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Based observation, interview, and record review, the facility's Governing Body failed to:

1. Oversee and evaluate contracted services to assure the contracted services were delivered in a safe and effective manner including Hemodialysis Services and Dietary Services. (Refer to A 084 and A 618).

2. Assure patients receive care in a safe setting. (Refer to A 144 and A700)

3. Have an ongoing Quality Assessment Performance Improvement (QAPI) program that evaluated and ensured effective oversight of the Food and Nutrition Services, and Hospital Environment of Care (EOC) rounds to identify physical environments that could cause harm to patients. (Refer to A 283)

4. Coordinate and oversee hospital wide infection control program including implement an infection control program that followed acceptable standards of practice in monitoring. (Refer to A 747)

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

Based on observation, interview and record review, the Governing Body failed to monitor and assure the services provided under a contract were safe and effective for hemodialysis and dietary services by failing to ensure nurses were trained to turn off a hemodialysis machine safely in an emergency event and there was emergency food supply available at Hospital B.

This deficient practice had a potential for the facility's inability to provide services in a safe and effective manner.

Findings:

1. During an observation on 11/22/19 at 10:40 a.m., on 1 West Unit accompanied by Dialysis Registered Nurse (RN 12), Patient 19 was 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 12 in the presence of Charge Nurse (RN 14) confirmed dialysis emergency kit and instructions was not on the dialysis machine. When asked if during hand off of the patient for emergency procedures during dialysis was discussed, he indicated they were not included in the hand off of the dialysis patient care.

During an interview with RN 14 and DON, on 11/22/19 at 10:45 am, when asked what to do in case of an emergency during a patient's dialysis including power outage or an incapacitated dialysis nurse during dialysis, RN 14 and DON 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.

During an interview with CNO on 11/22/19 at 11:00 am, she indicated no nurses were provided in service 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, DON indicated patients are admitted to any ward, there is no specific dialysis ward, all nurses provide care for the dialysis patients. It was also noted that ICU nurses were not trained on how to turn off the dialysis in an emergency.

A policy and procedure for the emergency during dialysis or if the dialysis nurse was incapacitated and in-service training was requested, there was none available.

A review of a facility's document titled" Dialysis care of the Patient" revised 01/2017 indicated "Nursing staff will continue to provide total nursing care and maintain responsibility of the patient ...." And "It will be necessary for the hospital nurse staff and the dialysis nurse to interface during hemodialysis to provide total care".

A Review of a Hemodialysis Contract document provided by Hospital A titled, "Contract Service Agreement" dated August 1, 2019 indicated the Hemodialysis Contract company will "perform services in accordance to implemented Hospital Policy and Procedures". A review of the facility's policy and procedures for Patient Dialysis did not discuss how the hospital will intervene and safely turn off the dialysis machine in case of an emergency situations including incapacitated dialysis nurse, fire, disaster and power failure.

2a. During an interview with the Director of Food and Nutrition on 11/22/19 at 12:10 p.m., he indicated food was transported from Hospital A to Hospital B daily by a regular vehicle with no refrigeration or special delivery containers. The contracted service did not provide documentation that it was safe and sanitary to transport food in a regular car. The dietary contract required Hospital B to stock with emergency supply of food. During an observation, there was no emergency food supply in Hospital B.

2b. A review of Patient Diet Orders documented by the Contracted Service indicated the dieticians wrote patient diet orders without physician orders.

A review of the facility's policy and procedure titled, "Evaluating Performance Safety and effectiveness of Contracted Services" dated 11/2019 indicated "The Governing Board has the responsibility for assuring that hospital services are provide in a safe and effective manner" and is responsible to "assess services furnished directly by hospital staff and those services provided under contract."

Based on observations, interviews, and record reviews, the facility failed to ensure the patient had the right to receive care in a safe setting by failing to ensure:
1. The Environmental Round of Care met the needs of the populations.
2. No screw driver kept in the kitchen accessible to the patient.

These deficient practices had the potential for not providing a safe environment for all patients.

Findings:

1. During a tour of the Main Campus Behavioral Health Unit (BHU), on 11/19/19, at 2:45 p.m., with Registered Nurses (RN 1 and RN 2), and Director of BHU, a screw driver was observed in the cabinet, above the kitchen counter.

RN 1 stated, the kitchen was used by patients and staff. RN 1 stated did not know why the screw driver was in the kitchen or cabinet. The Director of BHU stated, the staff were conducting daily Environmental Rounds.

During an interview, on 11/19/19, at 3:30 p.m., with Behavioral Health Worker, (BHW) 1, who was assigned to BHU, the BHW 1 stated, he conducted environmental rounds and made note on his clip board. A review of the clip board had a form titled, BHU Environment of Care Rounds, which listed 12 sub titles and each sub title had points to be checked off "Yes of "No," or comments.

When the surveyor asked how often he conducts environmental rounds, BHW 1 stated, "Every shift, environmental round were done which included check the light if working, glass not loose, and no loose beds. So far, no concerns to report."

2. During a tour, on 11/20/19, at 9:05 a.m., of South Campus with Director of BHU, RN, and (3) three scribes (facility's staff take notes of what the surveyor is asking and requesting), the following was observed in the Day Room #1261.
a. An outlet, on the far-left side across the refrigerator, had black stains (photograph taken by facility's staff "scribes"). A count was conducted of the outlets and there were 13 uncovered outlets in the Day Room.

When the surveyor asked the Director of BHU, when the uncovered outlets were counted in the BHU Environment of Care Rounds, she stated, "If not listed on Environmental of Care Rounds form then not checked." When asked how long this particular outlet had have with black stains, she replied, she was not aware how long the outlet had been like this. She further stated, "There always be two staff in the day room when patients are present." The other facility's staff on tour, with the surveyors did not reply and had no comments. The surveyor asked the Director of BHU if she knew what "arcing" was, she stated, "No."

The surveyor requested documentation of the black stains outlet. None was provided as of 11/21/19.

(Electrical arcing are faults and arc flashes are extremely dangerous because it is a concentration of the arc fault current and voltage in one place, resulting in the release of enormous energy that could potentially cause injury through severe burns and fire. Photos provided from a website of outlets which had been arc and the photo of the facility's outlet also provided and compared).

During an interview at 10:08 a.m., BHW 2, was asked what his job was today, he stated, "Environmental Rounds, which included safety precautions such as no loose screws, loose items, if loose record on Environmental Care Rounds and report to charge nurse. When asked by the surveyor how often he conducted environmental rounds, BHW 2 stated, he conducted environmental rounds every 15 minutes same as patients rounds. When asked where he would document any additional concerns he observed if not on the list, BHW 2 stated, "On the last page of Environmental Care Rounds under comments."

A review of the BHU Environment of Care Rounds forms provided by the facility for 1 West, dated 11/17/19, (7 p.m. - 7 a.m.), 11/18/19 (7 a.m. - 7 p.m., 7 p.m.- 7 a.m.), and 11/19/19 7 a.m. - 7 p.m.) and South Campus dated 11/17/19 through 11/19/19, for shifts (7 a.m. to 7 p.m., and 7 p.m. to 7 a.m.) had 12 subtitles. The subtitle "Dining and Recreation Rooms," included the following points:
1. Room is free of items
2. Floors are clean and dry
3. Table and furniture are undamaged and clean
4. T.V. is securely fastened and working
5. No food is present during non-meal times
6. Lights are secured and working
7. Window area is undamaged and clean

There was no documented evidence to indicate the uncovered outlets in the Dining and Recreation Room. There was no point for monitoring the uncovered outlets. There was no documentation provided by the facility for the outlet with the black stains. Furthermore, there was no documented evidence of any outlet (s) being monitored in any of the sub title which included patient care areas.

A review of a facility's policy tilted, "Surveillance Rounds," reviewed 10/2018, indicated the purpose was to provide a mechanism for assuring safety and patient care practices were followed by staff in a collaborative effort. Held in conjunction with Safety Rounds. Regular attendance by Administration, Engineering, EVS, and Nursing Administration, and Unit Managers attend as needed. Monthly environmental rounds would be conducted within the facility. Suggestions from the staff will be solicited, recorded an assessment of environment will be made as it relates to safety.

Attached to the policy was a copy of the EOC Rounding Form, rev. 02/2019, had 4 pages. The subtitles included Electrical Safety. In this subtitle the first question was do all list and junction boxes have covers. The last page had a statement which stated, I have examined this area to the best of my ability and noted any deficiencies.

