The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

SANTA BARBARA COTTAGE HOSPITAL 400 WEST PUEBLO SANTA BARBARA, CA 93102 May 8, 2015
VIOLATION: PATIENT RIGHTS Tag No: A0115
This CONDITION is not met as evidenced by:
Based on interviews and patient record review, the facility failed to follow their process or demonstrate a clear knowledge of what the process was for investigation of adverse patient incidents in the facility.
Findings:
The facility did not provide evidence to ensure adverse patient events/incidents were investigated to improve quality care and safe patient outcomes. Refer to A 144.
VIOLATION: PATIENT RIGHTS: NOTICE OF RIGHTS Tag No: A0117
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review the facility failed to ensure patient's rights were given to each patient or responsible party (RP) for each admission. This failure had the potential for patient's to receive unwanted care, treatment, and services.

Findings:

A review of the facility's policy and procedure titled, "Conditions of Service", dated 12/2011, indicates, "Each patient, or their legal representative, will be asked to sign the electronic Conditions of Services (COS) prior to or at the time of, each respective visit to.....The hospital representative obtaining the signature will legibly print their name in the appropriate space on the electronic COS form. If unable to print the electronic COS form than the representative would affix a label printed with the patient's name, Medical Record, and account number to a hard copy of the COS in the provided space and scan into the registration. The hospital representative will document, by means of an account comment in the registration system, that the signature was obtained. The hospital representative will document as applicable, in the space provided, that the following information was given to, or obtained from the patient: Patient Rights & Responsibilities.....".

A review of 6 (Patient's N300, N301, N302, N303, N304, N305) of 30 sampled medical records revealed there was no documentation that patient's or their representatives had received any notification of patient's rights.

A review of N300's medical record revealed there was no patient's rights signed by the RP anywhere in N300's medical records.

During an interview on 5/4/15 at 2:30 p.m., N300 and her RP both indicated they had not been asked about patient's rights, and they had not signed anything regarding patient's rights since early on in N300's illness course. They both indicated nothing had been signed for this hospital stay.

A review of N301's medical record on 5/6/15, revealed there was no patient's rights signed by the RP anywhere in the paper portion or in the Electronic Medical record portion of N301's chart.

A review of N302's record revealed patient N302 was admitted on [DATE]. N302 was a minor infant admitted to the Neonatal Intensive Care Unit (NICU). There was no documentation of patient rights for N302 anywhere in the medical record. N302's medical record documented the responsible party had visited many times between the date of admission and the current survey date 5/6/15.

A review of N303's medical record revealed there was no documentation of patient's right's having been signed by N303 in either the hard copy or the Electronic portion of N303's chart.

A review of N304's medical record revealed there was no documentation of patient right's being signed by the RP anywhere in the medical record.

A review of N305's medical records revealed there was no documentation of patient rights anywhere in N305's medical record. There was a spot for documentation on the labor and delivery admission record in the computer. The boxes regarding patient's right's were marked N/A.

During an interview with a licensed nurse (LN 1) in the labor and delivery area, regarding N305's patient's rights, on 5/7/15 at 10:30 a.m., LN1 stated, "I don't ask about patient's rights because those are done in admitting."

During an interview with the Admissions Director (AD), on 5/7/15, at 3:30 p.m., the AD stated, "I only have to get the patient's right's signed once a year." The AD also stated, "We are allowed to use the mom's patient's rights for the baby even if they have to be admitted to the NICU." The AD also stated, "Seventy percent of our moms are pre admitted ." When asked where the documentation was for the preadmission patient's regarding patient's rights, the AD stated, "We aren't following that policy that I gave you, because that policy is wrong." The AD indicated it was the responsibility of the admission clerk to scan the information into the system. The AD did not have an explanation for the missing documentation.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

