HospitalInspections.org

The Condition of Participation: Quality Assessment & Performance Improvement was not met.

Findings included:

1.) The Hospital failed to ensure analysis of data collected, monitor the effectiveness of services and quality of care.

Refer to TAG: A-0273.

2.) Based on records reviewed and interviews the Hospital failed to ensure identification of opportunities for improvement regarding Performance Evaluation Documentation of IV Competency.

Refer to TAG: 0283.

3.) The Hospital failed to ensure Radiologic Services QAPI activities monitored contracted services.

Refer to TAG: A-0309.

Based on records reviewed and interviews the Hospital failed for six patients (Patients #1, #2, #4, #5, #8, & #9) of ten patients sampled to ensure analysis of data collected and monitor the effectiveness of services and quality of care.

Findings included:

1.) The Hospital failed to conduct a thorough investigation of Radiologic Services following a Complaint regarding Radiologic Services.

The Hospital Report, dated 7/7/2021, indicate a Complaint regarding Patient #1 and Radiologic Services.

The Emergency Department Document, dated 6/20/21, indicated Patient #1 presented to the Emergency Department (ED) with abdominal pain. The ED Document indicated Patient required a Computerized Tomography (CT) scan.

Refer to Radiologic Services.

2.) The Hospital failed to analyze data collected regarding Radiologic Services Staff IV (intravenous) Competencies and implement QAPI activities.

A.) Regarding IV extravasations:

1.) The Hospital Report, 1/1/2021 through 12/31/2021, indicated 20 of 22 (90%) reports regarding IVs and IV extravasation (intravenous catheter comes out of the vein and the contrast leaks into the tissue).

During the interview, at 1:15 P.M. on 2/24/2022, the Director of Quality of Quality said staff were educated regarding IV infiltration and that the date the education started was not found.

The Hospital provided no documentation that education regarding IV infiltration was implemented.

Regarding Patients #2, #4, #5, #8, & #9:

The Hospital policy titled Extravasation of Imaging Contrast Media, dated 6/22/2021, indicated the most common complication of imaging contrast media was compartment syndrome (a limb-threatening complication), and that a Radiologist or Emergency Department Physician was notified of the extravasation.

The Hospital policy titled Administration of Intravascular Contrast Media, dated 6/22/2021, indicated prior to administration (the check list included on page two of the document titled History Sheet - CT Radiology) was confirmed (undefined) by two appropriately trained personnel that administered contrast. The document titled History Sheet - CT Radiology form did not provide two confirmation (signature) areas. The Administration of Intravascular Contrast Media policy indicated an LIP contrast order included time, dose, and route.

The Hospital Policy titled Intravenous Therapy Peripheral and Central Line Care, dated 3/12/2019, indicated an LIP order for infusion therapy or saline lock was required, venipunctures in affected extremity from a cerebrovascular accident were avoided, cleansing with skin was with Chlorhexidine, insertion was documented in the medical record and notification of the LIP for extravasation was required.

The policy titled Signed Orders for Administration of Intravascular Imaging Contrast Media, dated 8/4/2020, indicated imaging contrast media administered intravascularly was considered a medication and required an order from an LIP.

The manual titled ACR on Contrast Media, dated 2021, indicated the flow rate should be appropriated for the catheter used, an antecubital (crook of the elbow) or large forearm vein was the preferred access vein for power injection (of the contrast), and hand, foot, ankle and wrist sites were more likely to result in extravasation, tissue injury and should be avoided.

Five patients (Patients #2, #4, #5, #8, & #9) of ten patients sampled received IV contrast, and had IV extravasations with administration of intravascular (in a vein) contrast. Four patients with extravasations (Patients #2, #4, #5 & #8), their medical record did not indicate documentation that a Radiologist or Emergency Department Physician was notified of the extravasation as required by the Hospital policy titled Extravasation of Imaging Contrast Media.

Five patients (Patients #2, #4, #5, #8, & #9) with IV extravasations had IV's placed in sites identified as sites at an increased risk of developing severe complications, or as sites that should not be used, inconsistent with Hospital policies Extravasation of Imaging Contrast Media and Intravenous Therapy Peripheral and Central Line Care.

Patients #2:

The Radiologic Services Report, dated 1/1/2021/12/31/2021, indicated Patient #2 had an IV in the right arm extravasation.

The Emergency Department Record, dated 2/23/2021, indicated Patient #2 presented to the Emergency Department with symptoms of a cerebrovascular accident (stroke). The Emergency Department Record indicated Patient #2 had paresis (paralysis) of the right arm and an IV infiltrated in the right arm.

The document titled History Sheet - CT Radiology, dated 2/23/2021, indicated Patient #1 had an IV in the left arm.

The Hospital provided no investigation regarding the IV right arm extravasation.

