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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.618 Emergency Services out of compliance.

C-0886 Drugs and biologicals commonly used in life-saving procedures, including analgesics, local anesthetics, antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids, antiarrhythmics, cardiac glycosides, antihypertensives, diuretics, and electrolytes and replacement solutions. Based on observations, interviews, and document review, the facility failed to ensure expired medications were removed and replaced to provide usable equipment in an emergency. Specifically, expired medications were not removed and replaced to be readily available for use in an emergency in one of three code carts.

C-0888 LIFE-SAVING EQUIPMENT AND SUPPLIES [Equipment, supplies, and medication used in treating emergency cases are kept at the CAH and are readily available for treating emergency cases. The items available must include the following:] (2) Equipment and supplies commonly used in life-saving procedures, including airways, endotracheal tubes, ambu bag/valve/mask, oxygen, tourniquets, immobilization devices, nasogastric tubes, splints, IV therapy supplies, suction machine, defibrillator, cardiac monitor, chest tubes, and indwelling urinary catheters. Based on observations, interviews, and document reviews, the facility failed to discard expired emergency medical supplies per manufacturer instructions for use (IFU). Specifically, expired emergency supplies were not removed and replaced to be readily available for use in an emergency in one of three code carts.

Based on observations, interviews, and document review, the facility failed to ensure expired medications were removed and replaced to provide usable equipment in an emergency. Specifically, expired medications were not removed and replaced to be readily available for use in an emergency in one of three code carts.

Findings include:

Facility policy:

According to the Medications Outdated policy, medications shall be removed from regular stock prior to their expiration dates to ensure safe and effective medication for patients. Crash cart drawers and medication kits will have a label denoting the earliest drug to expire. Pharmacy will check the crash carts and medication kits monthly for outdates. Any outdated drugs, drawers, or kits will be replaced/restocked prior to the expiration date.

1. The facility failed to ensure expired medications were removed and replaced to provide usable equipment in an emergency.

A. Observations

i. Observations conducted on 6/10/24 at 3:24 p.m. revealed the adult crash cart (a wheeled container carrying medicine and equipment for use in emergency resuscitations) in trauma bay #1 contained a sealed medication tray with expired medications. The following medications were expired in the crash cart: five vials of amiodarone (a medication used to treat a fast or irregular heartbeat) 150 mg/3 ml expired 5/2024, four vials of naloxone (a medication used to reverse an opioid overdose) 0.4 mg/1 ml expired 5/2024, and two vials of lidocaine (a medication used to treat sudden cardiac arrest caused by dangerous heart rhythms) 2% 100mg/5 ml expired 5/1/24.

This was in contrast to the Medications Outdated policy which read, medications should have been removed from regular stock prior to their expiration dates to ensure safe and effective medication for patients.

B. Interviews

i. An interview was conducted on 6/10/24 at 3:30 p.m. with RN #10. RN #10 stated expired medications should not be administered to patients because the efficacy of the medication could not be guaranteed beyond the expiration date. RN #10 stated administration of expired medications could have harmed patients, altered the patient's treatment outcome, and potentially caused patient decompensation.

ii. An interview was conducted on 6/11/24 at 11:13 a.m. with RN #12. RN #12 stated if an expired medication was administered, the medication might not work the way it was supposed. RN #12 stated patients who received administration of expired medications were at risk of experiencing life-threatening adverse reactions.

iii. An interview was conducted on 6/10/24 at 3:45 p.m. with pharmacist (Pharmacist) #11. Pharmacist #11 stated medication outdates were checked monthly by the pharmacy technicians. Pharmacist #11 stated the pharmacy department was responsible for removing all expired medications from the crash cart. Pharmacist #11 stated patients who were administered expired medications were at risk for adverse reactions since the effectiveness of expired medications could not be guaranteed.

Based on observations, interviews, and document reviews, the facility failed to discard expired emergency medical supplies per manufacturer instructions for use (IFU). Specifically, expired emergency supplies were not removed and replaced to be readily available for use in an emergency in one of three code carts.

Findings include:

Facility policy:

According to the Expired Supplies policy, staff will monitor supply expiration dates and remove expiring supplies from inventory prior to the expiration date. Each clinical department manager is responsible for the handling of departmental supplies. Each clinical department manager will assign staff to monitor and remove expiring supplies prior to the expiration date.

References:

The Chloraprep Single Swab packaging read, do not use if expired.

The Becton Dickinson (BD) 16 gauge (16 G), 18 G, and 20 G Insyte Autoguard peripheral intravenous (IV) catheter package read, sterile, do not reuse, and do not use if expired.

The BD 0.9% Sodium Chloride Injection (saline flush) package read, sterile, do not use if expired.

The i-Gel Supraglottic Airway, sizes two through five packaging read sterile, intended for single use, do not use if expired.

The McKesson 3 cc luer lock tip syringe package read, sterile syringe, do not reuse. Do not use if expired.

The McKesson Sterile Lubricating Jelly 3 g packet read, sterile if unopened, do not use if expired.

The McKesson Bougie Endotracheal Tube Introducer package read, single-patient use only, do not use if expired.

The Molnlycle Biogel PI Micro Sterile Gloves package read, do not use if the packaging is damaged. Do not use if expired.

1. The facility failed to ensure medical supplies used in emergencies were not expired, were discarded according to the medical device's IFU, and were not readily available for patient use.