This STANDARD is not met as evidenced by: Based on interview and record review, the facility failed to ensure patient safety in a safe setting, as there was no evidence of a formalized process for investigating issues related to adverse patient incidents that either caused harm or had the potential to cause harm.
Findings:
During the course of a complaint investigation, the facility failed to demonstrate it had conducted a thorough investigation in response to the following adverse patient incident:
A review of the Emergency Department (ED)notes indicated Patient 801, a [AGE] year old male, was transferred to the hospital on [DATE] following administration of TPA (tPA, the only FDA approved treatment for ischemic strokes works by dissolving the clot and improving blood flow to the part of the brain being deprived of blood flow) for an acute ischemic stroke. Upon arrival to the hospitals ED, Patient 801 was noted to have no clear response to the previously administered TPA with continued left sided weakness and due to the severity of symptoms decision was made to proceed to emergent angiography.
Following angiography Patient 801 was admitted to the Surgical Intensive Care Unit (SICU) for monitoring. From the SICU, the patient was transferred to the medical floor until he was stabilized for angioplasty and stent placement under general anesthesia on 1/2/15. Following this last intervention Patient 801 was once again admitted to the SICU for recovery and continued monitoring according to the history and physical (H&P) review.
According to the anesthesia notes the general anesthesia ended at 6:03 p.m. Patient 801 was sent to the SICU for recovery.
Following an hour of recovery by 2 nurses, Patient 801's care was assumed by the oncoming night shift RN (RN1). RN1 was charged with the care of Patient 801 and a 2nd patient in the adjacent room. According to RN 1, her 2nd patient was in isolation requiring her to don isolation clothing and wash hands with each entry and remove isolation clothing and wash hands with each exit. RN 1 stated her 2nd patient was "heavy" care. At 8:00 p.m., RN 1 documented an assessment for Patient 801 which indicated; Patient 801 was at high risk for falls with a score of 70. Per facility policy a score over 45 is an indication the patient is at a "high" risk to fall. Further, the 8:30 p.m. assessment indicated Patient 801 had a RASS score of " -2 " indicating light sedation, and a CAM ICU score of "Positive" indicating the presence of delirium. RASS assessment is The Richmond Agitation and Sedation Scale (RASS), a validated and reliable method to assess patients' level of sedation in the intensive care unit. The CAM-ICU score is a validated and commonly used score to help monitor patients for the development or resolution of delirium (a serious disturbance in a person's mental abilities that results in a decreased awareness of one's environment and confused thinking per Mayo Clinic).
On 1/2/2015 at 8:40 p.m.,following general anesthesia, Patient 801, fell to the side of his bed with all four side rails up, he sustained a head injury which resulted in bleeding. According to a review of the H&P, following the fall a CAT scan (CT) of the brain indicated "Diffuse traumatic subarachnoid hemorrhage" According to the same H&P, A repeat CT overnight indicated, "Very large extensive left frontal contusion with hemorrhage and midline shift". The patient was "Obtundant and unresponsive". After discussion with the family Patient 801 was moved out of the SICU and placed on comfort care. Patient 801 expired on [DATE], and according to the H&P the cause was "Intracranial hemorrhage due to head trauma and fall."
During an interview with RN 1 on 5/6/15, RN 1 stated another RN (RN 2, who was unavailable for interview) found the patient on the floor and went to get RN 1. RN1 stated Patient 801 had 4 side rails up on the bed, bed alarms were not on and the patient was found crumpled up on the floor at the side of the bed, his PICC line had come out, (thin, soft, long catheter (tube) that is inserted into a vein in the arm, leg or neck. The tip of the catheter is positioned in a large vein that carries blood into the heart), the heart monitor had fallen off and according to Rn 1, "It was clear he had taken the brundt of the fall on his head", RN 1 described blood on the floor and the laceration he sustained on his head required sutures. RN 1 stated she recalled no alarms were sounding and wasn't sure why the heart monitor wasn't sounding as the heart leads had fallen off. According to RN 1 she was not present for the facility Root Cause Analysis (RCA), and had not been questioned by Quality Staff as to the fall. RN 1stated in retrospect she believed the patient should have been recovered longer. RN 1 also noted in her practice as a traveler at many different hospitals the RN caring for the patient generally gets a thorough report from the sending floor. RN 1 stated while the patient originated from the medical surgical unit, the only report she received was from the Interventional Radiology staff. RN 1 also stated the patient had previously been in the SICU as a patient and RN 2 as well as "Other staff" shared with RN 1, after the fall, that Patient 801 had a history of this sort of agitation and restlessness. RN 1 stated "I wish I would have known that, we could have recovered him longer, and I would have kept a "Birdseye" view on him.
According to Quality staff, RN 2 was unavailable for interview, we requested to speak with her by phone but this was never arranged.
The following day Quality staff were interviewed.The RCA folder related to Patient 801's fall was sitting in front of the Quality Staff Member (QM 1) and we questioned whether there had been any note as to the patients previous history of confusion and restlessness in both the medical surgical unit and the original admission to SICU during this stay as seen on record review. QM 1 looked at the RCA folder and stated "I don't know I'd have to read it". When requested to do so, QM 1 said she would have to check to see if she was allowed to do that. I further questioned why four side rails were up but no bed alarms were on, wondering if the side rails were intended for safety or as a restraint, or as in this case creating a larger fall to the ground if indeed Patient 801 went over the rails? QM 1 stated "I believe he was found at the foot of the bed", this was in contradiction to the nursing staff interviewed and present for the incident. I requested to review the RCA, and was denied. According to the COO the RCA is considered "Protected under a legal umbrella". The team shared concerns during a Quality meeting on 5/8/15 as to the investigation of the incident. QM 1 stated RN 1 was not interviewed as she was "Out of the country" However, RN 1 was currently working in the facility and according to her had not been interviewed by the Quality staff since the incident 4 months ago.
Quality staff were asked how they determine what to investigate and how it is tracked, the COO stated " I think she is referring to the data collection?", to which the Chief of Quality responded "No CMS isn't that advanced" Quality staff was guarded during the meeting and not transparent with their investigations so it was unclear where the lack of detail occurred or if there truly was a lack of detail in their investigation as there was no evidence shared of an investigation.
VIOLATION: QAPI Tag No: A0263
This CONDITION is not met as evidenced by: Based on observation, interview and record review, the hospitals Quality Assurance and Performance Improvement (QAPI) program could not provide evidence they were effective in identifying a significant adverse event, and identifying performance improvement measures to deal with such events in the future. An adverse event was identified for which the facility could not provide evidence the QAPI program had adequately investigated the event.
Findings:
The hospitals performance improvement activities did not track an adverse patient event, analyze the cause, and implement preventative actions and mechanisms that include feedback and learning throughout the hospital. Refer to A 286
VIOLATION: PATIENT SAFETY Tag No: A0286
This STANDARD is not met as evidenced by:
Based on interview and record review, the Quality Assurance and Performance Improvement (QAPI) program did not thoroughly investigate an adverse event (Patient 801) leading to an inability to analyze the cause. The facility provided no evidence that performance improvement activities analyzed the cause, and implemented preventative actions and mechanisms to include feedback and learning throughout the hospital. This resulted in a failure of the hospital to make improvements to reduce adverse events and provide educational feedback to the hospital staff.
Findings:
On 5/4/15 and 5/5/15 the Surgical Intensive Care Unit (SICU) and Medical Intensive Care Unit (MICU) were toured with management staff. Several nurses were interviewed related to the use of bed alarms on patients assessed to be at "High risk" to fall. All four nurses interviewed (RN 3,4,5, and 6) as well as two Charge Nurses (CN 7 and 8) in the SICU and MICU indicated they "Always" use bed alarms on high risk fall patients. The RN's were asked how they would know if the bed alarms were on when viewing the patient in bed. RN's 5 and 7 stated you know when the bed alarms are on by the large green bar on the foot of the bed, when that bar light is illuminated the bed alarms are on. The Clinical Nurse Specialist (CNS) confirmed this. Since there was some discrepancy between the RN's as to what light indicated the bed alarms were on management staff had the Resource Nurse (Res N) investigate. Res N explained the facility had purchased these 50,000 dollar beds which did numerous things. Res N stated the green bar actually indicates the Head of the Bed (HOB) is elevated. There was a small amber light in the upper right corner of the FOB which when lit indicated the bed alarm was on. Res N also explained the bed alarms had a feature which allowed them to be adjusted according to the patient. The beds alarm in three different levels, each level indicates more body surface area is covered. Res N explained in this way if a patient is sedated and mechanically ventilated, not moving much we can adjust the alarms down. On the other hand if the patient is restless we can adjust the alarm up to be more sensitive to movement. RN 9 was interviewed and stated she does a lot of research for the facility on different issues. RN 9 stated, while the hospital policy does leave the implementation of bed alarms on high fall risks up to the nurse she believed this was to encourage nursing to review the safety implementations and to encourage the nurse to "Think " before randomly checking boxes on a computer screen. RN 9 further shared the practice in the ICU is to use the alarms on patients at high risk to fall unless you are standing in the room, ie 1:1 ratio. RN 9 stated the hospital was utilizing yellow treaded socks, yellow wrist bands and in the Emergency Department (ED) yellow blankets as well. RN 9 shared the SICU went a step farther and puts yellow stickers next to the monitors at the nurses station so that anyone seeing an odd rhythm or no cardiac rhythm on the monitor would be sensitive to the fact the patient is a fall risk.
The ED was toured on 5/4/15 and staff were aware of the yellow bands and slippers but stated the yellow blankets hadn't arrived yet. The ED didn't use the yellow stickers on the monitors. The Medical Surgical floor was toured with management staff on 5/8/15 and the CN there stated they had been using the yellow system for quite a while and also placed yellow stickers on the chart but hadn't heard about the yellow stickers next to the monitor which she thought might be a good idea.
While nursing staff was transparent and implementing precautions there did not seem to be clear communication between the different floors. This was also seen in practice between floors as it related to the "SBAR" form and the "Ticket to Ride" these are tools the hospital uses to give a quick hand off and share information between departments and with transporters. Both tools have an area to indicate whether the patient is at "Fall Risk". The SICU stated they save the SBAR forms in the chart. The Medical Surgical floor stated they throw them out.
Another incident indicating a lack of communication between floors occurred on 5/5/15 during a tour of the SICU. There was an expired med noted on a sheet in the red cart, seen through a plastic window. Since it was unclear whether there truly was an expired drug the surveyor requested management to find a staff member to open the cart. Two staff nurses and one charge nurse attempted to open the crash cart but were not able. The staff members believed the red button on the side would "Cut" the tie when pushed down. Management staff shared the yellow locks on the crash cart were new and something pharmacy had implemented. The pharmacist then came to the SICU and stated the red button doesn't cut anything, the nurse needs to pull the plastic board covering the drawers out and up and the tie will break. The same demonstration was followed up in the ED where the director and staff member were having difficulty opening the crash cart and the Director stated "We never use the carts anyway" . Management staff touring with the surveyor agreed when new processes are implemented in the hospital there needs to be communication, in this case between pharmacy and the nursing floors in the SICU and ED.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on record review and interview a licensed nurse (LN1), failed to document a verbal order prior to administration of a medication. This failure has the potential to lead to other patient's being given medications without a current documented order. Further, the hospital staff failed to ensure a controlled substance medication (medication with a high potential for abuse and addiction) was used and wasted in accordance with the hospital policy and procedure for one of five Emergency Department (ED) records reviewed, to ensure patient safety and to prevent medication loss, misuse, or abuse.

Findings:

A review of the facility's policy and procedure titled, "Patient Care Orders", dated 12/14, indicated "Hospital staff will receive patient care orders.....Via the telephone when: The CPOE (Computerized Physician Order Entry) system is not available.....Patient has immediate intervention needs upon admission"...and, "Telephone orders for medication will be written on the Doctor's Order Form and telefiled to Pharmacy who will enter into CPOE. All other telephone orders should be entered directly into CPOE by the licensed staff member who took the order."

A review of N304's medical record revealed there was no written order for administration of Cervdil (a medication used to ripen the cervix for the induction of labor). LN1 had administered the medication on 5/7/15 at 9:06 am. The verbal order was not documented in Patient N304's medical record until 5/7/15 at 10:18 a.m.

During an interview on 5/7/15 at 10:15 a.m., LN1 acknowledged she had forgotten to check off the box for the Cervidil order in the computer orders for N304's. LN1 stated, "Oh my goodness, it is an error and there is no excuse for it." LN1 indicated she had taken a telephone order from the physician for the medication, had failed to document the order, and had failed to check the orders prior to administration of the medication.

LN1 was observed on 5/7/15 at 10:16 a.m. writing an order for the medication she had already administered and telefiling the order to the pharmacy.

On 5/5/15 at 2:45 p.m. in the company of Pharmacist 1 and Pharmacist 2, five random Emergency Department (ED) medical records with controlled substance medication use were selected for review.

A review of Patient P104's medical record revealed the patient was seen in the ED on 5/3/15 for flank pain. During this visit, the physician prescribed 3 one-time doses of Dilaudid (a potent narcotic for pain) as follows:

- 1 milligram (mg) at 2041 (8:41 p.m.)
- 0.5 mg at 2233 (10:33 p.m.)
- 0.5 mg at 0002 (midnight on 5/4/15)

The AcuDose (an automated dispensing device where Dilaudid was stored) report and the medical record showed an ED nurse withdrew 1 mg of Dilaudid from the AcuDose at 8:35 p.m. and gave 1 mg at 8:57 p.m. This corresponded with the first order at 8:41 p.m. The same nursing staff withdrew another 1 mg of Dilaudid at 10:03 p.m. and gave 0.5 mg at 10:33 p.m. This corresponded with the second ordered dose at 10:33 p.m. However, the remaining amount of 0.5 mg was not shown as wasted. The third dose, 0.5 mg, was documented as given at midnight on 5/4/15, one and half hours later. This corresponded with the third ordered dose.

Thus, there were two Dilaudid withdrawals from the AcuDose for three single doses at three separate times, indicating the nurse kept the remainder from the second dose vial and administered it one and half hours later.

During this review, Pharmacist 2 said, per hospital policy and procedure, any unused controlled medication must be wasted within 30 minutes of use. She said the staff was not to keep controlled medication on her body or anywhere else to prevent loss/abuse.

During an interview on 5/5/15 at 3:40 p.m., the ED Manager said she expected unused controlled substance medication was to be wasted with another staff within 30 minutes of administration. She acknowledged the said nursing staff did not use and waste the controlled medication as per hospital policy and procedure.