Patient #2's medical record indicated no indication of an LIP order for contrast as a medication in accordance with the Hospital policy titled Signed Orders for Administration of Intravascular Imaging Contrast Media; medical record did not include the form titled Contrast Media Extravasation Report Form; medical record did not include two signatures on document titled History Sheet - CT Radiology.

Patients #4:

The document titled History Sheet - CT Radiology, dated 4/1/2021, indicated Patient #4 had an IV infiltrate after three attempts to insert the IV.

During the interview, at 2:00 P.M. on 2/23/2022, Radiologic Technologist (CT) #3 said following an extravasation the extravasation form (Diagnostic Imaging Services Contrast Material-Extravasation Report Form) was completed.

Patient #4's medical record indicated no copy of the form titled Diagnostic Imaging Services Contrast Material-Extravasation Report Form was completed; the medical record indicated the Radiology Report did not include the extravasation nor Patient #4's medical record include documentation regarding the extravasation; in accordance with the Hospital policy titled Extravasation of Imaging Contrast. Patient #4's medical record indicated no LIP order for an IV insertion, no documentation of an IV insertion, nor by whom, as required by the Hospital Policy titled Intravenous Therapy Peripheral and Central Line Care. The medical record indicated no documentation to indicate a notification of an Emergency Department physician or Radiologist of the infiltration in accordance with the Hospital Policies titled Intravenous Therapy Peripheral and Central Line Care and Extravasation of Imaging Contrast Media.

Patients #5:

The Radiologic Report, dated 8/10/2021, indicated Patient #5 had an IV extravasation during a CT.

Patient #5's medical record indicated no document of the IV extravasation in the Radiology Report nor did Patient #5 include the document titled History Sheet - CT Radiology that the Radiologic Technologist documented. The medical record indicated no indication of a physician order for contrast media. The medical record did not include the form titled Contrast Maternal Extravasation Report Form.

Patients #8:

The Radiologic Report, dated 10/16/2021, indicated Patient #8 had an IV extravasation.

Patient #8's medical record indicated no indication of the document titled History Sheet - CT Radiology for two CT scans. Two Radiologic Services Reports, both dated 10/16/2021, did not indicated Patient #8 had an IV extravasation; the medical record indicated no indication of a physician order for contrast as a medication; the medical record did not include the form titled Contrast Maternal Extravasation Report Form.

Patients #9:

The Radiologic Services Report, dated 12/3/2021, indicated Patient #9 had an IV extravasation.

Patient #9's Radiology Report, dated 12/9/2021, did not indicate Patient #9 had an IV extravasation. The medical record indicated no indication of a physician order for contrast as a medication; the medical record did not include two signatures on the document titled History Sheet - CT Radiology.

2.) Regarding an Emergency Department Technician:

The History Sheet - CT Radiology, dated 4/1/2021, indicated Patient #4 had and IV extravasation after three attempts. Patient #4's medical record indicated no documentation to indicate who started the IV.

During the interview, at 10:50 P.M. on 2/23/2022, the Director of Quality said an Emergency Department Tech was contacted to start Patient #4's IV. The Director of Quality indicated ED technicians inserted IV's. The Director of Quality said personnel working as ED technicians had the required computer access to document the IV insertion in the patient's medical record.

The Hospital provided no investigation to clarify documentation regarding starting IV's for Radiologic Services.

B.) The Hospital failed to timely ensure Radiologic Services' phones were working to activate the Rapid Response Team in the event of a patient emergency:

The Radiologic Hospital Report, dated 3/11/2021, indicated the telephones were not working in the Radiologic Services at the time of Patient #3 anaphylactic (life-threatening) reaction.

During the interview, at 2:30 P.M. on 2/24/2022 eleven months following Patient #3's anaphylactic reaction, Radiologic Technologist Computerized Tomography #1 said that the backup phones in Radiologic Services were not programmed to call the Rapid Response Team (to a patient care emergency) and that the Radiologic Services staff now called either the Emergency Department Charge Nurse or the Hospital Supervisor.

The Hospital provided no corrective action that ensured timely response to a potentially life-threatening anaphylactic reaction (i.e., activation of their Rapid Response Team).

3.) The Hospital failed for one psychiatric Patient (Unsampled Patient #1) to ensure the Hospital completed a thorough investigation, implemented corrective actions and monitored compliance of the corrective actions.

The Hospital Reports, dated 12/4/2021 & 12/9/2021 , indicated a bottle of insulin was recorded as missing from the locked medication dispensing unit (Omnicell) in the Emergency Department.

The Hospital Report, dated 12/5/2021, indicated an Emergency Department patient (Unsampled Patient #1) with suicidal ideation obtained a syringe, an insulin bottle and injected an undefined amount of insulin in Unsampled Patient #1 body. The Unsampled Patient #1 required intravenous (IV) dextrose (sugar), continued blood glucose (sugar) monitoring and continued IV fluid therapy.

