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Based on interviews and record reviews, the hospital's Governing Body failed to ensure contracted Registered Dietitian (RD) services were appropriate to meet the needs of the hospital and meet the nutritional needs of the patients. This failure occurred when the contracted Registered Dietitian did not provide the required oversight in the Dietary Department to ensure the nutritional needs of the patients were being met. The contracted RD also did not have the qualifications based on education and experience in acute psychiatric hospital for nutrition care of these specialized patients and this lack of experience was not considered when executing the contract (cross refer A-0621). This failure also occurred when patients at nutrition risk were not identified to be at risk by the dietitian when the nursing screen failed to identify them as such (cross refer A-0395 and A-0621). This failure to ensure the contracted service of the RD met the specialized needs of the patient population resulted in patients who were at nutrition risk not receiving nutrition assessment and appropriate interventions to ensure their nutrition needs were met. This put 118 patients at risk for inadequate or imbalanced nutrition status

Findings:

A review of the Dietary Services Agreement [contract for RD services] dated 2/16/16, stated the "Group (contracted service) shall engage qualified, licensed dietitians ("Dietitians") to provide temporary nutrition services for Hospital's Dietary Department, as needed and requested by Hospital; Group shall require Dietitians to actively participate in Hospital's overall patient care evaluation program and assist Hospital in the performance of utilization review and cost containment functions; ...It is understood that the Hospital has established expectations for the performance of services by Dietitians and has communicated such expectations by way of this agreement. Hospital shall appropriately evaluate all services rendered by Dietitians in relation to the established expectations, and shall take steps to improve any services rendered by the Dietitians that do not meet expectations."

During the course of the survey between 4/2/19 and 4/5/19, deficient practices in the Food and Nutrition Services were noted. During an interview with the Director of Food Service (DFS) on 4/2/19, at 10 a.m., the DFS stated that the hospital's Registered Dietitian (RD) comes into the facility only in the evenings between 4 and 6 pm because she has another full-time job. The DFS stated that the RD comes in on Mondays, Wednesdays and Fridays as needed based on consults received from nursing and physicians and did not perform any other screening of patients to determine if they were at nutrition risk. She further stated that the RD approved the hospitals menus but did not provide any other oversight in the Food Service department to ensure sanitary conditions were being followed or meals service was conducted in such a manner to meet the needs of the patients. The DFS stated that if we needed to speak to the RD we would have to do so over the phone, she could not come into the building because of her other full time job. She was not available to the hospital if there was an urgent need for patient nutrition care.

During a telephone interview with the RD on 4/3/19 at 12 :15 p.m., the RD stated that she has worked at the hospital since July 2018 and worked mainly in the evening. She stated that she only saw patients who had been referred to her by a consult from either a nurse or a physician. The RD further stated that she saw those patients with consult within 72 hours of receiving the consult. When asked if she had a system to determine if there are any patients who are at nutrition risk who do not have a consult ordered, the RD responded that she had no system. The RD stated that she did not perform any chart reviews to determine if there were patients at nutrition risk who were not referred to her through a consult. She stated that she did not screen the patients for nutrition problems and relied on only nursing and the physician consults.

The RD further stated that nursing completes a Nutrition Screen of the patients on admission. Based on that screen, an RD referral would be generated if certain criteria are met such as: recent unexpected weight loss; diagnosis of malnutrition or poor food intake; difficulty with chewing or swallowing that affected meal intake; Gastric Bypass (weight loss surgery); special diet; or, over the age of 62. No other screening is done by the food and nutrition services or the RD. The RD stated that she does not work over 5 hours a week at the hospital and does not provide any oversight in the Food Services to ensure sanitary conditions in the dietary department or to ensure the patients nutrition needs are met during meal preparation and service.

A review of the hospital's organizational chart did not include the position of the RD on the chart.

A review of the Independent Contractor Consultant Dietitian Job Description, dated 7/18/2018 indicated that the consultant RD (the hospital's RD):
-Shall perform nutrition assessment and intervention on required patients/residents as per standards of practice.
-Prioritizes and provides timely and proper nutrition care for all patients/residents
-Assesses, implements and monitors patient's/residents' nutritional status and nutrition progress accurately
-Monitors quality of food service as required per client
-Assists with planning, implementing and evaluating nutrition care policies, staff in-services and education programs as required per client."

A review of the resume for the RD (undated) indicated that the RD became an RD in June 2018. Her work experience did not indicate that she had worked in an acute psychiatric hospital.

During an interview with the Director of Risk Management (RM) on 4/4/19 at 8:50 a.m., she stated that the intent was that the RD reviewed the menus. The RM verified that the quality of the RD service provided by the contracted RD was not effectively evaluated by the hospital or the Governing Body. She further stated that some of the issues identified during this survey regarding the lack of adequate RD involvement in the nutrition care of the patients had been identified during a previous survey by another agency on 2/22/19. The RM stated that they had plans to resolve the concerns but had not implemented any of the plans to date.

During an interview with the Vice President (VP) on 4/4/19, at 4:30 p.m., he stated that he was on the Governing Board. He further stated that he was not aware of the issues regarding lack of RD involvement with patient care and oversight of food service.

Based on observations, staff interviews and document review, the facility failed to ensure its written emergency medical equipment protocol was maintained when 4 out of 4 medical emergency boxes (non-pharmaceutical) were missing supplies for the initial treatment of a medical emergency.

The failure to ensure the availability of adequate emergency supplies had the potential to delay and/or compromise patient care.

Findings:

Units 1 and 3

On 4/2/19 at 11:30 a.m., the Medical Emergency Box and its contents, stored between Units 1 and 3, were reviewed with Nurse Manager 3 (NM 3). The Medical Emergency Box consisted of a locked orange tool box with a list of contents attached to the outside. The list read:

Medical Emergency Box
Blood pressure cuff
Stethoscope/pulse oximeter (a device that measures blood oxygen saturation level and heart rate)
gloves/microshield
Code Blue/Code 100 forms
Pens
Scissors
Nasal cannula and mask
Band-Aids
Alcohol Pads
Gauze
Plastic locks
tape

The box contained all of the listed supplies except a pulse oximeter.

In a concurrent interview with NM 3, she stated, "The pulse oximeter isn't in there."

Unit 2

On 4/3/19 at 1 p.m., the Unit 2 Medical Emergency Box and its contents were reviewed with Registered Nurse 3 (RN 3). Although listed on the exterior of the box, the box did not contain a pulse oximeter. In a concurrent interview, RN 3 acknowledged a pulse oximeter was missing.

Units 3 East and 3 West

The orange Medical Emergency Box of supplies, stored at the nursing station between Units 3 East and 3 West, was reviewed with RN 5 on 4/3/19 at 1:15 p.m. On the exterior of the box was a list of its contents, including "pulse oximeter". In a concurrent observation and interview, RN 5 acknowledged the box did not contain a pulse oximeter.

Units 2 East and 2 West

On 4/3/19 at 2 p.m., the list and contents of the 2nd floor Medical Emergency Box were reviewed with RN 6. The list on the outside of the box included: "microshield" (a lightweight face conforming mask that prevents mouth-to-mouth contact during CPR). RN 6 could not find a microshield in the box. In a concurrent interview, RN 6 acknowledged it was missing.

In a interview with NM 1 on 4/4/19 at 9:35 a.m., NM 1 stated all the items listed on the outside of the medical emergency box, even if handwritten, should be found in the box.

During an interview with the Director of Performance Improvement and Risk Management (RM) on 4/3/19 at 5 p.m., she stated the facility did not have a policy specific to the management of the medical emergency boxes, but a "protocol" existed with a list of required contents.

According to an undated facility protocol titled, "Emergency Medical Equipment", "Emergency medical equipment consists of items that are required to be available in case of a medical emergency. Medical emergencies (identified as Code Blue and Code 100) include cardiac, respiratory, fainting, seizure or other change[s] in condition that adversely affect the health of the patient." The protocol included a list of emergency equipment that was to be brought to the code site; neither a pulse oximeter nor microshield were listed. The protocol also addressed restocking the emergency medication box, but not the medical emergency boxes with first aid supplies.

Despite request, the facility did not provide documented evidence of any oversight or review of the medical emergency box process or contents.

Based on interview and document review, the hospital failed to grant Patient 49 the right to make informed decisions regarding her care by failing to notify her of abnormal laboratory test results concerning sexually transmitted infections.

This failure to inform Patient 49 of her health status compromised her rights to be involved in the plan of care, including the right to request or refuse treatment.

Findings:

On 4/2/19, review of Patient 49's medical record indicated that she was discharged on 8/17/18. Physician G dictated the discharge summary at 11:01 am. Laboratory tests had been received by the off-site lab on 8/15/18, but the final lab results, positive for sexually transmitted infections, were reported to the hospital on 8/17/18 at 5:18 pm.

Patient 49's abnormal lab reports, received by the hospital, were absent any indication in the record that they had been reviewed by the professional staff, or communicated with Patient 49. Patient 49 was readmitted to the hospital one week later.

Review of the medical record of the subsequent admission demonstrated that the abnoraml lab results had not been addressed in the interim and were not mentioned or addressed during Patient 49's second admission.

Review of the hospital's policy "Critical Test Results", dated 8/25/17, demonstrated that it is the hospital's policy to improve effectiveness of communication among caregivers by ensuring prompt and accurate communication of test results deemed "critical" or abnormal to the treating physician for interpretation and any subsequent patient care directions.

In an interview on 4/4/19 at 8:30 am, the Director of Performance Improvement and Risk Management stated that the hospital had no policy requiring physicians to follow up on positive laboratory results that were reported after patient discharge.

Based on interview and record review, the hospital failed to provide personal privacy for 2 patients (Patient 8 and 10) with a sample of size of 54, when:

1. Patient 8's walk-in bathroom curtain was missing, and;
2. Patient 10's shower curtains were missing.

These failures created violations of Patient 8 and 10's rights to respect, dignity, and comfort.

Findings:

1. During an interview on 4/3/19 on 11 a.m., Patient 8 complained her walk-in bathroom curtain was missing. Patient 8 stated, "They [hospital staff] finally got it up today after waiting two weeks." Patient 8 further stated her medications had a side effect of urinary frequency and leakage which made her feel increasingly "uncomfortable" using the bathroom without a privacy curtain.

During an interview on 4/4/19 at 8:15 a.m., Patient 8 stated "They are always having a shortage on curtains here."

During an interview on 4/4/19 at 2 p.m., Environmental Services Manager (ESM) stated he was informed by a housekeeper that the rings of Patient 8's curtain were missing. ESM further stated the housekeeper would have placed the new rings and curtain up in the bathroom after a few hours.

2. During an interview on 4/3/19 at 8 a.m., Patient 10 complained the shower curtains in two separate rooms have been missing within the past two months. Patient 10 stated she did not think she should be without a shower curtain due to the lack of privacy and she did not like taking showers without one.

During an interview on 4/4/19 at 8:15 a.m., Patient 10 stated, "There are not enough shower curtains here."

During an interview on 4/4/19 at 2:30 p.m., Mental Health Technician 1 (MHT 1) stated she did not know that Patient 8 and 10's curtains were missing. MHT 1 stated the staff place the curtains back up when they fall down, but curtains may be missing up to one to two days at a time.

During an interview on 4/4/19 at 9:45 a.m., Nurse Manager 2 (NM 2) stated bathroom and shower curtains were provided for the patients. NM 2 stated, "The curtains pull off easy and put back on easy. We round at least every 15 minutes and sometimes every five minutes to closely monitor our patients so, we would put the curtains back up right away if they were down." NM 2 stated she wasn't sure why the curtains were down, but was glad to see they were back up in Patient 8's bathroom.

A review of the Patient's Rights Handbook, revised May 2014, titled "Rights for Individuals In Mental Health Facilities," indicated on page 20, "Persons with mental illness have the same legal rights and responsibilities that are guaranteed all other persons...the right to dignity, privacy and humane care. You also have the right to treatment services that promote your potential to function independently. Treatment must be provided in ways that are least restrictive to you."

A review of the patient care staff competency, revised 2019, titled "Patient Bathrooms," indicated all shower curtains should be in place and intact. It further indicated staff will maintain the patient's dignity and respect an individual's privacy.

Based on observations, staff interviews and document review, the Acute Psychiatric Hospital (APH) failed to promote care in a safe setting when:

1. An emergency pull cord with a pull knob (ligature risk) was observed in the bathroom of the Adolescent Unit (Unit 3) Seclusion Room (Quiet Room). This failure put patients at an increased risk for patient self-harm or harm to others and;

2. Medical record documentation for Patients 18, 19 and 20 did not reflect essential patient care information was communicated to General Acute Care Hospital Emergency Department (GACH ED) staff prior to patient transfer. This failure had the potential to preclude ED staff from creating a safe care environment for these patients and their caregivers prior to their arrival.

Findings:

1. An initial tour of Unit 3, the Adolescent Unit, was conducted with Registered Nurse 7 (RN 7) on 4/2/19 at 10:40 a.m. An observation was made of the Quiet Room (Room 125). The Quiet Room consisted of an ante-room, a room with a bed and a bathroom. In the bathroom, a functioning nurse call/emergency pull cord was observed on the wall near the toilet. The emergency pull cord consisted of a string (exiting from the wall) freely falling toward the floor (approximately 8 inches in length), with a pull knob. The pull knob consisted of a hard plastic pendant and sharp metal sleeve.

In a concurrent interview, RN 7 explained that the Quiet Room was used in the event there was a need for restraints or seclusion. "It is offered [to patients] and used voluntarily [too]," RN 7 said. RN 7 was asked about patient monitoring (observation) on Unit 3. "It depends on the patient's risk for self harm or suicide," RN 7 stated, as well as "the physician orders." Some patients, as an example, RN 7 continued, required monitoring every 5 minutes or every 15 minutes.

During an interview with RN 6 on 4/3/19 at 2 p.m., RN 6 stated an emergency pull cord in a quiet room bathroom was "not ok."

On 4/4/19 at 9:20 a.m., a second observation of the Quiet Room on the Adolescent Unit was made with Mental Health Technician 2 (MHT 2). In a concurrent interview, MHT 2 stated that a patient was currently assigned to the Quiet Room (Room 125). MHT 2 explained that due to an increase in patient census, the Quiet Room was serving as a regular patient room.
Upon further observation, the emergency pull cord in the Quiet Room bathroom was brought to MHT 2's attention. "I don't know the point of it; no other quiet room has a pull string," MHT 2 stated. MHT 2 was observed handling the pull cord, the plastic pull knob and metal sleeve. "No string is allowed [in the patient care area], or anything that can be tied together" that may pose a ligature risk to patients, MHT 2 said. With further discussion, MHT 2 reflected saying, "I never realized how sharp [the metal sleeve] was..." MHT 2 acknowledged the emergency pull cord and attachments posed a risk to patient safety. "You have to be careful with adolescents; they can be very creative [when it comes to self-injury]", MHT 2 said.

An observation of the Adolescent Unit Quiet Room bathroom was made with Nurse Manager 1 (NM 1) on 4/4/19 at 9:50 a.m. In a concurrent interview, NM 1 acknowledged the nurse call/emergency pull cord created a patient safety concern.

According to the "Patient Possessions/Contraband" policy, revised August 2012, "For health and safety reasons, the following items are not allowed on the unit/inpatient rooms:..."Shoe laces...cords...hard plastic items that upon inspection by staff, are considered to be potentially dangerous".

An undated "Contraband List" was observed posted between Nursing Stations 1 and 3. This list included, "Any strings...sharp objects."

