staff to access medical records and PHI from a separately certified facility.

Based on interviews and document review, the facility allowed staff and other individuals to access, process, and store medical records containing Protected Health Information (PHI) from a separately certified facility in their medical records department.

This failure allowed unauthorized individuals to access medical records and PHI from a separately certified facility.

FINDINGS:

POLICY

According to Storage, Retention, and Destruction of Medical Records, medical records shall be maintained and their contents protected against loss, defacement, tampering, use by unauthorized individuals, and damage due to fire and or water.

1. Health Information Management (HIM) staff from the facility (Hospital A) were allowed access to process and store medical records from a separately certified facility (Hospital B).

a) On 03/07/16 at 11:50 a.m., a tour of the medical records department was conducted with the HIM Manager (Manager #24). The sign to the entrance of the medical records department showed Hospital A/Hospital B Medical Records, Hours: 8:00 a.m. - 4:00 p.m. Inside the department a bookshelf was observed filled with medical records from patients at Hospital B. Manager #24 confirmed that the medical records on the bookshelf were from patients of Hospital B. S/he stated the medical records department at Hospital A would regularly process, store, and monitor medical records from Hospital B.

A follow up interview was conducted with Manager #24 on 03/10/16 at 9:08 a.m. who revealed Hospital A contracted medical record scanning, maintenance and storage services to Hospital B. Manager #24 stated s/he and approximately 6 employees would work with medical records from Hospital B. Manager #24 further stated s/he was not employed with Hospital B and had not signed a contract or agreement permitting access to medical records from Hospital B.

b) On 03/15/16 at 11:19 a.m., an interview was conducted with a HIM front desk staff member (Employee #32) who confirmed s/he was employed with Hospital A. Employee #32 explained that his/her job responsibilities included printing out medical records and distributing them to patients from Hospital A and Hospital B upon request. Employee #32 further stated patients from both Hospital A and Hospital B would enter the medical records department to request copies of their medical records.

c) On 03/14/16 at 2:35 p.m., an interview was conducted with a HIM Technician (Tech #29) who confirmed s/he was an employee of Hospital A. Tech #29 stated his/her main job responsibilities involved scanning and processing medical records of patients from Hospital B. Tech #29 explained that s/he would perform duties related to the processing of medical records from Hospital B at his/her desk located in Hospital A. S/he added that occasionally, if there was extra time and help was needed, s/he would help with Hospital A's medical record processing.

d) On 03/21/16 at 2:20 p.m., an interview was conducted with a HIM Technician (Tech #26) who stated s/he was an employee of Hospital A. Tech #26 explained if needed s/he would go to Hospital B to help process medical records during his/her shift at Hospital A. Tech #26 further stated s/he had access to Hospital B and their medical records although s/he had never received orientation or signed a confidentiality agreement to access PHI with Hospital B.

e) On 03/21/16 at 2:45 p.m., an interview was conducted with a HIM Technician (Tech #28) who confirmed s/he was an employee of Hospital A. Tech #28 stated s/he was able to gain access to locked areas within Hospital B using his/her identification badge from Hospital A in order to help process their medical records. Tech #28 further stated s/he had received training from the manager of Hospital A on processing medical records for Hospital B and had never had a formal employee orientation at Hospital B.

f) Review of a contract, dated 06/15/10, between Hospital A and Hospital B included the following documentation:

The services to be provided by Hospital A shall include associates from the following departments: Clinical Information Management: process all records for completion; notify physicians of record completion; scan records to Meditech; process transcription; complete release of information/records requests; provide access to records upon request.

g) On 03/22/16 at 3:37 p.m., an interview was conducted with the Chief Financial Officer (CFO #8) who revealed the agreement between Hospital A and Hospital B had been created when Hospital A had opened. CFO #8 further stated the issue of comingling medical records services with Hospital B was never considered to be a concern warranting discussion with the Governing Body.

Based on the onsite validation survey, completed March 15 through March 17, 2016, the facility failed to comply with the regulations set forth for Life Safety and, therefore, deficiencies were cited under Life Safety Code tags K0018, K0025, K0029, K0038, K0050, K0052, K0062, K0067, K0070, K0072, K0130, K0147 (on building A2), K0052, K0062, K0146 (on building A3), K0029, K0052, K-0062, K-0146 (on building A4)
See survey ID0X21 for details pertaining to each deficiency.

Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.42, INFECTION CONTROL, was out of compliance.

A-0749 - Standard: The infection control officer or officers must develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel. The facility failed to maintain appropriate infection control processes in the areas of food storage and intravenous (IV) fluid storage. This failure created the potential for patients to experience illness secondary to the exposure to food borne pathogens if unlabeled food or expired/unsafely prepared food was served to patients. Further, this failure created the potential for patients to receive previously spiked IV fluids past the expiration; potentially exposing them to microbial growth in the fluid and increasing the risk of hospital acquired infections.