A. Observations

i. Observations conducted on 6/10/24 at 4:05 p.m. revealed the adult crash cart (a wheeled container carrying medicine and equipment for use in emergency resuscitations) in the radiology department contained expired emergency supplies. Among the expired supplies were five Molnlycke Biogel PI Micro Sterile Gloves ( disposable gloves that have been sterilized to remove dangerous germs and protect against bacteria and viruses) expired between 8/28/23 through 5/28/24, seven i-gel (an airway device used in anesthesia and resuscitation) sizes 2-5 expired between 6/2023 through 9/2023, three Kendall Defibrillation Electrodes (adhesive pads placed on the chest to treat sudden cardiac arrest) expired 6/2023 through 2/2024, one Teleflex Endotracheal Tube Oral/Nasal (a flexible tube inserted through the mouth or nose into the windpipe to help patients breathe) expired 5/2024, two Covidien Adult Colorimetric CO2 Detectors (a device used to confirm the placement of a breathing tube) expired 12/2022, and two McKesson Bougie Endotracheal Tube Introducers (a tools that helps place a breathing tube into a patient's windpipe) expired 1/10/24. In total, sixty-five individual supplies were expired.

This was in contrast to the Expired Supplies policy which read, staff should have monitored supply expiration dates and removed expiring supplies from inventory prior to the expiration date.

This was also in contrast to the IFUs for the Chloraprep Single Swab, the BD) 16 gauge (16 G), 18 G, and 20 G Insyte Autoguard peripheral intravenous (IV) catheter, the BD 0.9% Sodium Chloride Injection (saline flush), the i-Gel Supraglottic Airway, sizes two through five, the McKesson 3 cc luer lock tip syringe, the McKesson Sterile Lubricating Jelly 3 g, the McKesson Bougie Endotracheal Tube Introducer, and the Molnlycle Biogel PI Micro Sterile Gloves which read, do not use if expired.

B. Interviews

i. An interview was conducted on 6/10/24 at 3:30 p.m. with RN #10. RN #10 stated staff should have conducted monthly checks of the medical supplies in crash carts to ensure supplies were not expired. RN #10 stated expired supplies should not be used because they may not work beyond the expiration date.

ii. An interview was conducted on 6/12/24 with RN #13. RN #13 stated when medical supplies expired, their sterility and integrity became uncertain. RN #13 stated the risk of using expired supplies would have been a patient not receiving intended medical treatment and an increased likelihood of an adverse reaction.

iii. An interview was conducted on 6/11/224 at 9:16 a.m. with the materials manager (Manager) #18. Manager #18 stated medical supplies were checked in the central supply room for expiration dates weekly to ensure supplies were not expired. Manager #18 stated once supplies were distributed to the emergency department, inpatient unit, or radiology department, staff in those departments would have been responsible for checking expiration dates on medical supplies.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.635 Provision of Services was out of compliance.

C-1006 The CAH's health care services are furnished in accordance with appropriate written policies that are consistent with applicable State law. Based on observations, interviews, and document review, the facility failed to ensure expired medical supplies were not readily available for patient use in five out of five observations.

C-1046 Nursing services must meet the needs of patients. (1) A registered nurse must provide (or assign to other personnel) the nursing care of each patient, including patients at a SNF level of care in a swing-bed CAH. The care must be provided in accordance with the patient ' s needs and the specialized qualifications and competence of the staff available.

C-1048 A registered nurse or, where permitted by State law, a physician assistant, must supervise and evaluate the nursing care for each patient, including patients at a SNF level of care in a swing-bed CAH. Based on observations, interviews, and document review, the facility failed to ensure a registered nurse (RN) reviewed and evaluated the nursing care provided by a licensed practical nurse (LPN) in accordance with the Colorado Revised Statutes (CRS).

C-1049 All drugs, biologicals, and intravenous medications must be administered by or under the supervision of a registered nurse, a doctor of medicine or osteopathy, or, where permitted by State law, a physician assistant, in accordance with written and signed orders, accepted standards of practice, and Federal and State laws. Based on observations, interviews and document review, the facility failed to ensure a licensed practice nurse (LPN) worked within the scope of practice of the Colorado Revised Statutes (CRS) and facility policy.

Based on observations, interviews, and document review, the facility failed to ensure expired medical supplies were not readily available for patient use in five out of five observations.

Findings include:

Facility Policy:

The Expired Supplies policy read, staff will monitor supply expiration dates and remove expiring supplies from inventory prior to the expiration date. Inventory management (survey and removal from stock) of expiring supplies will be completed on a monthly basis. Staff assigned to inventory management will remove any supplies from use that are expiring within the next thirty days.

The Malignant Hyperthermia (MH) Cart policy read, the Operating Room (OR) will have a cart stocked for the management of malignant hyperthermia (a life-threatening reaction to anesthesia that can occur during or after surgery) at all times. The MH cart will be maintained by the Anesthesia Department staff, OR staff and pharmacist jointly and checked monthly by the perioperative nurse on duty for expired inventory and/or expired medications.

1. The facility failed to ensure expired supplies were removed and not readily available for patient use.

A. Observations

i. Observations conducted on 6/10/24 at 3:50 p.m. in the inpatient supply area revealed fourteen surgical gowns ( personal protective garments worn by healthcare workers during surgeries to protect patients from the transfer of body fluids and germs) expired on 9/2023.

ii. Observations conducted on 6/11/24 at 8:10 a.m. in operating room #1 revealed seven Stratafix Knotless Tissue Control Devices expired on 5/31/2024, and fifteen Biogel Sterile Gloves (disposable gloves that have been sterilized to remove dangerous germs and protect against bacteria and viruses), size 6.5-8, expired on 8/28/23 through 5/28/24.

iii. Observations conducted on 6/22/24 at 9:24 a.m. of the OR Malignant Hyperthermia Cart revealed one Alaris Pump Infusion set (a flexible plastic tube that connects a bag of fluids or medication to a patient's vein) expired on 5/28/24.