The Hospital Report dated 12/10/2021 indicated the bottle of insulin was missing from the locked medication dispensing unit.

During an interview, at 1:00PM. on 2/24/2022, the Director of Quality said the Hospital investigation into the 12/4/2021 event regarding the missing insulin, the locked medication unit normally dispensed a sticker (label) for insulin administrations for nurses to bring to the bedside and scan (electronically verify correct patient and meditation) when administering insulin to the patients. The Director of Quality said the medication dispensing unit was not dispensing the stickers for the insulin, therefore nurses were bringing the insulin bottle to the bedside to scan, and insulin was remained out of the locked cabinet as a result.

The Hospital provided no documentation that a corrective action was implemented as a result of the event.

Based on records reviewed and interviews the Hospital failed for one patient (Patient #10) to ensure identification of opportunities for improvement regarding Contract Services monitoring and Performance Evaluation Documentation of IV Competency.

Findings included:

1.) The Emergency Department (ED) Record, dated 2/9/2022, indicated Patient #10 presented to the ED with a new onset swollen left leg.

The Radiology Report, dated at 5:35 P.M. on 2/9/2022, indicated Patient #10 had a Computerized Tomography (CT) Scan which revealed blood clots in the right lung. The Radiology Report Addendum, dated at 10:52 P.M. on 2/9/2022, indicated that this report contained findings that may be critical to the patient care and this result was reported to the Physician.

The Hospital policy titled Communicating Critical and or Significantly Abnormal Results of Tests and Diagnostic Procedures, dated 1/12/2021, indicated a critical result of an ordered procedure for which the finding may indicate a life-threatening situation or that had the potential to result in severe time-sensitive morbidity (disease) and requiring emergency clinical attention.

The Nurse's Note, dated at 11:00 P.M. on 2/9/2022, indicated the Nurse received a telephone call from Virtual Radiologic (a Contracted Service) reporting critical findings to report to the covering physician, the Nurse contacted the on-call Nurse Practitioner who directed the Nurse to call the Attending Physician.

The Virtual Radiologic Corporation Service Agreement, indicated the Physicians (Virtual Radiologic) provided a verbal communication with an Attending Physician providing the Hospital made the Attending Physician available.

During an interview, 11:30 on 2/24/2022, the Director of Quality said the Virtual Radiology Radiologist did not communicate (initially) directly with the Attending Physician.

During the interview, at 12:30 P.M. on 2/24/2022, the Medical Director of Radiologic Services said this was a good opportunity to fix.

2.) The document titled Performance Evaluation and Competency Evaluation, dated 8/2013, indicated the Job Description for CT Radiologic Technologists and that CT Radiologic Technologists demonstrated IV competency skills.

The Hospital policy titled Performance Appraisal, dated 6/11/2021, indicated performance appraisals were conducted once a year in July to evaluate performance in the prior twelve months. The Performance Appraisal Policy indicated the Hospital assessed each employee's work performance related to criteria and objectives in the job description.

The Hospital policy titled Competency Assessment, dated 3/9/2021, indicated competency was assessed annually and technical skills as effective utilization of knowledge, ability and psychomotor coordination (IV competency) in any type of process of technique involved in the performance of job requirements.

The document titled Employee Performance Review, dated 8/1/2019 through 8/1/2020, indicated Radiology Technician #3's performance evaluation as competent in all mandatory competencies. The Employee Performance Review form indicated no documentation for Radiologic Technician competency in IV therapy specific to Radiologic Services.

The document titled Department of Imaging Services Competency for CT (Radiologic) Technologist, dated 3/5/2020, indicated Radiologic Technologist #3's Competencies. The Competency for CT (Radiologic) Technologist form indicated CT Radiologic Technologist #3 was competent in documenting all infiltrates (extravasations). The Competency for CT (Radiologic) Technologist form indicated no documentation that CT Radiologic Technologists were competent in IV therapy specific to Radiologic Services; caring for the patient receiving IV contrast, discontinuation of the IV nor documentation of IV placement in accordance with Hospital policy.

The document titled HR and Nurse Educator Transcript Report, dated 7/14/2020 through 7/23/2020, indicated Radiologic Technician's education. The Report indicated no documentation of IV Therapy specific for Radiologic Services.

During an interview, at 10:50 A.M. on 2/24/2022, the Director of Human Resources said all clinical staff were evaluated yearly on competency skills. The Director of Human Resources said she was unaware of who evaluated clinical staff on IV competency.

The Hospital provided no corrective action to ensure Radiologic Staff were evaluated for IV competency following IV extravasation data collected.

The Hospital provided not documentation to indicate Radiologic Technician #3 was evaluated in 2021 consistent with the Hospital policy titled Performance Appraisal.

Based on records reviewed and interviews Hospital Executives failed for seven patients (Patients #1, #2, #4, #5, #8, #9 & 10#) of ten patients sampled to ensure Radiologic Services QAPI activities and monitor contracted services.