3. During a tour, on 11/20/19, at 11:09 a.m., of the Hawthrone Campus, the following was observed:
Patient 1 was on 1:1 status (the patient is assigned a constant one to one staff member at arms length from patient at all times) coming out of the dayroom. BHW 3 was asked by the surveyor, what was the reason for 1:1 status, BHW 3 stated, Patient 1 was 1:1 for self harm (Danger To Others - DTO).

A review of Patient 1's medial record indicated she was admitted as inpatient on 11/16/19, at 6:20 a.m., arrived via ambulance accompanied by two EMT"s and was place on a 5150. (Welfare and Institutions Code 5150 - professional person designated by the county may the person into custody for a period of up to 72 hours for assessment, evaluation, and crisis intervention.)

The patient's "5150 Note" indicated Patient 1 attempted to jump out of a car on the 405 freeway. Final Report Notes dated 11/18/19, at 6:07 p.m., Patient 1 remains on 1:1 observation due to grabbing the scalpel from the housekeeping workers' pocket to cut her arm.



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4. During an initial tour of a Hospital BHU 1 West, on 11/19/19 at 2:15 p.m., the following was observed:

4a. Thirteen of 17 beds had wheels that were locked stationary. All beds had handles and open areas that could be used for ligature at the foot bed boards. There were two metal cylinder rods and metal chains attached to openings at each end of the foot of the bed. (A ligature risk (point) is defined as anything which could be used to attach a cord, rope, or other material for the purpose of hanging or strangulation.)

4b. Room 166 had two lotion bottles, 1 unlabeled urinal, and 1 labeled dirty urinal dirty with smell of urine and 2 combs.

4c. Room 168 had self-made bracelets and 2 lotion bottles

4 d. Room 172 had mouthwash, lotion, shampoo, toothbrush, toothpaste and comb.

5. During a Tour of Hospital B BHU SU on 11/20/19 at 9:05 a.m., in Room 6, there were 2 hair clips, 2 hair ties, and in clean utility room were curtain and curtain rods

During tour of the Hospital BHU I South (Hospital B) on 11/19/19 at 0215 p.m. with RN 16 and DON indicated the curtain and Rods should not be there. RN 16 indicated patient safety rounds are done every 15 and contraband checks are done every 15 minutes.

During an interview with the DON at 11/19/19 at 2:40 p.m., she indicated the shampoo, toothpaste all toiletry items should not be in rooms. During an interview with Director of Quality and CEO on 11/21/19 at 9:05 a.m., they stated Center for Medicare and Medicaid Services provided the hospital an extension to Ligature Proof for the three facilities till 3/2020. On 9/20/2019, the patient ligature risk assessments were done and are ongoing and products to ligature proof have been ordered and there is ongoing retrofitting of all three hospitals to become ligature free.

A review of a facility's document titled, "Patient Safety and Ligature Risk Checklist: 2019" documented ongoing ligature risk assessments hospital wide.









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6. On November 22, 2019 at 11:19 a.m., during initial tour of the radiology department with the Director of Diagnostic Imaging (DDI), one scalpel was observed without a safety cover inside the storage room #1135.

Concurrently, DDI stated the scalpel should not be without a safety covering in the storage room.

Based on interview and record, five out of seven employee personnel files did not have a copy of a valid "Crisis Prevention Intervention" in their files for validation of employee training.

This deficient practice resulted in facility not adhering to their policy and had the potential for the staff not knowing how to care for the patients who require the us of restraints or seclusion.

Findings:

On 11/21/19 during the Personnel File Review, a visual validation of Employees 1, 2, 3, 4 and 5, the Crisis Prevention Intervention (CPI) certificates could not be obtained.

During an interview on 11/21/2019 at 11:40 a.m., the Director of Human Resources confirmed that the CPI certificates were not available in the personnel files at the time.

A record review of the facility's policy dated 6/2018 and titled "Licenses, Certifications and Degrees" indicates staff are properly credentialed for positions requiring certifications, when visual validation is not available online for CPI verification, photocopies must be placed in the employee personnel file.

Based on observation and record review, the hospital Quality Assessment Performance Improvement (QAPI) program failed to:

1 Evaluate and ensure effective oversight of the Food and Nutrition services to maintain sanitary conditions.

2. Implement effective oversight of the Hospital EOC rounds to identify physical environments that could cause harm to patients.

Findings:

A review of a document titled "Quality and Performance Improvement Dashboard" 2019 did not include any dietary studies. There was no ongoing QAPI oversight studies monitoring and evaluating dietary services. There were no studies monitoring cleaning and maintaining of ice machines. There was no oversight assuring emergency supply of food available at Hospital B. There was no documentation of evaluating the method of daily food transport from Hospital A to Hospital B. There was no oversight to monitor the scope of the dietitians including assuring dieticians did not write diet orders without physician orders.

The Hospital Quality Performance studies documented EOC Data and EOC Management was documented as 100% for first and Second quarter in 2019 as meeting or exceeding Benchmark. During the facility tours findings included: in the common areas of Hospital B: electrical outlets; hanging curtains and hospital beds with chains, -handles wheels, cylinder rods hospital A BU. There were contraband including a scalp was brought into the facility. (Refer to A 144)

A review of a facility document titled "Quality Management System" undated documented is a structure "that enhances quality" hospital wide and "address known risks and identify opportunity for risk reduction".

Based on observation, interview and record review, the facility staff failed to ensure that Patient 19's care during dialysis was supervised, monitored and coordinated between the primary nurse and contracted dialysis registered nurse in order to meet the patients' needs.

This deficient practice resulted in the patient not receiving the corrected dialysis treatment per the physician's order.

Findings:

On November 22, 2019, at 10:30 a.m., Patient 19 was observed lying in bed receiving hemodialysis treatment via left IJ permacath.

The patient was dialyzing on 4 K (potassium) and 2.5 CA (calcium) bath , the DFR (dialysate flow rate) was 800 and BFR (blood flow rate) was 300 and the dialyzer (artificial kidney) was F 180 NR (non-reuse).

Review of the hemodialysis physician order dated 11/22/19 indicated BFR of 400 ml/minute, DFR of 500 ml/minute on a F160 dialyzer.

During an interview with Dialysis Nurse at the time of observation, the nurse stated he reads the physician order before hooking up the patient to the hemodialysis machine. He further stated that the primary Registered Nurse (RN) does not double check the setting of the machine prior to starting the hemodialysis treatment. This was clarified with the DON and concurred with what the Dialysis Nurse stated.

Review of the Hemodialysis Treatment Record indicated :
On 11/22/19 indicated the pre weight was not taken and the patient was already receiving hemodialysis treatment.
On 10/07/19 indicated the pre and post weight was not taken.

The following facility policy numbers:
a. PCM-04-103 titled Care of the Dialysis Patient reviewed on 01/2017 indicated the patient's condition must be reviewed prior to and after dialysis between the dialysis nurse and the nurse
in charge of that patient.
b. Reference # 9010 titled Dialysis Services revised 01/05/2019 indicated the Dialysis RN will perform a nursing assessment before initiating dialysis that shall include pre-dialysis weight.
c. Reference # 9037 titled Dialysis Services revised 01/05/2019 indicated to obtain and document the patient's vital sign and weight. The patient should weigh less, have lower blood pressure and a higher temperature than before dialysis.
d. Reference # 9038 titled Dialysis Services revised 01/05/19 indicated the Dialysis Nurse shall be responsible for recording vital signs and weight.

Based on interview and record, two out of seven employees (Employee 4 and 7) did not have a current advanced cardiovascular life support certification present in their file and seven out of seven employees (Employee 1, 2, 3, 4, 5, 6, and 7) did not have an Evaluation of Performance and Satisfactory Performance present in their files during the personnel file review.

This deficient practice resulted in facility not adhering to its policy which had the potential to result in employee decline competency which could have negative patient outcome.

Findings:

1. On 11/21/19 during the Personnel File Review, a visual validation of Employee 4 and 7 showed that their advanced cardiovascular life support (ACLS) had expired. Employee 4 (a registered nurse in the emergency room) ACLS expired 4/2019 and Employee 7 (a registered nurse in Surgery) ACLS expired 1/2018.

During an interview on 11/21/2019 at 12:26 a.m., with the Director of Human Resources he stated current ACLS is required for both staff and employee files are supposed to be updated with current documents.

