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Based on interview and document review, the hospital did not have an effective governing body that carried out the functions required of a governing body to provide a safe and secure environment for patients by the following:

1. Ensure effective implementation of the Food and Nutrition Service in a safe and sanitary manner and in accordance with current standards of practice. (see A749)

2. Ensure the Director of Food and Nutrition Services utilized competent staff to provide oversight of the sanitary practice in the department and had the appropriate management skills to identify and resolve high-risk deficient practices in the kitchen in a timely manner. (see A622)

3. Develop and effective quality assurance and performance improvement program for Food and Nutrition services when high risk, high volume deficient practices were not identified for effective remediation. (see A263)

4. The hospital failed to ensure data collected for the Endoscopy suite and Access patient registration process, accurately reflected staff current practices related to the transport and storage of endoscopes, and monitoring the process that Patients signed Agreement for Services (AFS) provided at the hospital. (see A273)

A review of the Governing Body (GB) and Quality Council (QC) minutes dated 4/2017 through 8/2017 was conducted on 9/19/17 at 9:23 A.M. There was no documentation in the minutes regarding knowledge deficit of dietary staff for safe food handling, or other food handling sanitary issues in the dietary department. In addition, there was no documentation regarding staff practices in transporting and storage of endoscopes or the process for patients to complete the AFS.

An interview with the Senior Director of Quality (SDQ) was conducted on 9/19/17 at 11:15 A.M. The SDQ stated that the QC minutes are reviewed at the Medical Executive Committee which the Governing Board members attend. The SDQ stated the GB members are informed of the issues in each department of the hospital by the reports provided in the minutes. The SDQ stated that there has been no report to quality or the GB of unsafe food handling or other food handling sanitary issues or knowledge deficit of dietary staff in the dietary department. The SDQ acknowledged that the GB had the ultimate responsibility in the oversight of the hospital's operations.

The cumulative effect of these systemic problems resulted in the facility's failure to deliver care in compliance with the Condition of Participation for Governing Body and failure to provide a safe and secure environment for patients.

Based on interview, record, and document review, the hospital failed to ensure Agreement for Services (AFS-consent to receive inpatient and/or outpatient services, general treatment, rights as a patient, and information about advance directives) were explained and signatures obtained thereof, for 3 of 35 sampled patients (13, 30, 33) and 17 randomly sampled patients (36-52).

In addition, Patient's 37 and 38, who were outpatients, were not informed upon arrival, of a potential additional fee for outpatient services.

As a result, Patient's advance notices of care were not communicated in accordance with the hospital's own Policies.

Findings:

1. A facility tracking log of missing registration documents was reviewed on 9/20/17. The Access personnel documented the following reasons for unobtained admission documents:

On 9/7/17, 9/8/17, 9/11/17-9/15/17, 9/18/17, and 9/20/17, Patient 30's AFS was not obtained due to contact precautions.

On 9/20/17, Patient 33's AFS was not obtained due to droplet precautions.

On 9/19/17-9/20/17, Patient 36's AFS was not obtained due to a Registered Nurse (RN) in the room for patient care and, the next day, the patient was asleep.

On 9/19/17, Patient 37's AFS, which pertained to an outpatient status, was not obtained upon arrival to the hospital. The tracking log indicated an attempt was made after Patient 37's name showed up on a missing AFS list. Patient 37 refused to sign after he was given late notice. As a result, the hospital provided cash cost for the one night stay.

On 9/20/17, Patient 38's AFS which pertained to an outpatient status, was not obtained upon arrival to the hospital. The tracking log identified Patient 38's name showed up on a missing AFS list, however, there was no documentation staff attempted to obtain.

On 7/28/17, Patient 39's AFS was not obtained due to contact precautions.

On 7/31/17, Patient 40's AFS was not obtained due to contact precautions.

On 9/20/17, Patient 41's AFS was not obtained due to contact precautions.

On 9/20/17, Patient 42's AFS was not obtained due to the patient was not in her room.

On 9/20/17, Patient 43's AFS was not obtained due to the patient was sleeping.

On 9/20/17, Patient 44's was not obtained due to the patient was not in her room.

On 9/20/17, Patient 45's AFS was not obtained due to contact precautions.

On 9/20/17, Patient 46's AFS was not obtained due to a Physician in the room for patient care.

On 9/18/17 and 9/20/17, Patient 47's AFS was not obtained due to the patient was sleeping, and had a procedure the second attempt.

On 9/20/17, Patient 48's AFS was not obtained due to the patient was sleeping.

On 9/20/17, Patient 49's AFS was not obtained due to the patient was not in her room.

On 8/31/17, 9/1/17, 9/6/17, 9/8/17, 9/11/17, 9/15/17, 9/19/17, and 9/20/17, Patient 50's AFS was not obtained due to contact precautions.

On 9/1/17, 9/5/17, 9/7/17, 9/8/17, 9/11/17, 9/12/17, 9/13/17, 9/14/17, 9/15/17, 9/18/17, and 9/20/17, Patient 51's AFS was not obtained due to contact precautions.

On 9/8/17, 9/11/17, 9/15/17, 9/19/17, and 9/20/17, Patient 52's AFS was not obtained due to contact precautions.

On 9/20/17 at 9:30 A.M., an interview was conducted with the Access Coordinator Supervisor (ACS). The ACS stated the hospital had a new electronic registration process which started 4/1/17. Missing registration forms automatically populated into a missing document file known as a "work queue" and the hospital expected the PS staff to document a reason if the AFS was not obtained. In addition, the ACS stated the work queue was reviewed daily by herself and/or the ACS Director (PSD). The ACS stated she had not reviewed the work queues for missing registration forms. Additionally, the PSD was not available for interview. The ACS was not aware how an AFS was obtained when a patient was placed on isolation precautions.

On 9/20/17 at 2:50 P.M., an interview was conducted with a Patient Service Specialist (PS) 1. PS 1 stated the AFS was signed prior to patient care, except in an emergency. In addition, PS 1 stated the PS staff were each allotted two hours on an assigned rotation, to visit patients and obtain AFS signatures. PS 1 further stated, when Patient's were admitted after hours, it was a challenge to complete the registration process the next day within a two hour time frame.

According to the hospital's document entitled, Notice of Outpatient Observation Services, dated 12/14/16 and Medicare Observation Notice, dated 3/26/14, "...Outpatient observation status...may affect your healthcare coverage reimbursement..." "You may be liable for some charges on your bill if they are not covered under your Part B Medicare or if you do not have part B Medicare."

According to the hospital's Policy, entitled, Agreement for Services at a Scripps Facility, dated 4/18/16, "The Agreement for Services documents the patient's general consent to receive services at a Scripps facility and informs him/her of the relationship between the patient and the hospital with regard to several important matters...Patients requesting services at Scripps are presented with and asked to sign an Agreement for Services...Personnel performing the registration function, present the appropriate Agreement for Services form to the patient or their representative..."

According to the hospital's Policy, entitled, Access to Scripps Care and Services, Patient Rights and Responsibilities, dated 10/18/16, "At registration patients/representatives are provided with a copy of Patient Rights and Responsibilities...Specific Patient Rights are highlighted with the patient at the time of registration including:..Scripps' policy regarding Examine and receive an explanation of your bill regardless of the source of payment."

These policies were not implemented when the hospital failed to ensure AFS's were explained and signatures were obtained prior to services provided.


29707

2. Patient 13's medical record was reviewed on 9/20/17.

Patient 13 was admitted to the facility on 8/21/17, and according to the medical record, the patient was in custody of law enforcement (forensic/prisoner).

Patient 13's medical record did not contain an Agreement for Services document.

On 9/21/17 at 9:40 A.M., the ACS was interviewed. The ACS stated it was the responsibility of the personnel in the Access department to present and review the Agreement for Services document with the patients, provide Patient Rights and Advanced Directive information and obtain patient signatures on the document to reflect the same. The ACS also stated a forensic patient was supposed to have the items presented and the Agreement for Services document signed, but facility management instructed the Access department personnel not to enter a forensic patient's room. The ACS stated there was no process in place for the provision of providing the required information and obtaining a signature on the Agreement for Services document for forensic patients.

According to a facility tracking log of missing documents the Access personnel wrote the following in regards to admissions documents for Patient 13:
On 8/22/17 - patient is an incarcerated patient with 2 guards; no visit
On 8/30/17 - no visit
On 9/6/17 - no visit
On 9/8/17 - patient under law enforcement watch/did not enter room
On 9/19/17 - unable to obtain signature. Patient is under law enforcement watch 24/7. No family at bedside.