The hospital policy and procedures entitled "Medication - Automated Dispensing Device," dated 12/2014, indicated: "4 b. Two nurses are required to waste a controlled substance and to document as a witness. This must happen within 30 minutes of administration."
VIOLATION: PHARMACY ADMINISTRATION Tag No: A0491
Based on observation, interview, and record review the facility failed to ensure

1. Medications for patient use were stored at appropriate temperatures.
2. Antibiotics being used had an indication for use.
3. Medications were stored in a secure manner.
4. Opened medications were not kept beyond 28 days.
5. Multi use medications entering into patient environments were used for only one patient.

These failures had the potential to cause unwanted organisms to spread and grow, thus increasing the chance of infection for all patient's in the affected areas and the potential for unneccessary antibiotics to be utilized in the pediatric, pediatric intensive care unit (PICU), and neonatal intensive care unit (NICU) areas and the potential to render medications ineffective, or make them unavailable during a procedure.

Findings:

A review of the facilities policy and procedure titled, "...System Policy on Restricted Antibiotics", dated, 4/12 indicated, Restricting the antibiotic to ID (Infectious Disease) physicians will ensure the indication has been review, that the antibiotic is appropriate for the patient and it is safe to dispense."

According to the Centers for Disease Control (CDC), "Multi-dose vials should be dedicated to a single patient whenever possible. If multi-dose vials must be used for more than one patient, they should not be kept or accessed in the immediate patient treatment area. This is to prevent inadvertent contamination of the vial through direct or indirect contact with potentially contaminated surfaces or equipment that could then lead to infections in subsequent patients. If a multi-dose vial enters the immediate patient treatment area, it should be dedicated to that patient only and discarded after use." and, "If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial."

A review of the facility's policy and procedure titled, "Storage", dated, 12/14, indicates "All medications will be stored in accordance with USP (United States Pharmacopoeia) and manufacturer recommendations.....Lockable medication carts are used outside the Pharmacy Department to store medications for direct patient use.....All expired, damaged, contaminated or deteriorated drugs will be removed from stock."

1. During an observation of the medication room in the labor and delivery area, on 5/4/15 at 11:45, a.m., the medication rooms felt warm. There was no thermostat and no thermometer noted in the room. There were multiple medications for patient use stored in the room along with an automatic drug dispensing system cart which also had multiple medications locked inside.

During an interview with the Director of Children's Services, on 5/4/15, at 11:50 a.m., the DCS acknowledged the warm temperature in the medication room on the labor and delivery unit. She indicated she was unaware of any monitoring of temperatures in the medication room.

During an interview with the Plant Operations manager (POM) on 5/8/14, at 11:00 a.m., the POM stated, "No we are not monitoring the medication room temperatures, I have no documentation to show those were monitored."

2. A review of NN302's medical record revealed there were several orders for antibiotics between the dates of 3/19/15 and the current date of review 5/5/15. There were no indications for use of any of the antibiotics in the medical record.

During an interview with a pharmacist, on 5/5/15 at 11:45 a.m., the pharmacist stated, "I called our pediatric clinical pharmacist and she told me we do not use indicators for antibiotics in the pediatric, PICU, or the NICU. We have a policy that should be followed throughout the entire hospital, and we are not following it in those units."

3,4,5. During an observation of the Gastrointestinal Lab (GI) area, on 5/7/14 at 3:00 p.m., there were five GI procedure rooms. One GI procedure room , room 2 was being utilized for storage of equipment. All other rooms were being utilized for GI procedures on patients. GI room 5 was noted to have an unlocked medication cart in the room. There was a multiuse canister of Hurricane Spray (a topical anesthetic spray often used for sore throats) which was opened on 3/31/15 and was not discarded after 28 days.
During an observation of GI procedure room 4, on 5/7/15 at 3:05, p.m., there was an unlocked medication cart with two Narcan 0.4 milligrams/milliliter injections (a medication used to counter the effects of opioids) both with an expiration date of 5/1/15.
During an observation of GI procedure room 3 on 5/7/15 at 3:10 p.m., there was an unlocked medication cart which had multiuse Mylicon infant drops which were opened on 3/31/15 and not discarded after 28 days. There was a multiuse bottle of Lidocaine, Hydrochloride topical solution 4% which was opened and used but had no open date on it.

During an observation of GI procedure room 1, on 5/7/15 at 3:15 p.m., there was an unlocked medication cart with had multiuse Mylicon infant drops which were opened on 3/12/15 and not discarded after 28 days, a multiuse canister of Hurricane Spray opened and used with no opened date on it, and a multiuse bottle of Lidocaine, Hydrochloride topical solution 4% which was opened and used but had no open date on it.

During an interview with the GI Clinical Manger (GICM), on 5/7/15 at 3:20 p.m., the GICM indicated it was the responsibility of the nurses to check the carts for expired or outdated medications, and to lock them. The GICM also acknowledged that multiuse medications that have entered the GI procedure rooms are to be used for only one patient. The GICM stated, "You are correct the carts should be locked, and the multiuse medications should be discarded after 28 days, that is our policy."
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interviews, and record review, the hospital failed to ensure pharmaceutical services were provided in accordance with applicable standards of practice and/or hospital policy and procedures when:

1. Compounded intravenous (IV, directly given through the vein) antibiotic medications prepared for pediatric and neonatal intensive care unit (NICU) patients were given a beyond-use-date (BUD, date after which a compounded preparation should not be used) inconsistent with the current professional standards of practice. This had the potential to expose patients to preventable infections;

2. There were not adequate safeguards in place to prevent errors (such as mix-up/selection error) with neuromuscular blocking agents. Error or misuse of these agents can lead catastrophic injuries or death.

3. A topical anesthetic solution (called L.E.T. gel preparation) was prepared in IV syringes. This presented a potential for the preparation to be given intravenously by error, which would result in serious harm for patients;

4. Non-hospital approved medications were available for override before the pharmacist safety review. Retrieving medications by the override mechanism and administering prior to pharmacy review increases the risk for medication errors;

5. The [DIAGNOSES REDACTED] (MH) cart was not stocked in accordance with hospital policy and procedures. The list of contents on top of the cart did not indicate the amount of each medication; the contents inside the cart did not match the amount documented in policy; and chilled 1-liter sodium chloride (to cool off patient during a hyperthermic state) bags were missing from the refrigerator. Timely management to regulate the patient's temperature is crucial during an MH crisis; and,

6. The pharmacist failed to recommend the triglyceride monitoring prior to the infusion of lipids via total parenteral nutrition (TPN) for Patient D105 in accordance with the hospital's policy. As a result, Patient D105 was placed at risk for an adverse health consequence.

Findings:

1. During a visit to the pharmacy on 5/4/15 at 4:15 p.m., inspection of a medication refrigerator identified multiple IV dilution bags of various antibiotics in a container labeled "Peds/NICU." The labels on the bags indicated they were assigned a 3-day beyond-use-date (BUD) (e.g., a product prepared on at 10 a.m. on 5/4/15 would be used up to 10 a.m. on 5/7/15). The refrigerator was located outside of the cleanroom (the area in the pharmacy designated for the compounding with controlled air quality). Upon interview, the director of pharmacy (DOP) stated each bag was a dilution solution prepared by the pharmacy so that individual doses for neonates and pediatric patients could be drawn from the bag at a later time. Each bag was attached with a dispensing pin (an access device for withdrawal of solution from the bag). DOP confirmed each bag was assigned a 3-day BUD. DOP said the pharmacy followed the standards in USP <797> for compounded sterile preparations (CSPs).

United State Pharmacopeia (USP) 797 refers to chapter 797 "Pharmaceutical Compounding - Sterile Preparations" in the USP National Formulary. USP <797> establishes best practices and regulations for the production of CSPs.

On 5/5/15 at 2:30 p.m., observation of the IV antibiotic dilution bags with Pharmacist 1 revealed: a bag of Zosyn 40 milligrams (mg)/milliliter (ml) dilution in normal saline (sodium chloride 0.9%); a bag of vancomycin 5 mg/ml dilution in dextrose 5% water (D5W) solution; a bag of cefazolin 20 mg/ml dilution in D5W; a bag of cefotaxime 20 mg/ml dilution in D5W; and, a bag of ceftriaxone 20 mg/ml dilution in D5W. Pharmacist 1 stated each dilution bag was used for multiple patients.

A review of the manufacturers' prescribing information for each above antibiotics and sodium chloride 0.9% and D5W solutions used in the preparation of the antibiotic dilution solutions, indicated that all these products did not contain any bacteriostatic or antimicrobial agents for the inhibition of microbial replication. Each final product contained no bacteriostatic or antimicrobial agent to prevent bacterial growth, and thus, should be for single use only.

The Centers for Disease Control and Prevention (CDC) indicated medications that lack antimicrobial preservatives can become contaminated and serve as a source of infection when they are used inappropriately; therefore, they should be for single patient use only. The CDC further guided that, in time of critical need, contents from unopened single-dose/single-use vials can be repackaged for multiple patients. However, this should be performed by qualified healthcare personnel in accordance with the standards in USP <797>. It further indicated that following the USP standards is imperative, as medication contamination and patient harm can occur when repackaging (e.g. splitting doses) is not done properly.

