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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the §482.12 Condition of Participation: Governing Body was out of compliance.

A-0084 The governing body must ensure that the services performed under a contract are provided in a safe and effective manner. Based on interviews and document review, the facility's governing body failed to ensure contracted services were provided in a safe and effective manner. Specifically, the governing body failed to ensure students had clinical oversight to ensure they performed within their scope of practice.

Based on document review and interviews, the facility's governing body failed to ensure contracted services were provided in a safe and effective manner. Specifically, the governing body failed to ensure students had clinical oversight to ensure they performed within their scope of practice. (Cross-reference A-0395)

Findings include:

References:

The Board of Trustees (Governing Board) bylaws read, the primary role of the Board of Trustees is to provide community perspective and advice to the company, thereby fulfilling responsibilities to the patient population served by the company by facilitating the establishment of policies, maintaining quality patient care. The Clinical Patient Safety and Quality Committee (CPSQC) is responsible for oversight of the assessment, preservation, and improvement of the quality and efficiency of patient care that is provided in a safe environment with the facilities.

The Department of Public Health and Environment Emergency Medical Services 6 CCR 1015-3 Chapter One - Rules Pertaining to EMS (emergency medical services) and EMR (emergency medical responder) Education, EMS Certification or Licensure, and EMR Registration (effective 6/14/22) read, a medical director is defined as a physician licensed in good standing who authorizes and directs, through protocols and standing orders, the performance of students-in-training enrolled in Department-recognized EMS or EMR education programs and/or EMS certificate holders or licensees who perform medical acts, and who is specifically identified as being responsible to assure the performance competency of those EMS providers as described in the physician's medical continuous quality improvement program. Under the section for Medical Acts Allowed, paramedics are permitted to insert nasogastric (NG) tubes for gastric decompression. The insertion of a transpyloric (TP) tube or other tube for feeding purposes was not listed under the section for Medical Acts Allowed as a permitted medical act.

1. The facility failed to ensure contracted services had clinical oversight that ensured students worked within their scope of practice.

A. Document Review

i. The medical record of Patient #2 was reviewed. The medical record review revealed Patient #2 was a 47 day old patient admitted on 12/21/23 for acute respiratory failure related to a respiratory virus and influenza. Orders were placed for a TP tube to be placed and an abdominal x-ray for placement confirmation. The medical record review revealed Patient #2 needed the TP tube placed for nutritional feeding purposes. The medical record revealed RN #3 documented the TP tube was placed per policy at the bedside. RN #3 measured the TP tube and supervised the procedure of a paramedic student as they placed the TP tube into Patient #2. Further review revealed Patient #2 had an episode of coughing, gagging, and dropped heart rate while the tube was placed. RN #3 placed a continuous positive airway pressure machine (CPAP) (a machine that used air pressure to keep the breathing airway open) and a bi-level positive airway pressure (BIPAP) (a machine that used high air pressure to keep the breathing airway open) on the patient. After Patient #2 was calm, the tube was flushed with 10 milliliters of water before an x-ray was obtained for placement confirmation. The medical record review revealed Patient #2 experienced a pneumothorax (a collapsed lung) following the TP placement.

This was in contrast with 6 CCR 1015-3, Chapter One - Rules Pertaining to EMS and EMR Education, EMS Certification or Licensure, and EMR Registration which did not include the insertion of a nasogastric tube, orogastric (OG) tube or TP tube for feeding purposes under medical acts allowed.

ii. A document review of the Medical Staff Rules and Regulations was completed. The review revealed the clinical oversight for students was for medical students only. Nursing and non-nursing students, including EMS students, were not included in this oversight.

iii. A document review was completed for the last 12 months of meeting minutes for the Board of Trustees, the Medical Executive Committee, and the CPSQC. The document review revealed no evidence that affiliation agreements for colleges who contracted student learning services with the facility were reviewed. (Cross-reference A-0395)

B. Interviews

i. On 12/27/23 at 3:20 p.m. an interview was conducted with the emergency medical services (EMS) clinical coordinator (Clinical Coordinator) #2. Clinical Coordinator #2 stated EMS students functioned under a physician's license. Clinical Coordinator #2 stated each college had a medical director who provided the clinical oversight and was unaffiliated with the facility. Clinical Coordinator #2 stated the college medical director did not come on-site to oversee the students clinically. Clinical Coordinator #2 stated the clinical oversight was provided by the physician on-site for students in the Emergency Department (ED) or by the school medical director through evaluation forms filled out and returned by nursing preceptors.

