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The Condition is not met as evidenced by: the Governing Body failed to ensure that daily operations of this hospital (Hospital A) in an effective safe and organized manner and failed to ensure:

1. The Governing Body failed to assure, while Hospital A and Hospital B (a separately licensed hospital) shared the same address, each hospital was distinct and separate. Hospital A was providing common services to their patients with Hospital B at the same site. The Governing Body failed to provide distinct and separate Hospital Code Services specific for each hospital. (A-075)

2. The Governing Body failed to assure Hospital A had staff dedicated to serve Hospital A and did not simultaneously serve both Hospital A and B at the same time including: Surgical service staffing for Operating rooms for Hospital A and Hospital B, Operating room Nurse director, Peri Operative and Outpatient Nurse Director, Supervisor of Radiology, and the Supervisor of Sterile processing department were not separate for Hospital A and Hospital B. (A-0386, A-0941)

3. The Governing Body failed to provide contracted services in a safe manner. The Governing Body failed to oversee and evaluate contracted services to assure contracted services were delivered in a safe and effective manner. The Governing Body failed to assure there were ongoing Quality assurance projects monitoring contracted services including: Dietary services, Sterile Central Processing, Laboratory services and Radiologic services. (A-084)

4. The Governing Body failed to assure there was a full time director of food and nutrition. The Governing Body failed to assure the Stand by Kitchen used in Hospital A had the necessary equipment. The Governing Body failed to assure Dietary contracted services were monitored and services were provided in a safe and sanitary environment. (A-0618)

5. The Governing Body failed to assure there was a Chief Nursing Officer (CNO) assigned to oversee and coordinate Nursing services for Hospital A. (A-0386)

6. The Governing Body failed to assure Laboratory services were provided in a safe manner and the contracted laboratory services provided by Hospital B were overseen and evaluated regularly by Hospital A. (A-0582)

7. Governing Body failed to Coordinate and oversee hospital wide infection control program including: Implement an infection control program that followed acceptable standards of practice, coordinate and oversee hospital wide infection control program. The Governing Body failed to implement an infection control program that followed acceptable standards of practice in monitoring Dietary Services, and that dietary servives were provided in a safe and sanitary manner. The Governing Body failed to provide and maintain a sanitary environment for surgical services. The Governing Body failed to monitor and assure Sterile Processing Department Services, that daily biological testing, was done with each sterilized load and daily controls were completed. Maintain a sterile Operating Room environment and failed to assure medical staff documented HepB (Hepatitis B, a disease that affects the liver) status. (A-0747).

8. The Governing Body failed to assure Surgical Services were provided in a Sanitary and Sterile environment. The Governing Body failed to monitor and oversee Sterile Processing Department services including assuring daily biological testing. (A-0951)

Based on observation, interview, and document review, the standard is not met as evidenced by:

1. The Governing Body failed to assure Hospital A had distinct and separate emergency code responses from Hospital B.
2. The Governing Body failed to provide separate nursing staff directors overseeing surgical services at Hospital A, independent of Hospital B.

These deficient practices had the potential of effecting the facilities ability to react to emergency situations and provide quality care to patients

Findings

1. During a review of a facility document titled 'CPR Code Blue/ Code White', dated 10/5/08, the document indicated that the Hospital B Code Blue TEAM would respond to Adult codes in Hospital A, Hospital B and MRI (Magnetic Resonance Imaging, part of radiological services). A review of the same document indicated that Hospital A's Neonatal Code White Team responded to all Neonatal Code Whites in both Hospital A and Hospital B. Hospital A's Pediatric Code White Team responded to all Pediatric code Whites in both Hospital A and Hospital B.

During an interview with Medical Doctor 11 (MD 11) and Administrator 7 (Admin 7) on 4/3/19 at 9:50 AM, both stated that the daily schedule of staff assignment for Hospital A Code Teams and Hospital A Rapid Response Team are made from staff working at Hospital A.

2. On 4/9/19 at 9:45 AM, during an interview with the Director of Nursing of Operating Rooms (DON of OR), the DON of OR stated that her assignment and the assignment of the following employees was for both Hospital A and Hospital B. During the current shift at the time of the interview, (DON of OR) indicated she was covering both Hospital A and Hospital B. During a concurrent interview, Registered Nurse 16 (RN 16) indicated she was director of Outpatient surgery and pre and post surgery care for both Hospital A and Hospital B. During the same concurrent interview, the Director of the Sterile Processing Department of (SPD) stated that she was the Director of SPD for Both Hospital A and Hospital B. During the same concurrent interview, RN 17 stated he was DON for the Birth Center (BC), as well as the Director of the Gastrointestinal Laboratory at Hospital B. SPD Tech 2 indicated she was SPD lead tech for Both Hospital A and Hospital B. During another concurrent interview, the SPD Tech Supervisor stated that the SPD staff were scheduled to cover both Hospital A and Hospital B.

A review of a facility document titled 'Pediatric Surgical Preparation Area', dated 4/1/2019, indicated, "The surgical Prep area is part of the Surgical Pavilion department, all staffing, flexing, and support comes from Hospital B. Staffing is combined between Hospital A and Hospital B Surgical Pavilion to meet the population needs".

A review of a facility document titled, Amendment#8 to agreement, Section 1. Organizational Structure, Section 1.3 General cooperation, [Hospital A] and [Hospital B] shall "cooperate promptly and efficiently in order to satisfy requirements related to hospital functions maintained by [Hospital A] and [Hospital B]..."

The Governing Body failed to assure Hospital A had distinct and separate code responses from Hospital B. The Governing Body failed to assure the staffing to meet the surgical services needs in Hospital A was not staff that were also assigned the same duty and responsibility, simultanously, in Hospital B.

Based on observation, interview, and record review, the Governing Body failed to oversee and assure contracted services were delivered in a safe and effective manner. The Governing Body failed to perform Quality Assessment Performance Improvement (QAPI) projects to monitor safety and effectiveness of the contracted services. The Governing Body failed to provided regular monitoring, assessment and tracking of any contracted services including: dietary services, Sterile Central Processing, Laboratory services, and Radiological services.

These deficient practice had the potential for the facility to not recognize possible deficient practices and not developing corrective actions for identified deficient practices.

Findings:

During a review of the facility contracts and contract list on 4/3/19 at 11:30 am, Administrator 7 (Admin 7) indicated contracts for Basic Hospital services for Hospital A were through contracts with Hospital B.

A review of a Contract for for Laboratory services titled 'Amendment #6, [Hospital A] Laboratory Purchased Services", indicated [Hospital A] purchased Laboratory services from [Hospital B] and the contract was renewed every three years from 9/1/2018 to 8/31/2021..." There was no documentation of any yearly evaluations of the contracted services by Hospital A. There were no documents of quality assurance projects or monitoring of the contracted services available for review

A review of a Contract titled "Amendment #5 radiology Purchased Services Agreement, indicated Hospital A purchased radiological services from hospital B and the contract was renewed every three years from 9/1/2018 to 8/31/2021.There was no documentation of any yearly evaluations of the contracted services by Hospital A. There were no documents of quality assurance projects or monitoring of the contracted services .

A review of the document titled Agreement #8, indicated that Hospital B provided Basic Hospital services through a purchase agreement contract to Hospital A, including the following Basic Hospital Services: Dietary Services, Central Plant services, Financial Management, Human resources, Central Sterile Supply, Biomedical Services, Medical waste management, Radiology services, Laboratory services, and Pharmacy services.

A review of the Purchase agreement contract for Central Sterile Supply, indicated "Hospital B shall supply Hospital A with sufficient sterile supplies and medical and surgical equipment, including without limitation, autoclaves, sterilizers. Hospital B shall be responsible for rotation of supplies, provide decontamination, sterile processing, sterile storage and delivery. Hospital B shall maintain all equipment in operating condition at all times and shall conduct all required checks and tests." There was no documentation of any yearly evaluations of Central Supply contracted services by Hospital A. There were no documents of quality assurance projects or monitoring of the contracted services including Sterile storage, decontamination and sterile processing contracted services available for review.

