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Based on interview and record review the facility failed to follow its Grievance process for one of two sampled patients (Patient 9) when Patient 9 was sent a resolution letter that exceeded the 30-day resolution time frame, and the letter did not have a completed date. This resulted in Patient 9 not receiving the resolution of her grievance in a timely manner and could possibly negatively affect the quality of care of other patients.

Findings:

During a review of Patient 9's Face Sheet (provides patients demographics, date of birth, admission date, contact numbers and address, insurance information, admitting diagnosis and more) it indicated Patient 9 arrival to the Emergency department (ED) was on 5/13/22 and a discharge date of 5/14/22.

During a concurrent interview and record review on 10/13/22, at 11:20 a.m. with the Patient Relations and Patient Experience coordinator (PRPE), a list of patient grievances from 7/1/22-9/28/22 were reviewed. The PRPE confirmed Patient 9 had submitted a grievance and was on this list. Pt 9 submitted the grievance on 8/5/22 to the Central Business Office for the date of service of 5/14/22.

During a review of the email sent to the PRPE on 10/13/22 at 1:05 p.m., the email indicated Patient 9's name call back number and "Description of call: Patient is disputing the Nurse Auditor findings for DOS [date of service] 5/14/2022. Patient message is as follows: Hello, I received a letter stating that the audit was conducted and the documentation for my visit supports a level 3. I am disputing this on record as there were NO tests ran, I saw a nurse, not a physician, and was not treated aide from being told form the NP [nurse practitioner] looking at me for less than 5 minutes, touching my skin for less than 10 seconds and telling me my issue was "too complicated". This is my formal dispute of this level 3 charge ... Thank you in Advance ..."

During a concurrent interview and record review on 10/13/22, at 1:57 p.m., the PRPE provided Patient 9's Resolution letter sent by the facilities Central Business Office, dated 9/15/22 was reviewed. The PRPE stated this resolution letter does not follow the facilities policy which states we will have a resolution and letter sent out within 30 days of receipt of the grievance, nor did it contain the completion date of the investigation. The PRPE stated she was not sure if the business office followed the same grievance policy as the facility.

During a concurrent interview and policy review on 10/14/22, at 3:10 p.m., with the PRPE, the following two facility policies were reviewed: 1) "Patient and Family Complaint/Grievance" dated 11/4/21 and 2) "Hospital Account Adjustments Policy for Quality of Care Complaints and Adverse Events including Hospital Acquired Conditions" dated 3/14/19. The PRPE pointed out in the first policy Patient and Family Complaint/Grievances there is this statement " ... (Billing issues are not usually considered grievances, but for this exception.) A complaint is a grievance when the patient or the patient's representative requests their complaint be handled as a formal complaint or grievance, or when the patient request a response from the hospital ... Procedures ... E. ... Every effort will be made to complete the follow-up within 7 days from the date the complaint/grievance is received. If the grievance will not be resolved, or if the investigation is not or will not be completed within the 7 days, an effort will be made to inform the patient/ patient representative of the status of the complaint/grievance and that the hospital will follow up with a written response within 30 days ..." The PRPE confirmed that the second Policy provided titled "Hospital Account Adjustments Policy for Quality of Care Complaints and Adverse Events including Hospital Acquired Conditions" dated 3/14/19 had no time frames in which they are required to resolve the issue. The PRPE stated the facility is going to start changing their process so they can control when the resolution letters go out and they are able to keep better track of the resolutions.

Based on interview and record review the hospital failed to follow their policy and procedure titled "Condition of Admission (COA- a document that represents a contract between the patient and the hospital and is intended to be an informed consent process to protect the patient. The COA is a legal document that ensures an ongoing communication process between the patient and the healthcare provider)," when the COA for two of 30 patients sampled (Patient 1 and 2) were not completed. This had the potential for Patient 1 and Patient 2 to be treated without their consent.

Findings:

During a review of Patient 1's Face sheet (provides patients demographics, date of birth, admission date, contact numbers and address, insurance information, admitting diagnosis and more) with admission date of 1/13/22, indicated Patient 1 is a 55-year-old man admitted to the hospital with Pneumonia (lung infection) due to COVID-19 virus (infectious disease caused by the SARS CoV-2 virus. Has multiple signs and symptoms, including respiratory issue).

