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Based on interview and record review, the facility failed to ensure Patient 16 received necessary information during discharge. This failure had a potential for the patients to limit their right to participate in implementing their plan of care with insufficient information.

Findings:

Review of Patient 16's procedure notes, dated 9/19/19, indicated the patient had an ultrasound (high-frequency sound waves to create images of the inside of the body) guided thoracentesis (a procedure in which a needle is inserted into the pleural space between the lungs and the chest wall. This procedure is done to remove excess fluid, known as a pleural effusion, from the pleural space to help the patient breathe easier).

Review of Patient 16's After Visit Summary (a paper or electronic document given to patients after a medical appointment, which is intended to summarize patients' health and guide future care, including self-management tasks), dated 9/19/19, indicated there was no information regarding activity instructions, diet instruction, warning signs and symptoms for discharge, and the procedure the patient had.

During an interview on 9/25/19 at 1:45 p.m. with the manager of quality and risk management (MQRM) and the director of interventional radiology (DIR), they reviewed Patient 16's After Visit Summary and confirmed some information were missing.

Review of the hospital's Medical Staff Bylaws indicated the discharge instructions are required on all hospital stays and must include the following elements: discharge medications reconciliation, discharge diet, follow-up appointments, activity level, and signs/symptoms to watch for.

Based on interview and record review, for 1 of 2 sampled adverse events (Patient 5), the hospital failed to monitor the effectiveness of 1 of 2 of its corrective actions. Refer to A-286 Part 1. For an additional 1 of 2 sampled adverse events (Patient 12), the hospital failed to implement 2 of 5 corrective actions, and failed to monitor the effectiveness of 2 of 5 corrective actions. Refer to A-286 Part 2. The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview and record review, for 1 of 2 sampled adverse events (Patient 5), the hospital failed to monitor the effectiveness of 1 of 2 of its corrective actions. For an additional 1 of 2 sampled adverse events (Patient 12), the hospital failed to implement 2 of 5 corrective actions, and failed to monitor the effectiveness of 2 of 5 corrective actions. The hospital also failed to track incidents of drug incompatibilities, and failed to adopt a policy stipulating that filing an incident report would be not be grounds for retaliation. The deficient practices allowed a problem identified as a factor in Patient 5's adverse event to be repeated for Patient 15, and created the potential for other patient safety problems to recur or not be identified.

Findings:

1. Review of a root cause analysis (RCA) dated 11/21/18 indicated Patient 5 died in the radiology department on 11/14/18 while awaiting a CT (computed tomography, a technique in which a computer reconstructs cross-sectional images of the body from multiple X-rays) scan. The RCA indicated one of two action items was "Concern with stability of patient to go without an RN [registered nurse] to Imaging exam. PI [performance improvement] group formed to review workflow for ED [emergency department] Imaging transports. A handwritten note next to the action item continued, "and developed policy." A "Status Update" on the RCA indicated, "PI group formed 12/12/18 with new ED workflow in place 1/29/19." An e-mail from the Nursing Educator for Emergency Services to 124 recipients dated 1/28/19 indicated attached criteria for patients requiring a nurse to transport them between the ED and CT would go live at 7 a.m. on 1/29/19. A policy attached to the RCA ("ED: Transport of Emergency Department (ED) Patient for Off Unit Procedures", dated 6/19) indicated it contained criteria for which patients leaving the ED for a procedure would "require nurse transport". A second policy, "Safe Transport of Patients in the Hospital" (dated 6/19) indicated it applied "throughout the hospital" and included criteria for "patients [who] require a nurse to be present during transport." No documentation was attached to the RCA indicating that the hospital was monitoring whether the new criteria for nurse transport were actually being implemented.