ii. On 1/3/24 at 10:21 a.m., an interview was conducted with Quality Director #6. Quality Director #6 stated the facility's chief executive officer (CEO) did not sit on the Board of Trustees. They explained the division CEO was not available for an interview and it was recommended that questions be directed to the vice president of quality and patient safety (VP) #7. Quality Director #6 stated the facility had representation on the Board of Trustees through the CPSQC. Quality Director #6 stated information about the event with Patient #2 was presented to the CPSQC as a subset committee of the Board of Trustees. Quality Director #6 stated Patient #2's information was not documented or entered into the meeting minutes, but rather shared as a live discussion with the members of the committee.

iii. On 1/3/24 at 7:17 a.m. an interview was conducted with VP #7. VP #7 stated they acted as a liaison to the Board of Trustees. VP #7 stated they were unsure of the kind of student supervision provided by the colleges for the EMS students. VP #7 stated the bylaws of the Board of Trustees defined oversight of the board as their primary responsibility. VP #7 stated the medical staff committee provided oversight to medical students but was uncertain about EMS or other contracted services that involved students. VP #7 stated CPSQC was aware of the event involving Patient #2 because the CPSQC met weekly via phone and discussed any facility root cause analyses (RCA). VP #7 stated facility leadership had not communicated to staff that students needed oversight that included the knowledge of the student's scope of practice.

iv. On 1/3/24 at 10:35 a.m., an interview was conducted with chief medical officer (CMO) #8. CMO #8 stated the oversight for students in the facility was determined by the type of student category such as medical, nursing, or allied health. CMO #8 stated the facility did not have a process in place to provide oversight for students other than medical students. CMO #8 stated once the EMS students got to the inpatient units, there was no clinical oversight. CMO #8 then stated having clinical oversight for all students ensured the students learned the functions of their roles correctly. CMO #8 further stated having no clinical oversight presented patient safety risks and potential patient harm if students provided patient care incorrectly.

v. On 1/3/24 at 1:36 p.m., an interview was conducted with the assistant vice president of academic affairs (AVP) #9. AVP #9 stated the affiliation agreements (contracts) between the colleges and the facility were managed by AVP #9 for nursing and allied health students and Clinical Coordinator #2 for EMS students. AVP #9 stated the contracts were renewed every two years for nursing students and every three years for EMS students. AVP #9 stated the contracts were approved at the corporate level of the organization and was unaware of what involvement the board had in the process. AVP #9 stated contracts were reviewed for non-clinical content such as vaccinations and background checks. AVP #9 stated this information was not reviewed by the board. AVP #9 stated all students had a staff preceptor and were evaluated through an online program. AVP #9 stated the allied health programs included dietary, EMS, health management, occupational/physical/speech therapy, phlebotomy, radiology, surgical technology, respiratory therapy, and ultrasound. AVP #9 stated these programs were not set up to have any clinical oversight from an instructor or guidance from training documents.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.23 Nursing Services was out of compliance.

A-0395 - A registered nurse must supervise and evaluate the nursing care for each patient. Based on document review and interviews, the facility failed to ensure staff working with students considered the student's scope of practice for patient care assignments in one of one patients reviewed who received a transpyloric (TP) feeding tube insertion by a paramedic student (Patient #2). Additionally, the facility failed to ensure staff had access to the preceptors' responsibilities and students' scopes of practice when precepting students.

A-0398 All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). Based on document review and interviews, the facility failed to ensure registered nurses adhered to the policies and procedures of the hospital in one of one medical records reviewed of a patient who received a transpyloric (TP) feeding tube (Patient #2). Additionally, the facility failed to ensure staff competencies for processes and procedures were validated in two of two personnel files reviewed. (registered nurse (RN) #3 and RN #15)

Based on document review and interviews, the facility failed to ensure staff working with students considered the student's scope of practice for patient care assignments in one of one patients reviewed who received a transpyloric (TP) feeding tube insertion by a paramedic student (Patient #2). Additionally, the facility failed to ensure staff had access to the preceptors' responsibilities and students' scopes of practice when precepting students.

