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Based on observation, interview, and record review, the facility failed to ensure:

1. Physicians and staff were able to properly identify the type of restraints being used (Refer to A171);

2. Restraints used for the management of violent behavior were limited to four hours per episode, and renewed if the need for restraint continued (Refer to A171);

3. A one hour face-to-face evaluation was conducted after restraints were applied for violent or self-destructive behavior (Refer to A178); and,

4. One hour face-to-face restraint evaluations contained the required elements to determine if other factors were contributing to the patient's violent or self-destructive behavior (Refer to A179).

The cumulative effect of these systemic problems resulted in failure to protect and promote the rights of patients in a safe and effective manner.

Based on observation, interview, and record review, the facility failed to ensure, for two of three sampled patients placed in restraints for the management of violent or self-destructive behavior (Patients 8 and 11):

1. Physicians and staff were able to properly identify the type of restraints being used when the orders were for, "Non-violent," restraints; and,

2. The restraints were limited to four hours per episode, and renewed if the need for restraint continued.

This failed practice resulted in the potential for unnecessary and unsafe use of restraints in violation of the patients' rights.

Findings:

1 a. On May 23, 2019, the record for Patient 8 was reviewed. Patient 8, a 47 year old female, presented to the facility Emergency Department (ED), on May 15, 2019, at 1:58 a.m., with diagnoses including altered level of consciousness and apneic breathing (periods of not breathing).

The Patient Notes dated May 15, 2019, at 2:19 a.m., indicated Patient 8 got out of bed, ripped out her intravenous (IV - directly into a vein) line, ran into the ED hallway naked, and, "started charging towards staff members."

A physician's order dated May 15, 2019, at 3:06 a.m., indicated, "non-violent," restraints were to be applied on all four extremities.

The Restraint Documentation dated May 15, 2019, at 3:30 a.m., indicated restraints were initiated, and the clinical justification was "combative, physical aggression, violent."

The Patient Notes dated May 15, 2019, at 3:40 a.m., indicated Patient 8 had "aggressive behavior."

During an interview with the Quality Manager (QM), on May 23, 2019, at 10 a.m., she reviewed the record for Patient 8, and was unable to find documentation of a restraint order for violent/self-destructive behavior. The QM stated the orders for restraints should have been written based on the patient's actions/behaviors.

b. During a tour of the Medical Surgical (MS) unit on May 20, 2019, at 1:53 p.m., accompanied by Registered Nurse (RN) 1, Patient 11 was observed sitting in an upright position in her bed. The head of the bed was not elevated to support her back. Both wrists were restrained to the bed. She did not have any intravenous lines, cables, or tubing attached to her.

In a concurrent interview, RN 1 stated Patient 11 was restrained due to restlessness and removing items from her bedside table. RN 1 stated, "out of the blue, she just throws things."

The record for Patient 11 was reviewed on May 21, 2019. Patient 11, a 43 year old female, was admitted on April 4, 2019, with diagnoses that included high blood pressure and altered mental status. The patient was free of any intravenous lines and tubing as of May 19, 2019.

The record indicated the following:

- Patient 11 was removed from restraints following the tour and interview with RN 1 (on May 20, 2019, at 6:07 p.m.);

- At 9:39 p.m., she became combative, confused, not following commands, agitated, throwing objects, and trying to push the sitter. An order was obtained for, "Non-violent," restraints; and,

- At 9:40 p.m., Patient 11 was placed back in bilateral wrist restraints. The level of the restraints was documented as, "non-violent."

During an interview with the Director of the MS unit (DMS) on May 21, 2019, at 1:45 p.m., the DMS stated the restraints were applied for violent behavior, and the order should have reflected that.

2 a. On May 23, 2019, the record for Patient 8 was reviewed. Patient 8, a 47 year old female, presented to the facility Emergency Department (ED), on May 15, 2019, at 1:58 a.m., with diagnoses including altered level of consciousness and apneic breathing (periods of not breathing).

The Patient Notes dated May 15, 2019, at 2:19 a.m., indicated Patient 8 got out of bed, ripped out her intravenous (IV - directly into a vein) line, ran into the ED hallway naked, and, "started charging towards staff members."

A physician's order dated May 16, 2019, at 8:53 a.m., indicated bilateral soft upper extremity restraints were to be applied for attempts of self-harm, combative, physical aggression, and unsafe mobile attempts; the level of restraint was "violent/self-destructive;" and the order expired in four [4] hours.

The Patient Notes dated May 16, 2019, indicated the following:

- At 9 a.m., Patient 8 was running down the hallway, and the patient was trying to kick the staff as they were trying to put the patient back to bed. Patient 8 was given Haldol (medication used to treat mental/mood disorders), and was placed in bilateral upper extremity restraints;

- At 10:30 a.m., Patient 8 was biting off her right upper arm restraint, was kicking whoever came close to her, and a code gray (combative person) was called; and,

- At 3:26 p.m. (six hours and 33 minutes after the restraints were applied), Patient 8 remained in restraints.

There was no evidence the order to place Patient 8 in restraints for violent/self-destructive behavior were renewed after four hours (May 16, 2019, at 12:53 p.m.), even though the restraints remained in place.

During an interview with the Quality Manager (QM), on May 23, 2019, at 10 a.m., she reviewed the record for Patient 8, and was unable to find documentation of a restraint order for violent/self-destructive behavior after May 16, 2019, at 12:53 p.m., even though the restraints remained on the patient. The QM stated the restraint order should have been renewed every four hours.

b. During a tour of the Medical Surgical (MS) unit on May 20, 2019, at 1:53 p.m., accompanied by Registered Nurse (RN) 1, Patient 11 was observed sitting in an upright position in her bed. The head of the bed was not elevated to support her back. Both wrists were restrained to the bed. She did not have any intravenous lines, cables, or tubing attached to her.

In a concurrent interview, RN 1 stated Patient 11 was restrained due to restlessness and removing items from her bedside table. RN 1 stated, "out of the blue, she just throws things."

The record for Patient 11 was reviewed on May 21, 2019. Patient 11, a 43 year old female, was admitted on April 4, 2019, with diagnoses that included high blood pressure and altered mental status. The patient was free of any intravenous lines and tubing as of May 19, 2019.

The record indicated the following:

- Patient 11 was removed from restraints following the tour and interview with RN 1 (on May 20, 2019, at 6:07 p.m.);

- At 9:39 p.m., she became combative, confused, not following commands, agitated, throwing objects, and trying to push the sitter, and an order was obtained for restraints;

- At 9:40 p.m., Patient 11 was placed back in bilateral wrist restraints; and,

- Patient 11 remained in restraints for 17 1/2 hours.

There was no evidence the restraint order was renewed after four hours of restraint use (for the management of Patient 11's behavior).

During an interview with the Director of the MS unit (DMS) on May 21, 2019, at 1:45 p.m., the DMS stated the restraints were applied for violent behavior, and the order should have been renewed every four hours.

The facility policy and procedure titled, "Restraint and Seclusion Guidance Policy," last revised by the facility February 2018, revealed "... Order for Restraint with Violent or Self-Destructive Behavior...Orders for restraint or seclusion must not exceed: Four (4) hours for adults, aged 18 years and older...To continue restraint or seclusion beyond the initial order duration, the RN determines that the patient is not ready for release and calls the ordering physician to obtain a renewal order. Renewal orders for restraint/seclusion may not exceed: Four (4) hours for adults, aged 18 years or older...."

Based on interview and record review, the facility failed to ensure a one hour face-to-face evaluation was conducted after restraints were applied for violent or self-destructive behavior for three of three sampled patients in restraints for violent behavior (Patients 8, 11, and 29). This failed practice may have resulted in failure to determine the underlying cause of the patient's behavior, and inappropriate use of restraints.

Findings:

1. On May 23, 2019, the record for Patient 8 was reviewed. Patient 8, a 47 year old female, presented to the facility Emergency Department (ED), on May 15, 2019, at 1:58 a.m., with diagnoses the included altered level of consciousness and apneic breathing (periods of not breathing).

The ED record indicated Patient 8 demonstrated combative, physically aggressive, and violent behavior, and was placed in four point (wrists and ankles) restraints for violence on May 15, 2019, at 3:30 a.m. ( the first episode of restraints for Patient 8).

There was no evidence a physician or other allied health care professional conducted a one hour face to face assessment of the patient after she was placed in the restraints.

During an interview with the Quality Manager (QM) on May 23, 2019, at 10 a.m., the QM stated she was unable to find evidence a one hour face to face assessment was conducted.

2. The record for Patient 11 was reviewed on May 20, 2019. Patient 11, a 43 year old female, was admitted on April 4, 2019, with diagnoses to include high blood pressure and altered mental status.

The multidisciplinary notes dated May 20, 2019, at 9:39 p.m., indicated patient 11 was combative, confused, not following commands, agitated, throwing objects, and trying to push the sitter.

The record indicated Patient 11 was placed in bilateral wrist restraints on May 20, 2019, at 9:40 p.m. The patient remained in the restraints for 17 1/2 hours.

There was no evidence a physician or other allied health care professional conducted a one hour face to face assessment of the patient after she was placed in the restraints.

During an interview on May 21, 2019, at 1:45 p.m., the Director of the Medical Surgical Unit (DMS) stated the restraints were applied for violent behavior, and there should have been a face to face assessment (physician visually assessing the patient) within one hour of the restraint application.


3. The record for Patient 29 was reviewed on May 23, 2019. Patient 29, a 47 year old male, presented to the ED on May 21, 2019, with an altered mental status.

