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Based on interviews, tours of the hospital, observations, a review of documents supplied by the hospital, the governing body failed to ensure a safe environment to meet the needs of its patients. This could lead to unsafe practices and environments for its patients.

Findings:

1. The Governing Body failed to assure hemodialysis contracted services were provided in a safe environment at Hospital A. Nursing staff were not provided training for emergencies during dialysis including if the dialysis nurse was incapacitated during dialysis. Instructions and equipment kit needed to safely stop dialysis during an emergency was not available at Hospital A. (Refer to A-084)


2. The Governing Body failed to ensure oversight and implementation of policies and procedures that assured Radiologic services were conducted in a safe manner including assuring Radiologic equipment that failed Physicist evaluation were promptly repaired and Risk assessment was completed for patients that had radiologic exams with the out of compliance machine at Hospital A. (Refer to A-0537)

The cumulative effects of these systemic problems resulted in the inability of the Governing Body to ensure safe patient care in a safe and sanitary environment.

Based on observation, interview, and record review, the standard is not met: The Governing Body failed to monitor and assure hemodialysis (a medical procedure to remove fluid and waste products from the blood) contracted services were delivered in a safe and effective manner.

1. The Governing Body failed to implement a policy and procedure to assure nurses were trained to turn off a hemodialysis machine safely in an emergency including if the hemodialysis nurse became incapacitated.

2. The Governing Body failed to assure Instructions and emergency equipment kit needed to safely stop dialysis during an emergency were attached to the dialysis machine and readily available at Hospital A.

Findings:

During an observation with Registered Nurse 8 (RN 8) and RN 10 on January 15, 2019 at 1:20 PM, Patient 12 was observed undergoing a dialysis procedure with RN 9. An observation of the dialysis machine did not have instructions on what to do in case of an emergency. An emergency kit with clamps and equipment needed to safely stop the dialysis in case of an emergency was not attached to the dialysis machine. During an interview with RN 9 in the presence of RN 8 and RN 10 confirmed dialysis emergency kit and instructions were not on the dialysis machine. When asked if during hand off of the patient was emergency procedures during dialysis discussed, he indicated they were not included in the hand off of the dialysis patient care.

During an interview with RN 8 and RN 10, on January 15, 2019 at 1:30 PM, when asked what to do in case of an emergency during a Patients' dialysis including power outage or an incapacitated dialysis nurse during dialysis, RN 8 and RN 10 did not know how to turn off the dialysis machine and where to clamp the lines to stop the dialysis safely. No emergency instructions or emergency clamping kit was available during the observation and interview. RN 8 and RN 10 indicated there was no in-service provided on how to clamp and turn off the dialysis machine in case of an emergency including if the dialysis nurse became incapacitated. When asked if there was a designated dialysis section of the hospital RN 8 indicated patients are admitted to any ward, there is no specific dialysis ward all nurses' care for the dialysis patients. When asked if each ward had a dialysis trained nurse there were none. RN 8 and RN 9 indicated 1 to 2 patients receive dialysis per day at Hospital A. RN 8 indicated none of the nurses received training for emergency dialysis procedure. A policy and procedure for the emergency during dialysis or if the dialysis nurse was incapacitated and in-service training was requested for Hospital A. None was available on January 15, 2019 at 1:40 PM.

A review of a facility document titled, "Hemodialysis Patients, Patient List at So Cal Hospital Hollywood", July 2018 to January 2019 documented 134 patient dialysis procedures.

During an interview with Vice President of Quality (VPQ) on January 18, 2019 at 2:30 PM, when asked for policy or procedure for review for emergencies during hemodialysis including emergency instructions if the dialysis nurse became incapacitated or power outage, she indicated there was none. There was no documentation of any nurses in-services on how to turn off the hemodialysis dialysis machine or what lines to clamp in case of an emergency.

There was no documentation of oversight assuring the instruction and clamps needed in case of an emergency during dialysis were visibly stored with the dialysis machine. A review of the Facility hemodialysis Quality Assurance Performance Improvement (QAPI) studies showed they did not include any studies or facility nurse training for emergencies during hemodialysis, including emergency instructions or equipment needed during an emergency to safely stop the dialysis.

A review of the facility document titled, "Southern California Hospital at Culver City Contract Evaluation Summary" 2018, did not include the Hemodialysis Contracting Company.

A Review of a document provided by the contracted hemodialysis service titled, "Dialysis Services agreement" dated August 1, 2017, under "Hospital Responsibilities" indicated, "Hospital shall intervene in emergency situations including, but not limited to cardiac arrest, fire, and disaster and power failure. Hospital will direct Agency personnel in emergency situations".

A review of a facility document titled, "Rules and Regulations of the Governing Board of Southern California health Care Systems, INC", undated, in section 2. "Professional Service Contracts. Indicated "The Governing Board shall periodically review the quality of service rendered by..Professional service contractors".

The Governing body failed to implement a policy and procedure for emergency protocols to safely turn off a hemodialysis machine during an emergency including if the hemodialysis nurse became incapacitated. The Governing Body failed to assure the emergency equipment kit and instructions were attached to the dialysis machine in case of an emergency. The Governing Body failed to monitor and assure hemodialysis contracted services were delivered in a safe and effective manner.

Based on observation, interview, and record review, the hospital failed to protect and promote patients rights as mandated in the Condition of Participation: Patient Rights by failing to ensure the following:

1. For one of 53 sampled patients (Patient 34), an informed consent for computerized tomography (CT or CAT scan-specialized x-ray) with contrast (a dye that shows up on x-ray or CT scan) was obtained by the physician. (Refer to A-0131)

2. An emergency defibrillator (device used during a heart related emergency) was plugged in to charge when not in use, and readily available for use. (Refer to A-0142)

3. Instruments and supplies necessary for patient care and life support were not expired in the patient care areas for a universe of 49 clinically compromised patients. (Refer to A-0144)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision and protection of patient rights.

Based on interview and record review, the hospital failed to ensure, for one of 53 sampled patients (Patient 34), an informed consent for computerized tomography (CT or CAT scan-specialized x-ray) with contrast (a dye that shows up on x-ray or CT scan) was obtained by the physician. This failure had the potential to result in the patient not having the information needed to decide whether or not to have the procedure.

Findings:

During a medical record review for Patient 34, it showed the patient was admitted to the facility on January 12, 2019.

Review of a document titled, "Consent for Radiology Requiring Injection of Contrast Materials" dated January 12, 2019, showed the form signed by the patient's representative. The section where the physician signs that the risks, benefits, and alternatives for the procedure were explained to the patient was blank.

There was no documentation in the patient's record that the physician discussed the risks, benefits, and alternatives to the procedure.

In an interview with the Intensive Care Unit Director on January 16, 2019 at 11:10 AM, he stated there should be an informed consent documented by the physician.

Based on observation, interview, and record review, the facility failed to ensure an emergency defibrillator (device used during a heart related emergency) was plugged in to charge when not in use, and available for use. This failure had the potential for patients to receive delayed emergency care due to an uncharged defibrillator, resulting in illness, injury, or death in a universe of 49 clinically compromised patients.

Findings:

During an observation on January 15, 2019 at 1:00 PM, an emergency defibrillator in the main emergency department was unplugged while not in use.

A review of a crash cart log for January 16, 2019 indicated in column 8, the licensed staff signature indicated, "emergency defibrillator (Manufacturer G) was plugged in / charging light on."

During an interview with Registered Nurse 13 (RN 13) on January 15, 2019, at 1:05 PM, RN 13 was asked if the defibrillator should have been plugged in when not in use, RN 13 stated, "Yes it should have been plugged in, it was probably unplugged when someone cleaned the room this morning."

A review of the facility policy and procedure titled, "Crash Cart Inspection, Maintenance, Exchange", with a review date of March 2016, indicated, "I. Purpose/Objective: ...B. To ensure that a standard and completely supplied cart or kit for all patient care and surrounding areas, with no lapse of time between use, will be available at designated areas throughout the hospital ...G. Defibrillator Inspection, Maintenance, and Testing ... iv. Defibrillators must be plugged into power source when not in use, and plugged into a red power outlet when there is a loss of power and the hospital reverts to generator back-up."

Based on observations, interviews, and record reviews, the hospital failed to ensure instruments and supplies necessary for patient care and life support were not expired in the Emergency Department and Cardiac Catheterization Laboratory for a universe of 49 clinically compromised patients.

These failures had the potential for patients to receive care with instruments and supplies that were beyond use date (expired) per manufacturer, which could result in infection, injuries, and death in a universe of 49 clinically compromised patients.

Findings:

1. During an observation on January 15, 2019 at 1:30 PM, in the Emergency Department, a box designated as "difficult airway box" (a box containing emergency airway specialty supplies and equipment), contained the following items:

a. One 8.0 sized endotracheal tube (a tube used for breathing failure) lot number:120102-106 with an expiration date of January, 2017.

During an interview on January 15, 2019 at 1:35 PM with Registered Nurse 13 (RN 13) in the Emergency Department, when asked if the items identified as expired are ready for use, the ED charge nurse stated, "Yes the items expired are ready for use, the nurses are responsible to check the box for expired items."

During an interview with the Emergency Department Medical Director (EDMD) on January 15, 2019 at 1:40 PM, was asked if the items in the "Difficult Airway Box" were items used for patient care, the EDMD stated, "Yes we use the box when needed and those items should have been checked for expired items."

Review of facility Policy and Procedure titled, "Rotation of Supplies," dated November 2012 indicated: "1.0 Purpose: ...to provide guidelines for the storage and rotation of sterile supplies within the hospital. 2.0 Scope; this procedure applies to all departments and services licensed by the facility and crosses interdisciplinary lines. ...4.2.16; All supply items should be reviewed monthly and upon issuance in respect to expiration dates. 4.2.17; All expired items will be immediately removed from the storage location and placed in a holding area until proper disposition can be made."

2. During an observation on January 16, 2019 at 3:00 PM, in the Cardiac Catheterization Laboratory, a cart designated as "pacemaker cart" (a cart containing specialty supplies and equipment), contained the following items:

a. One 500 milliliters (ml.- a measurement of volume) bag of Heparin (anti-clot medication) 1000 units per 500 ml. lot number: 77-053-JT expired November 1, 2018.

During an interview with the Director of Surgical Services (DSS) on January 16, 2019 at 3:08 PM, the DSS was asked if the medication in the pacemaker cart should have been removed before the expiration date, and which staff are responsible for checking the cart for expired items. The DSS stated, "Yes, the medication should have been removed and nursing is responsible for the cart checks on a routine basis."

Review of facility Policy and Procedure titled, "Return, Handling, and Disposal of Medication Waste," dated, March 10, 2015 indicated: "Procedure: 1. All outdated or recalled medications and contaminated or deteriorated medications shall be disposed of properly."

Based on interview and record review, the hospital failed to maintain an effective and on-going Quality Assessment and Performance Improvement program by failing to ensure the following:

1. Immediate remediation (correction) of fungal organisms identified in the air in front of the pharmacy compounding hood at Hospital A in compliance with The United States Pharmacopeia (USP - standard of practice for sterile (germ-free) compounding (mixing)) <797>. This failure had the potential to expose patients administered compounded sterile preparations (CSPs) to an increased risk of fungal infections due to contamination. (Please refer to A-0283, A-0489, and A-0501).

2. Assure Radiologic equipment that failed Physicist Annual evaluation were repaired at Hospital A within the recommended time frame of the physicist. (Refer to A-0537)

3. There was no look back and risk assessment for patients that had radiologic exams using X-ray machine B. (Refer to A-537)

4. Failed to follow its policy and procedure and have ongoing monitoring of radiologic equipment to determine and evaluate how long X-ray machine B had been out of compliance. (Refer to A-537)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview and record review, the Quality Assessment and Performance Improvement program failed to monitor and take action to ensure the immediate remediation (correction) of fungal organisms identified in the air in front of the pharmacy compounding (mixing) hood in compliance with The United States Pharmacopeia (USP - standard of practice for sterile (germ-free) compounding) <797>. This failure had the potential to expose patients administered compounded sterile preparations (CSPs) to an increased risk of fungal infections due to contamination.

Findings:

1. A review of USP <797> in the section titled "ENVIRONMENTAL VIABLE [living] AIRBORNE PARTICLE TESTING PROGRAM ...Action Levels, Documentation, and Data Evaluation", indicated "Regardless of the number of cfu [abbreviation for colony-forming unit - a unit of measurement used to estimate the number of viable bacteria or fungal cells in a sample] identified in the pharmacy, further corrective actions will be dictated by the identification of microorganisms recovered (at least the genus [rank in organism hierarchy] level) by appropriate credentialed laboratory of any microbial bioburden captured as a cfu using an impaction air sampler [device]. Highly pathogenic microorganisms (e.g. ...molds [fungus] and yeast [fungus]) can be potentially fatal to patients receiving CSPs [abbreviation for compounded sterile preparations] and must be immediately remedied, regardless of cfu count, with the assistance of a competent microbiologist, infection control professional, or industrial hygienist."

Hospital A's environmental viable airborne particle testing report from Company D indicated the air samples were collected on December 6, 2018, and reported on December 14, 2018. On page 1 of 6, the report indicated it was reviewed in handwriting on December 28, 2018. On page 3 of 6, the report indicated for "Client Sample #: VA-1, 10:53am" ..." ...Pharmacy, In Front of Hood" ..."Test: 1107, USP 797 Culture, Air, Bacterial Counts" ..."Comments: 1 Mold colony isolated on bacterial plate". On page 4 of 6, the report indicated for "Client Sample #: VA-1, 10:53 am" ..." ...Pharmacy, In Front of Hood" ..."Test: 1108, USP 797 Culture, Air, Fungal Counts" ..."Organism(s) Isolated: Gliocladium species." On page 5 of 6, the report indicated, "Regardless of ISO Class, any fungal identification on an air or surface identification on an air or surface sample will cause the sample to be Out of Compliance."

On January 17, 2019, at 9:44 AM, during an interview, the Hospital A Director of Pharmacy (DOP) stated the facility followed USP <797> standards of practice for sterile compounding.

On January 18, 2019, at 9:50 AM, during an interview and concurrent record review, Hospital A's environmental viable airborne particle testing report from Company D reported on December 14, 2018, was reviewed with the Hospital A DOP. The Hospital A DOP stated the isolated organism Gliocladium was a fungus.

On January 22, 2019, at 9:58 AM, during an interview and concurrent record review, the Hospital A DOP stated she was notified of the organism Gliocladium isolated from the front of the pharmacy hood (device used to prepare CSPs) on December 28, 2018. She stated she verbally discussed the report with the Corporate Director of Infection Control (Corporate Director of IC). The hospital could not demonstrate implementation of corrective actions prior to the survey team entering on January 15, 2019. The Hospital A DOP stated the hospital "cleaned the vents" and "put in a prefilter" on January 21, 2019. The time period calculated from the date of notification of fungal results to the date of implementing corrective actions was approximately 24 days.

On January 22, 2019, at 10:23 AM, during an interview, the Regional Director of Pharmacy (RDOP) stated the date to assess if the fungal results were remedied was to be conducted on January 29, 2019.

On January 22, 2019, at 11:02 AM, during an interview, the Quality Coordinator stated the monitoring of the sterile compounding at Hospital A was tasked to the Corporate Director of IC.

On January 22, 2019, at 11:09 AM, during an interview and concurrent record review, the Corporate Director of IC acknowledged Hospital A's environmental viable airborne particle testing report from Company D reported on December 14, 2018. The Corporate Director of IC stated she discussed the December 2018 fungal results with the Hospital A DOP. She stated they would monitor to see if "it happens again" to see if there is a pattern in the future. When asked about the monitoring for quality issues related to sterile compounding, the Corporate Director of IC stated she was consulted but she was not responsible for the monitoring.

On January 22, 2019, at 2:07 PM, during an interview, the Vice President of Quality (VPQ) stated she was responsible for the oversight of Quality. The VPQ stated she was aware of sterile compounding problems in the organization since Thanksgiving (November) 2017. She stated she would depend on the expertise of Infection Prevention Professionals for the monitoring of quality issues related to sterile compounding.

The facility policy and procedure (P & P) titled, "Sterile Compounding" dated October 2018, indicated "[The name of the hospital(s)] will comply with all state and federal regulations to ensure the highest possible standards of sterility and stability of CSPs." The policy indicated "References ...USP <797>."

The facility P & P titled, "Performance Improvement Plan" dated September 2017, indicated on page 3 "Measuring and Monitoring Performance ...Incorporating information within the organization and from other similar organizations." On page 5, the policy indicated, "Documentation ...All meetings will have minutes that are reflective of the issue, discussion, and action and follow-up if required." On page 8, the policy indicated "Quality Council ...Reviews, analyzes and acts upon ...Center for Medicare [federal agency that provides healthcare] / Medicaid Services [agency that provides health coverage for low income individuals] ...California Department of Public Health [state agency to evaluate compliance with regulations] and other local regulatory agency mandated required measures."

Based on interview and record review, the hospital failed to maintain an organized Nursing Services by failing to ensure the following:

1. The doctor's order of daily wound care for one of 54 sampled patients (Patient 6) was not verified and carried out as ordered. This failure had the potential for delayed wound healing and further infection of Patient 6's right foot. (Refer to A-0395)

2. The hospital failed to effectively assess one (Patient 51) of 54 sampled patients who was admitted to the hospital. This failure resulted in the development of one Stage II and two Stage I pressure ulcers (localized damage to the skin and/or underlying tissue that usually occur over a bony prominence as a result of pressure). (Refer to A-0395)

3. At Hospital A, for one (Patient 17) of 52 sampled patients, the medical record did not indicate the rate or dose the insulin (drug to treat high blood sugar) drip was first (administered) at. This failure resulted in unknown information if the insulin drip was administered in accordance with the physician's order. (Refer to A-0405)

4. At Hospital A, for one (Patient 17) of 52 sampled patients, the medical record indicated the insulin drip was adjusted multiple times with no documentation of a second nurse double check. This failure had the potential for the patient to receive the wrong dose or rate of the insulin drip which could result in unsafe (demonstrated by measurements lower than target range) ineffective (demonstrated by measurements higher than target range) blood sugar management. (Refer to A-0405)

5. At Hospital A, for one (Patient 17) of 52 sampled patients, the medical record did not indicate a physician's order was obtained to adjust the insulin drip outside of the protocol. This failure had the potential to demonstrate lack of physician oversight over the care of the patient. (Refer to A-0405)

6. At Hospital A, for one (Patient 18) of 52 sampled patients, the insulin drip protocol was not followed multiple times with respect to the measured blood sugar value and the corresponding (matching) insulin drip rate or dose. This failure had the potential to result in unsafe or ineffective blood sugar management. (Refer to A-0405)

7. At Hospital A, for one (Patient 22) of 52 sampled patients, the medical record indicated the heparin (blood thinner) drip was adjusted multiple times with no documentation of a second nurse double check. This failure had the potential to for the patient to receive the wrong dose or rate of the heparin drip which could result in ineffective (demonstrated by measurements lower than target range) or unsafe (demonstrated by measurements higher than target range) drug therapy. (Refer to A-0405)

8. At Hospital B, for one (Patient 46) of 52 sampled patients, the facility failed to ensure an injectable vial was disinfected according to standards of practice prior to inserting a hypodermic needle into the vial when (Registered Nurse 7) RN 7 prepared pantoprazole (decreases stomach acid) for injection for Patient 46 during a medication pass observation on the Medical Surgical floor. This failure had the potential for an increased chance of contamination of the pantoprazole given to Patient 46. (Refer to A-0405)

9. At Hospital B, for one (Patient 47) of 52 sampled patients, the facility failed to ensure staff administered normal saline (NS - 0.9% sodium chloride) intravenously (IV - via the vein) to Patient 47 at 10 milliliters/hour (ml/hr) as ordered by the physician during a medication pass observation on the Medical Surgical floor. This failure had the potential for the loss of the IV on Patient 47 as the slow rate of administration was intended to keep the vein open. (Refer to A-0405)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview and record review, the facility failed to evaluate and supervise care when:

1. The doctor's order for daily wound care for one of 54 sampled patients (Patient 6) was not verified and carried out as ordered. This failure had the potential for delayed wound healing and further infection of Patient 6's right foot.