A review of the hospital policy and procedure entitled "NICU IV PREPARATION," dated 12/2014, indicated medication "expiration dates will be same as those outlined in USP <797>."

According to USP <797>, opened or needle-punctured single-dose containers, such as bags, bottles, syringes, and vials of sterile products and compounded sterile preparations shall be used within 1 hour if opened in worse than ISO Class 5 (i.e. IV hood) air quality, and any remaining contents must be discarded. Single-dose vials exposed to ISO Class 5 or cleaner air may be used up to 6 hours after initial needle puncture.

During an interview on 5/6/15 at 9:40 a.m., Pharmacist 1 acknowledged that multiple entries (multiple withdrawals at various times over a 3-day period) to the dilution solution without antimicrobial agent increased the risk of accidental microbial contamination of the product. He agreed the antibiotic dilution solutions prepared for pediatric and NICU patients should be treated as single-use/single-dose containers, and when prepared in accordance with the standards in USP <797>, should not be used beyond 6 hours once punctured. He stated the pharmacy will change this practice right away.

2. During a visit to the Emergency Department (ED) with Pharmacist 1 on 5/5/15 at 10:30 a.m., inspection of medications found several counts rocuronium and succinylcholine (neuromuscular blocking agents; works by blocking nerve impulses to the muscles, resulting in temporary muscle paralysis) in each of the two refrigerators. The rocuronium vials and succinylcholine vials were in individual open bins, as were other refrigerated medications. Except for the manufacturer's inscription of "WARNING: PARALYZING AGENT" on the vial cap (which could be overlooked), there were no special packaging or cautionary labelings warning the staff that they were neuromuscular blocking agents. In other words, there were no mechanism to prevent them from being selected for use by mistake.

During a visit to the Surgical Intensive Care Unit (SICU) with DOP and Pharmacist 1 on 5/6/15 at 8:30 a.m., several vials of rocuronium and succinylcholine were also identified in the medication refrigerator, each type in its own bin, adjacent to other bins containing other refrigerated medications. When asked about special safeguards against potential mix-ups with other medications, Pharmacist 1 said the hospital did not want to institute too many labels on medications, fearing it would lead to "label fatigue." When commented that the hospital current storage of neuromuscular blocking agents did not make it difficult for a mix-up (selection error) to happen, Pharmacist 1 said, "I agree with you."

In a Medication Safety Alert, dated 9/22/05, the Institute for Safe Medication Practices (ISMP, a nationally recognized institution focusing on safe medication practices) indicated neuromuscular blocking agents have been inadvertently administered to patients who were not receiving proper ventilator assistance. Because the respiratory muscles were paralyzed, some patients have died or sustained serious, permanent injuries. The Alert indicated ISMP had received over 50 reports concerning misuse of these agents over the past several years.

The 12/18/14 ISMP Medication Safety Alert entitled "Tragic Error With Neuromuscular Blocker Should Prompt Risk Assessment by All Hospitals," indicated, "Preventing errors with neuromuscular blocking agents, including, rocuronium, must be given the highest priority at every hospital." This Alert indicated that hospitals institute error-reduction strategies such as identifying neuromuscular blockers available within the organization and where and how they are stored; storing them highly visible red storage container; affixing bright, easily visible warning labels on vials and admixtures that clearly communicate that respiratory paralysis will occur and that the patient must be intubated and ventilated; safeguarding storage in the pharmacy, etc.

3. On 5/5/15 at 11:35 a.m., during a visit to the ED accompanied by Pharmacist 1 and the ED Manager, six IV syringes containing a semi-clear gel-like solution were identified in the medication refrigerator. Pharmacist 1 stated the syringes contained lidocaine jelly, epinephrine, and tetracaine (L.E.T.), which the pharmacy compounded into a gel solution for ED use. The ED Manager said the L.E.T. gel was used as a topical anesthetic for relieving pain. The L.E.T. syringe had a luer-lock tip, making it compatible (connectable) with IV tubing, IV access device, or needles (whereas the oral syringe would not). Pharmacist 1 agreed that providing the L.E.T in such syringes presented a risk for them to be given via IV route inadvertently.

In the August 2012 Medication Safety Alert, ISMP indicated mis-administration errors, such as oral medication being given through the IV route, happen when there is a break in mental concentration.

An article entitled "Oral medications Inadvertently Given via the Intravenous Route" from the Pennsylvania Patient Safety Advisory, Vol. 10, No.3 - September 2013, indicated, "[C]ertain types of errors, including wrong-route errors, are more likely to result in patient harm compared with other error types, even though they may occur less often relative to other errors. For example, infusion of non-sterile, particulate fluid can be fatal, as it carries the risk of sepsis, diffuse intravascular coagulation, or emboli to major organs, which can to lead to organ damage and pulmonary embolism." As a risk reduction strategy, the Article indicated, "It is crucial to procure the appropriate drug delivery devices to help minimize the temptation to use devices intended for other routes of administration."

4. AcuDose (automated dispensing device) override is the process where the user removes the medication before the pharmacist reviews the order for appropriateness (assessing for correct dose, allergies, drug interactions, contra-indications, etc.)

The hospital policy and procedures entitled "Medication - Automated Dispensing Device," dated 12/2014, indicated "all medication orders shall be reviewed by a pharmacist prior to dispensing," and "[i]n the event of an urgent need for a medication, the override function should be used. Medications permitted for the override function must be approved by the P&T [Pharmacy and Therapeutics] committee."

On 5/6/15, the hospital staff provided a list of the hospital approved override-able medications, updated 1/2014, and a hospital-wide AcuDose override activities report for a 15-day period from 4/20/15 to 5/6/15.

On 5/6/15 at 2:45 p.m., a review of the AcuDose override activities report with Pharmacist 1 reflected certain non-approved medications were removed by the override function. For example, the Risby South (a rehabilitation unit) staff were able to remove metoclopramide (to treat nausea/vomiting) tablets and oral solution by override function on 4/23/15. Similarly, the report showed the Pediatric Unit staff were able to remove acetaminophen (generic for Tylenol) suspension and acetaminophen suppositories on multiple occasions by override function during this period. Neither metoclopramide nor acetaminophen were on the approved override list. Upon interview, Pharmacist 1 confirmed they were not on the approved override list and should not have been available for override.

On 5/6/15 at 3 p.m., Pharmacist 1 reviewed the AcuDose configuration in the AcuDose cabinet located in the Pediatric Unit and stated the override function was not configured correctly for acetaminophen suspension and suppository, thus allowing these medications to be available for override.

5. During an inspection of the [DIAGNOSES REDACTED] cart with Pharmacist 1 and licensed nurse (LN) 2 at approximately 3:45 p.m. on 5/5/15, a review of the cart content list reflected it listed the different types of medications but did not indicate the quantity (how many) of each medication the cart was to contain. LN 2 provided the hospital policy which indicated the cart was to have 5 sodium bicarbonate (to counteract situations when the blood contains too much acid) 50 milliequivalent (unit of measurement) vials. Inspection of the cart found 6 vials instead. Also, during this visit, chilled 1-liter sodium chloride 0.9% solution bags (to infuse intravenous to cool off hyperthermic patient) could not be located. LN 2 stated there were supposed to be 4 bags in the refrigerator.

[DIAGNOSES REDACTED] is a rare life-threatening medical emergency that is usually triggered by exposure to certain drugs used for general anesthesia. It is characterized by a rapid rise in a patient's temperature up to 110 degrees Fahrenheit or more. Timely management to regulate the patient's temperature is crucial in preventing fatal outcome.

6. On 5/6/15 at 10:45 A.M., Patient D105's medical record was reviewed. Patient D105 was admitted on [DATE] with necrotizing pancreatitis (an infection with inflammation of the organ called pancreas) with enlarged pseudocyst (a fluid-filled cavity resembling a cyst but lacking a wall or lining) per the history and physical (H & P), dated 5/3/15. The same H & P indicated Patient D105 had a medical history that included diabetes, hypertension (blood pressure), chronic pancreatitis (inflammation of the pancreas) and HLD ([DIAGNOSES REDACTED] -an abnormally high concentration of fats or lipids in the blood).

On 5/4/15 the physician ordered total parenteral nutrition (TPN) that included lipid (fat) to be infused at 45 grams per day.