RN 4 who was a Supervisor on the unit Patient 13 was housed on, stated in an interview on 9/21/17 at 9:55 A.M., the nurses on the unit were not instructed to present and obtain signatures on the admission Agreement for Services for forensic patients. RN 4 also stated she understood that it was the responsibility of the Access department to present and obtain the signatures for the Agreement of Services.

According to the facility policy, entitled, Agreement for Services at a Scripps Facility, dated 4/18/16, "The Agreement for Services documents the patient's general consent to receive services at a Scripps facility and informs him/her of the relationship between the patient and the hospital with regard to several important matters...Patients requesting services at Scripps are presented with and asked to sign an Agreement for Services...Personnel performing the registration function, present the appropriate Agreement for Services form to the patient or their representative..."

The policy did not address any different process to follow for a forensic patient.

According to the facility policy, entitled, Access to Scripps Care and Services, Patient Rights and Responsibilities, dated 10/18/16, "At registration patients/representatives are provided with a copy of Patient Rights and Responsibilities...Specific Patient Rights are highlighted with the patient at the time of registration including:...Scripps' policy regarding advanced directives and their right to formulate an advance directives..."

According to the facility policy, entitled, Forensic Services, Nursing Care, Officer Orientation Education, dated 3/19/16, "Patient in Custody Rights: Have the right to refuse treatment; the right to be treated with respect and dignity; the right to be educated related to their plan of care, medications and treatments; the to and must consent for procedures, treatment and blood transfusion."

Based on interview and document review, the hospital failed to develop, implement and maintain an effective, ongoing, hospital wide, data driven quality assessment and performance improvement program as evidenced by the following:

1) The hospital failed to develop an effective quality assurance and performance improvement program for Food and Nutrition services when high risk, high volume deficient practices were not identified for effective remediation. (see A273)

2) The hospital failed to ensure data collected for the Endoscopy suite and Access patient registration process, accurately reflected staff current practices related to the transport and storage of endoscopes, and monitoring the process that Patients signed Agreement for Services (AFS) provided at the hospital. (see A273)

An interview with the Senior Director of Quality (SDQ) was conducted on 9/19/17 at 11:15 A.M. The SDQ stated that the QC minutes are reviewed at the Medical Executive Committee which the Governing Board members attend. The SDQ stated the GB members are informed of the issues in each department of the hospital by the reports provided in the minutes. The SDQ stated that there has been no report to quality or the GB of unsafe food handling or other food handling sanitary issues or knowledge deficit of dietary staff in the dietary department. The Manager of Epidemiology (MGR-E) stated she was not aware of staff current process related to endoscope transport, or endoscope cabinet disrepair via communication with the Endoscopy staff or Environment of Care/Infection Prevention rounds and no data had been provided to the Quality Department. The SDQ acknowledged that the GB had the ultimate responsibility in the oversight of the hospital's operations.

The cumulative effect of the facility's failure to have a quality assurance system in place to ensure oversight of the hospital's Food and Nutrition services, transport and storage of endoscopes and monitoring of patient singing agreement for services resulted in the facility's failure to deliver care in compliance with the Condition of Participation for QAPI and failure to provide care to their patients in a safe environment.

Based on interviews and record review, the hospital failed to ensure an effective quality assurance performance improved program in the Food and Nutrition Services department when high risk, high volume deficient practices in the kitchen were not identified, data tracked and analyzed and a performance improvement plan developed for effective remediation. This failure resulted in allowing unsanitary conditions in the department to continue. (refer A749)

In addition, the hospital failed to ensure data collected for the Endoscopy suite and Access patient registration process, accurately reflected staff current practices related to the following:

1. The transport and storage of endoscopes.
2. Patients signed Agreement for Services (AFS) provided at the hospital.

The lack of accurate data collection did not ensure staff current practices, which were not implemented or were not developed in accordance with the hospital's policies, identified opportunities for improvement.

Findings:

On September 20, 2017 starting at 8:20 am, the Food and Nutrition Service's quality assurance and performance improvement (QAPI) plan dated October 2016 through August 2017 was reviewed with the Director of Food and Nutrition Services (DFANS) and the Clinical Manager of Patient Services Dietitian (PSD). Review of the plan revealed that a sanitation audit was one of the performance indicators to ensure sanitary practices were being followed to in the department. A review of the audit tool used showed that unsafe dietary practices identified during the course of the survey were not identified in the audit tool. Although safe cooling of cooked foods was identified by the DFANS and the Chef Supervisor (CS) as being a problem in July 2017, this high-risk, high volume practice was not being studied. In addition, staff competencies were also not studied in order to determine where in-service education might be appropriate to ensure safe food handling and prevent cross contamination.

During the concurrent interview, the DFANS stated that she does not document the results of daily department walk-throughs that she conducts. She stated that she had identified the problem with cooling of cook foods but had not put a plan in place to study and fix the problem.

During an interview with the QAPI committee on September 20, 2017 at 11 am, the Director of Risk Management stated that the committee was not informed of any sanitary condition issues in the kitchen. She stated that each department head was responsible for their staff's competencies and the Governing Body was ultimately responsible.


29499


1a. On 9/18/17 at 10:00 A.M., an Endoscopy Assistant (EA) 1 transported an uncovered disinfected endoscope, in his gloved hand from the endoscope cleaning room, across a patient care hallway within the Endoscopy suite, and entered the endoscope storage room.

On 9/21/17 at 11:30 A.M., the hospital's Endoscopy Data collected was reviewed .

The data did not identify the current endoscope transport practice potentially posed a risk for endoscope contamination with infectious microorganisms. In addition, the data did not identify this practice deviated from the hospital's current Endoscopy Department Policy.

The hospital's Policy titled Flexible Endoscope Processing Program and Procedures, dated 2/1/16 was reviewed.

The Policy indicated "...All departments authorized to perform scope processing must comply..." "After high-level disinfection, transport ready for use endoscopes using clear bins or bags ensuring that the endoscope is contained."

1b. On 9/18/17 at 11:45 A.M., an observation of the endoscope storage room was conducted with EA 1 and the Lead Endoscopy Technician (LET). An endoscope (SIF- a long scope ) was draped on a hook and coiled around another endoscope, in the middle of one of the cabinets.

In addition, the LET stated the Endoscopy Technicians initialed a document titled "AM Scope Cabinet Check." The document did not stipulate components of the cabinet inspection other than the date and staff initials.

Another endoscope cabinet had visible debris present on the shelf which supported the endoscope hooks. According to the LET, the cabinet door rolled open via a track similar to a garage door, and each time it rolled open, debris particles fell into the scope cabinet. In addition, he stated he thought it had been reported to management for a work order.

On 9/21/17 at 11:30 A.M., the hospital's Endoscopy Data collected was reviewed.

The data was based on Endoscopy staff initials related to a document "AM Scope Cabinet Check." The Scope Cabinet Check document contained two areas, one for the date and the second for staff initials. Further data collected included observations when staff cleaned endoscopes. There were no documented observations of endoscope transport or endoscope cabinet disrepair.

The hospital's Policy entitled Flexible Endoscope Processing Program and Procedures, dated 2/1/16 was reviewed.

The Policy indicated "...All departments authorized to perform scope processing must comply..," "...Endoscopes are hung in a vertical position..."

On 9/21/17 at 11:45 A.M., an interview was conducted with the Endoscopy Registered Nurse Supervisor (ENS) 1. ENS 1 stated she was not aware the policy was not implemented or the cabinet was in disrepair and the hospital expected staff implemented Departmental policies.

2. A hospital tracking log of missing registration documents was reviewed on 9/20/17. The Access personnel documented various reasons for multiple patient's unobtained admission documents. Reasons documented included patient's had isolation precautions, were asleep or not in their room, and/or staff were in the patient's room.

On 9/20/17 at 9:30 A.M., an interview was conducted with the Access Coordinator Supervisor (ACS). The ACS stated missing registration forms automatically populated into a missing document file known as a "work queue" and the hospital expected the PS staff documented a reason if the AFS was not obtained.

The ACS stated she had not reviewed the work queues for missing registration forms. Additionally, the ACS was not aware how an AFS was obtained when a patient was placed on isolation precautions.