During a concurrent interview and record review on 10/12/22, at 2:15 p.m., Patient 1's Conditions of Admission (COA) form was reviewed with the Float Pool Manager (FPM). The FPM confirmed that Patient 1's COA was not filled in correctly, it was missing the "Witnesses (2) only required for telephone consent, physical inability to sign, or signature by mark ..." The FPM confirmed that on the patient signature line was the word "verbal".

During a review of Patient 2's document titled, "Critical Care Consult," date of 6/19/22, the Critical Care Consult indicated, "Chief Complaint: melena (dark sticky feces containing partly digested blood) ... 65 year old female ... who presented to ED [emergency department] with a h/o [history of] 3 X bloody-maroon BM [bowel movement] onset last night. She is actively passing maroon colored stool during my interview. In ED she had bloody vomitus X 2 as well. Patient complained of feeling generally weak and cold. She denies abdominal pain. She complains of "pain to her sides." Patient is somewhat poor historian, even with the Laotian interpreter ..."

During a concurrent interview and electronic healthcare record (EHR) review, on 10/12/22, at 3:20 p.m., with the FPM, Patient 2's EHR for admission date 6/19/22 was reviewed. The FPM confirmed that there was no COA for Patient 2's admission starting on 6/19/22. The FPM stated she would have to have someone from admissions explain why there was no COA.

During a concurrent interview and record review on 10/13/22, at 2:20 p.m. Patient 1's and Patient 2's COA's were reviewed with the Patient Access Leader Representative (PALR). PALR stated it is the Patient Access Departments job to get patients to sign the COA's, it is not the nurse's job but that they work with the nurses to help let them know when patients' family is available for signatures. PALR confirmed Patient 1's COA is missing the witness signatures for the patient's verbal authorization. PALR confirmed that Patient 2's COA is missing all together but was able to provide documentation that his department has spoken with Patient 2's daughter and she gave consent for treatment but refused to give consent for liability (payment). PALR then stated his department documented 10 separate attempts to get the patient to sign the COA, not once did they attempt to call the 2nd daughter on the patients contact list. The PALR stated the importance of having the patient sign their COA is, so they are aware of their rights in the facility, their financial responsibility, consent for treatment, and confidential census information.

During a review of the facility's policy and procedure titled "Condition of Admission (COA)," dated 3/1/22, the COA indicated, "PURPOSE: A. To obtain Conditions of Admission on all pre-registered and registered patients as well as provide guidance and direction when obtaining Conditions of Admission consents. POLICY: A. All patients will be asked to sign a Conditions of Admission consent form. The exceptions are ... patients whose medical condition may prevent them from physically signing ... B. At the time of registration, the adult patient will be asked to sign a Conditions of Admission consent form ... D. The Patient Access Representative will then sign, date and time as a witness to the patient's signatures. E. Admission under special circumstances: 1. When there is a patient who lacks decision making capacity, consent must be signed by a legal guardian or conservator ... The arrangements will be made for the legal guardian or conservator to come in so that we may obtain a consent for admission ..."

Based on interview and record review, the hospital failed to provide care in a safe setting for one of 30 sampled patients (Patient - Pt 2), when Pt 2 underwent a femoral central line placement on 7/22/21 and the retained J-wire from that placement was not identified until 7/1/22, approximately one year later. Pt 2 was admitted to the hospital two times prior to the 7/1/22 date and opportunities to identify and address the retained foreign object were missed.
These failures resulted in missed opportunities to identify and correct a retained foreign object, provide appropriate care to Pt 2 and increased the risk for negative effects from the retained foreign object and possible health decline.

Findings:

During a concurrent interview and record review on 10/11/22 at 3 p.m., Patient 2's Electronic Healthcare Records reviewed with the Health Risk Specialist (HRS) and the Director of Critical Care Services (DCCS). The HRS stated that the hospital reported the retained foreign object (RFO) to the State on 7/5/22 and that it was found on 7/1/22 when one of their doctors was attempting to place a central line (a central venous catheter placed into a large vein for giving patients fluids, medications and providing access for drawing blood) in Patient 2, took an x ray (photographic of digital image of a part of the body) and saw two wires in the patient. The HRS confirmed that Patient 2 was admitted to this hospital on 6/19/22, when Patient 2 presented to the emergency department (ED) for active bleeding. The HRS stated Patient 2's family was told of the finding and per the family this is the only hospital that the patient has been to. The HRS stated an investigation was done to determine when the J-wire was introduced and left in the patient. The HRS stated the last time Patient 2 had a line placed was on 7/22/21 by Emergency Department Physician (EDP 1), prior to this line placement there was a CT (computed tomography- computerized x-ray imaging procedure in which a narrow beam of x-rays is aimed at a patient and quickly rotated around the body, producing images) done of the patients abdomen and pelvis and no guidewires were seen, then 30 minutes later the doctor placed the right femoral line (central line placed in the groin). The HRS stated at this time x rays were not being done for femoral lines. The DCCS stated on 3/7/22 Patient 2 was admitted to the hospital and had a chest x ray for chest pain which showed "a right paraspinal wire which appears to terminate in the right internal jugular vein". The DCCS stated no lines were placed during this admission and the finding was not placed in the impression and it was never addressed by any of the providers during this admission. The DCCS stated the next admission on 6/19/22 Patient 2 had a chest x ray, and it was placed under the impression "J-wire projecting to the right of the spine," but that the radiologist and the ED Physician did not realize it was not supposed to be there.