This was in contrast to the Malignant Hyperthermia Cart policy which read the OR should have had a cart stocked for the management of MH at all times.

iv. Observations conducted on 6/11/24 at 9:42 a.m. of the PACU Pain Cart revealed one Smith Medical 22 g Hypodermic NEEDLE-PRO (a needle safety device) expired on 11/28/23.

v. Observations conducted on 6/13/24 at 2:34 p.m. in the Infusion Center supply area revealed two HEME FRESH Blood/Bone Marrow Aspirate Kits (a kit that contains tools needed to extract bone marrow from the body) expired on 4/20/24.

This was in contrast to the Expired Supplies policy which read staff should have monitored supply expiration dates and removed expiring supplies from inventory prior to the expiration date.

B. Interviews

i. An interview was conducted on 6/10/24 at 3:30 p.m. with RN #10. RN #10 stated staff should have conducted monthly checks of the medical supplies in crash carts to ensure supplies were not expired. RN #10 stated expired supplies should not be used because they may not work beyond the expiration date.

ii. An interview was conducted on 6/12/24 with RN #13. RN #13 stated when medical supplies expired, their sterility and integrity became uncertain. RN #13 stated the risk of using expired supplies would have been a patient not receiving intended medical treatment and an increased likelihood of an adverse reaction.

iii. An interview was conducted on 6/11/224 at 9:16 a.m. with the materials manager (Manager) #18. Manager #18 stated medical supplies were checked in the central supply room for expiration dates weekly to ensure supplies were not expired. Manager #18 stated once supplies were distributed to the emergency department, inpatient unit, or radiology department, staff in those departments would have been responsible for checking expiration dates on medical supplies.

Based on observations, interviews, and document review, the facility failed to ensure patients received care in accordance with their needs. Specifically, the facility failed to ensure nurses continuously and appropriately monitored patients receiving ketamine infusions per guidelines. The facility also failed to ensure emergency equipment, including a crash cart and suctioning equipment, was immediately available in the infusion center to ensure the delivery of safe patient care. The facility additionally failed to ensure nursing staff initiated blood transfusions at the appropriate rate per facility policy. (Cross-reference C-1048 and C-1049)

Findings include:

Facility policy:

According to the Blood and Blood Component Administration policy, begin the transfusion slowly (50 milliliters (mL) per hour) for the first 15-30 minutes, slowly increasing the rate (10mL per hour) so that the blood is completely transfused.

References:

According to UptoDateLexiDrug (provided by the facility) Ketamine medication information, ketamine is a schedule (controlled) III medication. Monitor heart rate, blood pressure, respiratory rate, and cardiac function (continuously monitored in patients with increased blood pressure or cardiac decompensation). Nursing physical assessment and monitoring requires monitoring of cardio/respiratory status. Cardiac monitoring and blood pressure monitoring are required.

Ketamine causes increased blood pressure, heart rate, and cardiac output; cardiac arrhythmia (abnormal rhythm), cardiac decompensation (failure), and decreased blood pressure and heart rate. Ketamine can exacerbate underlying myocardial dysfunction which can result in increased blood pressure, heart rate, and cardiac output. Onset is rapid and a peak in blood pressure occurs within a few minutes of administration.

Ketamine can cause respiratory depression (slowing down or absence of breathing) or apnea (temporary cessation of breathing) which can occur in slow sub-anesthetic intravenous (IV) infusion. The onset is typically, one to two minutes after IV administration. In the case of respiratory depression and apnea during slow subclinical IV infusions, onset occurred 25 minutes after the start of ketamine infusion.

According to the Ketamine Package Insert, adverse reactions associated with ketamine administration include elevation of blood pressure and pulse rate, hypotension (low blood pressure), bradycardia (slow heart rate), and arrhythmia. Resuscitative (revive from death or unconsciousness) equipment should be ready for use.

According to the Colorado Revised Statute (CRS) IV Therapy/Venous Blood Sampling and Scope of Practice for a Licensed Professional Nurse (LPN), the LPN scope of practice includes the following, observing and monitoring adult patients receiving IV solutions and administration of IV fluids, pre-mixed IV fluids containing electrolytes and vitamins, and premixed antibiotic solutions.

1. The facility failed to ensure nurses continuously and appropriately monitored patients receiving ketamine infusions in accordance with guidelines.

A. Observations

i. On 6/18/24 at 11:12 a.m., observations of the infusion center revealed an exam room without windows or other means of visualizing patients when the door was closed. This room did not contain a call light or other means for patients to contact staff during the infusion. During an interview with LPN #4 on 6/18/24 at 11:12 a.m., LPN #4 stated this room was most often used for ketamine infusions as the patients were given privacy once the door was closed. LPN #4 stated they placed patients in the room, exited, closed the door, and re-entered at 10-minute intervals to assess vital signs.

This observation was in contrast to the Ketamine UptoDateLexiDrug information which read, ketamine infusions had the potential for respiratory and cardiac reactions which happened within minutes. Nursing staff were required to physically assess and monitor the patient's cardio/respiratory status throughout treatment.