In an interview on 9/25/19 at 3:49 p.m., when the surveyor asked how the hospital was monitoring implementation of the new nurse transport policies, the Director of Risk Management and Patient Safety (DRMPS) stated there had been staff huddles to implement the changes; the DRMPS did not address monitoring of the implementation. The Director of Diagnostic Imaging Services (DDIS) stated the radiology department collected stickers with the name and medical record number of each patient who had been transported without a nurse, but did not explain how the stickers were used to ensure those patients who needed a nurse transport had received one. The Director of Critical Care Services (DCCS) stated she had met with her subordinate managers to see how the implementation was going, but she did not know if there was an audit sheet because there had been an interim manager of the emergency department at the time. In an interview on 9/25/19 at 4:05 p.m., the Emergency Department Manager (EDM) stated there had been delays transporting patients to radiology after implementation of the new policy, but there were no numbers. The EDM then stated a "unit partnership" had been watching implementation; the DDIS stated there had been documentation at meetings. In an interview on 9/26/19 at 10:22 a.m., the DCCS stated she was not able to find the "patient sheet" that had been discussed the previous day. The DCCS stated a spreadsheet had been created in January which she could not find. The DCCS stated problems with implementation had been discussed in February, but she did not know if there were any minutes. The DCCS stated she would look through her calendar and her handwritten notes. In an interview on 9/26/19 at 10:50 a.m., the DCCS stated the nurse transport issue had been discussed in the "unit partnership council" minutes prior to March 2019. The DCCS stated her calendar showed meetings on the topic and occasional notes, but there was no particular tracking of implementation of the new policy.

Review of the minutes provided by the DCCS indicated they were for an unspecified committee on unspecified dates in January and February, 2019. The January minutes included a discussion of the pros and cons of the new nurse transport policy and potential solutions to barriers. The February minutes included a qualitative discussions regarding successes and challenges implementing the new transport policy. Neither set of minutes included monitoring to determine whether the patients meeting the criteria received a nurse transport.

Review of additional documents presented by the hospital regarding follow-up to Patient 5's adverse event indicated they included a binder containing dated sheets of paper with stickers attached; the stickers included patient names, medical record numbers, and the type of CT scan each patient received. The documents also included an e-mail dated 9/25/19 (after the start of the survey) from the Risk Management Specialist (RMS) to 29 recipients thanking staff for meeting "to address our gaps in following the new Transport Procedure..."; the e-mail discussed training, revisions to the process, and follow-up meetings. The documents included a log of patients (entries dated 7/10/19 through 9/1/19) transported from units 3B and 3C indicating who transported each patient. The documents included the DCCS' Outlook calendars for ten dates between 1/30/19 and 2/15/19 showing meetings scheduled to discuss patient transport between the ED and CT. None of the documents included an analysis of whether patients meeting criteria for a nurse transport were receiving a nurse transport.

In an interview on 9/26/19 at 2:42 p.m., the RMS stated she had just started auditing the implementation of the transport policy and had a pile of transport tickets. She stated the tickets were not always being completed correctly, but she had yet to get rates and data.

Review of a stack of transport tickets presented by the RMS indicated they were sorted into six smaller stacks: "oxygen device no [check] or signature for oxygen", "blank responsible nurse", "oxygen incomplete", "Is this OK?", "?", and an unlabeled stack. No information was present regarding whether or not patients meeting criteria for nurse transport were receiving nurse transport.

In an interview on 9/16/19 at 5:04 p.m., the DCCS acknowledged the transport logs for units 3B and 3C did not address patients transported from the ED.

Refer to A-395 Part 2 regarding Patient 15 being transported without a nurse on 9/18/19 in spite of meeting the hospital's criteria for nurse transport.

2. Review of an e-mail from the RMS to 10 hospital staff dated 8/1/19 indicated Patient 12 experienced a code blue (cardiac arrest) and prolonged resuscitation attempts before dying on 7/20/19. The hospital's "event review" included five suggestions for "process improvements", three of which were follow-up with staff regarding when to call a "Cardiac Alert", a discussion regarding when to call in a second team to the cardiac catheterization lab (cath lab), and a request for the CPR (cardiopulmonary resuscitation) committee to address the use of "slap bands" (a wrist bracelet identifying the wearer's role). No documentation was present indicating that the hospital had implemented the recommendations or evaluated their effectiveness.