2. The hospital failed to effectively assess one (Patient 51) of 54 sampled patients who was admitted to the hospital. This failure resulted in the development of one Stage II and two Stage I pressure ulcers (localized damage to the skin and/or underlying tissue that usually occur over a bony prominence as a result of pressure).

Findings:

1. During a review of the clinical record for Patient 6, the History and Physical dated January 5, 2019, at 9:00 AM, indicated Patient 6's admission due to gangrene (death of body tissue caused by lack of blood flow) of right big toe and left second toe diabetic ulcer (breakdown in the skin).

A review of the Operative Note indicated a surgery done on January 7, 2019, that included right foot incision and drainage with removal of all nonviable (not capable of living) tissue and right foot hallux amputation (removal of big toe).

A review of the doctor's order for Patient 6 dated January 9, 2019, indicated "Flush right foot wound deep with saline syringes (a mixture of sodium chloride in water), pat dry, apply betadine (antiseptic) on incision and plantar (sole of the foot) blister. Pack wound with ½ (one half) inch plain packing and cover with dry dressings" daily.

During an interview with the Registered Nurse (RN 1), on January 15, 2019, at 2:27 PM, she reviewed Patient 6's clinical record and was unable to find documentation that the above wound care order was implemented daily.

During an interview with the Wound Care Nurse (WCN), on January 15, 2019, at 2:40 PM, the WCN stated she evaluated Patient 6 on January 8, 2019 and January 14, 2019. She further stated that the order for daily wound care was not communicated to her, "He [Patient 6] was not even on my list."

During an interview with the Assistant Chief Nursing Officer (ACNO 2), on January 15, 2019, at 2:46 PM, ACNO 2 stated whenever a doctor enters an order for wound consult or treatment, the wound care nurse will receive it and will be alerted by the computer. She further stated, "I am not sure why it did not flag (transmit and alert the staff) the order."

Further review of Patient 6's record by RN 1 on January 15, 2019, at 2:50 PM, indicated no documentation that the daily wound care order was verified (to identify if the order has been discontinued) with the doctor.

The facility policy and procedure titled, "Wound Management Team", dated January 2016, indicated " ...A. The Wound Management Team serves in a consulting role, with the intention to insure timely and appropriate wound care is provided for patients with impaired skin integrity. B. The Wound Nurse will communicate with the primary physician all pertinent information related to wounds treated. This information will be entered into the Medical Record by the wound nurse."



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2. The National Pressure Ulcer Advisory Panel (NPUAP) defines a pressure ulcer as a localized injury to the skin and/or underlying tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear". Pressure sores are most likely to appear on the sacrum, buttocks and hips. There are six pressure ulcer stages as defined by NPUAP. Individuals with stage 1 pressure ulcer have intact skin with non-blanchable erythema (skin redness) of a localized area, normally over a bony prominence.

Stage II pressure ulcers are characterized by partial thickness dermis (the deeper layer of the skin which contains sweat glands, nerve endings, hair follicles, sebaceous glands and blood vessels) loss, they present as shallow, open ulcers without slough (a layer or mass of dead tissue separated from surrounding living tissue, as in a wound, sore, or inflammation) or as intact or open/ruptured serum filled or serosanguinous (containing both blood and serum) filled blisters ....."

Patient 51 was admitted to the hospital through the emergency department (ED) with diagnoses including dehydration, failure to thrive, chronic kidney disease and history of diabetes.

According to the transfer records from the skilled nursing facility, that Patient 51 had been residing, Patient 51 had rashes on his back but no pressure ulcer. A review of the Physician notes titled, "EDMD, General, Adult" completed in the ED (Emergency Department) at 00:13 (12:13 AM) indicated Patient 51 had no rash. The physician also indicated no stool incontinence, no urinary incontinence. The notes did not indicate the presence of a pressure ulcer.

Patient 51 was admitted to the hospital and transferred to a medical/surgical floor for care. A document titled Physician H & P (History and Physical) showed the attending physician conducted a physical exam on Patient 51. The attending physician documented "no rash" on the face or the skin. There were listed nine problem areas and related assessment and plan of care. Skin problems including rash and/or pressure ulcer were not included in the problem list.

Nursing narrative notes completed by a licensed nurse on 1/15/19 at 0320 (3:20 AM), indicated that body assessment noted rashes on the face, neck and back. The licensed nurse also noted that Patient 51 was "incontinent both B/B (bowel and bladder), refused to be repositioned and check his back". At 05:32 (5:32 am), a licensed nurse completed a nursing assessment on Patient 51 in which the licensed nurse documented, under the sub heading "Skin Assessment Integrity", that Patient 51's skin was "intact". Patient 51 was also assessed at a score of 14 (medium risk) for the Braden Scale. The Braden Scale is a tool that was developed to help health professionals, especially nurses, assess a patient's risk of developing a pressure ulcer.

On 1/15/19 at 0600 (6 AM), the licensed nurse "noted redness on right knee and non-blanchable redness on sacrococcyx with stage 2 measuring 0.3 cm x 0.3 cm. Good pericare (washing the genitals and anal area ) rendered".

On January 15, 2019, at 08:40 another licensed nurse documented the skin as intact. On January 15, 2019, at 17:40 (5:40 pm), a wound nurse (Wound RN) completed a Wound Care Initial assessment on Patient 51 in which three areas were documented as having pressure injury. The wound nurse documented Stage 2 pressure wound to sacrum and stage 1 pressure injury to left and right foot. The documentation described onset as "unknown, wound present on admission". The document review did not support this assertion.

Wound 1 was Staged as Stage 2 on the sacrum measuring 1 cm x 1 cm x 0.1 cm (length x width x depth). Wound 2 was staged as a Stage 1 pressure injury on the left foot and Wound 3 was described as pressure injury right foot, stage 1. These descriptions indicated the worsening of the pressure ulcer originally identified on the sacrum and the development of new areas of pressure injury.

A review of the care plan showed the treatment plan for Wound 1 included low air loss mattress (pressure redistribution mattress), a skin protectant (cream) and a wound dressing. In addition, offloading, repositioning every two hours, keeping the dressing clean and dry, pericare after each incontinence. The treatment/care plan for Wounds 2 and 3 were similar except for the skin protectant and wound dressing.

Review of nursing notes from January 15 through 18, 2019 showed licensed nurse documentation of care provided to Wound 1. There was no documentation of the treatment or care provided for Wound 2 and 3 throughout the patient stay. If these wounds were resolved or healed, nursing staff failed to document. The hospital failed to prevent the development of pressure ulcers in Patient 51.

A review of hospital policy titled "Skin Integrity" did not include what information licensed nurses are required document as part of ongoing wound care.

Based on observation, interview, and record review, the facility failed to ensure medications were prepared and administered in accordance with policies and procedures or accepted standards of practice when:

1. At Hospital A, for one (Patient 17) of 52 sampled patients, the medical record did not indicate the rate or dose the insulin (drug to treat high blood sugar) drip was first (administered) at. This failure resulted in unknown information if the insulin drip was administered in accordance with the physician's order.

2. At Hospital A, for one (Patient 17) of 52 sampled patients, the medical record indicated the insulin drip was adjusted multiple times with no documentation of a second nurse double check. This failure had the potential to for the patient to receive the wrong dose or rate of the insulin drip which could result in unsafe (demonstrated by measurements lower than target range) ineffective (demonstrated by measurements higher than target range) blood sugar management.

3. At Hospital A, for one (Patient 17) of 52 sampled patients, the medical record did not indicate a physician's order was obtained to adjust the insulin drip outside of the protocol. This failure had the potential to demonstrate lack of physician oversight over the care of the patient.

4. At Hospital A, for one (Patient 18) of 52 sampled patients, the insulin drip protocol was not followed multiple times with respect to the measured blood sugar value and the corresponding (matching) insulin drip rate or dose. This failure had the potential to result in unsafe or ineffective blood sugar management.

5. At Hospital A, for one (Patient 22) of 52 sampled patients, the medical record indicated the heparin (blood thinner) drip was adjusted multiple times with no documentation of a second nurse double check. This failure had the potential to for the patient to receive the wrong dose or rate of the heparin drip which could result in ineffective (demonstrated by measurements lower than target range) or unsafe (demonstrated by measurements higher than target range) drug therapy.

6. At Hospital B, for one (Patient 46) of 52 sampled patients, the facility failed to ensure an injectable vial was disinfected according to standards of practice prior to inserting a hypodermic needle into the vial when (Registered Nurse 7) RN 7 prepared pantoprazole (decreases stomach acid) for injection for Patient 46 during a medication pass observation on the Medical Surgical floor. This failure had the potential for an increased chance of contamination of the pantoprazole given to Patient 46.

7. At Hospital B, for one (Patient 47) of 52 sampled patients, the facility failed to ensure staff administered normal saline (NS - 0.9% sodium chloride) intravenously (IV - via the vein) to Patient 47 at 10 milliliters/hour (ml/hr) as ordered by the physician during a medication pass observation on the Medical Surgical floor. This failure had the potential for the loss of the IV on Patient 47 as the slow rate of administration was intended to keep the vein open.

Findings:

1. A review of Patient 17's medical record at Hospital A indicated a physician's order for an insulin infusion (drip) dated November 9, 2018, at 2:23 PM. The physician order indicated for the insulin drip to "Give [dose] 2 units/hr [hour]. Run [rate] at: 2 mL [abbreviation for milliliters - a unit of measurement]/hr [rate]. The medical record indicated the insulin drip was first administered on November 9, 2018, at 4:06 PM with an "Administered Dose: 100 Unit(s) [the contents of the entire bag]."

On January 17, 2019, at 10:19 AM, during an interview and concurrent record review, Patient 17's medical record was reviewed with the Clinical Informatics Registered Nurse (CIRN). The CIRN acknowledged the above physician's order for the insulin drip to "Give 2 units/hr. Run at: 2 mL/hr." The CIRN acknowledged the insulin drip was documented as first administered on November 9, 2018, at 4:06 PM at an "Administered Dose: 100 Unit(s) [the contents of the entire bag]." When asked if there was any documentation to indicate the rate or dose the insulin drip was first administered at, the CIRN stated, "I don't see anything."

The facility policy and procedure (P & P) titled, "Preparations and Administration of Medications" dated September 2018, indicated "An ...RN [abbreviation for Registered Nurse] ...may administer ...medications in accordance with the Six Rights of medication administration ...Right [correct] dose ...Right documentation." On page 8, the policy indicated "Charting of all doses administered is to be done on the patient's MAR [abbreviation for Medication Administration Record - where medications are documented in the medical record]."

2. A review of Patient 17's medical record at Hospital A indicated a physician's order for an insulin infusion (drip) dated November 9, 2018, at 2:23 PM. The medical record indicated nursing adjusted the insulin drip rate and/or dose for the following dates and times listed below with no documented second nurse double check:

" November 9, 2018 at 6 PM
" November 9, 2018 at 11 PM
" November 10, 2018 at 1 AM
" November 10, 2018 at 5 AM

On January 17, 2019, at 10:51 AM, during an interview and concurrent record review, Patient 17's medical record was reviewed with the CIRN. The CIRN stated he did not see documentation of a second nurse double check when the medical record indicated nursing adjusted the insulin drip rate and/or dose for the following dates and times listed below.

" November 9, 2018 at 6 PM
" November 9, 2018 at 11 PM
" November 10, 2018 at 1 AM
" November 10, 2018 at 5 AM

The facility P & P titled, "Preparation and Administration of Medications" dated September 2018, indicated "8.8.1 Two licensed nurses verify accuracy of insulin ...The signature of both the nurse and the observer are necessary."

The facility P & P titled, "High Alert Medication Safety" dated December 1, 2016, indicated "Administering Medications:
i. Double-checking is defined as:
a. Independently comparing the label and product contents in hand versus the order or pharmacy-generated medication administered record
ii. High Alert Medications require documentation of the double-checking process. Two nurses double checking a High Alert Medication must provide their initials on the Medication Administration Record (MAR) ...
IV. Definitions
A. High Alert Medications are drugs that have a high risk of causing injury, either as a result of a narrow therapeutic range or a historically high incidence of reported serious adverse events.
" Insulin ...
High Alert Medication Summary of Double Check Requirements
Insulin (IV [intravenous - into the vein] /SC [subcutaneous - under the skin]) Any time an insulin drip is initiated or adjusted the pump settings nurse initiates or adjusts the pump settings for an insulin drip, a second nurse must double check the chart order or MAR with: Concentration, Calculated rate, Correct pump settings.

The double check is documented with the initials of both nurses on the Medication Administration Record.

3. A review of Patient 17's medical record at Hospital A indicated a physician's order for an insulin infusion (drip) protocol dated November 9, 2018, at 2:23 PM. The medical record indicated on November 9, 2018, at 6 PM, the measured blood sugar was 386. The insulin drip protocol indicated the for a measured blood sugar greater than 381 milligrams (a unit of measurement) per deciliter (unit of measurement), the insulin drip dose was 10 units/hour.

The medical record indicated a "Nursing Narrative Note" signed November 9, 2018 at 8:09 PM, ">1800 [6:00 PM] ...Contacted urgent care [the name of the physician] regarding high glucose level - instructed to increase insulin level to 8ml [milliliters - a unit of measurement]."

On January 17, 2019, at 10:19 AM, during an interview and concurrent record review, Patient 17's medical record was reviewed with the Clinical Informatics Registered Nurse (CIRN). The CIRN stated for a measured blood sugar of 386 milligrams per deciliter, the insulin drip rate or dose should be 10 units per hour or 10 mLs per hour. The CIRN acknowledged the "Nursing Narrative Note" signed November 9, 2018, at 8:09 PM. When asked if there was a signed verbal medication order in the medical record to adjust the insulin drip rate to 8 mLs/hour, the CIRN stated he did not see any medication orders.

The facility P & P titled, "Medication Administration and Ordering Privileges, Verbal Orders" dated June 2014, indicated "Verbal Medication Orders: Verbal orders for drugs shall be given only to individuals so authorized by law and hospital medical staff, and only by a person lawfully authorized to prescribe at this hospital ...The order must be promptly recorded in the physician order sheet on that specific patients chart along with the signature and the title of the person who received the order ...The order must be countersigned by the person prescribing within 48 hours."

The facility P & P titled, "Preparation and Administration of Medications" dated September 2018, indicated "Any medications administered to a patient must have an order from an individual authorized to prescribe medications ...If the order is given verbally by telephone, it must be written as a verbal order from the person prescribing and signed by the ...RN [Registered Nurse], LVN [Licensed Vocational Nurse] ...receiving the order. The order must be countersigned by the prescriber within 48 hours."

4. A review of Patient 18's medical record at Hospital A indicated a physician's order for an insulin infusion (drip) protocol dated October 19, 2018 at 12:01 PM.

On January 17, 2019, at 11 AM, during an interview and concurrent record review, Patient 18's medical record was reviewed with the Clinical Informatics Registered Nurse (CIRN).

The medical record indicated on October 19, 2018, at 11 PM, the measured blood sugar was 234 milligrams per deciliter and the documented insulin drip dose was 2 units per hour. The CIRN stated the insulin drip dose should have been 4 units per hour for the measured blood sugar of 234 milligrams per deciliter.

The medical record indicated on October 20, 2018, at 5 AM, the measured blood sugar was 186 milligrams per deciliter and the documented insulin drip rate was 2 mLs per hour. The CIRN stated the insulin drip rate should have been 3 mLs per hour for the measured blood sugar of 186 milligrams per deciliter.

The medical record indicated on October 20, 2018, at 9 PM, the measured blood sugar was 246 milligrams per deciliter and the documented insulin drip rate was 4 mLs per hour. The CIRN stated the insulin drip rate should have been 6 mLs per hour for the measured blood sugar of 246 milligrams per deciliter.

The medical record indicated on October 20, 2018, at 10 PM, the measured blood sugar was 248 milligrams per deciliter and the documented insulin drip rate was 4 mLs per hour. The CIRN stated the insulin drip rate should have been 6 mLs per hour for the measured blood sugar of 248 milligrams per deciliter.

On January 17, 2019, at 11:26 AM, during an interview and concurrent record review, the CIRN was asked if there were any physician orders to deviate from the insulin drip protocol for the following dates and times: October 19, 2018, at 11 PM; October 20, 2018 at 5 AM; October 20, 2018, at 9 PM; and October 20, 2018, at 10 PM. The CIRN stated "I don't see anything."

The facility policy and procedure (P & P) titled, "Preparations and Administration of Medications" dated September 2018, indicated "An ...RN [abbreviation for Registered Nurse] ...may administer ...medications in accordance with the Six Rights of medication administration ...Right [correct] dose ...Right documentation."

The facility P & P titled, "High Alert Medication Safety" dated December 1, 2016, indicated "Administering Medications:
i. Double-checking is defined as:
a. Independently comparing the label and product contents in hand versus the order or pharmacy-generated medication administered record
ii. High Alert Medications require documentation of the double-checking process. Two nurses double checking a High Alert Medication must provide their initials on the Medication Administration Record (MAR) ...
IV. Definitions
A. High Alert Medications are drugs that have a high risk of causing injury, either as a result of a narrow therapeutic range or a historically high incidence of reported serious adverse events.
" Insulin ...
High Alert Medication Summary of Double Check Requirements
Insulin (IV [intravenous - into the vein] /SC [subcutaneous - under the skin]) Any time an insulin drip is initiated or adjusted the pump settings nurse initiates or adjusts the pump settings for an insulin drip, a second nurse must double check the chart order or MAR with: Concentration, Calculated rate, Correct pump settings.

The double check is documented with the initials of both nurses on the Medication Administration Record.

5. A review of Patient 22's medical record at Hospital A indicated a physician's order for a heparin infusion (drip) dated September 13, 2018, at 9:45 PM. The medical record indicated nursing adjusted the heparin drip rate and/or dose for the following dates and times listed below with no documented second nurse double check:

" September 14, 2018 at 1:35 PM
" September 14, 2018 at 10 PM

On January 17, 2019, at 12:14 PM, during an interview and concurrent record review, Patient 22's medical record was reviewed with the Clinical Informatics Registered Nurse (CIRN). The CIRN stated he did not see documentation of a second nurse double check when the medical record indicated nursing adjusted heparin drip rate and/or dose for the following dates and times listed below.