A review of a document titled "Purchased service agreement", undated, Section III Authority Responsibility and Accountability 3.2, indicated Hospital A evaluation assessment and QAPI of the purchased services contracted services shall be submitted to Hospital A by Hospital B for quarterly evaluation. There was no documentation that Hospital A was conducting quartely evaluations on contracted services. No ongoing evaluation by Hospital A of any of the listed contracted services were provided for review.

On 4/9/19 at 3:40 PM, when asked for the QAPI Evaluation and tracking oversight of the contracts and the evaluation of the contracted services for Hospital A, Administrator 8 (Admin 8) indicated there were none. There was no documentation provided to review the oversight assessment and the monitoring of contracted serviced including: dietary services, Sterile Central Processing, Laboratory services, and Radiological services. There was a lack of evidence that the Governing Body had regularly monitored, assessed, and tracked any contracted services including: dietary services, Sterile Central Processing, Laboratory services, and Radiological services

A review of a facility document, titled Agreement #8 Section I Organizational structure, indicated "[Hospital B] is the Corporation owning [Hospital A] and [Hospital B]. The document also indicated the Corporation oversees and is responsible for purchased service contracting for [Hospital A]."

The Governing Body failed to oversee, and assure regular QAPI studies and monitoring of the contracted services were complete and available for review and assure contracted services were delivered in a safe and effective manner.

Based on observation, interview and record review, the facility failed to meet the Condition of Participation for Nursing Services by failing to:

1. Ensure Hospital A's Director of Nurses (DON) was not DON of Hospital B at same time and both Hospitals were independent general acute care hospitals on the same campus (Refer to A-0386).

2. Ensure facility staff followed manufacturer's instruction to perform glucometer quality control testing (Refer to A-0392).

3. Ensure the job description for Registered Nurses clearly indicated their work location (Refer to A-0395).

The cumulative effects of these systemic problems resulted in the facility's inability to meet the patients needs.

Based on observation, interview and record review, the facility's Director of Nurses (DON) was in charge of two (2) independent general acute care hospitals on the same campus.

Findings:

On April 2, 2019, at 9 a.m., after the entrance conference, the facility provided a copy of the Executive Organizational Structure as of 2/18/19, which indicated the Chief Nursing Officer 1 (CNO 1) was the CNO for hospitals A and B. The Executive Organizational Structure as of 4/2/19, indicated there were different positions that are under CNO 1. For example: the Vice President (VP) for Patient Care Services for Hospital A reports to CNO 1.

During an interview with CNO 1 at the entrance conference, CNO 1 stated that CNO 1 was responsible for Hospitals A and B.

A review of Nurse Executive's personnel file indicated the Nurse Executive signed their job description and Human Resources Director signed on 5/28/2018. The position title is Vice President, Patient Care Services for Hospital A, the Department was Nursing Administration and Reporting Relationships to Chief Operating Officer for Hospital B. The Nurse Executive was Responsible for patient care quality, budgetary oversight and operations relate to the clinical/administrative management of Pediatric, ICU, Neonatal ICU, Hematology/Oncology, General Pediatrics, Transport Program, Jonathan Jasques Children's Cancer Care Center, Palliative Care and Child Life.

A review of the Position Description, signed and dated 4/2/19, by Nurse Executive, Reporting Official and Human Resource Director. The position title was Vice President, Patient Care Services, the Department was Nursing Administration, the Facility was Hospital A and Reporting Relationships were to the CNO for Hospital B. The Nurse Executive for Hospital A, has overall responsibility and accountability for patient care, safety and quality, budgetary oversight and operations related to clinical/administrative management of the facility.

During an interview with Nurse Executive on April 5, 2019 at 10:30 a.m., Nurse Executive stated they were hired on July 16, 2015 as Vice President for Patient Services. CNO 1 was responsible for Hospital A and B, the Nurse Executive reports to CNO 1. CNO 1 makes decisions for Hospitals A and B. the Nurse Executive stated that they signed a new job description as Nurse Executive but not Chief Nurse Executive for Hospital A.

Review of the Nurse Executive's personnel file indicated there was no performance evaluation after six (6) months being in the job. An interview with the Senior Human Resources, while reviewing the personnel file, the Senior Human Resources stated that management personnel had to have a performance evaluation after six (6) months of being in the position.

Based on observation, interview and record review, the facility staff failed to follow Manufacturer's instruction when performing quality control testing for the facility glucometer.

This deficient practice had the potential for obtaining an inaccurate blood sugar level and providing incorrect medication to patients.

Findings:

On April 3, 2019, at 10:45 a.m., during an observation of Glucometer Quality Control monitoring demonstration by Registered Nurse 6 (RN 6), the following was observed:

The Glucometer (Nova StatStrip) was the brand the facility uses. RN 6 took a glucometer test strip and inserted it into the test port and then turned the meter on. RN 6 took the Level 1 solution bottle, shook the vial and placed a drop of Level 1 solution onto the test strip. The Level 1 solution test result was 54 mg/dl (parameter was 44 to 74). RN 6 than took Level 3 solution bottle, shook the vial and placed a drop of the Level 3 solution onto the test strip. The Level 3 solution test result was 305 mg/dl (parameter was 250 to 350). RN 6 stated the glucometer is cleaned with sani wipe cloth after each use.

A review of the Manufacturer's recommendation on quality control testing indicated the following:
--- Gently mix the StatStrip Glucose Control Solution before each use.
--- Discard the first drop of control solution from the bottle to avoid contamination.

During an interview with the Clinical Lab Specialist (CLS), the CLS was made aware of the RN 6's failure to follow the instruction when performing the quality control testing.

A review of RN 6's personnel file indicated that a competency evaluation for Glucometer (NovaStatStrip) testing was performed on May 14, 2018. Also RN 6's personnel file did not have a current job description as Clinical Nurse IV.

Based on interview and record review, the facility failed to ensure job descriptions for four (4) registered nurses (RNs) clearly indicated their work location.

This deficient practice had the potential for the work location to be unclear and possible sharing of nursing services.

Findings:

On 4/4/19 at 2:37 PM, during a concurrent interview and review of the personnel files, the Director of Professional Nursing stated that the job descriptions in the files were for both hospitals, and that human resources was shared by both Hospital A and Hospital B.

Concurrently, the administrative staff, stated that human resources from the Hospital B was combined with Hospital A.

a. The job description for RN 2, dated 11/27/18, indicated RN 2 worked in the Pediatric Acute Department. The job description also contained the names of three locations, marked with an "x", in the square corresponding to each location. The locations included the Hospital A and Hospital B.

b. RN 4 was hired on 2/13/07. The job description was not marked as to which hospital RN 4 worked at, whether it be Hospital A or Hospital B.

c. RN 3 was hired on 6/28/99. The job description dated 10/31/17 indicated RN 3 worked in the Post Surgical Care Unit (PSCU). The job description also contained the names of three locations, marked with an "x" in the square corresponding to each location. The locations included Hospital A, and Hospital B.

d. RN 1 was hired on 1/20/05. The job description, dated 9/2/12, indicated RN 1 worked in the Obstetrics Acute Department. The job description was not marked as to which hospital RN 1 worked at, whether it be Hospital A or Hospital B.

Based on interview and record review, the hospital failed to ensure the records of sterile (germ-free) compounding process (a process of making sterile medications) contained all the elements required by its policies and current standards of practice. The missing elements included but not limited to: the preparation date, time, and the beyond use dates (BUD, expiration dates which describe when the medications should no longer be dispensed, administered, or stored) which could be determined or limited by the preparation time. This deficient practice had the potential for incomplete records for quality control or quality assurance purposes, as well as potential negative patient outcome if compounded products were assigned inaccurate beyond use dates.