In an interview on 9/26/19 at 11:04 a.m., the Interim Interventional Manager stated she had discussed with her staff in the cath lab during daily huddles that they should not be afraid to call in backup. She stated the monitoring of whether backup was called had been conducted by the code blue committee. The RMS stated she would provide documentation of the monitoring.

In an interview on 9/26/19 at 11:24 a.m., the Educator for Telemetry (remote monitoring of the electrical activity of a patient's heart) and Telemetry/Stroke (ETTS) stated the hospital reminded staff of when to call a cardiac alert during orientation, in weekly e-mails, and in staff huddles. The ETTS stated the hospital tracked overhead pages to monitor the use of cardiac alerts. When the surveyor asked to see evidence of the monitoring, the ETTS stated there was not a good way to track cardiac alerts and restated the criteria for calling a cardiac alert.

Review of a document provided by the ETTS indicated it was an e-mail dated 7/11/19 (prior to Patient 12's event) from the ETTS to the nurses on units 3B and 3C discussing a case requiring a cardiac alert. No documents were present regarding additional training on cardiac alerts after Patient 12's event, or monitoring of whether or not cardiac alerts were being called.

In an interview on 9/26/19 at 2:40 p.m., the RMS stated the hospital was planning for a committee to address adding slap bands to every emergency cart, but nothing else had been done regarding slap bands. In an interview on 9/26/19 at 2:42 p.m., the RMS stated the flex nurses (who work in different areas of the hospital as needed) had been educated on cardiac alerts, but nurses on "3B" (a unit which cares for cardiac patients) had not yet received the training. The RMS stated the hospital performed code critiques which showed slap band use at individual events. The RMS stated the critiques were on individual paper documents which would be provided to the surveyor after they were "extrapolated" onto a spreadsheet; the surveyor asked the RMS to provide the documents as is.

Review of a stack of documents labeled "Code Critiques" provided by the RMS indicated every document in the stack pertained to Patient 12. There was no documentation of monitoring whether additional teams were being called in to the cath lab when needed, nor was there documentation of appropriate use of slap bands in other code blue events.

Review of an undated, "Plan for Crash Cart Conversion, Logistics", indicated the plan included the question, "Can slap bands be deployed to be available on every cart?" The document indicated the discussion had been planned for 9/23/19, but was canceled due to the survey.

3. Review of medication safety documents provided by the hospital indicated they addressed adverse drug reactions and medication errors, but not drug incompatibility incidents.

In an interview on 9/24/19 at 1:37 p.m., the surveyor asked the Manager of Pharmacy Operations (MPO) how the hospital tracked drug incompatibility incidents. The MPO replied with a description of how the hospital prevents drug incompatibility incidents. In an interview on 9/24/19 at 1:42 p.m. the MPO stated he could query the database of incident reports for drug incompatibility incidents. The MPO acknowledged he had not done so prior to the survey.

4. Review of the hospital's policy, "Administrative-Patient Safety/Unusual Occurrence Incident Reporting (Quality Review Report- QRR)", dated 10/2018, indicated the policy did not address non-retaliation for submitting an incident report. The policy stated, "El Camino Hospital supports a just culture approach in its management of errors and occurrences." The policy did not elaborate on what constituted a just culture.

In an interview on 9/28/19 at 1:43 p.m., the Director of Accreditation and Public Reporting (DAPR) stated there was no just culture policy. The DAPR stated the non-retaliation policy was contained in a slide presented during general orientation for new employees. The DAPR acknowledged the training slide was not a hospital policy. The DAPR stated the corporate compliance and harassment policies contained non-retaliation language, and there was no other policy addressing non-retaliation aside from those.