The January 2019 Environmental/Ligature Risk Assessment for "Location: Seclusion Room/Bathroom/Anteroom" was reviewed. There was no mention of the emergency pull cord in the Risk Assessment.



29821

2. In a 9:20 a.m., 4/4/19 interview, Registered Nurse 6 (RN 6) indicated that nursing unit leadership "rarely send staff" with patients who need ED transfers.

During an 8:48 a.m., 4/3/19 interview, a nursing unit supervisor (Sup 1) stated that when a patient requires ED care, the APH will "try to send" a caregiver to accompany but would not create a staffing shortage on the unit in order to do so.

In an 11:07 a.m., 4/5/19 interview, the Director of Nursing (DON) confirmed that patients are sent to the ED without accompanying staff members if APH staffing will not safely allow a caregiver member to leave. To the question of what percentage of time patients go to the ED without an APH escort, the DON indicated, "I don't know how to answer [that question]."

The DON stated that APH staff document pre-transfer telephone reports made to ED staff on "Transfer for Emergency Treatment" forms which are sent to the GACH with patients. The form reflected whether the patient was on a legal hold, admitting diagnosis, and listed documents sent with the patient (including physician order sheet, progress notes and Medication Administration Record among others). When asked during the 11:07 a.m., 4/5/19 interview whether ED staff received information regarding triggers for difficult patient behaviors, the DON stated, "We wouldn't talk about triggers. We wouldn't go into that kind of detail."

2a. Review of Patient 20's 3/23/19 "Initial Psychiatric/Psychological Admission History" indicated he was admitted with psychosis (a loss of contact with reality, usually including false beliefs about what is taking place, who one is, and seeing or hearing things that aren't there) and a desire to commit suicide, He was on an involuntary hold.

"Physician's Order Sheets" reflected the need for staff precautions to prevent elopement, self-harm and suicide, and included orders for the administration of emergency medication administration on 3/23/19 and 3/30/19 to manage behaviors which could not be otherwise controlled.

A 1:48 p.m., 3/28/19 "Psychiatric Progress Note" read, "Continued suicidal ideas and psychotic with auditory hallucinations [hearing things that aren't there]. At risk for self harm, decompensation...." A 1:50 p.m., 3/28/19 mental health technician note reflected, "Depressed mood...Suicidal ideation...Appeared anxious about any sort of mess and spent a lot of time trying to tidy things...." A 9:30 p.m., 3/28/19 "Nursing Progress Note" indicated that earlier in the shift Patient 20 had refused medication ordered to treat his mental illness.

An 11 p.m., 3/28/19 physician order directed that Patient 20 be transferred to an ED for treatment of chest pain. Review of the "Transfer for Emergency Treatment" form timed and dated 10:05 p.m., 3/28/19 reflected a diagnosis of schizophrenia (a mental disorder causing disturbed or unusual thinking and/or emotional instability) and that he was on a hold. There was no documentation on the transfer form or in nursing progress notes that the ED was advised in advance that Patient 20 was on suicide precautions, was an elopement risk, displayed difficult-to-manage behaviors in the past, and interventions used to prevent, reduce or stop these behaviors.

3/29/19 "Nursing Progress Notes" and "Interdisciplinary Notes" did not document Patient 20's condition upon return from the ED.

Review of the APH's 3/28/19 "Daily Staffing Report" reflected that Patient 20's nursing unit was staffed with the minimum two caregivers required on night shift, making the ability to send an escort to the ED with Patient 20 unlikely.

2b. Review of Patient 19's physician orders reflected she was admitted to the APH from an ED on an involuntary hold for treatment of schizophrenia. She was placed on assault precautions. Her 3/22/19 "Psychiatric Evaluation/Admission History" noted, "She was agitated in the Emergency Department and she required restraint and emergency medication...Very angry and irritable..Illogical...Insight and judgment is [sic] poor..."

Patient 19's physician order sheet indicated she required emergency medication for agitation in the APH on 3/22/19, 3/23/19, 3/24/19, 3/27/19, 3/28/19, 3/29/19, three times on 3/30/19, and once for uncontrolled mood swings on 3/27/19.

10:30 a.m., 3/27/19 "Nursing Progress Notes" reflected that Patient 19 "was seen punching on her roommate. She was asked to come to the Quiet Room...."

A 3/27/19 "Psychiatric Progress Note" read, "Received ER [emergency] medication in the morning today due to increased psychotic agitation...getting upset very easily...Thought processes were illogical...Judgment and insight is [sic] poor...."

A 3 a.m., 3/28/19 "Interdisciplinary Notes" entry indicated, "Patient called 911 and requested to be transferred to hospital...MD [Medical Doctor] was notified. Orders were received to transfer patient to ER [Emergency Room] for general physical check up."

Review of Patient 19's "Transfer for Emergency Treatment Form" timed and dated 3 a.m., 3/27/19 [error] reflected that the ED had been informed of her schizophrenia diagnosis and involuntary hold. There was no documentation on the transfer form or in nursing progress notes, however, that the ED was advised in advance that Patient 19 was on assault precautions, had exhibited agitation several times during her hospitalization, and what interventions had been used to prevent, reduce or end her agitation.

A 6:50 a.m., 3/28/19 "Interdisciplinary Note" read, "Pt. [patient] came back from ER. Does not want to go back on the unit. Threw cream at staff, tried to bite staff. Threatened to hurt staff. MD was notified. Order for ER medication was received. Pt. was held down by staff to administer medications. After that she was escorted to Quiet Room...."
During a 9:12 a.m., 4/3/19 interview, Sup 1 stated that Patient 19 "didn't have an escort [to the ED] because we didn't have anyone [staff member] extra that night."

Review of the APH's 1/10 "Emergency Services" policy reflected, "When transferring a patient for emergency care...The "TRANSFER FOR EMERGENCY TREATMENT" form must be filled out completely...In all cases of emergency transfer, the charge nurse is responsible for notifying the receiving facility prior to transfer to that facility to prepare them to receive the patient. Information to be provided by telephone to the receiving facility will include: Patient's name, Birth date, Attending and/or Family Physician, Diagnosis, Description of illness and/or injuries, Allergies, Medications given in last 24 hours...Responsibility for the patient remains with [APH name] during the transfer and until the patient is received by the accepting facility for admission there."





39797


2c. Patient 18 was involuntarily admitted to at the Acute Psychiatric Hospital (APH) in March 2019 with suicidal ideation (SI).

Review of facility forms titled "Involuntary Patient Advisement" indicated the following:

On 3/22/19 at 10:30 p.m., Patient 18 was placed on a 72-hour hold (5150, a legal hold to protect an individual from harm to self or others) due to " ...that as a result of a mental disorder, you are: Dangerous to yourself ...We feel this is true because you report feelings of depression ...You reported that you are afraid that if you do not get help you will kill yourself by either walking in front of a truck, cutting your wrist, or by O/D (overdose). The 72-hour hold began "3/21/19 at 10:30 p.m., and expired on 3/24/19 at 10:30 p.m."

A document titled "Documentation of Emergency Medication Administration" indicated the following:

3/22/19 at 8 p.m., "...Patient was angry and agitated, and assaulted peer by hitting him multiple times to the body and face."
3/23/19 at 5 p.m., "...Patient verbally and physically aggressive, yelling and screaming, hitting and punching the ground with his injured R(right) hand causing more injury and swelling."
3/23/19 at 5:45 p.m., "...Patient continues to be angry, agitated, yelling and screaming. He also threw a chair and broke it in the office area (sic)."

Review of facility forms titled "[APH name], Nursing Progress notes" provided the following information:

"3/23/19 at 10:30 p.m.,..Prior to being sent out, he (Patient 18) became angry in which he picked up a chair and threw it on the ground and breaking it. He was escorted out of the lobby with staff where he went to the ER willingly. While in the ER, we got report that he assaulted staff there and "AWOL'D (absent without official leave). Police got involved and brought him back to the ED and they plan to send him back after being medically cleared.

Review of facility form titled "Interdisciplinary Notes" indicated the following:

"3/23/19 at 10:35 p.m.,"While at ER, he assaulted a security guard, AWOL'd, threw rocks at staff and then returned..,
3/24/19 at 9 p.m.,...Upon returning to the unit sp (status post) AWOL attempt, pt noted to have abnormally dilated pupils...Pt agitated in hallway...attempted to strangle self in wall nook...psychiatrist notified for 1:1 safety (observation)...at 9:30 (p.m.) attempted another strangulation with own pant...9:45 (p.m.) he tied the towels together and attempted to strangle self...at 9:50 (p.m.) pt proceeds to wrap twisted towel around his neck twice and pulls at the ends with hands to tighten...2155... he (patient 18) grabbed staff's pen and attempted to stab staff..."
3/24/19 10:22 p.m. Contraband was found inside the pt's room. It's a brown hard rock unknown substance hidden behind the table..."
3/27/19 6 a.m.,...Agitation escalated to anger threatened staff..."
4/3/49 10:22 p.m.,..Pt got agitated in the hallway, punching the walls. Took a piece /frame from the wall and use as a weapon. Pt is a danger to others and self..."

A review of Patient 18's physician orders dated 3/22/19, 3/23/19, 3/27/19 and 4/3/19 instructed nurses to "Send (Patient 18) to ER" for a right hand evaluation.

A review of facility forms titled "Transfer for Emergency Treatment", confirmed the following documentation:

"3/23/19 at 5:10 p.m., ... Patient Legal Status: involuntary...reason for transfer ... "R hand dislocation r/o (rule out) FX (fracture)." The form failed to include Patient 18's vital signs (blood pressure, temperature, pulse, respiration rate) name of individual contacted at receiving facility, notification of attending doctor, updated status of patient's condition, a physician signature with date and time, a selection of information required post emergency room visit, a received by nurse signature or information, or indicate if ER staff was provided information related to behaviors prior to transfer.

No date, or time...Patient Legal Status: involuntary...reason for transfer...R/O Rt (right) hand fracture." The form failed to include name of receiving facility contact name, updated status of patient's condition, a physician signature with date and time

4/3/19 at 6:35 p.m., Patient Legal Status: voluntary...reason for transfer...Patient has possible fractures to hands d/t (due to) repeated punching walls and floor..." The form failed to include name of receiving facility contact name, selection of information required post emergency room visit, a received by nurse signature or indicate if ER staff was provided information related to behaviors prior to transfer. However, the form's updated status of patient condition expressed,"at 7:40 p.m.., the patient attacked an employee of [GACH] and was evicted off the property by their security team...

A review of a facility form titled "APH observation rounds" failed to provide observations from 7:05 p.m. to 9:25 p.m. per the staff Patient 18 arrived back to the APH after he was "evicted" from the GACH. However, there was not a progress note to provide details on how and when Patient 18 arrived back to the APH.

Based on observations, interviews and record reviews, the hospital failed to identify opportunities for improvement and take action to improve performance in the Food and Nutrition Service Department when the department failed to identify multiple deficient practices observed during the survey as high risk, high volume, patient safety concerns. This failure to identify, collect data and take action to remediate these practice put the 118 patients at continued risk for foodborne illness and a decline in nutritional status. (Cross refer A749, A621, A392)

Findings:

1. During the course of the survey, multiple food safety and sanitation concerns were identified which included:
a. Lack of cleanliness of the shelves, floors, drains and equipment (meat slicer, dish machine racks), as well as lack of maintenance of equipment (a freezer rack, rusty strainers and compromised can opener blade)
b. Dishwasher staff who was not competent with hand hygiene between handling dirty and clean dishes and did not know how to measure the concentration of the sanitizer for the chemical sanitizer in the dish machine.
(Cross refer A-0749)

During an interview with the Director of Risk Management (RM) on 4/4/19 at 8:50 a.m., she indicated that these deficient practices in safe food handling and sanitary practice had not been identified by the Quality Committee or the Director of Food Service for Performance Improvement activities. The performance improvement studies being conducted by the Food and Nutrition Service department were patient satisfaction scores regarding the food, quality control checks appropriate for dietary practices, timeliness of Nutrition Consults and chart audits for dietary consults requirements and process follow through. The chart audits were conducted only on those patients who received Nutrition Consults from either nursing or physicians.

2. During the course of the survey, multiple lapses in coverage of Registered Dietitian duties in the hospital were identified:
a. The RD did not provide oversight in the dietary services to ensure the dietary staff was trained to provide food to meet the dietary needs of the patients
b. The RD approved the hospital menus despite not having a comprehensive nutrition analysis of the menus available
c. The RD failed to ensure menus were followed for patients who required a vegetarian or vegan diet
c. The RD failed to ensure patients who were at nutrition risk were provided a nutrition assessment and appropriate interventions to ensure their nutrition needs were met (cross reference A-0395)
e. The RD failed to provide guidance to the hospital on the disaster food plan to ensure the nutrition needs of the patients would be met during a disaster.
(Cross reference A-0621)

During an interview with the RM on 4/4/19 at 8:50 a.m., she stated that during another organization's survey dated 2/22/19, some of these same lapses had been identified. She further stated that discussions and plans had been discussed but no action had been taken to resolve them. The hospital had not set up a study to determine how to resolve this deficient practice.

During a review of the hospital's Scope of Quality Improvement Activities Plan, dated 2018, it stated "The hospital will monitor its performance by collecting measurements in each of the functional areas listed below [includes Dietary Services]. Processes and outcomes are monitored based on hospital mission, scope of practice and services provided, and those processes that involve risk ....The organization will utilize this information to .....describe process performance or stability ....identify areas for more focused data collection; and sustain improvement."

A review of the hospital's policy titled Dietary Services Department - Purpose and Responsibility, dated 9/3/18, stated' "The department (Dietary Services) will take an active part in quality assurance programs and participate in hospital wide education programs."

Based on observations, interviews and record reviews, the hospital failed to ensure patients who were at nutrition risk received appropriate nutrition care when: one of four patients (patient 43) reviewed for nutrition care who was identified by nursing to be at nutrition risk and was not referred to the Registered Dietitian; one of four patients reviewed for nutrition care who should have been triggered by nursing for nutrition risk was not and therefore not referred to the Registered Dietitian (Patient 21); and, two of four patients reviewed for nutrition care and were at nutrition risk were not consistently monitored by nursing to determine if their food and nutritional supplement intake was sufficient to meet their nutrition needs (Patients 43 and 44).

These failures had the potential to result in nutrition imbalances and inadequacies in three of four patients reviewed for nutrition care.

Findings:

1. a. During a review of the medical record for Patient 43 it was noted the patient was admitted with diagnoses that included B-Cell Lymphoma (a blood cancer). During a review of the Nursing Admission Assessment for Patient 43, dated 3/29/19, the nutrition screening section identified that the patient was at nutrition risk because he was over 62 years old; Patient 43 was 72 years old. According to the directions contained in the Nutrition Screening section, it stated, "Any 'yes' below, refer to Registered Dietitian on Nutrition Services Communication Form". "Over 62 years of age" was one of the items that should have triggered this consult. There was no indication that a Registered Dietitian Consult was communicated.

During a concurrent interview with Nurse Manager 1 (NM 1) on 4/5/19, at 11 a.m., NM 1 stated that the "yes" box next to the instructions to order a Registered Dietitian Consult was not checked, indicating that the consult was not communicated to the dietitian. NM 1 also verified that the nutrition referral was not made and the chart did not contain a Nutrition Assessment by the Registered Dietitian.

Further review of Patient 43's medical record indicated a physician's order for a nutritional supplement three times a day dated 3/30/19, in addition to a regular diet. Nutritional supplements are routinely ordered for patients who are unable to meet their nutrition needs with a regular diet alone.