The ED record indicated Patient 29 demonstrated aggressive and combative behavior, and was placed in four point restraints for violence on May 21, 2019, at 3 p.m.

There was no evidence a physician or other allied health provider conducted a one hour face to face assessment of the patient after he was placed in the restraints.

During an interview with the Vice President of Quality (VPQ) on May 23, 2019, at 1:10 p.m., the VPQ stated she was unable to find evidence a one hour face to face assessment was conducted.

The facility policy and procedure titled, "RESTRAINT AND SECLUSION GUIDANCE POLICY," last revised February 2018, indicated, "Order for Restraints with Violent or Self-Destructive Behavior...age 18 years and older...A face to face assessment by a physician or (Licensed Independent Practitioner) LIP, (registered nurse) RN or physician assistant with demonstrated competence, must be done within one (1) hour of restraint or seclusion initiation."

Based on interview and record review, the facility failed to ensure the one hour face-to-face restraint evaluation for one of three sampled patients placed in restraints to manage behavior (Patient 8), contained the required elements to determine if other factors were contributing to the patient's violent or self-destructive behavior. This failed practice resulted in the potential for unnecessary and prolonged use of restraints.

Findings:

On May 23, 2019, the record for Patient 8 was reviewed. Patient 8, a 47 year old female, presented to the facility Emergency Department (ED), on May 15, 2019, at 1:58 a.m., with diagnoses that included altered level of consciousness and apneic breathing (periods of not breathing).

The physician's order dated May 16, 2019, at 8:53 a.m., indicated bilateral soft upper extremity restraints were to be applied for attempts of self-harm, combative, physical aggression, and unsafe mobile attempts; the level of restraint was "violent/self-destructive;" and the order expired in four hours.

The Patient Notes dated May 16, 2019, at 9 a.m., indicated Patient 8 was running down the hallway, and the patient was trying to kick the staff as they were trying to put the patient back to bed. Patient 8 was given a dose of Haldol [medication used to treat mental/mood disorders], and was placed in bilateral upper extremity restraints.

Patient 8 was seen by the physician, on May 16, 2019, at 9:20 a.m.

There was no evidence the physician evaluated the patient's immediate situation (running down the hallway, trying to kick staff), evaluated the patient's reaction to the intervention, evaluated the patient's behavioral condition, and evaluated the need to continue or terminate the restraints.

During an interview with the Quality Manager (QM), on May 23, 2019, at 10 a.m., she reviewed the record for Patient 8, and was unable to find documentation of the required elements for the one hour face-to-face evaluation by the provider. The QM stated the one hour face-to-face evaluation of the patient, with restraints for violent/self-destructive behavior, should have contained the required elements.

The facility policy and procedure titled, "Restraint and Seclusion Guidance Policy," last revised by the facility February 2018, revealed "... At the time of the face-to-face assessment, the LIP/physician/RN/PA will...Evaluate the patient's immediate situation. Evaluate the patient's reaction to the intervention. Evaluate the patient's medical and behavioral condition. Evaluate the need to continue or terminate the restraint or seclusion. Revise the plan of care, treatment and services as needed. ..."

Based on interview and record review, the facility failed to ensure nursing staff completed a comprehensive nursing admission assessment for 1 patient who presented with a pressure injury (Patient 40). This failed practice may have resulted in delayed treatment of the patient.

Findings:

The National Pressure Ulcer Advisory Panel (NPUAP) describes a Pressure Injury as localized damage to the skin and underlying soft tissue, usually over a bony prominence or related to medical or other devices. The injury can present as intact skin or an open ulcer and may be painful. Pressure injuries are classified into six different stages, four of which are Staged as 1-4.

A Stage 2 pressure injury is described as partial-thickness loss of skin with exposed dermis (the layer below the skin). The wound bed is viable, pink or red, moist.

A Stage 3 pressure injury is described as full thickness loss of skin, in which fat tissue is visible in the ulcer and granulation tissue and epibole (rolled wound edges) are often present. Slough and/or eschar (dark scab like tissue) may be visible.

Stage 4 pressure injury is described as full thickness skin and tissue loss with exposed muscle, tendon, ligament, cartilage or bone in the ulcer. Slough and/or eschar may be visible.

It would be the standard of practice to comprehensively document any skin issues at the time of hospital admission, including measurements of length, width and depth]

The record for Patient 40 was reviewed. Patient 40 was admitted on May 12, 2019, with a previous left hip fracture, which was determined at the time to be non-operable. An admission history and physical dated May 12, 2019, indicated the family was requesting a second surgical opinion. Patient 40 was transferred from a skilled nursing facility after a recent fall.

The nursing admission assessment dated May 12, 2019, included a skin assessment listing a Stage 2 or 3 pressure injury. There was no additional information documented at the time of admission.

A follow up nursing entry dated May 12, 2019, documented a stage 3 pressure injury. There were no additional descriptions or photographs of the wound.

A wound consult and two photographs were completed on May 17, 2019, (5 days after admission).

A review of the nurse's note titled. "Skin Integrity Photo Documentation," indicated with the exception of the date, time, location, and an indication the wound was present on admission, there was no additional information.

A review of the facility policy titled, "Skin Integrity Management," dated May 2017, indicated photographs of all wounds requiring treatment would be completed on admission, within the first 4 hours. Additionally, the procedure guided nursing staff to include measurement of wound dimensions including the wound length, width, and depth by recording the measurements in centimeters (a metric unit of measure).

In an interview on May 23, 2019, at 10:25 a.m., Administrative Staff 10 stated nursing staff should be staging and documenting all wounds at the time of admission, as the hospital currently was limited to one wound nurse.

Based on interview and record review, the facility failed to ensure pharmaceutical services were implemented in accordance with the facility's policy and procedure (P&P), when the data mining tool ("Vigilanz") used to identify patients on medications for possible conversion from intravenous (IV) route to oral (PO) route did not include all medications listed in the facility's P&P.

This failed practice resulted in the potential for complications from prolonged use of IV access/medications, and the potential for an increased length of hospital stay for patients not identified by the data mining tool.

Findings:

On May 22, 2019, at 8:20 a.m., Registered Pharmacist (RPH) 1 stated clinical pharmacists reviewed patients identified by Vigilanz for IV-to-PO conversion based on the rules programmed into the software. RPH 1 stated the medications with rules programmed into the software were predetermined at the corporate level. RPH 1 stated the software-identified patients on listed medications would be reviewed by the clinical pharmacist daily for IV-to-PO conversion if the criteria specified in the P&P were met.

On May 22, 2019, at 8:50 a.m., RPH 2 stated the IV-to-PO conversion report was reviewed daily. RPH 2 stated she relied on the software to identify patients currently receiving IV medications that were on the P&P list. RPH 2 stated if the software did not identify patients receiving any of the medications on the list, she would not do a review for IV-to-PO conversion. RPH 2 stated she did not have other ways to identify and include those patients.

On May 22, 2019, at 10 a.m., the Director of Pharmacy (DOP) agreed Vigilanz did not include all the medications listed in the P&P, therefore it did not identify all patients eligible for review.

On May 22, 2019, at 1:15 p.m., RPH 1 confirmed not all of the medications on the P&P list were programmed into Vigilanz.

The facility P&P titled, "Intravenous to Oral Conversion Policy," last approved, "6/18," indicated:

"The Treatment & Surveillance and Medical Executive Committee will establish criteria for the intravenous to oral administration conversion of select therapeutic agents with acceptable oral bioavailability...

Anti-infective medications listed in Appendix A may be changed from the intravenous route to the oral route...

Other medications that are ordered with an intravenous route in Appendix A may be changed to the oral route..."

A review of Appendix A of the P&P indicated there were 35 medications for inclusion in IV-to-PO conversion. The following IV medications were listed in the P&P, but not included in the software to identify the patients eligible for possible IV-to-PO conversion:

1. Ampicillin/Sulbactam (antibiotic);

2. Cefazolin (antibiotic);

3. Cefuroxime (antibiotic);

4. Ceftriaxone (antibiotic);

5. Phenytoin (Dilantin - treatment for seizures);

6. Paricalcitol (Zemplar - treatment for increased parathyroid hormone); and,

7. Valproic Acid (Depacon - treatment for seizures).

The Centers for Disease Control and Prevention (CDC) online publication titled, "Core Elements of Hospital Antibiotic Stewardship Programs," indicated:

"...Improving the use of antibiotics is an important patient safety and public health issue as well as a national priority...

A growing body of evidence demonstrates that hospital-based programs dedicated to improving antibiotic use, commonly referred to as "Antibiotic Stewardship Programs (ASPs)", can both optimize the treatment of infections and reduce adverse events associated with antibiotic use...

This document summarizes core elements of successful hospital Antibiotic Stewardship Programs...

Pharmacy-driven Interventions...

Automatic changes from intravenous to oral antibiotic therapy in appropriate situations, and for antibiotics with good absorption (e.g., fluoroquinolones, trimethoprim-sulfamethoxazole, linezolid, etc.), improves patient safety by reducing the need for intravenous access..."

Based on observation, interview, and record review, the facility failed to ensure medications requiring protection from light were stored in accordance with the manufacturer's recommendations, when injectable vials and compounded intravenous (IV) bags containing octreotide (medication to treat certain abnormal cancerous growth) were exposed to ambient light in the Pharmacy.

This had the potential for administering sub-potent and ineffective medications to patients.