Findings included

1.) Hospital Executives failed for six patients (Patients #1, #2, #4, #5, #8, & #9) of ten patients sampled to ensure analysis of data collected and monitor the effectiveness of services and quality of care.

2.) Hospital Executives failed for one patient (Patient #10) of Ten patients sampled to ensure Hospital QAPI activities monitored Virtual Radiologic Corporation, (a Contracted Service).

The Professional Services Agreement, dated 7/24/2017, indicated a Contracted Service between Steward Medical Group (a corporation, not the Hospital) and Corporation for Radiologic Services (VRAD). The Professional Services Agreement indicated no authentication (dated with signature to indicate authentication). The Professional Services Agreement for radiologic services with Virtual Radiologic Corporation did not indicate an agreement between the Hospital and Virtual Radiologic Corporation.

The Hospital provided no documentation to indicate the Hospital monitored Virtual Radiologic for Radiologic Services provided to Hospital patients.

3.) Hospital Executives failed to ensure diagnostic services [Computerized Tomography (CT) scans] were provided in accordance with professionally approved standards (Hospital policy) for safety and personnel qualifications (Refer to TAG: 0528).

The Condition of Participation: Radiologic Services was not met.

Findings included:

The Hospital failed for nine patients (Patients #1, #2, #3, #4, #5, #6, #7, #8, #10) to ensure diagnostic services [Computerized Tomography (CT) scans] were provided in accordance with professionally approved standards (Hospital policy) for safety and personnel qualifications.

Refer to TAG: A- A-0535.

Based on observations, records reviewed, and interview the Hospital failed for nine patients (Patients #1, #2, #3, #4, #5, #6, #8, #9, & #10) to ensure diagnostic services [Computerized Tomography (CT) scans] were provided in accordance with professionally approved standards (Hospital policy) for safety and personnel qualifications.

Findings included:

The Hospital policy titled Medication Reconciliation, dated 11/5/2019, indicated contrast was a medication; medication included diagnostic and contrast agents (radiocontrast agents were substances such as iodine or barium compounds, administered to a patient using imaging technology, to increase the contrast of an image) administered to patients.

The Hospital policy titled Prescribing, Ordering of Medications, 12/10/2019, indicated only licensed (independent) practitioners (LIP) privileged by the Medical Staff may prescribe and or order medication for patients of the Hospital. The Prescribing, Ordering of Medications policy indicated medication orders contained:

-the patient's name, one unique identifier,

-name of the medication, dose, route, rate, frequency, and

-prescribed concentration and volume to be administered.

The Prescribing, Ordering of Medications policy indicated the Medical Executive Committee approved protocols were acceptable only after approval by the Hospital Pharmacy and Therapeutics Committee and the Medical Executive Committee.

The Hospital policy titled Medication Administration, dated 2/25/2020, indicated the medication order was sent to the Pharmacy for review, before administering a medication, a nurse verified the order was transcribed correctly, from the LIP order to the Electronic Medication Administration Record and medication education was documented in the patient's medical record. The Medication Administration policy indicated medication was scanned (medication safety procedure) prior to administration; if unable to scan the individual (nurse) would enter the bar code or National Drug Code manually into the Electronic Medication Administration Record; the portion of the packaging which contained the bar code was saved if possible and reported to the Pharmacy.

The Hospital policy titled Use of Oral Contrast in Diagnostic Imaging Services, dated 9/25/2020, indicated:

-oral contrast mixing was performed according to manufacturer's recommendations and these instructions were posted in the area where oral contrast was prepared.

-oral contrast for inpatients (patients admitted to the Hospital) and Emergency Department patients was delivered to the nurse responsible for the patient and this person (the nurse) was responsible for providing the oral contrast and instructions to the patient.

-General Radiology (undefined) oral contrast was administered by the Radiologist during the procedure.

During the interview, at 2:30 A.M. on 2/22/2022, the Director of Imaging said contrast was a medication, Radiologic Technologists administered IV Contrast, the IV Contrast was not documented as a medication (on the medication administration record) and the contrast was not scanned (consistent with the Hospital policy Medication Administration).

The Hospital provided no documentation to clearly document IV Contrast as a medication specific to the Radiologic Service consistent with Hospital policy.

Regarding Contrast Protocols & IV Contrast:

The document titled Diagnostic Imaging Services Adult IV Contrast Protocols CT Department, dated 1/20/2022, indicated the Hospital utilized Omnipaque 350. The Protocol indicated the Study of an abdominal & pelvis CT required a Volume of Contrast of 80 milliliters (mL).