On 9/20/17 at 11:00 A.M., a Quality Assurance Performance Improvement (QAPI) meeting was conducted with Leadership. During the interview, the Manager of Epidemiology (MGR-E) stated she was not aware of staff current process related to endoscope transport, or endoscope cabinet disrepair via communication with the Endoscopy staff or Environment of Care/Infection Prevention rounds and no data had been provided to the Quality Department.

On 9/21/17 at 9:45 A.M., an interview was conducted with the Senior Director Corporate Access Management (SDCA) and Senior Director Quality (SDQ). The SDCA stated the hospital's data related to Access patient's missing Agreement for Services (AFS) included staff completion of the work queue. She stated, the hospital expected management reviewed the missing documents and then reviewed by Leadership. In addition, the SDCA stated the data was sent to an outside "Reporting Team" who, extracted a seven day rolling data. The hospital was not able to provide documentation of the rolling data in comparison to their own clarity report.

The hospital's QAPI 2017 Plan indicated performance measures were based on high volume, high risk, problem prone areas. The hospital's environment of care (EOC) rounds, infection prevention rounds, and Endoscopy department data did not capture staff transport of disinfected endoscopes or the condition of the endoscope storage cabinets in this high volume, high risk area.

The lack of communication, inaccurate recording and reporting between staff and management, did not ensure current practices were accurately analyzed, tracked, or measured to identify opportunities for improvement in accordance with the hospital's Performance Improvement Plan.

Based on interview, and document review, the hospital failed to ensure one patient (Patient 18) on Patient-Controlled Analgesia (PCA, patient controls the medication administration) was provided with education and monitored for safety and effectiveness as required by the hospital's policy and procedures.

As a result, the hospital could not ensure the medication was safely administered to the patient, and the patient's pain was adequately managed.

Findings:

Patient 18's clinical record was reviewed on 9/19/17 and 9/20/17 with Pharmacist 2 and Registered Nurse (RN) 1.

Patient 18 was admitted to the hospital on 9/8/17 for surgery on his spine. Patient 18 was prescribed hydromorphone (pain medication) PCA on 9/8/17.

The PCA was initiated on 9/8/17 at 12:24 P.M., and discontinued on 9/10/17 at 12:30 P.M.

According to the hospital's policy, Pain Management: Patient-Controlled Analgesia (PCA), effective date 12/1/16, "Initiation: The time that the patient is using the PCA independently. Initiation may exclude PCA set up in PACU [recover area after surgery], before the patient is engaged in PCA self-administration... If the patient does not have the capacity, either physically or cognitively to self-administer the medication using a PCA device, then alternative pain medication therapy must be selected... RN will assess the patient's capacity for appropriateness for PCA therapy... The RN will educate the patient on how to use PCA therapy and assess the patient's understanding and ability to use PCA therapy effectively. The RN will provide patient and family education regarding the dangers of PCA by proxy [someone else administers the PCA to the patient]... medical record documentation will include... Patient's level of pain, comfort-function goal...."

According to the PCA hydromorphone order, end-tidal CO2 (EtCO2, patient's ventilation or breathing status) for the patient was to be documented every 4 hours.

1. During the interview on 9/19/17 at 3:40 P.M., RN 1 stated the education was provided to Patient 18 on 9/8/17 at 9:01 P.M. (approximately 8 hours after the PCA was initiated).

During the interview on 9/20/17 at 2:30 P.M., RN 1 acknowledged the education was not provided to Patient 18 prior to initiation of the PCA. In addition, the RN did not perform the assessment of patient's understanding and ability to use PCA prior to initiation of the PCA.

2. On 9/9/17, the EtCO2 was documented at 4:06 A.M., then again at 11 A.M. (approximately 7 hours apart, instead of every 4 hours).

On 9/10/17, the EtCO2 was documented at 1 A.M. (approximately 14 hours since the last documented EtCO2 at 11 A.M. on 9/9/17, instead of every 4 hours). Additionally, the EtCO2 was documented at 3:38 A.M., and again at 12:30 P.M. (approximately 9 hours apart, instead of every 4 hours) on 9/10/17.

3. During the interview on 9/20/17 at 2:30 P.M., RN 1 acknowledged the acceptable level of pain (comfort-function level) for Patient 18 was not document before the initiation and during the PCA use. The earliest documentation of comfort-function level was on 9/11/17 (after the PCA was discontinued). RN 1 stated, as a result, additional interventions to manage Patient 18's comfort (pain) level were not considered.

Based on interview and record review, the hospital failed to ensure consents related to surgery were readily accessible and available in the medical record at all times for 1 of 35 sampled patients (2).

Findings:

The medical record was reviewed on 9/18/17 and 9/19/17.

Patient 2 was admitted to the hospital on 9/15/17 for an abdominal surgery, per the admission record.

On 9/18/17 at 10:30 A.M. an interview and joint record review was conducted with RN 3. According to RN 3, Patient 2 was four days post-op, however RN 3 was unable to locate the consents for surgery and anesthesia in the EMR. RN 3 stated the consents are paper documents that are scanned and uploaded into the EMR. RN 3 further stated, "They should be in there."

During an interview on 9/18/17 at 1:50 P.M., the CRS stated the new EMR system was implemented in April, however the policies and procedures have not been updated or revised since the EMR started.

HIM 1 (the lead tech) and HIM 2 were jointly interviewed on 9/18/17 at 2:05 P.M. HIM 1 stated that all paper medical records come to HIM (medical records) to be scanned and uploaded. HIM staff round several times a day to all the patient care units to pick up the paper documents. For surgical patients, the paper consents are picked up in PACU. According to HIM 1, there is no medical records staff working on the weekends.

HIM 2 stated that Patient 2's consents stayed in PACU from the day of surgery until Monday (9/18/17), three days later, when they were picked up.

HIM 1 also acknowledged, "That's how this incident happened. The consents stayed in PACU."

According to the hospital's policy & procedure titled, Health Information, Documentation and Management of Health records, last approved 9/26/14, "Health records shall be readily accessible to physicians and caregivers ..." The policy further indicated, "The most recent information should remain in the patient's health record to allow for continuity of patient care and information trending."

Based on observation, interview, and record review, the hospital failed to ensure medications were stored under sanitary conditions.

As a result, the hospital could not ensure medications were safe for administration.

Findings:

1. A tour of the Pharmacy was conducted on 9/18/17 at 9:25 A.M. with the DOP and Pharmacist 2. The medication storage bins for the following medications had debris inside:

Verapamil (medication to treat heart conditions) injection 1,000 mcg in 10 mL; and
Nitroglycerin (medication to treat chest pain) injection 1,000 mcg in 10 mL.

Pharmacist 2 acknowledged the bins needed to be "cleaned."

2. A tour of the Operating Room (OR) was conducted with the DOP and Pharmacist 2 on 9/18/17 at 4 P.M. The following medications were inspected:

Insulin infusion (drip); and
Insulin regular (R) injection.

Pharmacist 2 acknowledged the store bins for these medications were "dirty."

According to the hospital's policy, Medication Storage and Security, effective date 6/17/14, "Drugs [medications] shall be stored under the proper conditions of sanitation... Storage areas shall be kept clean...."

Based on observation, interview, and document review, the hospital failed to ensure the pharmacist provided oversight for the medication storage in the Supply Chain.

As a result, the hospital could not ensure the medications were stored under proper conditions.

Findings:

A tour of the Supply Chain was conducted with the DOP on 9/19/17 at 11:30 A.M. The intravenous (IV, medications administered directly into the vein) solutions were stored in Supply Chain.

The Supply Chain Manager (MGR 1) was interviewed via telephone during the tour.

MGR 1 stated she did not have temperature monitoring for the IV solutions stored in Supply Chain. MGR 1 also stated the pharmacist did not provide the oversight for the storage of these IV solutions.

The DOP was interviewed on 9/20/17 at 11 A.M. The DOP acknowledged the pharmacist did not provide the oversight for the storage of these IV solutions.

According to the hospital's policy, Medication Storage and Security, effective date 6/17/14, "The Director of Pharmacy ensures the proper storage and security [of] medications throughout the hospital." In addition, "All drugs [medications] shall be stored at appropriate temperatures that do not exceed manufacturer's recommendations."

Based on observation, interview, and document review, the hospital failed to ensure medications were secured to prevent unauthorized access.

As a result, the hospital could not ensure medications were securely stored.