A review of the medication administration record (MAR) for Patient 43's length of stay indicated that the nurses were initialing that Patient 43 received the nutritional supplement, but there was no documentation if he consumed the supplement or not. During an interview with NM 1 4/5/19 at 11 a.m., she verified that there was no documentation in the medical record of how much of the nutritional supplement Patient 43 consumed during his length of stay.

A review of the "Observation Rounds" documents dated 3/29/19 through 4/4/19 in Patient 43's medical record indicated that out of 19 meals observed, only 8 meal percentage consumed were documented. During the same interview on 4/5/19 at 11 a.m., NM 1 verified that there were many meal percentage documentations missing to indicate how much he was eating. She verified that the meal percentage information was important to determine if Patient 43 was able to maintain or improve his nutritional status.

During an observation of Patient 43 in the nursing unit on 4/5/19 at 11:15 a.m., Patient 43 was thin in his appearance. He was not cooperative with answering question regarding his meal consumption while at the hospital in order to determine if he was able to meet his nutrition needs.

b. During a review of the medical record for Patient 44, it was noted that the patient was admitted to the hospital on 3/29/19 with medical diagnoses which included osteoarthritis (a joint disease) of the left knee and had been previously admitted to the general acute care hospital on 3/22/19 with weakness. A review of Patient 44's medical record noted that a physician order dated 3/30/19 for a nutritional supplement three times a day with meals. Nutritional supplements are routinely ordered for patients who are unable to meet their nutrition needs with a regular diet alone.

A review of the Nutrition Assessment/Consult document dated 4/1/19 indicated the Registered Dietitian (RD) documented Nutrition Goals: 1. PO (oral) intake greater than 75 % of meals, and 2. PO intake greater than 25 % of [nutritional supplement] three times a day.

A review of the "Observation Rounds" documents dated 3/29/19 through 4/4/19 in Patient 44's medical record indicated that out of 20 meals observed, only 8 meal percentage consumed were documented. Also noted on the MAR was documentation that Patient 44 received his nutritional supplement, but there was no documentation that indicated how much he consumed.

During an interview with NM 1 on 4/5/19, at 11;10 a.m., NM 1 verified that there were many meal percentage documentations missing in Patient 44's medical record throughout his length of stay. She was unable to state how the hospital determined if Patient 44 was able to meet his nutrition goals when there was lacking documentation on how much he consumed.

c. During a review of the medical record for Patient 21, it was noted that the patient was admitted to the hospital on 3/31/19 with medical diagnoses including diabetes (elevated blood sugar), under suboptimal control and noncompliance with medication recommended for his diabetes. According to Patient 21's emergency room records dated 3/31/19, Patient 21's diagnosis was hyperglycemia (high blood sugar) and poorly controlled diabetes. The document titled "Diabetic Record/Daily Lab Flow" dated 3/31/19 through 4/5/19 noted blood sugar levels documented 248 - 333 mg/dL (milligrams per deciliter). Normal glucose levels range 70 - 99 mg/dL.

Further review of the medical record noted a physician order for a low carb (carbohydrate) DM (diabetic) diet dated 3/31/19. Also noted was a physician order for double portion (of meals) also dated 3/31/19.

A review of the Nursing Admission Assessment dated 3/31/19, in the Nutrition Screening section of the document, Special Diet was checked "no". Had this nutrition screen correctly indicated that Patient 21 was on a special diet, the form required that a Registered Dietitian referral be made. No dietitian consult or referral was made.

During an interview with NM 1 on 4/3/19 at 3 p.m., she verified that there was no nutrition assessment in Patient 21's medical record and no nursing referral was made to the Registered Dietitian. She further verified that since Patient 21 was on a special diet, a nutrition referral/consult should have been ordered and it was not.

During an interview with Patient 21 on 4/4/19 at 12:15 p.m., he stated, "I try to follow a diabetic diet but I'm trying to find a place to live. My blood sugars before coming here were 200's to 300's." Patient 21 further stated that he would like to speak to a dietitian while he is at the hospital.

Based on observation, interview and record review, the facility failed to ensure active Interdisciplinary Master treatment plans were were reassessed and updated for two of 54 sampled patients (Patient 22 and Patient 23) when:

1. Patient 22 and Patient 23 had no updated Interdisciplinary Master Treatment Plan, and

2. Patient 23 had no alternative treatment plan, no social services progress notes and no Mental Health Technician (MHT) progress notes.

These failures prevented the care team from accurately communicating to each other to ensure the care and treatment of patients were reassessed and updated per facility policy to promote that patients attain their best practicable ability.

Findings:

1a. Patient 22 was admitted to the facility in March of 2019 for suicidal ideation (a desire to commit suicide or harm self) and hearing voices and hallucinations (sensations that appear real but are created by your mind) with a diagnosis of schizoaffective disorder bipolar type (a psychiatric condition that includes hallucinations or delusions, as well as symptoms of a mood disorder).

A concurrent interview and medical record review for Patient 22 on 4/3/19 at approximately 10:00 a.m. was conducted with Social Worker (SW) 2. Patient 22's medical record included an admission Interdisciplinary Master treatment plan dated 3/20/19. No additional treatment plans were noted. SW 2 stated each patient's plan was updated every seven days or sooner. SW 2 concurred there were no additional Interdisciplinary Master treatment plans in the medical record and stated there should have been an updated one for 3/27/19 and one for 4/3/19.

1b. Patient 23 was admitted to the facility the end of March 2019 with a diagnosis of psychosis (a loss of contact with reality, usually including false beliefs about what is taking place, who one is, and seeing or hearing things that aren't there) not due to substance abuse and admitted on a 5150 hold (a 72 hour involuntary psychiatric commitment of individuals who present a danger to themselves or others due to signs of mental illness) due to grave disability (person's mental disorder prevents the person from providing for their own basic life-sustaining needs).

A concurrent interview and medical record review for Patient 23 was conducted on 4/3/19 at approximately 9:30 a.m. with SW 2. Patient 23's medical record included an admission Interdisciplinary Master treatment plan dated 3/26/19. No additional treatment plans were noted. SW 2 stated each patient's plan was updated every seven days or sooner. SW 2 concurred there were no additional Interdisciplinary Master treatment plans in the medical record and there should have been one dated for 4/3/19.

2. During an observation on 4/4/19 at 9 a.m., Mental Health Technician (MHT) 3 was observed negotiating with Patient 23 to take a shower and change clothes. Patient 23 agreed.

A concurrent interview and medical record review for Patient 23 on 4/3/19 at approximately 10:00 a.m. was conducted with SW 2. Patient 23's medical record indicated Patient 23 had refused to go to the following groups:
- Psychoeducation group ("These skills include improving adherence to treatment regimes, managing stressful events and symptom relapses, enhancing social and familial integration and unity, and decreasing the need for hospitalizations") on 3/26/19, 3/28/19 through 3/31/19
- Process Group (Offer the abilities for further exploration of factors leading to hospitalization with multiple perspectives, support encouragement and feedback from other individuals in a safe and confidential environment) on 3/31/19
Additionally, there were no social services or MHT progress notes in the medical record.
SW 2 stated if a patient missed three or more therapy sessions, an alternative plan would be developed with one to one social services meetings with the patients." SW 2 concurred there were no social services notes in the medical record and no MHT notes in the medical record. SW 2 further stated the alternative plan would need to be documented every day.

During an interview with MHT 1 on 4/4/19 at 9:45 a.m., MHT 1 stated the MHTs complete "PIE" charting. (P = Problem, I = Intervention, E = Evaluation). MHT 1 stated she helps train new MHTs and teaches that a patient should be charted on by the MHT at least every shift. MHT 1 further indicated the following should always be charted:
- an altercation with another patient or staff,
- Failure to participate in groups, and
- Any negotiation to get a patient to comply with the treatment plan.

The facility document titled Interdisciplinary Master Treatment Plan indicated information including:
- Nursing update with notes regarding psychotropic medications, physical holds, seclusion, labs, and education
- Social Services update with notes regarding support systems, barriers to discharge, placement post discharge, and group participation
- Psychiatrist Update with notes regarding medication changes, precaution levels, observation levels, changes to current diagnosis and reason patient requires current level of care

During an interview with Director of Performance Improvement and Risk Manager (RM) on 4/3/19 at 2:30 p.m., the RM stated, "...there was not policy on documentation." The RM further stated it is the expectation that the social workers chart on the patient every 4 days with contact and every 7 days with a face to face meeting. Additionally, the RM stated MHTs should chart every shift, especially any unusual occurrences or any intervention from the treatment plan.

The RM further stated "...all patients have an active treatment plan...going to group is part of active treatment... if no group then must have daily contact with a social worker with an alternative treatment plan." She further stated, "..the multidisciplinary plan is initiated within 72 hours of admission and every 7 days it is updated."

Review of the Position Description for Mental Health Technician, revised 4/2018 stipulated "Standards of Performance: Assessment - ...Observe and document changes in patient's appearance, behavior, and ability to work towards treatment plan goals...Interventions - Ensure timely documentation of interventions and ensure interventions are based in the patient's plan of care....Document services rendered in accordance with established criteria."

Review of the facility policy titled Multidisciplinary Treatment Planning dated 1/13/97 and updated 3/2018 stipulated "All patients admitted to [Facility Name] will have an individualized treatment plan. The Multidisciplinary Treatment Plan will be completed within 72 hours of admission. The Multidisciplinary Treatment Plan will be reviewed at least once per week after the initial treatment plan review. The plan will be revised to reflect the patient's needs, strengths, and goals...Treatment Plan/ Modification Update will occur at a minimum of once per week."

Based on observations, staff interviews and document review, the facility failed to ensure nursing staff could demonstrate sufficient competencies related to the location and use of medical emergency equipment and supplies (non-pharmaceutical).

This failure to ensure adequate nursing staff competencies put patients at an increased risk of delayed and/or compromised care.

Findings:

According to an undated facility "Emergency Medical Equipment" protocol, "Emergency medical equipment consists of items that are required to be available in case of a medical emergency. Medical emergencies (identified as Code 100 and Code Blue) include cardiac, respiratory, fainting, seizure or other change in condition that adversely affects the health of the patient...The emergency equipment (protocol non-specific) is located at the nurses station on Units 1/3, 2nd floor and 3rd floor."

The facility provided two separate policies for medical emergencies. A February 2016 policy titled, "Code 100", indicated "a Code 100 is to be initiated...in the event of a medical emergency (such as choking, seizures, change in level of consciousness, etc.), other than a cardiac arrest or respiratory arrest...Registered Nurses (RNs) on staff, as identified on the Nursing Assignment Sheet, are to respond to the location with an emergency kit (policy does not specify if "emergency kit" refers to the medical emergency supply box or emergency medication box) and oxygen." According to the February 2016 facility policy and procedure titled "Code Blue", "a Code Blue is initiated in the event of a cardiac arrest or respiratory arrest, i.e. the patient does not have a pulse and/or is not breathing...RNs on staff, as identified on the Nursing Assignment Sheet, are to respond to the location with an emergency kit (again, non-specific) and AED (automated external defibrillator)...Other nursing staff on the unit will respond to the location of the Code Blue as assigned on the Nursing Assignment Sheet and will bring an oxygen tank with tubing and mask."

Unit 2

A review of the 4/3/19 Unit 2 day shift "Nursing Assignment Sheet" revealed the Charge Nurse's (RN 4's) "Off Unit Assignment" was "Code Blue", meaning RN 4 was assigned to respond to any Code Blue in the facility with the appropriate equipment and supplies.

During a 4/3/19 12:50 p.m. interview with RN 4 on Unit 2, RN 4 was asked to locate the medical emergency box with nursing supplies. RN 4 was observed entering the medication room in search of the box. RN 4 opened up one of the cupboards in the medication room and explained that if staff needed nursing supplies like bandages, those items could be found "here". RN 4 left the medication room and walked around Unit 2's nurses station in search of the medical emergency box. When asked, "Where is the AED?", RN 4 was observed asking the unit clerk, who told her the AED was on Unit 1. RN 4 then walked into the chart room adjacent to the nurses station and incidentally found the orange medical emergency box on a shelf.

RN 3 was interviewed on Unit 2, 4/3/19 at 1 p.m. RN 3 was asked to locate the oxygen cylinder used for medical emergencies. RN 3 was observed going in and out of the medication room then out to the nurses station in search of the oxygen tank. RN 3 eventually discovered the green oxygen cylinder in the chart room. When asked, "Where is the AED?", RN 3 looked around the chart room and nurses station before asking RN 4 where the AED was located. RN 3 volunteered that he was not always assigned to Unit 2 since he "floated" between Units 1, 2 and 3.

In a further interview with RN 3 on 4/3/19 at 1:15 p.m., RN 3 explained he has not had an opportunity to review the contents of the medical emergency box because during "a life-saving code, we are doing CPR."

Unit 3 West

RN 5 was assigned to the "Off Unit Assignment" of Code Blue/Code 100 according to the 3 West 4/3/19 day shift "Nursing Assignment Sheet".

RN 5 was interviewed on 4/3/19 at 1:20 p.m. at the Unit 3 West nurses station in the presence of Nurse Manager 1 (NM 1) and NM 3. RN 5 stated she has not had an opportunity to use or review the contents of the medical emergency box. RN 5 was asked to locate the oxygen cylinder on the unit and demonstrate its use. In a concurrent observation, RN 5 located the oxygen tank in the chart room adjacent to the nurses station. RN 5 was unable to select the correct outlet on the oxygen flow regulator (attached to the top of the cylinder) in a timely manner.

During an interview with NM 1 on 4/4/19 at 9:35 a.m., NM 1 explained that upon hire, staff were oriented to the location of the emergency equipment, however, there was no formal training regarding the Medical Emergency Box and its contents. NM 1 continued saying the nursing staff should be able to locate the emergency equipment and identify supplies right away in the event of a Code Blue/Code 100. NM 1 said she would expect the nurses to have a working knowledge of the "basic" supplies in the medical emergency box. NM 1 acknowledged the difficulty RN 5 displayed in the selection of the oxygen flow outlet when asked to demonstrate use of the oxygen cylinder/regulator.

Unit 2 East

On Unit 2 East, RN 6 was interviewed about emergency equipment and supplies on 4/3/19 at 2 p.m. When asked to locate the microshield (a lightweight face conforming mask that prevents mouth-to-mouth contact during CPR) from the medical emergency box, RN 6 asked, "That's a mask right?"

According to the facility April 2018 Staff Nurse Position Description, a registered nurse must "utilize appropriate interventions in psychiatric and medical emergencies", have a working "knowledge of all code procedures" and must be "able to use medical and nursing equipment and supplies."

Based on observation, interviews, and record reviews, the hospital failed to administer medications in accordance with the physician's orders and/or accepted professional standards of practice for 3 of 54 sampled patients (Patients 11, 13, and 17) when:

1. Patient 11's Advair (medication to treat breathing disorders) was documented as given for 9 doses but only one dose was actually delivered. This failure had the potential to cause an increase in symptoms or worsening of the patients' medical condition;

2. A dose of prednisone (medication for inflammation) for Patient 13 was omitted (not given). This failure had the potential to cause an increase in symptoms or worsening of the patients' medical condition;

3. Patient 17's insulin orders did not provide nurses clear instructions on the amount of insulin to administer and;

4. There were no guidelines for the provision of care related to insulin (a high-risk medication, to treat high blood sugar) administration, monitoring or treatment of the blood sugar (BS) fluctuations. This practice resulted in Patient 17 having two episodes of low BS without documented interventions.