Regarding Patient #1: The Emergency Department Document, dated 6/20/21, indicated Patient #1 presented to the Emergency Department (ED) with abdominal pain and a history of diabetes. The ED Document indicated Patient required a CT scan. An Order, dated at 3:47 P.M. on 6/23/2021, indicated a Physician Assistant ordered Patient #1 for a CT scan of the abdomen and pelvis with con(trast) for evaluation of a perforated diverticulitis (infection or inflammation of intestinal pouches) with the use of water soluble oral (PO) contrast (medication). The CT scan order indicated St. Anne's Hospital as the Name of a Non-Radiology Attending or Supervising MD. The CT scan indicated no name of a Non-Radiology Attending or Supervising MD, as signing or authentication of the CT scan order. The CT Order indicated no documentation that Patient #1 was a diabetic, as required in the order.

The document titled History Sheet - CT, Radiology, dated 6/24/21, indicated Patient #1 received contrast for an evaluation of perforated diverticulitis. The History Sheet indicated Patient #1 received 950 cc's of the (oral contrast medication) Barium, Oral Omnipaque 240. The History Sheet indicated no documentation if Patient #1 received Barium or Oral Omnipaque 240. The History form indicated no indication of a dilutant with water for the oral contrast per the CT order. The History Sheet indicated an initial of a Technologist instead of a Signature of the Radiologic CT Technologist as required on the History form.

The Medical Record indicated no LIP order for Patient #1's the specific (medication) oral contrast. The Medical Record indicated no LIP order for the IV contrast administered to Patient #1.

Regarding Compounding Oral Contrast Observations:

The Surveyor observed, at 3:00PM. on 2/24/2022, CT Radiologic Technologist #1, demonstrated mixing (compounding) oral contrast. The Surveyor observed the process of gathering of supplies: Omnipaque 240 bottle (the contrast, medication) in a 50 mL volume bottle from a cabinet in a CT Room, a gray plastic pitcher, and packet of Crystal Light lemonade flavored drink mix powder. The Surveyor observed Radiologic Technologist #1 pour the bottle of Omnipaque 240 into the gray plastic pitcher, add Crystal Light and filled the gray pitcher with an unmeasured amount of water from an automated water dispenser in the CT room. The Surveyor observed no graduated markings or measurements to ensure an accurate contrast concentration.

During an interview, at 3:00PM. on 2/24/2022, Radiologic Technologist #1 said a "small amount" of the Crystal Light powder was poured into the contrast. Radiologic Technologist #1 said the pitcher held approximately 950 mL.

Regarding Oral Contrast Observation & Gray Pitcher Labeling:

The Use of Oral Contrast in Diagnostic Imaging Services policy dated. 9/25/2020, indicated Radiologic Services used Oral Contrast to visualize internal organs. The Use of Oral Contrast in Diagnostic Imaging Services policy, indicated the containers used for oral contrast were labeled with oral contrast type (name), concentration, date and time prepared, expiration date and time, and patient label was affixed to the container. The Use of Oral Contrast in Diagnostic Imaging Services policy indicated no indication that the label was generated from Hospital admitting services as a patient label, in effort to minimize patient identification and medication transcription errors.

The Surveyor observed a gray pitcher cap was then applied to the gray pitcher and a preprinted CT Oral Contrast Prep label contained the following information: Oral Omnipaque 240 (240 mg organically bound iodine, 1.21 mg tromeththamine, 0.1 mg edentate calcium disodium) 93% volume with water: 950 mL total volume. The Surveyor observed the label included transcribed handwritten information that included patient name, medical record number; and also included the following handwritten information: birth date, nursing unit, room number, medical record number, and expiration time. The preprinted CT Oral Contrast Prep label contained no documentation of date and time prepared, expiration time, nor a hospital generated patient label affixed to the pitcher. The preprinted CT Oral Contrast Prep label did not indicate the Crystal Light as an additive, the preprinted CT Oral Contrast Prep label did not identify the volume of Crystal Light added, nor did the preprinted CT Oral Contrast Prep label list the individual components of Crystal Light or volume of each component. The preprinted CT Oral Contrast Prep label did not indicate a warning regarding aspartame in accordance with Federal Regulation 21 CFR 172.804.

Federal Regulation 21 CFR 172.804 (https://www.ecfr.gov/api/renderer/v1/content/enhanced/2022-03-01/title-21?chapter=I&part=172§ion=172.804&subchapter=B&subpart=I) indicated the label of any food containing the additive shall bear, either on the principal display panel or on the information panel, the following statement: Phenyketonurics: Contains Phenylalinine. The statement shall appear in the labeling prominently and conspicuously as compared to other words, statements, designs or devices and in bold type and on clear contrasting background in order to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Regarding Contrast Media and Oral Contrast Instructions (Protocol):

The ACR Manual on Contrast Media, dated 2021, indicated the Physician should have knowledge of the volume and concentration of the appropriate contrast media required for a given examination. The Physician was responsible for defining the examination protocol, including specifying the type, timing, dosage, rate of injection, and route of administration of contrast media.