Findings:

During an inspection of the Pharmacy on May 20, 2019, at 10:20 a.m., the following was observed:

- a compounded IV bag containing octreotide 500 microgram (mcg) in 100 milliliter (ml) of 5% dextrose was on the pharmacy counter without any protection from ambient light; and,

- vials of desmopressin 50 mcg/ml and 500 mcg/ml were stored out of the manufacturer's packaging in the Pharmacy medication refrigerator.

The label on the octreotide vials indicated: "Protect from light."

In an interview on May 20, 2019, at 11:45 a.m., the Medication Safety Pharmacist (MSP) confirmed the vials needed to be protected from light.

The facility policy and procedure titled, "Medication Procurement Storage and Security," last approved, "4/17" indicated:

"Medications are stored according to the manufacturer's recommendations..."

According to Lexicomp, the nationally recognized pharmacy medication reference, for octreotide,

"Injection solution: Octreotide is a clear solution and should be stored at refrigerated temperatures...Protect from light...

Based on observation, interview, and record review, the facility failed to ensure radiation workers were wearing their dosimetry badges/rings while performing procedures in the Nuclear Medicine Department. This failed practice resulted in the potential for an inaccurate reading of radiation exposure for the employees and providers.

Findings:

A dosimetry badge/ring consists of a radiation-sensitive material, such as film, worn in a small package on a person's clothing, to record the accumulated radiation exposure of the person over a period of time; - used to monitor the exposure of individuals.

On May 21, 2019, at 9:20 a.m., a tour of the Nuclear Medicine Department was conducted with the Supervisor of Nuclear Medicine (SNM).

The SNM stated the dosimetry radiation badges/rings for the staff and providers were stored in the plastic box attached to her office door, and each morning the staff would clock in and pick up their badge from the box, then return the badge to the box at the end of their shift.

The dosimetry radiation badges/rings for Nuclear Medicine Technicians (NMT) 1 and 2, and Nurse Practitioner (NP) 1 were observed to still be in the plastic box attached to the SNM's office door.

During a concurrent interview with the SNM, she stated since coming to work that morning, NMT 1 had done a bone scan, NMT 2 had done two resting cardiac procedures, and NP 1 was the medical provider for the cardiac procedures.

NMT 1, NMT 2, and NP 1 were not wearing their assigned dosimetry radiation badges/rings.

On May 21, 2019, at 9:37 a.m., NMT 1 was observed entering the, "hot lab," and preparing of a dose of radiopharmaceuticals (radioactive compounds used for diagnostic or therapeutic purposes). NMT 1 stated NMT 2 had done the daily dose calibration that morning prior to the start of the days cases. NMT 1 stated he had not put on his dosimetry badge/ring since the start of his shift.

During a subsequent interview with the SNM on May 21, 2019, at 10:08 a.m., she verified NMT 1, NMT 2, and NP 1 were not wearing their dosimetry badges/rings while working in the department, and should have been wearing them to determine their radiation exposure.

The facility policy and procedure titled, "Dosimetry Radiation Badges," last reviewed by the facility April 2019, revealed, "... To monitor and maintain radiation exposure to all personnel in ionizing radiation procedures and maintain compliance within maximum allowable limits on a monthly, annual and lifetime basis. All personnel involved in procedures utilizing ionizing radiation will be provided with a dosimetry badge and ring (if applicable) ... The badge must be worn at all times while on duty. ..."

The facility policy and procedure titled, "Isotope Administration," last revised by the facility September 2017, revealed, "... Wear personnel monitoring devices (film badge or TLD [Thermoluminescent dosimeters]) at all times in areas where radioactive materials are used or stored. These devices should be worn at chest or waist level. ..."

Based on observation, interview, and record review, the facility failed to:

1. Ensure departmental staffing patterns that supported the implementation of dietetic services (Refer to A619);

2. Ensure the Director of Food Services provided effective oversight into all areas of dietetic services operations (Refer to A620);

3. Ensure position related competency for two dietetic services staff and two vocational staff (Refer to A622);

4. Develop a menu that fully reflected the physician ordered diets, when the menu associated with four therapeutic diets (Pureed, Carbohydrate Consistent, Cardiac and Renal) did not meet physician approved parameters as outlined in the hospital approved diet manual (Refer to A631);

5. Ensure maintenance of equipment in accordance with manufacturers' guidance and standards of practice (Refer to A701); and,

6. Ensure effective implementation of dietetic services in a safe and sanitary manner and in accordance with current standards of practice (Refer to A749).

The cumulative effect of these systemic problems resulted in failure to ensure food and dietetic services were provided in a safe and effective manner.

Based on observation, interview, and record review, the facility failed to perform an effective organizational assessment of dietetic services to ensure adequate staffing in a manner consistent with accepted standards of practice. Failure to comprehensively evaluate departmental needs may lead to practices associated with contamination of food, equipment, and utensils, as well as menu development that does not meet the nutritional needs of the patients.

Findings:

During the survey from May 20, 2019 - May 23, 2019, deficient practices were identified in relationship to overall kitchen cleanliness, hand hygiene, storage of sanitized food equipment.

On May 20, 2019, at 1:50 p.m., an interview regarding staffing in the dish room was conducted with the Director of Food Services (DFS). The DFS stated normally there should be two employees in the dish room, one to load dirty dishes and one to unload clean dishes. The DFS stated occasionally other dietary positions helped unload clean dishes, however there were times the dishwasher worked both clean and dirty sides of the dish machine.

During an interview with the FFS on May 21, 2019, at 2 p.m., the DFS stated if staffing was up to him, he would staff two dishwashers for the dish room.

In an interview on May 21, 2019, beginning at 1:50 p.m., with the Clinical Nutrition Manager (CNM) and the DFS, both of which were employed by a Contracted Vendor, they stated foodservice operations were evaluated through various corporate mechanisms. They stated operations included evaluation of tray line (meal distribution) flow, patient meal delivery, and the implemented menu system. As an example, the CNM stated they recently adjusted the menu items, which included an evaluation of staffing in relationship to the production requirements for patient and cafe menus.

The surveyors asked the DFS to describe how the contracted vendor evaluated staffing needs. The DFS stated staffing standards were based on the number of licensed beds. He also stated the current staffing plan was essentially the same as 18 months ago, and since that time the facility added an additional 105 licensed beds. The DFS stated the most recent staffing analysis was completed approximately two years ago and it was forwarded to administration, however the employees in those positions were no longer with the facility.

The DFS stated the increase in volume resulted in an increase in an average of 40-50 patient meals per day, and the increase in licensed beds added an additional 200 staff non-dietary members, resulting in an increase of 45% in café volume. The DFS stated overall the foodservice demand in operations increased significantly, the exception being a small decrease in catering activity. The CNM stated patient menu selections, which consisted of many convenience items such as pre-cooked meats, hermitically sealed canned fruit, instant mashed potatoes, and powdered gravy, were selected based, in large part, on allocated staffing. The DFS also stated the public café was closed several hours during the day secondary to staffing levels. On May 22, 2019, at 9 a.m., the surveyor requested the staffing assessment completed by the contracted food service vendor.

In an interview on May 23, 2019, at 3:40 p.m., the Vice President of Operations (VPO) stated he was unable to locate any previous assessment. The VPO stated staffing needs were evaluated based on adjusted patient days. The facility presented a review of staffing for 2017-2019 (three years). Each year had a plan for low, average, and peak patient census. While the submitted report demonstrated an increase in full time equivalents (FTE), the assessment included contracted vendor leadership staff. The report did not evaluate whether the proposed FTE's, for direct staff (excluding leadership), would meet operational needs, nor did the report demonstrate if all positions were effectively filled.

A review of the facility non-select menu revealed repetitiveness for multiple meals. As an example, some type of potato was on the menu for both lunch and dinner on the Sunday and Monday. A non-select menu includes food provided when patients cannot request alternate selections. The Tuesday, Wednesday, and Friday menu also called for potatoes for dinner. Similarly, canned fruit was included for eight of 14 meals.

Based on observation, interview, and record review, the facility failed to ensure the Director of Food Services (DFS) provided comprehensive oversight of dietetic services operations when:

1. There was lack of identification of a substance, identified by an industrial hygienist as mold;

2. Two vocational coaches were not adequately trained, and the coaches and the vocational staff did not meet health screening parameters in accordance with hospital policy;

3. There was no system for temperature monitoring of café foods capable of supporting bacterial growth associated with foodborne illness;

4. Staff stored dry goods in trash bags;

5. Disaster food supplies did not include sufficient cooking utensils for preparation of emergency food; and,

6. Multiple food items were not dated.

Failure to ensure comprehensive and effective oversight of departmental operations may result in practices associated with food borne illness, food contamination, and the departments' ability to implement foodservice operations to meet the nutritional needs of patients.

Findings:

1. During general dietetic services observations on May 20, 2019, beginning at 2:40 p.m., a rust colored substance was observed along the length of walls, above the conveyor belt leading from the cafeteria, measuring approximately five inches high and greater than eight feet long. The substance resembled mold. Additionally, there were also multiple additional kitchen areas that were not clean.

In a concurrent interview, the Director of Food Services (DFS) stated staff washed the walls down nightly, however the area was probably not cleaned within the last 24 hours. In an interview and concurrent document review on May 20, 2019, at 2:50 p.m., the Infection Control Preventionist (ICP) indicated the substance was probably mold.

A review of six documents from April 6, 2019, through May 11, 2019, titled, "Cleaning Schedule Week Ending," indicated position #12 was responsible for cleaning the pulper and waste storage room. There was no documented scheduled cleaning for the walls in the area, or for the stainless steel railing above the pulper. An additional five weekly documents titled, "Daily Routines," from April 7, 2019, through May 12, 2019, revealed the condition of the wall above the pulper was not included in the supervisory review. It was also noted with the exception of the fryer and warmer box, there was no schedule for deep cleaning in kitchen areas.