Findings:

The medication storage area for the Infusion Services was inspected on 9/19/17 at 10:38 A.M. with Pharmacist 1 and the Manager for the Transplant Clinic (MGR 2).

A supply cart, containing intravenous (IV, medications administered directly into the veins) solutions, was in the hallway unattended, unlocked, with the curtain open. The hallway was in between the Infusion Clinic and Transplant Clinic. The following medications were in the cart:

Normal Saline (NS, salt solution), 1 liter (L);
NS 500 milliliter (mL);
NS 10 mL; and
Sterile Water for Irrigation 1 L.

MGR 2 stated when the patients and visitors were done with their visit, the could go out through this hallway by themselves.

The patients and visitors, therefore, would have access to these medications.

According to the hospital's policy, Medication Storage and Security, effective date 6/17/14, "Drugs [medications] shall be kept in locked storage or be inaccessible to patients, visitors...."

Based on observation, interview, and document review, the hospital failed to ensure:

1. Intravenous (IV, medications administered directly into the vein) antibiotics (medications to treat infections) were stored according to the manufacturer's specifications;

2. Medications were protected from light as specified by the manufacturers; and

3. Expired medications were not available for use.

As a result, the hospital could not ensure the quality and safety of its medications.

Findings:

1. A tour of the Pharmacy was conducted on 9/18/17 at 11:40 A.M. with the DOP and Pharmacist 1.

The temperature for the medication freezer was at negative 19.2 Celsius (C, a temperature measurement unit).

The following medications were in the freezer:

Zosyn (IV antibiotics) 3.375 gram (g), 240 doses; and
Zosyn 4.5 g, 120 doses.

The manufacturer stated the medications should be "store[d] at or below [negative] 20 C."

The temperature log for the freezer in August and September was reviewed with Pharmacist 1 on 9/18/17 at 11:55 A.M. Forty (40) percent of the temperatures recorded were above negative 20 C.

The temperature log June and July 2017 was provided. Forty-one (41) percent of the temperatures recorded were above negative 20 C.

During the interview on 9/18/17 at 11:55 A.M., Pharmacist 2 stated pharmacy staff did not take any corrective actions when the temperatures were above negative 20 C.

During an interview on 9/20/17 at 3:20 P.M. with the DOP and Executive Director of Pharmacy Operations, they stated 292 patients were on Zosyn 3.375 g, and 140 patients were on Zosyn 4.5 g from June to September, 2017.

According to the hospital's policy, Medication Storage and Security, effective date 6/17/14, "Drugs [medications] shall be stored under the proper conditions of ... temperature... Drugs shall be stored according to the ... manufacturer specifications so the integrity, stability, and effectiveness are maintained... Biologicals and thermo-labile drugs that require refrigeration or freezing shall be stored in the a refrigerator or freezer that is capable of maintaining the necessary temperature."

2a. A tour of the Pharmacy was conducted on 9/18/17 at 9:25 A.M. with the DOP.

The DOP stated medications required protection from light should have been stored in amber lidded bins or in manufacturer's box.

The following medications were exposed to ambient light:

Cefazolin (antibiotic) injection 1 gram (g), quantity 3; and
Ceftriaxone (antibiotic) injection 1 g, quantity 12.

According to the manufacturer's specifications, these medications should have been protected from light.

The DOP acknowledged they should have been protected from light, but were not.

2b. The medication storage on 3 West was inspected on 9/19/17 at 10:25 A.M. with the DOP.

Protonix (medication to lower stomach acid) injection 40 milligram, quantity 14, were exposed to light.

According to the manufacturer's specifications, the medication should have been protected from light.

The DOP acknowledged they should have been protected from light, but were not.

According to the hospital's policy, Medication Storage and Security, effective date 6/17/14, "Drugs [medications] shall be stored under the proper conditions of ... light... Drugs shall be stored according to the ... manufacturer specifications so the integrity, stability, and effectiveness are maintained... All light-sensitive medications are protected from excessive light by covering or enclosing in UV light protective plastic."

3a. A tour of the Pharmacy was conducted on 9/18/17 at 9:25 A.M. with the DOP and Pharmacist 2.

A bottle of metoprolol (medication to treat heart conditions) 10 milligram (mg) per milliliter (mL) oral contained the label "Use by 9/11/2017" was stored in the Main Refrigerator 2 in the Pharmacy.

Pharmacist 2 stated the medication expired, and expired medications should not have been stored.

3b. A tour of the Intensive Care Unit was conducted on 9/19/17 at 10:15 A.M. with the DOP.

Keppra (medication to treat seizure) injection 500 milligram (mg) in 100 milliliter (mL) of normal saline (salt solution) contained the label "Use by 9/18/17 1952 [7:52 P.M.]" for Patient 16.

The DOP acknowledged the medication expired "yesterday."

According to the hospital's policy, Hazardous Material Disposal, Manage-Up Program, effective date 4/4/17, "Intact expired or unusable medications ... are collected from all pharmacy drug storage areas, by pharmacy or other designated personnel, segregated from intact, usable pharmaceuticals...."

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

1. Ensure effective implementation of the Food and Nutrition Service in a safe and sanitary manner and in accordance with current standards of practice. (refer A749)

2. Ensure the Director of Food and Nutrition Services utilized competent staff to provide oversight of the sanitary practice in the department and had the appropriate management skills to identify and resolve high-risk deficient practices in the kitchen in a timely manner. (refer A 622).

3. Develop and effective quality assurance and performance improvement program for Food and Nutrition services when high risk, high volume deficient practices were not identified for effective remediation. (refer A273).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the Condition of Participation for Dietary Services was met.

Based on observations, interviews and record reviews the hospital failed to ensure effective oversight of the Food and Nutrition Services by the Director when the sanitary conditions of the department were under the direction of the Chef Supervisor (CS) who was unable to effectively maintain sanitary conditions in the department. The Director of Food and Nutrition Services (DFANS) failed to ensure the CS was competent in safe food handling and had the management skills to remediate the high risk food safety procedures and systems when problems were identified. The department's quality assurance and performance improvement (QAPI) program further did not identify the unsafe food handling practices and therefore allowed the practices to continue without remediation. These failures resulted in unsanitary conditions in the Food and Nutrition Services department. (refer A749)

Findings:

During a tour of the kitchen on September 18, 2017 at 10 am, cooked pasta and rice were stored in the refrigerator and had not been monitored for safe cooling. A review of the hospital's cooling log showed that multiple cooked food items between October 2016 and July 2017 were not monitored for safe cooling.

Excessive time for cooling of cooked TCS foods has been consistently identified as one of the contributing factors to food borne illness (Food Code 2013).

During an interview with the CS on September 18, 2017 at 10 am, the CS stated that she had identified a systemic problem with the staff not monitoring the safe cooling of foods that should be monitored "a while back" and she had a "Fishbone Diagram" plan (a tool used to determine cause and effect relationships within processes) to resolve the issue. She had not moved forward with any action to resolve the issue yet. She could not explain why the staff was not competent in monitoring the safe cooling of TCS foods when the process was a high risk of food borne illness to patients in the hospital and she had identified cooling as a problem "a while back."

During a tour of the kitchen and concurrent interview with the Chef Supervisor (CS) on September 18, 2017 at 10:40 am, the table-mounted can opener and its holder were observed with a significant build-up of a sticky black residual. The blade on the can opener was worn with the black, sticky residual built up. The CS stated a lack of cleanliness of the can opener had previously been identified and she had been working on a plan to ensure it was clean. She stated the can opener was not clean and it looked like it had not been cleaned recently due to the black sticky build-up that did not appear fresh. She stated that the can opener should be cleaned and sanitized continuously after each use by running it through the dish machine.

The employee file for the CS was reviewed and included a competency evaluation dated May 3, 2016 for Safe Food Handling which included the topics of personal hygiene; food safety; purchasing, receiving and storage; preparing, cooking and serving; cleaning and sanitizing; and chemical usage. The method of evaluation included simulation and document review. The competency was signed by the Director of Food and Nutrition Services (DFANS).

During an interview with the DFANS on September 19, 2017 at 11:00 am, the DFANS stated that she had provided additional training for the CS to ensure the CS's competency. The DFANS stated that she was surprised that the CS showed knowledge lapses during the survey.