During the interview, at 2:30 on 2/22/2022, the Director of Radiologic Services said the document titled DIC-CT Instructions served as the Oral Contrast protocol.

The document titled DIS (Diagnostic Imaging Services) - Computerized Tomography (CT) Instructions indicated, the recommended oral dosage of Omnipaque (contrast) diluted to concentrations of 6 mg I/mL to 9 mg I/mL for contrast enhanced Computerized Tomography of the abdomen in adults was 500 mL to 1000 mL. The document DIS - CT Instructions indicated one recipe for oral contrast which included; to achieve one liter of contrast at a final concentration of 12 mg I/mL add stock concentration of Omnipaque 240 mg I/mL (50 mL volume) to 950 mL of water, carbonated beverage, milk or juice. The document DIS - CT Instructions indicated no recipe for 6 mg I/mL to 9 mg I/mL.

The document DIS - CT Instructions indicated no documentation:

- clear instructions to compound [combining medication(s), and altering the ingredients to create a medication specific for a patient] the medication,

-that Crystal Light contained Phenylalinine nor the clinical significance pediatrics nor pregnancy,

- Radiologic Services reviewed if Pharmacy Services were responsible for compounding medications consistent with other Hospital medication compounding needs, and

-of an Oral Contrast (Omnipaque) Protocol nor that the document DIS - CT Instructions were reviewed in accordance with the Prescribing, Ordering of Medications policy.

The Director of Radiologic Services said the document titled DIC-CT Instructions was not approved by the Pharmacy and Therapeutics Committee.

The Hospital provided no documentation that the Radiologic Services approved the Oral Contrast Instructions as the Hospital's Oral Contrast Protocol in order for a Radiologic Technician to have knowledge of the volume and concentration of the appropriate contrast required for a given examination nor included specifying type, timing, dosage, rate of injection, and route of administration for the oral contrast.

Regarding Oral Contrast Administration on Patient Care Units:

During the interview, at 2:30 A.M. on 2/22/2022, the Director of Imaging said the CT Radiology Technicians do not document the time an inpatient or an emergency department patient was administered oral contrast.

During an interview, at 3:15 P.M. on 2/22/2022, Radiologic Technologist #1 said a CT Radiologic Technologist brought the filled gray pitcher of oral contrast to a Nurse and the Nurse administered the oral contrast to the patient. Radiologic Technologist #1 said a CT Radiologic Technologist also brought filled gray pitchers of oral contrast to secretaries on the patient care units and a Nurse administered the oral contrast to the patient. Radiologic Technologist #1 said a CT Radiologic Technologist filled out the History Sheet- CT Radiology (documentation) in the Radiologic Department after the patient had consumed the oral contrast. Radiologic Technologist #1 said a CT Radiologic Technician called the Nurse for the time the patient started to drink the oral contrast and documented this start time in the Physician Order for the CT in the comments section.

Hospital Quality and Patient Safety Plan dated, 11/2021, indicated the Hospital identified Medication Bar Coding (Scanning) as a Hospital Quality Indicator.

The article titled Using Barcode Medication Administration to Improve Quality and Safety, Barcode (AHRQ.gov) indicated medication administration and electronic medication administration record technologies are two ways to improve inpatient medication safety by automating the process of medication checking (scanning), and making the medication administration record electronic. The Article indicated research demonstrated successful reductions in the rate of medication administration errors and dispensing errors after the implementation of barcoding systems, especially when the barcodes are affixed to medications at the level of the unit-dose.

The Hospital provided no documentation or information to indicate the Oral Contrast (as a medication) was scanned in Radiologic Services as a quality measure to monitor medication errors, in accordance with Hospital Medication Administration policy and the Hospital Quality and Patient Safety Plan.

Regarding Oral Imaging Contrast Media Outpatient Administration:

During the interview at 2:00 P.M. on 2/23/2022, CT Radiologic Technologist #3 said a CT Radiologic Technologist brought oral contrast to the Radiologic Services front desk for outpatients to receive their oral CT prep contrast. CT Radiologic Technologist #3 said the CT Radiologic Technologist provided the patient with education and an instruction sheet. CT Radiologic Technologist #3 said CT Radiologic Technologists did not document providing (dispensing) CT preparation contrast media to the patient and did not document education provided or that the CT Radiologic Technologist provided instructions. CT Radiologic Technologist #3 did not describe a process to identify the patient.

Regarding Oral Imaging Contrast Media Outpatient Administration in the Emergency Department:

CT Radiologic Technologist #3 said a CT Radiologic Technologist brought the oral contrast to Emergency Department patients and either an Emergency Department Nurse or the CT Radiologic Technologist administered the oral contrast to the patient. CT Radiologic Technologist #3 said she did not know how the Emergency Department Nurse documented the administration of the oral contrast. CT Radiologic Technologist #3 said the Emergency Department had a "criteria".