Findings include:

Facility policy:

The Observation and Shadowing policy read, the Education Affiliation Agreement is part of a formalized training program or part of a formal agreement with the facility, where they are learning under supervision to practice or improve their skills. Observation hours and student placements are directed by the Education Affiliation Agreement and are not governed by this policy.

References:

The Preceptor Competency Based Staged Orientation (CBSO) training information guide read, students may participate in direct patient care including any skill or task that falls within the scope of nursing practice as long as it is approved by the school, the student has been instructed on it through the school, and the student has been deemed competent to perform it under the supervision of an RN. There was no evidence referenced in the guide for emergency medical services (EMS) students.

According to the The Department of Public Health and Environment Emergency Medical Services 6 CCR 1015-3, Chapter One - Rules Pertaining to EMS and EMR Education, EMS Certification or Licensure, and EMR Registration (effective 6/14/22), under the section for Medical Acts Allowed, paramedics are permitted to insert nasogastric (NG) tubes for gastric decompression. The insertion of a transpyloric (TP) tube or other tube for feeding purposes was not listed under the section for Medical Acts Allowed as a permitted medical act.

1. The facility failed to ensure staff understood the preceptor's responsibilities or scope of practice for students they precepted during clinical rotations.

A. Medical Record Review

i. The medical record of Patient #2 was reviewed. The medical record review revealed Patient #2 was a 47 day old patient admitted on 12/21/23 for acute respiratory failure related to a respiratory virus and influenza. Orders were placed for a TP tube to be placed and an abdominal x-ray for placement confirmation. The medical record review revealed Patient #2 needed the TP tube placed for nutritional feeding purposes. The medical record revealed RN #3 documented the TP tube was placed per policy at the bedside. RN #3 measured the TP tube and supervised the procedure of a paramedic student as they placed the TP tube into Patient #2. Further review revealed Patient #2 had an episode of coughing, gagging, and dropped heart rate while the tube was placed. RN #3 placed a continuous positive airway pressure machine (CPAP) (a machine that used air pressure to keep the breathing airway open) and a bi-level positive airway pressure (BIPAP) (a machine that used high air pressure to keep the breathing airway open) on the patient. After Patient #2 was calm, the tube was flushed with 10 milliliters of water before an x-ray was obtained for placement confirmation. The medical record review revealed Patient #2 experienced a pneumothorax (a collapsed lung) following the TP placement.

This was in contrast with 6 CCR 1015-3, Chapter One - Rules Pertaining to EMS and EMR Education, EMS Certification or Licensure, and EMR Registration which did not include the insertion of a nasogastric tube, orogastric (OG) tube or TP tube for feeding purposes under medical acts allowed.

B. Document Review

i. A document review of the Education Affiliation Agreement for College #1 and College #2 was reviewed. The document review revealed the facility provided supervision for educational and clinical activities that were reasonable and appropriate to the student's level of training.

ii. A document review was completed for College #2's Emergency Medical Services (EMS) Academy Paramedic Education Program Clinical Manual. The document review revealed the scope of practice was defined in the State of Colorado Department of Public Health and Environment, Health Facilities and Emergency Medical Service Division: 6 CCP 1015-3 Appendix A Medical Acts Allowed; Appendix C. The clinical manual read, the expectation of the preceptor was to read and review the EMS student's clinical competencies as well as any policies and procedures pertinent to the EMS student while assigned to the clinical unit.

iii. A document review was completed for College #3's Emergency Medical Services (EMS) Program Clinical Internship Policies and Procedures Manual. The document review revealed no evidence of reference to the EMS student's scope of practice, the role of the student, or the expectations of the role of the preceptor for the EMS student. The document review revealed a preceptor feedback form filled out by the student at the end of each shift. This evaluation included whether or not the clinical preceptor allowed the student to perform the skills they were qualified to perform. The review also revealed the feedback form included whether or not the clinical preceptor took time to learn the reason the student was at the clinical and what the student could perform.

iv. A document review was completed for College #1's Emergency Room: Clinical Orientation and Objectives. The document review revealed the school followed Chapter Two of the Code of Colorado Regulations Health Facilities and Emergency Medical Services Division for the scope of practice for the EMS students. The document review revealed no evidence of the expectations of the role of the preceptor for the EMS student.

v. A document review was completed for College #4's Advanced Student Internship Manual. The document review revealed no evidence of reference to the EMS student's scope of practice, the role of the student, or the expectations of the role of the preceptor for the EMS student.