" September 14, 2018 at 1:35 PM
" September 14, 2018 at 10 PM

The facility P & P titled, "Preparation and Administration of Medications" dated September 2018, indicated "8.8.1 Two licensed nurses verify accuracy of ...heparin ...The signature of both the nurse and the observer are necessary."
The facility P & P titled, "High Alert Medication Safety" dated December 1, 2016, indicated "Administering Medications:
i. Double-checking is defined as:
a. Independently comparing the label and product contents in hand versus the order or pharmacy-generated medication administered record
ii. High Alert Medications require documentation of the double-checking process. Two nurses double checking a High Alert Medication must provide their initials on the Medication Administration Record (MAR) ...
IV. Definitions
A. High Alert Medications are drugs that have a high risk of causing injury, either as a result of a narrow therapeutic range or a historically high incidence of reported serious adverse events.
" ...Heparin ...

High Alert Medication Summary of Double Check Requirements
Heparin (IV) Anytime a nurse prepares an IV infusion [drip] of HEPARIN a second nurse must double check the chart order or MAR and verify the pump settings are accurate for the dosage rate to be infused assuring that the volumetric rate is accurate prior to starting the pump.



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6. On January 17, 2019 at about 8:45 A.M., RN 7 prepared a vial of pantoprazole for Patient 46 by removing the plastic cap on top of the vial and injecting NS into the vial to dissolve the powder in the vial. She did not swab the rubber diaphragm on top of the vial with an alcohol pad to disinfect the diaphragm prior to inserting the hypodermic needle into the diaphragm. It is a standard of practice to do this as the rubber diaphragms of vials of injectable medications are not sterile even though they are protected by a removable plastic cap. At that point RN 7 was requested to step into the hall before administering the medication to Patient 46 and requested to obtain a fresh vial and swab it with an alcohol pad as part of the preparation process.

On January 18, 2018 at 12:20 P.M. during an interview of the Infection Control Senior Director, she stated it was a standard of practice to disinfect the rubber diaphragms of vials of injectable drugs with alcohol before introducing a hypodermic needle into the vial (to add fluid to dissolve a powder in the vial or to remove the contents of the vial to inject it into a patient). During a second interview of the Infection Control Senior Director, she stated there was no hospital policy directing staff to swab the rubber diaphragms of vials of injectable drugs.

7. On January 17, 2019 at 9:13 A.M. RN 4 passed medications to Patient 47. On January 17, 2019 at 9:34 A.M., a review of Patient 47's electronic medication administration record (eMAR: an electronically formatted document used by nurses to accurately medicate their patients and to document the date and time a dose of medication was administered) at the Medical/Surgical Nursing Station indicated that on January 14, 2019, a physician had ordered NS to run at 75 ml/hr with a hang time of 13.33 hours (the expected time the 1000 ml IV bag would empty when running at 75 ml/hr) and the record indicated this order was discontinued at 10:06 A.M. on January 15, 2019.

On January 15, 2019 at 10:07 A.M. a physician had ordered NS to run at 10 ml/hr on Patient 47 with a hang time of 24 hours. During a concomitant interview of RN 5 at that time she stated the IV was only to hang for 24 hours. RN 7 stated the order was an active order. After reviewing the eHR, RN 7 stated she had found nothing in the nursing narratives indicating the stopping of the NS IV infusion. During a concomitant interview of RN 4 at that time she stated there was no evidence in the eHR that the IV had been started on Patient 47.

On January 17, 2019 at 9:38 A.M. an inspection of the area around Patient 47's bed indicated a 1000 ml IV bag of NS was hanging on an IV pole to which was attached an IV pump. The pump was not running and the IV line was not attached to the patient. A red label affixed to the IV bag indicated the IV bag had been hung on 1/14/19 at 10:15 A.M. and the rate written on the label was 10 ml/hr. These observations were verified by the Director of Education during a concomitant interview at that time.

The United States Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines. The USP drug standards are enforceable in the United States by the Food and Drug Administration and are published in the United States Pharmacopeia/National Formulary (USP/NF). The USP revised general chapter <797> (USP 797) entitled PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS documents in the Introduction that "The objective of this chapter is to describe conditions and practices to prevent harm, including death to patients that could result from ... microbial contamination ..." among other things. If a hospital puts all the environmental controls as well as all the personnel training, certification, and compounding practices into place as described in USP 797, the hospital can assign beyond use dates (BUDs: date or time beyond which an IV product cannot be stored or transported) to compounded IV products as described in USP 797.

Based on observations of the compounding area of Hospital A and B (where staff made compounded sterile preparations) in the pharmacy, review of hospital policies, and interview of staff at Hospital A and Hospital B the Hospitals failed:

1. to immediately remedy the finding of fungal organisms cultured from air samples taken in front of the Hospital A compounding hood which is contrary to USP 797 guidelines.

2. to test the air outside of the compounding aseptic isolator (CAI: a sealed units accessed by sleeves used to compound medications) located in the Hospital B pharmacy even though air had been considered a source of contamination of the CAI after microbial colony forming units including fungi were isolated from within the ante-chambers the CAI during an air sampling procedure on two out of five weekly tests conducted between December 5, 2018 and January 2, 2019 (see 4 in A-0501 below).

3. to identify the ante-chambers (or "airlocks") of the Hospital B CAI as ISO 5 classified spaces (after purging the air as indicated in the manufacturer's manual) in a meeting that took place on January 3, 2019 regarding contamination found in the CAI on December 19, 2018 (see 4 in A-0501 below).

4. to identify, in Hospital B, that even one colony forming unit of a fungus breached thresholds as documented in USP 797 (publication which establishes recognized standards for safely compounding sterile preparations) as it is identified in the chapter as a "highly pathogenic" microorganism that must be immediately remedied (see 4 in A-0501 below).

5. to ensure hospital policy for conducting gloved fingertip sampling (testing for the ability to don sterile gloves without contaminating them) reflected USP 797 standards for conducting the test as the policy did not clearly describe the process for the initial process for the GFS test conducted on new employees and the policy for the annual test only provided for testing one hand, not two as per USP 797. The hospital process for testing new employees for the initial three GFS tests was conducted using the same pair of gloves rather than after donning three separate pair of gloves after conducting the hand hygiene procedure as described in USP 797. Staff had annual testing on only one hand not two hands as required by USP 797 (see 5 in A-0501 below).

As a result, the staff at these two campuses did not (Hospital A) or could not (Hospital B) immediately put measures into place to eliminate fungi from the compounding areas in these campuses as stipulated in USP 797, the recognized standard for assuring the quality and safety of compounded sterile preparations either because they did not take action on the findings until the CDPH survey team entered the hospital on January 15, 2019 (Hospital A) or were not aware that the ante chambers ("airlock") of the PEC were in fact ISO 5 (extremely clean) areas when purged with filtered air (Hospital B) and that even one cfu of fungus breached USP 797 thresholds as it is identified as a highly pathogenic organism in the USP chapter (Hospital B).

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on inspection of an Intubation Kit (contained drugs, syringes, and hypodermic needles used to facilitate the placement of a tube in the airway of a patient who was having difficulty breathing on their own) stored in the refrigerator located on the Medical/Surgical Unit medication room, unit dose medication cassettes located in the Surgical Intensive Care Unit (SICU) and Telemetry Unit, document review, and staff interview, the hospital failed:

1. to establish all the contents of the Intubation Kit. The label on the kit listed the drugs contained in the kit but not the syringes or needles. Hence staff had no guidance from the organized medical staff, via approval of the contents by the Pharmacy and Therapeutics Committee (P&T Committee: committee with responsibility for the pharmaceutical services in the hospital), as to the type and number of units of syringes and needles the members of the P&T Committee felt should be in this supply (see 1 below).

2. to ensure pharmacy staff filled in the "Opened by" and "Use by" date on the label of Advair Diskuses (device containing medication used to treat asthma) as the medication has a shortened shelf life once removed from a sealed pouch the Diskuses are packaged in by the manufacturer (see 2 below).

3. to ensure nursing staff followed the hospital policies and procedures for returning medications to the pharmacy for relabeling and re-dispensing by pharmacy staff if the patient was transferred to a new unit or for disposal if the patient had been discharged from the hospital (see 3 below).

As a result, the Intubation Kits may not be filled in consistently by pharmacy staff and the P&T Committee members would not have had input as to what type of syringes and needles should be in the supply. Also Advair may be available for use by patients after the date the manufacturer would no longer guarantee the potency of the product. Finally, the nurses dispensed Advair six times to Patient 49 and Patient 49 missed two doses due to unavailability of the Advair which could have compromised her health and may have been prevented if the policy had been carried out (see 4 below).

Findings:

1. On January 17, 2019 at 10:01 A.M. an inspection of the medication room located on the Medical/Surgical Unit indicated it contained a plastic tackle box labeled as "Intubation Kit" and was sealed by a breakable plastic seal. This box was stored in a refrigerator located in the medication room. The label on the outside of the box indicated it contained two five milliliter(ml) vials of rocuronium 10 milligrams (mg)/ml and two 10 ml vials of succinylcholine 20 mg/ml. The label also documented that one 10 ml vial of etomidate 2 mg/ml was part of the kit but was located in the automated dispensing cabinet located in the medication room instead of inside the tackle box. Rocuronium and succinylcholine are used to paralyze muscles to facilitate the placement of an air tube (airway) in a patient who is having trouble breathing on their own. Etomidate is used to induce anesthesia. Inspection of the box indicated it contained these medications. The box also contained one 10 ml syringe, two 5 ml syringes and three 18 gauge (G) 1.5 inch hypodermic needles. This equipment did not appear on the label.

On January 17, 2019 at 11:00 A.M., during an interview of both the Hospital B Lead Pharmacy Technician and the Hospital B Pharmacy Manager, the Hospital B Lead Pharmacy Technician stated that individual pharmacists added syringes and needles into the kit as they felt the kit required these supplies. The Hospital B Pharmacy Manager stated there was no standardized list of syringes and needles approved by the Pharmacy and Therapeutics Committee to place in the intubation kit available to staff at that time.

2. Advair is used to treat asthma and it packaged in a round flat plastic container (the Diskus) that contains a wheel with sealed blisters that contains two different medications to treat asthma: an anti-inflammatory drug and an airway dilating drug. The wheel is turned and the blisters punctured via a lever on the side of the Diskus. The powder is then inhaled by the patient via a mouthpiece located on the side of the Diskus. The plastic Diskus is packaged by the manufacturer in a sealed pouch which must be opened to gain access to the Diskus. As long at the pouch remains sealed, the Diskus is good to the expiration date printed on the box that the foil pouch/Diskus is packaged in by the manufacturer. Once opened, the manufacturer stipulates in the approved product labeling included in the box that the shelf life of the Diskus decreases to one month. The manufacturer provides labeled spaces on the Diskus label which enables staff to write, directly on the Diskus label, the date staff removed the Diskus from the pouch and the date, a month later, that the Diskus should no longer be used by a patient. This information cues staff to remove the Diskus from active use after the date the manufacturer will no longer guarantee the strength of the drugs contained in the Diskus.

On January 17, 2019 at 3:47 P.M. an inspection of an Advair Diskus labeled for use by Patient 49 that staff had placed in a unit dose medication cassette stored in the SICU medication room indicated the manufacturer had printed the following verbiage on the manufacturer's label affixed to the Diskus: "Pouch opened ____________" and "Use by ____________" which provided spaces on which staff could write dates. Staff had not filled in dates in these spaces. During an interview in the SICU medication room of Charge Nurse 1 at that time, she stated pharmacy staff had told them to fill in a date on the Advair Diskus and she verified that nursing staff had not filled in the dates on Patient 49's Advair Diskus.

On January 17, 2019 at 4:19 P.M. an inspection of an Advair Diskus labeled for use by Patient 49 that staff had placed in a unit dose cassettes stored in the Telemetry Unit medication room indicated staff had not filled in dates in these spaces. This observation was verified by the Director of Education during an interview conducted at that time.

On January 17, 2019 at 5:59 P.M. during an interview of Hospital B Pharmacy Tech 1 he stated pharmacy staff removed Advair Diskuses from their pouches and labeled them for the intended patients (before sending them to the floor where the respective patients were housed). He stated he was not aware the Advair Diskus had "Opened by" and "Use by" spaces on the Diskus label that needed to be filled in.

On January 17, 2019 at 6:02 P.M. during an interview of the Hospital B Pharmacy Manager, she stated she did not expect pharmacy technicians to fill in the date spaces on the Advair Diskus label. She stated she did not know the Advair Diskus had a one-month shelf life after staff had removed the Diskus from the sealed pouch it was packaged in and therefore she did not direct her staff to label the Diskus with "opened" and "use by" dates.

On January 17, 2019 at 6:07 P.M. a review of the patient instructions for use included with the product labeling shipped with the Advair Diskus by the manufacturer indicated it provided direction to patients (and thus hospital staff) to fill in the dates on the Advair Diskus label and to give it a "1 month" use by date after the "open" date.

3. On January 17, 2019 at 3:47 P.M. an inspection of an Advair Diskus labeled for use by Patient 49 that staff had placed in a unit dose medication cassette stored in the SICU medication room indicated the Diskus was located in a unit dose medication cassette labeled for Patient 48. During an interview in the SICU medication room of Charge Nurse 1 at that time, she stated Patient 48 was on the unit but Patient 49 was not. She stated when patients are discharged or transferred, nursing staff were to place any medications located in a unit dose medication cassette labeled for that patient into a "discharge bin" and subsequently pointed out a large yellow plastic bin located in the medication room with a label on it that read "Return to Pharmacy". A concomitant review, at that time, of the "Patient Location Roster" stored in a three ring binder stored on the SICU Unit indicated Patient 49 had transferred to the Telemetry Unit on January 14, 2019 at 11:55 P.M.

On January 17, 2019 at 4:19 P.M. an inspection of a unit dose medication cassette in the Telemetry Medication Room and labeled for use by Patient 49 indicated it contained an Advair Diskus labeled for Patient 49. This observation was verified by the Director of Education during an interview conducted at that time. A review of the "Patient Locator Log" provided by staff at that time indicated Patient 49 had arrived on the Telemetry Unit on January 15, 2019 at 10 minutes after midnight.

On January 17, 2019 at 5:32 P.M. during a second inspection of the Telemetry Unit medication room, Patient 49's name had been removed from the unit dose medication cassette yet it still contained the Advair Diskus labeled for Patient 49. The medication room had a large yellow bin labeled "Pharmacy Return Bin." During an interview of Hospital B Pharmacy Tech 1, who was working in the medication room at that time, he stated Patient 49 had been discharged. He stated he had not known that the Advair Diskus was in the unit dose medication cassette that had previously been labeled with Patient 49's name. He stated he only picked up medications that had been placed in the Pharmacy Return Bin. During a concomitant interview of the Director of Telemetry at that time he stated that when a patient was discharged from the hospital, a nurse was supposed to place medications from that patient's unit dose medication cassette into the Pharmacy Return Bin. A review of the "Patient Locator Log" at that time indicated Patient 49 had been discharged from the hospital on that day at 1:06 P.M.

On January 17, 2019 at 6:11 P.M. a review of Policy and Procedure PHA.060 titled PROCESSING TRANSFERS AND DISCHARGES (Reviewed without changes on March 7, 2018) indicated it stipulated the following:

Under "Policy Purpose": "The orders for discharge and transfer are provided by the physician. The nursing staff shall return medications to the Pharmacy."

Under "Patient Discharge": "When the patient is discharged, the medication is removed from the medication cassette, IV shelf and IVPB refrigerator drawers by the nurse and placed in the return to Pharmacy bin" (IV refers to intravenous solutions and IVPB means intravenous piggy back: a small solution "piggybacked" onto a larger IV via a common IV line).

Under "Patient Transfer": "Transferring a patient's medication involves returning the medications to Pharmacy to re-label including:

- Medication for bedside use.

-Medication in the unit dose drawer.

-IV Solutions.

-IVPB's from the refrigerator."

"Nursing shall be responsible for sending all medications and parenteral solutions to the Main Pharmacy. The Pharmacy Department shall then dispense medication to the new patient location."

On January 17, 2019 at 6:17 P.M., during an interview of the Director of Education, he stated that in both cases investigated that day the nursing staff did not carry out this policy.

On January 18, 2019 at 9:11 A.M., a concomitant review, with the Hospital B Director of Pharmacy, of the refill record for Patient 49's Advair Diskus indicated the Diskus had been dispensed six times during Patient 49's stay in the hospital from admission on January 8, 2019 through her discharge on January 17, 2019. One Diskus was dispensed on January 9, 2019, three Diskuses were dispensed on January 15, 2019, and two Diskuses were dispensed on January 16, 2019. During a concomitant interview of the Hospital B Director of Pharmacy at that time she verified these observations and stated all of these were actual fills of Advair (the medication was actually dispensed).

On January 18, 2019 at 1:56 P.M., a concomitant a review of Patient 49's electronic medication administration record (eMAR: an electronically formatted document used by nurses to accurately medicate their patients and to document the date and time a dose of medication was administered) with RN 6 indicated Patient 49 did not receive her Advair at 9 A.M. on January 15, 2019 and at 9 A.M. on January 16, 2019. The eMAR documented RN 6 as the person documenting this information in the eMAR. During a concomitant interview of RN 6 at that time she verified these observations and stated the Advair was not available for administration to Patient 49 at those times.

Based on observation, interview, and record review, the facility failed to ensure compliance of The United States Pharmacopeia (USP - standard of practice for sterile (germ-free) compounding (mixing) <797> when:

1. In Hospital A, the hospital could not demonstrate the immediate remediation (correction) of fungal organisms identified in the air in front of the pharmacy compounding hood. This failure had the potential to expose patients administered compounded sterile preparations (CSPs) to increased risk of fungal infections due to contamination.

2. In Hospital A, the environmental viable airborne particle testing report did not indicate the selected sampling sites included locations within (inside) the ISO (abbreviation for the International Organization for Standardization - a standard-setting body) Class 5 (measurement of air cleanliness) environment. This failure had the potential to result in the inability to trace back and sample the location where the isolated organisms were originally identified to ensure optimal corrective actions.

3. In Hospital A, the cleaning and disinfecting of the compounding area was performed with non-sterile 70% (concentration) isopropyl alcohol. This failure had the potential to expose patients to intravenous (IV - given into the vein) medications with microbial contamination.

4. In Hospital B, to test the air outside of the compounding aseptic isolator (CAI: a sealed units accessed by sleeves used to compound medications) located in the hospital pharmacy even though air had been considered a source of contamination of the CAI after microbial colony forming units including fungi were isolated from within the CAI during an air sampling procedure on two out of five weekly tests conducted between December 5, 2018 and January 2, 2019 (see 4 below).

5. In Hospital B, to identify the ante-chambers (or "airlocks") of the hospital CAI as ISO 5 classified spaces (after purging the air as indicated in the manufacturer's manual) in a meeting that took place on January 3, 2019 regarding contamination found in the CAI on December 19, 2018 (see 4 below).