Findings:

1. On 4/2/19 at 1:45 p.m., an inspection of medications in the 3 West Medication Room with the Director of Pharmacy (DOP) identified an Advair Diskus (an inhaler containing a combination of medications for treating breathing disorders) for Patient 11 containing 14 doses. The pharmacy label indicated it was dispensed on 3/26/19 (seven days before survey date). The dose counter (a small window on the inhaler showing the number of doses remaining; count goes down by 1 every time a dose is given correctly) on the Diskus indicated there were 13 doses left, meaning only one dose had been consumed since 3/26/19.

A review of the Patient 11's clinical record with the DOP revealed a physician order, dated 3/26/19, for Advair 250/50 mg 1 puff by mouth twice daily for chronic obstructive pulmonary disease (a group of lung diseases that block airflow and make it difficult to breathe).

A review of the 3/26/19 to 4/2/19 Medication Administration Records (MAR) showed 7 doses were documented as given; at other times, the MAR indicated the patient refused the Advair.

During a follow-up interview on 4/3/19 at 9:40 a.m., the DOP said she was unable to find an alternative Advair Diskus that may have been used for Patient 11.

On 4/3/19 at 11:15 a.m., review of Patient 11's MAR with the DOP showed 2 additional doses of Advair were administered since 4/2/19; a total of 9 doses were documented as given. A concurrent examination of Patient 11's Advair Diskus showed 13 doses remained in the inhaler.

During an interview on 4/3/19 at 9:46 a.m. in the presence of DOP and a pharmacy personnel, Registered Nurse 9 (RN 9) said she gave a dose of Advair to Patient 11 that morning. When asked to demonstrate, RN 9 pulled on the thumb grip to expose the mouthpiece and stated she gave it to the patient like this to self administer. RN 9 did not pull on the lever (to prime the diskus prior to administration) during this demonstration. The pharmacy personnel, taking the Diskus, was observed pulling down on the lever; at the same time, the dose counter went down from 13 to 12. RN 9 confessed she did not pull down on the lever every time she gave it to the patient for self-administration. RN 9 acknowledged it was her responsibility to make sure the medication was given correctly.

With further interview, RN 9 and DOP acknowledged 9 doses of Advair were documented as given, but only one dose was actually delivered.

Additionally, Patient 11's clinical record did not include a physician order for the self-administration of medications.

To date, the manufacturer's Instructions for Use for the Advair Diskus indicated the following instructions:

"Step 1. Hold the DISKUS in your left hand and place the thumb of your right hand in the thumb grip. Push the thumb grip away from you as far as it will go until the mouthpiece shows and snaps into place.

Step 2. Hold the DISKUS in a level, flat position with the mouthpiece towards you. Slide the lever away from the mouthpiece as far as it will go until it clicks. The number on the counter will count down by 1. The DISKUS is now ready to use."

2. During a medication pass observation on 4/3/19 at 8:25 a.m., RN 8 was observed preparing 5 medications for Patient 13. Prednisone was not included in the preparation.

On 4/3/19 at 10:40 a.m., a review of Patient 13's clinical record with DOP revealed a physician order, dated 3/29/19, for a tapering schedule of prednisone: to start with 40 mg (unit of measure) daily for two days, then 30 mg daily for two days, then "20 mg qday [every day] 4/02, 4/03 then stop."

A review of the 4/3/19 MAR showed there was no schedule for prednisone to be given on this day.

During an interview on 4/3/19 at 10:45 a.m., RN 8 said there should have been a dose of 20 mg given today (4/3/19); she said it was not carried over correctly (transcribed) from last night's MAR. RN 8 and DOP acknowledged this error.

The hospital's "Transcription and Audit of Medication Orders" policy and procedures, revised 9/2018, indicated, "During the night shift (23000 -0730), RNs will change out old MARs for new MARs.
a. Compare new MARs to previous MARs ensuring accuracy of the new MAR through verification and if needed correction."



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3. Patient 17 was admitted to the Acute Psychiatric Hospital (APH) on an 5150 (an involuntary 72 hour legal hold) in February 2019 with a diagnosis of schizophrenia (a mental disorder causing disturbed or unusual thinking and/or emotional instability) and diabetes mellitus II (high blood sugar).

A review of a facility form titled [name of contracted services] Patient Report (PR), dated 2/25/19 at 9:16 p.m., indicated Patient 17's blood glucose level was 292. Per the PR, the level was considered "high" based on a desired reference range (RR) (normal range in a healthy individual) of 65-99 mg/dl (milligrams per deciliters, a unit of measure).

A review of a facility form titled [name of contracted services] PR, dated 2/25/19 at 12:18 p.m. indicated Patient 17's Hemoglobin A1c (a blood test to measure average blood glucose levels over a three month period) level was 12.1% (percent). Per the PR, the level was considered "high" based on a desired RR of 4.8 - 5.6 %.

A review of a facility form titled Physician's Order Sheet, dated 3/31/19 at 8 a.m., indicated a physician (MD) order read "Renew [insulin brand name]."

A review of a facility form titled Physician's Order Sheet, dated 3/31/19 at 4 p.m. (eight hours after 8 a.m. order was written) indicated a telephone order from the MD instructed the nurses' as follows:

"Order clarification: Renew [name brand] Insulin = (equal) blood sugar (BS) - (minus)100 ÷ (divided by) 30 = number of [name of insulin] units subcutaneously (under the skin); Do not cover (administer insulin) if BS < 160."

A review of a facility form titled Diabetic Record/Daily Lab flow sheet (DR), dated 2/23/19 - 4/3/19 provided the date and time blood levels were performed, "fingerstick" (method in which blood was retrieved through finger pierced by sterile needle), Name of insulin (manufactured medication used to treat diabetes) administered, blood sugar level, comments related to amount of insulin administered, and the signature and co-signature of the nurses who administered and validated the amount of administered medication. The document indicated the following:

1. On 3/12/19 at 7 a.m., Resident 17's blood sugar level was 159 mg/dl. Per the DR, Resident 17 received 2 units of [insulin brand name].
2. On 3/14/19 at 2 a.m., Resident 17's blood sugar level was 158 mg/dl. Per the DR, Resident 17 received 2 units of [insulin brand name].
2. On 4/2/19 at 6 a.m., Resident 17's blood sugar level was 159 mg/dl. Per the DR, Resident 17 did not receive insulin.

During a concurrent record review and interview with Registered Nurse (RN 13) and the Director of Nursing (DON) on 4/3/19 at 12:30 p.m., RN 13 explained the amount of insulin administered based on the MD insulin order calculation required the nurse to "round up or down" to determine how much insulin was to be administered. The DON, explained to RN 13 and the Department, "You would need to call the doctor for an order. We do not have the authority to round up or down. You will need a doctor's order." Per the DON, the insulin order was not acceptable and the practice of written insulin orders in this manner was discussed during a leadership meeting.

During a concurrent record review and interview with the Nurse Manager (NM 1) on 4/4/19 at approximately 11:30 a.m., NM 1 provided additional documents from Patient 17's health record. The review did not provide evidence of order clarification on how to "round up or down" to determine the amount of insulin to be administered prior to 4/3/19. Per NM 1, "There should be an order clarifying how much insulin to give, no rounding or down permitted (sic)." When NM 1 was asked if Patient 17 required insulin coverage at 159 mg/dl, NM 1 read the insulin order and stated, "do not cover, (sic)."

A review of a facility form titled "Medical Staff Bylaws, Preamble", review date of 5/12/16, stipulated the following:
"...Member Orders 5.4.1 All orders for medication and /or treatment for patients admitted to the facility...Orders must be written clearly and legibly and must be complete..."

A review of a facility form titled "[Facility Name] Administration of Medication", revised date February 2009, stipulated "...Procedure: 1. General Information A. An order from the physician is necessary before a medication can be given...II. Administering Medications A. The Nurse administering medication is responsible for assessing the patient before dispensing any medication. She/he will follow the established protocols for questioning physician's orders if the the order is not appropriate/safe for the patient's condition the the time of medication administration..."




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4. The hospital identified insulin as a high-risk medication. The Institute for Safe Medication Administration (ISMP) defined high-risk medications as "drugs that bear a heightened risk of causing significant patient harm when they are used in error."

On 4/4/19, a review of Patient 17's clinical record reflected the following physician orders to control Patient 17's BS:

- Novolog insulin (medication to lower BS quickly) injection three times daily before meals based on measured BS using a formula with a parameter to hold medication if BS less than 160 mg/dL (units of measure), dated 2/28/19.

- Glargine insulin (medication to keep BS in normal range over a 24-hour period) injection 25 units daily, dated 3/4/19 and;

- Metformin (BS lowering medication) 500 mg twice daily, dated 2/25/19.

A review of the clinical record revealed physician orders did not include when to call the physician if the patient's BS was too low or too high or parameters that defined a low or high BS.

Record review of Patient 17's Diabetic Record Flow Sheet from 2/23/19 to 3/24/19 indicated a total of 83 entries. The BS was out of the desired range of less than 160 mg/dL in 45 out of 83 measurements during a 4-weeks period.

The BS level documented on Diabetic Record Flow Sheet on 3/10/19 at 0600 a.m. and 3/11/19 at 11:30 a.m., indicated low sugar levels of 62 mg/dL and 66 mg/dL respectively. There was no documented evidence of nursing intervention or physician notification in Patient 17's medical record. Additionally, there was no repeat BS level following these measurements.

During an interview on 4/4/19 at 10:29 a.m., Nurse Supervisor 1 (Sup 1) acknowledged there was no physician order or written guidelines for treatment of low BS. Sup 1 was unaware of emergency kit contents for use of reversal medication in the event of emergent need to reverse abnormally low BS.

During an interview on 4/4/19 around 10:42 a.m., Registered Nurse 2 (RN 2) stated she was aware of signs and symptoms of low BS; however, she was "not sure what is considered low per guidelines or policy."

On 4/4/209 at 10:30 a.m., the DOP stated the hospital did not have any guidelines for the treatment of low BS.

The American Diabetic Associations (ADA) 2018 guidelines defined hypoglycemia (low BS) as a critical low BS level less than 70 mg/dL. It recommended rechecking a patient's BS 15 minutes after any episode of severe hypoglycemia or hyperglycemia (high BS) treatment. The ADA also recommended re-evaluation of the treatment regimen with one or more episodes of inadequate BS control in diabetic patients (http://care.diabetesjournals.org/content/42/Supplement_1, accessed 4/9/19).

Based on interview and record review, the hospital failed to ensure the medical records for 5 of 54 sampled patients were complete and/or authenticated by the prescriber according to hospital policy and procedures when:

a., b., and c. Multiple medication orders for Patients 12, 19, and 20 were not authenticated by the prescriber within 24 hours;

d. Patient 2's Nursing Discharge Summary did not include an RN (Registered Nurse) signature or date and time of the signature; and

e. Active medication orders for Patient 12 and Patient 17 were not available for use by direct patient care staff.

This failure prevented other members of the healthcare team from having access to accurate, complete and vital medical information, potentially affecting clinical decision making and ensuring safe, effective care.

Findings:

a. On 4/3/19 at 10 a.m., a review of Patient 12's medical record with the Director Of Pharmacy (DOP) and Registered Nurse 8 (RN 8) revealed nursing staff received a telephone order, on 3/29/19 at 12:20 p.m, for three medication orders: Prilosec (to prevent heart burn), Motrin (medication for pain and inflammation), and Artificial Tears (for dry eyes). There was no prescriber's signature, date, and time as required for this telephone order. RN 8 and DOP said telephone orders were to be authenticated by the prescriber within 24 hours. They acknowledged these medication orders had not been authenticated.

The hospital's 5/2/16 Medical Staff "Rules and Regulations" indicated, "Physicians making...telephone orders shall countersign such orders within 24 hours."



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b. During a concurrent interview and review of Patient 19's medical record at 10:58 a.m. on 4/3/19, a Nursing Unit Supervisor (Sup 1) confirmed that telephone orders taken at 2:40 a.m., 3/30/19 had not been authenticated by a physician within 24 hours.

During a 10:18 a.m., 4/3/19 interview, Sup 1 stated that telephone orders from physicians must be cosigned within 24 hours after being received.

During the 10:58 a.m., 4/3/19 interview and record review, the Director of Clinical Services (DCS) verified that orders cosigned for 3 a.m., 3/28/19 lacked the date and time of authentication.

In a 10:55 a.m., 4/3/19 interview, the DCS added that physician authentication of telephone orders must include signature, date and time of authentication.

Review of the hospital's 2/04 "Medication Ordering, Dispensing and Administration" policy reflected, "Physician must hand write or transmit to Nurse...a telephone or Medication Ordering, Dispensing, and Administration verbal order, reduced to writing by the nurse receiving the order...and countersigned by the Physician originating the order...Physician must include in the order...Date and time of order...."

c. In a 9:40 a.m., 4/4/19 concurrent interview and review of Patient 20's medical record, the DCS indicated that 1:40 a.m., 3/23/19 orders had not been cosigned by a physician.



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d. A review of Patient 2's closed medical record revealed a document titled Nursing Discharge Summary with a discharge date of 4/2/19. The document did not include an RN signature, or date and time of the signature.

A 4/3/19, 2:30 p.m. interview with the Director of Performance Improvement and Risk Managment (RM), she stated, "There is no specific policy for documentation."

In an interview with the Director of Health Information Management on 4/4/19 at 10:15 a.m., she stated it was expected that all documents be signed by the staff, "With a full signature, including first and last name, title, date and time."


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e. During a review of Patient 12's clinical record on 4/3/19 at 8:25 a.m., RN 8 was unable to find the original physician's orders for medications she was administering.

The active medical record was missing the original medication orders beyond the previous two weeks. Review of the clinical records indicated Patient 12 was admitted almost 6 weeks earlier on 2/14/19, and the physician orders were removed from the active chart on 3/28/19.

During an interview on 4/2/19 around 8:35 a.m., RN 8 indicated the paper sheets of active orders were removed from the chart (a paper based medical record binder) to reduce the paper volume. They were sent to medical record office (a central location in the facility where all old records were maintained). The thinned documents were not easily accessible to direct care staff at all hours.

During a review of Patient 17's clinical record on 4/4/19 around 9:05 a.m., the DOP was unable to find the original physician orders for medications prior to 3/19/19 in the active chart. The records indicated Patient 17 was admitted almost 6 weeks ago on 2/22/19, and the chart was thinned on 3/19/19. The active medical record contained only the physician's orders for previous two weeks.

During an interview on 4/5/19 around 8:30 a.m., the Director of Nursing (DON) said, "It's safer to keep the active orders in the chart at all times."

During an interview on 4/5/19 around 1:24 p.m., the Director of Health Information Management (HIM) said certain parts of patient's charts were thinned out to reduce paper burden while the patients were still in the hospital. HIM further stated active orders were not part of the thinning process per hospital policy, and "We need to look into revising the policy to keep the active orders in chart at all times."

The hospital's policy titled, "Thinning of an open/active medical records," dated 6/2018, indicated that certain documentation may be thinned using a two weeks timeline. The policy did not address any timeline for the removal or thinning of active orders.

The 2013 American Society of Health-System Pharmacies (ASHP) Guidelines: Minimum Standard for Pharmacies in Hospitals recommended: "All patient medication orders shall be contained in the patient's medical record."