A record review of the facility's policy dated 6/2018 and titled "Licenses, Certifications and Degrees" indicates staff are properly credentialed for positions requiring certifications, when visual validation for certificates are not available online for instance BLS photocopies must be placed in the employee personnel file.

2. A file review indicated Employees 2, 3, 4, 5, 6, and 7 did not receive their annual Evaluation of Performance and Satisfactory Performance present in their employee files. In addition, Employee 1 who was hired on 7/9/16 did not have her 90-day evaluation for new hire.

During an interview on 11/21/2019 at 9:30 a.m., with the Nurse Educator she stated, we do not have a Performance evaluation for Employee 1 it is not here. Furthermore, she stated Performance Evaluation are done 90 days after each employee hire and annually thereafter.

During an interview on 11/21/2019 at 9:35 a.m., with the Director of Human Resources confirmed Performance Evaluation are done every year and 90 days for new hire. He stated Evaluation of Performance and Satisfactory Performance should be present in the employee files. Regarding Employees 1, 2, 3, 4, 5, 6, and 7 missing Evaluation of Performance and Satisfactory Performance he stated "I don't see it.

A record review of the facility's policy dated 6/2017 and titled "Staff Competency" indicates all employees will participate in the continuous assessment program, the competency program includes position description and performance evaluations, employee must obtain satisfactory rating on performance evaluation, the department director will review competency of each staff member each year, keep complete annual/mandatory competencies in employee department file.

Based on interviews and medical record reviews, there was no evidence the nurse was aware of the drug-drug interaction that increased sedation or sought the pharmacist review prior to Ativan (lorazepam, a benzodiazepine medication used to treat anxiety) 1 milligram (mg) and Norco (contains an opioid [narcotic] pain reliever [hydrocodone] and a non-opioid pain reliever [acetaminophen] used to treat pain) 7.5/325 mg were administered to a patient (Patient 5) at the same time.

This deficient practice resulted in the patient was too sedated to have dialysis performed which could have detrimental reaction to the patient.

Findings:

1. During a review of the hospital's automated dispensing cabinet (ADC) devices for PRN (as needed) medication removal and administration record log on 11/21/19 at 10:56 a.m., with the director of pharmacy (DOP) a random patient (Patient 5) was selected for drug utilization review.

A retrospective review of the ADC dispensing record for the Medical Surgical Unit (MedSurg) indicated on 11/14/2019 at 8:32 a.m. one tablet of Ativan 1 mg was removed from the ADC for Patient 5; and on 11/14/19 at 8:34 a.m. one tablet of Norco 7.5/325 mg was also removed from the ADC for Patient 5.

During a concurrent interview the DOP could not explain if the nurse removing two medications with a potential interaction would be alerted. DOP was unable to provide documentation that the pharmacy was consulted prior to the removal or administration of Ativan and Norco to Patient 5.

According to DailyMed the official provider of FDA label information (package inserts), dated 10/22/2019, included a Black Box Warning (BBW, the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects) for Norco that indicated, "Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death."

Review of Patient 5's physician orders indicated Patient 5 had orders dated:

11/14/2019 at 4:29 a.m. for Norco 7.5/325 mg via G-tube (gastrointestinal tube, a surgically placed device used to give direct access to the stomach for supplemental feeding, hydration or medication) daily PRN for pain

11/14/2019 at 4:31 a.m. for Ativan 1 mg via G-Tube every 8 hours as needed for anxiety

Review of Patient 5's medication administration record (MAR) indicated a nursing staff (ICU/Tele Nurse) administered Norco and Ativan at the same time on 11/14/19 at 8:54 a.m.

Review of the Medical Surgical (MedSurg) and Telemetry (Tele) result history for Patient 5 indicated the patient was on the MedSurg/Tele Unit on 11/14/19 and at 8:54 a.m. the RASS (Richmond Agitation-Sedation Scale Ranks agitation and possibility for sedation) Score was 0 (alert and calm) and had a pain intensity of 10 (worst possible pain). The documented assessment of alert and calm was inconsistent with the documented reason for administering Ativan for anxiety.

According to the American Journal of Respiratory and Critical Care Medicine dated 11/15/2002, indicated, RASS is a 10-point scale, with four levels of anxiety or agitation (+1 to +4 [combative]), one level to denote a calm and alert state (0), and 5 levels of sedation (1 to 5) culminating in unarousable (5).

On 11/21/19 at 11:20 a.m., during a medical record review with the clinical coordinator pharmacist (CCP) the clinical records indicated at approximately 1400 (2 p.m.) Patient 5 was documented to be too sedated to receive dialysis.

On 11/21/19 at 11:54 a.m., during a medical record review and interview in the presence of CCP, the Director of MedSurg/ICU stated the combination of Ativan and Norco could cause respiratory depression, synergistic effects (the activity of two drugs when they are used in combination, the cumulative effect is greater than individually), and typically the medication nurse would administer one medication and wait to see the effect before administering the second medication.

The hospital's policies and procedures for medication removal from ADC did not address drug-drug interactions or BBW between opioids and benzodiazepines.

Based on observation and interview, the facility failed to ensure patient records were protected from unauthorized access in accordance with federal or state laws.
This deficient practice had the potential for confidential information from patient records being accessed by unauthorized individuals.

Findings:

On November 22, 2019 at 9:41 a.m., during initial tour of radiology department with the Director of Diagnostic Imaging (DDI), five log books containing protected health information were observed in an unlocked cabinet in the nuclear medicine room. Concurrently, DDI stated she was not aware that patient records should have been locked up in the cabinets.

On November 22, 2019 at 2:43 p.m., during initial tour of the laboratory department with Clinical Lab Specialist (Lab Tech.) and Director of Laboratory (DL), medical records for antibody workup, containing protected health information (PHI), were observed in nine unlocked drawers. Concurrently, Lab Tech stated that patients cannot enter the laboratory department and that she did not know PHI had to be locked up.

Based on observation, interview, and record reviews, the hospital failed to:

1. Ensure the medications used in treating emergency cases were readily available. This had the potential for adverse patient outcomes during emergency treatment in the Emergency Room (ER), Gastrointestinal Laboratory (G.I. Lab), and the Operating Room (OR).

2. Ensure patient's own/home medications were accurately accounted for while held at an offsite facility listed on the hospital's license, Hawthorne Unit (Campus 3) and waiting to be returned to the patient on discharge.

Findings:

1a. During an observation of the ER on 11/19/19 at 11:27 a.m., in the presence of the director of pharmacy (DOP) and the clinical coordinator pharmacist (CCP). The DOP stated the ER had two adult crash carts and one pediatric crash cart used for emergency cases.

On 11/19/19 at 12:12 p.m., the DOP opened the pediatric crash cart and the contents were examined. The contents list of the pediatric crash cart was held in a binder outside of the crash cart and did not match the actual medication available inside the pediatric crash cart. The content list on the outside of the pediatric crash cart failed to indicate the following medications were not available:

- Atropine Sulfate 0.5 milligrams (mg) per 5 milliliter (ml)
- Dextrose 25 % (percent) Infant 2.5 grams (gm)/ 10 ml PFS (prefilled syringe)
- Sodium Bicarbonate (pediatric) 8.4 % 10 millequivalents (MEq)/ 10 ml PFS

During a concurrent interview with the CCP and DOP, the DOP stated, "There are no pediatric dilution instructions for what we have in stock." CCP stated ER sees pediatric patients, yet they are not admitted to the hospital. CCP stated the pediatric crash cart would be corrected.

1b. During a medication area inspection of the gastrointestinal (G.I.) Laboratory (Lab) on 11/20/19 at 2:49 p.m., the DOP opened the G.I. Lab crash cart and the contents were examined. The contents list of the G.I. Lab crash cart held in a binder outside of the crash cart did not match the actual medication available inside the G.I. crash cart. The content list on the outside of the G.I. crash cart failed to indicate the following emergency blood pressure medication was not available:

- Labetalol 20 mg/4 ml

During a concurrent interview the DOP stated the Labetalol included on the content list on the outside of the G.I. crash cart was not available and the content list inside the G.I. crash cart did not match. DOP stated they would review and correct the crash carts.