Findings:

On 4/3/2019 at 10:45 a.m. during a tour of the pharmacy department, the pharmacy had a cleanroom for the sterile compounding process. The pharmacy also had a segregated compounding area located outside of the cleanroom that was "separated" from the rest of the pharmacy area by a green demarcation line on the floor. The executive director of pharmacy (EDOP) indicated the glove box (a laminar airflow glovebox/isolator and a type of compounding aseptic isolator that was designed to provide a germ-free environment within the isolator throughout the compounding process) in the segregated compounding area was primarily used for compounding the first dose of new orders during the cleanroom downtime; downtime included such as scheduled cleaning during the night shift. When requested, a pharmacist presented the compounding log for the glovebox. The compounding log indicated there were six (6) production labels for six (6) different intravenous (IV) medications, each for a different patient, compounded on 4/2/2019.

During a concurrent review and interview, the EDOP confirmed that four (4) out of six (6) aforementioned labels, or compounding records, were overlapping. The labels were placed in a way that the "date and time prepared" and "expires" areas were covered up. The hospital pharmacists on duty were not able to verify that such information had been documented. Furthermore, the "date and time prepared" and "expires" areas for one of the remaining two labels were blank. During a concurrent interview, both the EDOP and the IV pharmacist acknowledged that the sterile compounding records were not consistently documented.

Based on observation and interview, the hospital failed to ensure outdated or expired sterile (germ-free, preservative free) water for injection and/or diluent use would be removed and not available from the floor stock in a medication room of a nursing unit.

This deficient practice had the potential for affecting the safety or health of the patients due to outdated injectable solutions may or may not be at risk for contamination.

Findings:

On 4/3/2019 at around 2:30 p.m. during an inspection of the medication storage room located on the third floor with the executive director of pharmacy (EDOP) and the unit supervisor, there was a countertop area next to the sink. On top of the counter, there was a clear plastic bucket containing vials of sterile water for injection. A closer look at those sterile water vials in the bucket revealed two vials had expiration dates of "1APR2018" printed on the vials.

During a concurrent interview, the EDOP confirmed those expired vials should have been removed from stock.

A review of the hospital policy and procedure, Floor Stock Inspection, revised in 11/2018, indicated " ... All patient care areas ... will be inspected for expired ... products."

Based on observation, interview and record review , the facility failed to meet the Condition of Participation for Laboratory Services by failing to:

1. The facility failed to have written documentation of a contract with Hospital B to meet the patients needs for laboratory services. (Refer to A582)

The cumulative effects of the systemic problems may result in the facility's inability to meet the patients laboratory needs.

Based on observation, interview and record review, the facility failed to have a contract with Hospital A to meet the patients needs for laboratory services.
This deficient practice had the potential of the facility being unable to meet the needs of patients.

Findings:

On April 4, 2019, at 10 a.m., during a tour of the laboratory area with the Director of Pathology was conducted.

During an interview with Director of Pathology, the Director of Pathology stated that the laboratory staff was shared by Hospital A and B. The Director of Pathology further stated that all venipuncture in Hospital A was conducted by the Hospital B's laboratory staff. The Hospital B's licensed nurses performed blood draw from the heplock or intravenous line of patients in NICU (neonatal intensive care unit) and PICU (pediatric intensive care unit).

Based on observations, interviews and record reviews, the hospital failed to:

1. Ensure that Hospital A had a full time Director of Food and Nutrition Services to manage the day to day operations of the department, maintain safe food handling practices and participate in performance improvement activities that addressed the deficient and non-compliant practices in the department.

Hospital A and Hospital B share the same physical space for their kitchen. There was only one full time Food and Nutrition Services Director who shares the responsibility of managing the Food and Nutrition Department between the two hospitals. Also, there was lack of adequate oversight when the Clinical Nutrition Manager, who shares responsibility between the two hospitals, relied on the Patient Services Manager in the kitchen to communicate patient needs. In addition, Hospital A failed to ensure, through lack of oversight, that the contracted Hospital B's Food and Nutrition Department maintain safe food handling practices. This occurred when Time and Temperature Control for Safety foods (TCS foods are foods capable of supporting bacterial growth that can result in food borne illness when not safely stored and prepared) were not maintained at temperatures of 41 degrees Fahrenheit or below. Additionally, contracted Hospital B's kitchen was unsanitary, there was a cockroach that was dying by the ice machine area. These deficient practices resulted in Hospital A not providing independent oversight that can potentially place patients, staff and visitors at risk for food borne illness, and lack of food and water during disaster and emergency. (Refer to A-0619, A-0749).

2. Ensure that Hospital A had the equipment necessary in the designated Stand by kitchen to provide food to patients, staff and visitors in the event of an emergency, when meal delivery will not be available through Hospital B. In addition, the three (3) day disaster food and supply was not secured on the premise of Hospital A. Also, the hospital failed to ensure that the adequacy of disaster food supplies was in accordance with the planned disaster menu. This resulted in the inability of Hospital A to ensure that it had the capability to independently provide all food and nutrition services including during disasters and emergency's to its patients, staff and visitors, without contracting from Hospital B. (Refer to A-0619).

3. Ensure that the contracted Hospital B providing food, maintained dietetic services equipment per manufactures guidance. The reach-in refrigerator did not maintain proper temperatures for food storage. Improper storage of TCS foods can result in the growth of microorganism that can cause food borne illness. The ice machine had mineral deposits, orange color rust and corrosion inside the bin where ice is stored. These deficient practices had the potential to cross-contaminate food and put 182 patients, staff and visitors at risk for food borne illness (Refer to A-0749).

The cumulative effect of these systemic problems resulted in the inability of the hospitals food and nutrition department to direct and staff in such a manner to ensure that the nutritional needs of the patients were met in accordance with acceptable standards of practice. The system problems resulted in the hospitals inability to meet the Condition of Participation for Food and Dietetic Services

Based on observation, interviews and record reviews, Hospital A failed to ensure effective oversight of the Food and Nutrition Services when Hospital A did not have a full time Director of Food and Nutrition Services to maintain sanitary conditions in the department and the Clinical Nutrition Manager, who also shared responsibilities between Hospital B and Hospital A, relied on the Patient Services Manager to communicate the needs of the department. This oversight failure also resulted in not maintaining the hospitals' stand by kitchen with food and equipment that was necessary to provide food to patients during an emergency situation and there was not enough water to meet the needs of patients, staff and visitors of the hospital. In addition, there was a lack of performance improvement activities that addressed the deficient and non-compliant practices in the department. A lack of activities that reflected the scope and nature of the food and nutrition services and that identified opportunities for improvement.
These failures resulted in continued deficient practices that put patients, staff and visitors at risk for food borne illness and inability to access food and water during an emergency situation. (Cross refer A-0749)

Findings:

1. During a tour of the kitchen on April 2, 2019, at 10:00 AM, the reach-in refrigerator had an internal thermometer temperature of 50 degrees Fahrenheit. During a concurrent observation and interview with Director of Food and Nutrition Services (DFNS) and patient services manager (PSM) they did not know why the temperature of the refrigerator was elevated.

There were three medium size pans of chicken salad with preparation date of 3/31/19 and use by date of 4/3/19, one medium pan of egg salad with preparation date of 4/2/19 and use by date of 4/5/19, three medium size pans of tuna salad with preparation date of 3/31/19 and use by date of 4/3/19, sliced ham and turkey. Patient services Manager (PSM) stated those salads are for sandwiches for alternates and also for salad plates. A temperature check of the tuna salad, chicken salad, egg salad and ham with the PSM and surveyor's thermometer the observed foods registered a temperature of 46 degrees Fahrenheit.

During a concurrent observation and interview the Director of Food and Nutrition Services for Hospital B did not know when the refrigerator started having problems and stated it had not been reported. The PSM did not know if those salads were used for sandwiches. The PSM stated that hospital policy is to hold cold foods at 40 degrees Fahrenheit and these salads will be discarded.

During a tour of the kitchen on April 2, 2019, at 12:00 PM, a cockroach that was dying was observed, on its back, next to the ice machine area.