6. In Hospital B, to identify in a meeting that took place on January 3, 2019 regarding contamination found in the CAI on December 19, 2018, that even one colony forming unit of a fungus breached thresholds as documented in USP 797 (publication which establishes recognized standards for safely compounding sterile preparations) as it was identified in the chapter as a "highly pathogenic" microorganism that must be immediately remedied (see 4 below).

7. In Hospital B, to ensure hospital policy for conducting gloved fingertip sampling (testing for the ability to don sterile gloves without contaminating them) reflected USP 797 standards for conducting the test as the policy did not clearly describe the process for the initial process for the GFS test conducted on new employees and the policy for the annual test only provided for testing one hand, not two as per USP 797. The hospital process for testing new employees for the initial three GFS tests was conducted using the same pair of gloves rather than after donning three separate pair of gloves after conducting the hand hygiene procedure as described in USP 797. Staff had annual testing on only one hand not two hands as required by USP 797 (see 5 below).

8. In Hospital B, to ensure all media-fill tests (used to evaluate one's ability to compound a sterile product without contaminating it) were performed to USP 797 standards. One (Hospital B RPh 1) out of 33 pharmacists' media-fill test was only incubated for 12 days instead of 14 days as required by USP 797 (see 6 below).

Findings:

1. A review of USP <797> in the section titled "ENVIRONMENTAL VIABLE [living] AIRBORNE PARTICLE TESTING PROGRAM ...Action Levels, Documentation, and Data Evaluation", indicated "Regardless of the number of cfu [abbreviation for colony-forming unit - a unit of measurement used to estimate the number of viable bacteria or fungal cells in a sample] identified in the pharmacy, further corrective actions will be dictated by the identification of microorganisms recovered (at least the genus [rank in organism hierarchy] level) by appropriate credentialed laboratory of any microbial bioburden captured as a cfu using an impaction air sampler [device]. Highly pathogenic microorganisms (e.g. ...molds [fungus] and yeast [fungus]) can be potentially fatal to patients receiving CSPs [abbreviation for compounded sterile preparations] and must be immediately remedied, regardless of cfu count, with the assistance of a competent microbiologist, infection control professional, or industrial hygienist."

Hospital A's environmental viable airborne particle testing report from Company D indicated the air samples were collected on December 6, 2018, and reported on December 14, 2018. On page 1 of 6, the report indicated it was reviewed in handwriting on December 28, 2018. On page 3 of 6, the report indicated for "Client Sample #: VA-1, 10:53am" ..." ...Pharmacy, In Front of Hood" ..."Test: 1107, USP 797 Culture, Air, Bacterial Counts" ..."Comments: 1 Mold colony isolated on bacterial plate". On page 4 of 6, the report indicated for "Client Sample #: VA-1, 10:53 am" ..." ...Pharmacy, In Front of Hood" ..."Test: 1108, USP 797 Culture, Air, Fungal Counts" ..."Organism(s) Isolated: Gliocladium species." On page 5 of 6, the report indicated, "Regardless of ISO Class, any fungal identification on an air or surface identification on an air or surface sample will cause the sample to be Out of Compliance."

On January 17, 2019, at 9:44 AM, during an interview, the Hospital A Director of Pharmacy (DOP) stated the facility followed USP <797> standards of practice for sterile compounding.

On January 18, 2019, at 9:50 AM, during an interview and concurrent record review, Hospital A's environmental viable airborne particle testing report from Company D reported on December 14, 2018, was reviewed with the Hospital A DOP. The Hospital A DOP stated the isolated organism Gliocladium was a fungus.

On January 22, 2019, at 9:58 AM, during an interview and concurrent record review, the Hospital A DOP stated she was notified of the organism Gliocladium isolated from the front of the pharmacy hood (device used to prepare CSPs) on December 28, 2018. She stated she verbally discussed the report with the Corporate Director of Infection Control (Corporate Director of IC). The hospital could not demonstrate implementation of corrective actions prior to the survey team entering on January 15, 2019. The Hospital A DOP stated the hospital "cleaned the vents" and "put in a prefilter" on January 21, 2019. The time period calculated from the date of notification of fungal results to the date of implementing corrective actions was approximately 24 days.

On January 22, 2019, at 10:23 AM, during an interview, the Regional Director of Pharmacy (RDOP) stated the date to assess if the fungal results were remedied was to be conducted on January 29, 2019.

On January 22, 2019, at 11:09 AM, during an interview and concurrent record review, the Corporate Director of IC acknowledged Hospital A's environmental viable airborne particle testing report from Company D reported on December 14, 2018. The Corporate Director of IC stated she discussed the December 2018 fungal results with the Hospital A DOP. She stated they would monitor to see if "it happens again" to see if there is a pattern in the future.

The facility policy and procedure (P & P) titled, "Sterile Compounding" dated October 2018, indicated "[The name of the hospital(s)] will comply with all state and federal regulations to ensure the highest possible standards of sterility and stability of CSPs." The policy indicated "References ...USP <797>."

2. Hospital A's compounding aseptic (contamination-free) isolator (CAI - device used to prepare CSPs specifically designed to maintain an aseptic compounding environment) was certified ISO Class 5 by Company D on December 6, 2018.

Hospital A's environmental viable airborne particle testing report from Company D indicated air and surface samples were collected on December 6, 2018, and reported on December 14, 2018. The above report indicated the main chamber and pass-through box were ISO Class 5. The above report did not indicate the selected sampling sites included locations within (inside) the ISO Class 5 environment.

On January 17, 2019, at 9:44 AM, during an interview, the Hospital A DOP stated the facility followed USP <797> standards of practice for sterile compounding.

On January 17, 2019, at 11:53 AM, during an interview and concurrent record review, the Hospital A DOP acknowledged Company D did not provide the selected sampling sites including the locations within the ISO Class 5 CAI for the samples collected on December 6, 2018.

A review of USP <797> in the section titled "ENVIRONMENTAL VIABLE [living] AIRBORNE PARTICLE TESTING PROGRAM ...A sampling program in conjunction with an observational audit is designed to evaluate the competency of compounding personnel work practices, allowing for the implementation of corrective actions on an ongoing basis. The sub-section titled "Sampling Plan" indicated, "An appropriate environmental sampling plan shall be developed for airborne viable particles based on a risk assessment of compounding activities performed. Selected sampling sites shall include locations within each ISO Class 5 (see Table 1) environment and in the ISO Class 7 [measurement of air cleanliness] and 8 [measurement of air cleanliness] (see Table 1) areas and in the segregated compounding areas at greatest risk of contamination (e.g., work areas near the ISO Class 5 [see Table 1] environment, counters near doors, pass-through boxes). The plan shall include sample location, method of collection, frequency of sampling..." The sub-section titled "Viable Air Sampling" indicated," ...For low-, medium-, and high-risk level compounding, air sampling shall be performed at locations that are prone to contamination during compounding activities and during other activities such as staging, labeling, gowning, and cleaning. Locations shall include zones of air backwash turbulence within LAFW [abbreviation for laminar airflow workbench - a device that provides an ISO Class 5 environment] and other areas where air backwash [the entry of unfiltered room air into the work area and may be created when the user inserts a hand or materials into the work area] turbulence may enter the compounding area (doorways, in and around the ISO Class 5 [see Table 1] PEC [abbreviation for Primary Engineering Control - a device that provides an ISO Class 5 air quality] and environments. Consideration should be given to the overall effect the chosen sampling method will have on the unidirectional airflow within a compounding environment. For low-risk level CSPs with 12-hour or less BUD [abbreviation for beyond-use date - the date or time after which a CSP shall not be stored] prepared in a PEC ( ...CAIs) that maintains an ISO Class 5 (see Table 1), air sampling shall be performed at locations inside the ISO Class 5 environment and other areas that are in close proximity to the ISO Class 5 (see Table 1) environment during the certification of the PEC."

The facility P & P titled, "Sterile Compounding" dated October 2018, indicated "[The name of the hospital(s)] will comply with all state and federal regulations to ensure the highest possible standards of sterility and stability of CSPs." The policy indicated "References ...USP <797>."

3. On January 15, 2019, at 3:15 PM, during an observation and concurrent interview in Hospital A Main Inpatient Pharmacy, an opened bottle of 70% (concentration) isopropyl alcohol from Manufacturer H (MFG H) was observed on the pharmacy counter next to the compounding aseptic isolator (CAI). The opened bottle of 70% isopropyl alcohol did not indicate it was sterile. The Hospital A Pharmacy Technician 2 stated she used the opened bottle of 70% isopropyl alcohol to clean the CAI. She acknowledged the bottle from MFG H did not indicate it was sterile.

On January 17, 2019, at 9:44 AM, during an interview and concurrent record review, the Hospital A DOP stated the facility followed USP <797> standards of practice for sterile compounding. The Hospital A DOP acknowledged the opened bottle of 70% isopropyl alcohol observed on January 15, 2019, on the pharmacy counter next to the CAI was not sterile.

A review of a letter from MFG H dated January 16, 2019, indicated "No, our [the name of MFG H] Isopropyl Alcohol 70% and 99% [concentration] are not sterile."
A review of USP <797> in the section titled "Cleaning and Disinfecting the Compounding Area" indicated, "Cleaning and disinfecting shall occur before compounding is performed ...This shall be followed by wiping with a residue-free disinfecting agent such as sterile 70% IPA [abbreviation for isopropyl alcohol]."

The facility P & P titled, "Sterile Compounding" dated October 2018, indicated "[The name of the hospital(s)] will comply with all state and federal regulations to ensure the highest possible standards of sterility and stability of CSPs [compounded sterile preparations]." The policy indicated in the section titled "Cleaning and Disinfecting the Sterile Compounding Areas ...This shall be followed by wiping with a residue free disinfecting agent, such as sterile 70% isopropyl alcohol (IPA)." The policy indicated "References ...USP <797>."




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4. The United States Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines. The USP drug standards are enforceable in the United States by the Food and Drug Administration and are published in the United States Pharmacopeia/National Formulary (USP/NF). The USP revised general chapter <797> (USP 797) entitled PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS documents in the Introduction that "The objective of this chapter is to describe conditions and practices to prevent harm, including death to patients that could result from ... microbial contamination ... (and) excessive bacterial endotoxins ..." among other things (endotoxins cause a fever). If a hospital puts all the environmental controls as well as all the personnel training, certification, and compounding practices into place as described in USP 797, the hospital can assign beyond use dates (BUDs: date or time beyond which a compounded sterile preparation cannot be stored or transported) to compounded sterile preparations (CSPs) such as intravenous (IV: in the vein) solutions as described in USP 797.

USP 797 stipulates that a compounding facility consists of an ante-area and a buffer area. The compounding facility is accessed from the outside via a door into the ante-area. The ante-area is used for pre-compounding activities such as donning protective clothing. The buffer area contains the primary engineering control (PEC: a clean air hood, biological safety cabinet, or a compounding aseptic isolator [CAI]) that creates a very clean environment in which staff compound CSPs such IV medications. The buffer area is accessed from the ante-area and is maintained at positive air pressure relative to the ante-area. The ante-area is maintained at positive pressure to the outside environment (the rest of the hospital pharmacy) to prevent particles from the outside environment from entering the ante-area and potentially contaminating it.

USP 797 defines a compounding aseptic isolator (CAI) as: "A form of isolator specifically designed for compounding pharmaceutical ingredients or preparations ...." It is a self-contained unit into which compounding ingredients and supplies are introduced to the cabinet via an ante chamber. The door to the ante chamber is closed and the individual performing the compounding inserts his or her arms into a sleeve/glove assembly built into the front wall of the CAI and which is used to access components in the main compounding area. An inner door between the ante chamber and the main compounding chamber is opened and the supplies are brought into the main chamber at which point the inner door is closed. Compounding can then proceed and the finished product is brought out by reversing the above process. This unit is commonly called a "glove box" and is also described as a "Primary Engineering Control" (PEC) in USP 797 as it creates a very clean environment by filtering air and maintaining positive pressure differentials relative to the outside environment to reduce the chance of contamination of CSPs to extremely low levels. USP 797 stipulates that CAI's must be located in a buffer room. A buffer room is a very clean room in which air entering the room is filtered through a high efficiency particulate air filter (HEPA filter: filters out 99.99% of all particles 0.3 micrometers or larger - as microorganisms ride on dust particles, the filter greatly reduces the microbial load in the buffer room) and is subsequently removed by air returns that USP 797 recommends be located low on the walls. Such rooms are classified as ISO 7 (no more than 352,000 particles 0.5 micrometers or larger per cubic meter) and is known as a "classified" space. The interior of the CAI is maintained as an ISO 5 environment (no more than 3,520 particles 0.5 micrometers or larger per cubic meter) and is considered and extremely clean environment required by USP to be so maintained in order to safely compound CSPs.

However, USP 797 does provide and exception to placing a CAI in an ISO 7 buffer room. A CAI may be placed in an unclassified space (such as the regular pharmacy area) if it meets three criteria documented in USP 797 for maintaining an ISO 5 state during active compounding while located in an unclassified space. USP 797 stipulates that the manufacturer must document in writing that the CAI can be so placed in an unclassified space.

Finally, USP 797 provides that if a PEC is placed in a non-classified space only the simplest compounding may be performed and only 12 hour beyond use dates may be assigned to CSPs compounded in this environment identified as a segregated compounding area (SCA).

Under "Environmental Viable Airborne Particle Testing Program" USP 797 stipulates that defined volumes of air (400 liters to 1000 liters) in all areas of a clean room including the primary engineering controls (PECs: the hoods or gloves boxes where staff compound sterile products) will be tested for microbial burden by looking for colony forming units (cfu) of bacteria or fungi that might grow out on culture medium in culture plates. The air sampling is conducted using specialized devices that contain a culture plate and can be set up to draw in a defined volume of air over the culture plate within a given period of time. The air sample culture plates are subsequently incubated for defined periods of time at defined temperatures specified in USP 797 to see if bacterial or fungal cultures grow out on the plates. A single growth area constitutes one cfu. USP 797 defines thresholds for the cfu depending on the cleanliness of the area tested (PEC is the cleanest, then the buffer area, and then the ante-area) with less cfu allowed for cleaner areas relative to the less clean areas. If the number of cfu a greater than USP 797 established thresholds, staff must closely review the compounding process to ascertain the cause of the breach and then remedy it to bring the compounding area back into control of the clean environment. USP 797 establishes a threshold of one 1 cfu of a microbe in an air sample taken in an ISO 5 environment. If more than 1 cfu is cultured out from the air sample taken in the ISO 5 environment of the PEC then the corrective measures described above must take place. Finally, USP 797 stipulates "Regardless of the number of cfu identified in the pharmacy, further corrective actions will be dictated by the identification of microorganisms recovered (at least the genus level) by an appropriate credentialed laboratory of any microbial bioburden captured as a cfu using an impaction air sampler. Highly pathogenic microorganisms (e.g. Gram-negative rods, coagulase positive staphylococcus, molds and yeast) can be potentially fatal to patients receiving CSPs and must be immediately remedied, regardless of cfu count, with the assistance of a competent microbiologist, infection control professional, or industrial hygienist." USP 797 stipulates that such testing must occur in all environments where CSPs are compounded whether it be an SCA up to and including a full-fledged compounding facility.

Genus is a name given to a group of organisms sharing common characteristics. Pathogenic means giving origin to disease. Coagulase is an enzyme that if found, by laboratory methods, in the genus of staphylococcus indicates that organism has a heightened capacity to cause disease. Molds and yeast are collectively called fungi.

On January 15, 2019 at 12:53 P.M., a review of Company A's manual for the PEC located in Hospital B's pharmacy titled LAMINAR FLOW LFGI (CAI or CACI) USER MANUAL indicated it was for a CAI/CACI (a CACI is a compounding aseptic compounding isolator used to compound hazardous drugs such as those used to treat cancer). It documented that LFGI meant Laminar Flow Glovebox/Isolator. On page 7 it provided a procedure for introducing materials into the main chamber of the CAI via "a sealed airlock that maintains complete environmental separation between the work area and the ambient room air. This sealed airlock is then purged with HEPA filtered air to equalize or better the cleanliness level of that contained air to the ISO Class 5 condition of the work area" (where the actual compounding takes place). In other words, once purged of room air, using a purge button located outside the "airlock" (another name for ante chamber), the whole CAI was maintained as an ISO 5 environment and therefore both the "airlocks" and the main work area would be considered ISO classified spaces. The manual documented on page 7: "The LFGI should be placed in a controlled environment (described as a room without a window that opens out of doors or without high foot traffic) ... A classified environment or a room that conforms to a particular particle count is not necessary."

On January 15, 2019 at 2:38 P.M., an inspection of the pharmacy compounding area indicated it was located in a back area of the pharmacy and only contained one CAI. A red line demarcated the compounding area from the rest of the pharmacy and ran the width of the room. In order to cross the line one would have to don protective garb such as shoe covers, a hair cover, a mask, a non-shedding gown, and gloves. There were no windows in the room and foot traffic was limited to those who used the CAI to compound CSPs.

The CAI had four glove sleeves located on the front panel through which staff could place their arms and hands to manipulate products located in the main chamber and through which they could open the door to the airlocks located in the main work area side walls to bring materials into the main work area and through which finished CSPs could then be placed into the airlock. After placing the CSP into the airlock the inner door would be closed and staff could subsequently remove the finished CSP from the airlock by opening the front door of the airlock. The CAI had an airlock located on the left side of the CAI. During a concomitant interview of the Hospital B Lead Pharmacy Technician at that time he stated the CAI had another airlock (which was not visible without donning protective garb and entering the compounding area) located on the right side of the CAI.

On January 15, 2019 at 3:03 P.M., a review of the compounding area certification report provided to Hospital B by Company B and dated November 12, 2018 indicated it documented the number of particles per cubic meter in the compounding area and in the CAI itself. It provided a map that showed the locations in which the air samples were taken within the CAI. Location 1 and 2 and 9 and 10 were taken in the left and right airlocks respectively. Locations 3, 4, 5, and 7 were taken within the work area of the CAI. Location 6 was labeled to be taken at the inner door of the right airlock and Location 8 was documented to have been taken at the inner door of the left airlock. The non-viable particle counts (counts per cubic meter meant to establish the ISO Classification of the space so tested) were all zero except for Location 4 with registered 35 particles per cubic meter with a ceiling threshold documented in the report of 3,520 particles per cubic meter which was in line with USP 797 standards for the ISO 5 environment in a PEC required for safe compounding of CSPs. This observation was verified by the Hospital B Director of Pharmacy at that time.

On January 15, 2019 between 1:56 P.M. and 2:13 P.M., a review of five viable air sample reports conducted in the compounding area of the hospital indicated the following:

Viable samples were taken weekly in the CAI on December 5, 2018, December 12, 2018, December 19, 2018, December 26, 2018 and January 2, 2019. Two samples each were taken in the right and left airlocks (four samples total) and four samples were taken in the main work area of the CAI on each of these dates.

On December 5th, 12th, and 26th, no cfu were isolated from the culture plates as reported out by Company C.

The results of the December 19th test indicated one cfu of Bacillus species subsequently grew out on the culture plate for the viable air sample taken in the center of the right airlock (described as a "pass through" in the report) and one cfu of Scopulariopsis species (a fungus) subsequently grew out on the culture plate taken in the center of the left airlock. No other growth was noted in the other locations tested in the CAI.