1c. During a medication area inspection of the OR on 11/20/19 at 3:10 p.m., the DOP opened the OR crash cart and the contents were examined. The contents list of the OR held in a binder outside of the crash cart did not match the actual medication available inside the OR crash cart. The content list on the outside of the OR crash cart failed to indicate the following emergency blood pressure medication was not available:

- Labetalol 20 mg/4 ml

During a concurrent interview the DOP stated the Labetalol included on the content list on the outside of the OR crash cart was not available and the content list inside the OR crash cart did not match. DOP stated they would review and correct the crash carts.

A review of the hospital policy and procedure, Crash Cart, last reviewed on 10/2019, indicated "The pharmacy medication inspection includes the following...The crash cart is adequately supplied with non-expired medications."

2. On 11/20/19 at 11:08 a.m., during an inspection of Unit 1 medication room at Campus 3, there were three sealed plastic bags observed inside a cabinet in the medication room. Inside the bags were bottles of medication and each bag was labeled individually for different patients (Patients 1, 2, and 3).

On 11/20/19 at 11:24 a.m., during an interview in the presence Unit Nurse 3, Unit Nurse 2 stated the plastic bags contained patients' own medications or medication brought from home upon admission and the number of bottles are counted, placed in a plastic bag and stored in the medication room's cabinet until the patients are discharged. Unit Nurse 3 agreed with Unit Nurse 2 that patients' medications brought from home were stored and kept in the medication room.

A review of the medication receipt forms attached to the sealed plastic bags stored inside Campus 3 Unit 1 medication room included signatures of the receiving nurse and the space that indicated "Medication received by pharmacy employee" were blank for Patients 1, 2, and 3. The medication receipt form indicated the following:

Patient 1, three medication bottles were documented to be contained inside a sealed plastic bag.

Patient 2, five medication bottles were documented to be contained inside a sealed plastic bag

Patient 3, three medication bottles were documented to be contained inside a sealed plastic bag

A review of the hospital policy and procedure, Medications Brought to the Hospital by Patients, last reviewed on 4/2018, indicated "This policy shall apply to inpatients and medical short stay patients for proper handling of patient's own medications brought into the Hospital ...Nursing will initiate the documentation of all medications brought in by the patient on the patient's medication receipt ...The receipt shall contain the following information ...Nurse's name and signature; Pharmacy employee's name and signature ...Upon transferring the medication bag from nursing to pharmacy, both parties shall verify the number of vials or containers in the bag ...The patient's own medications will be stored in the locked cabinets in Pharmacy ...At the time patient is discharged ...The nurse or the patient will request the return of patient's own medications and present the receipt (for the medications) to pharmacy staff."

Based on observation, interview and record review, the hospital failed to ensure a pharmacist performed and documented the visual confirmation of ingredients, prior to the pharmacy staff participating in the pharmaceutical compounding of sterile (CSP) intravenous (IV) medications for a patient (Patient 4) per policy.

This deficient practices resulted in the safety and quality measures were not followed to prevent potentially avoidable medication errors that may negatively affect the safety or health of the patients.

Findings:

During a tour of the pharmacy department on 11/21/2019 at 10:15 a.m., there was a pharmacy staff inside a segregated compounding area (SCA, a room designated for the compounding of sterile medications) preparing a sterile intravenous (IV) product.

On 11/21/19 at 12:22 p.m., during an interview, the Pharmacy Staff stated he had completed compounding an IV bag that contained potassium chloride 40 millequivalents (mEq) for Patient 4. Pharmacy Staff stated the pharmacist would review the compounded medication after he mixed and prepared it. However, the compounding formula worksheet was blank. Pharmacy Staff stated he was going to document the ingredients used now and have the pharmacist review the final product.

During a concurrent interview, the director of pharmacy (DOP) stated a pharmacist was required to perform a visual confirmation of additives and review documentation before the Pharmacy Staff proceed to prepare sterile IV product. DOP reviewed the aforementioned prepared IV product and stated he could not verify the actual ingredients and/or the volume added to the IV bag.

On 11/21/19 at 3:49 p.m., during an interview the clinical coordinator pharmacist (CCP) stated that IV potassium chloride is on the hospitals list for high risk medications.

A review of the hospital policy and procedure, Compounding Sterile Preparations (CSP), last reviewed 6/2019, indicated, "Pharmacist checks ...visual confirmation of additives and their volumes or quantities ...pre-production visual confirmation of the amount of each ingredient prior to being added to the final container is required when compounding ...handwriting the amount of an additive on the final preparation label is not used as the sole method of verification of any CSP."

Based on observation, interview and record review, the facility failed to ensure that patient's medication was not left unattended by the the patient's bedside for Patient 18 and the medication for personal use of an employee, not be kept in the facility.

This deficient practice had the potentail for medication errors.

Findings:

1. On November 20, 2019, at 10 a.m., during the tour of the unit with Director of Behavioral Unit, Patient 18 was observed lying in bed and was covered with a blanket. On her bedside was a plastic cup that contained a translucent white substance.

During an interview, the Director of BHU stated it was a Vitamin A and D topical ointment. She further stated medications should not be left at the patients' bedside. The medication should be administered when prepared or if not possible store it in a safe place prior to administration.

A review of Patient 18's medical record indicated the patient was admitted to the facility on November 15, 2019, with diagnosis of psychosis NOS. The physician had an order for Vitamin A and D topical (vitamin A and D topical ointment) BID (twice a day) PRN (as needed) for dry skin for 30 days. However, there was no order for medication to be left at the bedside table.

The facility's policy number #PCM-13-113 dated 4/20/18 indicated medication may be left at the patient's bedside (in a drawer or cabinet) with specific orders permitting bedside storage from a physician. The medication may be stored in the Medication Room if there are no orders allowing storage at bedside. Unauthorized drugs shall be sent to the Pharmacy.


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2. On November 22, 2019 at 10:31 a.m., during initial tour of radiology department with the Director of Diagnostic Imaging (DDI) and the Ultrasound Technician (UT), one vial of Lidocaine 1% with an expiration date of November 2021 and one bottle of an over-the-counter medication, for the personal use of an employee, were observed in a drawer of the ultrasound room #1.

During interview, UT stated she kept the lidocaine medication vial for in case it was needed for a procedure for a patient and that the other medication bottle was for her personal use. Concurrently, DDI stated no medications are to be stored in the patient care area.

Based on observation, interview and review of hospital documents, the hospital failed to:
1. Ensure diet orders and nutritional supplements were ordered by the health professional responsible for the care of patients. Registered Dietitians were routinely ordering diets and nutritional supplements electronically without a physician order (Refer to A 630).
2. Dietary staff were not competent in regards to testing the sanitizer for the sanitizer bucket used for wiping countertops, in addition they were not competent in testing the sanitizer for the dish machine and the manual ware washing if it was at an effective concentration to sanitize dishes and countertops used for patient food service (Refer to A 622).
3. Ensure adequate food and water were on hand for use in an emergency (Refer to A 619).
4. Ensure an organized dietetic services as evidenced by findings of unsafe food handling practices and inadequate oversight of the dietary department (Refer to A 749).

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

Based on observation, review of hospital documents and staff interviews, the hospital failed to ensure that the food and dietetic services department was properly organized. The person in the position of leadership had responsibilities in all three hospitals (main campus Hospital A, South campus Hospital B and Hawthorne Hospital C). One of the hospitals did not have a dietary supervisor. The hospital (Hospital B) that did not have a dietary supervisor, did not have adequate food and water for use in an emergency and food including TCS (Time and Temperature Control for safety foods capable of supporting bacterial growth that can result in food borne illness when not safely stored and prepared) were not monitored for safe temperatures and was delivered in a pick-up truck that had no cover or refrigeration from the main hospital (Hospital A) to (Hospital B). These deficient practices had the potential to affect the quality of care being provided due to failure to meet the nutritional needs of patients, poor food safety practices that put 36 patients, staff and visitors at risk for food borne illness (cross reference A 0749).

Findings:

During an interview with the Food Service Director (FSD) on November 20, 2019 at 9:00AM, FSD stated he manages all three hospital Food and Nutrition Service Department. He stated he visits (Hospital B) two to three times per week and stays for a couple of hours on each visit. He stated a dietary staff (DS1) was responsible for the day to day operation of the food service department. He stated he visits (Hospital C) once per week since there is a full time Dietary services supervisor.