During an interview with the DFANS on September 20, 2017 at 8:20 am, the department's QAPI program was reviewed. Unsafe food handling deficient practices that were identified during the survey were not being studied in their plan. Sanitation audits were monitored but the results failed to identify deficient practices with cooling cooked foods safely, cleanliness of equipment and lack of staff knowledge on monitoring the sanitizer concentration and hand hygiene allowing these deficient practices to continue. (refer A 749)

Based on observations, record reviews and interviews, the hospital failed to ensure the Food and Nutrition Staff (Cook 1 and Dietary Staff 1) and the Chef Supervisor (CS) were competent in the their respective duties when multiple unsanitary conditions were identified in the department. The Director of Food and Nutrition Services (DFANS) allowed the CS to have oversight over the sanitation of the Food and Nutrition Services without adequate oversight to ensure competency. These failures had the potential to result in food borne illness in a highly susceptible patient population of 57 patient who were served food at the hospital, as well as staff and visitors who ate the food from the cafeteria. Of the 57 patients who were served the food, three patients had physician orders for a Transplant Diet that the Hospital's Diet Manual (approved 2015) described as, "This nutrition therapy addresses the food safety concerns of individuals whose immunity is suppressed and who are at high risk for food borne illness."

Findings:

a. Safe cooling of TCS foods requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of TCS foods has consistently been identified as one of the leading contributing factors to food borne illness. During slow cooling, TCS foods are subject to the growth of a variety of pathogenic (disease causing) microorganisms. A longer time near ideal bacterial incubation temperatures of 70 °F to 125 °F (degrees Fahrenheit) is to be avoided. If food is not cooled in accordance with this Code requirement, pathogens may grow to sufficient numbers to cause food borne illness. Time/temperature control for safety foods includes plant food that is heat treated or cooked (Food Code 2013).

During an observation in the walk-in refrigerator in the kitchen on September 18, 2017 at 10 am, a two inch hotel pan of cooked penne pasta and the same size pan of cooked rice were being stored and both were dated September 16, 2017.

During a concurrent interview with the Chef Supervisor (CS) she stated that the rice and pasta were cooked on September 16, 2017, and they were good for three days. She further stated that although the pasta and the rice should have been monitored for safe cooling, they were not. She stated that she had identified a systemic problem with the staff not monitoring the safe cooling of foods that should be monitored "a while back" and she had a "Fishbone Diagram" plan (a tool used to determine cause and effect relationships within processes) to resolve the issue. She had not moved forward with any action to resolve the issue yet. She could not explain why the staff was not competent in monitoring the safe cooling of TCS foods when the process was a high risk of food borne illness to patients in the hospital and she had identified cooling as a problem "a while back."

A review of the hospital's "Cooling Temperature Log" dated October 17 [2016] through July 24 [2017], indicated instructions, "Potentially hazardous food [now referred to as TCS food] must be cooled from: 135 °F to 70 °F within two hours, AND THEN FROM 70 °F to 41 °F or lower in the next four hours." The cooling log included eight items, one of which was rice (dated December 14 [2016]). Of the eight items on the cooling log, only one items had been cooled according to the instructions. Four of the eight TCS foods on the cooling log were not monitored to ensure that the food reached 70 °F or less within the two hours required by the Food Code and the log's instructions. There were no entries on the log after July 24, 2017.

During an interview with the Director of Food and Nutrition Services (DFANS) on September 19, 2017 at 10:20 am, she stated that she knew about the problem with staff not correctly monitoring the safe cooling of TCS foods in July, 2017. She further stated that the staff responsible for cooling had not been in-serviced on the process. She was not aware that cooked TCS foods were being saved and stored.

b. During an observation of Cook 1 on September 18, 2017 at 10:50 am, Cook 1 was observed, with gloved hands, cutting open bags of cooked chicken and sauce and pouring the food into pans. Cook 1's gloved hands contacted the food as it was poured into the pans. He opened and poured four bags and between each bag he used his gloved hands to pull the trash can out from under the table he was working at and push it back under the table. Cook 1 did not wash his hands after touching the trash can and continuing to prepare the food.

During a concurrent interview with the Chef Supervisor (CS), the CS stated she observed Cook 1 doing this as well. She further stated that he should have washed his hands between handling the trash can and handling the food. She stated that it was the Food and Nutrition Services staff practice to keep the trash cans under the tables so that they are covered, even while in use.

During a concurrent interview with the Director of Food and Nutrition Services, she could not explain why the trash cans were stored under the food preparation table requiring them to be handled throughout the food preparation process.

According to the 2013 Food Code, receptacles and waste handling units shall be kept covered inside food establishments when not in continuous use.

A review of the hospital's policy titled "Infection Control and Sanitation" (approved February 14, 2017) indicated: "Hand Hygiene: Wash hands with soap and warm water for 20 seconds before starting work, before putting on clean single-use gloves, between glove changes and before handling clean single use equipment and utensils. Change gloves and wash hands when changing task and during food preparation as often as necessary to remove soil and contamination. Also after handling soiled articles ...."

c. During a tour of the kitchen and concurrent interview with the Chef Supervisor (CS) on September 18, 2017 at 10:40 am, the table-mounted can opener and its holder were observed with a significant build-up of a sticky black residual. The blade on the can opener was worn with the black, sticky residual built up. The CS stated a lack of cleanliness of the can opener had previously been identified and she had been working on a plan to ensure it was clean. She stated the can opener was not clean and it looked like it had not been cleaned recently due to the black sticky build-up that did not appear fresh. She stated that the can opener should be cleaned and sanitized continuously after each use by running it through the dish machine.

During a concurrent interview with the Director of Food and Nutrition Services, she stated the can opener was not clean. She further stated that the cleanliness of the can opener was a part of the sanitation audits that the staff leads complete twice a month. She stated that the CS was responsible for ensuring the equipment and utensils were cleaned and sanitized effectively to prevent cross contamination. She verified that the can opener blade needed to be replaced.

d. During an observation and concurrent interview with Dietary Staff 1 (DS 1) on September 19, 2017 at 9:45 am, DS 1 demonstrated how he tested the sanitizer concentration in the pots and pans sinks. He stated that the patient food pots and pans were cleaned and sanitized in these sinks. In the third sink, sanitizer was used to ensure the pots and pans were effectively sanitized before they were air-dried. DS 1 immersed a paper test strip in the sanitizer solution in the third sink for approximately 15 seconds. He then compared the strip to a color chart posted on the wall and stated the concentration was 200 parts per million (ppm) which was what it was supposed to be. The color of the strip did not match the colors on the posted color chart. DS 1 agreed that the strip was not consistent with the color chart on the wall. He stated that he was trained the way he just demonstrated on how to check the sanitizer concentration.

A review of the manufacturer's instructions on the test strips package indicated, "Dip about one inch of a test paper into the solution to be tested and hold there for 90 seconds. Then compare the test paper against the color standards shown above (on the strip label)." The color standard on the strip label was not the same as the one posted on the wall.

During a concurrent observation, the test strip that DS 1 used was compared against the color standard on the test strip package and it did not match any of those colors either. DS 1 was unable to state how he could determine the concentration of the sanitizer when the color of the strip did not match either of the two charts he compared it to.

During a concurrent interview with the Chef Supervisor (CS), she stated that these were new test strips and she did not know they had different instructions than the ones they had been previously using. She did not know how long they had been using these new strips. She noted the new requirement to immerse the strips for 90 seconds and acknowledged that 90 seconds was too long and not practical.

During a follow-up interview with DS 1 and the CS the same day at 10 am, DS 1 stated that the pots and pans should be immersed in the sanitizer for at least 30 seconds. The CS then stated a minimum of 10 seconds.

A review of the manufacturer's posted instructions for the sanitizer stated "Apply [sanitizer] at the proper use solution. Expose all surfaces of equipment, ware or utensils to the sanitizing solution for a period not less than one minute."

A review of the hospital's log titled "Dishroom 3 compartment sink log" (dated September 2017) indicated that DS 1 had documented the concentration of the sanitizer on 10 of the 58 entries on the log. All the entries from DS 1 indicated the concentration was either 250 ppm or 300 ppm. Neither of the color charts have a color labeled 250 ppm. They both have colors for 200 or 300 ppm, not 250 ppm. The directions to the staff on the log stated' "For sanitizer tank, immerse strip for 10 seconds before recording. Record the number that corresponds to the color of your strip ...."

During a concurrent interview with the Director of Food and Nutrition Services, she stated that the CS had oversight of the kitchen's sanitation.