B. Document review

i. Upon request, the facility was unable to provide policies on assessment and reassessment and cardiac monitoring within the infusion center.

ii. Medical records

a. A review was conducted of Patient #29's medical records. Patient #29 was a 53-year-old who presented for a series of ketamine infusions. Review revealed Patient #29 had a past medical history of chronic pain and major depressive disorder. The ketamine order, dated 8/31/23, from an outside provider revealed they required the patient to have electrocardiogram (EKG) (records the electrical signals in the heart) monitoring while receiving ketamine, from the time of admission to discharge.

The nursing progress notes read Patient #29 was placed on a cardiac monitor and their vital signs were assessed every 10 minutes while receiving ketamine infusions. However, after Patient #29's first visit for a ketamine infusion on 7/11/23, the medical record did not reveal evidence of EKG monitoring throughout treatment or any assessment or interpretation of heart rhythms.

This lack of monitoring and assessment was in contrast to the provider's order for Patient #29 and in contrast to the Ketamine UptoDateLexiDrug information which read, ketamine had the potential to cause changes in heart rate and rhythm and respiratory depression, both within minutes of administration. Nursing assessments and monitoring required cardiac monitoring and cardio/respiratory status to be monitored.

Patient #29's medication administration record (MAR) revealed LPN #4 administered Patient #29's ketamine infusion during their induction (starting doses) phase on 7/17/23 and 7/19/23. LPN #4 also administered Patient #29's ketamine infusion on 10/24/23, 1/3/24, and 5/1/24. The progress notes revealed LPN #4 additionally monitored Patient #29 on 7/17/23, 10/24/23, 1/3/24, and 5/1/24 while they received their ketamine infusion. This review of the medical record for Patient #29 was in contrast to an interview with registered nurse (RN) #6 on 6/17/24 at 4:00 p.m., which revealed LPNs were not allowed to administer Ketamine during the induction phase of the treatment and also the Colorado Revised Statutes on LPNs scope of practice, which revealed administering ketamine infusions and cardiac monitoring (if required for patients) were outside the LPNs' scope of practice.

b. A review was conducted of Patient #31's medical records. Patient #31 was a 49-year-old with who presented for a series of ketamine infusions. Review revealed a past medical history of chronic pain and chronic depression. The medical record did not reveal a history and physical (a doctor's assessment of a patient) over the past year. However, a consultation note with a neurologist on 3/8/24 (during the time Patient #31 was in the maintenance phase of ketamine) revealed a history of hypertension (high blood pressure) which was being treated with several blood pressure medications, although this diagnosis was not written into Patient #31's "problem list" (relevant diagnoses). This history of hypertension was in contrast to an interview with the director of oncology, infusion, and pharmacy (Director) #7 on 6/18/24 at 2:16 p.m. during which they stated none of the ketamine infusion patients had diagnoses of hypertension.

The nursing progress notes read Patient #31 was placed on a cardiac monitor and their vital signs were assessed every 10 minutes while receiving ketamine infusions. However, the medical record did not reveal evidence of EKG monitoring throughout treatment or any assessment or interpretation of heart rhythms. Additionally, on 3/28/24, Patient #31's blood pressure (BP) at 1:42 p.m. was 146/90 (normal was 120/80), at 2:00 p.m. the BP had increased to 164/100, and at 2:10 p.m., the BP had increased to 170/99. The progress note on 3/28/24 by an RN read Patient #31 had tolerated the infusion well with no signs or symptoms of an adverse reaction. The progress note did not reveal any evidence the RN had identified Patient #31 was hypertensive or had implemented any interventions or additional monitoring for the increased blood pressure.

This lack of monitoring and assessment was in contrast to the Ketamine UptoDateLexiDrug information which read, ketamine had the potential to cause changes in blood pressure, heart rate and rhythm, and worsen heart problems within minutes of administration. Nursing assessments and monitoring required monitoring of cardio/respiratory status and cardiac monitoring was required.

Additionally, the MAR and nursing progress notes revealed on 11/2/23 and 12/28/23, LPN #4 administered and monitored Patient #31's ketamine infusion. This review of the medical record for Patient #31 was in contrast to the Colorado Revised Statutes on LPNs scope of practice, which revealed administering ketamine infusions and cardiac monitoring (if required for patients) were outside the LPNs' scope of practice.

c. A review was conducted of Patient #32's medical records. Patient #32 was a 77-year-old who presented for a series of ketamine infusions. Review revealed they had a past medical history of major depressive disorder. The order from the provider revealed they required the patient to have electrocardiogram (EKG) monitoring while receiving ketamine, from the time of admission to discharge.

The nursing progress notes read Patient #32 was placed on a cardiac monitor and their vital signs were assessed every 10 minutes while receiving ketamine infusions. However, the medical record did not reveal evidence of EKG monitoring throughout treatment or any assessment or interpretation of heart rhythms.

This lack of monitoring and assessment was in contrast to the Ketamine UptoDateLexiDrug information which read, ketamine had the potential to cause changes in heart rate and rhythm and respiratory depression, both within minutes of administration. Nursing assessments and monitoring required monitoring of cardio/respiratory status and cardiac monitoring was required.

The MAR and progress notes also revealed on 1/3/24 and 2/27/24, LPN #4 administered and monitored Patient #32's ketamine infusions. This review of the medical record for Patient #32 was in contrast to the Colorado Revised Statutes on LPNs scope of practice, which revealed administering ketamine infusions and cardiac monitoring (if required for patients) were outside the LPNs' scope of practice.

C. Interviews

i. On 6/17/24 at 1:43 p.m., an interview was conducted with LPN #4. LPN #4 stated they received training in IV administration in school and they were certified to administer IV therapies. They stated they were generally aware the LPNs' scope of practice was limited due to having fewer years of education than RNs. LPN #4 stated they were jointly overseen by Director #7 and director of nursing (DON) #5, however, Director #7 had advised LPN #4 which nursing practices were permissible within the LPN scope of practice.