During an interview with Dietary Staff (DS1) on November 20, 2019 at 9:10AM, DS1 stated that she works at the hospital Monday through Friday and is responsible for making sure food is labeled and dated and adequately stored in the refrigerator and dry storage area. She also makes sure that food supply is adequate to prepare for the menu. She is responsible for overall cleanliness and also delivering snacks, nourishments to nourishments refrigerator in the nurse's station. She is also responsible to deliver snacks to an outpatient behavior unit on campus.

During an observation in the dry storage area on November 20, 2019 at 9:30AM, there were 30 cans of either garbanzo beans, pinto beans, red beans, mixed beans, vanilla and chocolate puddings. There was one large bag of lentils and another bag of rice. There were disposable plates and utensils. During an observation in the walk in refrigerator there was a large tray of pulled pork for lunch menu, there was carton of eggs and produce including tomatoes, zucchini, peppers. There was inadequate food on hand to meet state requirements of seven days of staples and two days of perishable foods to meet the requirements of the menu.

During an interview with Food Service Director (FSD) on November 20, 2019 at 10:00AM, FSD stated that there is no outside food vendor set up to deliver food to (Hospital B). He stated all food and disposable paper supplies are delivered from the main hospital (Hospital A). He also stated the menu in (Hospital B) is the same as the main hospital (Hospital A). He further stated the cook will plan for two days' menu and will make a list of supplies needed. The food is then delivered from the main hospital on a pick-up truck.

During the same interview with FSD, he stated that (Hospital B) does not have disaster food and water on campus to accommodate 36 patients, staff and visitors on campus. He also stated during an emergency and disaster the food and water will be delivered from the main campus. When asked if during a disaster all roads were shut down, how would the hospital assure that patients, staff and visitors food and water needs will be accommodated. The FSD responded that he has ordered a four-day disaster food and water supply to accommodate patients and staff in Hospital B during a disaster.

During an interview with FSD on November 21, 2019 at 10:30AM, FSD verified that there is no disaster food and water in (Hospital B). FSD also verified that there is no adequate amount of food on hand to meet the requirements of the menu for a week. He stated food supply is delivered from the main campus on daily basis via a pick-up truck. FSD stated that food supply is stored in a heavy duty plastic covered containers and food carriers then placed on the pick-up truck. FSD agreed there is no temperature control on the food while being transported on the truck and also agreed that the truck is not covered.

During an interview with of Food and Nutrition Services Regional Director on November 21, 2019 at 10:30AM, when asked why there was no disaster food and water supply for patients, staff and visitors in (Hospital B). He stated that disaster food and water has been ordered and will arrive soon. He also stated that food supply for Hospital B is delivered from Main Hospital (Hospital A) via a vehicle transported back and forth between the two hospitals. He acknowledged that the truck did not have temperature control system for safely transporting food. He also acknowledged that the truck was not covered to prevent possible food contamination during transportation.

During an interview with Infection Control Preventionist (ICP) on November 22, 2019 at 2:40PM, ICP stated that she was not aware that food was transported via a pick-up truck to other hospital location. ICP stated food should be transported in such a manner to prevent cross contamination. Vehicle should be secure and make sure it maintains food temperature at safe levels.

A review of the contract between the hospital and Food and nutrition management company dated 2/3/2016 indicated, "The management company's furnished items for food services department includes (meat, poultry, produce, eggs, dairy products, bread, grains, gats, oils, pantry supplies, provisions to meet cultural /religious needs of client, provisions dedicated for emergency or disaster use only (four day emergency menus), Dry and non-food supplies (disposables), chemicals and other products used for dishwashing, cleaning and sanitizing.)" The Food and nutrition management company will, "comply with all federal, stated and local laws, ordinances, rules and regulations, any and all client policies, rules and regulations, which may be issued or amended from time to time by client, maintain all records relative to such complicate and provided to client accordingly, purchase routine food, supplies and provide services which company shall deem necessary for operation of the food services department. Adhere to OBRA and title 22 requirements at all times, including dietary services supervisor requirements, per California Code of regulations section 72035."

A review of the job description of the food services director indicated the director "plans, organizes, develops, and directs all operations of the Food and Nutrition Services department in accordance with applicable federal, state, and local guidelines. Order, monitor, and maintain adequate food supplies."

A review of the 2017 U.S. Food and Drug Administration Food Code standard operating procedure guide indicated food operators must ensure that, "Food is received from approved sources, food is managed so that the safety and integrity of the food from the time of delivery to the establishment through its storage, preparation, and transportation to the point of sale or service to the consumer is protected, and time and temperature control for safety foods is maintained, including freezing, cold holding, cooking, hot holding, cooling, reheating, and serving in conformance with the temperature and time requirements."

Based on observation, interviews and record reviews, the hospital food and Nutrition Services failed to ensure staff was competent with respect to testing the concentration of the sanitize to ensure it was effective in sanitizing countertops and pots and pans.

This deficient practice had the potential to result in ineffectively sanitizing the countertops and pots and pans used to cook and prepare patient food. Ineffective sanitizing had the potential to result in food borne illness in a medically vulnerable patient population of 82 patients who were served food.

Findings:

During an observation of the kitchen in the main campus on November 19, 2019, at 12:10PM, Cook 1 used the sanitizer solution in the red bucket to wipe countertops. During a concurrent observation and interview, Cook1 demonstrated how he tested the concentration of the sanitizer in the red bucket. He placed the test strip in the solution, and then compared the test strip to the color chart. The recommended concentration level for the quaternary Ammonium sanitizer used is between 150-400 parts per million (PPM) per manufacturers guidelines. The testing strip indicated a color range of 500 part per million.

During a concurrent interview with Cook1, he stated the level is 500ppm, when asked if that's ok he stated I think so. When asked what is the recommended level for the sanitizer used, Cook 1 did not know.

During an observation of the kitchen in the main campus on November 19, 2019, at 12:25PM, (Dietary staff (DS2) was asked to demonstrate dish machine operation and test the sanitizer effectiveness. DS2 started the machine and when the wash and rinse cycle was finished, DS2 took a test strip and immersed it in the rinse water for 1 second and tested against the color chart of the container. The test strip indicated a color change that showed sanitizer was above recommended level. The recommended concentration level for chlorine sanitizer is between 50-100 parts per million (PPM). The solution tested was at 200PPM.

During a concurrent interview with DS2, he stated the normal level for the sanitizer solution is 200PPM, he added the higher the number the better. He also stated when there is a problem with the sanitizer he will let the supervisor know. When asked if there is any problem now with the sanitizer, he replied no problem.

During an interview with Food Service Director (FSD) on November 19, 2019, at 12:30PM, FSD stated that normal level is between 50-100PPM. He also stated he will contact dish machine repair company to assess the dish machine. FSD added that he will provide in-service to staff on sanitizer testing.

A review of job description for the Dietary Staff indicated will possess the required knowledge and skills to assist in preparation and service of assigned patient and staff food items. In addition will sanitize dishes and service ware.

A review of the job description for the cook indicated the cook performs many varied tasks with the department, demonstrates awareness of and adherence to safety and legal requirements established at the facility and department level, as well as follows sanitization.
A review of hospital policy titled "Dish machine temperature log" Policy No.FN3-04-002 (Revised 8/2018) indicated, "To ensure that dishes and small ware are sanitized, final rinse sanitizer solution concentration at 50-100ppm (parts per million) chlorine on dish surface in final rinse."

Based on observation, interview and record review, the hospital failed to ensure patient diets including nutritional supplements were ordered by the practitioner responsible for the care of the patients. Electronic orders for nutritional supplements and diet orders, entered by the Registered Dietitian was carried out by the Food and Nutrition services without physician orders, were noted in 2 of 3 medical records reviewed. For Patient 12, RD was able to change diet order and for Patient 11, RD was able to discontinue a Nutritional Supplement.

Findings:

During a concurrent interview and electronic medical records review with Registered Dietitian (RD1) on November 21, 2019 at 10:30AM, RD1 changed patient 12 diet from a renal diet to cardiac diet. RD 1 stated diet changes are entered electronically as protocol order and its immediately communicated electronically to the Food and Nutrition Services. RD1 stated physician will sign off on the orders. RD1 stated the physician has not signed yet but the patient now has a new diet order. RD1 was also able to discontinue a nutrition supplement order for patient 11.

During the same interview RD2 stated that routine diet orders and nutrition supplements are entered by RDs as a protocol order, but tube feedings (a medical device used to provide nutrition to people who cannot obtain nutrition by mouth, are unable to swallow safely) are more complicated and RDs will speak with physician first, then recommend an appropriate tube feeding and the physician will enter the order.