During a concurrent observation and interview with the PSM, the PSM stated she will let the maintenance know about the pest.

During an interview with Executive Chef (EC), the EC stated that he comes early in the morning and has not seen cockroaches and will contact the pest control management company.

During an interview with the DFNS on April 3, 2019 at 9:30 AM, the DFNS stated that the pest control Management Company is in the facility twice a month. The DFNS also stated that he has not seen any cockroaches in the kitchen.

2. During an interview with PSM on April 3, 2019 at 10:00 AM, the PSM stated that she reports to the DFNS of Hospital B and she is an employee of the contracted Food and nutrition Management Company. the PSM's role involves managing the diet clerks who make sure diets ordered are appropriate and to monitor for updates in diet orders, and ensure patient satisfaction of meals. In this role the PSM is the liaison between the Clinical Nutrition Dietitians at Hospital B and Hospital A and the Food and Nutrition Services Department.

The PSM stated that she attends a meeting with the Clinical Nutrition Manager once a month to bring back feedback and communicate identified problems. The PSM also stated that she is working on projects such as taste paneling and conducts daily taste panel of foods served, meal rounding to make sure meals are delivered on time and correctly. The PSM also does spot checks on food temperatures. The PAM added that none of the infection control issues identified during the survey were part of a performance improvement project.

A review of the organizational chart for Food and Nutrition Services indicated the PSM reports to the DFNS for Hospital B, contracted with the food Management Company.

A review of the job description of Patient Services Manager indicated, the position is responsible for maintaining patient meal satisfaction, manages diet office activities, coordinates menu development, works with clinical departments to develop patient needs, ensures compliance with all federal, state and local regulations.

During an interview with Clinical Nutrition Manager (CNM) on April 3, 2019, at 3:06 PM, the CNM stated that she reports to the Executive Director of Pharmacy of Hospital B and Hospital A. The CNM stated that her team reports to hospital administration and not part of the contracted Food and Nutrition Management Company. The CNM also stated that she has a shared responsibility for management of the Clinical Nutrition Department for both hospitals (A and B). The CNM stated that it is challenging to manage both hospital but tries her best to provide equal amount of attention to both hospitals. The CNM added that she does not have any responsibilities in the kitchen and that she relies on the PSM for communication regarding food service department. The CNM also stated that she meets with the PSM only once a month.

During an interview with the CNM on April 9, 2019 at 09:30 AM, the CNM stated that she does not visit kitchen and she wasn't aware of any infection control issues. The CNM added that she relies on the PSM to communicate issues or projects related to Food and Nutrition Department. There was no mechanism for the CNM to identify food safety issues in the kitchen because she doesn't visit the kitchen. The CNM agreed that the meetings between the food and nutrition department and clinical nutrition manager should be more than once a month for comprehensive oversight of the food and nutrition services department.

During an interview with the Director of Food and Nutrition Services (DFNS) on April 4, 2019 at 1:20PM, the DFNS stated that the current position as Director of Food and Nutrition Services for Hospital B, which contracted with the food management Company on 10/2018. The DFNS stated that he is the only Director of Food and Nutrition Services and has shared responsibility for both hospitals A and B. The DFNS added that it is difficult to explain how his time is split between the two hospitals and everything is under one budget. The DFNS added that there is only one kitchen and that the DFNS is responsible for the kitchen that is located at Hospital B. All food procurement, ordering, production, preparation and service is through the kitchen located at Hospital B.

During an interview with the DFNS on April 5, 2019 at 12:00 PM, the DFNS stated that Food and Nutrition Services Department was recently added in the Managing Daily Improvement meeting. The DFNS started attending the meetings about two (2) weeks ago. The DFNS also stated that he does not attend QAPI meetings for the hospital and has not worked with any performance improvement projects. The DFNS stated that the facility does monthly audits and the Patient Services Manager (PSM) conduct daily audits, but have not done long term performance improvement projects. When asked if any of the food safety issues identified during the survey were part of performance improvement project, the DFNS replied that they are not and that he has started a performance improvement project using the survey findings on infection control and food safety as the baseline.

A review of the job description for Director of Food and Nutrition Services indicated that the position monitors and manages inventory, maintains kitchen and storage facilities to meet/exceed sanitary conditions. The DFNS monitors internal quality assurance and food safety audit process, prepares and updates statistical reports to ensure compliance with federal, state, local regulations.

During an observation of the disaster food supply on April 4, 2019 at 12:40 PM, it was observed that the hospitals disaster food supply was located in three different locations, all on Hospital B's premise. One location was the Hospital B's kitchen dry storage area and the other two locations were in the basement of Hospital B. During a review of the disaster menu it was noted that the disaster menu was for children nine (9) months old to 21 years old and adults.

During a concurrent review of the inventory list and disaster plan indicated that total number of population at Hospital A was 967 people and because the hospital is designated as disaster resource center they are prepared to serve a 4 day emergency menu.

During a concurrent interview with Director of Food and Nutrition and Patient Services Manager, both stated that formulas and infant feeding for less than nine (9) month old is managed by the Clinical Nutrition Manager and is stored in the milk lab in Hospital A. No other infant formula location was shared with the surveyor by either the Patient Services Manager or the Director of Food and Nutrition Services during the tour of disaster food and supply locations.

During an observation of the water supply and inventory count on April 4, 2019 at 1:20 PM the hospital had 1000 gallons of water available on campus for both hospitals.

During an interview with Patient Services Manager (PSM) on April 4, 2019 at 1:20 PM, The PSM stated that the facility needed one gallon of water per person per day for four days totaling a need for approximately 4000 gallons of water for four days only for Hospital A. The PSM agreed that the water supply was not enough to serve Hospital A.

During a concurrent interview with the DFNS, the DFNS stated the disaster and emergency inventory is his responsibility and water will be ordered immediately. The DFNS also added that space has been a big problem and it has been a challenge to store supplies for both hospitals in the kitchen and on Hospital B's premise.

During an observation of the infant disaster supply on April 9, 2019 at 10:51 AM, it was observed that the disaster supply for infants was in three locations. The first location was in the milk lab, where ready to use, powdered formulas and milk are stored, the second location was in a storage room adjacent to the main kitchen located in Hospital B and the third location was the central supply room located in Hospital B. During a concurrent interview with Clinical Nutrition Manager (CNM), the CNM stated that she is responsible for the inventory of the infant formulas and supplements. The CNM stated that Milk Lab technicians come down to the kitchen and get the supply of the formulas that they need from the infant disaster supply storage room in the kitchen.

During an observation in the Stand by Kitchen, located on the 2nd floor of Hospital A on April 9, 2019 at 3:00 PM, it was observed that the Stand by Kitchen had a three (3) compartment sink, ice machine and one under counter cabinet. The space was empty with no other equipment, cookware or utensils necessary for food preparation. The space was not emergency and disaster ready.

During a concurrent interview with the DFNS, the DFNS stated there is no food items stored in the Stand By Kitchen. The DFNS also stated that it was his understanding that this space will be utilized if there is an emergency situation and when there is no access to main kitchen located in Hospital B. The DFNS added that emergency food supplies are located in the kitchen dry storage area and the other two locations in the basement of Hospital B.

A review of a correspondence between Hospital Clinical Nutrition Manager and Licensing and Certification dated July 24, 2000 and September 22, 2000, regarding application for approval of alternate methods in dietetic service and stand by kitchen which was submitted by the hospital to request an approval from the licensing and certification for a standby kitchen, indicated, "the hospital will maintain the following equipment in the 2nd floor kitchen area (Stand By Kitchen) in the case the alternate methods in dietetic services is revoked. The hospital stand by kitchen will include Stainless steel kitchen sink, under counter storage, microwave, toaster, rice cooker, 19 cubic foot refrigerator /freezer, induction cooking range, cookware appropriate for induction range top surface, ice/water machine, coffee pot. In addition a 3 day disaster food supply is secured on the premises of Hospital A and will be rotated quarterly."