LPN #4 stated LPNs were not allowed to perform initial patient assessments so they were not able to administer any of the induction series, during which time the patient was assessed and monitored for reactions. LPN #4 stated they were only able to administer ketamine as part of the maintenance phase, which was in contrast to a review of the medical records for Patient #29.
They stated their scope allowed them to administer scheduled (controlled) medications, including ketamine infusions, as long as they were not administering any of the induction series (the initial six doses of ketamine). This statement was in contrast to the Colorado Revised Statutes on LPNs scope of practice, which revealed administering ketamine infusions, or any controlled medication, was outside the LPNs' scope of practice.

LPN #4 stated ketamine infusions were performed to treat depression, post-traumatic stress disorder (PTSD), chronic pain, and autoimmune (the body attacks healthy cells) disorders. They stated ketamine infusions required the patients' blood pressure, pulse rate, respirations, and oxygen saturation to be continuously monitored due to the possibility of an adverse reaction. However, LPN #4 stated they and the other nursing staff typically placed patients in a private room which allowed the patient a more restful treatment, connected them to a cardiac monitor, started the ketamine infusion, and then left the room. LPN #4 stated they re-entered at 10-minute intervals to document the vital signs. This was in contrast to a later interview on 6/18/24 at 8:42 a.m. during which LPN #4 stated they connected the patient to a cardiac monitor to record vital signs but did not perform cardiac monitoring.

LPN #4's performing cardiac monitoring on patients was in contrast to the Colorado Revised Statutes on LPNs' scope of practice, which revealed cardiac monitoring was outside the LPNs' scope of practice. However, not continuously monitoring a patient, including not cardiac monitoring, when infusing ketamine was in contrast to the Ketamine UptoDateLexiDrug information which read, nursing assessments and monitoring required cardiac monitoring and cardio/respiratory status to be monitored.

LPN #4 stated it was important to ensure they performed only those patient care tasks that were within their scope to protect patient safety. However, they stated there was no risk to an LPN administering ketamine without RN oversight as Director #7 had determined these medications and practices were safely within LPN #4's scope of practice, which was in contrast to the Colorado Revised Statutes on LPNs' scope of practice.

ii. On 6/17/24 at 4:00 p.m., an interview was conducted with oncology (cancer) RN #6. RN #6 stated patients who received ketamine infusions were not on cardiac monitoring. They stated they used the leads (adhesive electrodes applied to the skin) only to record the patients' heart rates. RN #6 stated they and the other RNs made sure LPN #4 stayed within their scope when they provided patient care. They stated if they were unsure about the extent of LPN #4's scope, they used outside resources to determine the answer. For example, they stated LPNs were not to provide cardiac monitoring as this was not within their scope, which was in contrast to an interview with LPN #4 and in contrast to a review of the medical records which read LPN #4 placed patients on a cardiac monitor. RN #6 stated LPN #4 was able to administer ketamine during the maintenance phase only, which was in contrast to the Colorado Revised Statutes on LPNs' scope of practice. They also stated if the LPN practiced outside of their scope, there were no risks to the patients as patient care was always overseen by the RNs, which was in contrast to a review of the medical records for Patients #29, #31, and #32.

iii. On 6/24/24 at 2:34 p.m., an interview was conducted with oncology physician (Physician) #15. Physician #15 stated they oversaw the medical care of patients in the oncology and infusion center. They stated however, they were more familiar cancer medications than ketamine. Physician #15 stated they had recently been provided the monitoring requirements for ketamine infusions and moving forwards, ketamine infusions would require close patient monitoring. They stated the facility's practice of taking vitals on ketamine patients every 10 minutes was not acceptable as there was a risk of arrhythmia (changes in heart rhythm), low blood pressure, and respiratory arrest (patient stops breathing). Physician #15 stated cardiac monitoring was real-time monitoring of cardiac rhythm, heart rate, and oxygen saturation. They stated cardiac monitoring was to be continuously performed and recorded as there was otherwise no point in placing the patient on a cardiac monitor. Physician #15 stated they wanted the nursing staff to cardiac monitor patients on a ketamine infusion, monitor these patients one to one, document the interpretation of the heart rate and rhythm throughout treatment, and place an EKG strip in the medical record. This was in contrast to a review of the medical records for Patients #29, #31, and #32 which did not reveal this monitoring. Physician #15 stated this whole process, including documentation of heart rate and rhythm, was important to provide quality patient care.

iv. On 6/18/24 at 9:11 a.m., an interview was conducted with DON #5. DON #5 stated they oversaw all nursing staff, except those in the infusion center who were overseen by Director #7. DON #5 stated they felt it was best practice for nursing staff to report to nursing leadership.

DON #5 stated ketamine infusions had the potential to affect respiration, exacerbate cardiac issues by increasing heart rate, and cause supraventricular tachycardia (SVT) (faster heart rate). They stated there was no policy on cardiac monitoring for infusion patients; however, continuous cardiac monitoring for patients receiving ketamine therapy was important to visualize changes from the baseline EKG which was in contrast to a review of the medical records for Patients #29, #31, and #32. DON #5 stated the infusion center did not have a central monitoring system and there was no way to safely monitor a ketamine patient in a private room. They stated this process of monitoring patients was important to ensure patient safety.

v. On 6/17/24 at 3:37 p.m., an interview was conducted with Director #7. Director #7 stated they oversaw the infusion center and LPN #4. They stated patients were to be continuously monitored with a cardiac monitor while receiving ketamine. During a later interview on 6/18/24 at 8:24 a.m., Director #7 stated none of the medications in the infusion center required cardiac monitoring so the infusion center did not use or perform cardiac monitoring. This was in contrast to her earlier statement and additionally in contrast to Ketamine UptoDateLexiDrug information which read, nursing assessments and monitoring required cardiac monitoring and cardio/respiratory status to be monitored.