The content of these documents was in contrast to the CBSO training information guide that read any direct patient care performed by students had to fall within the scope of practice and the student had been deemed competent by the school.

C. Interviews

i. On 12/28/23 at 7:32 a.m., an interview was conducted with RN #3, who was precepting the EMS student who inserted the TP tube into Patient #2. RN #3 stated when they precepted an EMS student, they asked about background and experience information. RN #3 stated they reached out to the unit educator or charge nurse if they needed to know what the scope of practice was for the student. RN #3 stated they also would look up the scope of practice on the Department of Regulatory Agencies (DORA) website if they had questions. RN #3 stated they were unaware of any verbal or written scope of practice used by the RN preceptors. RN#3 stated they did not look up the EMS student's scope of practice prior to the student inserting the NP tube into Patient #2. RN #3 stated it was not necessary because the EMS student performed the skill with RN #3's direct supervision.

ii. On 12/28/23 at 1:25 p.m., an interview was conducted with RN #11, who worked in the labor and delivery unit. RN #11 stated the labor and delivery unit did not have a reference binder for guidance on precepting EMS students. RN #11 stated if there was an immediate need to know the scope of practice, the RN asked the charge nurse.

iii. On 12/28/23 at 1:50 p.m., an interview was conducted with RN #12, who worked in the pediatric unit. RN #12 stated there was no reference binder on the pediatric unit for guidance on precepting EMS students. RN #12 stated if they needed to know what the EMS student's scope of practice was, they would look it up on the DORA website or ask the unit educator.

iv. On 12/28/23 at 2:00 p.m., an interview was conducted with RNs #13 and #14, who worked in the pediatric intensive care unit (PICU). RNs #13 and #14 reported they were not aware of a reference binder that identified the EMS students' scope of practice for the PICU. RNs #13 and #14 further reported if they had questions about the scope of practice, they asked the charge nurse or unit educator.

v. On 12/27/23 at 10:15 a.m., an interview was conducted with charge nurse (CRN) #10. CRN #10 stated all RNs precepted students. CRN #10 stated preceptors needed to be advanced and experienced nurses to teach students or new hires. CRN #10 stated EMS students on the unit shadowed as well as cared for patients under the supervision of the RN. CRN #10 stated the charge nurses would ask an instructor or educator if the student's scope of practice was not understood.

vi. On 12/27/23 at 1:11 p.m., an interview was conducted with Clinical Educator #1. Clinical Educator #1 stated registered nurses (RNs) precepted emergency medical system (EMS) students that included emergency medical technicians (EMTs) and paramedic students. Clinical Educator #1 stated there were no specific precepting guidelines for the EMS students and the nurses were instructed to follow the same guidelines used for nursing students and newly hired nursing staff. Clinical Educator #1 stated the facility had a class that trained nurses to precept students and new hires, but nurses were not required to take the class before they precepted students. Clinical Educator #1 stated the guidelines informed nurses that oversight for EMS students was appropriate as long as the skill was within the EMS student's scope of practice. Clinical Educator #1 stated the RNs who precepted EMS students needed to look up the student's scope of practice. Clinical Educator #1 stated they did not know where the EMS scopes of practice were found and thought most staff nurses would not know where to look for information.

vii. On 12/27/23 at 3:20 p.m., an interview was conducted with EMS clinical coordinator (Clinical Coordinator) #2. Clinical Coordinator #2 stated RNs received a one-page summary from the students which gave them information about precepting EMS students because most nurses did not know the scope of practice for EMS students. Clinical Coordinator #2 stated there was a notebook binder on each unit provided by the students' schools which explained the scope of practice for the EMS students and the preceptor's responsibilities. Clinical Coordinator #2 stated the facility followed the Department of Public Health and Environment Health Facilities and Emergency Medical Services Division Emergency Medical Services 6 CCR 1015-3 regulations as the guidance for EMS scope of practice.