During an interview with IT staff (ITS) familiar with hospital electronic medical records on November 21, 2019 at 10:50AM, ITS confirmed that orders entered by RD1 will be carried out by the Food and Nutrition Service department. He continued that the program is set up in a manner that allows RD to enter diet orders and then it will populate in physician's orders to sign.
During a review of physicians orders for patient 12, the orders indicated a diet change to cardiac diet and the physician had not signed the order yet.

During an interview with RD1 and RD3 on November 22, 2019 at 12:08PM, RD1 and RD3 verified that there are no protocol orders for diet orders and they agree that all orders will be initiated by physician caring for the patient. RD1 and RD3 verified that the hospital policy for diet orders should be reviewed to clarify that orders are initiated by physician only.

A review of the hospitals policy titled "Continuous Nutrition Monitoring" Policy No.FN4-05-002 (revised 7/2017) indicated, "When recommendations are made which require a physician order, the dietitian will follow up within 48 hrs. to verify a response to the recommendation. If the physician does not respond to the recommendation by ordering the requested intervention or by another entry in the medical record, the dietitian will do one or all of the following: 1. Contact the physician to discuss the recommendations made and document the results of the discussion 2. Enter the information on the approved medical record form requesting a response. If still no response, the dietitian will contact the physician to discuss the recommendation and documents the results of the discussion."

A review of the hospital policy titled "Diet orders" Policy NoFN4-04-004 (revised 7/2017) indicated, "Diets are ordered in writing by the responsible physician prior to the service of the diet."
A review of the same policy indicated that the procedure to for writing diet orders had Physicians and Clinical Dietitians can write and enter orders in medical record.

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.

Based on observation, interview and record review, the facility did not meet the Condition of Participation in Physical Environment by failing to:

1. Provide care in a safe setting. (Refer to A 144)
2. Maintain safe environment. (Refer to A 701)
3. Monitor the humidity (moisture) in the medication storage and preparation areas. (Refer to A 726)

The cumulative effect of these systemic failures resulted in the facility's inability to ensure patient safety.

Based on observation, interview, and record review, the facility failed to maintain a safe environment.

This deficient practice resulted in the facility's inability to provide safety and well-being of the patients.

Findings:

A. On November 19, 2019, at 11 a.m., during the tour of the different areas of the hospital the following was observed:
1. In the Emergency Department
a. In Bay 1, the eye wash station was missing a cover. The cabinet which stores patient supply, the door knob was missing.
b. The railings were found to has sharp edges.
c. Bathrooms 1 and 2 had fixtures (flushing mechanisms) that could be potential harmful to the patient
2. In 1 West (BHU)
a. There was a missing wood underneath the sink.
3. The shower room was not functioning. It had not been used for three (3) days.
4. Room 166 with 2 patients/occupants had two (2) lotions and comb. There was a missing fluorescent lamp. Room 165 had the flexi light glass that contained removable metal screw, bedside drawer missing door, chipped tiles on shower area and shower was not working.
5. Room 167 had the flexi light glass that contained removable metal screw, shower was not working and light fixture was tied with plastic to hold it in place.
Room 170 with 2 patients , the bedside drawer was missing door, Room 169, bedside drawer was missing door, base of the toilet bowl had an expose metal screw (missing plastic cover). The meal tray table in the common area dining/activity had chips and residual tapes.

B. On November 20, 2019 at 9 a.m., during tour of the different areas the following was noted:
1. South Campus (BHU)
a. The shower room had metal rack and metal rails.
b. The faucet in the Day Area had an aerator, coving coming off, curtain rails and rods and corrugated cardboard boxes that contained syringes and plastic bags for storing personal belongings, a missing water fountain that left a hole/space potential to stick fingers and get hurt, the refrigerator handle potential for applying ties, refrigerator cord was about 2 to 3 feet and electric sockets uncovered (13 of them).
c. The Clean Utility Room had cardboard boxes that contained cleaning rugs, residual tapes and faucet had aerators.
d. The Anteroom (by the hallway) had a table /desk that had chipped and missing door.
e. Room 6's bathroom a chipped wall tile, coving coming off, shower was not working and rusted. Room 8 with 2 beds the base of the toiled bowl had metal screws exposed and missing cover. The water fountain between Room 12 and 14 and by the nurses station faucets was sticking out as well as sprinklers sticking out in the outside patio.

2. Hawthorne Campus
a. There was a chipped floor tile and coving coming out in the bathroom .
b. In the Dining Area, the water fountain was sticking out.
c. In the dining/Recreation area the bathroom could not be opened. There was a chipped floor tile and coving.
d. In the washroom where the washer and dryer was located, the dryer handle was broke and an improvised metal string was placed.
e. In Room 1011 the toilet flush fixture /tubing was exposed. In the shower room the shower head was sticking out.
f. The Court Room had a extension cord about 20 feet hanging by the cart. In the bathroom was a sticking shower head, soap holder and sliding rail which could potential risk. The storage cabinet orange in color could not be locked and residual tapes on the door.

Based on observation and interview, the facility failed to ensure medical supplies were maintained to provide an acceptable level of safety for patients' needs.
This deficient practice had the potential for emergency supplies not being readily available when needed.

Findings:

On November 22, 2019 at 9:41 a.m., during initial tour of radiology department with the Director of Diagnostic Imaging (DDI) and Imaging Lead Tech, the following supplies were observed inside the hot lab room:
1. One 21-gauge needle with an expiration date of June 2019
2. One box of intravenous catheters with an expiration date of November 2016.
3. One box of 50 injection needles with an expiration date of August 2009.

Concurrently, the DDI stated those supplies should have been checked and removed from storage prior to manufacturer's expiration date.

Based on observation, interview, and record review, the hospital failed to ensure there were monitoring for humidity (moisture) in the medication storage and preparation areas, such as medication rooms at each nursing units at the main hospital (Campus 1) and the two offsite locations (Campus 2 and 3) that were included on the hospital's license. This deficient practice had a potential affecting the integrity and/or potency of the products.

Findings:


During an inspection of the Campus 1 medication room inside the first floor Behavioral Health Unit West (BHUW) on 11/19/2019 at 2:15 p.m., in the presence of the director of pharmacy (DOP), the unit nurse (1) stated they did not monitor for humidity within the medication room. The hospital staff provided a list of medication storage areas that included 12 locations for Campus 1, one medication room for Campus 2, and two medication rooms for Campus 3.

On 11/20/19 at 9:36 a.m., during an inspection and concurrent interview inside of Campus 2 medication room, the DOP acknowledged there was no humidity monitoring device in the medication room.

On 11/20/19 at 11:08 a.m., during an inspection and concurrent interview inside of Campus 3 medication room the, DOP acknowledged there was no humidity monitoring device in the medication room.

On 11/21/19 at 9:10 a.m., during an interview, the DOP stated, that the medication storage and preparation areas, located throughout Campus 1, Campus 2, and Campus 3, were not monitored for humidity.

A review of the hospital policy and procedure, Storage of Drugs and Biologicals, last reviewed 7/2019, indicated, "Drugs shall be stored under the proper conditions of sanitation, temperature, light, moisture, ventilation...must be stored in such a way as to insure that the integrity, stability and effectiveness of the product are kept intact."

Based on observation, interview and record review, the facility did not meet the Condition of Participation in Infection Control by failing to provide a sanitary environment to avoid sources and transmission of infections and communicable disease. (Refer to A 749)

The cumulative effect of these systemic failures resulted in the facility's inability to maintain an ongoing infection control program that seeks to minimize infections and communicable diseases.

Based observation, interview, and record review, the infection control officer failed to maintain an going infection control program that seeks to minimize healthcare-associated infections and community-acquired infections.

This deficient practice had the potential to cause infections and communicable diseases to the patients.

Findings:

A. On November 19, 2019, starting 11 a.m., during the tour of the different areas in the facility, the following was observed:

1. Emergency Department
a. In Bay 1, the handwashing sink that was used to store two soiled intravenous pump, with an aerator in the spigot of the faucet had mineral deposit in the fixture. The coving was coming off.
Inside the cabinet, there were seizure pads made of corrugated cardboard boxes exposed and stored in the cabinet. There were rust with brown color stain on the shelves. The paper towel dispenser when paper towel is released it lay flat on the counter (meaning it is too long).
b. In between the Braslow Cart and Crash Cart was a trash bin. The plastic bag hanging from the two (2) carts that contained the air bag and other emergency supply were almost laying on top of the trash bin.
c. There was residual tapes on the light fixture (lamp).