Director #7 stated they had researched the LPN scope of practice when they created the LPN position. They stated chief operating officer (COO) #9, who was an RN, and DON #5 determined the scope of LPN #4's practice and COO #9 had approved the LPN job description which outlined their job duties and responsibilities. Director #7 stated LPN #4's ability to administer medications and monitor patients was limited as LPNs did not have the training to understand the anatomy and physiology of patients with complex medical needs. They stated they were not aware administering scheduled medications was outside of the LPNs' scope of practice. Director #7 stated although there could be a risk to the patients with LPN #4 administering ketamine and monitoring patients throughout the infusion, they felt comfortable with LPN #4's practice as they had been educated on medication administration and the side effects of medications. Director #7 stated the biggest risk of infusing ketamine infusions, which was psychosocial dissociation, happened during the induction phase which LPN #4 did not oversee, which was in contrast to the Ketamine UptoDateLexiDrug information which read, ketamine had the potential to cause changes in heart rate and rhythm and respiratory depression, both within minutes of administration, and required close monitoring and assessment by nursing staff.

vi. On 6/26/24 at 12:49 p.m., an interview was conducted with director of quality (Director) #17. Director #17 stated the facility did not require history and physicals (H&P) for the ketamine infusion patients. This lack of H&Ps which created a lack of knowledge on the medical histories of infusion patients was in contrast to Director #7's statement on 6/18/24 at 2:16 p.m. that none of the ketamine infusion patients had diagnoses of hypertension while Patient #31's medical record revealed a prior diagnosis of hypertension. This was important as the Ketamine UptoDateLexiDrug information read, ketamine had the potential to cause changes in heart rate and rhythm, within minutes of administration, and required close monitoring and assessment by nursing staff.

vii. On 6/18/24 at 8:42 a.m., an interview was conducted with COO #9. COO #9 stated they were an RN with a background in nursing. They stated the infusion center had a private room for patients to receive treatment in a quiet environment. COO #9 stated patients in this room were not visible to or able to be monitored by staff without staff entering the room. COO #9 stated cardiac monitoring was only required for ketamine patients with a cardiac history and if patients experienced a problem during treatment, they were brought to the emergency department (ED). This statement was in contrast to the interview with LPN #4 and their own earlier statement which revealed patients were checked on every 10 minutes and nursing staff would be unaware of a patient emergency without being physically present in the patient room.

COO #9 stated Director #7 oversaw LPN #4 although DON #5 was available for questions. COO #9 stated LPN #4 used a cardiac monitor only to monitor the vitals of patients receiving ketamine infusions and did not provide cardiac monitoring. This statement was in contrast to the earlier interview with LPN #4 and also in contrast to the review of the medical records for Patients #29, #31, and #32. COO #9 stated the risk of an LPN exceeding their scope of practice was patient harm.

2. The facility also failed to ensure emergency equipment, including a crash cart and suctioning equipment, was immediately available in the infusion center to ensure safe patient care.

A. Observations

i. On 6/18/24 at 11:12 a.m., additional observations of the infusion center did not reveal a crash (emergency) cart or suctioning equipment located within the infusion department. This was in contrast to the Ketamine Package Insert which read, as ketamine had the potential to cause changes in heart rate and rhythm, resuscitative equipment was to be ready for use. During an interview conducted on 6/18/24 at 11:12 p.m., LPN #4 stated they were concerned with the lack of availability of emergency equipment as this was necessary to ensure safe patient care.

B. Interviews

i. On 6/24/24 at 2:34 p.m., an interview was conducted with Physician #15. Physician #15 stated they had not seen a problem with the lack of emergency equipment on hand in the infusion center. They stated the center stored many medications for use in emergencies and if a patient suffered ill effects during treatment, ED staff were able to reach the patient within one to two minutes.

ii. On 6/18/24 at 8:42 a.m., an interview was conducted with the chief operating officer (COO) #9. COO #9 stated if a patient had an adverse event while receiving their infusion, the infusion was stopped, and the patient was brought to the emergency department. This was in contrast to the Ketamine Package Insert which read, as ketamine had the potential to cause changes in heart rate and rhythm, resuscitative equipment was to be ready for use.

3. The facility failed to ensure nursing staff initiated blood transfusions at the appropriate rate per facility policy.

A. Medical record review

i. A review of Patient #33's medical record revealed Patient #33 was a 64-year-old who presented to the infusion center for a blood transfusion (the transfer of blood products) for iron deficient anemia (a lack of healthy red blood cells). On 5/29/24, the RN notes read the RN started transfusing Patient #33's first unit of blood at 9:18 a.m. at a rate of 10mL per hour. The note read the RN also started the second unit of blood at 11:55 a.m. at 10mL per hour.

This review of Patient #33's medical record was in contrast to the Blood and Blood Component Administration policy which read, the blood transfusion was started slowly (50 mL per hour) for the first 15-30 minutes and the rate was slowly increased.