Review of an undated Powerpoint printout (printed 9/23/19), "Quality, Patient Safety, and Risk Management Culture of Safety", indicated slides 6 and 7 indicated the hospital had a culture of safety, that "punishing individuals for mistakes is contrary to a Culture of Safety" and "Welcoming the reporting of errors or near misses" was a key feature of a culture of safety. Slide 14 stated "A QRR is... Non-punitive..." None of the three slides referenced a hospital policy containing similar terms.

Review of the hospital's policy, "Corporate Compliance: Compliance Hotline", (dated 1/2019), indicated the policy provided "a mechanism... to report a concern regarding policies and procedures stated in the Standards of Conduct or a potential unlawful or unethical situation." The policy indicated the hospital would not tolerate retaliation for reports filed under the policy. The policy did not address reporting of patient safety concerns. Review of the hospital's policy, "HR [human resources]-Harassment", (dated 10/16), indicated the policy addressed harassment in the workplace, and prohibited retaliation for complaints of harassment or participation in investigations or proceedings by government agencies. The policy did not address non-retaliation for filling incident reports.

Based on observation, interview, and record review, the hospital failed to comply with the Condition of Participation for Nursing Services as evidenced by:

1. Failure to assign two nurses to care for the patients receiving moderate sedation per the association of perioperative registered nurses (AORN) guideline (refer to A392).

2. Failure to adopt current standard of practice to assign two nurses to care for the patients receiving moderate sedation to the hospital policy (refer to A392).

3. Failure to provide necessary nursing staff and monitoring equipment during the patient transportation to the radiologic department per the hospital policy (refer to A395).

4. Failure to complete required orientation and validate competency for registered nurses (refer to A397).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observation, interview, and record review, the hospital failed to assign two nurses to care for the patients receiving moderate sedation (a drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation) per the hospital's accepted guideline. Also, the hospital policy did not adopt the current standard of practice to follow. These failures had the potential to miss early detection of potential complications for patients receiving moderate sedation.

Findings:

Review of Patient 10's clinical records, dated 8/15/19 at 8:45 a.m., indicated the patient was scheduled for image guided lung biopsy (use of computerized tomography scan to guide a needle go through a chest wall and into the lung) under moderate sedation. Patient 10 was newly diagnosed with right upper lobe lung nodule. Present during the procedure included the attending provider, a registered nurse, and a radiology technician.

During an interview on 9/24/19 at 9:25 a.m., registered nurse M (RN M) stated the attending provider attempted at least 4-5 times to insert a needle to Patient 10's upper chest. During the second attempt, Patient 10 became short of breath, oxygen saturation level went down, and started coughing out small unmeasurable amount of blood. RN M called for help to have another nurse. RN M also stated the staff in the Radiology Department had been asking to have two licensed staff assigned to every scheduled procedure requiring moderate sedation.

Review of Patient 9's clinical records dated 8/15/19 at 12:18 p.m., indicated the patient was scheduled for percutaneous image guided biopsy of the lesion (a method of using a special needle to take a small piece of tissue from inside the body) under moderate sedation. The treatment team included an MD, a nurse, and an imaging technologist. During the procedure, Patient 9 developed hemoptysis (coughing up blood from respiratory tract) requiring airway management and emergent suctioning to protect the airway. A second nurse was called to assist the nurse for the emergent needs of Patient 9.

During a concurrent interview with RN M, she stated Patient 9's case was the second case of lung biopsy wherein the patient developed hemoptysis on that day. RN M stated she had to ask for help for Patient 9's emergency situation.

Review of Patient 18's clinical records, dated 9/26/19, indicated the patient was scheduled for image guided bone biopsy. The treatment team included the primary physician, an RN, and an imaging technician.

During a tracer observation on 9/26/19 at 9 a.m., of Patient 18's procedure, the patient received moderate sedation and there was one RN assigned for the procedure.


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During an interview with RN J on 9/26/19 at 9:40 a.m., the nurse stated only one nurse was assigned to a procedure for the patient receiving moderate sedation, there was one nurse scheduled during the weekend, and nurses had a concern about staffing on the weekend. She stated on the weekend, procedures requiring moderate sedation were added and it was unsafe for the patients with one nurse.