Based on observations, interviews, and document review the facility failed to maintain appropriate infection control processes in the areas of food storage and intravenous (IV) fluid storage.

This failure created the potential for patients to experience illness secondary to the exposure of food borne pathogens if unlabeled food or expired and unsafely prepared food was served to patients. Further, this failure created the potential for patients to receive previously spiked IV fluids past the expiration; potentially exposing them to microbial growth in the fluid and increasing the risk of hospital acquired infections.

POLICY

According to Patient Food Provided by Outside Sources, food bought from home should follow the guidelines: If more than one serving is brought, put the unused portion in a container, label with the date, patient's name, and room number; and place in the patient refrigerator. Nursing and Food and Nutrition Services staff will check the patient refrigerator daily and throw away food that is not labeled or dated.

According to Food and Nutrition Nourishment Kitchens, on a daily basis, perishable food items will be inspected and rotated. Expired, out-of-date, opened or uncovered, unlabeled and improperly stored items will be discarded. The Food Service employee will inspect and rotate nonperishable foods and floor stock weekly. All outdated, expired, unlabeled or improperly labeled and improperly stored items and items not for patient use will be discarded. Temperatures of patient refrigerators are recorded daily by the food and nutrition staff. All patient food will be stored according to policy.

According to Refrigerators: Maintaining, all items placed in patient food refrigerators are to be labeled with the patient's name, room number and date. Patient food refrigerator temperatures must be checked daily and the results charted.

According to Medication Labels, any time one or more medication or solutions are prepared but are not administered immediately, the medication container must be labeled. At a minimum, all medications prepared in the hospital are labeled with: drug name, strength, amount, expiration date and time, and the date prepared.

According to Medication Labeling in Procedural Areas, medications or other solutions that are not immediately administered must be labeled. This applies even if there is only one medication being used. This policy applies to medication and solutions in peri-operative and other procedural settings, on and off the sterile field including pre-procedure areas.

REFERENCES

According to the Sodexo Food Product Shelf-Life Guideline, spices are shelf stable for 6 months, frozen solid muscle meat is shelf stable in freezer for up to 6 months and 3 to 4 days in refrigerator storage, and cream cheese is shelf stable for 2 weeks in refrigerator storage.

1. The facility's kitchen failed to ensure food intended for patients was labeled to indicate the expiration date. Further, the kitchen failed to ensure food intended for patients was stored in a manner to avoid contamination.

a) During a tour of the kitchen on 03/08/16, at 8:15 a.m., Executive Chef (EC) #1 was interviewed. S/he stated the date on produce was the date the box was received. Staff were trained to go by sight and smell and to check with EC #1 before produce was discarded. EC #1 stated the kitchen staff followed the Sodexo Food Product Shelf-Life Guideline.

According to EC #1, spices were usable for 1 year if opened, frozen marinated meat remained good for 1 year, and cream cheese was considered appropriate to use up to 6 months. These statements were in contrast to the Sodexo guidelines noted above.

EC #1 further stated his/her expectation was frozen meat should not have been stored above or with frozen bread. S/he went on to state staff had gotten lazy when retrieving goods from the freezer and did not put items back in the correct location.

b) An interview with Cook #27 was conducted 03/09/16, at 10:10 a.m. S/he explained the dates on produce boxes were the use-by dates and produce was not to be used past the date on the label. This was in contrast to the statements provided by EC #1. Cook #27 reported working in the kitchen for 8 years.

c) An interview was conducted 03/10/16, at 09:09 a.m., with Food/Dietetic Director (FDD) #25. FDD #25 stated the frontline staff were trained to go by sight, smell, and feel to determine produce freshness. Produce should have been discarded within 2 days of being cut, and the produce box should have been dated with the date it was cut. Further contradicting the interview with EC #1 and Cook #28, FDD #25 stated, frontline staff should have been trained to know the date on produce was the day the produce was cut.