The Hospital provided no documentation of the Emergency Department Criteria, referred to by CT Radiologic Technologist #3, following Surveyor request.

Regarding Intravascular Contrast :

The Hospital policy titled Signed Orders for Administration of Intravascular Imaging Contrast Media, dated 8/4/2020, indicated a Radiologic Services policy. The Signed Orders for Administration of Intravascular Imaging Contrast policy indicated imaging contrast media administrated intravascularly was a medication and required an appropriate order from a physician or LIP prior to administration. The Signed Orders for Administration of Intravascular Imaging Contrast policy indicated, unlike other medication order signed orders for Intravascular Imaging Contrast Media need only to authorize the Use of Intravascular Imaging Contrast Media.

The Signed Orders for Administration of Intravascular Imaging Contrast policy indicated other components of a typical order including the specific Intravascular Imaging Contrast Media; agent (medication), concentration, dose and rate; were specified in the ICM protocol approved by the Hospital-Level Pharmacy & Therapeutics Committee.

The document titled Diagnostic Imaging Services Adult Intravenous Contrast Protocols (for) Computerized Tomography (CT) Department indicated no documentation of concentration, dose nor rate consistent with the Hospital's The Signed Orders for Administration of Intravascular Imaging Contrast policy.

Regarding Radiologic Documentation, History Sheet- CT Radiology:

The Hospital policy titled Use of Oral Contrast in Diagnostic Imaging Services indicated the patient's history regarding hydration was reviewed prior to administration. The Use of Oral Contrast in Diagnostic Imaging Services policy indicated no documentation of who was responsible for the patient's evaluation of fluid balance (hydration) in-order-to avoid complications associated with fluid shift in the bowel consistent with the policy.

The document titled History Sheet- CT Radiology indicated no area where a qualified person evaluated a patient's hydration history and status prior to oral contrast administration.

During the interview, at 4:00 P.M. on 2/23/2022, the Clinical Director of Pharmacy said the Radiologic Services used ACR (American College of Radiology) Manual on Contrast Media as the Hospital's Standard of Care.

The ACR Manual on Contrast Media, dated 2021, indicated the following four patient care goals, to:

1. ensure the administration of contrast was appropriate for the patient and indication,

2. balance likelihood of an adverse event with the benefit of the examination,

3. promote efficient and accurate diagnosis and treatment, and

4. to be prepared to treat a reaction should one occur.

The ACR Manual indicated the physician should have knowledge of the volume and concentration of the appropriate contrast media required for a given examination. The physician is responsible for defining the examination protocol, including specifying the type, timing, dosage, rate of injection, and route of administration of contrast media.

The History Sheet- CT Radiology indicated no:

- documentation to ensure the administration of contrast was appropriate for the patient as the History Sheet did not contain clear documentation of the contrast administered, an appropriate patient identifier label,

- consistent completion of the History Sheet, LIP acknowledgement for medical patient history review nor documentation in the Radiology Report review of the History Sheet in accordance with Hospital policy, and

- clear documentation (signature or name) of a qualified individual that administered the contrast.

Regarding Radiologic Service Emergencies:

The ACR Manual on Contrast Media indicated a patient care goals to be prepared to treat a reaction should one occur.

During the interview, at 2:30 P.M. on 2/22/2022, the Director of Diagnostic Imaging said there was an adult code cart and a pediatric code cart, in the Diagnostic Imaging Department (department of Radiologic Services). The Director of Diagnostic Imaging said pediatric patients received oral and IV contrast at the Hospital.

During the interview at 12:30 P.M. on 2/24/2022, the Medical Director of Radiologic Services said the document titled ACR Manual on Contrast Media was the primary resource for the Diagnostic Imaging Service on the use of contrast in the Hospital.

The Document titled ACR Manual on Contrast Media, 2021, indicated dedicated pediatric emergency resuscitation equipment (including various sizes of supplemental oxygen facemasks) should be available in locations using contrast in children.

During the interview, at 3:00 PM. on 2/24/2022, CT Radiologic Technologist #4 said the Diagnostic Imaging Department had a red cart that served as the adult code (emergency) cart and an orange plastic box that served as the pediatric code cart.

The Surveyor observed, at 3:00 P.M. on 2/24/2022:

1.) the Radiologic Services Diagnostic Imaging Services Emergency Drug Box form, was not signed or dated, and

2.) the Diagnostic Imaging Department contained a pediatric orange box that served as the pediatric emergencies, with the Diagnostic Imaging Services Emergency Drug Box Form attached. The Diagnostic Imaging Services Emergency Drug Box Form indicated no pediatric specific emergency airway resuscitative supplies were contained within the Emergency Drug Box; pediatric sized oxygen delivery masks nor pediatric appropriately sized resuscitation-bags (manual resuscitative device used to provide a child breaths).

The Surveyor observed an under-prepared Radiologic Service in the Diagnostic Imaging Department to manage a pediatric emergency.