The results of the January 2nd test indicated one cfu of Bacillus species and one cfu of Pencillium species (a fungus) subsequently grew out on the culture plate for the viable air sample taken in the center of the left airlock and one cfu of Bacillus species subsequently grew out on the culture plate taken in the center of the right airlock. No other growth was noted in the other locations tested in the CAI.

On January 16, 2019 at 9:19 A.M., during an interview of the Hospital B Director of Pharmacy she verified the above results. The Hospital B Director of Pharmacy stated she consulted with the Chief Pharmacy Officer, the Infection Control Senior Director, and the Regional Director of Quality. Possible sources of contamination for the cfu cultures from air samples taken in the CAI included the environmental air and the certification technicians. She presented a hypothesis that since the negative results from the December 5th, 12th, and 26th tests were done by the same technician and each of the tests from which positive cultures were obtained on December 19, 2018 and on January 2, 2019 were performed by two different technicians that possibly the negative tests were done correctly and the positive test resulted from contamination of by the other two technicians. She did not mention that perhaps the technician who obtained negative results had not performed the sampling correctly. The Hospital B Director of Pharmacy stated no testing was conducted outside of the CAI.

On January 18, 2019 at 8:54 A.M., a review of the document titled CORRECTIVE ACTION PLAN FOR THE GROWTH FROM THE 12/19/2018 CAI SAMPLES indicated it documented the following points:

"The airlock chambers are not classified space."

"Scopularriopsis (sic) is thought to be a soil base fungus. Each area is not classified and the growth does not meet any threshold requirements."

On January 18, 2019 at 9:19 A.M., during an interview of the Hospital B Director of Pharmacy regarding corrective action plan, she stated she was the author of this document and that she wrote it to share the results from the December 19, 2018 report "with infection control and quality." She identified the Infection Control Senior Director, the Corporate Director of IC, the Chief Pharmacy Officer, and the Regional Director of Quality as those persons with whom she shared this document during a Skype meeting she and the HOSPITAL B PHARMACY MANAGER conducted with these people on January 3, 2019. The Hospital B Director of Pharmacy stated the document was the minutes of the meeting. She stated the stood behind the statement in the report that the "airlock" chambers were not a classified space. The Hospital B Director of Pharmacy stated she stood behind the statement there was no threshold for Scopulariopsis growth from the air sample taken in the left airlock (of the CAI). The Hospital B Director of Pharmacy stated they had not tested the air in high risk areas around the CAI since November 29, 2018. The surveyor reminded the Hospital B Director of Pharmacy she had mentioned air as one possible source of contamination (during 9:19 A.M. interview conducted on January 16, 2019).

5. Under "Competency Evaluation of Garbing and Aseptic Work Practice" - "Gloved Fingertip Sampling" USP 797 documents: "All compounding personnel shall successfully complete an initial competency evaluation and gloved fingertip/thumb sampling procedure (zero cfu) no less than three times before initially being allowed to compound CSPs for human use. Immediately after the compounding employee completes the hand hygiene and garbing procedure (e.g., donning of sterile gloves prior to any disinfection with sterile 70% IPA), the evaluator will collect a gloved fingertip and thumb sample from both hands ... onto appropriate agar plates by lightly pressing each fingertip into the agar. The plates will be incubated for the appropriate incubation period and at the appropriate temperature ... re-evaluation ... shall occur at least annually for personnel who compound low and medium risk level CSPs ...." (cfu means colony forming unit of microbes, CSP means compounded sterile product, IPA means isopropyl alcohol, and low and medium risk CSPs are compounded from sterile ingredients and differ only in the complexity of the compounding process as defined in USP 797) ... Plates filled with nutrient agar with neutralizing agents such as lecithin and polysorbate 80 added shall be used when sampling personnel fingertips. Personnel shall 'touch' the agar with the fingertips of both hands in separate plates in a manner to create a slight impression in the agar. The sampled gloves shall be immediately discarded and proper hand hygiene performed after sampling ..." (cfu means colony forming unit of microbes, CSP means compounded sterile product, IPA means isopropyl alcohol, and low and medium risk CSPs are compounded from sterile ingredients and differ only in the complexity of the compounding process as defined in USP 797). The chapter makes it clear that the employee must don sterile gloves before each test after completing the hand hygiene procedure which is a 30 second washing of the hands up to the elbows (i.e. the three tests are not done on the same gloves after donning a pair of sterile gloves on one occasion).

On January 16, 2019 at 11:33 A.M., during an interview of the Hospital B Lead Pharmacy Technician he stated that all staff underwent gloved fingertip sampling (GFS) after the new CAI was installed in Hospital B during October 2018. He stated that only one hand was tested as the policy only required one hand to be tested. Immediately at that time a review of Policy and Procedure PHA 062, provided by the Hospital B Lead Pharmacy Technician and titled STERILE COMPOUNDING (Revised 11/18) indicated it documented under "IX Training of Compounding Staff C. (f) that GFS would be done three times (during the training process). There was no description as to how this would be done. Under "XI Compounding Quality Assurance (QA) B. (j)" that annual testing would be done on one hand only, either the right or left hand fingers. During a concomitant interview of the Hospital B Lead Pharmacy Technician at that time he stated new employees would have both hands tested but the test would be conducted using the same pair of gloves. After a concomitant review of USP 797 and interview of the Hospital B Lead Pharmacy Technician at that time he stated the GFS process (used by Hospital B) did not reflect the standards documented in USP 797.

6. Under "Aseptic Manipulation Competency Evaluation, USP 797 provides for testing personnel compounding ability by utilizing a Media-fil

Based on observation, interview, and record review, the hospital failed to ensure a multiple dose vial of injectable lidocaine (numbing agent) mislabeled with the incorrect Beyond-Use Date (BUD - the date or time after which a medication shall not be stored) was not available for patient use at Hospital A. This failure had the potential for patients to receive the deteriorated (reduced quality) medications.

Findings:

On January 15, 2019, at 2:54 PM, during an observation and concurrent interview at Hospital A Urgent Care, an inspection of the Urgent Care medication cabinet was conducted with the Hospital A Director of Pharmacy (DOP), Registered Nurse 12 (RN 12), and Licensed Vocational Nurse 13 (LVN 13). An opened and needle-punctured 20 milliliters (a unit of measurement) multiple dose vial of injectable lidocaine 1 % (concentration) from Manufacturer F (MFG F) was observed stored in the medication cabinet. The opened injectable lidocaine vial from MFG F was labeled with a sticker indicating a BUD of "09/22 [September 2022]". The BUD of "09/22" matched the manufacturer expiration date of "09/22" imprinted on the lidocaine vial. The Hospital A DOP, RN 12, and LVN 13 acknowledged the multiple dose vial was labeled with a sticker indicating the BUD of "09/22". The Hospital A DOP, RN 12, and LVN 13 each stated multiple dose vials were good for 30 days once opened.

The facility policy and procedure (P & P) titled, "Single Use and Multiple Use Vials" dated March 3, 2015, indicated, "The beyond use date for opened or entered (needle punctured) Multidose containers shall be 28 days, unless specified by the manufacturer."

The facility P & P titled, "Preparations and Administration of Medications" dated September 2018, indicated "4.5 All multi-dose vials must be dated, when opened, with the day of expiration (28 days) and must be discarded within that time frame."

Based on observation, interview, and record review, the hospital failed to ensure oversight and implementation of policies and procedures that assured Radiologic services were conducted in a safe manner including:

1. Assure Radiologic equipment that failed Physicist Annual evaluation were repaired at Hospital A within the recommended time frame of the physicist. (Refer to A-0537)

2. There was no look back and risk assessment for patients that had radiologic exams using X-ray machine B. (Refer to A-537)

3. Failed to follow its policy and procedure and have ongoing monitoring of radiologic equipment to determine and evaluate how long X-ray B had been out of compliance. (Refer to A-537)

These failures had the potential to result in patients receiving a excess dose of radiation.

An Immediate Jeopardy was announced for Radiology to the hospital staff on January 17, 2019 at approximately 5:00 PM. Present for the meeting included: Chief Executive Officer (CEO), Chief Operating Officer (COO),Vice President of Quality (VPQ), Assistant chief Nursing Officer (ACNO), Associate Administrator (AA) and Vice President of Patient Safety(VPOPS). The Immediate Jeopardy was called due to a review of the facility "Medical Physicist Quality Test Report" survey completed on December 4, 2018, documented Picker-Clinix-T x-ray machine (X ray B) had failed. The Physicist report indicated X-ray B failed on December 4, 2018, and indicated "Measured high kVp (kilo Volt peak) stations exceed 10% limit from the indicated settings. The Physicist indicated "this is a violation and should be corrected in 30 days". Hospital A did not complete the recommended repair of X-ray B in the 30 days and continued to use X-ray B. Hospital A did not have a Radiation Safety committee and no Radiology meetings. Hospital A had not evaluated and determined how long X Ray B had been out of compliance. There was no risk assessment of the patients that had Radiologic exams using x-ray B.

On January 22, 2019, at 3:35 PM, the Immediate Jeopardy was abated (lifted) in the presence of the VPQ. The facility Corrective Action Plan was approved through interview and record review. The facility conducted a Radiation Safety meeting and the minutes were reviewed. "Look back Procedure for Imaging Machine Testing Failure" policy was created and reviewed. The facility completed education of the radiology staff. The facility indicated that they will conduct a test of the x-ray machine 4 times a year and the Physicist will do on-site visits 2 times a year. The radiology safety training sign-in sheets were reviewed and all staff that were currently working had been in-serviced.

The cumulative effect of these deficient practices resulted in the hospital failing to meet the Condition of Participation for Radiology Services.

Based on observation, interview, and record review, the hospital failed to ensure oversight and implementation of policies and procedures that assured Radiologic services were conducted in a safe manner including:

1. Assure Radiologic equipment that failed Physicist Annual evaluation were repaired at Hospital A within the recommended time frame of the physicist.

2. There was no look back and risk assessment for patients that had radiologic exams using X-ray machine B.

3. Failure to follow its policy and procedure and have ongoing monitoring of radiologic equipment to determine and evaluate how long X-ray machine B had been out of compliance.

These failures had the potential for patients to receive an excess dose of radiation.

An Immediate Jeopardy was announced for the Radiology to the hospital staff on January 17, 2019 at approximately 5:00 PM. Present for the meeting included: Chief Executive Officer (CEO), Chief Operating Officer (COO),Vice President of Quality (VPQ), Assistant chief Nursing Officer (ACNO), Associate Administrator (AA) and Vice President of Patient Safety(VPOPS). The Immediate Jeopardy was called due to a review of the facility "Medical Physicist Quality Test Report" survey completed on December 4, 2018, documented Picker-Clinix-T x-ray machine (X ray B) had failed. The Physicist report indicated X-ray B failed on December 4, 2018, and indicated "Measured high kVp (kilo Volt peak) stations exceed 10% limit from the indicated settings. The Physicist indicated "this is a violation and should be corrected in 30 days". Hospital A did not complete the recommended repair of X-ray B in the 30 days and continued to use X-ray B. Hospital A did not have a Radiation Safety committee and no Radiology meetings. Hospital A had not evaluated and determined how long X Ray B had been out of compliance. There was no risk assessment of the patients that had Radiologic exams using x-ray B.

On January 22, 2019, at 3:35 PM, the Immediate Jeopardy was abated (lifted) in the presence of the VPQ. The facility Corrective Action Plan was approved through interview and record review. The facility conducted a Radiation Safety meeting and the minutes were reviewed. "Look back Procedure for Imaging Machine Testing Failure" policy was created and reviewed. The facility completed education of the radiology staff. The facility indicated that they will conduct a test of the x-ray machine 4 times a year and the Physicist will do on-site visits 2 times a year. The radiology safety training sign-in sheets were reviewed and all staff that were currently working had been in-serviced.

Findings:

On January 15, 2019 at 2:15 PM during a tour of Hospital A's Radiology department with MD 11 and Lead radiology Technician (Rad T1) indicated all Radiologic equipment had preventative maintenance done once a year. Medical Physicist Quality control evaluation of radiation emitting equipment was completed annually. There was weekly fluoroscopy. No other ongoing monitor of the radiologic equipment was completed.

On January 16, 2019 at 5:05 PM in the presence of MD 11, during a review of the Facility document titled "Medical Physicist's Quality Control Test Summary" survey dated December 4, 2018, in the Picker -Clinix-T ( x-ray B), annual survey overall score documented "Fail" for kVp 100 to 120." Action limit "the maximum tolerance limit for kVp accuracy in the State of California is +/- 10%. For Quality improvement, however, we recommend adjusting the generator to within less than 5 % nominal." MD 11 was shown the results of the physicist report for x-ray B, no documentation was provided to indicate a review of the Physicist report and documentation of addressing the Failed Physicist test for x-ray B

On January 17, 2019 at 9:20 AM, Hospital A provided an updated document titled "Medical Physicist's Quality Control Test Summary" survey date December 4, 2018, in X-ray B, annual survey overall score documented "Pass". Administrator 1 (Admin 1) indicated the x-ray machine was fixed only on the evening of January 16, 2019 not December 4, 2018.

In a concurrent interview with Rad T1, when asked if X-ray B was in use since the failed Physicist survey on December 4, 2018 until it was fixed on January 16, 2019 after it was discovered during the California Department of Public Health survey, Rad T1 indicated it was in use during that time. When asked if X-ray B had any repairs, he indicated last repairs and Last PM (preventive maintenance) for X-ray B was completed February 27, 2018. When asked if there was daily performance monitoring for the out of range X-ray machine, Rad T1 indicated X-ray B had annual QI (Quality Indicators) by the Physicist and annual preventative maintenance. There was no other documentation of monitoring X-ray B. When asked who reviewed the Physicist report, there was no Documentation of the Physicist report being reviewed. When asked for documentation of Hospital A's radiation safety committee minutes, radiology in-services for the past year, Rad T1 indicated there were none for the past year.

Hospital A did not have a Radiation Safety Committee. When Rad T1 was asked for any meetings discussing any concerns with the Medical Physicist report there were none. When asked who evaluated the Physicist reports. He stated he reviews the Badges and the Aprons for Hospital A. When asked what QI projects were done throughout the year to monitor if X-ray B was in compliance Rad T1 indicated the annual physicist Quality control test was the only studies done to monitor X-ray B.

During a review of a document titled "Radiographic Imaging Co" dated January 16, 2019 at 9:30 PM, indicated an emergency repair of X-Ray B and documented "kVp stations exceeded 10 % limit from the indicated settings' and documented calibration to within 10%."

An Immediate Jeopardy was called for Radiology on January 17, 2019 at approximately 5 PM. Present for the meeting included: Chief Executive Officer (CEO), Chief Operating Officer (COO),Vice President of Quality (VPQ), Assistant Chief Nursing Officer (ACNO), Associate Administrator (AA) and Vice President of Patient Safety (VPOPS). The Immediate Jeopardy was called due to a failed Medical Physicist Quality Test Report done on x-ray machine B on December 4, 2018. The Physicist report indicated the X-ray machine "Measured high kVp stations exceed 10% limit from the indicated settings. This is a violation and should be corrected within 30 days".

Hospital A had not completed the recommended repair in the recommended time frame. Hospital A did not have any documentation of what process and who oversees the annual physicist's reports and reviews and implements Physicists recommendations. There was no documentation as to how long x-ray B had been out of compliance. X-ray B had been in use since the failed Physicist Survey dated December 4, 2018 until repaired on January 16, 2019.

Hospital A did not have a Radiation Safety committee. Hospital A had not identified and evaluated any risk assessment to the patients that had radiologic studies with x-ray B and did not look back and review the Patients affected for any risk assessment. There was no system in place to monitor and prevent the use of X-ray B when it failed the Physicist annual test and evaluation.

On January 22, 2019, at 3:35 PM, the Immediate Jeopardy was abated (lifted) in the presence of the VPQ. The facility Corrective Action Plan was approved through interview and record review. The facility conducted a Radiation Safety meeting and the minutes were reviewed. "Look back Procedure for Imaging Machine Testing Failure" policy was created and reviewed. The facility completed education of the radiology staff. The facility indicated that they will conduct a test of the x-ray machine 4 times a year and the Physicist will do on-site visits 2 times a year. The radiology safety training sign-in sheets were reviewed and all staff that were currently working had been in-serviced.

On January 18, 2019, during a meeting with Admin 1, CEO, ACNO, VPQ and Admin 1. When asked if the facility can explain if the radiation was greater or less than 10 % radiation exposure, Admin 1 did not have any additional documentation. Admin 1 confirmed a look back and risk assessment of the patients that had radiologic studies done on X-ray B from December 4, 2018 until January 16, 2019 had not been done. There were no Radiation safety committee minutes for review.

On January 22, 2019 at 9:45 AM, during an interview with Admin 1 and Rad T1, Admin 1 confirmed X-ray B was repaired on January 16, 2019.

A review of a document provided by Hospital A titled" Ledger for patient exams on Picker-Clinix-T machine Tube serial number: 68725" (X-ray B) from November 2017 to January 2019, indicated there were 340 patient exams done exposed to 10% in excess to the allowable calibration.

A review of a Hospital A Policy and Procedure titled, "Radiation Safety committee composition:" dated January 2019 indicated, "The radiation Safety Committee is responsible for the safe use of radiation producing devices..." and "Reviewing Radiation safety incidents, issues, and violations and recommended corrective action."

A review of a Hospital A policy and Procedure titled, "Quality Control Department of Radiology" last reviewed November 2012, documented under equipment "Preventative maintenance is done on all equipment, by troubleshooting and reporting daily the status of each radiographic room. All x-ray tubes are calibrated by the radiation physicist to the specification of the state and national standards."

A review of Hospital A Policy and Procedure titled "Responsibility and accountability to Administration and Medical Staff" last reviewed November 2012 documented, "To endure responsibility and accountability of the Imaging department... and to Insure that regulatory guidelines are followed and patient safety maintained. The Chairman of the Department of Radiology is responsible to oversee the services in the radiology department."

Based on observation, staff interview, and review of facility documents, the hospital failed to ensure that the food and dietetic department was organized in a manner appropriate to the scope and complexity of the food service operations.

Findings:

As a result of the deficient practices identified during the January 14-22, 2019 inspection, the hospital failed to ensure activities within the department were implemented in a manner to ensure that dietary services met the needs of all patients as evidenced by failure to:

1. Ensure subcontracted temporary labor received health and criminal screening in accordance with hospital policy resulting in an Immediate Jeopardy situation (Cross Reference A-0749);

2. Ensure effective training and evaluation of staff competency for staff (Cross Reference A-0622);

3. Provide organized dietetic services as evidenced by findings of unsafe food handling practices and inadequate oversight of the dietary department (Cross Reference A-0749).

4. Lack of an effective system to ensure that physician ordered diets were followed (Cross Reference A-0629, A-0630,).

5. Maintenance of ware washing and food production equipment (Cross Reference A-0724).

6. Ensure diet orders and nutritional supplements were ordered by the health professionals responsible for the care of patients. (Cross reference A-0630)

7. Ensure meals were portioned in accordance with the approved menus (Cross Reference A-0629)

8. Ensure meal substitutes were of equal nutritive value. (Cross Reference A-0629)

The cumulative effect of these systemic problems resulted in the inability of the hospitals' food and nutrition services to direct and staff in such a manner to ensure that the nutritional needs of patients were met in accordance with practitioners' orders and acceptable standards of practice.