Based on interviews and document and record reviews, the hospital failed to ensure the provision of pharmaceutical services and care met the needs of patients when:

1. The hospital did not have a mechanism to limit overrides (when an authorized user removes a medication for patient use before the pharmacist reviews the order for appropriateness) from the Med Dispense (automated drug dispensing device) units in the patient care areas throughout the hospital to certain approved medications only. All medications available in the Med Dispense could be removed via the override function (refer to A500);

2. The amount of Med Dispense overrides was excessive. There were 1,257 override transactions by the nursing staff in a 14-day period (refer to A500);

3. Of the 1,257 override transactions, 412 transactions (or approximately 33%) did not have a witness, a requirement by the hospital P&P (refer to A500);

4. A review of the Med Dispense override transactions for four patients (Patient 19, 38, 39, and 42) revealed:

- Seven out of eight override transactions did not have a witness, as required;

- Medications for three of four patients (Patient 19, 38, and 42) were removed via override after the pharmacist had already entered the medication orders in the patient-specific medication profile;

- A clonazepam (a controlled substance medication to treat anxiety/agitation) tablet for Patient 39 was removed via override four times on two days without the medication order being reviewed and verified by the pharmacist; and

- Two clonazepam tablets were removed via override on the same day within 10 minutes apart and were given to Patient 39, which resulted in a medication error (refer to A500); and

5. Patient 17's medication order for Lantus (medication to regulate blood sugar) was incorrectly transcribed (documentation into the pharmacy database) in the electronic medical record for a month (refer to A500);

The cumulative effects of these systemic problems resulted in the hospital's inability to provide pharmaceutical services and care in a safe and effective manner in accordance with the statutory-mandated Conditions of Participation for Pharmaceutical Services.

Based on interviews and record and document reviews, the hospital failed to ensure the safe and effective distribution and administration of medications according to accepted professional standards of practice and hospital policy and procedures (P&P) when:

1a. The hospital did not have a mechanism to limit overrides (when an authorized user removes a medication for patient use before the pharmacist reviews the order for appropriateness) from the Med Dispense (automated drug dispensing device) units in the patient care areas throughout the hospital to certain approved medications only. All medications available in the Med Dispense could be removed via the override function;

1b. The amount of Med Dispense overrides was excessive. There were 1,257 override transactions by the nursing staff in a 14-day period;

1c. Of the 1,257 override transactions, 412 transactions (or approximately 33%) did not have a witness, a requirement by the hospital P&P;

1d. A review of the override transactions for four patients (Patient 19, 38, 39, and 42) revealed:

- Seven out of eight override transactions did not have a witness, as required;

- Medications for three of four patients (Patient 19, 38, and 42) were removed on override after the pharmacist had already entered the medication orders in the patient-specific medication profile;

- A clonazepam (brand name: Klonopin; a controlled substance medication to treat anxiety/agitation) tablet for Patient 39 were removed on override four times on two days without the medication order being reviewed and entered by the pharmacist; and

- Two clonazepam tablets were overridden on the same day within 10 minutes apart and were given to Patient 39, which resulted in a medication error.

These failures resulted an identified medication error, and unsafe and ineffective medication-use process in the hospital.

2. Patient 17's medication order was incorrectly transcribed (documentation into the pharmacy database) in the electronic medical record for a month. This had the potential for medication errors.

Findings:

1. The hospital utilized an automated drug dispensing device (called the Med Dispense) from which nursing staff could retrieve medications for patient administration after the pharmacist reviewed the medication orders for appropriateness. After the pharmacist reviewed, verified, and entered the physician orders into the patient-specific profile, the pharmacy system is interfaced (a program enabling communication between two systems) with the Med Dispense to allow authorized staff to access the medications in the Med Dispense, under the patient's profile, for patient administration. This is called "profiled mode." Bypassing the pharmacist review process is referred to as an "override."

According to the 2019 Guidelines for the Safe Use of Automated Dispensing Cabinets, the Institute for Safe Medication Practices (ISMP), a nationally known nonprofit patient safety organization with recognized national expertise in medication error prevention, indicated, "The use of an ADC [automated dispensing cabinet] in 'PROFILED mode' is considered an important safety feature throughout the healthcare industry as it directs PRACTITIONERS to a patient-specific medication profile and limits access to only medications that have been reviewed and verified by a pharmacist as appropriate for the patient."

In the 2013 ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals by the American Society for Health-System Pharmacist (ASHP), a nationally recognized professional organization that represents pharmacists who serve as patient care providers in acute and ambulatory care settings, it indicated:

"All medication orders shall be prospectively reviewed by a pharmacist and assessed in relation to pertinent patient and clinical information before the first dose is administered or made available in an automated dispensing device, except in emergent situations in which the treatment of the patient would be significantly compromised by the delay that would result from pharmacist review of the order."

The hospital's "Override Medications - Med Dispense" P&P, revised 11/2014, indicated:

"The Joint Commission of Health Care Accreditation (JC) requires that a pharmacist review all physician's orders prior to administration...

During established hours of operation, a pharmacist will review all physicians' orders for medications prior to any dose being administered. When the pharmacy is closed and no pharmacist is available to review new orders, no new medications will be administered to patients. Exceptions to this may occur when a delay in administration might cause harm to the patient. Exceptions included the following:
1. Emergency medications
2. Physician order for "now" doses of medications
3. Pain medications such as Tylenol and ASA [aspirin]
4. Antibiotics

In order to ensure that the patients' five rights [right patient, drug, dose, route, and time] of medication administration... the following process must be followed when administering medications prior to a pharmacist's review of the physician's order:
1. Retrieval of medication from the Med Dispense machine requires the presence of two nurses, one of whom must be a registered nurse..."

On 4/2/19 at 10:25 a.m., a visit to the pharmacy was conducted with the director of pharmacy (DOP) and another pharmacy personnel. DOP said the pharmacy was opened from 6:30 a.m. to 2:30 p.m. on Mondays through Fridays; and from 7 a.m. to 11 a.m. on Saturdays and Sundays. She said, for any orders received after the pharmacy hours, the nursing staff would remove the medications from the Med Dispense through the override function. She said the hospital required two licensed staff members, one as witness (as a safety check), to override the medications. DOP said the nursing staff could override any medications from the Med Dispense; there was no limit to what medication could be overridden.

A 14-day Med Dispense override activity report was requested for review.

On 4/3/19, DOP provided the Med Dispense override transactions report (MDOR) for all seven patient care area units in the hospital. The report was from 3/21/19 to 4/3/19 (14 days), consisting of 144 pages, each page had 9 transactions.

On 4/4/19 at 1:45 p.m., the override transactions for four patients (Patients 19, 38, 39, and 42) were selected for review with DOP and reflected the following:

For Patient 38, the MDOR showed a lorazepam (controlled medication for anxiety/agitation) 1 milligram (mg, unit of measurement) tablet was removed via override on 3/28/19 at 6:33 a.m., with the override reason of "new order." The pharmacy record showed the pharmacist entered the physician's order for lorazepam 1 mg in the patient's profile on 3/27/19 at 7 a.m. (a day prior). In addition, there was no witness for this override transaction.

For Patient 42, the MDOR showed a nursing staff overrode a lorazepam 2 mg tablet on 3/28/19 at 6:36 a.m., with the override reason of "new order." The pharmacy record showed the pharmacist entered the lorazepam 2 mg order in the patient's profile on 3/27/19 at 7 a.m. (a day prior). Again, there was no witness for this "new order" override transaction.

For Patient 19, the MDOR showed a nursing staff overrode a lorazepam 2 mg/ml injection on 3/28/19 at 7:12 a.m., with the override reason of "ER MEDS." There was no witness for this emergency medication override. Additionally, the MDOR showed a nursing staff overrode a tablet of lorazepam 1 mg, on 3/31/19 at 1:21 p.m., with the override reason of "NOT ON PROFILE." There was no witness for this override. The pharmacy record indicated the pharmacist entered the lorazepam 1 mg order in the patient's profile on 3/22/19 at 7 a.m. (10 days prior).

For Patient 39, the MDOR showed the nursing staff overrode clonazepam 1 mg tablet four times, as follows:
*3/31/19 at 11:23 a.m., with witness, override reason "fdn [first dose now]"
*3/31/19 at 3:35 p.m., with no witness, override reason "new"
*4/1/19 at 7:33 a.m., with no witness, override reason "prn [as needed] order"
*4/1/19 at 7:43 a.m., with no witness, override reason "not on profile"

A review of Patient 39's clinical record showed a physician order, on 3/31/19 at 11:20 a.m., for clonazepam 1 mg by mouth twice daily, "first dose now." DOP reviewed her pharmacy system and verified this order had not been reviewed and entered by a pharmacist as of the time of review, at 2:10 p.m. on 4/4/19. DOP said the order should have been reviewed and entered by the pharmacist shortly after it was ordered as the order was made during the pharmacy operational hours.

Thus, the above override transactions for Patient 39 showed 3 out of 4 transactions did not include a witness; medications were overridden repeatedly without review and order entry into the system by a pharmacist; and two clonazepam tablets were retrieved through override within 10 minutes apart on 4/1/19, at 7:33 a.m. and 7:43 a.m.

During the review above, the DOP said she did not know why the overrides did not require a witness. On 4/4/19 at 2:35 p.m. in the presence of DOP, Pharmacist 1 called Med Dispense technical support and learned the device was set to require witness for "first dispense" only, not for subsequent dispenses. The DOP said all overrides should require a witness because medication override meant the order had not been reviewed and profiled by a pharmacist.

During an interview on 4/4/19 at 2:55 p.m., DOP acknowledged: seven out of eight override transactions had no witness as required by the hospital P&P although they were for new orders or first orders; medications for Patient 19, 38, and 42 were being removed on override by the nursing staff after the orders had already been entered by the pharmacist; clonazepam for Patient 39 was overridden 4 times on two days without the pharmacist review and entry into the patient's profile; and two clonazepam tablets for patient 39 were retrieved on override within 10 minutes on 4/1/19.

During a follow-up interview on 4/4/19 at 4:50 p.m., DOP said her investigation revealed the nursing staff gave an extra dose of clonazepam 1 mg tablet to Patient 39 on the morning of 4/1/19. She stated it was a medication error, and the staff filed an incident report on that day.

On 4/5/19, a review of the said incident report indicated, "...The patient [Patient 39] was given his morning dose of Klonopin at 0730. The patient continued to be highly agitated and the RN inadvertently [accidentally] gave an additional dose of Klonopin. Investigation showed miscommunication between the licensed staff on the unit was the cause."

On 4/5/19, further review of the MDOR showed a total of 1,257 override transactions during this 14-day period from 3/21/19 to 4/3/19. Of these 1,257 override transactions, 412 did not have a witness, as required by the hospital P&P. Many of the unwitnessed overrides had the override reason of "new order", "new order 1st now", "not on profile", and "first dose now" or "fdn."

The review also showed all types of medications such as multivitamins, escitalopram (anti-depressant), sertraline (anti-depressant), losartan (blood pressure medication), thiamine (a vitamin supplement), fexofenadine (for seasonal allergies), famotidine (to prevent heartburn), simethicone (for gas/bloating), etc., were removed by override, not just those indicated by the hospital P&P as mentioned above.

During an interview with the Director of Nursing (DON) and DOP on 4/5/19 at 8:35 a.m., they said two nurses were required to override medications as a double check system. DOP said the Med Dispense currently could not be configured to limit override to certain approved medications only; therefore, nurses could override any medications in it. Both acknowledged the overrides had been excessive and posed an increased risk of medication errors. The DON said, "We will look into a new system. We need to decrease the risk of misappropriation of meds."

During another interview on 4/5/19 at 1 p.m., DOP said her quality improvement activities included reviewing eight days' worth of Med Dispense overrides per month. Her review, since August of 2018, had identified "inappropriate overrides," which had been reported to the hospital Pharmacy and Therapeutics Committee on a quarterly basis. She acknowledged the number of overrides was excessive and posed an increased risk of inappropriate use and/or medication errors for patients. During this interview, DOP acknowledged there were approximately 1,000 Med Dispense overrides during a 14-day period (as indicated above), and 412 of them did not have a witness. She also said the hospital currently did not have a list of approved overrideable medications.

In the 2010 ASHP Guidelines on the Safe Use of Automated Dispensing Devices, it indicated, "Clearly stated organizational policies and criteria for system overrides should be developed that limit access to medications before orders have been reviewed and approved by a pharmacist. Override access to medications should be limited to cases in which the drug product has been approved by a multidisciplinary committee of physicians, pharmacists, and nurses as having a clinically urgent need for the medication that outweighs the potential risk of medication error."

The ISMP's 2019 Guidelines for the Safe Use of Automated Dispensing Cabinets indicated, "Optimize the use of ADCs in a PROFILED mode that allows medication selection after orders have been reviewed and verified by a pharmacist... Review and approve all medications designated for OVERRIDE, clinical locations where medications can be removed on OVERRIDE, PRACTITIONER types who can remove medications on OVERRIDE, and associated policies through the Pharmacy and Therapeutics (P&T) Committee..."



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2. During a record review on 4/4/19 around 09:05 a.m., the Medication Administration Records (MAR) for Patient 17 was noted to have an order for insulin glargine (known as Lantus, medication to regulate the blood sugar), and the dose was hand-written by the nursing staff on daily basis for the past month, from 3/4/19 to 4/4/19.

During an interview on 4/4/19 around 10:00 a.m., the Director of Pharmacy (DOP) stated the printed MAR reflected the order entry by a pharmacist based on the physician order. She stated the pharmacist missed entering the dose in the electronic record. The error was not communicated to pharmacy by the nursing staff after nightly MAR checks, and they continued hand writing the dose in the daily printed MARs.

Hospital policy number 1701.11 titled "Pharmacist Review of Orders," updated on 2/20/09, indicated all medication orders shall be reviewed by a pharmacist prior to dispensing and administering the medication for accuracy.

Hospital's policy on "Transcription and Audit of Medication Orders," updated on 9/2018, indicated licensed nurses will audit the transcription of all medication orders in the MAR and validate the accuracy. The night shift nurse will "Compare new MAR to the previous MAR ensuring accuracy through verification and if needed correction."

Based on observation, interview, and document review, the hospital failed to ensure a multi-dose vial of tuberculin (an agent indicated to aid diagnosis of tuberculosis infection) was dated incorrectly after opened to ensure it would not be given beyond its use date; and a Spiriva Handihaler (a device to deliver a Spiriva capsule via inhalation; to treat breathing disorders) was labeled with a patient's name. This had the potential for mix-ups with other patients' Spiriva Handihalers.

Findings:

a. On 4/2/19 at 2:20 p.m., an inspection of medications in the 3West Medication Room with the director of pharmacy (DOP) identified an unlabeled Spiriva Handihaler in a medication drawer labeled for Patient 11. DOP said pharmacy would normally send the Spiriva Handihaler with an attached pharmacy label, and the nursing staff was to affix the label on the Handihaler when they opened the packaging upon first use. She said the Handihaler should have been labeled.

The hospital's "Administration of Medication" policy and procedures, revised 9/2016, indicated, "Medications will be administered from: 1. Properly labeled unit dose containers... Medication is never given from an unlabeled container..."

b. During a medication inspection in the 3East Medication Room in the presence of DOP on 4/2/19 at 2:35 p.m., an opened multi-dose vial of tuberculin was identified in the refrigerator. It was labeled as opened on 3/20/19 and had an expiration date of 4/26/19 (36 days). The DOP said opened multi-dose vials were good for only 28 days; it should have been dated with an expiration date of 4/16/19 (not 4/26/19).

The manufacturer's label on the tuberculin vial indicated to discard the vial in use after 30 days.

Based on observations, interviews and record reviews, the hospital failed to ensure the Condition of Participation, CFR 482.28 Food and Dietetic Services was met by:

1. Failing to have a Director of Food Service who was effective at managing the daily operation of the department (cross refer A-620)
2. Failing to ensure the Registered Dietitian was qualified on the basis of education and experience to provide for the nutritional needs of the patients (Cross refer A-0621).
3. Failing to have an effective quality assurance and performance improvement plan for the food and nutrition services (Cross refer A-0283)
4. Failing to ensure sanitary conditions in the dietary service and nursing station panties. (Cross refer A-0749)

The cumulative effects of these systemic problems resulted in the failure of the hospital to deliver food and Nutrition Services in a safe and effective manner in compliance with the Condition of Participation for Food and Dietetic Services and had the potential to result in food borne illness, nutrition inadequacies and imbalances in a patient population of 118.