Regarding Pediatric Intravenous Contrast (Omnipaque 350) and Pediatric Emergencies:

The document titled Diagnostic Imaging Services Pediatric IV Contrast Protocol CT Department, dated 3/17/2021, indicated the Hospital utilized Omnipaque 350.

The document titled Full Prescribing Information: Omnipaque (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018956s101lbl.pdf) indicated the safety and effectiveness of OMNIPAQUE 350 have not been established in pediatric patients for CT imaging of the head and body.

The Diagnostic Imaging Services Pediatric IV Contrast Protocol CT Department, indicated a header of column labeled as Weight in lbs. (pounds) with nineteen of nineteen weights listed in the column all as kg (kilograms). The Diagnostic Imaging Services Pediatric IV Contrast Protocol indicated an inconsistency in the use of weight in pounds and weight in kilograms and inconsistent with the American Academy of Pediatrics.

The American Academy of Pediatrics (2017) indicated Kilograms as a measurement for pediatric patient weights.

The Diagnostic Imaging Services Pediatric IV Contrast Protocol CT Department indicated a life-threatening potential medial error regarding inconsistent unit of weight measurement in the pediatric population.

Regarding Intravenous (IV) Insertion:

The Hospital policy titled Extravasation of Imaging Contrast Media, dated 6/22/2021, indicated the most common complication of imaging contrast media was compartment syndrome (a limb-threatening complication), and that a Radiologist or Emergency Department Physician was notified of the extravasation.

The Hospital policy titled Intravenous Therapy Peripheral and Central Line Care, dated 3/12/2019, indicated:

1. cleanse the skin with Chlorhexidine,

2. an LIP order for infusion therapy or saline lock order was required,

3. IV insertions were avoided in the affected extremity from a cerebrovascular accident (stroke),

4. Selection of the IV catheter was based on therapy, duration of treatment, availability of vascular site, diagnosis, and complications (extravasations), and

5. document the IV insertion in the Electronic Medical Record.

The Document titled ACR Manual on Contrast Media, indicated the flow rate should be appropriate for the gauge of the catheter used. Although 22-gauge catheters may be able to tolerate flow rates up to 5 ml/sec, a 20-gauge or larger catheter is preferable for flow rates of 3 ml/sec or greater. An antecubital or large forearm vein is the preferred venous access site for power injection. If a more peripheral (e.g., hand or wrist) venipuncture site must be used, flow rates should be reduced if feasible (e.g., 1-2 mL/sec).

During the interview, at 3:15 P.M. on 3/22/2022, CT Radiologic Technologist #1 said 2.5 mL/second injection rate to 4 mL/second injection (infusion) rate was dependent on the diagnostic imaging examination (i.e., CT scan) protocol. CT Radiology Technologist #1 said injection flow rates were built into diagnostic imaging examination protocols, built into the injector (machine), the machine manufacturer did not set injection rate, injection rates were part of best practice in the ACR Standards as determined by the Radiologist recommendations. Radiology Technologist #1 said the injection (flow) rate delivered was 2.5 mL/second to 4 mL/second.

The IV packing indicated the IV catheter flow rate of 35 mL/minute (0.58 mL/second). (the IV catheter used by the Radiologic Services most likely was not designed to administer the flow rate of the Contrast Media administered).

The Diagnostic Imaging Services Adult IV Contrast Protocols CT Department, dated 1/20/2022, indicated no documentation of an injection flow rate of 2.5 mL/second injection rate to 4 mL/second injection (infusion) rate for each diagnostic imaging examination.

The Surveyor observed a demonstration of an IV insertion, at 3:00 P.M. on 2/24/2022, that included gathering of supplies; an alcohol swab, a 22-gauge IV catheter and a prepackaged IV start kit. The Surveyor observed the 22-gauge IV catheter package selected by CT Radiologic Technologist #1 had the size, length and maximum flow rate printed on the package provided by the manufacturer. The manufacturer's guidelines indicated a maximum flow rate of 35 mL/minute (0.58 mL/second). The demonstration included supplies inconsistent with the Intravenous Therapy Peripheral and Central Line Care that required cleansing the skin with Chlorhexidine.

Five patients (Patients #2, #4, #5, #8, & #9) of ten patients sampled received IV contrast, and had IV extravasations with administration of intravascular (in a vein) contrast. Four patients with extravasations (Patients #2, #4, #5 & #8), their medical record did not indicate documentation that a Radiologist or Emergency Department Physician was notified of the extravasation as required by the Hospital policy titled Extravasation of Imaging Contrast Media.

Five patients (Patients #2, #4, #5, #8, & #9) with IV extravasations had IV's placed in sites identified as sites at an increased risk of developing severe complications, or as sites that should not be used, inconsistent with Hospital policies Extravasation of Imaging Contrast Media and Intravenous Therapy Peripheral and Central Line Care.