Based on dietetic staff interview and document review, the hospital failed to ensure staff competency when: 1) there was no documented training, orientation or competency assessment of temporary labor prior to assuming duties; 2) One staff (Food and Nutrition Staff 11) did not clean fixed equipment in accordance with facility policy and standard of practice; 3) One staff (Food and Nutrition Staff 2) did not prepare pureed diets in accordance with the recipe. This failure to ensure staff competency may result in compromising the nutritional needs of inpatients further complicating medical status.

Findings:

Hospital A and Hospital B Campuses

On 1/16/19 at beginning at 4:15 p.m., a Food and Nutrition Staff (FNS 12) was observed washing food service equipment and utensils in the 3 compartment sink in the dish room. FNS 12 was requested demonstrate the testing of the sanitizer in the sanitizing compartment of the sink. FNS 12 proceed to test check for the concentration by tearing off a test strip and immersing the test strip in the solution. FNS 12 left the test strip in the solution for approximately 23 seconds without a color change in the strip. FNS 12 blamed the lack of color on the fact that too much time had lapsed since the sink was last filled. FNS 12 refilled the sanitizing compartment with water from the faucet till the sanitizing compartment was about half full. FNS 12 then proceeded to open the sanitizer dispenser above the sink adding the sanitizer running from the attached hose into the half- filled sink for about 10 seconds. FNS 12 retests the sink with the new solution and there was still no color change on the strip.

The correct procedure was to fill the sanitizing compartment with the solution directly from the dispenser above the sink. Using the test strip for a quaternary ammonia solution, the strip should be immersed in the solution for 10 seconds. FNS incorrectly filled the sink and test for sanitizer concentration. FNS 12 was asked how she had been trained on the dish washing process. FNS explained in the concurrent observation and interview on 1/16/19 at 4:20 p.m., that she was a contract employee, was familiar with the dish washing process and had been trained by the hospital staff on the dish washing process.

Another Food and Nutrition staff was asked to demonstrate the process of filling the sanitizing compartment and testing of the sanitizer concentration. FNS 13 correctly filled and tested the sanitizer concentration. The solution indicated it was 400 parts per million (ppm). The acceptable ppm is between 150 - 400 ppm.

The Director of Food and Nutrition (DFN) and Regional Dietitian (RD 4) were present during the observation and interview. The DFN stated in an interview on 1/16/19 at 4:42 p.m., that FNS 12 was a contract employee and received "verbal education". The DFN stated there was no personnel file or documentation of training and evaluation of competency on FNS 12.

Between August 2018 and January 2019, documents (time sheets) provided by the hospital indicated there were over eighty persons hired in various positions include dishwashing. There was no documented evidence of training and competency evaluation, health and criminal background screening on any of these contract employees. (Cross refer A749)

In an interview with the interim and new director of food services on 1/17/19 at 1:58 PM, both acknowledged the campus had utilized contract staff in the previous six months. Documents provided did not include training or evaluation of competency for any of the contract employee.

Hospital B

2. On 1/15/19 beginning at 11:50 a.m., the departments' process for cleaning stationary food production equipment was reviewed with Food and Nutrition Staff (FNS) 11. FNS 11 described the cleaning process for the electric kettle as washing with detergent and rinsing with clear water. There was no sanitation of the equipment. FNS 11 described the same process for cleaning the steam kettle. Additionally, FNS 11 stated once the kettle was rinsed it would be towel dried.

Hospital policy titled "Sanitizing Food Contact Surfaces" dated 5/18 guided staff to sanitize food contact surfaces after they have been thoroughly washed and rinsed. The procedure also instructed staff after sanitation to allow the surface to air dry. Wiping cloths were intended only to wipe food off of plates during tray preparation.

Hospital C

3. The standard of practice for the preparation of pureed diets would be to ensure the texture of the final product is a smooth consistency, like pudding or mashed potatoes, without lumps. Rice generally does not usually puree well; tiny, hard particles will remain that some can't tolerate. The Michigan Department of Community Mental Health recommends the substitution of cream of rice cereal in place of cooked rice.

During food production observation on 1/17/19 beginning at 11 a.m., Food and Nutrition Staff (FNS) 2 was preparing pureed rice for the noon meal. FNS 2 placed approximately 1.5 cups of cooked brown rice in a blender, proceeded to turn the blender on to begin breaking up the particles. FNS 2 then slowly added approximately ¼ cup of water intermittently pulsating the blender for 1 minute. The resulting product resembled small curd cottage cheese. In a concurrent interview FNS 2 confirmed this was pureed rice for the noon meal.

In an interview on 1/17/19 beginning at 1:30 p.m., Registered Dietitian (RD) 2 described her primary duties as providing nutrition assessments and medical nutrition therapy. Duties also included monthly in-service training of staff and monthly kitchen inspections. RD 2 acknowledged that she personally did not review the menus or recipes that were provided by the hospitals' main campus. Additionally, training was based on observations during monthly kitchen inspections. RD 2 stated the contracted company had a list of trainings that were suggested, but not required.

Departmental document titled "Seasoned Rice" dated 2/2/06 guided staff to utilize cream of rice cereal for the preparation of rice.

Based on dietetic services observations, dietary management staff interview, and departmental menu review, the hospital failed to 1) Ensure meals were portioned in accordance with the approved menus; 2) meal substitutes were of equal nutritive value. Failure to ensure meals are plated in accordance with approved menus and standards of practice may result in choking risk and nutritional deficiencies, further compromising medical status.

Hospital B

During lunch tray line observation on 1/15/19 starting at 11:20 AM, the surveyor observed the tray of a sampled patient (Patient 53). The tray card for the patient indicated a mechanical soft/ Dysphagia (difficulty swallowing) 3 diet. Seafood allergy. The tray contained a plate of whole Danish, a whole chicken sandwich. The tray had been placed into the cart for distribution on patient floors. Two food service employees (RD 4 and Director 4) were observed checking the trays. Director 4 on 1/15/19 at 11:23 a.m., explained that the hospital checks for accuracy of high risk diets which include allergies, texture modifications and thickened liquid. Based on the criteria discussed, Patient 53's meal tray was checked. Both waved on the cart to be taken to the floor and no changes were made to Patient 53's tray.

According to the hospital's Manual of Clinical Nutrition, a "Mechanical Soft (Dental Soft)/ Dysphagia III" Diet is indicated for the "resident who has difficulty chewing or swallowing, or an impairment in one or all stages of swallowing, ..... and possible reduction in oral safety during feeding". The manual also described the foods as "moist, soft, in bite-sized pieces and nearly regular in texture ..."

In an interview, with RD 4, on 1/15/19 at 11:25 a.m., stated she checked all the trays to make sure that condiments and diets were correct, and that the food on the tray was appropriate for the diet. When RD 4 was asked about the items on the tray for Patient 53, RD 4 indicated that it was moist and that it would be appropriate for a patient who is on a dental soft diet and that their therapeutic spreadsheet or policy does not call for cutting the sandwich.

There was no indication that Patient 53 was dental soft. There was no designation or marking on the tray cards that would prevent the service of a food item with the inappropriate size to a person with swallowing problems. The bite size would reduce the risk of choking. None of the other patients with Mechanical soft received items that were bite sized.

During the lunch meal on January 16, 2019, there were many patients in the behavioral health unit that had orders for double portions. There was a lack of consistency between the amount of food a patient would receive based on the food choices. According to the clinical nutrition manual, a double portion or high calorie High Protein diet "provides double portions of meat/egg items based off the regular diet.

If the Patient was served meatloaf they received two servings of the meat and two servings of the mashed potatoes that was served with it. On the other hand, if the patients asked for a sandwich like grilled cheese or chicken salad, they received two sandwiches. This was equivalent to 2 servings of meat and four servings of bread.

Hospital C

The hospital which has a consolidated license with three campuses has an acute psychiatric, in patient and/or out-patient behavioral unit in each of its campus. During conversations with hospital staff, the issue of the high number of patients who suffer from homelessness came up as a recurring theme of the patient population. In an interview on 1/17/19 at 1:15 p.m., Administrative Staff 12 explained the challenges of finding permanent housing for patients receiving services from the hospital as there a significant percentage of patients were homeless at the time of admission.

Many homeless persons eat fewer meals per day, lack food more often, and are more likely to have inadequate diets and poorer nutritional status than housed U.S. populations. Additionally, many homeless people lack appropriate health care, and certain nutrition-related health problems are prevalent among them. The risks vary among homeless persons for malnutrition, nutrition-related health problems, drug and alcohol abuse, and mental illness (Public Health Report 1991).

During initial tour on 1/17/19 beginning at 10 a.m., there were multiple pre-packaged sandwiches in the refrigerator adjacent to the café area. In a concurrent interview Food and Nutrition Staff (FNS) 1 stated the items were delivered through an outside food vendor and were used as meal substitutes and snacks.

Concurrent review of the protein content of the peanut butter and jelly sandwich revealed one sandwich contained 10 grams of protein which equated to slightly more than 1 ounce of edible protein.

Review of the standardized menu, approved by a Registered Dietitian, revealed the protein portion of a typical noon meal was 3 ounces equating to 21 grams of protein. Additionally, it was noted that greater than 50 percent of admitted patients had physician ordered double portions. The hospital policy for double portions was described as two portions of the protein (main) entrée. Review of physician ordered diets for 1/17/19 revealed greater than 50 percent of meals were ordered as double portions to meet the nutritional needs of inpatients. As a result, patients received two, rather than six, ounces of protein if the peanut butter sandwich was used as a meal substitute.

In an interview on 1/17/19 at 1:15 p.m., Administrative Staff 12 explained the challenges of finding permanent housing for patients receiving services from the hospital as there a significant percentage of patients were homeless at the time of admission.

In an interview on 1/17/19 beginning at 1:30 p.m., Registered Dietitian (RD) 2 described her primary duties as providing nutrition assessments and medical nutrition therapy. Duties also included monthly in-service training of staff and monthly kitchen inspections. RD 2 acknowledged that she personally did not review the menus that were developed by the hospitals' main campus, however was aware that sandwiches were used as meal substitutes. RD 2 stated the peanut butter sandwiches were a popular item among the patients however, was unaware the substitute was not equal in nutritive value to approved entrees.

Hospital A

During tray line observation on 1/17/19 starting at 12:00 PM, Patient 51 was served the following: 2 Puree pepper steak servings, 1 serving of squash, two servings of steamed brown rice, sugar free pudding, 2 pats of margarine, 1 carton of 2 % milk, I serving of soup. According to his diet tray card and physician's order Patient 51 was on a Puree, consistent carbohydrate 2300 to 2500 calorie diet. A review of the menu indicated that he should have received a 7 carb consistent carbohydrate meal pattern. There were menus for patients on the pureed 5, 6 and 7 consistent carbohydrate meal pattern at breakfast. None had been written in advance for the pureed 7 consistent carbohydrate meal pattern for lunch.

A review of the carbohydrate content of the meal indicated it was less than the 7 carbohydrate that was needed at the meal. In an interview with the diet clerk (DC) on 1/17/19 at 1:28 PM, the DC stated the diet spreadsheet (menu) does not give instructions on the pureed 7 carbohydrate diet. DC stated offered non-fat milk like in the 6 carbohydrate pattern and nothing else." In addition, a substitution was made, sugar free pudding instead of the peach mold. The registered dietitian (RD 1) who was present during the interview acknowledged it was not the correct amount of carbohydrate.

The significance of the correct amount of carbohydrate is that it helps in keeping blood sugar consistent. Fluctuations in the amount of carbohydrate in the meals could cause fluctuations in blood sugar and insulin delivery. Clinical record review indicated that Patient 51's diagnoses included diabetes and treatment included the use of insulin when blood sugar levels exceed set guidelines. Low blood sugar could cause hypoglycemia and dangerous reaction to insulin. According to the hospital's clinical nutrition manual, "the consistent carbohydrate diet is indicated for patients where diabetes is diagnosed ...."

RD 1 stated in the same interview on 1/17/19 at 1:30 PM, he was not aware that the patterns were not on the menu and it had not been brought to his attention.

During the same meal observation on 1/17/19, patients on 2-gram (2000 milligram) sodium diets, received the same entrée as patients on the regular diet. A 2-gram sodium diet is a diet low in sodium, indicated for patients who have high blood pressure and other heart conditions. The amount of sodium is usually between 2000 to 3000 milligrams of sodium.

A taste test of the pepper steak patty revealed a product that lacked salt and was not palatable. The interim food service director (IFSD) stated the chef followed the recipe and that the recipes did not call for the use of salt; but that patients on the regular diet are provided with salt packets to increase the salt content of the meal. A review of the menu and nutrient analysis for the meal showed there was no salt packet for the meal. The total sodium content of the meal was 750.7 milligrams of sodium. A review of breakfast showed patients were offered 3 packets of salt. It was unclear how the food and nutrition services expected the salt to be used as the menu choices were French Toast with pancake syrup, Bacon, raisin bran cereal, mandarin orange sections, milk and coffee.

The total sodium for the day was 3109 milligrams of sodium of which 896.6 mg was the probably unused three salt packets at breakfast, leaving 2212 .7 milligrams of sodium for the day. The same amount for a patient receiving a sodium restricted diets (2000 to 3000 mg per day). The patients on regular diets were therefore being offered a low sodium diet without an order by the physician.

Nutrition Screening

The hospital which has three campuses has units in two of the hospitals (Hospital A and Hospital B) that treat patients with both medical and behavioral health diseases, the third campus treats only patients with acute psychiatric diseases. Electronic record review showed that the nutritional screening criteria was the same for all patients whether or not there were psychiatric or behavioral health issues. A review of the assessment questions was not tailored to the mental health population served.

A sample 2006 document titled "Assessment of Eating Behaviors for patients with Acute Mental Illness" by The Dietetics in Developmental and Psychiatric Disorders Practice Group of the American Dietetic Association, lists assessment of cognitive behaviors such as decreased awareness of need to eat, paranoid about food, Eating Behaviors such as bites too large for safe swallow, social behavior such as demanding behavior in the dining room as part of the assessment for the population served. Some of the same behaviors documented in the patients in the hospital. Patient 54 exhibited an aggressive behavior during meal service on 1/17/19 in the Van Nuys Campus that could have resulted in a physical altercation with another patient. (Cross refer A 144)

In an interview with RD 1 on 1/17/19 at 5:20 PM, RD 1 explained that the nutritional screening and assessment that was conducted in the hospital was based on the guidelines that he had been trained on. The regional RD (RD 2) in an interview on 1/18/19 at 9:30 AM stated that the screening and assessment were not tailored to patients with psychiatric health issues but that the hospital will look into it.

According to the 2006 ADA (American Dietetic Association) Core Registered Dietitian Standards of Practice Indicators, the RD in Behavioral health "completes a more detailed analysis of the indicators to evaluate the complexity of problems and correlate one problem to another (i.e. using advanced clinical judgement skills reflecting the holistic focus of behavior health care as a complex disorder). According to Academy of Nutrition and Dietetics (formerly American Dietetic Association) RDs in behavioral Health are urged to be familiar with the Standard of Practice and Standard of Professional Performance in Behavioral Health Care.

Based on review of electronic clinical record, staff interviews, and review of facility documents, the hospital failed to ensure that the attending physician or professional responsible for the care of patients ordered diet in accordance with State law. These failures occurred when:

1. Registered nurses ordered diets for patients, one sampled patient (Patient 52) and two unsampled patients, without specific orders from the physicians after NPO (nothing by mouth) orders were discontinued by the physicians. Licensed nurses resumed previous diets that patients were on before the NPO were instituted. For Patient 52, there were five NPO orders and only two diets orders were ordered after the NPO was discontinued. Other unsampled patients were identified whereby nurses ordered diets after NPO orders were discontinued or physicians asked nursing staff to advance diets without stating under what conditions the patient may receive the advanced diet, for example, from Clear liquid to Mechanical soft.

2. The policy of the hospital indicated that it had established means to delegate authority to the qualified Registered Dietitian (RD) for ordering oral nutrition supplements as part of all diet orders.

According to the California Business and Professions code, RDs may not prescribe dietary treatments. The registered dietitian ordered nutritional supplements without a physician's order. Electronic orders for nutritional supplements entered by the RD and carried out by the nursing or Food and Nutrition Services, were noted in the electronic medical record of one sampled patient (Patient 50).

These practices resulted in an immediate threat to the health and safety of the hospital patients as patients may receive meals or supplements that may be inappropriate for their medical condition. An incorrect diet after a gastrointestinal procedure may result in vomiting and contribute to complications of the procedure including but not limited to constipation (hard or decreased frequency of bowel movements), fecal Impaction (mass of dry, hard stool that will not pass out) and bowel obstruction (a bowel obstruction is a blockage of the small or large intestine). The nutritional composition of some of the meals or supplements may affect the laboratory values and interaction with food and medications, affecting the absorption.

Immediate jeopardy was declared on 1/18/19 at 11:20 AM. The survey team informed the hospital's chief executive officer, vice president of quality, chief nursing officer, assistant nursing officer, associate hospital administrator of the observations made about licensed nursing staff and registered dietitian ordering diets and nutritional supplements respectively for patients without physician's orders.

The hospital provided an acceptable plan of action and the actions to remove the immediate jeopardy situation included: Educating both the nursing staff on limiting orders for diets and nutritional supplements to the physician, physician assistant and nurse practitioner, reinforcing that telephone orders may be taken by needs to be co-signed by the practitioner responsible for care; removing the functionality on the computer that allowed the RNs and RDs to order diets and nutritional supplements without physician's order.

The immediate jeopardy was abated (reduced in amount, degree or intensity and immediacy) on 1/22/19 at 5:31 PM.

In addition, the hospital failed to ensure meals were plated in accordance with Physicians Orders'.

Findings:

Hospital A

1. Registered Nurse
During lunch tray line on 1/17/19 at 1:30 PM, the diet clerk received a call requesting a diet tray for Patient 52. In response to a question by the surveyor who was present during the concurrent observation and telephone order conversation, the diet clerk stated the food and nutrition services department had received an order for NPO but did not receive any new orders for a diet. The RD (RD 2) who was also present reviewed the diet ordering system and acknowledged that there was no written order for any diet when the diet clerk received the telephone call ordering food for Patient 52.

Patient 52 was admitted to the hospital with diagnoses including Bloody stools, coffee-ground vomiting, abdominal pain, acute blood loss secondary to acute gastrointestinal blood loss/ upper GI bleed, acute renal (kidney) failure, cachexia (a condition that causes extreme weight loss and muscle wasting) and dementia (a decline in mental ability severe enough to interfere with daily life).

Review of the electronic medical record indicated that there were five instances where the physicians had placed Patient 52 on an NPO diet between January 12 and January 16, 2019. There were only two times where the physicians ordered a specific diet for Patient 52 after the NPO diets were discontinued. The licensed nurses reactivated the clear liquid diet or whatever diet the patient was on prior to the physician ordering an NPO diet. The reason for orders for clear liquid after the NPO order was discontinued was "auto activate" status "active."