Review of Patient 2's document titled Results XR Chest 1 View Portable dated 3/7/22 at 10:11 a.m. indicated, "INDICATION: Chest Pain COMPARISON: 7/22/2020 FINDINGS: ... There is a right paraspinal wire which appears to terminate in the right internal jugular vein. IMPRESSION: Vascular congestion. Electronically Singed by: [Radiologist's Name- RAD 1] 3/7/2022 10:42 AM"

Review of Patient 2's document titled Results XR Chest 1 View Portable dated 6/19/22 at 7:15 a.m. indicated, "CLINICAL INDICATION: Chest Pain. COMPARISON: March 10, 2022 TECHNIQUE: Portable semi-upright frontal examination of the chest. FINDINGS: Lines and Tubes: Apparent J-wire projecting to the right of the spine with jay projecting in the expected location of the right internal jugular vein. Present on prior chest radiographs ... IMPRESSION: ... J-wire projecting to the right of the spine as discussed above. Electronically Signed by: [Radiologist's Name - RAD 2] 6/19/2022 7:41 AM"

During an interview on 10/12/22, at 9:08 a.m. with Radiologist (RAD 1), RAD 1 stated he was aware of the investigation done for the retained J-wire on Patient 2. RAD 1 stated, "A line should not be left in place, it is a very uncommon complication. Ideally, it is the primary responsibility of who placed it (to remove it)." RAD 1 stated femoral lines do not get x rays because they are removed and do not run the risk of injury to the patient that chest lines do. RAD 1 stated the chest x ray done on 3/7/22 for Patient 2 was read as an emergency room case and staff didn't think there was anything unusual because central lines are placed all the time in ED. RAD 1 stated the J-wire was mischaracterized and from a radiology perspective "they didn't appreciate it as a finding, didn't appropriately note what it was and didn't connect the dots that it shouldn't be there and what communication needed to happen. It just didn't occur. J tip wires have a natural J turn in the wire, when they are put in a wire it becomes straight but once the introducer needle is removed the tip will curve like a J which indicates that is the tip ... The tip is flexible, so you don't ram the end into something and cause damage. It was started in the pelvis (referring to the wire found on the 3/7/22 x ray)."

During a concurrent interview and record review on 10/12/22, at 10 a.m. with Emergency Department Physician (EDP 1), Patient 2's CLIP form (form created to document central line placement) dated 7/22/21 was reviewed. EDP 1 stated he placed a right femoral line in Patient 2 on 7/22/21. The EDP 1 stated he has placed over 500 of these lines and has never left the wire in and does not remember leaving it in this time either. The EDP 1 confirmed that at the time of the insertion the facility was using a CLIP form where it is documented that the wire was removed. The EDP 1 stated the facility is claiming he left the wire in based on their investigation and the family telling them that the patient has not gone to any other facilities.

During an interview on 10/12/22, at 11 a.m. with the Imaging Manager (IM), the IM stated there is a specific process for when an x-ray is being taken for line placement but for Patient 2 these x-rays were not for line placement, so the protocol was not followed. The IM stated it may be a preexisting line so it is not always addressed, and the x-ray technician would not know if it should or shouldn't be there. The IM stated she would expect the radiologist to recognize the type of line and comment on it.