During an interview on May 22, 2019, at 1:50 p.m., the DFS described oversight of the department by completing undocumented daily walk-through's, as well as reviewing cleaning logs and supervisory reports. There was no indication the presence of mold or cleanliness was identified.

2. During general dietetic services observations on May 21, 2019, at 11 a.m., dietary staff and vocational staff were observed removing cleaned/sanitized dishes from the dish machine. The items were wet, and were immediately stacked in storage locations. Similarly, multiple one-quarter and one-half steam pans were also stored wet.

On May 23, 2019, at 9:15 a.m., an interview was conducted with the Patient Services Manager (PSM) regarding training of vocational coaches (VC) and vocational students (VS). The PSM stated the VC was responsible for the VS working under them. The surveyor asked how the VCs were trained. The PSM stated there was no formal training or assessment of job competency completed. The PSM stated the VCs received a copy of a task analysis and were encouraged to ask questions. The PSM also stated the VC was responsible for making sure the VSs were trained. Additionally, the facility was unable to document VC's and VS's received health screenings in accordance with hospital policy.

A review of the facility policy titled, "Recruitment of Volunteers," dated July, 2014, indicated volunteers, once selected would be notified of a date for hospital orientation, and given instructions to obtain immunizations, including TB and Rubella screening.

The facility policy titled, "Health Screening and Examinations," dated March, 2016, indicated the policy applied to all personnel, departments and entities of the facility including volunteers. The policy included a procedure for ensuring the completion of a variety of screenings including but not limited to a medical history, immunization screenings, tuberculosis testing, and Hepatitis C virus testing.

3. According to the Food Code, 2013, food safety requires cold foods capable of supporting bacterial growth associated with foodborne illness to be held at 41 degrees Fahrenheit (F) or below.

On May 20, 2019, beginning at 2:25 p.m., food holding temperatures were reviewed in the café area in the presence of the Clinical Nutrition Manager (CNM) and the Executive Chef (EC). There were two, open front, grab and go refrigerators, each holding foods requiring time/temperature control for food safety. The refrigerator closest to the cash registers had fruit cups containing cut melons at a temperature of 45.7 degrees F.

The second refrigerator contained protein based sandwiches. A roasted chicken sandwich had a temperature of 50.5 degrees F. A second chicken sandwich, which was placed further back in the refrigerator, was 46.9 degrees F.

It was also noted that while each item was marked with an expiration date placed by the food production vendor, there was no marking when the item was placed into the café refrigerators. There was no system in place to monitor the time and/or temperature of foods capable of supporting bacterial growth associated with foodborne illness in the café.

4. During the initial kitchen tour on May 20, 2019, beginning at 9:50 a.m., there were three under counter storage bins containing items such as flour and sugar. The bin was lined with a black plastic bag, resembling a trash can liner. In a concurrent interview, Dietary Staff (DS) 2 stated the liners were used for multiple purposes within the kitchen. DS 2 also pointed out the box which was labeled as can liners. There was no indication on the label these bags were suitable for food storage.

The facility policy titled, "Food Storage," dated August, 2017, indicated dry bulk foods such as flour and sugar were stored in metal or plastic containers. There was no indication items should be placed in bags prior to bin storage.

5. A review of the facility document titled, "California Hospital Emergency Food Planning Tool," dated October 13, 2013, indicated the estimated population to be served equaled 1,754 individuals.

A review of the facility policy and procedure titled Emergency Mass Feeding Plan dated June, 2017, indicated a total of 459 cases of canned food was stored in the event of an emergency. Under the section titled Food Preparation, the instructions stated to stir contents into boiling water.

On May 21, 2019, at 11 a.m., an observation of the disaster food supply, and concurrent interview with the Director of Food Services (DFS) and the Clinical Nutrition Manager (CNM) was conducted. The DFS stated the facility used a dehydrated food product stored in #10 cans (a type of can holding approximately 109 ounces). The surveyor asked where the utensils for food preparation were stored. The DFS referred to a plastic bin containing serving utensils, but was not able to locate utensils needed for mixing the dehydrated food product once water was added.

6. A review of the facility policy and procedure titled, "Food Storage," dated August, 2017, indicated all food items were to be covered, labeled, and dated.

During initial kitchen tour on May 20, 2019, at 10:30 a.m., multiple items were observed without dates:

- The walk-in freezer contained undated beef franks, cooked bacon, and menudo;

- The walk-in refrigerator contained thawing meat, and undated pot roast and turkey;

- The dry storage area contained an open box of grits (not covered or dated), an open pancake syrup with no opened date, an open bottle of pure sesame oil with no opened date, an open bottle of vegetable oil with no opened date, an open bottle of white balsamic vinegar with no opened date, and an open bag of basmati rice with no opened date.

The EC acknowledged all food items should have been labeled and/or dated.

Based on observation, interview, and record review, the facility failed to ensure kitchen staff had the appropriate skill set to perform the duties necessary to prevent food borne illnesses when;

1. The sanitizer testing procedure was not in accordance with manufacturers' guidelines;

2. The sanitation of manual dishwashing was not in accordance with standards of practice; and,

3. Vocational Coaches and Vocational Students were not trained in accordance with standards of practice when handling sanitized equipment.

Failure to ensure staff competency may result in practices associated with food borne illness, further compromising the medical status of patients.

Findings:

1. According the 2017 Food Code, food contact surfaces and utensils shall be effectively washed to remove or completely loosen soils, rinsed so cleaning chemicals are removed, then sanitized before use.

a. In an interview conducted on May 20, 2019, beginning at 2:10 p.m., the surveyor asked Dietary Staff (DS) 1 to describe the cleaning/sanitation of large cooking equipment. DS 1 described a process whereby items were washed with detergent, rinsed, and sanitized. The surveyor also asked DS 1 to describe the testing process for ensuring chemical strength for the sanitizer currently in use. DS 1 demonstrated the testing process by comparing a test strip to a poster on the wall above the 3-compartment sink. Concurrent review of the manufacturer's insert accompanying the test strips guided staff to use the insert (not the poster on the wall). It was noted that while the colors on the poster resembled the colors printed on the manufacturers insert, the poster was not an accurate reflection of those colors. While the manufacturer's instructions guided the staff to compare the strip to the insert, they were using the poster instead.

b. The surveyor asked DS 1 to describe the cleaning process for food contact surfaces. DS 1 stated upon completion of food production activities, counters would be wiped down with detergent, however would only be sanitized if working with raw food such as meat, otherwise the counters would not need to be sanitized.

2. An interview was conducted with DS 3 and the DFS on May 21, 2019, at 11:35 a.m. The surveyor asked DS 3 to describe the manual dishwashing process. DS 3 stated he washed the pots and pans with detergent, rinsed, then sanitized the pots and pans. The surveyor asked DS 3 how long the pots and pans were kept in the sanitizing solution. DS stated the pots and pans were kept in the sanitizing solution for 30 seconds. The surveyor asked DS 3 to refer to a poster on the wall above the 3-compartment sink for instructions on correct sanitizing. The posted manufacturers' guidance for the sanitizer listed an immersion time of 1 minute. The DFS confirmed 30 seconds was the correct time frame to sanitize the pots and pans.

3. According to the 2019 Food Code, after cleaning and sanitizing, equipment and utensils shall be air-dried prior to storage. Items must be allowed to drain and to air-dry before being stacked or stored. Stacking wet items such as pans prevents them from drying and may allow an environment where microorganisms can begin to grow. Cloth drying of equipment and utensils is prohibited to prevent the possible transfer of microorganisms to equipment or utensils.

During general dietetic services observations on May 20, 2019, at 10:40 a.m., dietary staff was observed removing cleaned/sanitized dishes from the dish machine. The items were immediately stacked in storage locations. The trays used to deliver patient meals were not fully dry after removal from the dishwasher and were immediately stored in the tray holding rack with moisture residue. Similarly, multiple one-quarter and one-half steam pans were also stored wet. In a concurrent interview the Clinical Nutrition Manger acknowledged the items should have been air dried prior to storage.

On May 21, 2019, at 11 a.m., an observation of dishwashing was conducted. The Vocational coach (VC) and the Vocational student were observed removing clean/sanitized pans from the dish machine. Both the VC and VS stacked the wet half and quarter pans together and placed them on a wire shelf.

On May 21, 2019, at 11 a.m., an interview was conducted with the VC. The surveyor asked how the VC was trained. The VC stated she was trained by the kitchen staff from the facility.

On May 21, 2019, at 1 p.m., an interview was conducted with the Vocational Supervisor (VS). The VS stated vocational coaches were trained by department managers, and the vocational coaches were responsible for the vocational students. The VS also stated all vocational coaches and students had gone through facility orientation and had a food handler card on file in the food service department.

On May 23, 2019, at 9:15 a.m., an interview was conducted with the Patient Services Manager (PSM) regarding training of vocational coaches and students. The PSM stated the VC was responsible for students working under them. The surveyor asked how the VCs were trained. The PSM stated there was no formal training or assessment of job competency completed. The PSM stated the VCs received a copy of a task analysis and were encouraged to ask questions. The PSM also stated the VS was responsible for making sure the VCs were trained.