2. 1 West (BHU - Behavioral Health Unit )
a. In Room (Labeled Kitchen), there was an ice machine needed cleaning. There was mineral deposit around the area drain pad. The ice machine did not have a visible preventative maintenance sticker at the time of observation.

During an interview with EVS on 11/20/19 at 8 a.m., the staff stated only the outside area of the ice machine was cleaned with 3M #23 Neutral Quat Disinfectant Cleaner Concentrate (one step disinfectant germicidal detergent and deodorant - neutral pH, disinfectant cleaner, use on washable hard non-porous surfaces of floors, cabinets, desks, doorknobs, metal bed-frame, bedrails, bathroom, fixtures and countertops).

Review of the Weekly Ice Machine Cleaning Log 2019 dated January 1, 2019 through November 10, 2019, indicated date, time and initial of performed the weekly cleaning. The section that asked Lime and/or Scale present (Yes/No) If Yes, contact EVS at a given number was not filled out/answered/addressed.

The facility policy number EOC-03-070 titled Ice Machine Cleaning reviewed 2/2019 indicated daily Cleaning of ice machine are inspected for calcium build up, dust/damp cleaned, wiped and where , the exterior metal surface polished. More extensive cleaning is done when scaling is present. It also indicated housekeeping staff perform cleaning the inner and outer ice dispensing spouts, monthly, clean drain grate and drain pan daily and keeps records of ice machine maintenance activities.
b. There were cardboard boxes that contained styroform drinking cups underneath the counter.
c. The spigot of the faucet by the sink had an aerator.

3. Seclusion Room
a. There was a brown/reddish substance on the bolted pole of the seclusion bed.
b. In the restroom, there were crutches and portable eating table stored. The call cord for the call light was note to be made of material that could not thoroughly clean or disinfected.

4. Room 166 with two patients occupying the room. The light cord was made of material that was not easily cleaned or disinfected. There were two (2) urinals, one with a patient name and the other one has no name.

B. On November 20, 2019, at 9 a.m., during tour of the different areas, the following was observed:
1. South Campus (BHU)
a. The CN was noted conducting round of the unit wearing a pair of gloves.
b. In the handwashing sink by the Nurses Station, the faucet spigot had aerator and mineral deposit around spout.
c. The shower in the Male Unit, the ventilation and sprinklers are rusted.
d. The portable oxygen tank was located between the trash cans.
e. In the Treatment Area, the soiled linen container was placed closed to the examination table and corrugated cardboard boxes that containing discharge planning kits.
2. Hawthorne Campus
a. In the Seclusion Room was a bolted bed, underneath was black/brown dried substance around the post. The walking feet shackle had brown/red stains and when the Director of BHU tried to clean but could not be removed.
b. Hand sanitizer at the entrance of the facility was not working.



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C. A review of Medical Staff Credential Files, ten out of ten Medical Staff files did not have Hepatitis B status or waiver documented.

During an interview on 11/21/19, the Medical Staff Director (MSD) indicated the facility monitored yearly flu vaccine or declination. MSD indicated TB testing is updated every two years. MSD stated the facility did not have a policy or document Hepatitis B status or waiver for Hepatitis B status.

On 11/20/19 during the Personnel File Review, there was no evidence for Employee 7 hepatitis B vaccination series, titer level to test for antibody nor was the statement of declination present in her employee file.

During an interview on 11/20/2019 at 12:50 a.m., with the Employee Health Nurse she stated, "we have no record of it".

During an interview on 11/19/19 at 10:45 a.m., the Infection Control Director (RN 25) indicated the facility followed AMEE and CDC guidelines for infection control.

D. During an initial tour of the OR on 11/21/19 at 9:20 a.m. with the OR DON and RN 25, an opening in an OR was covered with Plastic and a zipper. When asked what happened, RN 25 indicated the door fell 2 days ago and being replaced. There was no Notice posted, no Infection Control Risk Assessment (ICRA) and no OSHPOD notice. When asked, RN 25 indicated she had not done an ICRA for the OR door replacement.

A review of a Hospital Document titled, "Construction and Renovation" revised 11/2019 indicated Infection Prevention and Project Manager will inspect the construction site to make sure appropriate barriers are in place before the project begins".

E. On 11/22/19 at 11:30 a.m., during a tour of the Material and Receiving Department with CNO and Assistant Director of Materials Management (Admin 25), corrugated boxes were observed on shelves and with patient care items throughout the materials supply area. Admin 25 indicated items delivered to the hospital are stored in this location and transferred up to patient care areas. There was no policy for use of Corrugated Boxes in patient supply storage or patient care areas.





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F. On November 22, 2019 at 9:41 a.m., during initial tour of radiology department with Director of Diagnostic Imaging (DDI), powdery dust was observed on the floor next to 2 blue plastic bins and one corrugated box of medical supplies, also on the floor, in the x-ray storage room.
Concurrently, DDI stated she did not know where the powdery dust came from and stated she was not aware that the two blue bins and the corrugated boxes were on the floor because they should not have been found on the floor.

In the hallway, one gurney was observed with multiple tears on the mattress and rust stains on the railings. Concurrently, DDI stated the mattress needed to be replaced.

In the patient restroom, the emergency pull cord was observed to be made of twine. Concurrently, DDI stated there was no way to disinfect the emergency pull cord made of twine.

In the ultrasound room #2, a gurney was observed with a mattress with tape and tape residue and stains. Concurrently, DDI stated the mattress needed to be cleaned better.

In the nuclear medicine room, the cabinets were observed with tape and tape residue on the outside. Inside the cabinets, corrugated boxes with medical supplies were observed. Concurrently, DDI stated the cabinets needed to be cleaned better.

In the hot lab, the handwashing sink was observed with mineral deposits on the faucet and the sink basin. Concurrently, DDI stated the housekeeping staff needed to clean the sink better.

G. On November 22, 2019 at 2:40 p.m., during initial tour of the laboratory department with Clinical Lab Specialist (Lab Tech.) and Director of Laboratory (DL), the counter tops and cabinets was observed with tape and tape residue and two sinks in the laboratory were observed with aerators containing mineral deposits and green stains on the spigot and the sink basin. Concurrently, Lab Tech stated she did not notice the tape and tape residues on the counter and on the cabinets and stated the sinks were sometimes used for handwashing.



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G1. During an observation of the ice machine on November 19, 2019, at 2:30PM, the ice machine stored in kitchen of the main campus (hospital A) was inspected. Observed a gap between the upper piece of the ice machine and the bottom ice storage piece. A gap is large enough to allow debris to enter the ice storage bin. A clean paper towel swipe of the ice storage bin ceiling and corners produces a black substance and dust.

During a concurrent interview with Food Service Director (FSD), he stated that the kitchen staff cleans the ice machine bin every month. He stated that an outside company cleans the ice machine internally twice a year. He also stated the gap shouldn't be there and it will be fixed. FSD further stated the ice machine was from two different pieces of equipment put together.

During an observation of the ice machine on November 20, 2019, at 9:20AM, the ice machine stored in kitchen of the south campus (Hospital B) was inspected. A clean paper towel swipe of the ice storage bin sides and corners produced a significant amount of brown substance.

During a concurrent interview with Food Service Director (FSD), he stated that he kitchen staff cleans the bin on monthly basis. FSD verified the ice machine was not clean. A review of the cleaning log indicated cook (cook2) cleaned the bin this month.

During an interview with cook2 on November 20, 2019, at 9:30AM, the cook verified that he cleaned the bin this month. He stated when he cleans, he turns off the machine, removes the ice from the storage bin and sprays sanitizer then wipes with cloth. He also stated that sometimes he washes the bin with water and soap.

A review of hospital policy titled "Sanitation Procedure - Ice machine" No.FN3-23-015 (Reviewed 3/2017) indicated, "Ice Bin Procedure: Empty ice bin, dump all the excess ice into the sink, spray all-purpose cleaner, wipe down interior, top, sides, spigot, and bottom with clean dishtowel, rinse thoroughly with clear water and sanitize."

A review of hospital policy titled "Ice machine cleaning procedure and ice machine cleaning checklist" indicated the ice bin should be rinsed with soap and water, thoroughly wipe down with sanitizer solution, and allow about 1 hour to air dry.