A review of program flexibility request for alternate dietetic services and stand by kitchen dated 10/18/2000, indicated, "[Hospital A] will add a three compartment sink and steam tables in the second floor pantry for their standby kitchen within 6 months."

A review of hospital policy titled "Activation of Stand-By Kitchen", policy No CN-672 (dated 11/30/2016) indicated, "[Hospital A] maintain designated specific space within the footprint of the hospital to serve as the stand by kitchen to meet the dietary needs of it inpatients at a moment's notice." It also indicates, "Provisions for 7 day non select menu including baby food have been made and can be immediately put into effect. The designated food and supplies will be secured on the premises of [Hospital A]." It further indicates, "All hot foods are served off of a steam table and cold food is stored in refrigerators."

Based on observation, interview and record reviews, the hospital (Hospital A) failed to meet the infection control Condition of Participation as evidenced by:

1. One (1) reach in refrigerator did not maintain safe food storage temperature for TCS (Time and Temperature Control for Safety) foods stored. The temperature of the refrigerator registered at 50 degrees Fahrenheit. The temperature of TCS food checked was at 46 degrees Fahrenheit. (Refer to A-0749)

2. A large container (bin) of expired sunflower seeds and a large container (bin) of expired bread, wrapped in a plastic bag, were stored in the cold food preparation area. A box full of approximately 24 individual milk cartons that were expired were stored in the walk in refrigerator. (Refer to A-0749)

3. The ice machine was not maintained in a sanitary manner to prevent mineralization and corrosion of the ice bin. This deficient practice had the potential to cross-contaminate food and put 182 patients, staff and visitors at risk for food borne illness. (Refer to A-0749)

4. A cockroach, that was on its back dying, was observed near the ice machine area in the kitchen. (Refer to A749)

5. Two (2) large trays of cooked chicken breast were stored in the walk in refrigerator without a cover. One (1) large box of frozen carrots, one (1) box of frozen peas, tortillas and a box of pepperoni were stored in the walk in freezer, open and exposed to freezer air. The improper storage of food can result in decrease quality of food, cross contamination and growth of microorganism that could cause food borne illness. This failure had the potential to effect 182 patients in addition to staff and visitors who consume the food prepared by the hospital. (Refer to A-0749)

6. One (1) bag of whole wheat spaghetti, previously opened and stored in the dry storage area, was not labeled and not monitored for use by date. One (1) large pan of chicken in juice, one (1) deep pan of roast beef and one (1) medium tray of raw, marinated chicken were stored in the reach in refrigerator with no label to identify the product in the trays. Three (3) large trays of tuna and one (1) large pan of bread slurry used for texture modified diet, were stored in the walk-in refrigerator without a label to identify the content of the trays. (Refer to A-0749)

7. Shelving in the dishwashing area, used to store clean pots and pans and dish covers, was observed to be rusted (Refer to A-0749).

8. The sanitizer in the milk lab, including infant feeding preparation room, that was used to sanitize food contact surfaces, was not food safe. This failure had the potential to result in chemical contamination of infant formulas and human breast milk used to feed patients. (Refer to A-0749)

9. The hospitals infection control committee did not identify, report, investigate or control these deficient practices in the food and nutrition services and infant feeding preparation room. (Refer to A-0749)

10. A sterilized pediatric Minor tray had instruments closed, crowded and a white paper bag that contained surgical instruments was placed on top of all the surgical instruments. (Refer to A-0749)

11. Seven (7) clean isolettes were lined up in the hallway in front of the decontamination area. (Refer to A-0749)

12. There was water marker pasted on the wall of the sink in the sterile processing area. (Refer to A-0749)

13. Sinks in different areas in the hospital had mineral deposits around and above the spigot. (Refer to A-0749)

14. Corrugated cardboard boxes were found in the decontamination area and laboratory department. (Refer to A-0749).

15. Relative humidity and chemical indicator results were not documented in the 3M steam sterilizer record keeping log. (Refer to A-0749).

16. A mattress that had tear on top and residual tape on it, was found in the operating room. (Refer to A-0749)

17. Nursing staff failed to label an Intravenous (IV, in the vein) solution for one of 20 sampled patients. (Refer to A-0749)

18. Disinfectant wipes were stored in the room where infant formula was stored. (Refer to A-0749)

19. Hospital staff failed to have documented evidence of having received hepatitis B (A disease that effects the liver) vaccine, PPD (A test used to determine if a person has or has pr is immune to the tuberculosis infection) or signed declination or waiver. (Refer to A-0748)

20. Medical Staff did not have documented Hepatitis B status or waiver in order to provide patient care in a safe and sanitary environment. (Refer to A-0748)

The cumulative effect of these systemic problems resulted in the hospitals inability to ensure the Condition of Participation for Infection control was met.

Based on record review and interview, the facility failed to ensure facility staff had the vaccinations/immunizations required in the provision of car for patients.

This deficient practice had the potential for patients to be exposed to infectious diseases.

Findings:

On April 4, 2019, at 2 p.m., during review of employee health files with the Epidimiology/Infection Nurse, the following was observed:

1. The Nurse Executive had her PPD (purified protein derivative, a test for exposure to tuberculosis) skin test result dated 8/16/2018, the test was read by a licensed vocational nurse.

2. RN 6's Surveillance Profile dated 8/7/09, indicated Hepatitis B Surface Antibody Quantity was S (susceptible). Also the report indicated RN 6 received two (2) Hepatitis B Vaccine series (each) with the next one vaccine due on 8/09/10. During the interview with the Epidimiology/Infection Nurse, while reviewing of health file, there was no further documentation if the vaccination for Hepatitis B was completed and a follow-up titer was drawn.
There was also no written documentation of a History and Physical (H and P) or a PPD skin test in RN 6's health file.

3. SPT 1' s (Sterile Processing Technician) Surveillance Profile dated 4/19/05 indicated Hepatitis B Surface Antibody Quantity was blank. The report indicated SPT 1 received three (3) Hepatitis B Vaccine Series vaccinations and the next vaccination was due 5/11/05. During the interview with the Epidimiology/Infection Control Nurse, while reviewing of health file of SPT 1, there was no further documentation if was the Hepatitis B vaccination series was completed and if a follow-up titer was drawn.
SPT 1's did not have written documentation of a recent Flu vaccination nor a signed declaration to receive the flu vaccine.

4. RN 7's health file did not have written documenting of H and P.

A review of the following facility policies indicated:

a. Influenza Vaccination and Protection Program Reference: HR-361 indicated all employees and other individuals (other than visitors or individuals delivering items at the entrance of an MHS Entity) who are regularly on the premises of an MHS Entity must obtain and provide proof of an influenza vaccination for the current influenza season.

b. indicated Hepatitis B vaccinations are offered free of charge to all employees whose tasks involve occupational exposure of some risk of occupational exposure or some risk of occupational exposure to blood or other potentially infectious material. New applicants will be offered the vaccine series within 10 days of initial assignment. Employees should not receive the vaccine if they provide documentation that they (1) have completed the Hepatitis B vaccination series, (2) are immune to Hepatitis B per antibody test , (3) indicate vaccine is contraindicated or medical reasons or (4) decline the vaccine.

c. Annual Employee Health Surveillance Old Policy/Procedure # : EH - 13.2, indicated the annual health assessment will consist of updating of medical medical history, annual T.B. testing ....

5. On 4/4/19 at 3:08 PM, registered nurse 1's (RN 1) health file was reviewed. There was no documented evidence that RN 1 received the hepatitis B vaccine or signed a declination or waiver.

Concurrently, the Epidemiology/Infection Control Nurse verified there was no documentation of Hepatitis B vaccine or a signed declination. The Epidemiology/Infection Control Nurse stated the vaccine was offered by the facility, if the employee refused the vaccine, they should sign a declination.

On 4/9/19 at 2:54 PM, the Epidemiology/Infection Control Nurse stated that employee's Hepatitis B titers were checked, it they were susceptible, they would be offered the hepatitis B vaccines, otherwise employee could decline the vaccine.