On May 23, 2019, at 8:30 a.m., an interview was conducted with the Administrative Assistant (AA) regarding food handler cards for VCs and Vocational students. The AA stated the VC was a substitute and she did not have a food handler card on file. The AA stated the purpose of the food handler card training program was to prepare food handlers to enter the workforce by providing food safety information as specified by regulations of the workers' state or local government.

Based on interview and record review, the facility failed to ensure patient menus met physician approved parameters when the nutritional analysis/adequacy of the hospitals pureed, consistent carbohydrate, cardiac, and renal diets were not in accordance with the physician approved diet manual.

Failure to ensure menu development was consistent with the hospitals' diet manual may result in clinical compromise of patient medical status when a patients' condition requires limitations in the nutrient composition of foods.

Findings:

According to the California Department of Public Health, All Facilities Letter 14-32, diet manuals establish a common language and practice for physicians and other health care professionals to use when providing nutrition care to patients. The diet manual is the cornerstone of menu development, and should mirror the nutritional care provided by the facility. The analysis of the menu is the foundation of meal planning to assure that the nutritional needs of the patient are in accordance with the physician order

The facility policy titled, "Diet Manual" dated March 2011, listed the purpose of the manual was to serve as a guideline to order diets and prepare accurate meals according to the prescribed diet order.

In an interview on May 22, 2019, beginning at 1:50 p.m., the Clinical Nutrition Manager (CNM) described the menu development process. The CNM described a recent revision of the menu. She stated the facility chose the EFY (Especially For You) menu template, which consisted of multiple pre-cooked, pre-prepared convenience items such as cooked meats, hermitically sealed beverages, and canned fruit. The CNM also stated menu items were selected based on contract foodservice vendors' input a menu template, patient favorites such as pot roast and meat loaf, patient satisfaction surveys, and staffing levels. The CNM stated the menu was implemented April 2019.

On May 23, 2019, beginning at 9 a.m., a sampling of non-select patient menus was reviewed and evaluated in relationship to the facility diet manual dated November 2016. The reviewed diets included pureed diets (for patients with swallowing or chewing disorders), consistent carbohydrate diet (CCD- for patients with diabetes), cardiac diet (for patients with heart disease), and the renal diet (for patients with kidney disease).

a. The description in the diet manual of the pureed diet listed the approximate nutritional composition range as 2000-2500 calories per day. The range based on the hospitals' nutritional analysis of the menu was 1999-2266 calories per day.

b. The diet manual described five different levels of the CCD diet ranging from very low (30 grams of carbohydrate per meal and 900-1300 calories per day) to very high (75 grams of carbohydrate per meal and 2400 or more calories per day). At the time of menu implementation there was only one analysis available. A review of the departmental document titled, "Daily Averages Summary," printed on May 22, 2019, listed carbohydrate ranges of 194 to 266 grams of carbohydrate, averaging 64-88 grams of CHO per meal, depending on the day of the week. There was no indication on the analysis whether the document was intended to describe a moderate, high, or very high CCD level.

According to the American Diabetes Association, the intent of a carbohydrate consistent diet is to provide consistent amounts of carbohydrate between meals and from day to day in an effort to minimize fluctuations in blood sugars.

c. The renal diet was described as consisting of 1800-2200 calories per day with less than 3,000 mg of sodium and potassium, less than 1200 mg of phosphorus and 80 grams of protein per day. One of seven days was limited to 1600 calories; two of seven days the sodium content was greater than the physician approved parameters; six of seven days the potassium content was greater than 3,000 mg (range 3416-4115 mg), and four of seven days the phosphorus content was greater than 1200 mg (range 1308-1630 mg). It was also noted in the renal diet description there was a section titled "Special Notation:" ...Vitamins B1, B2 ...phosphorus, ...are underreported due to lack of manufacturer supplied nutrient data ..."

According to the National Kidney Foundation, the use of manufacturer supplied convenience foods may result in a significant underreporting of mineral data such as phosphorus. In chronic kidney disease the kidneys cannot remove phosphorus very well. High phosphorus levels can cause damage by pulling extra calcium from the bones making them weak.

d. Composition of the cardiac diet was listed as less than 2,400 mg (milligrams-a metric unit of measure) of sodium. One of seven days the sodium content was listed as 2,792 mg.

Based on observation and interview, the facility failed to:

1. Ensure one handwashing sink maintained water temperatures in accordance with standards of practice; and,

2. Adhere to manufacturer guidelines for preventive maintenance on two separate brands of ice machines.

These failed practices resulted in the potential for employee injury, or inadequate sanitation of patient related equipment.

Findings:

[According to the 2017 Food Code Annex, handwashing is a critical factor in reducing fecal-oral pathogens that can be transmitted from hands to Ready to Eat food, as well as other pathogens that can be transmitted from environmental sources. Many employees fail to wash their hands as often as necessary, and even those who do may use flawed techniques. Research has shown a minimum 10-15 second scrub is necessary to remove transient pathogens from the hands, and when an antimicrobial soap is used, a minimum of 15 seconds is required. Soap is important for the surfactant effect in removing soil from the hands, and a warm water temperature is important in achieving the maximum surfactant effect of the soap. Water that is too hot to comfortably wash for required timeframes may not adequately reduce pathogens that can be transmitted by food employees].

[According to the 2018 Food Code, the temperature of water in handwashing sinks shall be at least 100 degrees Fahrenheit (F), but no more than 108 degrees F].

1. On May 21, 2019, at 10:50 a.m., an observation of the hand sink located to the right of the door to the cafeteria, and a concurrent interview with the Retail Operations Manager (ROM) were conducted. The water in the hand sink registered 118 degrees F. The ROM confirmed this temperature and stated the water temperature should not be more than 110 degrees F. The ROM also stated the water temperature of the hand sinks were monitored daily on the closing checklist completed by the supervisors.

A review of facility documents titled, "Closing Checklist," from April 1 - April 30, 2019, did not indicate hand sink water temperature was monitored.

The facility policy titled, "Preventive Maintenance [PM]," dated August 2017, indicated the PM responsibilities were assigned to the Engineering Department.

2. On May 23, 2019, at 11:05 a.m., an interview was conducted with Maintenance Staff (MS) 2 regarding ice machine cleaning. MS 2 stated the facility housed multiple different brands of ice machines throughout the building. MS 2 stated he used the ice machine cleaning and descaling solutions specifically for Follet® brand ice machines on all ice machines in the building.

A review of the Scotsman® ice machine cleaning guidelines indicated to prepare the cleaning solution, mix eight ounces of Scotsman Ice Machine Cleaner with three quarts of hot water. Similarly, review of the Manitowoc® ice machine cleaning guidelines indicated to use only Manitowoc approved Ice Machine Cleaner and Sanitizer.

Based on interview and record review, the facility failed to ensure there was proper temperature controls in appropriate areas when the temperature and humidity were not monitored in the operating rooms (ORs) for six months, and humidity in OR 1 was not maintained within acceptable levels. This failed practice resulted in an increased risk for fire.


Findings:


The outpatient surgical center temperature and humidity logs were reviewed with the Plant Operations Lead (POL) on May 23, 2019, at 8:40 a.m. The logs indicated temperature and humidity were monitored on May 22 and 23, 2019, with the following results:

May 22, 2019:

a. Operating room (OR) 1 - Temperature 68 degrees Fahrenheit (normal 68-73), humidity 16.3% (low) (normal 20-60%);

b. OR 4 - Temperature 69 degrees Fahrenheit, humidity 47%;

c. Recovery Room - Temperature 69 degrees Fahrenheit, humidity 47%; and,

May 23, 2019:

a. OR 1 - Temperature 68 degrees Fahrenheit, humidity 17.10% (remained low);

b. OR 4 - Temperature 70 degrees Fahrenheit, humidity 48%;

c. Recovery Room - Temperature 70 degrees Fahrenheit, humidity 48%.

There was no evidence of monitoring prior to May 22, 2019.

In a concurrent interview, the POL stated there was no prior temperature and humidity monitoring data for the outpatient surgical center. The POL stated there was a, "problem," with the monitoring system, so there had been no monitoring for, "about six months," and they just started monitoring again the previous day (May 22, 2019).

According to the AORN Guideline for a Safe Environment of Care;

Recommendation IV.e.1:
The relative humidity in a restricted area should be maintained within a range of 20-60% [According to the AORN, operating rooms are considered restricted areas]; and,

Based on observation, interview, and record review, the facility failed to ensure they had an effective infection control program for the prevention and control of infections. The infection control program did not meet the needs of all patients as evidenced by:

1. A lack of an effective system to identify unsanitary conditions in the dish washing room when dietetic and infection control staff did not identify a rust colored substance, identified by a industrial hygienist as mold, on the wall adjacent to the pulper (Refer to A-620);

2. Two vocational coaches were were not adequately trained and both the vocational coaches and the vocational staff did not meet health screening parameters in accordance with facility policy (Refer to A-620);

3. A lack of temperature monitoring of cafe foods capable of supporting bacterial growth associated with foodborne illness (Refer to A-620);

4. Dry goods stored in trash bags (Refer to A-620);

5. Multiple undated food items (Refer to A-620);

6. Sanitizer testing procedure not conducted in accordance with manufacturers guidelines (Refer to A-622);

7. Sanitation of manual dishwashing not conducted in accordance with standards of practice (Refer to A-622);

8. A lack of training of Vocational Student Coaches and Vocational students regarding how to handle sanitized equipment according to standards of practice (Refer to A-622);

9. The failure to conduct preventative maintenance in accordance with standards of practice and manufacturers guidelines for two ice machines (Refer to A-701);

10. The failure to provide and maintain a clean and sanitary environment which included appropriate monitoring of housekeeping and maintenance, to include waste handling, supply storage, equipment cleaning and cleaning of patient care areas (Refer to A-749);

11. The failure to perform current health screenings for students and staff supervisors from a facility training program (Refer to A-749);

12. Foods capable of supporting bacterial growth associated with foodborne illness were held at elevated temperatures (Refer to A-749);

13. Hand hygiene not conducted in dietetic services (Refer to A-0749);

14. The area designated for infant formula preparation not maintained in accordance with standards of practice (Refer to A-0749);

15. A lack of an effective air gap in ice machines in the Vintage tower (Refer to A-749);

16. Food preparation equipment and utensils were not air dried (Refer to A-749);

17. Multiple areas of the kitchen and equipment were not clean (Refer to A-749);

18. Cutting surfaces in the kitchen were scratched and actively used (Refer to A-749);

19. An ineffective use of hair restraints (Refer to A-749);

20. Instruments opened during procedures performed in the outpatient surgical center were not disinfected prior to using them in another procedure, resulting in an increased risk for infection (Refer to A-940, Findings); and,

21. Temperature and humidity were not monitored in the sterile instrument storage area in the outpatient surgical center, resulting in an increased risk for infection (Refer to A-940).