During an interview on 10/14/22, at 10 a.m., with the Emergency Department Medical Director (EDMD), the EDMD stated the expectation is that the ED Physician that orders the radiologic image will also review them. The EDMD stated she was part of the root cause analysis for the retained foreign object (RFO) found in Patient 2. The EDMD stated the RFO was found on a chest x ray of Patient 2 in March of 2022. The EDMD stated the report indicated the findings of a J-wire but no indication that a physician was called "I would have expected radiology to call the doctor for any incidental findings". The EDMD stated, "anytime you have a foreign body left in you worry about it migrating and doing damage to vessels and infection."

During a concurrent interview and record review on 10/14/22, at 11:30 a.m., Patient 2's Emergency Department (ED) Note dated 6/19/22, was reviewed with the ED Physician (EDP 2). The ED Note indicated Patient 2 came into the ED with hypotension (low blood pressure) and active bleeding. The EDP 2 stated she treated Patient 2 on 6/19/22 and remembers she was actively bleeding and remembers having to use the trauma cart supply of blood to keep her blood pressure up while they tried to find the bleeding. The EDP 2 stated she did not place any central lines in Patient 2 and if she had ordered a chest x ray it would have been portable, and she would have looked at the picture right after it was done. The EDP 2 stated she would have been focused on why she ordered the chest x ray which was for aspiration in the lungs and does not recall seeing the J-wire in the x-ray. The EDP 2 stated the note under the x ray in her ED Note indicated that she agreed with what the radiologist report of the chest x ray and the findings of the J-wire but that she didn't see the J-wire, if she had she would have reported it to the admitting doctor, but it would not have changed her care of Patient 2 at that time.

During an interview on 10/14/22, at 11 a.m., with the Chief of Radiology (CR), the CR stated the expectation is that the radiologist will put all findings in the impression of the report and expect the doctor to read it and follow up on it. The CR stated this is the safest way to communicate with the physician, a signed report that is done usually within an hour of the x-ray. The CR stated if he thought the doctor would recognize it (whatever the issue is) then he wouldn't call the physician to report it.

During a review of the facilities policy and procedure titled "IV Therapy- Central Line Care and Management: Percutaneous Catheters, Percutaneous Insertion of Central Venous Catheter by Physicians," dated 7/21/20, it indicated, "PURPOSE: A. to give guidance and direction in assisting the physician with insertion of a Central Venous Catheter ... D. Use of femoral access is discouraged in adult patients due to increased risk of infection and deep vein thrombosis ... F. Post Insertion Responsibilities: ... b. Femoral catheters do not require x-ray confirmation of position ..."

During a review of a professional reference by The Joint Commission a Sentinel Event Alert 51: Preventing unintended retained foreign objects (no date) was reviewed, it indicated, "The unintended retention of foreign objects (URFOs) - also called retained surgical items (RSIs) - after invasive procedures can cause death, and surviving patients may sustain both physical and emotional harm, depending on the type of object retained and the length of time it is retained. There may be an extended time frame between occurrence and detection of an URFO. Retained foreign objects are most commonly detected immediately post-procedure; by X-ray; during routine follow-up visits; or from the patient's report of pain or discomfort." Retrieved from: https://www.jointcommission.org/resources/sentinel-event/sentinel-event-alert-newsletters/sentinel-event-alert-issue-51-preventing-unintended-retained-foreign-objects/#.Y1slVXbMLZs

Based on interview and record review, the hospital failed to provide background check (an investigation of a person to identify criminal history) documentation for two of six sampled staff members (Registered Nurse [RN] 2 and 3).

This failure had the potential to allow persons with a criminal history to work in the hospital and not provide a safe environment for care.

Findings:

During a concurrent interview and record review on 10/14/22, at 10:13 a.m., with the Human Resource Partner (HRP), RN 2 and RN 3's personnel files were reviewed. RN 2's date of hire was 4/24/00 and RN 3's date of hire was 11/29/04. When HRP was asked to provide clearance documentation of the background check on RN 2 and RN 3, HRP stated, there was no documentation of the background check on RN 2 and RN 3 since the hospital transitioned to electronic (digital records) format in 2013 and all background checks conducted prior to 2013 was in paper format. HRP stated, the hospital was unable to locate the background check paper format documents for RN 2 and RN 3. HRP stated, a complete personnel file should include documentation of a cleared background check on all staff members.

During an interview on 10/14/22, at 2:45 p.m., with the Chief Nursing Executive (CNE), CNE stated, the purpose of conducting background checks was to make sure the hospital did not hire felonies or anyone with a drug abuse history in order to provide a safe working environment for staff and patients. CNE stated, the Human Resource Department (HRD) was responsible to ensure background checks were completed and obtained on all employees hired. CNE stated, HRD should have notified RN 2 and RN 3 and or any staff member without documentation of a cleared background check that a background check was to be reconducted electronically in order to complete their personnel file.