On 5/6/15 at 10:45 A.M., a clinical registered dietitian (RD 103), and the Clinical Nutrition Manager (CNM) reviewed the labs that were ordered, and verified that a triglyceride level had not been ordered for the current admission prior to infusion of lipids via TPN. RD 103 reviewed the electronic medical record (EMR), and stated, "[Patient D105] had a recent admission to the hospital in April 2015 and her triglycerides were obtained then which were elevated at 260 [mg/dL- milligram per deciliter]." RD 103 stated that a triglyceride level should have been recommended to be obtained due to chronic pancreatitis and known history of elevated triglycerides.
On 5/6/15 at 2:15 P.M., the clinical coordinator (Pharmacist 1) stated it was the responsibility of the IV pharmacist position to monitor pertinent labs as related to TPN, including recommending to the physician to obtain a triglyceride lab value when indicated. Pharmacist 1 verified that there had not been an order for a triglyceride lab to be done, "and should've been" for Patient D105.
Concurrently, Pharmacist 1 stated that the hospital's approved "Adult Total Parenteral Nutrition Order Form" included, "Monitoring... Prior to start of TPN and every 3 days: ...triglycerides ..."
Concurrently, Pharmacist 1 stated that the TPN order set that hospital staff currently used was located in the EMR, "and the entire TPN order set had not been transferred over to the EMR system when we switched from the paper medical record back in October 2014. So the monitoring portion of the approved order set just got dropped off. It was an error." Pharmacist 1 clarified that the portion of the order set that "got dropped off " from the order set available to order from in the EMR included the monitoring portion of the TPN order set that included "Prior to start of TPN and every 3 days: Expanded Metabolic Profile, Triglycerides, pre-albumin..."
On 5/6/15 at 2:43 P.M., an IV Pharmacist reviewed Patient D105's medical record, and stated, "[Patient D105] should've had a triglyceride level recommended secondary to chronic pancreatitis." The IV Pharmacist acknowledged an error was made in regard to not recommending to the physician that a triglyceride lab value be obtained prior to infusion of lipids via TPN.
The hospital's policy and procedure entitled, "Parenteral Nutrition Preparation and Administration," Policy # CC04.1.2 reviewed 6/11, indicated, "Purpose; These policies and procedures are intended to provide uniform guidelines for the preparation and administration of parenteral solutions ..., Policy ...Lab studies should be evaluated before determining what TPN solutions should be prepared ..., XI. Monitoring of TPN solutions a. It is the responsibility of the IV pharmacist as the Nutritional Support Pharmacist to monitor the lab values of patients receiving parenteral nutrition. These values should be used as a guidelines in preparation of future TPN's. Any abnormalities in values should be conveyed to the attending physician prior to preparation of the mixtures. The pharmacist should be able to assist the physician by making any recommendations that will stabilize the patient with regards to the electrolytes and solutions used."
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
Based on observation, interview, and record review the facility failed to
1. Ensure open medications were not kept beyond 28 days.
2. Ensure multi use medications entering into patient environments were used for only one patient.

These failures had the potential to result in the spread of unwanted infections in patients, and the use of ineffective medications in the Gastrointestinal Lab (GI) procedure areas.

Findings:

According to the Centers for Disease Control (CDC), "Multi-dose vials should be dedicated to a single patient whenever possible. If multi-dose vials must be used for more than one patient, they should not be kept or accessed in the immediate patient treatment area. This is to prevent inadvertent contamination of the vial through direct or indirect contact with potentially contaminated surfaces or equipment that could then lead to infections in subsequent patients. If a multi-dose vial enters the immediate patient treatment area, it should be dedicated to that patient only and discarded after use." and, "If a multi-dose has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial."
A review of the facility's policy and procedure titled, "Storage", dated, 12/14, indicates "All medications will be stored in accordance with USP (United States Pharmacopeia) and manufacturer recommendations.....All expired, damaged, contaminated or deteriorated drugs will be removed from stock."

During an observation of the Gastrointestinal Lab (GI) area, on 5/7/14 at 3:00 p.m., there were five GI procedure rooms. One GI procedure room , room 2 was being utilized for storage of equipment. All other rooms were being utilized for GI procedures on patients. GI room 5 was noted to have an unlocked medication cart in the room. There was a multiuse canister of Hurricane Spray (a topical anesthetic spray often used for sore throats) which was opened on 3/31/15 and was not discarded after 28 days.
During an observation of GI procedure room 4, on 5/7/15 at 3:05, p.m., there was an unlocked medication cart with two Narcan 0.4 milligrams/milliliter injections (a medication used to counter the effects of opioids) both with an expiration date of 5/1/15.
During an observation of GI procedure room ,3 on 5/7/15 at 3:10 p.m., there was an unlocked medication cart which had multiuse Mylicon infant drops which were opened on 3/31/15 and not discarded after 28 days. There was a multiuse bottle of Lidocaine, Hydrochloride topical solution 4% which was opened and used but had no open date on it.

During an observation of GI procedure room 1, on 5/7/15 at 3:15 p.m., there was an unlocked medication cart with had multiuse Mylicon infant drops which were opened on 3/12/15 and not discarded after 28 days, a multiuse canister of Hurricane Spray opened and used with no opened date on it, and a multiuse bottle of Lidocaine, Hydrochloride topical solution 4% which was opened and used but had no open date on it.