The cumulative effect of these systemic problems resulted in failure to ensure implementation of a safe and effective infection control program.



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Based on observation, interview, and record review, the facility failed to:

1. Provide and maintain a clean and sanitary environment which included appropriate monitoring of housekeeping and maintenance which includes waste handling, supply storage, equipment cleaning and cleaning of patient care areas;

2. Ensure temperature and humidity were being monitored in the sterile instrument storage area, resulting in an increased risk for infection.

3. Ensure there were current health screenings for students and student supervisors from a facility training program;

4. Ensure there was an effective system to identify unsanitary conditions in the dish washing room when dietetic and infection control staff did not identify a rust colored substance, identified by a industrial hygienist as mold on the wall adjacent to the pulper;

5. Ensure foods capable of supporting bacterial growth associated with foodborne illness were held at appropriate temperatures;

6. Ensure hand hygiene was conducted;

7. Ensure the area designated for infant formula preparation was maintained in accordance with standards of practice;

8. Ensure there was an effective air gap in ice machines in the Vintage Tower (oldest building);

9. Ensure food preparation equipment and utensils were air dried;

10. Ensure multiple areas of the kitchen and equipment were clean;

11. Ensure cutting surfaces which were heavily scratched were not retained; and,

12. Ensure effective use of hair restraints.

These failed practices resulted in an increased risk for spread of infection between patients and staff, and the potential for development of foodborne illness.

Findings:

1 a. On May 20, 2019, at 9:06 a.m., during a tour of the Med/Surg 6 unit, accompanied by Regulatory Compliance Manager (RCM) and the Director of Med-Surg (DMS), the shower room was observed to contain a large pile of wet towels and washcloths on the floor. A toilet seat was also found on the floor of the shower.

In a concurrent interview, the DMS stated the soiled linen should have been placed in a soiled linen hamper. She could not explain why the toilet seat was on the shower room floor.

At 9:15 a.m., the storage room (where patient equipment was being stored) had thick layers of dust on the floor, and a wall charging unit had a thick layer of dust on the top surface.

In a concurrent interview with Environmental Services (EVS), the EVS stated it was part of her job to clean the storage room.

b. On May 20, 2019, at 10:10 a.m., a tour of the medical/surgical unit (D3) was conducted with Registered Nurse (RN) 9. The hallway shower room, between rooms D320 and D322, had a sign posted on the door which indicated, "In use 5/17/19, at 11 a.m." When the door was opened, the ante-room to the shower had dirty, wet towels and linen on the ground and on the bench seat. The ground of the shower stall contained a brown, odorous substance, about the size of a bar of soap, with a towel partially covering the brown substance.

During a concurrent interview with RN 9, she stated the shower had not been used since May 17, 2019 (3 days earlier), the brown odorous substance on the ground of the shower stall was probably feces, and the shower should have been cleaned immediately after being used on May 17, 2019. RN 9 stated it was the nurses responsibility to notify housekeeping that the shower needed to be cleaned, and that should have been done on Friday, May 17, 2019.

The facility policy and procedure titled, "INFECTION CONTROL PLAN," dated February 2019, indicated the, "Infection Prevention and Control Manager has the responsibility for implementing, coordinating, and directing a program of surveillance, prevention and control of infection...Each Director is responsible for monitoring compliance...Routine "walking rounds" are integrated with safety, risk management, and environmental services..."

2. The outpatient surgical center temperature and humidity logs were reviewed with the Plant Operations Lead (POL) on May 23, 2019, at 8:40 a.m. The logs indicated temperature and humidity were not being monitored in the sterile storage area.

In a concurrent interview, the POL stated there was no temperature or humidity monitoring being done in the sterile storage area.

According to the AORN Guideline for a Safe Environment of Care;

Recommendation IV.e.2:
The humidity in the sterile storage area should reach a maximum of 60%.

3. On May 23, 2019, at 9:10 a.m., an interview was conducted with Staff Supervisor (SS) 1, who was with a facility training program. SS 1 stated the facility training program had seven students, four staff supervisors, and a substitute staff supervisor currently covering Dietary Services. SS 1 stated students were at the facility Monday through Friday from 8:30 a.m. to 3 p.m., for a school year. SS 1 stated the students were placed in the facility in various locations to include the cafeteria, admitting, housekeeping, sterile processing, and the gastroenterology lab. SS 1 stated the student and staff supervisors went through hospital orientation, the education department, and employee health to meet the facility's requirements.

The facility was able to provide the files for two students and two staff supervisors.

On May 23, 2019, at 1 p.m., the student and staff supervisor files were reviewed.

The files did not contain hospital orientation, department orientation/education, or current health screening.

During an interview with the Vice President of Quality (VPQ), on May 23, 2019, at 1:20 p.m., the VPQ stated the facility did not currently have documentation of current health screening, hospital orientation, or department training for the students and staff supervisors. The VPQ stated the students and staff supervisors should have met the requirements to work/volunteer at the facility.

The facility policy and procedure titled, "Recruitment of Volunteers," last revised by the facility April 2016, revealed "... Once selected, the applicant will receive a letter notifying him/her of hospital orientation date and instruction sheet for the following: TB Screening, Rubella Screening, Health Questionnaire, ID Badge, Authorization for background check, Drug screening for all CCE [Clinical Care Extender] and Cuddler Program volunteers. ..."



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4. According to the University of Central Florida (UCF) extension article titled "Mold Growth", "There are four critical requirements for mold growth - available mold spores, available mold food, appropriate temperatures and considerable amount of moisture. The removal of any one of these will prohibit mold growth" (www.fsec.ucf.edu).

In the same UCF article "Mold Growth", there are four critical requirements for mold growth - available mold spores, available mold food, appropriate temperatures, and considerable moisture.

Mold spores are described as being "everywhere" and cannot be completely eliminated (the first requirement).

Oils from the skin or soap residue left from a good cleaning will provide sufficient nutrients to support the growth of some molds (the second requirement).

The dish machine uses water that is 180 degrees Fahrenheit (F). The area is generally warm and humid (the third and fourth requirements).

According to the CDC (Centers for Disease Control and Prevention), document "Molds in the Environment," "Some people are sensitive to molds. For these people, molds can cause nasal stuffiness, throat irritation, coughing and wheezing, eye irritation and in some cases skin irritation. People with mold allergies may have more severe reactions. Immunocompromised people and people with chronic lung disease may get serious infections in their lungs when they are exposed to mold".

In the Molds in the Environment document, the CDC indicated, "In 2004, the Institute of Medicine (IOM) found there was sufficient evidence to link indoor exposure to mold with upper respiratory tract symptoms, cough and wheeze in otherwise healthy people. The IOM also found limited or suggestive evidence linking exposure to damp indoor environment in general to shortness of breath, to respiratory illness and to potential development of asthma in susceptible individuals."

According to the Restoration Sciences Academy (R. Driscoll, 2018) while mold may become visible within 72 hours, the growth time may begin as long as 18 days after conditions are optimal.

During general dietetic services observations on May 20, 2019, beginning at 2:40 p.m., a rust colored substance was observed along the length of walls above the conveyor belt leading from the cafeteria. The substance was approximately 5 inches high and greater than 8 feet long. In some areas it was removable with a paper towel and had a slimy appearance. Additionally, there was a black discoloration underneath the caulking that sealed the stainless steel back splash to the wainscoting on the wall. There was also a build-up of the rust colored substance on a T-bar that connected the wainscoting wall panels to one another as well as the rack directly above the pulper conveyor belt. The rust colored substance resembled mildew (mold). It was also noted the pulper area contained residue from cooking and eating utensils and equipment that were being prepared for washing.

In a concurrent interview the Director of Food Services stated staff washed the walls down nightly, however acknowledged the area was probably not cleaned within the last 24 hours.

In an interview and concurrent record review on May 20,2019, at 2:50 p.m., the Infection Control Preventionist (ICP) stated the substance was probably mold. The ICP also stated she would call engineering staff to have the area tested.

The most recent infection control inspection, completed by the ICP, titled, "Infection Control Environmental Surveillance Inspection," dated March 27, 2019, indicated all floors, walls, and ceilings were clean and in good repair.