A review of the hospital's policy titled "Cleaning and Sanitation" (approved February 14, 2017) indicated, "Warewashing: Manual Cleaning and Sanitizing. The three compartment washing area consists of three tanks, each designed to handle: Soaking and Washing; Rinsing; Sanitizing .....All wares will be completely submerged for at least one minute in the final third sink containing sanitizing/antibacterial agent ....Ppm is checked each time the sanitizer is changed."

e. During a review of employee files for Cook 1, Dietary Staff 1 (DS 1) and the Chef Supervisor (CS) the competency evaluations of these staff were reviewed. The employee file for the CS included a competency evaluation dated May 3, 2016 for Safe Food Handling which included the topics of personal hygiene; food safety; purchasing, receiving and storage; preparing, cooking and serving; cleaning and sanitizing; and chemical usage. The method of evaluation included simulation and document review. The competency was signed by the Director of Food and Nutrition Services (DFANS).

During an interview with the DFANS on September 19, 2017 at 11:00 am, the DFANS stated that she had provided additional training for the CS to ensure the CS's competency. The DFANS stated that she was surprised that the CS showed knowledge lapses during the survey.

The employee file for Cook 1 was reviewed. Competencies dated June 1, 2017 were noted and validated by the CS. Validated competencies included proper personal hygiene and use of PPE (personal protective equipment), hand hygiene procedure. The competency was validated using observation and inspection of work according to the document..

The employee file for DS 1 was reviewed. The competency dated August 24, 2017 included safe food handling, cleaning and sanitizing. The competency was validated by the Café Supervisor but the method of validation was not indicated according to the document.

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

1. There was an effective system to identify unsanitary conditions in the Food and Nutrition Services and the nursing unit nourishment rooms when:

a. Cooked TCS foods (Time and Temperature Controlled for Safety foods are potentially hazardous foods capable of sustaining disease causing microbial growth when stored or processed inappropriately) were not monitored for safe cooling. There was no system in place to monitor cooked TCS foods to ensure rapid cooling. Excessive time for cooling of cooked TCS foods has been consistently identified as one of the contributing factors to food borne illness (Food Code 2013).
b. Cook 1 failed to wash his hands multiple times between handling cooked food and touching the trash can to move it in and out from under the cooks table.
c. Food preparation equipment was not maintained in a clean and sanitary condition when: the table-mounted can opener was observed with a significant build-up of a sticky black substance; the griddle had a significant accumulation of a black greasy substance; and, the ice machine had a significant build-up of a black residual along the top of the deflector in the ice storage bin.
d. Dietary Staff 1 (DS 1) who was responsible for washing the pots and pans used for patient food service and the Chef Supervisor (CS), DS 1's supervisor, did not know how to check the concentration of the sanitizer in the sink used to ensure the utensils were effectively sanitized. In addition, neither DS 1 nor the CS knew how long the pots and pans had to remain in the sanitizer solution in order to effectively sanitize the utensils.
e. Perishable food items stored in the Food and Nutrition Services refrigerators were not dated or were not effectively dated to ensure safe storage times and prevent spoiled foods from being served to patients.
f. Perishable patient food, brought in by visitors from the outside the hospital and stored in the nursing unit nourishment refrigerators, were not date monitored or discarded to ensure the food remained safe for the patients to consume. In addition, almond milk that had been opened and placed in the nursing unit nourishment refrigerator was not dated to monitor for safe storage time.
g. The hospital's Infection Control surveillance of the Food and Nutrition Services was inadequate to identify unsanitary conditions in order to develop a plan for remediation.

These failures had the potential to result in food borne illness in a highly susceptible patient population of 57 patient who were served food at the hospital, as well as staff and visitors who ate the food from the cafeteria. Of the 57 patients who were served the food, three patients had physician orders for a Transplant Diet that the Hospital's Diet Manual (approved 2015) described as, "This nutrition therapy addresses the food safety concerns of individuals whose immunity is suppressed and who are at high risk for food borne illness."

2. In addition, the hospital failed to ensure the transport and storage of disinfected endoscopes was maintained in a sanitary manner related to the following:

2a. A staff transported a disinfected endoscope, which was not covered, across a patient care hallway and into the Endoscopy suite during the presence of 1 of 35 sampled patient's (31).

2b. An endoscope, which was inside of a scope storage cabinet, was not placed in a manner to effectively air dry.

2c. A shelf inside of an endoscope storage cabinet was observed lined with particle debris.

The lack of covered endoscopes during transport, improper storage of endoscopes, and endoscope cabinet disrepair, did not ensure disinfected endoscopes were protected from potential microorganisms.

Findings:

1. Unsanitary conditions in the Food and Nutrition Services and nursing unit nourishment rooms:

a. Safe cooling of TCS foods requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of TCS foods has consistently been identified as one of the leading contributing factors to food borne illness. During slow cooling, TCS foods are subject to the growth of a variety of pathogenic (disease causing) microorganisms. A longer time near ideal bacterial incubation temperatures of 70 °F to 125 °F (degrees Fahrenheit) is to be avoided. If food is not cooled in accordance with this Code requirement, pathogens may grow to sufficient numbers to cause food borne illness. Time/temperature control for safety foods includes plant food that is heat treated or cooked (Food Code 2013).


During an observation in the walk-in refrigerator in the kitchen on September 18, 2017 at 10 am, a two inch hotel pan of cooked penne pasta and the same size pan of cooked rice were being stored and both were dated September 16, 2017.

During a concurrent interview with the Chef Supervisor (CS) she stated that the rice and pasta were cooked on September 16, 2017, and they were good for three days. She further stated that although the pasta and the rice should have been monitored for safe cooling, they were not. She stated that she had identified a systemic problem with the staff not monitoring the safe cooling of foods that should be monitored "a while back" and she had a "Fishbone Diagram" plan (a tool used to determine cause and effect relationships within processes) to resolve the issue. She had not moved forward with any action to resolve the issue yet. She could not explain why the staff was not competent in monitoring the safe cooling of TCS foods when the process was a high risk of food borne illness to patients in the hospital and she had identified cooling as a problem "a while back."

A review of the hospital's "Cooling Temperature Log" dated October 17 [2016] through July 24 [2017], indicated instructions, "Potentially hazardous food [now referred to as TCS food] must be cooled from: 135 °F to 70 °F within two hours, AND THEN FROM 70 °F to 41 °F or lower in the next four hours." The cooling log included eight items, one of which was rice (dated December 14 [2016]). Of the eight items on the cooling log, only one items had been cooled according to the instructions. Four of the eight TSC foods on the cooling log were not monitored to ensure that the food reached 70 °F or less within the two hours required by the Food Code and the log's instructions. There were no entries on the log after July 24, 2017.

During an interview with the Director of Food and Nutrition Services (DFANS) on September 19, 2017 at 10:20 am, she stated that she knew about the problem with staff not correctly monitoring the safe cooling of TSC foods in July, 2017. She further stated that the staff responsible for cooling had not been in-serviced on the process. She was not aware that cooked TSC foods were being saved and stored.

During a concurrent interview with the Clinical Manager of Patient Services Dietitian (PSD) she stated that she does not provide oversight over the food production except to review the sanitation audits that the lead dietary staff conduct twice a month. She stated that she does a paper review of the audits to review any issues and ensure they are complete. She stated that monitoring of the cooling process is not one of the items on the sanitation audits that she reviewed.

b. During an observation of Cook 1 on September 18, 2017 at 10:50 am, Cook 1 was observed, with gloved hands, cutting open bags of cooked chicken and sauce and pouring the food into pans. Cook 1's gloved hands contacted the food as it was poured into the pans. He opened and poured four bags and between each bag he used his gloved hands to pull the trash can out from under the table he was working at and push it back under the table. Cook 1 did not wash his hands after touching the trash can and continuing to prepare the food.

During a concurrent interview with the Chef Supervisor (CS), the CS stated she observed Cook 1 doing this as well. She further stated that he should have washed his hands between handling the trash can and handling the food. She stated that it was the Food and Nutrition Services staff practice to keep the trash cans under the tables so that they are covered, even while in use.

During a concurrent interview with the Director of Food and Nutrition Services, she could not explain why the trash cans were stored under the food preparation table requiring them to be handled throughout the food preparation process.

According to the 2013 Food Code, receptacles and waste handling units shall be kept covered inside food establishments when not in continuous use.