A review of the electronic medical record for Patient 52 on January 17 and 21, 2019 showed that on 1/12/19 at 12:34 a.m., a licensed nurse entered an NPO order for Patient 52 that was requested by a physician. On January 12, 2019 at 12:27 PM, the NPO order was discontinued and a new order for clear liquid was placed.

On 1/13/19, there was an order for NPO after midnight. On 1/14/19, the order was discontinued by the physician via telephone according to the electronic medical record and entered by a registered nurse. There was no order for a new diet after the NPO order was discontinued. 1/14/19 there was a similar order, NPO after midnight. This order would imply that the patient was eating by mouth on 1/14/19. However, it was unclear what the diet was. There was a phone order to discontinue the NPO order without any specific diet ordered to resume food by mouth.

On 1/15/19 there was an order for "clear liquid, mechanical soft/dental soft diet. Instruction: advance to mechanical soft diet as tolerated" after Patient 52 had been taken to the operating room for a gastrointestinal procedure.

On 1/16/19, there was an order "NPO-Ice chips only, NPO except Medication". The order was discontinued on 1/15/19 without any specific diet order given by the physician. The same pattern was observed on January 16 and 17, 2019 whereby the physician places the patient on a NPO diet, discontinues the NPO diet via telephone and does not order a new diet for the patient.

In an interview with Nurse Educator RN N2, on 1/17/19 at 4:50 PM, RN N2 stated that nurses do not specifically ask for new diet orders after an NPO order. RN N2 stated they "resume the old diet" after the physician discontinues the NPO order, we do not write new orders."

On 1/18/19, the physician ordered a "clear liquid, mechanical soft/dental soft diet. Instruction: advance to mechanical soft diet as tolerated." There were no strict instructions on what parameters needed to be met before the registered nurse orders the mechanical soft diet.

A review of the facility document titled "Active diet orders" showed other patients with three NPO diet orders with no new diet ordered in between the NPO orders. There were two unsampled patients that had orders for advancing diet as tolerated.

Review of the electronic medical record indicated that RD 1 ordered two different kinds of nutritional supplement for the Patient, Beneprotein and Ensure. These supplements were added to the Patient 52's diet without a physician's order.

A review of the hospital document titled "General Medical Staff Rules and Regulations" does not indicate physician responsibilities in ordering diets for patients. A review of the California Nursing Practice Act does not confer to a licensed nurse the ability to order treatment or medical nutrition therapy to patients without a physician's order.

Registered Dietitian
According to the California Business and Professions Code 2586(a) (1) Notwithstanding any other law, a registered dietitian, or other nutritional professional meeting the qualifications set forth in subdivision (e) of Section 2585 may, upon referral by a health care provider authorized to prescribe dietary treatments, provide nutritional and dietary counseling, conduct nutritional and dietary assessments, and develop and recommend nutritional and dietary treatments, including therapeutic diets, for individuals or groups of patients in licensed institutional facilities or in private office settings. The referral for medical nutrition therapy shall be accompanied by a written prescription signed by the health care provider detailing the patient's diagnosis and including either a statement of the desired objective of dietary treatment or a diet order. The registered dietitian, or other nutritional professional meeting the qualifications set forth in subdivision (e) of Section 2585, may perform nutritional assessments and initiate nutritional interventions within the parameters of the prescribed diet order pursuant to a licensed health care facility's approved nutrition screening policy and procedure. The registered dietitian, or other nutritional professional meeting the qualifications set forth in subdivision (e) of Section 2585, shall collaborate with a multidisciplinary team, which shall include the treating physician and the registered nurse, in developing the patient's nutrition care plan. Unless otherwise stated in the diet order by a patient's provider, the registered dietitian, or other nutritional professional meeting the qualifications set forth in subdivision (e) of Section 2585, may individualize the patient's nutritional or dietary treatment when necessary, by modifying the distribution, type, or quantity of food and nutrients within the parameters of the diet order. Any modification, and the rationale for the modification, shall be documented in the patient's record for review by the practitioner, or other licensed health care professional, who is legally authorized to prescribe and is responsible for the care of the patient. Nothing in this subdivision shall be construed to authorize a registered dietitian, or other nutritional professional meeting the qualifications set forth in subdivision (e) of Section 2585, to order or administer a central vein or peripheral vein nutrition.

This state law does not allow registered dietitians to prescribe or order dietary treatments. A review of the hospital's diet manual and an undated hospital document titled "Approved Nutritional Interventions (ONS protocol)" showed "All diet orders include the option of an Oral Nutrition Supplement" A registered dietitian upon further assessment, may add, change, or discontinue an ONS based on guidelines set forth in the facility diet manual".

Patient 50 was admitted with diagnoses including pneumonia. Patient 50 weighed on admission 49 kg (kilogram) or 107.8 lbs. with a BMI of 17. BMI or Body Mass Index is a useful measure of overweight and obesity. It is calculated using height and weight information. Normal is 18.5 to 24.9. Underweight is 18.5 or below. The physician had placed her on a regular diet.

The registered dietitian (RD 1) completed a nutrition assessment on Patient 50 and documented a past history of cachexia. RD 1 documented Patient 50's ideal body weight (IBW) is 59 kg (or 129.8 lbs.) Patient was 12 pounds below the IBW range for sex and height.

The RD also documented Patient 50 had "observable signs of wasting ... with temporal and orbital wasting (fat and muscle loss)". In addition, the RD documented that Patient 50 "meets ASPEN (American Society for Parenteral and Enteral Nutrition) guidelines for malnutrition.

The nutrition plan was "nutrition diagnosis of malnutrition related to inability to meet energy need as evidenced by po. (oral) intake of 50%." The nutrition recommendation was "Ensure (a nutritional supplement) three times daily with all meals."

A review of the electronic medical record indicated that (RD 1) placed the order for the nutritional supplement. There was no indication that RD 1 received a telephone order from the physician responsible for the care of the patient or a written order signed by a physician or any other licensed practitioner responsible for Patient 50's care.

In an interview with RD 1 on 1/17/19 at 5:00 PM, RD 1 explained that according to hospital policy and the way he was trained, RDs are allowed to order nutritional supplements. In a telephone interview with the chief of staff (COS) on 1/18/19 at 1:48 PM, the COS who is lead hospital physician stated that RD cannot order diets. The COS further stated the RD can recommend, then the physician agrees or disagrees.

In regards to RNs resuming diets after an NPO order, the COS stated in the same telephone interview on 1/18/19, the COS stated when a physician discontinues an NPO order for a patient, "basically it means the patient can resume eating". The COS further stated the physician should state the diet the patient can receive.

A review of the hospital's document titled General Medical Staff Rules and Regulations under the sub section "Orders" states "all diagnostic and therapeutic orders shall be in writing."

Hospital C

2. During meal plating observation on 1/17/19 beginning at 11:45 a.m., Patient 55's meal ticket listed a 2300-2500 calorie physician ordered diabetic diet. Food and Nutrition Staff (FNS) 3 verbally communicated the diet order as written to the cook. In a concurrent interview FNS 3 confirmed the plated meal consisted of a green salad, ½ cup of fresh fruit, 1 dinner roll, non-fat milk, 1 margarine pat and diet Italian dressing, the same as a regular diet.

In an interview on 1/17/19 beginning at 1:30 p.m., Registered Dietitian (RD) 2 explained the basic diabetic meal pattern is the same for all calorie level diets. The pattern consisted of 5 servings of carbohydrate per meal and one serving of entrée, the protein component of the meal. RD 2 additionally stated that if additional calories were ordered by the physician staff should have added additional food items. Concurrent review of the menu spreadsheet for 1/17/19 revealed that the basic diabetic meal plan consisted of 1900-2000 calories. For a 2300-2500 calorie carbohydrate consistent diet staff should have added 4 ounces of orange juice as well as one serving of sugar free ice cream to the noon meal.

In an interview on 1/17/19 beginning at 1:30 p.m., Registered Dietitian (RD) 2 described her primary duties as providing nutrition assessments and medical nutrition therapy. Duties also included monthly in-service training of staff and monthly kitchen inspections. The RD 1 also stated that in-service trainings were based on questions that Food and Nutrition Staff had or issues that were observed while completing the kitchen inspections. RD 2 did not recall providing specific training on carbohydrate consistent diets.

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

1. Kitchen equipment was maintained in a safe and effective manner when:

a. the dishwasher failed to consistently function within food safety and manufactures' recommendations since August 2018;

b. there were multiple pieces of equipment that were compromised: Walk-in refrigerator number one was leaking from underneath the unit; the outdoor freezer had a compromised gasket and did not close completely, there was also a build-up of ice in the outdoor freezer; there was condensation build-up under the tray line refrigerator; there was leaking from the steamer and steam kettle.

2. Their policy and procedure and the manufacturers guidelines were followed when:

a. The pediatric (child 14 and under) code cart (lifesaving equipment) in the Urgent Care was not maintained (checked to assure all lifesaving equipment is in or on the code cart, functioning properly, and defibrillator (lifesaving machine) is plugged into an outlet, fully charged and ready to use daily.

b. The defibrillator on the adult code cart in the Respiratory Department was not plugged into an electrical outlet or maintained daily.

Failure to ensure proper maintenance of equipment may result in total and systematic equipment failure compromising the hospitals' ability to meet the nutritional and care needs of patients in a safe and effective manner.

Findings:

1a. The standard of practice would be to ensure the recommended final rinse water temperature is 180 degrees Fahrenheit (°F), with higher limits no greater than 194°F. According to 2017 Food Code Section 4-501.112 "in a mechanical operation, the temperature of the fresh hot water sanitizing rinse as it enters the manifold may not be more than 194°F. The temperature of hot water delivered from a ware washer sanitizing rinse manifold must be maintained according to the equipment manufacturer's specifications and temperature limits specified in this section to ensure surfaces of multiuse utensils such as kitchenware and tableware accumulate enough heat to destroy pathogens that may remain on such surfaces after cleaning.

The surface temperature must reach at least 160°F as measured by an irreversible registering temperature measuring device to affect sanitization. When the sanitizing rinse temperature exceeds 194°F at the manifold, the water becomes volatile and begins to vaporize reducing its ability to convey sufficient heat to utensil surfaces. (Food Code Annex 2017,).

On 1/15/19 beginning at 3:15 p.m., dish room operations were observed in the presence of the Director of Food and Nutrition Services and Food and Nutrition Staff (FNS) 6. The dish machine was a multi-tank machine that had a total of 4 temperature gauges and 1 pressure gauge each of which listed guidance for manufacturers specifications for temperature and pressure. As an example the power scrapper had guidance to maintain water temperature between 110-140°F (degrees Fahrenheit). During greater than 10 dish machine cycles the temperature indicator did not move, rather was resting at the 100°F indicator. Similarly, the power wash did not reach the recommended temperature of 150-165°F. Multiple observations revealed the temperature was consistently below 120°F. The power rinse tank had manufacturers' guidelines to maintain water temperatures between 160-190°F. The observed temperature for multiple cycles ranged between 110-130°F. It was also noted the final rinse temperature indicator depicted a temperature of greater than 200°F. Manufacturers' recommendations listed temperature ranges of 180-195°F.

In a concurrent interview FNS 6 was asked to describe how she ensured the dish machine was working properly. FNS 6 explained she would check the wash and sanitation temperatures and record it on a dish room log. The surveyor asked FNS 6 to explain the observed temperature gauges in comparison to the manufacturers' recommendations. FNS 6 stated that the gauges did not consistently work, they were often broken. FNS 6 further explained they would use an irreversible temperature monitoring device to determine final rinse temperatures.

FNS 6 explained they had two different types of strips that were run through the dishwasher. One was a paper strip. The paper strip measured approximately ½ inch wide and 4 inches long. At the end of the strip there were 3 different colored bars, two orange and one blue-black bar. The manufacturers guidance printed on the strip was the blue-black bar turns bright orange when the water temperature was above 160°F. The paper strip would be attached to a silverware caddy with a paper clip and run through the dishwasher. FNS 6 also presented a self-adhesive temperature thermo label. The label had a grey square in the middle with guidance the grey square would turn black when the label reached 160°F. FNS stated the thermos labels were recently placed in the dish room.

On 1/15/19 beginning at 3:28 p.m., both types of labels were run through the dishwasher. The blue-black bar on the paper strip turned orange, however the thermo label grey indicator did not turn black. On 1/15/19 the DFNS and the surveyor ran holding thermometers through the dish washer. There was no expiration date listed on the paper strip and there was no indication of when the strips were purchased from the vendor.

The purpose of a holding thermometer is to record the maximum water temperature of a dish washer. The hospital thermometer recorded a temperature of 161°F. The surveyor thermometer recorded 131°F. Both thermometers were calibrated at the time of the discrepancy by placing them in an ice/water bath at which point the expectation is the thermometer reads 32°F plus or minus 2 degrees. Both were found to be accurate.

On 1/15/19 at 3:45 p.m., a second surveyor thermometer was obtained and run through the dishwasher. The second thermometer recorded a water temperature of 128°F. The DFNS was asked to clear his thermometer setting and run it through again. Upon clearing the thermometer, the hospital device read 131°F, which was consistent with the two surveyor thermometers. In a concurrent interview the DFNS stated there were issues with the dish washer and was recently serviced. The surveyor requested dish machine logs for the previous 12 months.

In a follow up observation on 1/16/19 beginning a 9:30 a.m., it was noted the dish machine continued to be out of service. In a concurrent interview the DFNS stated the heat booster on the machine was not functioning during the 1/15/19 observation. The DFNS acknowledged the machine was currently not functioning to manufacturers specifications.

Review of departmental documents titled "Dishmachine Temperature Logs" dated November 2017 through January 2019 revealed that the dish machine was out of order for the full month in November. There were no logs for December 2017. The January 2018 documented "original log went missing on Jan 14th ..." During June 2018 there were 4 days that the machine was out of use and an additional 4 days where the gauges were broken. There was no log for July 2018. The machine was out of order August 1 - October 6, 2018. Similarly, in December 2018 there were 16 days where the final rinse temperature gauge was documented as broken.

In an interview on 1/16/19 at 10:20 a.m., the Director of Plant Operations (DPO) stated Environment of Care rounds are completed twice each year. He also stated with the exception of the ice machine there was no preventive maintenance program or evaluation of the functionality of dietary services equipment. In a follow up interview on 1/18/19 at 9:30 a.m., the DPO stated there was no risk assessment with respect to age and functionality of hospital equipment.

In an interview, with the Director of Quality on 1/22/19 at 4:30 p.m., the director of quality indicated that the work order was the mechanism by which the food services department makes the hospital aware of the problems with the machine. She did not respond when she was asked if management ever reviewed the work order to determine what equipment might need to be replaced based on use and frequency of repairs.

Review of invoices presented to the surveyor revealed on the 4/6/18 service the final rinse was disconnected. Similarly, there was a steam leak under the machine and the pressure valve was leaking. On 6/18/18 the pressure value was not operating properly. Again on 7/20/18 the rinse gauge was not working. At that time the technician also ran a temperature sensor through the machine and noted that the water temperature was not adequate for food safety. On 9/20/18 the facility replaced the booster heater however the technician noted there were multiple leaks around the dish machine. A 9/26/18 service request indicated all tubing leading to the dish machine required replacement due to corrosion build up inside the pipe.

*b. During general foods service observations on 1/16/19 beginning at 9:30 a.m., there were multiple pieces of food production equipment that were leaking water. There was a steam pan measuring approximately 18 inches wide and 24 inches long collecting condensing water underneath the air curtain refrigerator. There was a pool of water from dripping pipes underneath the steam kettle, griddle and steamer. Additionally, there was water seeping from underneath the walk-in refrigerator that was directly adjacent to the cold production area.

The exterior door of the freezer did not readily close, there was a metal strip protruding from the door. There was also a build-up of ice on the blower, ceiling of the unit and wire shelving. Ice build-up in a freezer is often caused by the mixing of warm outside air with cold internal air, causing condensation of water and ultimately ice build-up. In a concurrent interview the DFNS stated there was a pending work order for gasket replacement. Review of pending open work orders dated 1/16/19 obtained from the DPO revealed there was no request for gasket replacement prior to 1/16/19.

Review of manufacturers' guidance for the air curtain refrigerator listed general maintenance requirements including regular cleaning of the condenser coil. Review of the manufacturers' guidance for the steamer revealed the equipment should be regularly checked for scale build-up of the generator. Additionally, the recommendations included checking of the boiler gasket, electrical connections and door fasteners. Review of the manufacturers' guidance for the tilting steam kettle revealed preventive maintenance and cleaning instructions for various valves on the equipment.

Hospital policy titled "Preventive Maintenance" dated 11/12 revealed that the engineer department is responsible for preventive maintenance either monthly, quarterly, semi-annually or annually. Additionally, all equipment in the inventory must receive a minimum number of preventive maintenance visits per year.




39646

2a. During an observation on January 15, 2019, at 3:30 PM, in the Urgent Care, the pediatric code cart did not have a defibrillator, did not have an oxygen tank, and was not maintained daily by staff.

During an interview with the Assistant Chief Nursing Officer (ACNO 2) on January 15, 2019, at 3:35 PM, she stated that the adult code cart defibrillator and oxygen tank would be moved to the pediatric code cart and used if there was a pediatric code (emergency situation). When asked if this would cause more staff stress to an already stressful situation, she stated, "Ya, probably."

The facility policy and procedure titled "Code White Pediatric Cardiopulmonary Resuscitation" dated March 2016, indicated under Purpose/Objective, "To outline the duties and responsibilities of all personnel in maintaining vital functions during the cardiopulmonary arrest of any patient younger than 14 years of age ...Standards of Care ...Nursing personnel and Code White team will respond in a rapid and organized manner."

The facility policy and procedure titled "Code Blue (Cardiopulmonary Resuscitation)" dated February 2016, indicated, "The Emergency Department (ED) maintains equipment and supplies needed for the resuscitation of the pediatric patient."

The manufacturers guidelines for the defibrillator indicated, "Always check that the equipment functions properly and is in proper condition before use."

2b. During an observation on January 18, 2019, at 9:35 AM, the defibrillator on the adult code cart in the Respiratory Department was not plugged into an electrical outlet and was not maintained daily.

During an interview with the Respiratory Therapist (RT 1) on January 17, 2019, at 9:25 AM, he stated that the adult code cart could be used in emergency situations, but when asked how it could be used if it is not plugged into an electrical outlet or maintained daily, he replied, "I don't know."

The manufacturers guidelines for the defibrillator indicated, " ...Always have a source of available backup power for all anticipated use environments. A fully charged spare battery or ready access to AC [(Alternating Current)] mains power from a local wall outlet can provide this backup power ...Always check that the equipment functions properly and is in proper condition before use."

Based on observation, interview, and record review, the facility failed to follow their Infection Prevention and Control Plan when:

1. Based on dietetic services observations, Food and Nutrition Staff, dietary management and infection control staff interview and review of hospital documents including policies, procedures and administrative contracts, the hospital failed to:

a. Ensure contracted food service staff were screened in accordance with hospital policies when:

The contracted food service vendor did not ensure temporary staff completed health or criminal justice screening in accordance with hospital policy. Dietary management staff failed to identify the lack of screening of temporary staff. Additionally, dietary management staff failed to notify the hospital administrative staff that temporary staffing was routinely used within the dietary department at Hospital A and Hospital C campuses. Failure to ensure staff completed pre-employment requirements may result in exposing hospitalized patients and staff to communicable diseases and an unsafe environment.