During a review of the hospital's policy and procedure (P&P) titled, "Background Checks and Sanction Screening Policy," dated 4/1/22, the P&P indicated, "Policy: It is policy to provide a safe working environment and high quality patient care, and perform reasonable background checks and, as applicable, Sanction Screening, for employees, applicants, board and committee members, temporary agency workers, travelers, independent contractors, volunteers and students ... A. Scope of Background Check Report. 1. Lawful background checks must be completed as a condition of employment ... c. Criminal background checks (seven (7) year search) - county and national criminal search ... D. Records Retention. 1. Background check documents are retained for the term of employment plus a minimum of two (2) years or two (2) years from the data of denial of employment, as applicable ..."

Based on interview and record review, the hospital failed to follow the policy and procedure "Chemotherapy/Biotherapy/Immunotherapy, Administration," when RN 4 did not obtain vital signs (heart rate, blood pressure, respiration, temperature, and oxygen saturation level) according to professional standards of practice during administration of Chemotherapeutic (powerful chemicals used to kill fast-growing cells such as cancer) and Immunotherapeutic (treatment that uses a person's own immune system to fight cancer) agents (drugs; medications) for two of three sampled patients (Patient 7 and 8).

This failure had the potential to delay the recognition of adverse effects (serious side effects) to the medications the patient was receiving, which could lead to serious harm.

Findings:

During a review of Patient 7's "Electronic Health Record" (EHR), on 10/12/22, the EHR indicated, Patient 7 had a history of Malignant Neoplasm of Upper Lobe in the Right Lung (lung cancer), Acute Renal Failure (sudden kidney dysfunction), Hypothyroidism (low thyroid hormone), Hypertension (low blood pressure), Uterine Cancer (cancer in the uterus), Diabetes Mellitus Type II (high blood sugar level resistant to insulin), and Asthma (a respiratory condition marked by spasms in the lungs causing breathing difficulty).

During a concurrent interview and record review on 10/12/22, at 9:33 a.m., with the Director of Oncology (DO), Patient 7's "Medication Administration Record" (MAR), dated 10/10/22, was reviewed. The MAR indicated, on 10/10/22, at 3:59 p.m., Patient 7 received "Paclitaxel (chemotherapeutic agent) 114 mg (milligram - unit of measurement) in NaCl (Sodium Chloride) 0.9% (percent - unit of measurement) in 100 mL (milliliter - unit of measurement) Chemo Intravenous (access port in the vein used to administer chemotherapeutic drugs) over 60 minutes." The MAR indicated, on 10/10/22, at 5:07 p.m., Patient 7 received "Carboplatin (chemotherapeutic agent) 180 mg in NaCl 0.9% in 250 mL." DO stated, Chemo-Certified Nursing Staff (Licensed Registered Nurses who have officially completed training on administering chemotherapy) were required to monitor patients while they are receiving the chemotherapy drugs according to policy and procedure, drug guidelines, and professional standards.

During a concurrent interview and record review on 10/12/22, at 10:30 a.m., with the DO, Patient 7's EHR was reviewed. The EHR indicated, Patient 7 was admitted to the Infusion Center (area of the hospital that administered medication intravenously to patients as an out-patient service) on 10/10/22 at 2:06 p.m. The EHR indicated, one set vital signs was obtained at 2:29 p.m. on Patient 7. The EHR indicated, Patient 7 was discharged from the Infusion Center on 10/10/22 at 6:05 p.m. after the completion of the infusion administrations with no vital signs obtained. DO validated only one set of vital signs was obtained on Patient 7 during medication administration. DO stated, according to the Oncology Nursing Society (a professional association representing nurses that sets standards of practice), vital signs were required to be taken at the start of the infusion administration, midway, and at the end.