B. Interviews

i. On 06/26/2024 at 10:57 a.m., an interview was conducted with RN #16. RN #16 stated they had experience with the administration of blood products. They stated it was important to start the blood transfusion at a low rate to allow nursing staff to monitor the patients for reactions. RN #16 stated the potential reactions to blood products included an allergic reaction, difficulty breathing, back pain, and could progress to patient death.

ii. On 6/26/24 at 11:49 a.m., an interview was conducted with DON #5. DON #5 stated blood transfusions were started slowly to ensure nursing staff recognized infusion reactions, which ranged from an allergic reaction up to and including death, early on. They stated nursing staff assessed patients for hypotension (low blood pressure), hypertension, tachycardia (high heart rate), and respiratory distress. DON #5 stated if the blood was administered at a higher rate than the policy specified, the staff were less likely to observe the early signs of an infusion reaction which put the patient at greater risk.

Based on observations, interviews, and document review, the facility failed to ensure a registered nurse (RN) reviewed and evaluated the nursing care provided by a licensed practical nurse (LPN) in accordance with the Colorado Revised Statutes (CRS).

Findings include:

Facility policy:

According to the Medication Administration policy, only authorized staff members may administer medications. Nursing staff may administer medications according to their licensure and per department policies.

Reference:

According to the CRS IV Therapy/Venous Blood Sampling Scope of Practice, LPNs with IV authority may perform the following procedures under the supervision of a professional nurse or physician: utilize peripheral veins for intravenous access with a peripheral short catheter, and administer intravenous fluids, premixed intravenous fluids containing electrolytes and vitamins, and pre-mixed antibiotics, and monitor the systemic effects of intravenous therapy.

1. The facility failed to ensure the nursing care provided by LPNs was supervised by an RN or physician.

A. Document review

i. A review of Patient #28's medical record revealed Patient #28 had outpatient appointments in the infusion center on 6/10/24 and 6/12/24 for an intravenous (IV) infusion of Ceftriaxone (a medication used to kill bacterial infections and to prevent bacterial growth). On 6/10/24 and 6/12/2024 LPN #4 administered the Ceftriaxone infusions and performed assessments before, during, and after the infusion of Ceftriaxone. There was no evidence in Patient #28's medical record that LPN #4's care of Patient #28, including IV access and IV antibiotic administration was supervised by an RN or physician.

ii. A review of Patient #29's medical record revealed Patient #29 had outpatient appointments in the infusion center on 7/17/23, 10/25/23, 1/3/24, and 5/1/24 for an IV infusion of Ketamine (a medication used for sedation or to treat depression that causes intoxication, hallucinations, and disassociation). On 7/17/23, 10/25/23, 1/3/24, and 5/1/24 LPN #4 inserted Patient #29's peripheral IV and administered Patient #29's Ketamine infusions. There was no evidence in Patient #29's medical record that LPN #4's care of Patient #29, including IV access and IV medication administration was supervised by an RN or physician.

This was in contrast to the CRS IV Therapy/Venous Blood Sampling Scope of Practice which read, LPNs with IV authority were permitted to perform the following procedures under the supervision of a professional nurse or physician: utilize peripheral veins for intravenous access with a peripheral short catheter, and administer intravenous fluids, premixed intravenous fluids containing electrolytes and vitamins, and pre-mixed antibiotics, and monitor the systemic effects of intravenous therapy.

B. Interviews

i. An interview was conducted on 6/17/2024 at 1:43 p.m. with LPN #4. LPN #4 stated they independently inserted peripheral IVs and accessed PICC lines and Ports without RN supervision. LPN #4 stated the director of the infusion center (Director) #7 checked in as things came up, with no set time for supervision or oversight of LPNs. LPN #4 also stated the director of nursing (DON) #5 was available if things came up. LPN #4 stated they utilized RNs in the infusion center if they had questions. LPN #4 stated they independently reconstituted IV antibiotic medications including Ceftriaxone, and administered IV medications such as Ceftriaxone and Ketamine. LPN #4 stated they were not permitted to administer the first dose of a new medication for a patient because this required an initial assessment. LPN #4 stated they were permitted to perform follow-up assessments independently.

This was in contrast to the CRS IV Therapy/Venous Blood Sampling Scope of Practice which read, LPNs with IV authority were permitted to perform the following procedures under the supervision of a professional nurse or physician: utilize peripheral veins for intravenous access with a peripheral short catheter, and administer intravenous fluids, premixed intravenous fluids containing electrolytes and vitamins, and pre-mixed antibiotics, and monitor the systemic effects of intravenous therapy.

ii. An interview was conducted on 6/17/24 at 4:00 p.m. with RN #6. RN #6 stated they worked in the infusion center with LPN #4. RN #6 stated it was the RNs role to make sure patients were appropriate for LPNs to care for. RN #6 stated they were available if LPN #4 had a question, or if LPN #4 was not comfortable performing a task.

iii. An interview was conducted on 6/18/24 at 9:11 a.m. with the director of nursing (DON) #5. DON #5 stated they did not have direct oversight over LPN #4 in the infusion center, although they did oversee all of nursing. DON #5 stated if an LPN accessed a port, it should have been under RN supervision. DON #5 stated Director #7 was not a registered nurse, and there should have been a registered nurse overseeing LPN #4's patient care and procedures.

iv. An interview was conducted on 6/17/24 at 3:37 p.m. with Director #7. Director #7 stated that a nurse manager would have been responsible for LPN #4's supervision of care, but there was not currently a nurse manager in the infusion center. Director #7 stated RNs in the infusion center were available to answer LPN #4's questions. Director #7 stated RNs would review any new intravenous medications with LPN #4 before LPN #4 was permitted to administer those intravenous medications independently.