During an interview with the GI Clinical Manger (GICM), on 5/7/15 at 3:20 p.m., the GICM indicated it was the responsibility of the nurses to check the carts for expired or outdated medications, and to lock them. The GICM also acknowledged that multiuse medications that have entered the GI procedure rooms are to be used for only one patient. The GICM stated, "You are correct the carts should be locked, and the multiuse medications should be discarded after 28 days, that is our policy."
VIOLATION: DIRECTOR OF DIETARY SERVICES Tag No: A0620
Based on observation, interview and record review, the director of the food and dietetic services failed to ensure dietary staff maintained safe food handling and sanitation practices when 1) TCS foods (TCS are foods that require time/temperature monitoring for food safety to inhibit bacterial growth) were consistently documented on a cool-down log, 2) A container of raw meat was stored directly against a container that stored raw vegetables, 3) Cooked chicken breasts located in the walk-in refrigerator was undated, and 4) The wash water of the 3-compartment sink was not maintained at the required temperature.
As a result, the highly susceptible patients (persons who are more likely than the general population to experience food borne illness and becoming ill if they ingest microorganisms or toxins) were placed at risk for a food borne illness.
Findings:
1. On 5/4/15 at 11:40 A.M., inside the walk-in refrigerator was a pan of cooked meatloaf that was covered with a plastic wrap and dated "5/3." There was a pan that contained pork, dated "5/2", and another pan was labeled as Thai noodle, dated "5/3". The executive chef (EC) stated that the dates indicated the day the food was cooked at the hospital.
Concurrently, the EC confirmed that the above items should have been cooled down, and documented on a cool down log. The EC reviewed the cool down log, and stated, "None of those items [meatloaf, pork, Thai noodle] are on the cool down log, and should've been." Review of the cool down log, dated 5/4/15, indicated a notation by cooks that eleven TCS foods began the cool down process as a time and temperature of initial cool down was documented. However, columns on the log for further required time and temperature was left blank. The documented cool-down process was not completed for 9 of the 11 TCS foods located on the log.
The EC stated that Cook 1 had cooked the pork and Thai noodle. On 5/4/15 at 12:10 P.M., Cook 1 was unable to locate documentation on a cool down log for the pork and Thai noodle that had been cooked on 5/2/15, and 5/3/15. Cook 1 was able to verbalize the proper cool down procedures in accordance with the directions on the cool down log.
According to the EC, another cook (Cook 2) had cooked the meatloaf on 5/3/15, which was not documented on the cool down log. Cook 2 was not available for an interview on 5/4/15.
On 5/4/15 at 4:30 P.M., during a joint interview with the EC, and the director of the food and dietetic services (DFDS), both acknowledged that they were unaware as to the extent in which the cooks had potentially not been documenting the cool down of TCS foods. The EC confirmed that the hospital utilized the method of pre-cooking which would require cool down on a daily, high volume basis. The EC and the DFDS acknowledged there had not been an effective oversight system in place to ensure cool down procedures for TCS foods were consistently implemented in accordance with the hospital's expectations.
According to the hospital's log entitled, "Cooling Food Temperature Log", the following were the directions; "Start temperature is 135 degrees F [Fahrenheit], cool from 135 degrees F to 70 degrees F in 2 hours, then from 70 degrees F to 41 degrees F in 4 hours ..."
The hospital's policy and procedure entitled, "Cooling Cooked Foods", Policy # 8340.155 revised on 1/5/15, indicated, "Goal: To insure safety and avoid contamination when cooling cooked food items. Policy: The rapid cooling of potentially hazardous foods shall be accomplished accordance with the time and temperature criteria ..."
Safe cooling requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of potentially hazardous foods (time/temperature control for safety foods) has been consistently identified as one of the leading contributing factors to foodborne illness. (FDA Food Code 2009: Annex 3 - Public Health Reasons / Administrative Guidelines - Chapter 3, Food 3-501.14 Cooling).
2. On 5/4/15 at 11:45 A.M., inside the walk-in refrigerator, on a lower shelf of a utility cart was a pan that contained raw turkey, dated 5/3/15, which was directly touching another pan that contained raw vegetables. The Executive Chef (EC) stated that the raw turkey should not have been stored on the same shelf as raw produce.
Concurrently, the director of the food and dietetic services (DFDS) was present for the above observation and stated that dietary staff were trained to store thawing meat and poultry in another walk-in refrigerator that was designated just for that purpose. The DFDS acknowledged dietary staff had not followed the hospital's expected procedures for storage of thawing poultry to help prevent cross-contamination.
On 5/4/15 at 4:30 P.M., the EC and DFDS stated dietary staff were trained to to follow an in-service training that was provided entitled, "Cross Contamination; Causes, Storage and Prevention", that indicated, "How contamination occurs ...raw food or juices that come in contact with ready to eat food ..., Storage to avoid cross contamination ...all raw meats and fish should be stored separately from cooked or ready to eat foods at all times ..., bottom shelf all raw poultry, raw turkey ..."
3. On 5/4/15 at 11:50 A.M., inside the walk-in refrigerator, was a pan with two chicken breasts on the pan, undated. The executive chef (EC), in the presence of the director of the food and dietetic services (DFDS), stated the chicken breasts were cooked chicken breasts that were undated, and "should've been dated." The EC and DFDS acknowledged that dietary staff was to date foods when cooked in order to implement the hospital's shelf life policy and procedure to ensure food safety and/or food quality.
The hospital's policy and procedure entitled, "Labeling and Dating of Prepared Items", Policy # 8340.114 revised on 1/2/15, indicated, "Goal: To ensure that all food items prepared in the Department of Nutrition are covered, labeled, and dated to maintain the safety of food and to prevent the spread of food-borne illness. Policy: ...Food items which are prepared and not served are stored appropriately, and are at all times clearly labeled and dated ..., Procedures: 1. Label and date all unused prepared food items, using a label gun, sticker with a marker, or a marker alone. 2. The label will indicate what the food item is and the date it was prepared. 3. Food service personnel, cooks, and supervisors will check unused, prepared food at the beginning of their shift and throughout the day. 4. Food service personnel will throw out leftover/prepared food held at 41[Fahrenheit] degrees or lower after 7 days. The day of preparation shall be considered Day 1 ..."
4. On 5/4/15 at 12:25 P.M., inside the kitchen, there was stainless steel pans located in the wash water of the 3-compartment sink. A dietary employee (DE 3) verified that the 3-compartment sink was currently in use. DE 3 stated that the pans would be washed, rinsed, sanitized followed by air dry, and then "would be available for use."
DE 3 stated that the process for the 3-compartment sink was to check the sanitizer of the third compartment with sanitizer test strips which was documented on a log for breakfast, lunch and dinner. DE 3 verified that he was not required to check the temperature of the wash water of the 3-compartment sink, and had not known how hot the wash water should have been.
Concurrently, DE 3, in the presence of two Patient Food Service Managers (PFSM 1), PFSM 2, and the director of the food and dietetic services (DFDS), DE 3 was requested to check the temperature of the wash water of the 3-compartment sink, and stated, "It's 108 degrees F [Fahrenheit]."
The PFSM 1 stated, "The wash water should be 110 degrees F." PFSM 1, PFSM 2, and the DFDS acknowledged that monitoring the wash water temperature of the 3-compartment sink, while in use, had not been incorporated into the daily practice/system.
The PFSM, and DFDS, stated that there was guidance located in PFSMs office, entitled "3 Compartment Sink", undated, that indicated, "2. Wash items in the first sink in a detergent solution. Use a brush, cloth or scrubber to loosen ..., 5. All washed, rinsed and sanitized items should be placed on a clean drain board to air dry ..., Task: Refilling Compartments; Each compartment must be refilled at the beginning of each meal period or as needed."
According to standards of practice in the food service industry, the manual wash solution temperature is essential for removing organic matter. If the temperature is below 110 degrees F, the performance of the detergent may be adversely affected, e.g., animal fats that may be present on the dirty dishes would not be dissolved. (FDA Food Code 4-501.19)
VIOLATION: QUALIFIED DIETITIAN Tag No: A0621
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure Registered Dietitians recommended a triglyceride level in order to monitor the nutritional aspects of patient care, as related to administration of lipids via total parental nutrition (TPN) for 3 of 59 sampled residents (D105, D106, D109).
As a result, the patients receiving TPN with lipids were placed at risk for a potential adverse health consequence
Findings:
On 5/6/15 at 10:45 A.M., Patient D105's medical record was reviewed. Patient D105 was admitted on [DATE] with necrotizing pancreatitis (an infection with inflammation of the organ called pancreas) with enlarged pseudocyst (a fluid-filled cavity resembling a cyst but lacking a wall or lining) per the history and physical (H & P), dated 5/3/15. The same H & P indicated Patient D105 had a medical history that included diabetes, hypertension (blood pressure), chronic pancreatitis (inflammation of the pancreas) and HLD ([DIAGNOSES REDACTED] -an abnormally high concentration of fats or lipids in the blood)
On 5/4/15 the physician ordered total parenteral nutrition (TPN) that included lipid (fat) to be infused at 45 grams per day.
On 5/6/15 at 10:45 A.M., a clinical registered dietitian (RD 103), and the Clinical Nutrition Manager (CNM) reviewed the labs that were ordered, and verified that a triglyceride level had not been ordered for the current admission prior to infusion of lipids via TPN. RD 103 reviewed the electronic medical record (EMR), and stated, "[Patient D105] had a recent admission to the hospital in April 2015 and her triglycerides were obtained then which were elevated at 260 [mg/dL- milligram per deciliter]."