During a concurrent interview and record review on 10/12/22, at 2:19 p.m., with Registered Nurse (RN) 4, Patient 7's EHR was reviewed. RN 4 stated, RN 4 admitted Patient 7 to the infusion center on 10/10/22 at 2:06 p.m. for infusion therapy. RN 4 stated, on 10/10/22 at 3:59 p.m., RN 4 administered Paclitaxel to Patient 7. RN 4 stated, at 5:07 p.m., RN 4 administered Carboplatin to Patient 7. RN 4 stated, only one set of vital signs was obtained for Patient 7 during the admission process and RN 4 discharged Patient 7 after the medication administrations. RN 4 stated, RN 4 was not aware of the hospital's policy and procedures requirement on obtaining vital signs during infusion therapy. RN 4 stated, RN 4 was Chemo-Certified and followed professional standards of practice when administering chemotherapeutic agents to patients. RN 4 stated, RN 4 was only trained to monitor initial vital signs and reaction during drug administration. RN 4 stated, it was important to follow policy and procedure and drug guidelines to make sure that patients were tolerating medications and to ensure safe practice.

During a review of Patient 8's "Electronic Health Record" (EHR), on 10/13/22, the EHR indicated, Patient 8 had a history of Chronic Lymphocytic Leukemia (a type of cancer in which the bone marrow makes too many lymphocytes [white blood cells]), Hypertension (high blood pressure), and Diabetes Mellitus Type II.

During a concurrent interview and record review on 10/13/22, at 2:58 p.m., with the DO, Patient 8's "Medication Administration Record" (MAR), dated 9/20/22, was reviewed. The MAR indicated, on 9/20/22, at 11:02 a.m., Patient 8 received "bendamustine (chemotherapeutic agent) 185 mg (milligram - unit of measurement) in NaCl (Sodium Chloride) 0.9% (percent - unit of measurement) in 50 mL (milliliter - unit of measurement) Chemo Intravenous infuse over 10 minutes." The MAR indicated, at 11:31 a.m., Patient 8 received "rituximab-pvvr (monoclonal antibodies used as Immunotherapy to help the immune system destroy cancer cells) 775 mg in NaCl 0.9 % in 250 mL Intravenous Rapid Infusion. Administration Instructions: RAPID RATE INFUSION - NOT to be used for first dose --- Administer 20% of dose in the first 30 minutes and remaining 80% of dose over 60 minutes." DO stated, Rapid Infusion administration instructions required vital signs to be obtained when changing the rate according to the Oncology Nursing Society standard of practice.

During a concurrent interview and record review on 10/13/22, at 3:00 p.m., with the DO, Patient 8's EHR was reviewed. The EHR indicated, Patient 8 was admitted by RN 4 to the Infusion Center on 9/20/22 at 9:30 a.m. and a set of vital signs was obtained at 9:33 a.m., 11:28 a.m., and 12:01 p.m. The EHR indicated, Patient 8 was discharged from the Infusion Center on 9/20/22 at 1:04 p.m. DO stated, a set of vital signs should have been obtained on Patient 8 at the start of the bendamustine administration at 11:02 a.m., the end of administration at 11:13 a.m., the start of rituximab-pvvr administration at 11:31 a.m., during the rate change of rituximab-pvvr at 12:01 p.m., and at the end of administration at 1:01 p.m. DO stated, RN 4 was Chemo-certified but did not follow policy and procedures, drug guidelines, and professional standards when administering chemotherapeutic and immunotherapeutic agents to Patient 7 and Patient 8.

During a review of the hospital's pharmacologic resource guideline application "Lexicomp,'' dated 10/12/22, Lexicomp indicated, "Paclitaxel ... Experienced physician: Paclitaxel should be administered under the supervision of a health care provider experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available ... Monitoring Parameters: Monitor for hypersensitivity reactions, vital signs (frequently during the first hour of infusion) ..."

During a review of the hospital's pharmacologic resource guideline application "Lexicomp,'' dated 10/12/22, Lexicomp indicated, "Carboplatin. Nursing Physical Assessment/Monitoring: Patient allergy history must be assessed prior to therapy. Assess other drugs patient may be taking for potential interactions (especially products that may be ototoxic or nephrotoxic and need for sequencing with taxane derivatives). Assess hematology, electrolytes, and renal and hepatic function tests prior to treatment and on a regular basis during therapy. Monitor for nausea and vomiting (pretreatment with antiemetic may be required), ototoxicity (audiometry may be advisable), bone marrow depression, anemia, bleeding, and peripheral neuropathy."