The facility's policy and procedure titled, " Hepatitis B Vaccine Program, Old Policy/Procedure #: EH-13.4 revised date 11/18/15", indicated hepatitis B vaccinations are offered free of charge to all employees whose task involve occupational exposure or some risk of occupational exposure to blood or other potentially infectious materials. New applicants will be offered the vaccine series within 10 days of initial assignment. Employees should not receive the vaccine if they provide documentation that they (1) have completed the hepatitis B vaccine series; (2) are immune to hepatitis B per antibody test results; (3) indicate vaccine is contraindicated; or (4) decline the vaccine.







36206

Based on observation, interview and record reviews, the hospital (Hospital A) failed to develop a system to identify, report, investigate and control unsafe food sanitation practices in the Food and Nutrition Services Department. The facility failed to verify all staff had current and complete health evaluations. The facility failed to verify that surgical instruments were processed to ensure sterility and that all surgical areas complied with industry standards.

The lack of a system to identify, report, investigate and control these unsafe food handling practices in the food and nutrition service, and infant feeding preparation room had the potential to result in food borne illness in a medically vulnerable patients population of 182 patients in addition to staff and visitors who consume the food prepared by the hospital. The failure to follow industry, CDC and AORN guidelines had the potential for increased patient infections.

Findings:

1. During an observation of the kitchen on April 2, 2019, at 10:25 AM the reach in refrigerator (number 7) internal thermometer registered at 50 degrees Fahrenheit.

During a concurrent interview with the Director of Food and Nutrition Services (DFNS) and Patient Services Manager (PSM), both stated that they were not aware of the refrigerator having problems.

There were three (3) medium size pans of chicken salad with a preparation date of 3/31/19 and use by date of 4/3/19, one (1) medium pan of egg salad with preparation date of 4/2/19 and use by date of 4/5/19, three (3) medium size pans of tuna salad with preparation date of 3/31/19 and use by date of 4/3/19, sliced ham and turkey inside the refrigerator. The PSM stated the salads are for sandwiches for alternates and also for salad plates. A temperature check of the tuna salad, chicken salad, egg salad and ham with the PSM's and surveyor's thermometer registered 46 degrees Fahrenheit.

During a concurrent observation and interview the DFNS for Hospital B the DFNS stated they did not know when the refrigerator started having problems and stated it wasn't reported. The PSM stated they did not know if the salads were used for sandwiches. The PSM stated that hospital policy is to hold cold foods at 40 degrees Fahrenheit and the salads will be discarded.

A review of hospital policy titled "Food Storage", Policy No. PC-253 (revised 1/2007) indicated, "There are mechanisms in place to ensure the safe storage of food and non-food products. Perishable foods are kept at optimal temperatures (Dairy products 30-40 degrees Fahrenheit, meats and poultry 38-40 degrees Fahrenheit). "

2. During an observation of the kitchen on April 2, 2019, at 10:23 AM a large bin full of sunflower seeds with open date of 2/11/19 and use by day of 2/14/19 was stored in the cold preparation area.

During a concurrent interview with PSM, The PSM stated that the sunflower seeds are used on salads. The PSM also stated that she didn't know why expired items were stored in the bin.
Another large bin contained bread in plastic bag with open date of 1/31/19 and use by date of 2/14/19 was stored in the cold preparation area.

During a concurrent interview with Executive Chef, the Executive Chef stated this bread is used to make croutons for salads.

During a concurrent interview with The DFNS and the PSM, both stated that the store room clerk is the person who dates and labels food items and that they didn't know if the store room clerk has a system to keep track of the food items.

During an observation of the kitchen on April 2, 2019, at 12:00 PM, a large box that contained approximately 24 individual size milk with expiration date of 3/24/19 was observed.

During a concurrent observation and interview with DFNS and PSM, both stated that box was prepared to be taken up to the nourishment area on hospital patient floors but was never delivered. The PSM stated that expired milk should not be in the walk-in refrigerator and will be discarded.

A review of hospital policy titled "Food storage", Policy No. PC-253 (revised 1/20017) indicated, "Food is labeled and dated, the first date is the day the product /item was prepared or opened and the second date is the expiration of the food when it must be disposed of."

A review of hospital policy title "Food Safety", Policy No.IC-407 (revised 1/2007) indicated, "The department has a comprehensive food safety self-inspection program to monitor adherence to [food and nutrition management company]'s protocols to ensure safe food is served."

A review of the 2017 U.S. Food and Drug Administration Food Code indicated, Time/Temperature control for safety refrigerated food must be consumed, sold or discarded by the expiration date.

3. During an observation of the ice machine on April 3, 2019 at 8:45 AM, the ice machine stored in the kitchen was inspected. The bin that stores ice was made out of metal. There was a significant amount of white colored mineralization on the side and back wall of the ice bin. There was also a spot that looked like corrosion, the spot was orange and looked like rust.

During a concurrent interview and observation with Kitchen Supervisor (KS), the KS stated that he cleans inside the bin once a month. The KS also stated that he had noticed the orange spot and mineralization but they do not go away after cleaning.

During a concurrent interview with DFNS, the DFNS stated that the ice machine is very old. The DFNS added that the ice never reaches the rust area since its high up in the bin because "we use so much ice".

During an interview with System Mechanic II (SM II) on April 3, 2019 at 9:00 AM, the SM II stated that he services the ice machine quarterly then every 6 months, he follows manufacturing guidelines and sanitizes the ice machine. When asked about the rust or corrosion inside the bin where ice is stored, the AM II stated he will be able to remove it today.

During a follow up visit to the kitchen on April 4, 2019 at 1:20 PM the ice machine was checked and the corrosion with orange color that looked like rust was still there.

During a concurrent interview with DFNS, the DFNS stated that he had requested a work order to assess the ice machine.

A review of the 2017 U.S. Food and Drug Administration Food Code (Cleanability 4-202.11) indicated, "Food contact surfaces which have imperfections such as cracks, chips, or pits allow microorganisms to attach and form biofilms. Once established, these biofilms can release pathogens to food. Biofilms are highly resistant to cleaning and sanitizing efforts."

4. During an observation in the kitchen on April 2, 2019 at 12:00 PM, a large cockroach that was on its back, dying, was observed next to the ice machine area. During a concurrent observation and interview with PSM, the PSM stated she will report the cockroach to maintenance.

During an interview and record review on April 3, 2019 at 9:30 AM, the Executive Chef (EC) stated that he contacted the pest control Management Company to come in right away to inspect the area.

During an interview with DFNS, the DFNS stated that he had never seen a cockroach at Hospital B's Kitchen.

A review of the service agreement between Hospital B and the pest control company. dated July 15, 2014 indicated that the pest control company will service the kitchen area twice a month and also will be available on as needed basis as well.

A review of the pest control company's Kitchen Service invoices for March and April indicated no cockroach activities have been noted during routine inspection.

A review of the Hospital Pest control program indicated the pest Control Company services the hospital for pest and vermin. Some cockroach activities have been noted during inspection in different areas of both Hospital B and Hospital A.

A review of hospital policy titled "Pest Control" Policy No.IC-408 (revised 1/204) indicated, "Routine pest control is manage by the department and special, non-routine, treatments are requested through service response center and or arranged by the Food Service director."

5. During an observation in the kitchen on April 2, 2019 at 11:28 AM, there were two large trays of cooked chicken breast with a preparation date of 4/2/19 and cook time of 10:29AM stored in the walk-in refrigerator number 2 without a cover. Both trays were set on a shelved cart, one tray was on the top and was not protected by possible overhead contamination. The other tray was set on the second shelf also uncovered.

During a concurrent observation and interview, the Executive chef (EC) stated they had just cooked it and put in the refrigerator uncovered to facilitate fast cool down. When asked should the trays be covered and he responded "yes". The PSM agreed that trays can be loosely covered to facilitate cool down, but need to be covered to prevent cross contamination.