During an interview with RN K on 9/27/19 at 11:50 a.m., the nurse stated only one nurse was usually scheduled to work on the weekends in interventional radiology (IR). She stated this was dangerous because patient procedures with physicians were scheduled so close together that demands for the IR nurse's attention from physicians and staff frequently distracted and interrupted her during the times she actively provided care to her own patients who were under moderate sedation. She stated some examples included receiving frequent calls, via her hospital-assigned communicator device, for her physical presence from other procedure rooms and face-to-face staff requests to verify urgent medications for other patients. She stated other inconveniences from having only one nurse on the unit included telephone consents for medications from patients' responsible parties that required witnessed signatures of two licensed nurses and having no time to take breaks or lunch throughout the workday.

During an interview with RN L on 9/27/19 at 11 a.m., the nurse stated one nurse was assigned to a procedure for the patient care under moderate sedation and felt it was unsafe. Also, she stated during the weekend, there was only one nurse in radiologic department and assist all procedures including patients care under moderate sedation.

During an interview on 9/29/19 at 11:30 a.m., the manager of quality and risk management (MQRM) and the director of interventional radiology (DIR) stated the hospital followed the association of perioperative registered nurses (AORN) guideline for moderate sedation.

Review of AORN, Moderate Sedation/Analgesia, indicated the collective evidence establishes the risk of moderate sedation/analgesia from complications associated with the respiratory system (e.g., hypoxia, hypercapnia, impaired airway reflexes, loss of airway patency, airway obstruction, respiratory depression) and cardiovascular system (e.g., hypotension, cardiac arrhythmias). Continuous monitoring and observation of the patient's physiological and psychological status can lead to early detection of potential complications. It indicated two perioperative RNs should be assigned to care for the patient receiving moderate sedation. One RN should administer the sedation medication and monitor the patient and the other RN should perform the circulating role.

Review of the hospital's policy "Moderate Sedation Policy, Adult and Pediatric", dated 1/2006 and revised 1/2016, indicated the registered nurse who administers moderate sedation is requiring to have knowledge and skills in administering medication to induce moderate sedation as well as the ongoing monitoring of the patient during and after the procedure. The policy did not reflect two RNs should be assigned to care for the patients receiving moderate sedation.

During a concurrent interview, MQRM and DIR stated the hospital assigned one RN for a procedure requiring moderate sedation and the hospital policy did not reflect current AORN's guideline to assign two RNs for a procedure of the patient receiving moderate sedation.

Based on interview and record review, the facility failed to ensure nursing staff safely transferred 2 patients (Patients 5 and 15) to radiologic services.

1. Patient 5, who complained of chest pain and had a physician's order for cardiac (heart) monitoring, was sent without a cardiac monitor and a nurse.

2. Patient 15, who was on Dobutamin (used in the treatment of cardiogenic shock and severe heart failure) was sent to a radiologic deparment without cardiac monitoring equipment and a nurse.
These failures left patients without ongoing supervision with staff competent to assess and respond to their immediate needs.

Findings:

Review of Patient 5's Patient Care Timeline indicated, "11/14/18... 17:04 (5:04:16 PM + 16 minutes) Chief Complaints... Chest Pain... 18:45 (6:45 PM) To CT (computed tomography, a process used to produce multiple cross-sectional x-ray images)... 18:54 (6:54 PM) Code... (i.e. code blue, an emergency call for staff to respond to a patient who loses heart and/or lung function)... 19:38 (7:38 PM) pt expired (patient died)..."

Review of Patient 5's physician's order, dated 11/14/18 at 5:13 p.m., indicated, "Cardiac Monitoring... Frequency: Continuous..."

During an interview on 9/24/19 at 2:22 p.m. with the emergency department manager (EDM), she stated because there was a physician's order for Patient 5 to be on continuous cardiac monitoring, he should have been with a nurse and on a portable cardiac monitor while he was transported outside of the ED and while at the CT imaging area.