Based on observations, interviews and record reviews, the Director of Food Service (DFS) was not effective at safely managing the daily operations of the Food and Nutrition Service when:
1. Food safety and sanitation deficient practices were observed in the dietary services (Cross refer A-0749)
2. Vegetarian menus were not used for patients on vegetarian diets
3. The department's performance improvement plan failed to identify opportunities for improvement and take action to improve performance in the Food and Nutrition Service Department when the department failed to identify multiple deficient practices observed during the survey as high risk, high volume, patient safety concerns (Cross refer A-0283).

These failures had the potential to result in food borne illness, inadequate or imbalance nutrition for the vegetarian patients and a failure to remedy high risk, high volume deficient practices for 118 patients.

Findings:

1. During the course of the survey multiple food safety and sanitary deficient practices were observed which included:
a. Lack of cleanliness of the shelves, floors, drains and equipment (meat slicer, dish machine racks), as well as lack of maintenance of equipment (a freezer rack, rusty strainers and compromised can opener blade) (cross refer A-0749)

b. Dishwasher staff (DA) who was not competent with hand hygiene between handling dirty and clean dishes and did not know how to measure the concentration of the sanitizer for the chemical sanitizer in the dish machine (cross refer A-0749). During an interview with DFS on 4/3/19 at 9:15 a.m. she stated that changing gloves between handling dirty and clean dishes was sufficient. According to the 2017 Food Code, hand washing between tasks is a critical factor in reducing pathogens that can be transmitted from environmental sources (FDA Food Code 2017). The DFS also stated that DA was per diem employee which is why she did not know how to check the sanitizer concentration. DFS could not explain how she rated DA as "commendable/acts as a resource" when DA did not know how to check the sanitizer concentration in the dish machine.

c. The only handwashing sink in the department delivered water at 123 to 124 degrees Fahrenheit which caused staff to perform inadequate hand hygiene due to the excessive temperature of the water. During multiple observation in the kitchen between 4/2/19 and 4/4/19, the handwashing sink water temperature was so hot, it was difficult to keep hands under the running water long enough for effective hand washing. It was noted that the floor pedal for cold water was not functioning which caused only hot water to be dispensed. During an interview with Cook 1 on 4/3/19 at 9:50 a.m., Cook 1 stated she did not know how to wash her hands effectively with the water being so hot. During a concurrent interview with the DFS, she stated that she had not reported the high water temperature problem to Plant Operations for repair. According to the 2017 Food Code, rinsing hand before soap and thoroughly rinsing hands after using soap shall be done in clean warm running water.

2. During a review of the Nursing Units diet lists dated 4/3/19, four patients were noted to have diet orders which included a vegetarian diet. During a review of the hospital menus and concurrent interview with the DFS on 4/3/19 at 9:30 a.m. the DFS stated although the menus system that the hospital uses had vegetarian menus available to use, the cooks do not use those menus. She stated that instead of using the vegetarian menus, the cooks made a vegetarian substitute for animal product on the menu. She further stated that the cooks determined what that substitute will be. The DFS could not explain why they chose not to use the vegetarian menu that were part of the menu system that the hospital used. During an interview with Cook 1 on 4/3/19 at 10 a.m., Cook 1 stated that she tried to make an appropriate substitute for patients on a vegetarian diet at each meal. A review of the hospital's policy titled Dietary Services - Care of Patients, dated 9/3/18, it stated "Dietary Service Staff utilize menus approved by the Registered Dietitian ...The menus is planned with consideration for the patients cultural background, religious background and food habits." The policy further stated, "The Registered Dietitian specifies what items need to be omitted or substituted on modified diets."

3. During the course of the survey, multiple food safety and sanitation concerns were identified which included:
a. Lack of cleanliness of the shelves, floors, drains and equipment (meat slicer, dish machine racks), as well as lack of maintenance of equipment (a freezer rack, rusty strainers and compromised can opener blade)
b. Dishwasher staff who was not competent with hand hygiene between handling dirty and clean dishes and did not know how to measure the concentration of the sanitizer for the chemical sanitizer in the dish machine.
c. Nursing station pantries where food was stored on the floor or with other supplies not appropriate for food storage and food service equipment was not properly washed and sanitized.
(Cross refer A-0749)

During an interview with the RM on 4/4/19 at 8:50 a.m., she stated that during another organization's survey dated 2/22/19, some of these same lapses had been identified. She further stated that discussions and plans had been discussed but no action had been taken to resolve them. The hospital had not set up a study to determine how to resolve this deficient practice.

During a review of the hospital's Scope of Quality Improvement Activities Plan, dated 2018, it stated "The hospital will monitor its performance by collecting measurements in each of the functional areas listed below [includes Dietary Services]. Processes and outcomes are monitored based on hospital mission, scope of practice and services provided, and those processes that involve risk ....The organization will utilize this information to .....describe process performance or stability ....identify areas for more focused data collection; and sustain improvement."

Based on observation, interviews and record reviews, the hospital failed to ensure the Registered Dietitian (RD) was qualified on the basis of education and experience in working in a behavioral health hospital as the sole RD in the hospital. This failure was evident when:
1. The RD did not provide oversight in the dietary services to ensure the dietary staff was trained to provide the service to meet the nutrition needs of the patients
2. The RD approved the hospital menus despite not having a comprehensive nutrition analysis of the menus available
3. The RD failed to ensure menus were followed for patients who required a vegetarian or vegan diet
4. The RD failed to ensure patients who were at nutrition risk were provided a nutrition assessment and appropriate interventions to ensure their nutrition needs were met (cross reference A-0395)
5. The RD failed to provide guidance to the hospital on the disaster food plan to ensure the nutrition needs of the patients would be met during a disaster.

These failures had the potential to result in the nutrition needs of the patient, including nutrition imbalances and inadequacies, to not be met in an inpatient population of 118 patients.

Findings:

1. During an interview with the Director of Food Service (DFS) on 4/2/19, at 10 a.m., the DFS stated that the hospital's Registered Dietitian (RD) comes into the facility only in the evenings between 4 and 6 pm because she has another full-time job. The DFS stated that the RD comes in on Mondays, Wednesdays and Fridays as needed based on consults received from nursing and physicians. She further stated that the RD approved the hospitals menus but did not provide any other oversight in the Food Service department. The DFS stated that if we needed to speak to the RD we would have to do so over the phone, she could not come into the building because of her other full time job.

During a telephone interview with the RD on 4/3/19 at 12 :15 p.m., the RD stated that she has worked at the hospital since July 2018 and works mainly in the evening. She stated that she only sees patients who have been referred to her by a consult from either a nurse or a physician. The RD further stated that she sees those patients with consult within 72 hours of receiving the consult. When asked if she had a system to determine if there are any patients who are at nutrition risk who do not have a consult ordered, the RD responded that she had no system. She stated that she did not screen the patients for nutrition problems and relied on only nursing and the physician consults.


The RD further stated that nursing does a Nutrition Screen of the patients on admission. Based on that screen, an RD referral would be generated if certain criteria are met. No other screening is done by the food and nutrition services or the RD. The RD stated that she does not work over 5 hours a week at the hospital.

A review of the hospital's policy titled Assessment of Patients - Care of Patients, dated 9/18, indicated Dietitian consults include but are not limited to: Diabetic diets, Renal diets (diets for patients with kidney disease), chronic poor nutritional state ...." A review of the hospital's policy titled Dietary Services Department - Purpose and Responsibility, date 9/3/18, stated "Therapeutic diets are provided as prescribed by the attending physician and are planned, prepared and served in consultation with the Dietitian."

2. During an interview and concurrent record review with the Director of Food Service (DFS) on 4/5/19 at 10 a.m., the nutrition analysis of the menus was reviewed. The nutrition analysis, dated Winter/Spring 2019, showed a nutritional breakdown of the Regular/No Added Salt diet only. When asked about other diets and their nutritional analysis, the DFS stated that there was no other nutrition analysis. She verified that the only nutrition analysis was for the regular and no added salt diets. The other therapeutic diet types for the patients were not analyzed.

During a telephone interview with the RD on 4/3/19 at 12:15 p.m., the RD stated that she does not provide any oversight in the kitchen in terms of sanitation or in-servicing dietary staff. The RD stated that she looked at the patient menus and signed them. But she was unable to say how she approved the menus without a nutrition analysis of the menus.

A review of the diet lists for patients currently in the hospital during the survey included No Concentrated Sweet (Diabetic), Vegetarian, and soft diets. There was no nutrition analysis of these diets.

3. A review of the diet lists for the inpatient dated 4/3/19, indicated that there were 4 patients on a vegetarian diet. During an interview with the DFS on 4/4/19 at 10 a.m., she stated that the hospital does not have vegetarian menus. She further stated that the cooks substitute a vegetarian entrée for those patients with an order for vegetarian. There no menu and no nutrition analysis for the four patients on a vegetarian diet to ensure their nutrition needs were met when the cooks made substitutions and did not get approval from the RD.

A review of the hospital's policy titled Dietary Services Department - Purpose and Responsibility, date 9/3/18, stated "Therapeutic diets are provided as prescribed by the attending physician and are planned, prepared and served in consultation with the Dietitian."

A review of the hospital's policy titled Dietary Services - Care of Patients, dated 9/3/18, it stated "Dietary Service Staff utilize menus approved by the Registered Dietitian ...The menus is planned with consideration for the patient's cultural background, religious background and food habits." The policy further stated, "The Registered Dietitian specifies what items need to be omitted or substituted on modified diets."

4. During a review of the medical record for Patient 43 it was noted the patient was admitted with diagnoses that included B-Cell Lymphoma (a blood cancer). During a review of the Nursing Admission Assessment for Patient 43, dated 3/29/19, the nutrition screening section identified that the patient was at nutrition risk because he was over 62 years old; Patient 43 was 72 years old. According to the directions contained in the Nutrition Screening section, it stated, "Any 'yes' below, refer to Registered Dietitian on Nutrition Services Communication Form". "Over 62 years of age" was one of the items that should have triggered this consult. There was no indication that a Registered Dietitian Consult was communicated.

During an interview with Nurse Manager 1 (NM 1) on 4/5/19, at 11 a.m., NM 1 stated that the "yes" box next to the instructions to order a Registered Dietitian Consult was not checked, so it appeared that the consult was not communicated to the dietitian. NM 1 also verified that the chart did not contain a Nutrition Assessment by the Registered Dietitian.

During a review of the medical record for Patient 21, it was noted that the patient was admitted to the hospital on 3/31/19 with medical diagnoses including diabetes (elevated blood sugar), under suboptimal control and noncompliance with medication recommended for his diabetes. According to Patient 21's emergency room records dated 3/31/19, Patient 21's diagnosis was hyperglycemia (high blood sugar) and poorly controlled diabetes. The document titled "Diabetic Record/Daily Lab Flow" dated 3/31/19 through 4/5/19 noted blood sugar levels documented 248 - 333 mg/dL (milligrams per deciliter). Normal glucose levels range 70 - 99 mg/dL.

Further review of the medical record noted a physician order for a low carb (carbohydrate) DM (diabetic) diet dated 3/31/19. Also noted was a physician order for double portion (of meals) also dated 3/31/19.

A review of the Nursing Admission Assessment dated 3/31/19, in the Nutrition Screening section of the document, Special Diet was checked "no". Had this nutrition screen correctly indicated that Patient 21 was on a special diet, the form required that a Registered Dietitian referral be made. No dietitian consult or referral was made.

During an interview with NM 1 on 4/3/19 at 3 p.m., she verified that there was no nutrition assessment in Patient 21's medical record and no nursing referral was made to the Registered Dietitian.

During an interview with Patient 21 on 4/4/19 at 12:15 p.m., he stated, "I try to follow a diabetic diet but I'm trying to find a place to live. My blood sugars before coming here were 200's to 300's." Patient 21 further stated that he would like to speak to a dietitian while he is at the hospital.

5. A review of the hospital's Disaster Plan Menu (revised 9/18) indicated it was the policy that "The Disaster Menu is planned so that the immediate food service will not be interrupted if there is a loss of water, gas, and electricity and minimum staff services available. The policy did not include a menu to prepare for patient during times with no utilities.

During an interview with the Director of Food Service (DFS) on 4/4/19 at 5 p.m., she stated that the disaster food plan when there were no utilities was to use emergency food rations. These rations consisted of bars that contained 400 calories and 3 grams of protein each per the manufacturer's product information. There was no direction to the staff that indicated how many bars each patient and staff required per day. According to the DFS, the bars and some stored water was all the emergency food supplies that the hospital maintained. The DFS further stated that the RD did not review the plan to ensure that the plan would meet the nutrition needs of the patients and staff during a disaster.

A review of the hospital's "Emergency Food Supply" attachment to the disaster food plan (undated) indicated that 1 case of food rations fed 10 people for 4 days. A review of the manufacturer's information indicated each case of food rations contained 10 packages and each package contained 9 servings of 400 calories and 3 grams of protein. Therefore, each case contained enough for each person to have 2.25 bars a day for 4 days or 900 calories and about 7 grams of protein a day.

A review of the regular diet nutrition analysis indicated the diet provided an average of 2340 calories and 100 grams of protein a day. The disaster plan to feed patients and staff during a disaster with no utilities is to provide 38 percent of these calories and 7 percent of these grams of protein.

The surveyors attempted to interview the RD regarding her approval of the disaster food plan and the problems found as listed above. The hospital RD did not make herself available for further interview despite multiple attempts to schedule a telephone interview.

A review of the hospital's organizational chart did not include the position of the RD on the chart.

A review of the Independent Contractor Consultant Dietitian Job Description, dated 7/18/2018 indicated that the consultant RD (the hospital's RD):
-Shall perform nutrition assessment and intervention on required patients/residents as per standards of practice.
-Prioritizes and provides timely and proper nutrition care for all patients/residents
-Assesses, implements and monitors patient's/residents' nutritional status and nutrition progress accurately
-Monitors quality of food service as required per client
-Assists with planning, implementing and evaluating nutrition care policies, staff in-services and education programs as required per client."

A review of the resume for the RD (undated) indicated that the RD became an RD in June 2018. Her work experience did not indicate that she had worked in an acute psychiatric hospital.

During an interview with the Director of Risk Management (RM) on 4/4/19 at 8:50 a.m., she stated that the intent was that the RD reviews the menus. She further stated that some of the issues identified during this survey had been identified during a previous survey by another agency on 2/22/19. The RM stated that they had plans to resolve the concerns but had not implemented any of the plans to date.

During an interview with the Vice President (VP) on 4/4/19, at 4:30 p.m., he stated that he was not aware of the issues regarding lack of RD involvement with patient care and oversight of food service.

Based on observation, interviews and record reviews, the hospitals failed to ensure one Dietary Aid (DA) was competent when:
1. DA was independently washing dishes with the dish machine and did not know how to check the sanitizer concentration in the dishmachine to ensure the dishes and equipment were effectively sanitized; and
2. DA did not wash hands between handling soiled dishes and clean dishes and changing gloves. In addition, the Director of Food Service (DFS) did not know that hand washing was required between changing gloves.

This failure in competency had the potential to result in cross contamination of clean dishes and equipment which potentially results in food borne illness in a patient population of 118 patients.