Clinical Coordinator #2 stated the EMS scope of practice for paramedic students included the placement of a nasogastric tube but stated they did not know what a transpyloric tube was. Clinical Coordinator #2 stated it was important for preceptors to know the EMS student's scope of practice and if they did not know, the RN should have contacted them for direction.

viii. On 1/2/24 at 4:25 p.m., an interview was conducted with the director of quality (Director) #6. Director #6 stated preceptor training was geared towards RNs and there was no training for RNs to precept EMS students. Director #6 stated there was no other facility policy for students other than the Observation and Shadowing policy, which excluded students such as the EMS students directed by the Education Affiliation Agreement.

ix. On 12/28/23 at 8:26 a.m., an interview was conducted with the director of outreach and collaboration (Director #4). Director #4 stated there was a large gap of understanding in the hospital about the differences between the levels of EMS students and what they were allowed to perform within their scope of practice. Director #4 stated they placed reference notebook binders from College #2 in all the units but did not know about binders or communication from other schools. Director #4 stated RNs were told to follow the information in College #2's binder if other notebooks were not available. Director #4 stated it was the responsibility of Clinical Coordinator #2 to get the information from the other schools to the clinical units.

This was in contrast to the interviews with Clinical Educator #1 and RNs #3, #10, #11, #12, #13, and #14, who stated they were unaware of where to find the guidance for scopes of practice for precepting students.

Based on document review and interviews, the facility failed to ensure registered nurses adhered to the policies and procedures of the hospital in one of one medical records reviewed of a patient who received a transpyloric feeding tube (Patient #2). Additionally, the facility failed to ensure staff competencies for processes and procedures were validated in two of two personnel files reviewed. (registered nurse (RN) #3 and RN #15)

Findings include:

Facility policy:

The Pediatric Nasogastric (NG) or Transpyloric (TP) Feeding Tube Placement and Enteral Nutrition policy read, only registered nurses (RN) with documented competency may insert NG or TP tubes independently. To reach the pylorus (the opening between the stomach and small intestine), while instilling 5-10 milliliters of air, advance the tube. Confirm placement with abdominal x-ray.

References:

The Elton B. Stephens Company (EBSCO) Nursing Skill: Inserting a Nasogastric Tube in Pediatric Patients (2023), provided by the facility, read, do not instill any liquids through NG tube or connect it to suction until correct placement has been confirmed. Verify proper tube placement immediately after insertion using facility-approved, evidence-based method (typically abdominal x-ray). X-ray is recommended in pediatric patients at high risk for incorrect tube placement, such as those with critical illness.

The AVANOS CORFLO Nasogastric/Nasointestinal Feeding Tubes manufacturer's instructions for use (IFU) read, misplacement of the feeding tube into trachea or lungs may result in serious injury. Confirm tube position and integrity per facility protocol. After tube position in the stomach is confirmed, remove stylet by flushing tube through the side port with up to 10 milliliters of water to activate internal lubricant immediately prior to stylet removal.

1. The facility failed to ensure staff had validated competencies for processes and procedures. Additionally, the facility failed to ensure staff followed facility guidelines and policies.

A. Document review

i. The medical record of Patient #2 was reviewed. The medical record review revealed Patient #2 was a 47 day old patient admitted on 12/21/23 for acute respiratory failure related to a respiratory virus and influenza. Orders were placed for a TP tube to be placed and an abdominal x-ray for placement confirmation. The medical record review revealed Patient #2 needed the TP tube placed for nutritional feeding purposes. The medical record revealed RN #3 documented the TP tube was placed per policy at the bedside. RN #3 measured the TP tube and supervised the procedure of a paramedic student as they placed the TP tube into Patient #2. Further review revealed Patient #2 had an episode of coughing, gagging, and dropped heart rate while the tube was placed. RN #3 placed a continuous positive airway pressure machine (CPAP) (a machine that used air pressure to keep the breathing airway open) and a bi-level positive airway pressure (BIPAP) (a machine that used high air pressure to keep the breathing airway open) on the patient. After Patient #2 was calm, the tube was flushed with 10 milliliters of water before an x-ray was obtained for placement confirmation. The medical record review revealed Patient #2 experienced a pneumothorax (a collapsed lung) following the TP placement.

ii. A review of staff employee files revealed competencies for RN #3 were not completed for NG or TP tube placement. The review of the staff employ files revealed RN #15 completed RN #3's orientation for the gastrointestinal (GI) disorders category of training, but there was no indication RN #3 had completed a competency for NG or TP placement.

iii. A focused competency review was conducted of the staff employee file for RN #15, who completed the GI disorders category of the orientation for RN #3. The review revealed no evidence of competency for NG or TP placement for RN #15.