During an observation of the nourishment room in 2 west in the main campus (Hospital A) on November 19, 2019 at 3:18PM, the ice machine was inspected. A clean paper towel swipe inside the chute of the ice machine produced brown and orange slimy substance. During a concurrent interview with FSD, he stated maintenance department cleans the ice machines in the nourishment room.

During an interview with Maintenance staff (MS1) on November 19, 2019 at 3:28PM, he stated he cleans the ice machine every three months. He stated he opens the ice machine, cleans the filter and soaks the ice dispenser piece in soap and water and puts the parts together. MS1 agreed that the ice machine is dirty and stated that it will get dirty because it is only cleaned every three months. He added that it should be cleaned more often. MS1 further stated his department which is the maintenance department cleans the ice machines in the nourishment rooms throughout the hospital every three month. There was no manufacturers instruction for cleaning the ice machine available to review.

During an observation of the nourishment room in ICU in the main campus (Hospital A) on November 19, 2019 at 4:01PM, the ice machine was inspected. A clean paper towel swipe inside the chute of the ice machine produced black substance. During a concurrent interview with FSD, he stated the ice machine is cleaned and maintained by the maintenance department.

During an interview with infection control preventionist (ICP) on November 22, 2019, at 2:40PM, ICP stated she does not check the ice machines in the nourishment rooms in the hospital. She stated she makes the infection control rounds quarterly. She stated she will start checking the ice machines in the nourishment rooms during her infection control rounds. ICP also stated that ice machine should be cleaned more often than every 3 months. ICP further stated that she has not done the quarterly infection control rounds or regular basis.

During a review of the infection control rounds documents, there was only one infection control rounds completed for year 2019.

A review of the 2017 U.S. Food and Drug Administration Food Code, indicated Equipment contacting food that is not Time/Temperature control for safety food: such as enclosed components of ice makers shall be cleaned at a frequency specified by manufacturer or if manufacturer specifications are absent then at a frequency necessary to preclude accumulation of mold.

2. During an observation in the dry storage area of the South campus (Hospital B) on November 20, 2019 at 9:30AM, there were 30 cans of either garbanzo beans, pinto beans, red beans, mixed beans, vanilla and chocolate puddings. There was one large bag of lentils and another bag of rice. There were disposable plates and utensils. During an observation in the walk in refrigerator there was a large tray of pulled pork for lunch menu, there was carton of eggs and produce including tomatoes, zucchini, peppers. There was inadequate food on hand to meet state requirements of seven days of staples and two days of perishable foods to meet the requirements of the menu.

During an interview with Food Service Director (FSD) on November 20, 2019 at 10:00AM, FSD stated that there is no outside food vendor set up to deliver food to (Hospital B). He stated all food and disposable paper supplies are delivered from the main hospital (Hospital A). He also stated the menu in (Hospital B) is the same as the main hospital (Hospital A). He further stated the cook will plan for two days' menu and will make a list of supplies needed. The food is then delivered from the main hospital on a pick-up truck.

During an interview with FSD on November 21, 2019 at 10:30AM, FSD stated food supply is delivered from the main campus on daily basis via a pick-up truck. FSD stated that food supply is stored in a heavy duty plastic covered containers and food carriers then placed on the pick-up truck. FSD agreed there is no temperature control on Time/temperature control for safety food while being transported on the truck and also agreed that the truck is not covered.

During an interview with of Food and Nutrition Services Regional Director (FSRD) on November 21, 2019 at 10:30AM, he stated that food supply for Hospital B is delivered from Main Hospital (Hospital A) via a vehicle transported back and forth between the two hospitals. He acknowledged that the truck did not have temperature control system for safely transporting food. He also acknowledged that the truck was not covered to prevent possible food contamination during transportation.

During an interview with Infection Control Preventionist (ICP) on November 22, 2019 at 2:40PM, ICP stated that she was not aware that food was transported via a pick-up truck to other hospital location. ICP stated food should be transported in such a manner to prevent cross contamination. Vehicle should be secure and make sure it maintains food temperature at safe levels.

3. During an observation of the nourishment room in 2 West in the main campus (hospital A) on November 19, 2019, at 3:18PM, the drain pipe from the ice machine was noted to be located behind a door of the under counter cabinet. There was no air gap maintained between the end of the drain pipe and the flood level of the drain fixture.

During a concurrent interview with Maintenance staff (MS1), he stated that the drain line from the ice machine is directly connected to the sink drain line. He verified that there was no air gap maintained. H also stated none of the ice machines had air gaps, he added that this is an old building.

During an observation of the nourishment room in 2 North and ICU in the main campus (Hospital A) on November 19, 2019 at 4:01PM there were no air gaps maintained for the ice machines.
A review of the 2017 U.S. Food and Drug Administration Food Code indicated, an air gap between the water supply inlet (drain pipe) and the flood level rim of the plumbing fixture (drain), equipment, or non-food equipment shall be at least twice the diameter of the water supply inlet and may not be less than 1 inch. This is required because during periods of extraordinary demand, drinking water systems may develop negative pressure in portions of the system. If a connection exists between the system and a source of contaminated water during times of negative pressure, contaminated water may be drawn into and foul the entire system.

4. During an observation in the kitchen on November 19, 2019, at 12:06PM, the cook (cook1) was preparing sandwiches for patients and did not cover his long facial hair. Cook 1 had a beard cover that was pulled down below his mouth. Cook 1 moved away from his sandwich preparation area and walked over to the lunch tray line (patient food assembly line) while his beard cover was below his mouth resting on his chin.

During a concurrent interview with cook 1, he stated sometimes he pulls the beard cover off his mouth to allow him to speak with his coworkers. He also stated the beard cover does not fit his face. He added that he is willing to try other kind of beard covers that fits his face.

During a concurrent interview with Food Service Director (FSD), he stated all staff should wear beard covers appropriately to cover facial hair. He also stated he will explore other beard cover options and provide in-service to staff.

A review of the hospital policy titled "Dress Code" Policy No.FN2-04-002 (revised 3/2017) indicated, "Long facial hair must be covered with a surgical mask and or hood. Mustache and or sideburns must be neatly trimmed. Mustache should not extend below the corners of the mouth; sideburns should not grow beyond earlobe."

A review of the 2017 U.S. Food and Drug Administration Food Code indicated, hair can be both a direct and indirect vehicle of contamination. Food employees may contaminate their hands when they touch their hair. A hair restrain keeps dislodged hair from ending up in the food and may deter employees from touching their hair.
In addition, according to Food Code 2017, Food Employees shall wear hair restrains 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 and unwrapped single service and single use articles.

5. During a tour of the kitchen in the south campus (Hospital B) on November 20, 2019, at 9:45AM, one can opener blade was worn and nicked. The blade was not smooth to the touch due to the nicks/dents on the surface of the blade.

During a concurrent interview with (FSD), he stated the can opener needs a new blade and he will replace it.

According to the 2017 U.S. Food and Drug Administration Food Code, cutting or piercing parts of can openers shall be kept sharp to minimize the creation of metal fragments that can contaminate food when the container is opened. It also indicates food-contact surfaces of equipment shall be smooth, free of breaks, open seams, cracks chips, inclusions, pits, and similar imperfections. Surfaces which have imperfections such as cracks, chips, or pits allow microorganisms to attach and form biofilms (a thin, slimy film of bacteria that adheres to a surface). Once established, these biofilms can release pathogens (disease causing organisms) to food. Biofilms are highly resistant to cleaning and sanitizing efforts.

Based on interview, the facility failed to ensure there was a designated requestor from the facility, who has completed a course offered by or approved by the Organ Procurement Organization (OPO) which was designed by the tissue and eye bank community.

This deficient practice had the potential for facility staff approaching the patient's legal next-of-kin regarding the opportunity to donate tissue and organs without adequate training in order to provide information regarding this endeavor.

Findings:

On November 21, 2019 at 10:15 a.m., during interview with Director of ICU (DICU) regarding Organ Procurement and Tissue Donation, DICU stated she did not know who the designated requestor from the hospital with special training from the OPO.

On November 21, 2019 at 10:20 a.m., during interview with the Executive Director of Risk Management (DRM), DRM stated he did not know who the designated requestor was from the facility who received special training from the OPO, who can approach the patient's legal next-of-kin regarding organ or tissue donation.