In an interview on May 23, 2019, beginning at 8:45 a.m., Vendor 1, an industrial hygienist, stated testing of mold was not generally done, rather remediation of the identified area was the most common standard of practice. He also stated the observed mold growth was likely related to aspergillus or ascospores, both species of penicillium, which could cause underlying lung disease and asthma (Mayo Clinic, 2018), or certain infections in compromised individuals, and did produce toxins unhealthy to humans (Estechlab.com). Vender 1 stated that effective mitigation of molds required an effective preventive maintenance program.

A review of six documents from April 6, 2019, through May 11, 2019, titled, "Cleaning Schedule Week Ending," indicated position #12 was responsible for cleaning the pulper and waste storage room. There was no documented scheduled cleaning for the walls in the area or the stainless steel railing above the pulper. An additional 5 weekly documents titled "Daily Routines" from April 7, 2019, through May 12, 2019, revealed that the condition of the wall above the pulper was not included in the supervisory review. It was also noted with the exception of the fryer and warmer box there was no schedule for deep cleaning in kitchen areas.

5. According to the United States Department of Agriculture (USDA) 2017 Food Code, time/temperature controlled foods are those capable of supporting bacterial growth associated with foodborne illness. Cut melons and protein based foods such as chicken require temperature control for food safety. To mitigate bacterial growth cold food holding temperatures should be 41 degrees Fahrenheit (F) or below. Except when only time is used as the public health control, both time and temperature control shall be maintained for food safety. Time without temperature control may be used as the public health control up to a maximum of four hours. If this process is used the food shall be marked or otherwise identified to indicate the time that is four hours past the point in time when the food is removed from temperature control.

On May 20, 2019, beginning at 2:25 p.m., food holding temperatures were reviewed in the café area in the presence of the Clinical Nutrition Manager (CNS) and Executive Chef (EC). There were two open front grab and go refrigerators, each holding foods requiring time/temperature control for food safety. The refrigerator closest to the cash registers had fruit cups containing cut melons with a temperature of 45.7 degrees F. The second refrigerator contained protein based sandwiches. A roasted chicken sandwich had a temperature of 50.5 degrees F. A second chicken sandwich, which was placed further back in the refrigerator was 46.9 degrees F. It was also noted that while each item was marked with an expiration date placed by the food production vendor, there was no marking when the item was placed into the café refrigerators. In a concurrent interview the EC stated his thermometer was recently calibrated and found to be accurate.

A review of the facility document titled, "County of Riverside Department of Environmental Health," dated June 21, 2018, indicated a previous identification of potentially hazardous foods held at temperatures of above 41 degrees F.

The facility policy titled, "HACCP/Food Safety Program Food Safety Standards & Requirements," dated August 2016, indicated cold foods were to be held at 40 degrees F or below.

6. According to the United States Department of Agriculture (USDA) 2017 Food Code, employees must wash their hands after any activity which may result in contamination of the hands.

The facility policy and procedure titled, "Handwashing and Personal Cleanliness," dated January 27, 2012, indicated employees must wash hands...after handling trash and other contaminated objects.

On May 20 2019, at 1:50 p.m., an observation of dishwashing was conducted with Dietary Staff (DS) 5 and the Director of Food Services (DFS). DS 5 returned to the kitchen after trash disposal. DS 5 picked up a clean cloth, put the cloth in a bucket with sanitizing solution and began to wipe the dishwashing area. Upon completion of this task, DS 5 washed his hands. Using the DFS as an interpreter, DS 5 stated he should have washed his hands after trash disposal.

On May 20, 2019, at 2 p.m., continued observation of dishwashing was conducted. With gloved hands, DS 6 removed clean/sanitized dishes from the dish machine. DS 6 then went to the dirty side of the dish machine, loaded dirty dishes onto the dish rack. DS 6 changed his gloves and returned to remove clean dishes from the dish machine. DS 6 confirmed he forgot to wash his hands when changing gloves.

7. According to the Infant Feeding Guidelines, Academy of Nutrition and Dietetics, a specific location with adequate space and equipment must be provided for any infant feeding preparation needs that facilitates aseptic (clean, no-touch) technique. A sink exclusively for hand hygiene is imperative near the preparation area. Work surfaces must be thoroughly washed, rinsed and sanitized using hospital approved chemicals. Upon completion of sanitation of work surfaces it is recommended it be wiped with a clean paper towel. Additionally, the area should be free of supplies associated with patient care activities. Preparation of infant feedings in an open but designated area increases the potential for microbiological contamination and tampering.

On May 23, 2019, at 10 a.m., an observation of the breast milk preparation area and concurrent interview was conducted with Registered Nurse (RN)15. RN 15 stated breast milk was prepared on a counter top in an area located inside the Neonatal Intensive Care Unit (NICU). The preparation area contained a refrigerator and a small counter. The counter top where infant feedings were prepared contained office supplies, glove boxes, and a plastic container labeled, "pharmacy in." The surveyor asked RN 15 how the counter top was cleaned prior to infant feeding preparation. RN 15 replied the counter top was wiped with a sanitizer prior to formula preparation.

A review of facility policy titled, "Collection, Storage and Thawing of Breast Milk," revised May 2018, revealed it did not include a procedure for maintaining the infant formula preparation area.

8. According to the United States Department of Agriculture (USDA) 2017 Food Code, an air gap is an amount of space that separates a water line, such as that from an ice machine drain to a sewer. Proper air gap installation makes sure dirty water doesn't contaminate the interior contents of the ice machine. An air gap prevents water from flowing back up a water line. Air gaps are required in food equipment that discharges water such as sinks and ice machines.

An observation was made on May 21, 2019, beginning at 12:15 p.m., in the nourishment station of the Pediatric unit, accompanied by the Clinical Nutrition Manager (CNM) and Maintenance Staff (MS) 1. Within the station there was an ice machine. The ice machine was plumbed directly into the waste water system.

In a concurrent interview MS 1 confirmed the observation. MS 1 stated in the facility's new tower, ice machines were installed with the required air gap, but the ice machines in the old (Vintage) tower were retrofitted to drain directly into the waste water system. MS 1 stated there were a total of 11 ice machines that were plumbed in that fashion.

9. According to the United States Department of Agriculture (USDA) 2019 Food Code, after cleaning and sanitizing, equipment, and utensils shall be air-dried prior to storage. Items must be allowed to drain and to air-dry before being stacked or stored. Stacking wet items such as pans prevents them from drying and may allow an environment where microorganisms can begin to grow. Cloth drying of equipment and utensils is prohibited to prevent the possible transfer of microorganisms to equipment or utensils.

During general dietetic services observations on May 20, 2019, at 10:40 a.m., dietary staff was observed removing cleaned/sanitized dishes from the dish machine. The items were immediately stacked in storage locations. The trays used to deliver patient meals were not fully dry after removal from the dishwasher and were immediately stored in the tray holding rack with moisture residue. Similarly, multiple one-quarter and one-half steam pans were also stored wet.

In a concurrent interview, the Clinical Nutrition Manager (CNM) acknowledged the items were not adequately dried prior to storage. She also stated drying should occur on two-four foot wire racks, each with three usable shelves which were placed at the clean end of the dishwasher. It was also noted the racks consisted of horizontal shelving and had limited drying space for food production equipment and utensils required for feeding a patient census of greater than 200 people.

On May 20, 2019, at 11 a.m., an observation of dishwashing was conducted with the Patient Operations Manager (POM). The POM was observed instructing Dietary Staff (DS) 4 to place clean/sanitized plastic plate covers on a drying rack. DS 4 placed the clean plastic plate covers on the drying rack, but immediately removed the plate covers stating they were still wet and needed to dry. DS 4 stacked the wet plate covers and put them on a wire rack. The POM acknowledged the drying rack should have been used to dry plate covers.

On May 21, 2019, at 11 a.m., an observation of dishwashing was conducted. Vocational coach (VC) and Vocational student 1 were observed removing clean/sanitized pans from the dish machine. Both the VC and Vocational student 1 stacked wet half and quarter pans together and placed them on a wire shelf.

On May 21, 2019, at 11:25 a.m., an interview was conducted with the Patient Operations Manager (POM) regarding wet stacking of pans. The POM stated pans should not be stacked together unless they were dry.

10. According to the United States Department of Agriculture (USDA) 2019 Food Code, it is the standard of practice to ensure kitchen areas are thoroughly cleaned in order to avoid creating an attractant or harborage for insects or rodents. Physical facilities shall be cleaned as often as necessary to keep them clean. Food contact surfaces and equipment shall be clean to sight and touch.

During the initial kitchen tour on May 20, 2019, beginning at 9:50 a.m., there were multiple unclean areas in the kitchen. There were multiple unidentified food particles on the floor throughout the kitchen. The food production area adjacent to the tray line had food particles underneath and surrounding equipment. Refrigerator doors in the surrounding the tray line area had a clear grease-like substance on the doors and handles.

On May 20, 2019, at 10:40 a.m., an observation of the storage of clean utensils was conducted with the Operations Manager (OM). The clean utensils were stored in a clear plastic bin. Multiple food crumbs and dust were observed inside the bin. More than five utensils used to serve food were observed with dried food debris on the serving side of the utensil. The OM confirmed the bins and utensils were not clean. The surveyor asked the OM how often the bins were cleaned. The OM stated three times a week but he stated it looked like that did not happen.

On May 20, 2019, at 10:50 a.m., during an observation of the can opener and knife rack, the Executive Chef (EC) confirmed the can opener blade was dirty and needed replacing. A knife with food debris was observed in the clean knife rack. The EC acknowledged a dirty knife should not be stored in the clean knife rack.