Findings:

1. "Effective sanitization procedures destroy organisms of public health importance that may be present on wiping cloths, food equipment, or utensils after cleaning, or which have been introduced into the rinse solution", FDA Food Code 2017. The Food Code specifies that a chlorine solution shall have a minimum temperature based on the concentration and pH of the solution.

During an observation and interview on 4/3/19 at 8:59 a.m., when asked about checking the sanitizer concentration on the low temperature dishwashing machine, Diet Aid (DA) stated that she did not know how to check the sanitizing solution for the dish machine. DA was the only staff washing dishes during the observation. DA further stated that washing dishes was her usual duty when she worked at the hospital.

During a concurrent interview with the Director of Food Service (DFS), she stated that DA was a per diem employee who does not work at the hospital very often. When asked if DA should be competent in sanitation requirements despite her per diem status, DFS stated yes.

According to the manufacturer's guidance labeled on the dish machine, the concentration of the sanitizer in the rinse cycle should be 50 parts per million (ppm).

During a review of the hospital's policies and procedures titled Infection Control, dated 09/2018, it stated that "Low temperature machine - 140 degree F (Fahrenheit) for wash and rinse with a chemical solution 55 ppm".

2. According to the FDA Food Code 2017, "food employees shall clean their hands and exposed portions of their arms, immediately before engaging in food preparation including working with exposed food, clean equipment and utensils ... and after handling soiled equipment or utensils". Hand washing between a glove change is important because "it is a critical factor in reducing fecal-oral pathogens that can be transmitted from hands to RTE (ready to eat) food as well as other pathogens that can be transmitted from environmental sources" (FDA Food Code 2017).

During an observation and interview with Dietary Aid (DA) on 4/3/19 at 8:59 a.m., DA was observed handling dirty dishes. She then removed her gloves and put on a new pair to handle clean dishes. She did not wash her hands between the glove change. DA stated that she was trained to change her gloves between dirty and clean dish handling.

During an interview on 4/3/19 at 8:59 a.m., the DFS stated that its ok to just change gloves when going from handling dirty to handling clean dishes. She stated you can either wash hands or change gloves.

During a review of the facilities policies and procedures titled Food Preparation and Service (Infection Control), dated 09/2018, it states that "hands must be washed thoroughly between contact with unclean and clean dishes, flatware, utensils or other wares". Changing gloves was not sufficient since hands and gloves can be recontaminted when removing dirty gloves.

During a review of the facilities policies and procedures titled Cross Contamination Prevention in the Dish Room, dated 09/2018, it states that "The dish room worker will wash hands prior to receiving clean dishes using the hand washing technique".

A review of the Dietary Services Orientation Checklist for DA dated 11/1/18 indicated a rating of "improvement needed/minimal experience" for equipment use, cleaning and safety specific to the dish machine. A re-evaluation of DA; competency on the same document dated 1/24/18, indicated the DFS rated DA as "commendable/acts as a resource." There was no specific category on the competency form for hand hygiene.

Based on interview and record review, the hospital did not ensure two physicians were on the utilization review committee.

This failure had the potential to cause poor quality patient care and inappropriate patient services.

Findings:

During an interview on 4/2/19 at 1:30 p.m., the Utilization Review Manager (URM) stated their Medical Director (Physician E) was a member of the utilization review committee.

During an interview on 4/4/19 at 10:05 a.m., the URM stated physicians were involved in the peer review process, but Physician E was the only physician on the utilization review committee.

A review of the 2019 Utilization Management Committee Members list, indicated Physician E was the only physician on the utilization review committee.

Based on observation, interview and record review, the facility failed to ensure a system was in place for identifying, investigating, and controlling infections and communicable diseases in accordance with internal policies and procedures, as well as nationally recognized infection control guidelines and regulations when:

1. 31 of 31 personnel files (including 11 nurses, 4 Mental Health Technicians, 9 Social Workers/ Therapists, 3 Dietary personnel, 3 Utilization Review/ Office personnel and 1 housekeeper), 6 of 13 physician files, and two contract files for radiology and laboratory personnel failed to have evidence of immunity or immunization status (see A0749, 1),

2. One Registered Nurse did not have evidence of the yearly required PPD (purified protein derivative, a test that helps diagnose tuberculosis) for 5 years (see A0749, 2), and

3. The hospital failed to develop a system for identifying and controlling potential infections resulting from unsanitary conditions in the Food and Nutrition Services department and nursing station nourishment (food pantry areas in the nurses stations of the hospital) areas which had the potential to result in food borne infections for 118 patients (see A0749, 3), and
4. Infection control practices were not followed during the medication pass for two patients (Patients 12 and 51) (see A0749, 4).

These failures in the hospital's ability to ensure the provision of quality health care in a safe and sanitary environment had the potential to endanger a vulnerable population from the spread of infection borne illnesses.

The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the Condition of Participation: Infection Control.

Based on observation, interview and record review, the facility failed to ensure a system was in place for identifying, investigating, and controlling infections and communicable diseases in accordance with internal policies and procedures, as well as nationally recognized infection control guidelines and regulations when:

1. 31 of 31 personnel files (including 11 nurses, 4 Mental Health Technicians, 9 Social Workers/ Therapists, 3 Dietary personnel, 3 Utilization Review/ Office personnel and 1 housekeeper), 6 of 13 physician files, and two contract files for radiology and laboratory personnel failed to have evidence of immunity or immunization status,

2. One Registered Nurse (RN), RN -- did not have evidence of the yearly required PPD (purified protein derivative, a test that helps diagnose tuberculosis) for 5 years, and

3. The facility failed to develop a system for identifying and controlling potential infections resulting from unsanitary conditions in the Food and Nutrition Services department and nursing station nourishment areas (patient food pantries in the nursing station) which had the potential to result in food borne illness in 118 patients when:
a. Shelving below the counter prep areas, and floors under shelving, were observed with dust like particles and greasy build-up that had the potential to lead to growth of microorganisms that employees could inadvertently transfer to food. It also had the potential to attract insects, rodents and other pests, (FDA Food Code 2017).
b. The floor drain for the food steamer and the floor drain for the vegetable washing sink were observed with old food particles and greasy build-up which had the potential to cause contamination and attract pests.
c. The meat slicer that was covered with a plastic bag to indicate that it was cleaned, it had meat residue on the blade and in crevices. This had the potential to lead to the buildup of pathogenic organisms (disease causing) that could be transmissible through food (FDA Food Code 2017).
d. Dish racks that were used to stack dishes to put in the dishwasher and used to air dry clean dishes, were visible dirty with build-up that could be scraped off. This had the potential to lead to growth of microorganisms that can contaminate clean dishes and potentially contaminate food.
e. The can opener blade was worn and nicked so that it was no longer a smooth surface. Surfaces that have imperfections such as chips, cracks or pits allow microorganisms to attach and form biofilms (potentially harmful bacteria that sticks together and on surfaces). These biofilms can release pathogen (disease causing bacteria) to food. Biofilms are highly resistant to cleaning and sanitizing efforts. (FDA Food Code 2017). Also there was no system in place to monitor and maintain the can opener blade.
f. Two utensils for straining food were hanging and ready to use with other clean utensils and were observed covered in rust. This had the potential to contaminate food.
g. Shelled eggs and frozen potatoes were removed from their original box and were not labeled with an expiration date or name of product. For the eggs, this had the potential for staff to use an expired egg and for the potatoes there was a risk of serving food that could potentially contain an ingredient that a patient is allergic to.
h. A can of tuna was used to support a shelf in a walk in freezer and had an accumulation of dirt and grim. This had the potential to attract pest and lead to a growth of microorganisms.
i. There was no system in place to monitor the shelf life of boxed juices, so staff did not know when the juice expired. This had the potential for hazardous juice to be served to patients.
j. Clean plastic food storage containers were stored on a shelf in a cardboard box in the food preparation area. Corrugated cardboard boxes are not considered clean and can harbor pests.
k. Nursing nourishment station refrigerators that contained perishable foods were not being monitored for adequate temperature. There were two refrigerators on Unit 2 and only one temperature log. This had the potential for food to be stored at an inappropriate temperature that could lead to growth of bacteria (FDA Food Code 2017).
l. Food crates were stored on the floor in the nursing nourishment area on Unit 2 east and west. This had the potential to contaminate food with dust and dirt from the floor.

4. Infection control practices were not followed during the medication pass for two patients (Patients 12 and 51).

These failures in the facility's ability to ensure the provision of quality health care in a safe and sanitary environment had the potential to endanger a vulnerable population from the spread of infection borne illnesses.

Findings:

1. According to the report titled "Immunization of Health-Care Personnel", dated 11/25/2011, recommendations for immunization of Health care Providers (HCP) by the Advisory Committee on Immunization Practice (ACIP), the Healthcare Infection Control Practices Advisory Committee (HICPAC) and Centers for Disease Control and Prevention (CDC), each of the following criteria is considered to provide presumptive evidence of immunity at the time of hire and on a regualr basis:

- Varicella (Chickenpox - a highly infectious disease transmitted by direct contact or droplet/ respiratory contact) - "Documentation of 2 doses of varicella vaccine; Laboratory evidence of varicella immunity or laboratory confirmation of disease; healthcare provider diagnosis or verification of history of varicella disease or herpes zoster (shingles)."

- Hepatitis B (an highly infectious virus transmitted through breaks in the skin, like an accidental needle stick, or contact with mucous membranes exposure to infectious blood or body fluids) - "Documentation of 3-dose hepatitis vaccine; documented immunity of > 10 mlU/ml [a unit of measure for immunity] tested 1-2 months after the vaccine series; documentation of a second 3-dose vaccine if no immunity after first series."

- MMR (Measles - a highly contagious rash illness transmitted by droplets and airborne spread with severe complications which may result in death. Mumps - an acute viral infection characterized by fever and swelling of the salivary glands. Rubella - also known as German Measles, a viral disease characterized by rash, low-grade fever, swollen lymph glands and generalized weakness)."Laboratory evidence of immunity or laboratory confirmation of disease; Documentation of 2 doses of live MMR vaccine; Birth before 1957, but should consider immunity testing."

- Tdap (A combination vaccine that includes the following: Tetanus -a serious disease caused by a bacterial toxin that affects your nervous system, leading to painful muscle contractions, particularly of your jaw and neck muscles. Diphtheria - a contagious disease transmitted by droplets and causes a thick covering in the back of the throat and can lead to difficulty breathing, heart failure, paralysis, and even death. Pertussis - a highly contagious bacterial infection, also known as whooping cough, transmitted by droplets causing uncontrollable, violent coughing which often makes it hard to breathe.) Documentation of previous Tdap. "Regardless of age, HCP [health care personnel] should receive a dose of Tdap as soon as feasible if they have not previously received Tdap."

During reviews of facility personnel files on 4/4/19 and 4/5/19, 31 employee health files were reviewed by the Department. Each file contained a form titled "[Facility Name] Vaccine Consent/ Declination Form." The form included the following statement below the title, "The federal Advisory Committee on Immunization Practice (ACIP) makes the following recommendations for the administration of vaccines and the California OSHA [Occupational Safety and Health Administration - responsible for worker safety and health protection] Aerosol Transmissible Diseases [diseases spread by droplet and respiratory means] standard requires employers to offer the following vaccines, at no cost, to non-immune healthcare personnel."

The facility immunization form included vaccines for Varicella (Chickenpox), Hepatitis B, MMR (Measles, Mumps and Rubella), Tetanus, TDAP (Tetanus, Diphtheria and Pertussis). Each vaccine had 3 areas for the employee to mark:
1. a box indicating the employee had a met the criteria for immunity, or
2. a place to document if the vaccine was given and a consent statement to receive the vaccine, or
3. a box to decline the vaccine if no immunity was present.
At the end of the document was a box for the employee to sign and date.

Further review of the 31 employee health records indicated no documented evidence of immunity. The forms in the employee files had either the first or the third box checked, there was no evidence of immunity.

A review of the contracted employees for radiology services and laboratory services did not contain any documentation of immunization status for the employees who came to the facility.


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Review of thirteen medical staff credentials files on 4/2/19 and 4/3/19 demonstrated that six files (Physician A, B, C, D, E and F) were absent confirmation that the physicians had either received immunizations required by regulation or documented immunity to the diseases covered by the required immunizations.

During an interview on 4/4/19 at 2 p.m., the Director of Performance Improvement and Risk Manager (RM) acknowledged documented evidence of immunity was required for all employees in contact with patients and was not present in the employee files.

During a concurrent interview and record review with the Human Resources Director (HRD) on 4/4/19 at 5:10 p.m., the 31 employee files were reviewed with the HRD. The HRD confirmed the lack of documented immunity status beyond the employee attestation. The HRD further confirmed any additional employee files reviewed would unlikely have any additional documentation of evidence of immunity.

During a telephone interview with the Infection Control Preventionist (IP) on 4/5/19 at 10:15 a.m., the IP confirmed any immunization information would be in the employee personnel file on the facility immunization form. The IP further stated the facility has not required proof or evidence of immunity status. Additionally, the IP stated there was not a centralized data base of employee immunity and if an outbreak or an exposure occurred in the facility, each individual employee file would need to be checked. The IP confirmed the facility followed CDC guidelines.

The report titled "Immunization of Health-Care Personnel", dated 11/25/2011, additionally indicated "HICPAC and CDC have recommended that secure, preferably computerized, systems should be used to manage vaccination records for HCP (health care personnel) so records can be retrieved easily as needed... Accurate records can help to rapidly identify susceptible HCP during an outbreak situation...The American Hospital Association has endorsed the concept of vaccination programs for both hospital personnel and patients. To ensure all HCP are up to date with respect to recommended vaccines, facilities should review HCP vaccination and immunity status at time of hire and on a regular basis (i.e. at least annually)... in conjunction with routine annual disease -prevention measures (e.g. influenza immunization and tuberculosis testing)."

The facility policy titled Employee Health Program Description, dated 2/2004, stipulated under the heading "GUIDELINES FOR HEALTH SCREENING,
1. Pre-employment Health Inventory...
d. Rubella - Employee must provide proof of immunity or immunization if no history of Rubella
e. Measles - Employee must provide proof of immunity or [sic] Mumps - Employee must provide proof of immunity or immunization if no history of mumps.
f. Chicken Pox Employee must provide proof of immunity or immunization if no history of chicken pox
g. Screening Tests
i. Tuberculin skin test.. and/or chest film (PA [posterior anterior] and lateral and lateral) - if positive skin test.
ii. Rubella titer.
iii. Any test required by state and local health departments...
h. Periodic Reappraisal...
ii. Tuberculin skin test for previous nonreactors

Per the facility policy titled Infection Control Program Description, last updated 3/2013 indicated' "The purpose of the Infection Control (IC) Program is to ensure that steps are taken to reduce the risks of acquiring and transmitting infections among patients, employees, physicians, students and visitors."

2. During a review of Nurse Manager (NM) 2's employee health file, a PPD test from 2014 indicated a negative reaction meaning no exposure to tuberculosis. No PPD tests were found for 2015 through 2018. Additionally, the file included screening surveys for symptoms for employees who had a previous positive PPD dated 2015 through 2018. There was no document indicating NM 2 had a prior positive PPD nor the required chest X-ray and follow up evaluations if there had been a conversion to a positive test.

During a concurrent interview and record review with the HRD on 4/4/19 at 5:10 p.m., the HRD confirmed the documents found in NM 2's employee file.

During a telephone interview with the IP on 4/5/19 at 10:15 a.m., the IP stated, "...in 2015, the facility had a shortage of PPD test and the facility screened staff to limit the PPD used to save it for the patients." The IP stated NM 2 must have been missed to go back to the regular PPD annual testing. The IP further stated NM 2 had not converted, to her knowledge, to a positive PPD.