A review of the hospital's policy titled "Infection Control and Sanitation" (approved February 14, 2017) indicated: "Hand Hygiene: Wash hands with soap and warm water for 20 seconds before starting work, before putting on clean single-use gloves, between glove changes and before handling clean single use equipment and utensils. Change gloves and wash hands when changing task and during food preparation as often as necessary to remove soil and contamination. Also after handling soiled articles ...."

c. During a tour of the kitchen and concurrent interview with the Chef Supervisor (CS) on September 18, 2017 at 10:40 am, the table-mounted can opener and its holder were observed with a significant build-up of a sticky black residual. The blade on the can opener was worn with the black, sticky residual built up. The CS stated a lack of cleanliness of the can opener had previously been identified and she had been working on a plan to ensure it was clean. She stated the can opener was not clean and it looked like it had not been cleaned recently due to the black sticky build-up that did not appear fresh. She stated that the can opener should be cleaned and sanitized continuously after each use by running it through the dish machine.

During a concurrent interview with the Director of Food and Nutrition Services, she stated the can opener was not clean. She further stated that the cleanliness of the can opener was a part of the sanitation audits that the staff leads complete twice a month. She stated that the CS was responsible for ensuring the equipment and utensils were cleaned and sanitized effectively to prevent cross contamination. She verified that the can opener blade needed to be replaced.

During a subsequent observation the same day at 11:15 am, the grill in the cook's area was noted to have a significant build-up of a black caked on residue. During a concurrent interview with Cook 2, he stated the grill was used to cook teriyaki chicken which was "pretty sugary" and this caused the build-up and also could be a pest attractant. He further stated that one of the staff cleaned the grill at night. He did not know how often it was cleaned and he verified that it did not look clean.

During a concurrent interview with the CS, she was not able to explain why the grill was not clean. She verified that it did not look like it had been cleaned for a while.

A review of the hospital's policy titled "Cleaning and Sanitation" (approved February 14, 2017) indicated for "Food Equipment Cleaning: 1. All equipment used in food preparation and service will be cleaned and sanitized after each use, every 4 hours, or as needed."

According to the 2013 Food Code, equipment food contact surfaces and utensils shall be clean to sight and touch. Nonfood contact surfaces shall be cleaned at a frequency necessary to preclude accumulation of soil residual.

During an observation of the ice machine in the kitchen on September 20, 2017 at 9:00 am, with Engineering Staff 1 (ES 1) and Engineering Staff 2 (ES 2), a white napkin swipe of the top of the ice deflector (a plastic part attached inside the ice storage bin that causes the ice to drop to the back of the storage bin) resulted in a significant amount of a black residual. The residual was also present on the ceiling and walls of the storage bin where the deflector was attached which was a potential ice contact surface. The deflector was simply removed utilizing thumb screws that were removed with just hands.

During a concurrent interview with ES 2, he stated that the hospital used a contracted service to perform the cleaning of the ice machine including the ice storage bin. He stated that the Engineering Staff does not check to ensure the contracted service does an effective job in cleaning the ice machine. He could not explain why the deflector was not removed and cleaned when the ice machine was being cleaned.

A review of the Preventive Maintenance (PM) record for the ice machine (printed on September 19, 2017) indicated the last time the ice machine was cleaned was September 14, 2017. The PM instructions included direction to clean and sanitize the reach-in storage bin with hypochlorite solution, rinse thoroughly and let dry.

The ice machine manufacturer's cleaning instructions (undated) included direction to "Clean the storage bin liner using a neutral cleaner. Rinse thoroughly after cleaning."

According to the 2013 Food Code, in equipment such as ice bins, beverage dispensing nozzles and enclosed components of equipment such as ice makers ....shall be cleaned at a frequency necessary to preclude accumulation of soil or mold.

d. During an observation and concurrent interview with Dietary Staff 1 (DS 1) on September 19, 2017 at 9:45 am, DS 1 demonstrated how he tested the sanitizer concentration in the pots and pans sinks. He stated that the patient food pots and pans were cleaned and sanitized in these sinks. In the third sink, sanitizer was used to ensure the pots and pans were effectively sanitized before they were air-dried. DS 1 immersed a paper test strip in the sanitizer solution in the third sink for approximately 15 seconds. He then compared the strip to a color chart posted on the wall and stated the concentration was 200 parts per million (ppm) which was what it was supposed to be. The color of the strip did not match the colors on the posted color chart. DS 1 agreed that the strip was not consistent with the color chart on the wall. He stated that he was trained the way he just demonstrated on how to check the sanitizer concentration.

A review of the manufacturer's instructions on the test strips package indicated, "Dip about one inch of a test paper into the solution to be tested and hold there for 90 seconds. Then compare the test paper against the color standards shown above (on the strip label)." The color standard on the strip label was not the same as the one posted on the wall.

During a concurrent observation, the test strip that DS 1 used was compared against the color standard on the test strip package and it did not match any of those colors either. DS 1 was unable to state how he could determine the concentration of the sanitizer when the color of the strip did not match either of the two charts he compared it to.

During a concurrent interview with the Chef Supervisor (CS), she stated that these were new test strips and she did not know they had different instructions than the ones they had been previously using. She did not know how long they had been using these new strips. She noted the new requirement to immerse the strips for 90 seconds and acknowledged that 90 seconds was too long and not practical.

During a follow-up interview with DS 1 and the CS the same day at 10 am, DS 1 stated that the pots and pans should be immersed in the sanitizer for at least 30 seconds. The CS then stated a minimum of 10 seconds.

A review of the manufacturer's posted instructions for the sanitizer stated "Apply [sanitizer] at the proper use solution. Expose all surfaces of equipment, ware or utensils to the sanitizing solution for a period not less than one minute."

During a concurrent interview with the Café Supervisor (CaS) and the CS, the CaS stated that he did not know they were using different strips. The CaS stated the CS ordered them and he did not know they were different with different instructions. The CS stated that she was indirectly involved with training the DS 1 on effectively washing and sanitizing pots and pans. The CS stated she relied on experienced staff to train the new staff.

A review of the hospital's log titled "Dishroom 3 compartment sink log" (dated September 2017) indicated that DS 1 had documented the concentration of the sanitizer on 10 of the 58 entries on the log. All the entries from DS 1 indicated the concentration was either 250 ppm or 300 ppm. Neither of the color charts have a color labeled 250 ppm. They both have colors for 200 or 300 ppm, not 250 ppm. The directions to the staff on the log stated' "For sanitizer tank, immerse strip for 10 seconds before recording. Record the number that corresponds to the color of your strip ...."

During a concurrent interview with the Director of Food and Nutrition Services, she stated that the CS and the CaS have oversight of the kitchen's sanitation.

A review of the hospital's policy titled "Cleaning and Sanitation" (approved February 14, 2017) indicated, "Warewashing: Manual Cleaning and Sanitizing. The three compartment washing area consists of three tanks, each designed to handle: Soaking and Washing; Rinsing; Sanitizing .....All wares will be completely submerged for at least one minute in the final third sink containing sanitizing/antibacterial agent ....Ppm is checked each time the sanitizer is changed."

e. During a tour of the kitchen, in the walk-in diary refrigerator, on September 18, 2017 at 10:00 am, a pan of cheese slices was marked with two different use by stickers: one indicated it was opened on Monday/Use by Wednesday; the second sticker indicated it was opened on Friday/Use by Sunday. During a concurrent interview with the Chef Supervisor (CS) she stated that the two stickers were confusing and did not direct staff as to when to discard the cheese.

The same day at 10:10 am, during an observation in the walk-in meat refrigerator, a basket containing two dozen eggs in shells was on a shelf with no date. During a concurrent interview with CS, she stated that the eggs were hard boiled and they should have been dated in order to determine their use by date.

In the same refrigerator, during a concurrent observation five eight pound cooked and five eight pound raw, manufacturer sealed, turkey breasts labeled "keep frozen" were thawing on a shelf with no date that the thawing started or a use by date.

During a concurrent interview with the CS, she stated that everything should be dated to ensure safe shelf life of the perishable food items. She stated that dating was not the practice because she knew when the food was placed in the refrigerator. She was unable to explain how the other staff would know how to monitor the shelf life of these items if she was not available. She stated that the system should be to date the food in the refrigerator that did not have a manufacturer's use by or expiration date.