On May 20, 2019, at 11:30 a.m., an observation of the delivery of patient trays was conducted with the Director of Food Service (DFS). The carts used to deliver patient trays were observed with dried food crumbs inside and outside the cart. The DFS confirmed the patient tray carts were not clean.

During food storage observation on May 20, 2019, at 11:45 a.m., in the nourishment room on 3 South, there were multiple unclean areas. There was a build-up of unidentified food particles throughout the cabinets and drawers. It was also noted there were multiple partially consumed staff beverage containers throughout the area. In a concurrent interview the Infection Control Practitioner acknowledged the area was not clean. She was also unsure who was responsible for routine cleaning of the area.

During an observation of the café area on May 20, 2019, beginning at 2:25 p.m., there were multiple areas that were not clean. There was a build-up of unidentified food particles on floors throughout the food production area. In the area to the right of the deep fryer, there was a stainless steel cabinet that did not have a solid surface top, it had a metal square frame that accommodated a one-half steam pan. In a concurrent interview the DFS stated when the fryer was used a steam pan was placed in the frame. On the floor was a large build-up of a clear substance resembling frying oil, as well as unidentifiable food particles. The DFS acknowledged the area was not clean.

On May 20, 2019, at 2:30 p.m., an observation of patient food preparation was conducted with Cook 1 and the EC. Cook 1 removed a half pan of pot roast from the oven and placed it on a plastic cart. The plastic on the top of the cart was cracked with a dark colored substance imbedded in the cracks. The EC confirmed the cart was not a cleanable surface and discarded the cart.

Review of six documents from April 6, 2019, through May 11, 2019, titled, "Cleaning Schedule Week Ending," indicated that cleaning of all kitchen areas were completed on a daily basis. An additional 5 weekly documents titled, "Daily Routines" from April 7, 2019, through May 12, 2019, failed to identify kitchen cleanliness as an area of concern. It was also noted with the exception of the fryer and warmer box there was no schedule for deep cleaning in kitchen areas. Review of two documents titled, "County of Riverside Environmental Health," dated October 23, 2018, and March 14, 2019, identified unclean areas within the kitchen.

The facility policy titled, "Environmental/Equipment Cleaning and Sanitation," dated August 2017, indicated the department should be maintained in a clean, safe, and effective environment of care to prevent the transmission of disease-carrying organisms.

The facility policy titled, "HACCP/Food Safety Program Food Safety Standards & Requirements," dated August, 2016, indicated no employees' coffee mugs or drinking cups stored in immediate work station or on equipment.

11. According to the United States Department of Agriculture (USDA) 2017 Food Code, cutting surfaces such as cutting boards and blocks that become scratched and scored may be difficult to clean and sanitize. As a result, pathogenic microorganisms transmissible through food may build up or accumulate. These microorganisms may be transferred to foods that are prepared on such surfaces.

During an observation of the café area on May 20, 2019, beginning at 2:25 p.m., the white cutting board affixed to the deli station had dark, heavily scored knife scratches. In a concurrent interview with the Executive Chef (EC), the EC acknowledged the presence of the dark, scored areas.

12. According to the United States Department of Agriculture (USDA) 2017 Food Code, food employees shall wear hair restraints such as hats, hair coverings or nets, beard restraints, and clothing that covers body hair, that are designed and worn to effectively keep their hair from contacting exposed food, clean equipment, and utensils ...

On May 20, 2019, at 10:30 a.m., and 11:15 a.m., during kitchen observations, the Vocational Coach (VC) was observed with a hair net not covering the front part of her hair. The VC stated she was not required to wear a hair net because she did not engage in food preparation.

The facility policy titled, "Personal Appearance Hygiene," dated August 2015, indicated food service employees were to wear a hair net in food preparing and serving areas. Additionally, the policy indicated hair should not fall outside of head covers. The policy was not consistent with acceptable standards of practice in accordance with the USDA Food Code.

Based on observation, interview, and record review, the facility failed to ensure surgical services were performed in accordance with acceptable standards of practice in the outpatient surgery center when all instruments opened during procedures were not disinfected prior to being used in another procedure. This failure placed all patients having surgical procedures in the outpatient surgery center at an increased risk for infection.


Findings:

1. During an interview with the Manager of Infection Prevention (MIP) on May 23, 2019, at 8:30 a.m., the MIP stated the facility followed Association of periOperative Registered Nurses (AORN) guidelines in the surgery departments.

A tour of the outpatient surgical center was conducted on May 22, 2019, at 10 a.m., with the Sterile Processing Department Manager (SPDM). During a concurrent interview, the SPDM stated when a surgical case was completed, the surgical technician who assisted with the procedure would separate used instruments from unused instruments, and transport them to the SPD for reprocessing.

The SPDM stated he would soak the used instruments in an enzymatic detergent, clean them with a brush, then rinse them, place them on top of the unused instruments in the instrument tray, and put the tray into the washer. The SPDM stated he did not clean the unused instruments.

2. During a tour of the outpatient surgical center on May 23, 2019, at 9:25 a.m., accompanied by the Director of Perioperative Services (DPS), the SPDM was observed reprocessing a tray of surgical instruments.

The instruments were observed on the back table in operating room number one. The SPDM stated the used surgical instruments were sprayed at the end of the case to keep them moist, and the unused instruments were not sprayed. The SPDM was observed placing the used instruments in a plastic tub, covering them, and placing them on a cart. The unused instruments were placed on the same cart in the surgical instrument tray they were originally stored in. The cart was covered and taken to the SPD area for the instruments to be reprocessed.

The SPD room had a two compartment sink. Each sink had a round basin sitting inside of it. The SPDM filled each basin with water, placed enzymatic detergent in the basin on the left hand side, and put the used instruments in the enzymatic detergent.

The unused instruments were placed on the counter next to the sink, in the instrument tray they were originally stored in.

The SPDM cleaned the used instruments, one at a time, with a brush. The SPDM dipped the instruments into the basin of water on the right hand side of the sink, then placed them on top of the unused instruments located in the instrument tray.

The SPDM placed the instrument tray into the washer, where he stated they would wait to be washed until there were more trays.

During an interview with the Director of Perioperative Services (DPS) on May 23, 2019, at 9:50 a.m., the DPS stated the SPDM should have washed all of the instruments that were opened during the surgical procedure, whether they had been used or not.

According to the AORN, Guideline for Cleaning and Care of Surgical Instruments;

Recommendation III.c:
All instruments opened onto the sterile field in the operating room or procedure room should be cleaned and decontaminated whether or not they have been used. Scrubbed persons may touch and contaminate instruments without being aware of it. Instruments that were used may come into contact with unused items. Airborne microorganisms may come in contact with instruments that have not been used. Contamination of unused instruments on the sterile field can occur without the occurrence being noticed.

Based on observation, interview, and record review, the facility failed to ensure an accounting was maintained of the wasted and unneeded radiopharmaceutical (radioactive compounds used for diagnostic or therapeutic purposes) products. This failed practice resulted in incomplete documentation for the tracking of radiopharmaceuticals.

[Definitions:

- Radionuclide - an atom that has excess nuclear energy, making it unstable.

- TC99M MAA - macroaggregated albumin - one of the technetium radiopharmaceuticals used in lung perfusion imaging.

- TC99M Sodium Pertechnetate - radioactive diagnostic agent used for the diagnosis of diseases in many tissues, particularly in the gastrointestinal system, cardiovascular and cerebral circulation, brain, thyroid, and joints.

- TL201 Thallium - radiopharmaceutical for intravenous administration.

- TC99M Cardiolite - radiopharmaceutical used for detecting coronary artery disease]

Findings:

On May 21, 2019, at 9:20 a.m., a tour of the Nuclear Medicine Department was conducted with the Supervisor of Nuclear Medicine (SNM).

Radiopharmaceuticals were observed in the room designated as the, "Hot Lab." In a concurrent interview, the SNM stated they were to be used for patients, and the containers would be returned to the vendor. Each special case/bag for returns contained up to eight containers of radiopharmaceuticals.

The facility, "Inventory Utilization Report," for May 20, 2019, dated May 21, 2019, indicated the facility received and used the following:

- Received 6 and used 5 unit doses of TC99M Cardiolite,

- Received 2 and used 0 unit doses of TC99M MAA,

- Received 2 and used 0 bulk of TC99M Sodium Pertechnetate; and,

- Received 5 and used 4 doses of TL201 Thallium.

There was no documented indication as to what occurred with the unused/unneeded doses/bulk.

The facility, "Inventory Disposition Report," for May 20, 2019, dated May 21, 2019, indicated, by patient, the following:

- radiopharmaceutical used;

-the amount used; and,

- the amount wasted.

For some patients, the amount of radiopharmaceutical used was more than the original quantity received, and the amount wasted was then a negative number.

The records did not accurately reflect the waste, and what occurred with the unused doses/bulk of radiopharmaceuticals.

During a concurrent interview with the SNM, she stated the facility received three deliveries of radiopharmaceuticals each day, at 7 a.m., 9:30 a.m., and 12 p.m. The SNM stated the unneeded/unused doses were returned to the vendor, but there was no tracking mechanism for this process. The SNM stated once the return special case/bag had eight containers, the bag was closed, and the vendor would pick up the special case/bag during one of the deliveries. The SNM stated there was no tracking mechanism for what was in the containers being returned to the vendor. The SNM stated the facility's electronic documentation system for the radiopharmaceuticals had a, "waste bin," which showed what was returned, but that function had not been working for sometime. The SNM stated the computer program was an older version, and the vendor was unable to get the, "waste bin," function to work. The SNM stated radiopharmaceutical waste should be tracked.