This was in contrast to the Pediatric Nasogastric (NG) or Transpyloric (TP) Feeding Tube Placement and Enteral Nutrition policy which read, only RNs with documented competency could insert NG or TP tubes independently.

B. Interviews

i. On 12/28/23 at 7:32 a.m., an interview was conducted with RN #3, who provided assistance and oversight in the placement of the TP tube for Patient #2. RN #3 stated when they placed a TP tube, they measured the tube for the patient, inserted the tube into the patient's nare, and progressed the tube into the stomach. RN #3 stated they then injected three milliliters of air into the tube and listened with a stethoscope placed on the patient's abdomen to hear if the air entered the stomach. RN #3 stated they then injected five to 10 milliliters of water into the tube as they progressed the tube past the pylorus and into the small intestine. RN #3 stated they then pulled the stylet out of the tube, taped the tube in place to prevent movement, and obtained an x-ray for placement validation.

RN #3 stated they were aware of the facility policy for NG and TP feeding tube insertion, however, RN #3 stated they did not use the policy because they were familiar with the procedure. RN #3 stated they referenced policies based on their comfort level with the procedure. RN #3 stated they were trained upon hire to place NG and TP tubes and had not changed their process to align with the policy because the tube passed into the small intestine more successfully when water was used before the x-ray validation. RN #3 stated adherence to policies was important because it ensured patients remained safe. RN #3 stated it was important that patient care aligned with policies because policies had the most updated practices and ensured the best patient outcomes.

This was in contrast to the Pediatric Nasogastric (NG) or Transpyloric (TP) Feeding Tube Placement and Enteral Nutrition policy which read, only registered nurses (RN) with documented competency were to insert NG or TP tubes independently and advancement of the tube into the pylorus used air, not water. Placement was confirmed with an abdominal x-ray.

Furthermore, it was in contrast to the AVANOS CORFLO Nasogastric/Nasointestinal Feeding Tubes IFU which read, the tube position and integrity were confirmed per facility protocol. After the position was confirmed, the tube was flushed with up to 10 milliliters of water before the stylet removal.

Additionally, this was in contrast to the national guidelines, the EBSCO Nursing Skill Inserting a Nasogastric Tube in Pediatric Patients which read, liquids were not to be instilled through the NG tube until correct placement was confirmed.

ii. On 1/2/24 at 2:24 p.m., an interview was conducted with nursing director (Director) #5. Director #5 stated staff competencies were determined by demonstration of the skill after education was completed. Director #5 stated staff competency was demonstrated initially upon hire, then annually, and also daily. Director #5 stated skills were analyzed daily by charge nurses, preceptors, and the unit educator. Director #5 stated the daily checks for competency were performed when staff were unsure of a skill, or when mistakes in performance were noticed. Director #5 stated a competency was different than educational learning. Director #5 stated competencies required demonstration to another staff member.

Director #5 stated facility policies were to be followed and staff were notified of changes to policies through email, staff huddles (a meeting at the change of shift), and online learning modules. Director #5 stated the facility policy for NG and TP tube feedings was last updated and approved in August 2022. Director #5 stated the policy had never instructed the water flush to be completed before the placement validation. Director #5 was unsure of why staff flushed the tube with water before the placement was verified and stated staff may have been confused with another policy that used ultrasound as immediate placement verification. Director #5 stated patient safety was ensured when staff followed policies and presented a risk of injury or harm to patients when policies were not followed. Director #5 stated competencies were checked and maintained to ensure procedures were done correctly. Director #5 stated staff who performed procedures that were not updated risked harm to patients when competencies were not validated.