S/he further stated marinated meat should not have been in the freezer, this was a mistake. FDD #25 went on to say food received that was not labeled should be set aside and the vender should be notified for clarification. S/he stated frozen meat should not have been stored with frozen bread products.

d) A tour of the facility's kitchen was conducted on 03/08/16, at 8:15 a.m., with EC #1 and FDD # 25. The following concerns were noted:

i) Expired items present in the kitchen included: a box of celery labeled 01/30, a box of leeks labeled 02/13, an opened box of lettuce labeled 03/2, a bag of chopped red onions labeled 02/27, a bag of chopped and peeled eggplant labeled 02/13, pepper spice labeled 06/2010, and marinated pork in freezer labeled 05/14.

ii) 5- 3 pound tubs of cream cheese not labeled to indicate the expiration date.

iii) Frozen beef patties stored above an open box of frozen pizza crust. Frozen pie crust in open plastic wrap stored on the same pan and touching frozen meat.

e) On 03/22/16, at 11:42 a.m., an interview with Infection Prevention Manager (IPM) #10 was conducted. S/he stated the IPMs did not have policies or a specific checklist to monitor the infection control of the kitchen. S/he would review Sodexo policies and trust the employees of the kitchen followed these policies. IPM #10 further stated s/he was present for the annual inspection with Safety Manager (SM) #13, and relied on SM #13 to conduct follow-ups if any issues were present.

f) On 03/22/16 1:40 p.m., an interview with SM #13 was conducted. S/he provided an Annual Inspection Environment Tour checklist for the St. Anthony Hospital Patient Nutrition and Kitchen on 02/10/16 and 02/11/15. The inspections both noted concerns of food storage, expired food items, and food items not labeled. The response from the kitchen noted completed or addressed on each inspection deficit. No further correction detail was noted in the report. SM #13 stated s/he expected the contracted kitchen staff to handle the concerns. S/he further stated these were typical findings and a revisit or re-inspection was not warranted.

g) An interview with Director of Quality (DQ) #2 was conducted 03/22/16 at 11:26 a.m. S/he stated the facility did not conduct any monitoring of the kitchen contracted company, Sodexo, by the quality department.

2. The facility failed to ensure food in patient areas was labeled and stored appropriately ensuring patients were not served expired or contaminated goods.

a) During a tour of the nourishment room in the Trauma and Cardiac Intensive Care Unit (ICU) on 03/07/16, at 9:41 a.m., 2 boxes of chicken bouillon were observed not labeled with an expiration date. During the same tour, the freezer in the cardiac ICU nourishment room was noted to have ice cream with a patient label, but no label indicating the expiration date was noted.

b) On 03/07/16, at 3:45 p.m., a tour of the infusion center was conducted. The temperature logs for the nourishment refrigerator and freezer revealed the last date the temperature was recorded was 02/24/16, 12 days earlier. Ten days from the month of February were missing temperature record data. In addition, 4 raspberry jell-o containers labeled with an expiration date of 02/27/16 were noted in refrigerator.

c) An interview with Registered Nurse #30 was conducted 03/07/16, at 3:45 p.m. RN #30 stated s/he was never told to monitor the refrigerator or freezer temperature. RN #30 further stated s/he was unaware of a policy pertaining to monitoring the refrigerator temperatures.

d) An interview with IPM #10, on 03/10/16 at 11:43 a.m., revealed the food and nutrition department should monitor the food and temperatures of refrigerators on outpatient units daily if the unit was opened. S/he further stated this was everyone's responsibility. IMP #10 stated any out-dated or un-dated food should have been discarded; food from outside sources needed to be labeled with patient name, date, and room number and discarded 3 days from when the items were received. IPM #10 stated s/he expected staff to follow the facility's policies.

e) On 03/21/16, at 1:40 p.m., an interview with SM #13 was conducted. S/he stated if food was not labeled it needed to be thrown out. Labels on patient food brought from outside of the hospital needed to include date, name, and room number. SM #13 stated s/he expected the temperatures to be recorded every day outpatient units were open.

3. The facility failed to ensure the prevention of hospital acquired infections through proper preparation and labeling of IV medication and fluid.

a) During a tour of the pre-operative area on 03/07/16, at 10:00 a.m., three 500 milliliter (ml) bags of Lactated Ringers (LR) and one 500ml bag of normal saline (NS) were observed to have been spiked with IV tubing and primed. No label was observed on any of the bags of fluid which indicated when they were spiked and the expiration date and time.

b) An interview with RN #17 was conducted at 10:04 a.m., on 03/07/16. RN #17 stated s/he thought this was acceptable practice as pre-operative patients had standing orders for fluid. S/he was unaware of a policy related to pre-spiking IV fluids.

c) On 03/07/16, at 10:10 a.m., an interview with Director of Operating Room (DOR) #16 revealed pre-spiking IV fluids was an unacceptable practice. S/he expected staff to follow the medication labeling policies.

d) During an interview on 03/10/16, at 11:43 a.m., IPM #10 stated it was not acceptable for IV fluids to be pre-spiked with no label. IPM #10 expected staff to follow the policy.

e) On 03/22/16, at 4:15 p.m., an interview with Chief Nursing Officer (CNO) #15 revealed s/he expected staff to follow facility policy.