The facility policy titled Employee Health Program Description, dated 2/2004, stipulated under the heading "GUIDELINES FOR HEALTH SCREENING,
1. Pre-employment Health Inventory...
g. Screening Tests
I. Tuberculin skin test.. and/or chest film (PA [posterior anterior] and lateral and lateral) - if positive skin test.
h. Periodic Reappraisal...
ii. Tuberculin skin test for previous nonreactors

Per CDC guidelines, all health care workers shall be tested on hire and annually for prior negative tests. Positive tests shall have a chest X-ray and complete a screening questionnaire annually.



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3. a. According to the FDA Food Code 2017, "nonfood-contact surfaces of equipment shall be kept free of an accumulation of dust, dirt, food residue and other debris," and "physical facilities shall be cleaned as often as necessary to keep them clean". "The presence of food debris or dirt on nonfood-contact surfaces may provide a suitable environment for the growth of microorganisms, which employees may inadvertently transfer to food. If these areas are not kept clean, they may also provide harborage for insects, rodents and other pests."

During an initial tour of the kitchen on 4/2/19 at 10:42 a.m., the shelves below the counter preparation area were observed with a significant accumulation of dust like particles and greasy build-up. Metal pans, containers and foam serving plates were stored face down on the visibly dirty shelves. The floors under the shelves were observed with dust like particles and dirt build-up.

During a review of the dietary services monthly cleaning schedule and cleaning log, both dated dated March 2019, cleaning of the shelves or the floors behind the shelves was not a task that was listed on these logs.

During an interview on 4/2/19 at 10:42 a.m., The Director of Food Services (DFS), stated that the shelves were cleaned monthly. The DFS stated that she did not think the accumulation of dust and grease was problematic. The DFS was unable to state why the cleaning of the shelves and floors under the shelves was not on the cleaning schedule or the cleaning log.

During a review of the facilities policies and procedures titled Dietary Services Department- Purpose and Responsibility, dated 9/3/18, it stated that "All food shall be prepared under strict sanitary conditions and in accordance with local and state regulations".

During a telephone interview with the Infection Preventionist (IP) on 4/3/19 at 2:05 p.m., the IP stated that she performs infection control rounds in the dietary services monthly. The last rounds were performed 1 ½ to 2 weeks prior to the interview. The IP stated that she did not observe the the dirty shelves or floors during her last inspection.

b. During an observation on 4/2/19 at 11:17 a.m., the floor drain for the food steamer and the drain for the fruit and vegetable washing sink were observed with old food particles and dirt and grease build-up. A clean paper towel was wiped along the inside of the drain and the paper towel showed signs of dirt.

During a review of the dietary services monthly cleaning schedule and cleaning log, both dated dated March 2019, the cleaning schedule indicated only that the drain were to be cleaned monthly. There was no date or staff initials indicating that the drains had been cleaned for the month.

During an interview on 4/2/19 at 11:19 a.m., the DFS stated that the drains were cleaned monthly. The DFS was not able to state the last time the drains had been cleaned. She stated that the departments cleaning schedule should indicate the last time they were cleaned. The DFS was unable to state why there was no documentation of the cleaning of the drains in the cleaning schedule or cleaning log.

During a telephone interview with the Infection Preventionist (IP) on 4/3/19 at 2:05 p.m., the IP stated that she performs infection control rounds in the dietary services monthly. The last rounds were performed 1 ½ to 2 weeks prior to the interview. The IP stated that she dad not noticed dirty drains the last time she did her surveillance.

c. According to the FDA Food Code 2017, "equipment food-contact surfaces and utensils shall be clean to sight and touch".

During an observation on 4/2/19 at 10:52 a.m., the meat slicer was observed with a plastic bag over it. When the bag was removed the meat slicer was observed with meat residue on the blade and in crevices.

During an interview on 4/2/19 at 10:52 a.m., the Director of Food Services (DFS) stated that the meat slicer was last used the previous night and the bag covering the machine indicated that it was cleaned and was ready for use. She stated that the meat slicer was supposed to be cleaned after each use. The DFS verified that the slicer was not clean. She verified that since the bag indicated to the staff that the slicer was clean, the next time it was used, there was the potential for cross contamination by the old meat residue.

During a review of the hospital's policies and procedures titled Sanitary Controls in Dietary, dated 09/2018, it stated, "wash meat grinder or slicer immediately after using. If not washed promptly, harmful bacteria will multiply on meat particles left on grinder [or slicer]".

During a telephone interview with the Infection Preventionist (IP) on 4/3/19 at 2:05 p.m., the IP stated that she performs infection control rounds in the dietary services monthly. The last rounds were performed 1 ½ to 2 weeks prior to the interview. The IP stated that when she observed equipment that was not clean, she reports it to the DFS. The expectation was that the equipment would be cleaned.

d. According to the FDA Food Code 2017, "nonfood- contact surfaces of equipment shall be cleaned at a frequency necessary to preclude accumulation of soil residues".

During an observation on 4/3/19 at 12:10 p.m., the six dish racks that are used to stack dirty dishes to be put into the dishwasher were caked with a layer of dirty build-up that could be scraped off. The clean dishes were kept on these racks to air dry.

During an interview on 4/3/19 at 12:10 p.m., the DSF confirmed that the racks were dirty. She could not explain why the racks were not clean despite their use for cleaning equipment and trays used in food preparation and service for the patients.

During a review of the hospital's policies and procedures titled Infection Control, dated 09/2018, it stated that "sanitized utensils should be stored so they are protected from dust, splashing or other forms of contamination".

During a telephone interview with the Infection Preventionist (IP) on 4/3/19 at 2:05 p.m., the IP stated that she performs infection control rounds in the dietary services monthly. The last rounds were performed 1 ½ to 2 weeks prior to the interview. The IP stated that she did not notice the dirty dish racks the last time she did her surveillance.

e. "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" (FDA Food Code 2017). Chipped surfaces allow microorganisms to attach and create biofilms (potentially harmful bacteria that sticks together and on surfaces that areresisitent to normal cleaning and sanitizing procedures). Once established, biofilms can release pathogens (disease causing bacteria) to food, (FDA Food Code 2017).

During an observation on 4/2/19 at 10:52 a.m. the can opener blade was observed to be nicked and worn.

During an interview on 4/2/19 at 10:52 a.m., the DSF stated that the can opener was cleaned nightly and the blade was changed when needed. She stated that this current blade was changed 9 months ago. She stated that she thinks they need to be changed only once a year. She did not think the condition of the blade warranted cleaning

During a review of the facilities policies and procedures titled Infection Control, dated 09/2018, it stated that "all utensils should be thoroughly check and all those that are cracked, chipped, badly corroded or stained should be discarded".

During a telephone interview with the Infection Preventionist (IP) on 4/3/19 at 2:05 p.m., the IP stated that she performs infection control rounds in the dietary services monthly. The last rounds were performed 1 ½ to 2 weeks prior to the interview. After reviewing the above deficient practices with the IP, she verified that the can oipener blade should be intact and not nicked and worn.

f. During an observation on 4/2/19 at 11:57 a.m. two strainers were observed hanging over the sink with other utensils. The strainers were covered in rust.

During an interview on 4/2/19 at 11:57 a.m., The Director of Food Services (DFS) stated the utensils were hanging because they were ready for use. She confirmed that they should not be used and should be thrown away.

During a review of the facilities policies and procedures titled Infection Control, dated 09/2018, it states that "all utensils should be thoroughly checked and all those that are cracked, chipped, badly corroded and stained should be discarded" and "all food preparation equipment must be maintained and kept in good condition".

During a telephone interview with the Infection Preventionist (IP) on 4/3/19 at 2:05 p.m., the IP stated that she performs infection control rounds in the dietary services monthly. The last rounds were performed 1 ½ to 2 weeks prior to the interview. The IP was not aware of the rusted utensils. She verified that they should not be retained in the department and should have been discarded.

g. During an observation on 4/2/19 at 11:17 a.m., In the walk-in refrigerator, shelled eggs were observed on a shelf and had been removed from their original box. There was no documentation of the expiration date of the eggs. Also, in the walk-in freezer, bag of a frozen food was observed with no label or date.

During an interview on 4/2/19 at 11:17 a.m., the Director of Food Services (DFS) verified that the eggs were not labeled with an expiration date. She could not state how the staff could know if the eggs had expired since the box with the expiration date had been discarded. The DFS further stated that the unlabeled bag was probably potatoes and that the bag should have been labeled.

During a review of the facilities policies and procedures titled Food and Supply Storage, dated 09/2018, it stated that "all food storage containers must be marked with item name and date".

During a telephone interview with the Infection Preventionist (IP) on 4/3/19 at 2:05 p.m., the IP stated that she performs infection control rounds in the dietary services monthly. The last rounds were performed 1 ½ to 2 weeks prior to the interview. The IP verified that all perishable foods should be labeled and dated.

h. During an observation on 4/2/19 at 10:52 a.m., a large can of tuna was being used to support shelving in the walk-in freezer due to a missing leg of the shelf. The can was observed with an accumulation of dirt and grim at the base. This had the potential to inadvertently contaminate food that was stored on these shelves.

During an interview on 4/2/19 at 10:55 a.m., the DFS stated that she verbally reported the maintenance need to fix the shelf to the maintenance staff. She stated that the hospital had an electronic work order system but she did not use it. Since she submitted the work order one month ago, staff in the maintenance department had turn over. There was no documented evidence that a work order was submitted.

During a telephone interview with the Infection Preventionist (IP) on 4/3/19 at 2:05 p.m., the IP stated that she performs infection control rounds in the dietary services monthly. The last rounds were performed 1 ½ to 2 weeks prior to the interview and the IP did not see the can of tuna supporting the shelving unit in the freezer at that time.

i. During an observation on 4/2/19 at 11:17 a.m., one case of 4-ounce apple juices was dated 3/20 and was two thirds full and six cases of 4-ounce orange juices were dated 3/27. The manufacturer's directions on the cases stated that juice should be discarded 14 days after thawing.

During a concurrent interview with the DFS she stated that the dates on the cases indicated the delivery date. She verified that there was no date to indicate when the juices were thawed. The DFS stated that the juices were used within a week of delivery. She could not explain why the apple juice was dated with a delivery date 13 days ago. The DFS verified that she lacked a system to ensure the juices were consumed within 14 days of thawing.

During a telephone interview with the Infection Preventionist (IP) on 4/3/19 at 2:05 p.m., the IP stated that she performs infection control rounds in the dietary services monthly. The last rounds were performed 1 ½ to 2 weeks prior to the interview. The IP was not aware that the juices required date monitoring. She depended on the DFS to monitor the dates.

j. Corrugated cardboard boxes are susceptible to moisture, water, insects, vermin and bacteria during warehouse and transportation environments. They can also be a reservoir for dust (Food Code 2017)

During an observation on 4/2/19 at 10:52 a.m. clean plastic food storage containers were observed stored in a corrugated cardboard box that was used to deliver coffee filters.

During an interview on 4/2/19 at 10:52 a.m., the DFS stated that they were stored in the box to keep separate from other items on the shelf. She verified that coorugated baxes were not considered clean and should not be used to store the food storage containers.

During a telephone interview with the Infection Preventionist (IP) on 4/3/19 at 2:05 p.m., the IP stated that she performs infection control rounds in the dietary services monthly. The last rounds were performed 1 ½ to 2 weeks prior to the interview. The IP stated that she had performed a risk analysis for the use of corrugated boxes in the hospital. She verified that corrugated boxes should not be used to store clean food storage containers.

During a review of the facilities policies and procedures titled Storage of Dry and Canned Products, dated 09/2018, stated to "remove empty boxes from the storeroom. Take all empty unused boxes to the garbage bin outside".

During a review of the facilities policies and procedures titled Food and Supply Storage, dated 09/2018, stated that "empty boxes from deliveries, etc. are to be removed from the kitchen immediately".

During a review of the facilities policies and procedures titled Risk Assessment, undated, it stated "Unnecessary corrugated boxes are broken down outside the dietary area and then disposed of. If any corrugated boxes are in the dietary area more than one month they will then be re-inspected".

k. "Maintaining foods under the cold temperature of 41 degrees Fahrenheit will limit the growth of pathogens that may be present in or on the food and may help to prevent food borne illness" (FDA Food Code 2017).

During an observation on 4/3/19 at 10:47 a.m. there was only one temperature log available for two refrigerators on Unit 2. Both refrigerators contained perishable foods including milk and perishable juices which should be stored under 41 degrees Fahrenheit.

During a record review and concurrent interview on 4/3/19 at 10:47 a.m., Nurse Manager (NM 1) verified that there was only one temperature log. NM 1 was unable to determine which of the two refrigerators the log was for since the lod was not labeled. In addition, she verified that there should have been two logs, one for each refrigerator.

During a review of the facilities policies and procedures titled Patient Refrigerators, dated 10/2018, it stated that "A thermometer will be kept in all refrigerators on the units. A log will be kept and will be assessable to staff". "Assigned staff will be responsible for: Checking and logging the temperature of the nourishment refrigerator on a daily basis".

l. Food shall be protected from contamination by storing the food: (1) In a clean, dry location, (2) where it is not exposed to splash, dust or other contamination; and (3) at least 15 centimeters (6 inches) above the floor, (FDA Food Code 2017).

During an observation on 4/5/19 at 10:24 a.m., two crates with food, including fresh fruits and packaged snacks, were stored on the visible dirty floor in the nursing station of 2 East and West creating the potential for cross contamination and pest infestation.

During an interview on 4/5/19 at 10:25 a.m., Nurse Manger (NM 1) stated that there used to be a table there where the food would be stored. She verified that the food should not be stored on the floor.

During a review of the facilities policies and procedures titles Food and Supply Storage, dated 09/2018, it stated "store food 12 inches above the floor".

During a telephone interview with the Infection Preventionist (IP) on 4/3/19 at 2:05 p.m., the IP stated that she performs infection control rounds in the dietary services monthly. The last rounds were performed 1 ½ to 2 weeks prior to the interview. She stated that she utilized a checklist to document problems in the dietary services during her rounds. The IP stated that the kitchen is a priority for surveillance for infection control due to the high risk for food borne illness.

A review of the hospital policy titled Infection Control Program Description, (revised 3/13) stated "The purpose of the Infection Control Program is to ensure that steps are taken to reduce the risks of acquiring and transmitting infections among patients, employees, physicians, students and visitors."


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4. During medication pass observation on 4/2/19 at 1:50 p.m., Registered Nurse 10 (RN 10) took Patient 51's medication cassette (a sub-dividable storage box for individual patient medication storage) to the bedside during medication administration.

The medication cassette was not cleaned before or after patient care contact during the medication administration process.

The medication cassette for Patient 51 contained extra medications that were not due for administration on 4/2/2019 around 2 p.m.

During a medication pass observation on 4/3/19 around 8:30 a.m., RN 8 took Patient 12's medication cassette to the bedside during medication administration.

The medication cassette was not cleaned before or after patient care contact during the medication administration process.

The medication cassette for Patient 12 contained extra medications that were not due for administration on 4/3/2019 around 8:30 a.m.

During an interview on 4/3/19 around 8:30 a.m., RN 8 explained that the nursing staff took the cassettes to the patient's bedside as an extra safety measure for patient identification; each cassette was marked with the patient's name tag.

During an interview on 4/5/19 around 8:30 a.m., the Director of Nursing (DON) said the practice of taking the medication cassette/drawer to the patient's room was a concern because of the potential for cross-contamination (a process by which disease-causing