During a review of the hospital's pharmacologic resource guideline application "Lexicomp,'' dated 10/26/22, Lexicomp indicated, "Rituximab. Monitoring Parameters: CBC with differential and platelets (pediatric and adult pediatric with lymphoid malignancies: baseline, prior to each treatment course, at weekly to monthly intervals and more frequently if cytopenias develop; pediatric and adult patients with granulomatosis with polyangiitis and microscopic polyangiitis: at 2- to 4-month intervals; in adult patients with rheumatoid arthritis: at 2- to 4-month intervals); continue to monitor for cytopenias after the final dose and until resolution, electrolytes (in patients at risk for tumor lysis syndrome [TLS]), renal function (in patients at risk for TLS), fluid/hydration status balance; blood pressure, vital signs ..."

During a review of the hospital's pharmacologic resource guideline application "Lexicomp,'' dated 10/26/22, Lexicomp indicated, "Bendamustine. Nursing Physical Assessment/Monitoring: Monitor infusion site closely to avoid extravasation. Monitor infusion reactions, including skin reactions; can occur with first or subsequent cycles and may require premedication or discontinuation."

During a review of the hospital's policy and procedure (P&P) titled, "Chemotherapy/Biotherapy/Immunotherapy, Administration," dated 10/11/22, the P&P indicated, "Purpose: A. To give guidance and direction in the administration of chemotherapy and biotherapy agent for the treatment of hematologic and oncologic diseases for adults ... Policy: This policy applies to all dosage forms of chemotherapy/biotherapy agents given to any malignancy ... Assessment: F. Patient Monitoring: 1. Monitor vital signs at the start and completion of chemotherapy infusion unless ordered otherwise ..."

During a professional reference review retrieved from https://www.ons.org/onf/44/1/2016-updated-american-society-clinical-oncologyoncology-nursing-society-chemotherapy titled, "2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology," dated 2022, the professional reference indicated, "Standards ... Domain 1: Creating a Safe Environment-Staffing and General Policy ... 1.1: The health care setting has policy to document the qualifications of clinical staff who order, prepare, (reference 14) and administer chemotherapy (reference 15-21) and documents: ... 1.6.2: Vital signs (frequency according to institutional policy based on regimen) ..."

Nicholette King-Rabetsimba

Based on interview and record review, the hospital failed to ensure all medications were compounded safely in accordance with hospital policy and accepted professional standards.
These failures had the potential to result in patient harm from contaminated IV medications.

Findings:
During a concurrent interview and record review on 10/11/22 at 3:37 p.m. with Pharmacy Director (PD) and Lead Pharmacy Technician (LPT), Environmental Services (EVS) "Pharmacy Cleaning Annual Evaluation records" and "Pharmacy- EVS cleaning logs" dated January 2022 and October 2022 were reviewed. Pharmacy EVS cleaning log dated January 2022 indicated EVS Staff (EVSS) 1 cleaned the pharmacy IV clean rooms (where sterile IV medications are prepared) and ante room (sterile compounding area for hand washing, garbing, and product decontamination) on 1/29/22 and 1/30/22. EVS cleaning log dated October 2022 indicated EVSS 2 cleaned the pharmacy IV clean rooms and ante room on 10/8/22 and 10/9/22. When asked, LPT was unable to provide Pharmacy Cleaning Annual Evaluation records for EVSS 1 and EVSS 2. LPT acknowledged EVSS 1 and EVSS 2 did not receive Pharmacy Cleaning Evaluation prior to cleaning the pharmacy IV clean rooms and ante room. PD stated, "Pharmacy is responsible for EVS competency and training. They [EVS staff] need to know how to properly clean and act in sterile environment. It [Improper cleaning] could result in growth in pathogen [disease causing microorganism] that you don't want. They [EVS staff] could harm themselves or dispose of hazardous drugs improperly."
During an interview on 10/14/22 at 11:55 a.m., with EVS Manager (EVSM), EVSM stated she was aware 2 EVS personnel (EVSS1, EVSS 2) did not receive training prior to cleaning the pharmacy IV clean rooms and ante room. EVSM stated, "Pharmacy does training of each EVS individual that cleans IV room... PM shift supervisor was responsible be scheduling ... supervisor assumed EVSS 2 was trained because another supervisor had put her in ... they [EVSS 1, EVSS 2]need to make sure job is done properly, done to standard and don't bring anything to area and keep themselves and staff safe."
During an interview on 10/14/22 at 2:29 p.m., with PD, PD stated expectation was for EVS staff to be trained in current policies and procedures for employee and patient protection, infection control and cross contamination with hazardous drugs.
During a review of the hospital's Policy and Procedure (P&P) titled, "Sterile Compounding Policy- IV Cleanroom", dated 1/19/22, the P&P indicated, "EVS [Environmental Services] and engineering staff shall have training related to require PPE and keeping a sterile environment. A list of trained staff will be kept on record and reviewed annually."
During a review of the hospital's P&P titled, "Cleaning The Pharmacy Department", dated 6/23/22, the P&P indicated, "Purpose: To maintain a clean and safe environment for patient and staff ... Environmental Services Department personnel will clean the Pharmacy Department on a daily basis."