During an observation in the kitchen on April 2, 2019 at 11:35 AM, one (1) box of frozen peas in bulk, a box of frozen carrots in bulk, a box of pepperoni in bulk and a box of tortillas were noted in the walk-in freezer number 10. The boxes were noted to be open and exposed to the freezer air and other contamination.

During a concurrent interview with Executive chef (EC), the EC stated that the staff had come in and taken the amount needed and left. The EC added that the boxes should be closed tight.

A review of hospital policy title "Food Storage" Policy No.PC-253 (revised 1/2007) indicated, "Bulk foods are stored in metal or plastic containers with tight fitting lids."

A review of the 2017 U.S. Food and Drug Administration Food Code (Preventing Food and ingredient contamination 3-302.11) indicated, "A food shall be protected from cross contamination by storing the food in packages, covered containers, or wrappings."

6. During an observation in the dry storage area on April 2, 2019 at 10:01 AM, a large bag of whole wheat spaghetti that was opened with no label or open date was observed.

During a concurrent interview with the DFNS, the DFNS stated the store room clerk is responsible for dating and labeling.

During a concurrent interview with Store Room Clerk (Clerk 1), Clerk 1 stated that kitchen staff opened the spaghetti to use a portion of it and didn't write the open date on it. Clerk 1 did not know when the product was opened.

During an observation in the kitchen on April 2, 2019 at 11:35 AM, a deep pan of chicken in its cooking juice was stored in the reach in refrigerator number 6. The pan of chicken was dated 4/2/19 -4/5/19 there was no label to identify the product. There was another deep pan of roast beef in the reach in refrigerator with no label to identify the item. In the same reach in refrigerator there was a medium tray of raw marinated chicken dated 4/2/19-4/5/19 with no label to identify the product.

During a concurrent observation and interview the EC agreed that the food items should clearly be labels with product name.

During an observation in the kitchen on April 2, 2019 at 12:00 PM, three large trays of canned tuna, taken out of the cans to drain and cool down was stored in walk-in refrigerator number 3. The trays were dated 3/31/19-4/3/19.

During a concurrent observation and interview with PSM, the PSM agreed that it is difficult to know whether the item is canned chicken or canned tuna.
In the same walk-in refrigerator there was a large and deep tray of a brown item that looked like dough. The tray did not have a label but was dated 4/1/19-4/4/19. The PSM was able to identify the product as bread slurry, used instead of bread for texture modified diets such as puree or soft diets. The PSM verified there were no labels on the tray and stated they should have labels to identify products.

A review of hospital policy titled "Food Storage" Policy No. PC-253 (revised 1/2007) indicated, "All prepared foods are labeled and dated, with the date product/item was prepared or opened, the date of the expiration of the food when it must be disposed of, the name of the product and the purpose of the product."

A review of the 2017 U.S. Food and Drug Administration Food Code indicated, certain foods may be difficult to identify after they are removed from their original packaging. The mistaken use of food from unlabeled containers could result in chemical poisoning or cause allergic reactions. For example, foodborne illness and death have resulted from the use of unlabeled salt, instead of sugar.

7. During an observation of the dish washing room on April 3, 2019 at 10:30 AM, there were three metal wire shelving carts next to the dish washing machine to hold washed, cleaned and dried pots and pans. The racks were rusted, and the original coating was peeled off.

During a concurrent interview with the DFNS verified that the racks that hold cleaned pots and pans were rusty.

According to the 2017 U.S. Food and Drug Administration Food Code, Nonfood-contact surfaces of equipment shall be cleaned at a frequency necessary to preclude accumulation of soil resides. Additionally, nonfood-contact surfaces shall be free of unnecessary ledges, projections, and crevices, and designed and constructed to allow easy cleaning and to facilitate maintenance.

8. During an observation in the Milk Lab on April 3, 2019 at 3:06 PM, the infant formula preparation area was observed. The product used to sanitize the feeding preparation area was observed to be Super Sani-Cloth Germicidal Disposable wipes (purple top). A review of the manufacturer's specifications on the wipes container did not indicate that they were food safe.

During a concurrent interview with the Clinical Nutrition Manger (CNM), the CNM stated that they use a food safe wipe to sanitize the refrigerators that hold the prepared formulas and milk, but hospital infection control committee decided to use the super Sani cloth purple top for the milk and formula preparation counter. The CNM added that the milk lab technicians who prepare infant formulas use the super Sani cloth to wipe the counters.

During an interview with Infection Control Director on April 9, 2019 at 2:30 PM, the Infection Control Director stated that the decision was made to use the super Sani cloth wipe on non-porous surfaces. The Infection Control Director added that it does not touch the milk or formula, also it kills more pathogens. The Infection Control Director further stated that there is no guidance from CDC that state what wipe to use on surfaces with food contact.

A review of the 2017 U.S. Food and Drug Administration Food Code indicated, "Code 7-204.11 Chemical sanitizers, including chemical sanitizing solutions generated on-site, and other chemical antimicrobials applied to food-contact surfaces shall Meet the requirements specified in 40 CFR 180.940 Tolerance exemptions for active and inert ingredients for use in antimicrobial formulations (Food-Contact surface sanitizing solutions)."

9. During an interview with the Hospitals Infection Preventionist on April 9, 2019 at 2:30 PM, the Hospital Infection Preventionist stated that infection control practitioner visits the kitchen twice a year for audit of the Food and Nutrition Department.

A review of the hospitals checklist titled Food service Compliance Rounds, dated 8/10/2018, indicated one (1) of the items investigated was food prepared in operation was covered, dated, and labels prior to storage in refrigerators. Even though there were concerns with labeling, this had not been identified as a deficient practice during infection control rounds. Another item that was identified during Infection control rounds was rust on the drying racks. This deficient practice was not monitored or controlled since there continued to be rust on drying racks.

10. On April 3, 2019, at 3:40 p.m., during opening of a sterilized Pediatric Minor Tray with the surgical administrative staff members, surgical instruments that were observed in the metal tray, such as hinged instruments on a stringer, the jaws were closed, instruments were crowded, on top of each other and a white paper bag that contained surgical instruments was placed on top of all the surgical instruments.

During an interview with RN 5 at the time of observation, RN 5 stated that she was aware that the tray was small for the number of instruments placed in it for sterilization. RN 5 further stated that the clamps/scissor hinges were observed to be closed.

According to the Association of Peri-Operative Registered Nurse (AORN), Perioperative Standards and Recommended Practices, Recommended Practices for Cleaning and Care of Surgical Instruments (2014)

Recommendation IV

Items to be sterilized should be packaged in a manner that facilitates sterilization and provides for an aseptic presentation of the package contents. Incorrect packaging may prevent sterilization from occurring. Inappropriate handling can lead to loss of package integrity. Incorrect packaging can make aseptic delivery of the contents to the sterile field or impossible.

IV.c. Items to be sterilized should be positioned within packages to allow sterilant contact with all surfaces. Sterilant contact is necessary for sterilization to be achieved.

IV.e. Instruments composed of more than one part that can be disassembled should be disassembled unless the manufacturer's written and validated IFU specifies that disassembly is not required. Sterilization of assembled instruments can prevent exposure of some areas of the device to the sterilant.

IV.f. Items to be sterilized that have concave or convex surfaces that create potential for water retention should be positioned within packages in a manner that prevents those surfaces from retaining water.

11. On April 3, 2019, at 4 PM, in the hallway by the decontamination room, there were seven (7) clean isolettes lined up on the hallway in front of the decontamination area. The hallway was a busy thorough fare for soiled/contamination equipments/devices to be take to the decontamination area.

12. On April 9, 2019, at 10 AM, during the tour of the sterile processing area, Sterile Processing Technician 1 (SPT 1) showed the sink that was used for the cleaning of soiled instruments. There was a water marker pasted on the wall of the sink. During an interview with SPT 1 at the time of observation, SPT 1 stated that the marker was changed when it started to peel off. A patient towel was observed on the counter where surgical instruments were placed after being rinsed.