During an interview on 9/25/18 at 8:25 a.m. with registered nurse A (RN A), she stated Patient 5 was transported out of the emergency department for CT without a nurse and without a portable cardiac monitor.

During an interview on 9/25/19 at 9:10 a.m. with CT Tech (technician/technologist) B, he stated, upon encountering Patient 5 in a holding area just prior to 6:53 PM, the patient was without a cardiac monitor or an assigned nurse. He stated Patient 5 complained of chest pain. He stated he brought Patient 5 into a CT room where the patient became unresponsive to touch and verbal questions.



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2. Review of Patient 15's medical record, dated 9/12/19, indicated the patient was a 70-year-old female with history of congestive heart failure (abnormal condition characterized by circulatory congestion and retention of salt and water by the kidneys). She was admitted from emergency department to 3C Telemetry Unit on 9/12/19 due to cough and shortness of breath with orthopnea (condition in which the person can breathe normally or comfortably only when sitting erect or standing), worst on exertion. She used her home oxygen at night and as needed.

Review of Patient 15's medication order, dated 9/13/19, indicated Dobutamine 4 mcg (microgram - metric unit of weight measurement equal to one-millionth of a gram)/kg (kilogram unit of weight measurement) / minute was ordered at 12.5 ml (milliliter- liquid measurement) per hour.

Review of Patient 15's medical record, dated 9/18/19, indicated the patient was scheduled for ultrasound of the abdomen (type of imaging test used to look at organs in the abdomen including the liver, gallbladder, spleen, pancreas, and kidneys).

During an interview on 9/27/19 at 9:25 a.m., Transporter O (Tr O) stated he received a transport request on 9/18/19 for Patient 15 to go to the ultrasound room and generated a transport ticket.

Review of Patient 15's Transport information from transport request includes patient's name, allergies, code status, mode of transport, and safety precautions including level of consciousness, use of oxygen, and fall risk. It also included special considerations including patient needs for remote/central monitoring. Transport request information for Patient 15 did not include information on her current IV infusion.

During a concurrent interview, Tr O stated they were not responsible in assisting patients transfer from bed to whatever mode of transportation was ordered for the patients. Tr O also stated, Patient 15 was already on a gurney when he arrived in the room with only a certified nursing assistant present in the room.

During an interview on 9/27/19 at 9:05 a.m., registered nurse N (RN N) stated Patient 15 was hemodynamically stable and send Patient 15 to ultrasound with remote monitoring unaccompanied by a licensed nursing staff . She further stated she forgot Patient 15 was on Dobutamine IV infusion and should have transported accompanied by an RN.

Review of the facility's 3/2016 policy and procedure "Telemetry Cardiac Monitoring" indicated, "Registered nurses... Place initial ECG (electrocardiogram, an electronic recording of the heart's electrical activity using wires leading from the patient's skin to an ECG machine, often viewable via a monitor and/or on paper printouts) electrodes (a sticky adhesive tab placed on a patient's skin that enables conduction of electric signals from the skin to an attached wire leading to an ECG machine) on the patient and initiate continuous cardiac monitoring based on the physician's order... Transport and Care of patients for off unit procedures... Patients will be transported off unit based on Level I and Level II criteria... Cardiovascular Status... LEVEL II RN (registered nurse) & ECG monitoring... Within last 24 hours, has patient experienced any of the following... chest pain..., Transport Personnel... Nurse or MD (physician) with unlicensed assistant for escort...,On-going care during procedure...RN/MD with tech..."

Based on interview and record review, the facility failed to ensure nursing staff completed the required orientation and/or their competency was validated prior to the assignment. This failure has the potential for patients to receive care from unqualified nursing staff.

Findings:

Six (6) Employee files were reviewed on 9/26/19 at 3:07 p.m. with Nursing Educator (NE).