During an interview with the Director of Food and Nutrition Services on September 20, 2017 at 2:20 pm, she stated that all food items without an effective manufacturer's expiration or use by date should be labeled with a date. She verified that both the cooked and raw turkey breasts should be dated to monitor the shelf life once thawed. The hard boiled eggs also should have been dated.

A review of the hospital's policy titled "Food Purchasing, Receiving, Inventory and Storage" (approved February 14, 2017) indicated "Dating of Food Items .....Individually opened potentially hazardous foods (PHF) will be dated and used within 3 days ....Prepared perishable items will be dated with an expiration date that is the earliest expiration date of all ingredients or dated and used within 7 days of preparation. Some items may be dated for 3 days to preserve freshness ....Fresh or thawed meats will be dated and used within 5 days ...."

f. During an observation in ICU nursing unit nourishment room patient refrigerator on September 18, 2017 at 3:10 pm, a brown bag that had a Chinese food container with cooked food stored inside it was noted in the patient refrigerator not dated or labeled. Also noted was an 8 ounce container of almond milk that had a broken seal and had a patient name on it, but no date.

During a concurrent interview with RN X, she stated that all items brought in from the outside or food items placed back in the patient refrigerators should be labeled with a date and patient name. She further stated that these food items should be discarded after 24 hours. Since they were not dated, she was unable to state how long the food had been in the refrigerator, but she said that the Chinese food was not brought in that day. In addition, the patient name on the container of unsealed almond milk was not a patient currently on the unit. The patient had not been on the unit since September 14, 2017.

During a concurrent interview with the Director of Food and Nutrition Services, she stated that it was the responsibility of the food and nutrition staff to inspect the food items in the nourishment room refrigerators daily and discard any food items that were not labeled and dated. She could not explain why the food found in the ICU nourishment room patient refrigerator had not been discarded.

During an interview with the Clinical Manager of Patient Services Dietitian (PSD) on September 20, 2017 at 2:40 pm, she stated that the Food and Nutrition staff that pass the meal trays to the patients during meal times, also stock the nourishment room patient refrigerators and are supposed to discard expired or unlabeled, undated food at that time. These staff should have discarded the food found in the nursing station nourishment room refrigerators. The PSD was unable to explain why the food had not been discarded.

A review of the hospital's policy titled "Food from Non-Hospital Sources" (approved March 24, 2017) indicated "Hot food must be discarded after two hours. Hot food cannot be refrigerated and reheated ....Cold food will be discarded the following morning ....All stored patient food will be labeled with the patient's name, date and date the food is to be discarded."

g. During an interview with the Infection Preventionist/Epidemiologist (IP) on September 20, 2017 at 11 am, the IP stated that she participated in Environment of Care (EOC) rounds annually in the Food and Nutrition Services department. She stated that the focus during these rounds was on cleanliness of the area and equipment. The IP stated that she looked at the cleanliness of the outside of the ice machine and did not open it up to inspect it. During the EOC rounds she observed staff hand hygiene, including appropriate use of gloves as well as other issues. The IP stated that the reports from the EOC rounds were reported to the Food and Nutrition Services department but no formal follow-up was required if gaps in infection control processes were found, unless they were significant.

A review of the most recent EOC rounds completed in Food and Nutrition Services dated May 30, 2017, indicated that one of the items listed was "Ice Machines clean" in which the standard was met. The EOC round form listed as "FNS Kitchen/Offices" included items such as "hand hygiene before use of glucometer strips" (a glucometer is a device used to check blood sugar, not used in the kitchen), "foley catheter (urine collection tube) tubing secured, not on the floor" which indicated the form was not specific for the kitchen despite being labeled such.

During an interview with the IP on September 20, 2017 at 2 pm, she confirmed that the form contained observations that would not occur in the kitchen. She could not explain why. She acknowledged that Food and Nutrition Services can be a high risk service related to the risk of spreading food borne illness if sanitary conditions were not maintained.

A review of the hospital's document titled "Infection Control, Prevention and Surveillance Plan" (approved November 18, 2016) indicated that the scope of the Infection Control Program was a "broad-based, multi-departmental program that uses epidemiologic methods for identifying healthcare associated infections (HAI) and communicable diseases. The focus of the program is on the prevention and control of healthcare associated infections among inpatients, employees, LIPs (licensed independent practitioners), volunteers and visitors. Infection Control (IC) serves as a resource for identification and investigation of infections, infectious exposure, and recommendations for the prevention of these infections and problem resolution. The principles of continuous process improvement guide the activities of IC."


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2a. On 9/18/17 at 11:00 A.M., a tour of the Endoscopy suite was conducted with the Lead Endoscopy Technician (LET), an Endoscopy Assistant (EA) 1, Intensive Care Unit Supervisor (ICU-S), Director of Regulatory (D-REG) and the Epidemiology Manager (MGR-E).

EA 1 transported an uncovered disinfected endoscope, in his gloved hand from the endoscope cleaning room, across a patient's care hallway within the Endoscopy suite, and entered the endoscope storage room. Patient 31 and a visitor were observed seated in chairs in the patient's care hallway during the uncovered endoscope transport.

On 9/18/17 at 11:30 A.M., an interview was conducted with EA 1, LET, and MGR-E. EA 1 stated he was trained to transport the disinfected endoscopes from the endoscope cleaning room to the endoscope storage room via a gloved hand. The LET stated he transported endoscopes via a gloved hand, without the use of clear bags or bins with lids. Furthermore, during the interview, MGR-E stated, in the past, the endoscopes were transported inside clear bags and bins with lids. She stated, the previous process was intended for infection prevention, however was not being implemented.

2b. On 9/18/17 at 11:45 A.M., an observation of the endoscope storage room was conducted with EA 1 and LET. Three endoscope cabinets were observed. An endoscope (SIF- a long scope ) was draped on a hook and coiled around another endoscope, in the middle of one of the cabinets. The LET stated because of the SIF length, it should be draped on the furthest right or left hook inside the cabinet, to allow the scope tubing to extend over the length of the cabinet, and then downward to properly dry. In addition, the LET stated the Endoscopy Technicians initialed a document titled "AM Scope Cabinet Check." The document did not stipulate components of the cabinet inspection other than the date and staff initials.

2c. Another endoscope cabinet had visible debris present on the shelf which supported the endoscope hooks. According to the LET, the cabinet door rolled open via a track similar to a garage door, and each time it rolled open, debris particles fell into the scope cabinet. In addition, he stated he thought it had been reported to management for a work order.

On 9/21/17 at 11:45 A.M., an interview was conducted with the Endoscopy Registered Nurse Supervisor (ENS) 1. ENS 1 stated the hospital expected staff corrected any improperly placed endoscopes on the spot. Per ENS 1, the responsibility was placed upon the staff which validated the endoscope placement when the Scope Cabinet Check document was initialed. Additionally, ENS 1 stated the hospital expected staff implemented Departmental policies.

The hospital's Policy titled Flexible Endoscope Processing Program and Procedures, dated 2/1/16 was reviewed. The Policy indicated "...All departments authorized to perform scope processing must comply..." "After high-level disinfection, transport ready for use endoscopes using clear bins or bags ensuring that the endoscope is contained."

This Policy was not implemented or revised to reflect the hospital's current process followed in the Endoscopy suite.

Based on interview, and record review, the hospital failed to ensure discharge instructions were signed by the patient/family/representative, per facility policy for 2 of 35 sampled patients (8, 10).

As a result, there was potential for patients to not fully understand discharge instructions if not provided a copy of the instructions to follow at the time of discharge.

Findings:

Patient records were reviewed on 9/20/17 and 9/21/17.

1. Patient 8 was admitted to the facility on 9/7/17 for a surgical procedure and was discharged from the facility on 9/18/17, per the face sheet.

Patient 8's medical record included discharge instructions, however, there was no signature to reflect the instructions were received by the patient/family/representative.

2. Patient 10 was admitted to the facility on 9/18/17 for a surgical procedure and was discharged the same day, per the face sheet.

Patient 10's medical record included discharge instructions; however, there was no signature to reflect the instructions were received by the patient/family/representative.

RN 2 stated in an interview on 9/25/17 at 9:25 A.M., the facility recently changed their electronic medical record system and the new system does not have a signature line built in to the system for a surgical patient/family/representative to sign for their discharge instructions.

The facility staff provided a policy, entitled Medical - Surgical Standards of Practice, dated 12/16, and indicated, "As applicable, obtain patient/family signature on the discharge form/s and provide patient/family with a copy."