Immediate Jeopardy was declared on 1/18/19 at 11:20 a.m., in the presence of the Chief Executive Officer, Chief Operating Officer, Vice President of Operations, Chief Nursing Officer, Assistant Chief Nursing Officer, Vice President of Quality and Associate Administrator. The survey team described the observations, interviews and document reviews in relationship to the use of temporary staffing without pre-employment health and criminal screening.

The survey team accepted the facility's plan of action on 1/18/19 at 5:36 p.m. The corrective action included, discontinuing the use of all sub-contracted temporary personnel from Dietetic Services at the (name of city) Hospital A and (name of city) Hospital C Campus. The contracted vendor will acquire all pre-employment documents to the hospitals' human resources department for all temporary labor prior to commencement of work in accordance with hospital policy. Development of a detailed orientation checklist to be completed prior to temporary labor assuming duties; the hospital reviewed the current staffing schedule to ensure adequate staffing in the absence of temporary labor

The immediate jeopardy was abated (removed) on 1/20/19 at 5:31 p.m. when the hospital demonstrated an effective system to ensure all temporary labor completed a comprehensive hospital orientation including but not limited to health and criminal justice screening. Additionally, the hospital demonstrated staffing shortages would be addressed by 1) offering overtime hours to current Food and Nutrition Staff at the Hospital A and Hospital C Campus; 2) offering additional hours to staff from affiliated hospital campuses who have been trained, oriented and have completed pre-employment screening in accordance with hospital policy and 3) the of temporary labor for staff who have completed all pre-employment screening and orientation would be utilized as a last resort.

b. Ensure previously thawed meats were not refrozen.

c. Ensure previously cooked foods were effectively monitored for cool down.

d. Ensure food production staff wore beard restraints to prevent hair from contacting exposed food.

e. Ensure corrugated boxes were not retained in food storage areas.

f. Ensure an effective air gap was maintained in food production equipment.

g. Ensure ready to eat foods were stored so in a manner to prevent cross contamination.

2. Clean supplies were stored with dirty supplies in a patient restroom on the 5th floor Medical Surgical Unit.

3. Dirty Utility Room (a room where dirty and used equipment is stored) was separated from the clean supplies with only a red piece of tape on 4th and 5th floor Medical Surgical Units.

4. Recovery Room (used for monitoring the patient recovering from surgery) does not contain an exposed hopper sink (sink used for disposal of liquid and solid waste).

These failures had the potential to result in cross contamination and spread of infection.

Review of the hospital census dated 1/18/19 showed there were 401 patients at Hospital A and C.

Findings:

Hospital A and Hospital C

1. Hospital policy titled "Pre-Employment Employee Health Policy" dated 7/18 listed the infection control component of an occupational health plan to promote a safe environment for the healthcare worker and those served by the worker. The implementation of this policy would be a collaborative effort between the Infection Control and Employee Health Departments to detect, prevent and control transmission of communicable diseases to patients, volunteers, and employees. The policy also outlined that the scope included all newly hired and contracted staff.

The pre-employment health policy required all staff to be screened for and offered vaccinations including Hepatitis B, Pertussis and influenza. Additionally, the procedure included a health questionnaire for latex allergy screening, Hepatitis B, measles and rubella immune status and tuberculosis screening.


In an interview on 1/15/19 beginning at 4:30 p.m., with the DFNS and the Regional Registered Dietitian (RRD) for Vendor 3 the surveyor requested orientation, training and competency documentation for Food and Nutrition Staff 12. The DFNS and RRD stated that FNS 12 was not part of the regular staff, rather was placed by Vendor 3 through a secondary agency that placed temporary labor. The DFS stated FNS 12 received on the job training from another staff member. He also stated he was unsure of the existence of any documentation. The DFNS stated he had time sheets for the placed employees.

In a follow up interview on 1/16/19 beginning at 9 a.m. the RRD confirmed that with the exception of timesheets there was no orientation, training, competency or health documentation for any of the temporary staff members.

In an interview on 1/16/19 at 3:30 p.m., with the Director or Infection Control (DIC) in the presence of Infection Preventionists (IC) 9 and 10 they described the employee health component of the Infection Control Program. They stated prior to accepting employment all staff must complete a pre-employment physical that included lab work for measles, mumps and rubella (MMR) immunity screening, vaccination screening for Hepatitis B, tuberculosis and tetanus/diphtheria as well as drug testing and flu vaccine status. The DIC stated all hospital employees received this evaluation. In addition to health testing the hospital also required that all employees complete a Department of Justice background check.

The surveyor asked how the hospital handled temporary staff such as nursing registry staff. The ICP stated the agency that placed the staff provided all of the information to the hospitals' employee health department prior to being placed on the schedule. She stated the requirements would be the same irrespective of whether the employee was a hospital staff member or a staff member placed through a temporary labor agency.

The surveyor inquired how the hospital monitored the hiring procedures for Vendor 3. She stated for the Vendor 3's staff the hospital maintained employee health records. The surveyor asked if she was aware Vendor 3 was utilizing a sub-contract for temporary labor. The ICD replied she was unaware. As a result, these employees did not receive employee health or back ground screening in accordance with hospital policy.

In an interview with the interim and new director of food services on 1/17/19 at 1:58 PM at the Hospital C Campus, both acknowledged the campus had utilized contract staff in the previous six months. Documents provided did not include training or evaluation of competency for any of the contract employee.

Review of timesheets beginning June 2018 revealed there were 73 different temporary labor staff who functioned as cooks, dishwashers or stock persons at the Hospital A Campus. The 73 temporary staff had a cumulative total of 295 shifts. Similarly, at the Hospital C campus there were 7 temporary staff, functioning as dishwashers, with a total of 22 shifts.

Review of Vendor 3's "Master Service Agreement" dated 8/1/17 directed Vendor 3 was responsible for the management of non-supervisory personnel in accordance with the hospitals' policies and procedures. Additionally, Vendor 3 was responsible for training the non-supervisory personnel in accordance with the vendors' training program.

Review of written communications from subcontracted Vendor 1 and 2 dated 1/17/19, revealed there was no requirement for temporary staff to complete pre-employment health screenings. Review of the sub-contract for Vendor 2 dated 10/1/15, failed to require the contracted vendor to complete any pre-employment screening. Additionally, the Vendor 2 subcontract placed the responsibility of staff training on Vendor 3.

Review of hospital document titled "Director of Food and Nutrition" dated 10/31/17 listed personnel management and regulatory compliance as a function of this position. Review of hospital document titled "Contract Evaluation Summary" dated 2018 revealed that Vendor 3 was not listed on the hospitals' contract evaluation document, therefore the effectiveness of the contract was not completed by the hospital.

Hospital B

On 1/16/19 at beginning at 4:15 p.m., a Food and Nutrition Staff (FNS 12) was observed washing food service equipment and utensils in the 3 compartment sink in the dish room. The surveyor requested that FNS 12 demonstrate the testing of the sanitizer in the sanitizing compartment of the sink. FNS 12 proceed to test check for the concentration by tearing off a test strip and immersing the test strip in the solution. FNS 12 left the test strip in the solution for approximately 23 seconds without a color change in the strip. FNS 12 blamed the lack of color on the fact that too much time had lapsed since the sink was last filled. FNS 12 refilled the sanitizing compartment with water from the faucet till the sanitizing compartment was about half full. FNS 12 then proceeded to open the sanitizer dispenser above the sink adding the sanitizer running from the attached hose into the half- filled sink for about 10 seconds. FNS 12 retests the sink with the new solution and there was still no color change on the strip.

The correct procedure was to fill the sanitizing compartment with the solution directly from the dispenser above the sink. Using the test strip for a quaternary ammonia solution, the strip should be immersed in the solution for 10 seconds. FNS incorrectly filled the sink and test for sanitizer concentration. The surveyor asked FNS 12 how she had been trained on the dish washing process. FNS explained in the concurrent observation and interview on 1/16/19 at 4:20 p.m., that she was a contract employee, was familiar with the dish washing process and had been trained by the hospital staff on the dish washing process.

The surveyor requested that another Food and Nutrition staff demonstrate the process of filling the sanitizing compartment and testing of the sanitizer concentration. FNS 13 correctly filled and tested the sanitizer concentration. The solution indicated it was 400 parts per million (ppm). The acceptable ppm is between 150 - 400 ppm.

The Director of Food and Nutrition (DFN) and Regional Dietitian (RD 4) were present during the observation and interview. The DFN stated in an interview on 1/16/19 at 4:42 p.m., that FNS 12 was a contract employee and received "verbal education." The DFN stated there was no personnel file or documentation of training and evaluation of competency on FNS 12.

Between August 2018 and January 2019, documents (time sheets) provided by the hospital indicated there were over eighty persons hired in various positions include dishwashing. There was no documented evidence of training and competency evaluation, health and criminal background screening on any of these contract employees. (Cross refer A749)


b. During initial tour on 1/15/19 beginning at 10:20 a.m., in the outdoor freezer unit there was a pan of uncooked frozen turkey dated 1/15/19. In a concurrent interview the Director of Food Service stated the item would have been received frozen then thawed. He also stated staff likely thawed too much and returned it to the freezer for use later.

In an interview on 1/16/19 at 1:30 p.m., the Chef confirmed that the turkey was received frozen with the breast and thigh and let as one piece. The item would be thawed, the breast removed after which the thigh and leg was used in items such as soups. The Chef also stated the item in the freezer was likely the thigh and leg and should not have been refrozen.

Facility policy titled "Food Handling Guidelines" dated 5/18 guided staff to not refreeze food.

c. During initial tour on 1/15/19 beginning at 10:20 a.m., there were four pans of cooked turkey breast in baking pans. Each pan contained 2 turkey breasts, each weighing approximately 2 pounds. In a concurrent interview the Chef stated these items would be used later in the day. It was noted the items were in the original baking pan, covered with parchment paper and had a small amount of meat juice on the bottom of the pan. The pan was warm to touch.

In a follow up observation on 1/16/19 at 2:30 p.m., the cooked turkey breast was in the refrigerator. The internal temperature of the item, using the surveyor thermometer was 38 degrees Fahrenheit (°F). time it was removed from the oven but estimated it was around 12 p.m. The Chef described the process for holding previously cooked foods. She stated the item would be cooked, lightly covered, labeled, dated and placed in the refrigerator. The Chef also stated the temperature should be monitored during the cooling process. The surveyor asked to review the cooling log. Concurrent review with the Chef and the DFS of documents on currently used kitchen logs as well as logs that were stored in department offices failed to demonstrate the item was monitored and temperatures recorded.

Hospital policy titled "Food Handling Guidelines" dated 7/09 guided staff to use the cooling log to document food temperatures when placed in the cooling equipment, at 1-1/2 hours, 2 hours and again at 6 hours. In a confirming document dated 1/21/19 the contracted vendor acknowledged the turkey was not monitored during the cool down process.

d. The standard of practice would ensure that all dietetic staff members 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, utensils, and linens (Food Code, 2017).

During food production observations on 1/15/19 beginning at 11:30 a.m., Food and Nutrition Staffs 4 and had that had facial hair without the benefit of a beard restraint. In a concurrent interview with FNS 4 he stated he had not been asked to cover his beard. Hospital policy titled "Uniform Dress Code" dated 10/17 guided staff facial hair must be effectively restrained when on duty per state and local regulations. Mustaches and sideburns were not required to be restrained if they were neatly trimmed. The policy was not consistent with the current standard of practice.

e. During initial tour on 1/15/19 beginning at 10:20 a.m., there were multiple corrugated boxes in the dry storage area. Some of the boxes were opened and the box was used to store food products, other boxes were unopened. In a concurrent interview with the Director of Food Services (DFS) he stated the retention of boxes was acceptable within the contracted food service policies.

In an interview on 1/16/19 at 3:30 p.m., the Director of Infection Control (DIC) stated the hospital policy was to eliminate all corrugated boxes that were designated as a primary shipping box. The DIC stated it would be acceptable to retain boxes that was a secondary box meaning the box was shipped within another box. The DIC also stated she was surprised that boxes were retained as previous infection control rounds did not find that the practice was occurring. The DIC was aware food and nutrition services were implemented through Vendor 3. She stated it would be expectation that all contracted services follow hospital approved policies.

Review of food and nutrition policy titled "Use of Corrugated Cardboard" dated 5/18, developed by the contracted food service, revealed that corrugated boxes are checked at delivery. The policy guided staff to remove product from torn/damaged boxes as well as guiding staff to remove product from corrugated boxes and promptly remove them from storage areas. Undated departmental document titled " ...Healthcare Risk Assessment Corrugated Cardboard Boxes" revealed boxes may be retained if the risk assessment is scored as less than 7. It was noted the risk assessment ranges for each of the areas reviewed ranged from 3-6. The assessment reviewed environmental contamination, infection, potential injury, storage environment and emergency preparedness. It was noted this risk assessment and policy was in conflict with the hospital policy.

Hospital policy titled "Guidelines for Storage of Patient Care Supplies and Corrugated Boxes" dated 7/18 guided staff to remove breakdown cardboard corrugated material and remove immediately.

Review of Environment of Care Rounds for Food and Nutrition Services dated 5/4 and 11/16/18 failed to note the retention of corrugated cardboard rather noted that food supplies were appropriately stored.

f. It would be the standard of practice to ensure all food service equipment drains, such as (sinks, ice bins, refrigerators, walk-ins, ice machines, etc.) are hard piped with an indirect drain a floor sink, with a proper air gap provided. (Food Code, 2017).

During review of manual dishwashing procedures on 1/16/19 beginning at 2:15 p.m., it was noted the 3-compartment sink, used for dishwashing was directly connected to the waste water system. There was no air gap to prevent the back flow from the waste water system. In an interview on 1/16/17 at 3 p.m., the Director of Plant Operations acknowledged the sink was directly connected to the waste water system. He also acknowledged in the past sinks were modified to ensure the presence of an air gap, however the dish room sink was likely missed.

Hospital C

g. During initial tour on 1/17/19 beginning at 10:15 a.m., in the presence of Food and Nutrition Staff (FNS) 6 in freezer #5, a 2-door freezer, there was raw chicken stored directly above croissants. In a concurrent interview FNS 6 stated the meat should have been stored on the other side of the freezer. Facility policy titled "Food Handling Guidelines" dated 5/18 listed food contamination precautions to include appropriately separating raw animal food from ready-to-eat foods during storage, preparation and service.

During meal distribution observation on 1/17/18 beginning at 11:30 a.m., FNS 7 was observed preparing sandwiches and placing them in Styrofoam container. In a concurrent interview FNS 7 stated the meals would be transported to the intensive outpatient program. As part of the meal preparation FNS 7 placed a bag of potato chips directly on top of the unwrapped sandwiches after which he closed the lid. Concurrent review of the storage practices of the chips revealed they were stored in the dry storage area, in an opened bin.

In an interview on 1/17/18 beginning at 1:30 p.m., Registered Dietitian 2 acknowledged the potential cross-contamination of the sandwich when plating the meals as observed.

Departmental policy titled "Food Handling Guidelines" dated 5/28 guided staff on procedures to ensure food safety. While the procedures did not specifically address plating of cold lunches it did include the concept of minimizing hand contact of ready to eat foods.




39646

2. During an observation on January 15, 2019, at 1:45 PM, in the restroom of a patient room on the fifth floor, two clean intravenous (IV) poles (device to administer fluids to patients) were stored with a dirty patient walker (device to help with walking) and a dirty patient bedside table.

During an interview with the Registered Nurse, Charge Nurse (CN 1) on January 15, 2019, at 1:50 PM, she stated that the clean IV poles should not be stored with dirty equipment, but there was no space to store them and that is why they were in the restroom.

During an interview with the Infection Control RN (ICP 1) on January 18, 2019, at 9:20 AM, she stated that it is not their practice to keep dirty and clean supplies and equipment together. She said she also noticed this was being done due to lack of space.

The facility Infection Prevention and Control 2018 Plan indicated under policy that the hospital "will maintain an ongoing Infection Control program designed to prevent, control, and investigate infections and communicable diseases among patients, healthcare workers, and visitor." Under authority: "The Infection Control Director shall have the authority to institute any appropriate surveillance, prevention, and/or control measures when any condition exists that could result in the spread of infection within the hospital or its facilities or create a hazard for any person at the hospital or its facilities."

The facility policy and procedure titled "Cleaning and Disinfection of Patient Care Equipment" dated July 2018, indicated, " ...Only clean equipment is stored in the clean equipment area ...All other equipment that is not clean or cannot be cleaned immediately after use shall be placed in the dirty equipment area or sent to Central Services."

3. During an observation on January 15, 2019, at 1:30 PM, on the 5th floor Medical Surgical Unit the Dirty Utility Room was separated from the Clean Supplies and Equipment by a piece of red tape on the floor.

During a concurrent interview with the Registered Nurse, Charge Nurse (CN 1) on January 15, 2019, at 1:30 PM, she stated that she did not know why the room was set up this way but that is how the room had always been.

During an interview with the Infection Control RN (ICP1) on January 18, 2019, at 9:20 AM, she stated that it is not their practice to keep dirty and clean supplies and equipment together. She said she also noticed this was being done due to lack of space.

The facility Infection Prevention and Control 2018 Plan indicated under policy that the hospital "will maintain an ongoing Infection Control program designed to prevent, control, and investigate infections and communicable diseases among patients, healthcare workers, and visitor." Under authority: "The Infection Control Director shall have the authority to institute any appropriate surveillance, prevention, and/or control measures when any condition exists that could result in the spread of infection within the hospital or its facilities or create a hazard for any person at the hospital or its facilities."

The facility does not have a policy and procedure regarding the storage of clean supplies with dirty utilities.



39701

4. During an observation on January 16, 2019, at 2:53 PM, a two empty patient beds were noted inside the recovery room. An exposed hopper sink was observed located at the corner of the room, near a patient's bed. It has no protective barrier aside from the splash shield that was installed in front of the sink.

During an interview with the Registered Nurse (RN 2), on January 16, 2019, at 3:25 PM, RN 2 stated the hopper sink was inside the room "ever since." She further stated they use it to dispose patient's urine and other waste.

During an interview with the Infection Control Preventions (ICP1), she stated the nearest bathroom from the recovery room is located in the nurse's lounge; there was none available for patient's use. ICP1 further stated the hopper sink inside the recovery room is being used to dispose patient's urine or, sometimes, vomit waste. ICP agreed that the hopper sink should not be installed open inside a patient's room; or it must need a better barrier to protect cross contamination that can affect the patients.

The facility Infection Prevention and Control 2018 Plan indicated under policy that the hospital "will maintain an ongoing Infection Control program designed to prevent, control, and investigate infections and communicable diseases among patients, healthcare workers, and visitor." Under authority: "The Infection Control Director shall have the authority to institute any appropriate surveillance, prevention, and/or control measures when any condition exists that could result in the spread of infection within the hospital or its facilities or create a hazard for any person at the hospital or its facilities."