Concurrently, RD 103 reviewed the Nutrition Assessment, dated 5/3/15, that indicated, "Nutrition Consult ordered for TPN recommendations ..., Plan of Care: ...Once PICC [central line] placed recommend TPN with 65 g [gram] protein, 200 g dextrose, and 48g lipids to run at 60ml/hr ..." RD 103, and the CNM, stated that a triglyceride level should have been recommended to be obtained due to chronic pancreatitis and known history of elevated triglycerides. RD 103, and the CNM verified that lipid recommendations for the TPN were provided without recommendations to obtain a triglyceride level before infusing lipids, and should have been included in a comprehensive nutrition assessment as related to TPN. RD 103 reviewed two other nutrition assessments/notes dated 5/4/15 and 5/5/15, and noted that although lipids were being recommended, an RD had not recommended a triglyceride level to be obtained.
At that time, RD 103, and the CNM, reviewed the nutrition assessments and labs specifically for a triglyceride list for the following patients that were listed on a TPN list (D105, D106, D107, D108, and D109). Three of the five patients listed had an RD recommending lipids via TPN without recommending a triglyceride lab be ordered. Out of those three patients, RD 103 and the CNM verified that a triglyceride lab value had not been ordered and obtained for those patients who received lipids via TPN. The nutrition assessments for those patients on TPN included, "Monitor intake, tolerance ..." The CNM acknowledged that without the benefit of obtaining a triglyceride level the plan to monitor tolerance to the lipids would not have been effectively implemented. The CNM was asked if the hospital had specific guidance to the RD's on what to include in recommendations as related to a nutrition assessment that involved TPN, and she stated, "It's not that specific, it is just standards of practice."
On 5/6/15 at 2:15 P.M., a pharmacist (Pharmacist 1) verified that there had not been an order for a triglyceride lab to be done, "and should've been" for Patient D105.
Concurrently, Pharmacist 1 stated that the hospital's approved "Adult Total Parenteral Nutrition Order Form" included, "Monitoring ...Prior to start of TPN and every 3 days: ...triglycerides ..."
The Clinical Nutrition Manger acknowledged that the dietitian's had not consistently incorporated recommending a triglyceride level when recommending lipids to be infused via TPN, in order to implement the plan for monitoring for tolerance.
VIOLATION: DIETS Tag No: A0630
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to document that nutritional supplements was provided to 2 of 59 sampled patients as ordered by the practitioner responsible for the care of the patient. In addition, there was lack of a system to document percent consumption of a planned nutrition intervention in order to monitor for effectiveness, and evaluate intake as related to assessed nutritional needs. Further, the hospital failed to develop nutrition care plans to reflect specific nutrition interventions that were planned for patients to address an identified nutritional concern. Lack of specific individualized nutrition care plans impedes effective communication to the multidisciplinary health care team responsible for monitoring the dietary and nutritional intake status of patients. (D101, D102)
As a result of ineffective monitoring of nutritional status, the patients were placed at risk of an inaccurate nutrition assessment that had the potential to negatively impact the medically fragile patients.
Findings:
1.On 5/5/15 at 3:45 P.M., Patient D101's medical record was reviewed. Patient D101 was admitted on [DATE] with an admission diagnosis of hypoxic respiratory failure (failed respiratory system with insufficient oxygen in the blood) per the Patient Facesheet.
On 5/4/15 at 1:26 P.M., the physician ordered Boost (an oral nutrition supplement for increased calories and protein) with breakfast and dinner for Patient D101.
On 5/5/15 at 3:45 P.M., a clinical registered dietitian (RD 103), in the presence of the Clinical Nutrition Manager (CNM) stated that if the Boost was documented by nursing staff, it would be located in the electronic medical record (EMR), on the flow sheet under a category entitled "Dietary Intake". RD 103 reviewed the dietary intake section on the flow sheet for 5/4/15 (for dinner meal), and 5/5/15, and stated, "There is nothing documented under dietary intake at all." RD 103 then clarified, and stated, "Sometimes nursing will document the percent po [by mouth] intake, and if so, the Boost supplement would be included in the overall dietary intake with other foods eaten from the meal tray." RD 103 stated, "I would have to ask the patient or the nurse if the patient was drinking the supplement." RD 103 acknowledged that lack of documentation of the specific nutrition intervention ordered (Boost), and quantity consumed, impeded effective and accurate monitoring of nutritional intake as compared to assessed nutritional needs.
On 5/5/15 at 4:24 P.M., a licensed nurse (LN 104) was asked to show the documentation that the order for Boost for dinner on 5/4/15, and breakfast for 5/5/15 was implemented. LN 104 stated that the physician ordered Boost was not specifically documented but that it would be included in the documentation of the overall percentage of the meal consumed. LN 104 stated the po (by mouth) diet intake should be documented on the flow sheet under the category of "Dietary Intake" as a "% Consumed." LN 104 reviewed that area for Patient D101 in the EMR, and stated, "There is zero documentation." LN 104 acknowledged there was no documentation of % consumption from the dinner or breakfast meal tray for 5/4/15, and 5/5/15, and verified there was no documentation in the medical record that the physician order for Boost was implemented.
Concurrently, the Clinical Nutrition Manager (CNM) and the Director of the Food and Dietetic Services (DFDS) was able to show via a meal tray ticket that the kitchen was providing the Boost to Patient D101. However, the hospital had not ensured a system for nursing oversight and documentation in the medical record that a physician ordered nutrition supplement (Boost) was given, lacked a method to document percent consumption of the planned nutrition intervention in order to monitor consumption/effectiveness, and inconsistently documented percent consumed from meals which impeded implementation of the hospital's nutrition assessment and re-assessment, and nutrition screening policies and procedures.
During the same interview, LN 104 stated that an interdisciplinary nutrition care plan had not been developed for Patient D101. LN 104 stated, "Nursing must not have identified the need for a nutrition care plan."
On 5/6/15 at 2:21 P.M., nursing administration (NA) stated, "A nutrition care plan should have been generated when there are specific interventions."
The hospital's policy and procedure (P & P) entitled, "Nutrition Assessment and Reassessment Policy", Policy # 8340.43 revised 1/7/15, indicated, "Policy: Nutrition assessment is completed for all acute patients identified by screening/re-screening to be at moderate or high nutrition risk, for any patient for whom a consult is ordered by a physician, and/or for all outpatients on initial intervention ..., 3. The Dietitian will evaluate available data to determine the appropriate intervention(s) required. All initial assessments will include evaluation of dietary history, current intake ..., evaluation and calculation of patients calorie, protein and fluid needs;..."
The hospital's P & P entitled, "Nutrition Screening Policy: Adult", Policy # 8340.42 revised 1/7/15, indicated, "Goal: To facilitate timely intervention/assessment for patients identified to be at moderate to high risk for malnutrition ..., 11. Re-screening will include a review of the following: Average intake and tolerance of diet ..."
The hospital's P & P entitled, "Nursing Documentation on Patient Record", Policy : N10.11 reviewed 11/14, indicated, "Purpose: To document the course and treatment of the patient's condition during the hospital stay ..., v). Documentation should relate to the individualized care plan for the patient ..., I) ii). Care planning includes the plan of care, goals and disciplines involved with care ..."
2. On 5/6/15 at 10:45 A.M., Patient D102's medical record was reviewed. Patient D102 was admitted on [DATE] with an admitting diagnosis of local skin infection per the Patient Facesheet.
On 5/1/15 the physician ordered renal high protein shake (specific to kidney disease) for breakfast, lunch and dinner, daily, for Patient D102.
On 5/6/15 at 10:50 A.M., a clinical registered dietitian (RD 104) and the Clinical Nutrition Manager (CNM), reviewed Patient D102's medical record and verified there was no documentation that the specific order for the renal high protein shake for breakfast, lunch and dinner was documented as being provided, and thus there was no documentation of percent intake for the specific planned nutrition supplement. In addition, record review on the flow sheet under "Dietary Intake" under "% Consumed" showed the column was left blank for six of thirteen meals that were provided, thus not indicating percent consumption of meal consumed.
Record review of a nutrition re-assessment completed by a clinical registered dietitian on 5/4/15 for Patient D102 indicated, "...unsure if she drinks shakes, ...Loss unintentional 7% weight loss over unspecified amount of time ..., follow up plan ...monitor intake ..." According to record review, Patient 102 had lost weight prior to admission, unintentionally.
Concurrently, RD 104 verified that the hospital had not had a system to document the specific physician order for an oral nutrition supplement, such as the renal high protein shake, which had a negative impact on the accuracy of a nutrition assessment, re-assessment, and nutrition screening. The CNM was able to verify that the renal high protein shake was being provided from the kitchen with meals three times a day to the patient as ordered, but acknowledged there was lack of documentation in the medical record to ensure the order/treatment was implemented, thus not providing an effective means for monitoring to ensure the nutritional needs of the patient are met.
Concurrently, RD 104 verified that hospital staff had not developed a nutrition care plan for Patient D102.
On 5/6/15 at 2:21 P.M., nursing administration (NA) stated, "A nutrition care plan should have been generated when there are specific interventions."
The hospital's policy and procedure (P & P) entitled, "Nutrition Assessment and Reassessment Policy", Policy # 8340.43 revised 1/7/15, indicated, "Policy: Nutrition assessment is completed for all acute patients identified by screening/re-screening to be at moderate or high nutrition risk, for any patient for whom a consult is ordered by a physician, and/or for all outpatients on initial intervention ..., 3. The Dietitian will evaluate available data to determine the appropriate intervention(s) required. All initial assessments will include evaluation of dietary history, current intake ..., evaluation and calculation of patients calorie, protein and fluid needs; ..."
The hospital's P & P entitled, "Nutrition Screening Policy: Adult", Policy # 8340.42 revised 1/7/15, indicated, "Goal: To facilitate timely intervention/assessment for patients identified to be at moderate to high risk for malnutrition ..., 11. Re-screening will include a review of the following: Average intake and tolerance of diet ..."
The hospital's P & P entitled, "Nursing Documentation on Patient Record ", Policy : N10.11 reviewed 11/14, indicated, "Purpose: To document the course and treatment of the patient's condition during the hospital stay ..., v). Documentation should relate to the individualized care plan for the patient ..., I) ii). Care planning includes the plan of care, goals and disciplines involved with care ..."
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
Based on observation and interview, the facility failed to ensure the maintainance of equipment in the sterilization room. The two separate sinks had a backflow preventer that had a rusted and corroded air gap fitting. One of the two sinks had two elbow drains underneath the sink that leaked. These failures had the potential to result in contamination of surgical equipment or materials being processed with rust and posed a hazardous working condition for staff.

Findings:

During an observation on 5/6/15 at 3:20 p.m., in the sterilization room, the two sinks had a backflow preventer. A component of the backflow preventer was an air gap fitting. On both sinks, the air gap fitting was rusty and corroded. One of the sinks had two drainage elbow pipes that were leaking. One elbow pipe drain had a basin underneath to collect leaking water while the other elbow pipe drain leaked water to the floor.

During an interview with the sterilization area department manager (SADM), on 5/6/15, at 3:25 p.m., the SADM was asked, "Were you aware of these problems and what did you do?" The SADM stated, "I was not aware of these problems but since I am now, I'll have them fixed."
VIOLATION: INFECTION CONTROL OFFICER(S) Tag No: A0748
Based on observation, interview and record review, the hospital failed to maintain infection control practices when a 3-compartment sink in sterile processing was used for dual purposes for surgical instruments, as well as to clean food utensils used to fortify (add calories and protein) formulas for the infants in the neonatal intensive care unit (NICU). In addition, an inappropriate sanitizer was used to sanitize the counter top that was designated for use for fortifying breast milk located in the NICU.

As a result, the immunocompromised infants were placed at a higher risk for an adverse health consequence.

Findings:

1.On 5/5/15 at 8:45 A.M., the clinical manager (D111) of the neonatal intensive care unit (NICU) stated the nursing staff would sanitize the counter top where fortifying of breast milk occurred, if ordered, for the infants in the NICU. The sanitizer was "Super Sani-Cloth" which had a manufacturer's label located on the container that indicated, "To disinfect nonfood contact surfaces only."

On 5/5/15 at 10:45 A.M., the hospital's infection control professional (ICP) was asked if Super Sani-Cloth was appropriate for a food contact counter which was used for fortifying breast milk in NICU. The ICP read the manufacturer's guidance from the label on the container of the sanitizer, and stated, "Should not be used on a surface that could be introduced directly into the human body." The ICP asked, "Did the nurse say she placed any food preparation equipment directly on the counter?"

On 5/5/15 at 10:55 A.M., in the presence of the ICP, and the Clinical Nutrition Manager, an interview with a licensed nurse (LN 112) in the NICU was conducted. LN 112 stated, "First, I sanitize the counter top with the sanitizer with the purple lid for preparation to fortify breastmilk with a liquid protein fortifier. I place the bottle, the bag to store the breastmilk and the container of liquid fortifier directly on the counter top." At that time, LN 112 verified that the "sanitizer with the purple lid" was the Super Sani-Cloth. The ICP acknowledged that an inappropriate sanitizer was used for the food contact preparation counter. A specific policy as to cleaning and sanitizing the food contact counter space specifically in NICU was not available.