The AORN 2019 Edition indicated the decontamination area should be stocked with the accessories and supplies needed to clean and decontaminate instruments in accordance with the manufacturer's written IFU. Suplies should include soft, linting cleaning cloths.

13. During the tour of the different areas in the hospital on April 2 through 5, 2019, at various times, it was noted faucets in the sinks were found to have mineral deposits around and above the spigot.

14. During the tour of the different areas of the hospital on April 2 through 5, 2019, at various times, it was noted corrugated cardboard boxes were found in the decontamination area, and laboratory department.

15. During review of the 3M Steam Sterilizer Record Keeping from April 4 through 8, 2019, the sections indicating RH (relative humidity), Chemical Indicator/ Integrator Lot No., Indicator Results (Circle One) (1491 30 min/1492V 1 hr) were not documented in the log.

A review of the 3M Attest Super Rapid Readout Biological Indicator Instructions for Log Sheet Use indicated the following; Check the Attest BI product used, Record the BI manufacturing lot number, record the % RH (relative humidity) in the room, for 3M Attest rapid read out biological indicators, record both the BI "Rapid Readout/Florescence and Visual results.

During an interview with Epidimiology/Infection Nurse, the Epidimology/Infection Nurse stated the Log Sheet for Super Rapid Readout will be monitored for completeness and accuracy of the results.

16. During tour of the back area of the operating room, there was a mattress with residual tape, tears/torn on top of the mattress.

17. On 4/3/19 at 9:03 AM, during a tour of pediatric units, Patient 3 was observed with an IV catheter to the left forearm and was receiving an IV solution at 10 cc (cubic centimeter or milliliter) per hour. The bag of IV solution had a sticker that indicated to "change Friday", it was not labeled with the date, time, or the initials of the nurse who administered the solution.

On 4/3/19 at 9:13 AM, during an interview, the registered nurse (RN 2) stated that the IV solutions should be labeled with date, time, and initials of the nurse who hung the bag.

A review of Patient 3's medical record indicated Patient 3 was a pediatric patient admitted to the facility on 3/28/19 for lymphadenitis (enlargement of lymph nodes,usually due to infection).

The facility's policy and procedure titled, "Medication and Parenteral Therapy Policies for Pediatric Patient," dated 10/1/18, indicated intravenous bags are changed at least every 24 hours, or as directed by pharmacy for specific medication fluids. The bags are labeled with the patient's name, medical record, date, time and initials.

18. On 4/9/19 at 10:57 AM, during an observation of the formula store room, twenty (20) containers of disinfectant wipes were stored on a bottom rack. The rack and the rest of the store room also contained many different types of infant formulas or supplemental drinks.

Concurrently, the vice president of ancillary and support services stated it was not appropriate to store chemicals in the formula room, and should be stored in a separate area.

Concurrently, the director of food service stated the disinfectant wipes would be removed right away.

The facility's policy and procedure titled, "Food And Nutritional Services, Subject: Hazardous Chemical Storage," reviewed 3/2017, indicated all chemicals are stored away from food and supplies in a separate closet.

19. During a review of Medical Staff credential files for ten of ten reviewed files there was no documentation of Hepatitis B status or waiver. During an interview with the Medical Staff Director on 4/4/19 at 3:15 PM, the Medical Staff Director indicated that none of the medical staff had a documented Hepatitis B status or waiver on file. The Medical Staff Director indicated there was no policy and procedure requiring documented Hepatitis B status or waiver as part of health assessment or screening required for Medical staff credentialing.

During an interview with the Infection Control Coordinator on 4/9/19 at 2:40 PM, The Infection Control Coordinator indicated that the facility followed CDC (Centers for Disease Control) guidelines for infection control that require Medical Staff to have yearly PPD, and Flu vaccination. The policy did not include documented Hepatitis B status or waiver as part of health assessment or screening required for Medical staff credentialing.

The Facility failed to follow CDC guidelines and assure patient care was provided in a safe and sanitary environment





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36206

Based on observation, interview, and document review, the Governing Body failed to provide separate nursing staff directors overseeing Surgical services at Hospital A independent of another hospital sharing the same address (Hospital B).
Thios deficient practice had the potential for inadaquate staffing for Hospital A

Findings:

On 4/9/19 at 9:45 am, during an interview, the Director of Nursing (DON) of Operating Rooms (OR) indicated her assignment and the assignment of the following employees was for both Hospital A and Hospital B. The DON of OR also indicated she was covering both Hospital A and Hospital B, during this current shift at the time of the interview.

During a concurrent interview, RN 16 indicated she was director of Outpatient surgery and pre and Post surgery care for both Hospital A and Hospital B.

During the same concurrent interview, the Director of Sterile Processing Department (SPD) indicated she was the Director of SPD for Both Hospital A and Hospital B.

During the same concurrent interview, RN 17 indicated he was DON for the Birth Center (BC), as well as the Director of the Gastrointestinal Laboratory at Hospital B. The SPD Tech 2 indicated she was SPD lead tech for Both Hospital A and Hospital B. During another concurrent interview, the SPD tech supervisor indicated the SPD staff were scheduled to cover both Hospital A and Hospital B.

A review of a facility document titled Pediatric Surgical Preparation area dated 4/1/2019 indicated the surgical Prep area is part of the Surgical Pavilion department "All Staffing, flexing, support comes from [Hospital B]... Staffing is combined between [Hospital A] and [Hospital B] Surgical Pavilion to meet the population needs".

The Governing Body failed to assure [Hospital A] Surgical services staffing was not combined with[ Hospital B] Surgical Services staffing.

Based on observation, record review, and interview, the facility failed to provide surgical services in a safe and sanitary manner and failed to:
1. Assure Decontamination of surgical instruments follow the standard guidelines.
2. Monitor and oversee the Sterile Processing Department (SPD) services, including assuring daily biological testing was done with each sterilized load and daily controls were completed.
These deficient practices had the potential for using unsterile instruments in the Operating Room.

Findings:

1. During an observation on 4/3/19 at 3:40 PM, in the Sterile Supply of the Operation Room (OR), a Pediatric Minor tray was opened. The surgical instruments were overlapping and hinged instruments on the stringer were in a closed position.

During a concurrent interview, the Director of SPD indicated she was aware the tray was small and the hinged instruments were closed. She indicated a bigger tray should be used and the hinged instruments should be in open position.

2. During a Tour on 4/9/19 at 9:45 am in the SPD, and a concurrent review of the Biological Log, the SPD director indicated there was missing and incomplete information for 4/4/19 to 4/8/19.

On 4/9/19 at 10 am, during a tour of SPD/ decontamination, patient towels were observed covering on the counters adjacent to the decontamination sinks. During a concurrent interview, the decontamination Techician indicated the patient towels were used to dry surgical instruments after being manually decontaminated, the towels were then sent back to be washed with the facility linen service.

A policy and procedure or reference for using patient blankets and patient towels in the decontamination room was requested and not provided.

A review of the Manufacturers IFU for drying the surgical instruments indicated using soft lint free cleaning cloths.

On 4/9/2019 at 3:15 PM, during an interview, the Director of Infection Control indicated the facility followed CDC and AORN recomendations. The director also indicated the infection control department would increase oversight in the Decontamination room and the sterile processing department.

A review of the Purchase agreement contracted service for Central sterile supply, indicated "[Hospital B] shall supply [Hospital A] with sufficient sterile supplies and medical and surgical equipment, including without limitation, autoclaves, sterilizers. [Hospital B] shall be responsible for rotation of supplies, provide decontamination, sterile processing, sterile storage and delivery. [Hospital B] shall maintain all equipment in operating condition at all times and shall conduct all required checks and tests." There was no documentation provided to review the contracted services provided for CentralSterile Supply by Hospital B had was regularly monitored and evaluated by Hospital A.

The Governing Body failed to assure surgical services were provided in a safe and sanitary manner.