During a concurrent interview, NE stated registered nurses (RNs) received the unit specific orientation for interventional services and their competency should be validated by completing Radiology Nursing Skills and Competency Checklist and Initial Competency Validation RN Interventional Services.

1. Review of RN D's employee file indicated the nurse was hired on 1/7/19. The nurse's Radiology Nursing Skills and Competency Checklist and Initial Competency Validation RN Interventional Services were missing and Unit Specific Interventional Services Documents (orientation document) was incomplete.

2. Review of RN E's employee file indicated the nurse was hired on 1/7/19. The nurse's Initial Competency Validation RN Interventional Services was incomplete.

3. Review of RN F's employee file indicated the nurse was hired on 6/17/19. The nurse's Radiology Nursing Skills and Competency Checklist and Initial Competency Validation RN Interventional Services were missing and Unit Specific Interventional Services Documents was incomplete.

4. Review of RN G's employee file indicated the nurse was hired on 4/11/16. The nurse's Radiology Nursing Skills and Competency Checklist was missing and Unit Specific Interventional Services Documents was incomplete.

5. Review of RN H's employee file indicated the nurse was hired on 6/4/18. The nurse's Initial Competency Validation RN Interventional Services was complete on 6/2019, which was a year after the hire. NE stated RN H's competency was not validated in a timely manner. It further indicated RN H's Radiology Nursing Skills and Competency Checklist was missing and Unit Specific Interventional Services Documents was incomplete.

6. Review of RN I's employee file indicated the nurse was hired on 9/25/17. The nurse's Interventional Services-Interventional Radiology Checklist (a type of orientation checklist) was incomplete and Interventional Services-Procedures Competency Checklist (a type of competency checklist) was remained blank.

Review of the hospital's policy, "Competency and Validation", dated 4/2018, indicated the policy was to assure that safe and consistent quality care is delivered to patients by clinical staff. It indicated the orientation includes the use of formal and informal assessment tools which assess job knowledge, critical thinking, interpersonal skills, and technical skills with the context of the organization. The results are used: to individualize the department specific orientation plan, in conjunction with preceptor's evaluations and observations to validate an individual's competency, and competencies for RN include baseline and unit specific.

Based on observation, interview, and record review, the hospital failed to comply with the Condition of Participation for Radiologic Services as evidenced by:

1. Failure to administer Versed (a medication used to sedate a person who is having a minor surgery or other medical procedure) per the hospital policy (refer to A535).

2. Failure to reflect the manufacturer's specification for use of Versed in the hospital policy (refer to A535).

3. Failure to administer Fentanyl (an opioid analgesic drug [medicines that are used to relieve pain]) for moderate sedation within the dose range, indicated in the policy (refer to A535).

4. Failure to maintain accurate document with the medication used (refer to A535).

5. Failure to assign two nurses to care for the patient receiving moderate sedation per the association of perioperative registered nurses (AORN) guideline (refer to A392).

6. Failure to complete required orientation and validate competency for registered nurses in radiologic services (refer to A397).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on interview and record review, the hospital failed to ensure:

1. Patient 22's Versed (a medication used to sedate a person who is having a minor surgery or other medical procedure) was administered per the hospital policy during the moderate sedation (a drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation);

2. The hospital's moderate sedation policy reflected the manufacturer's specification for use of Versed in geriatric patients;

3. Patients 22, 27, 28, and 31 receive the initial dose of fentanyl (an opioid analgesic drug [medicines that are used to relieve pain]) within the dose range indicated in the policy; and,

4. Patient 23's procedure note had an accurate information for the medications used.

These failures had the potential for patients who receive moderate sedation, to have excessive medications possibly causing deep sedation (a drug-induced depression of consciousness during which patients cannot be easily aroused) or health complications.

Findings:

1. Review of Patient 22's procedure notes, dated 4/18/19, indicated the patient was a 75-year-old female and had a CT (Computed tomography, a imaging test used to create detailed images of internal organs, bones, soft tissue and blood vessels) guided lung biopsy (an examination of tissue removed from a living body to discover the presence, cause, or extent of a disease).