Based on observation, interview, and record review, the hospital failed to ensure pharmacy technician failed to perform proper aseptic (free from contamination caused by harmful bacteria, viruses, or other microorganisms) hand cleansing prior to compounding intravenous (IV) medication in accordance with hospital policy and accepted professional standards.
This failure had the potential to result in patient harm from contaminated IV medications.

Findings:
During a concurrent observation and interview on 10/11/22 at 2:55 p.m., with Lead Pharmacy Technician (LPT) and Pharmacy Technician (PT), PT was observed washing her both hands in the IV ante room (sterile compounding area for hand washing, garbing, and product decontamination) sink. PT was observed to have the sleeves of her protective gown down to her wrists. LPT acknowledged PT was not performing proper aseptic technique and stated PT should be washing her forearms. PT stated she had entered the IV ante room and did not know she had to wash her forearms as part of handwashing aseptic technique. PT stated proper hand washing was important to prevent contamination which can cause infection.
During an interview on 10/14/22 at 2:25 p.m., with Pharmacy Director (PD), PD stated, "expect technicians to follow procedure for hand hygiene, we have established protocols to prevent contamination in hood, infection control ... patient can be exposed to a pathogen [disease causing microorganism]."
During a review of the hospital's Policy and Procedure (P&P) titled, "Sterile Compounding Policy- IV Cleanroom", dated 1/19/22, the P&P indicated, "Pharmacy establishes and follows a written program of training and performance evaluation designed to ensure each person working in the designated area has the knowledge and skills necessary to perform their assigned tasks properly. This program of training and performance must address the following: proper hand hygiene- compounding personnel must properly complete a 60 second initial hand wash before donning the clean room gown."
During a review of US Pharmacopeia (USP) 797, a nationally recognized organization that sets quality standards for medicines, USP 797 indicated, "order of compounding garb and cleaning in ante -area: shoes or shoe covers, head and facial hair covers, face mask, fingernail cleaning, hand and forearm washing and drying; non-shedding gown."

Based on observation, interview, and record review, the hospital failed to ensure intravenous (IV- inject into vein) bags were labeled and dated in accordance with hospital policy and procedures and accepted professional principles.

These failures had the potential to result in patient harm from ineffective drug treatment, contaminated treatment.

Findings:

During a concurrent observation and interview on 10/11/22 at 10:34 a.m., with Registered Nurse (RN) 1, in IR PACU, an undated, unlabeled one-liter IV normal saline bag was observed hanging on a pole next to a patient bed, spiked and ready for patient administration. RN 1 acknowledged the IV normal saline bag was not labeled and was unable to determine what time the IV bag had been spiked. RN 1 stated, "Yes, it [IV normal saline bag] should be labeled with time so bags aren't hung more than 24 hours."
During a concurrent observation and interview on 10/11/22 at 10:37 a.m., with Advanced Medical Diagnostic Center Manager (AMDCM) in IR PACU, an undated, unlabeled one-liter IV normal saline bag was observed hanging on a pole next to a patient bed, spiked and ready for patient administration. AMDCM acknowledged the IV normal saline bag was not labeled or dated and stated, "It's been labeled right now."
During an interview on 10/14/22 at 2:20 p.m. with Pharmacy Director (PD) and Float Pool Manager (FPM), PD stated, "We would date and time the bag, based on USP [United State Pharmacopeia- a nationally recognized organization that sets quality standards for medicines] guidelines that would be for microbial contamination." FPM stated it was standard of practice to ensure IV bags were labeled with date and time of spike.
During a review of the hospital's Policy and Procedure (P&P) titled, "IV Therapy- Equipment: Site/Bottle/Bag/Tubing Care & Labeling", dated 10/14/19, the P&P indicated, "No intravenous infusion botte/bag/syringe will be left infusing for longer than 24 hours from the time it was "spiked" or accessed. The infusion will be started within 1 hour from the time the bottle/bag/syringe was "spiked" or accessed ... Solutions >/ [greater than or equal to] 100 ml and