The hospital's policy and procedure (P & P) entitled, "Procedure for Tube Feeding and Mixed Formula Initiation, Preparation and Delivery for Pediatric Patients", Policy # 8340.305 revised 3/5/15, indicated, "2. Work area for formula preparation; a. Before infant formula is prepared, all work surfaces must be cleaned with an antibacterial sanitizing solution that is appropriate for food contact surfaces..."

2. On 5/5/15 at 9:00 A.M., a registered dietitian (RD 113) stated that foodservice utensils (beakers, measuring spoons and containers) that were used for fortifying formula, when ordered, for the infants in the neonatal intensive care unit (NICU) were cleaned and sanitized in the hospital's sterile processing department.

On 5/6/15 at 8:25 A.M., the director of the food and dietetic services (DFDS) stated that there was a designated 3-compartment sink located in the sterile processing department that was used only for cleaning and sanitizing of the food service utensils used to fortify formula for the infants in NICU, when ordered by the physician.

On 5/6/15 at 3:45 P.M., an observation of the sterile processing department was conducted. One three compartment sink was being utilized to clean nutritional items used in fortifying infant formulas as well as being used as an area to process and clean dirty equipment from different hospital procedures. There were two leaking drain pipes underneath the three compartment sink which was designated for equipment and instrument processing only. Both drain pipes were covered in white hard substance with black and green coloration in it.

During an interview with the SADM, on 5/6/15 at 3:55 p.m., the SADM indicated the sinks should have been reported to maintenance for repairs, but that he did not notify maintenance about the sink problems. The SADM also stated, "We use the sink that is dedicated for nutritional purposes to process instruments and other equipment at least two to three times a week."

On 5/6/15 at 4:15 P.M., the above observation of the sink in sterile processing used for cleaning of food service utensils that pertained to feedings provided to infants in the NICU was shared with the DFDS, and the CNM. The DFDS verified that it was his expectation that the sink used for cleaning of foodservice equipment was used only for that purpose. The DFDS stated, "I am disappointed to hear that. We will stop this practice immediately. That is not a safe and sanitary practice."

The hospital was unable to provide a policy and procedure that was specific to cleaning of the foodservice utensils used to prepare the fortified formulas used for the infants in NICU.






Based on observation, interview, and record review the facility failed to ensure policies and procedures for infections control were followed by staff members in the facility with regard to:
1. Isolation precautions.
2. Proper cleaning of Sterilizer units.
3. Proper maintenance of sinks used to clean items in the sterilizer processing area.
4. Following manufacturers recommendations for properly disinfecting surgical equipment in
the operating room.
5. Using appropriate skin disinfectant prior to lumbar puncture.
6. Storage of emergency oxygen tanks, and compressed air tanks in the biohazard room.

These failures had the potential to spread unwanted germs throughout the facility thus placing all patients at risk for infections.

Findings:

1. A review of the facilities policy and procedure entitled, "Isolation Precautions", dated, 01/15, indicated for "Contact Precautions...Gown and glove before entering the room....and for HCP (health Care providers)/Visitor protection, Wear gloves and gown when entering the room", and, "Do not leave the environment without first cleaning contaminated surfaces."

During an observation of the pediatric intensive care unit (PICU) on 5/5/15 at 2:30 p.m., two licensed nurses (LN's) were observed providing care to a newly admitted patient (N305). Both LN's were noted to be wearing personal protective equipment (PPE). They both had gowns, gloves, and were wearing facemasks. The sign posted outside the door indicated the patient was on contact isolation precautions. A radiology technician was noted to observe the sign, put on a gown and gloves and enter the patient care area. The physician was asked what kind of precautions the patient was on by the Pediatric Clinical Manager (PCM). The physician's response was, "Droplet precautions".

During an interview with the PCM on 5/6/15 at 2:35, "The PCM indicated this was a new patient."

A review of patient N305's record revealed an order for Droplet precautions was entered into the computer system by the physician at 13:26 (1:26 p.m.). The order for Contact precautions was not entered until 18:33 (6:33 p.m.).

During an observation on 5/7/14 at 10:00 a.m., Patient N305's signs outside the room indicated Patient N305 was on droplet and contact isolation precautions. A hospital staff case manager (CM), was observed in Patient N305's room, wearing a mask and gloves, sitting and talking to the parents of Patient N305. The CM then exited the isolation room carrying a small foldable stool. The CM did not have a gown on while in Patient N305's room.

During an interview with the CM, on 5/7/14 at 10:05 a.m., the CM stated, "I can take this stool anywhere and in any room because it doesn't touch anything but the floor." When asked about the type of precautions Patient N305 was on, the CM indicated contact precautions and had to be prompted to realize there was a second isolation sign posted. The CM stated, "I don't need to wear a gown because, I am not in contact with the patient."

During an interview with the PCM, and the Director of Children's Services (DCS), on 5/7/14 at 10:15, a.m., both the PCM and the DCS indicated it was facility policy that all staff members wear gowns for droplet and contact precautions. The PCM stated, "I can't believe she went in there without a gown." The DCS stated, "Anyone entering an isolation room on the pediatric unit is supposed to wear a gown."

2. During an observation and concurrent record review of the sterilizer units on 5/6/15 at 3:20 p.m., there was no documentation found showing daily cleaning of the sterilizer units.

During an interview with the sterilization area department manager (SADM), on 5/6/15 at 3:25 p.m., the SADM stated, "No we do not document daily cleaning of the sterilizer units. We do weekly cleaning and then have the machines deep cleaned and checked on an annul basis."

During a review of the manufacturer's instructions and concurrent interview with the SADM, on 5/7/15 at 11:30 a.m., for all three types of the viewed sterilizer units being utilized in the facility manufactureres instructions revealed all have directions and recommendations for daily cleaning of the units. The SADM acknowledged the manufacturer's recommendations for daily cleanings and stated, "We will correct this and fix the daily cleaning so there is a log of what we are doing."

3. During an observation of the sterile Processing area, on 5/6/15, at 3:45 p.m., two three compartment sinks were observed to be in use for cleaning of supplies and equipment used for procedures within the facility. Both sinks had a large pipe fitting with an open area where water flows though (air gap). The air gap portion of the pipe is open to the outside environment and is corroded with white, blue, and dark red colored substance noted where water can come in contact with those surfaces before being used to clean items used in procedures. One three compartment sink was being utilized to clean nutritional items used in fortifying infant formulas as well as being used as an area to process and clean dirty equipment from different hospital procedures. There were two leaking drain pipes underneath the the three compartment sink which was designated for equipment and instrument processing only. both drain pipes were covered in white hard substance with black and green coloration in it.

During an interview with the SADM, on 5/6/15 at 3:55 p.m., the SADM indicated the sinks should have been reported to maintenance for repairs, but that he did not notify maintenance about the sink problems. The SADM also stated, "We use the sink that is dedicated for nutritional purposes to process instruments and other equipment at least two to three times a week."

4. During an interview with environmental services (EV 1), on 5/5/15, at 10:10 a.m., EV 1 said they used LpH (type of germicidal detergent) to disinfect all the operating room equipments and surfaces. A review of the label on the LpH container indicated manufacturers recommendation is to leave the surface wet for 10 minutes with Lph solution. When EV 1 was asked how they were able to ensure that the surface remained wet for 10 minutes, EV 1 could not answer the question.

During an interview with the clinical manager of surgery (CMS), on 5/5/15, at 10:15 a.m., CMS stated, "We do not track the time."

5. During an observation of a spinal epidural (anesthesia produced by the injection of an anesthetic into the lumbar area of the spine) on 5/7/15, at 7:20 a.m, the patients' skin by the lumbar area was disinfected using ChloraPrep with Tint. The package label of the ChloraPrep with Tint had a warning:
Do not use: for lumbar puncture.

The National Center for Biotechnology Information (NCBI) study titled, Neurologic complications after chlorahexidine antisepsis for spinal anesthesia indicated, "It is not approved by the US Food and Drug Administration for use before lumbar puncture because of absence of clinical safety evidence."

6. During an observation on 5/5/15, at 9:50 a.m., in the biohazard room of the operating room, emergency tanks for oxygen and compressed gas were stored inside the biohazard room. The biohazard room also stored soiled linens, cleaning carts for the operating rooms, suction machines, and biohazard wastes from the operating room. The suction machines are sanitized in the biohazard room in close proximity to the oxygen and compressed tanks. These emergency tanks are used inside the sterile operating rooms.
VIOLATION: REASSESSMENT OF DISCHARGE PLANNING PROCESS Tag No: A0843
Based on record review and interview the facility failed to ensure there was a process in place to collect data from post acute providers regarding the discharge planning process. This failure had the potential to affect the discharge planning process for all patient's.

Findings:

A review of the discharge planning policy and procedure showed there was no process in place to collect data from outside providers regarding how the discharge plan was working for the patient.

During an interview with the Manager of Case Management (MCM) on 5/7/15 at 11:05 a.m., the MCM stated, "We are developing the process to collect data from providers, home health agencies, and the community, but we don't have one in place yet."