Review of Patient 22's IR (interventional radiology) Timeline, dated 4/18/19, indicated for moderate sedation, the patient received Versed 1.5 mg at 9:14 a.m. as an initial dose and followed by 0.5 mg at 9:15 a.m., which was a minute after the initial dose was administered.

Review of manufacturer's package insert (a document included in the package of a medication that provides information about that drug and its use) of Versed, dated 7/2017, indicated for patients age 60 or older, because the danger of hypoventilation (breathing at an abnormally slow rate), airway obstruction, or apnea (the cessation of breathing) is greater in elderly patients and those with chronic disease states or decreased pulmonary reserve, and because the effect may take longer in these patients, increments should be smaller and the rate of injection slower. No more than 1.5 mg should be given over a period of no less than 2 minutes. Wait an additional 2 or more minutes to fully evaluate the sedative effect.

Review of the hospital's policy, "Moderate Sedation Policy, Adult and Pediatric", dated 12/2006 and revised on 5/2012, indicated for Versed, 0.5-2.5 mg/dose may repeat every 2-3 minutes, total dose rarely to exceed 10 mg. It indicated as a consideration, to administer slowly over at least 2 minutes to avoid respiratory depression or apnea.

During an interview on 9/27/19 at 8:30 a.m., the manager of quality and risk management (MQRM) confirmed Patient 22's Versed was administered too soon after the first dose was administered and the hospital policy did not reflect the manufacturer's specification for the elderly.

2. Review of Patient 22's procedure notes, dated 4/18/19, indicated the patient was a 75-year-old female and had a CT guided lung biopsy.

Review of Patient 22's IR (interventional radiology) Timeline, dated 4/18/19, indicated for moderate sedation, the patient received 75 micrograms (mcg, a unit of mass) of fentanyl as an initial dose.

Review of Patient 27's procedure notes, dated 8/21/19, indicated the patient was a 67-year-old male and had a CT guided liver biopsy.

Review of Patient 27's IR Timeline, dated 8/21/19, indicated for moderate sedation, the patient received 100 mcg of fentanyl at 8:58 a.m. as an initial dose.

Review of Patient 28's procedure notes, dated 8/23/19, indicated the patient was 58-year-old male and had a CT guided lung biopsy.

Review of Patient 28's IR Timeline, dated 8/23/19, indicated for moderate sedation, the patient received 100 mcg of fentanyl at 9:51 a.m. as an initial dose.

Review of Patient 31's H&P (history and physical, the clinical evaluation and examination of the patient), dated 9/27/19, indicated the patient was a 53-year-old male and had CT guided bone marrow (a soft and sponge-like tissue in the center of most bones) biopsy.

Review of Patient 31's IR Timeline, dated 9/27/19, indicated for moderate sedation, the patient received 100 mcg of fentanyl as an initial dose.

During an interview on 9/27/19 at 11 a.m., the MQRM confirmed Patients 22, 24, 28, and 31 received a fentanyl dose greater than the dose the hospital's policy indicated.

Review of the hospital's policy, "Moderate Sedation Policy, Adult and Pediatric", dated 12/2006 and revised on 5/2012, indicated to start fentanyl at 25-50 mcg.

3. Review of Patient 23's procedure notes, dated 4/18/19, indicated the patient had a CT guided lung biopsy. It indicated during the procedure, "Total of 2 mg of Versed and 100 mcg of fentanyl were used".

Review of Patient 23's IR Timeline, dated 4/18/19, indicated the patient received Versed 1 mg at 9:32 a.m., 9:45 a.m., and 9:59 a.m., which was a total of 3 mg. Fentanyl 50 mcg was administered at 9:32 a.m., 9:48 a.m. and 9:59 a.m., which was a total of 150 mcg.

During an interview on 9/27/19 at 8:30 a.m., the MQRM confirmed Patient 23's procedure note was inaccurate for the medication dosages used.