Based on observations, interviews and document review, the facility failed to ensure a licensed practice nurse (LPN) worked within the scope of practice of the Colorado Revised Statutes (CRS) and facility policy.

Findings include:

Facility policy:

According to the Medication Administration policy, only authorized staff members may administer medications. Nursing staff may administer medications according to their licensure and per department policies.

According to the Vascular Access Device-Implanted Ports policy, implanted ports (a device that is surgically placed under the skin to provide long-term medication access to veins extending near or inside the heart) are utilized for intravenous (a procedure that involves inserting a needle or tube into the vein) access. Only registered nurses may access or de-access an implanted port.

References::

According to the Infusion LPN job description, the LPN must be proficient in IV insertions for adults, and management of Ports. The LPN's essential duties, functions, and responsibilities include accessing ports, completing dressing changes, performing injections and IV therapy, and administering medications according to pharmacy guidelines.

According to the CRS IV Therapy/Venous Blood Sampling Scope of Practice, LPNs are not authorized to perform access or deaccess of implanted central venous access ports (ports). The LPN scope of practice permits the administration of the following intravenous fluids: dextrose 5%, normal saline, lactated ringers, sodium chloride 0.45%, sodium chloride 0.2%, pre-mixed (meaning IV solution prepared and labeled by a pharmacist or manufacturer) intravenous fluids containing electrolytes and vitamins, and pre-mixed antibiotic solutions.

1. The facility failed to ensure LPNs with intravenous (IV) authority practiced within their scope for IV access and administration of medications in accordance with the CRS.

A. Observations

i. Observations conducted on 6/13/24 at 9:35 a.m. in the infusion center revealed two antibiotics, Ertapenem (a medication used to treat severe infections caused by bacteria) and Ceftriaxone (a medication used to kill bacterial infections and to prevent bacterial growth) were available in the Pyxis. These medications were only available in a powdered form and required mixing with saline before they were administered to a patient.

B. Record Review

i. A review of Patient #28's medical record revealed LPN #4 administered two grams of Ceftriaxone intravenously to Patient #28 in the infusion center on 6/10/24 and 6/12/24.

ii. A review of Patient #29's medical record revealed LPN #4 administered IV Ketamine (a medication used to cause sedation or treat depression)) to Patient #29 in the infusion center on 7/17/23, 7/19/23, 10/25/23, 11/27/23, 1/4/24, and 5/1/24.

This was in contrast to the CRS IV Therapy/Venous Blood Sampling Scope of Practice which read LPNs were not authorized to administer intravenous fluids except for dextrose 5%, normal saline, lactated ringers, sodium chloride 0.45%, sodium chloride 0.2%, pre-mixed intravenous fluids containing electrolytes and vitamins, and pre-mixed antibiotic solutions.

C. Interviews

i. An interview was conducted on 6/13/24 at 9:35 a.m. with RN #14. RN #14 stated the Pyxis (an automated dispensing system that stores and manages medications in patient care units) located in the infusion center contained two antibiotics, Erapenem and Ceftriaxone. RN #14 stated the two antibiotics were in powder form and would have required reconstitution with normal saline prior to administration. RN #14 stated LPNs were permitted to reconstitute powdered antibiotics within their scope of practice.

This was in contrast to the CRS IV Therapy/Venous Blood Sampling Scope of Practice which read, LPNs were only permitted to administer pre-mixed antibiotic solutions.

ii. An interview was conducted on 6/17/24 at 1:43 p.m. with LPN #4. LPN #4 stated they were required to obtain an additional IV certification before administering IV infusions and obtaining IV access. LPN #4 stated they had accessed and deaccessed patients' ports in the infusion center. LPN #4 stated there were restrictions for LPN's scope of practice with IV infusions because LPNs received less education than RNs. LPN #4 stated if they had questions about their scope of practice for medication administration or IV infusions they would have asked the director of the infusion center, consulted pharmacy, or contacted the director of nursing. LPN #4 stated they routinely reconstituted powdered antibiotics, including ceftriaxone, with saline prior to IV administration. LPN #4 stated the LPN scope of practice did not permit mixing medications, including antibiotics, due to a lack of education and the need to perform dosing calculations. LPN #4 stated reconstituting was not mixing because they used the entire vial of medication with saline. LPN #4 stated they routinely administered maintenance doses of Ketamine to patients intravenously. LPN #4 stated they were not permitted to administer the initial loading doses of Ketamine to patients. LPN #4 stated Ketamine could cause hypotension (abnormally low blood pressure), hypertension (abnormally high blood pressure), and could cause a patient's oxygen level to decrease suddenly. LPN #4 stated it was important to practice within the LPN scope of practice for patient safety. LPN #4 stated the risks of not properly administering infusions included cardiac problems, dizziness, fluid overload, and death.

This was in contrast to the Vascular Access Device-Implanted Ports policy which read, only registered nurses may access or de-access an implanted port.

This was also in contrast to the CRS IV Therapy/Venous Blood Sampling Scope of Practice which read, LPNs are not authorized to perform access or deaccess of Ports or to administer intravenous fluids except for dextrose 5%, normal saline, lactated ringers, sodium chloride 0.45%, sodium chloride 0.2%, pre-mixed intravenous fluids containing electrolytes and vitamins, and pre-mixed antibiotic solutions.

iii. An interview was conducted on 6/18/24 at 9:11 a.m. with the director of nursing (DON) #5. DON #5 stated they had not assisted in creating LPN #4's job description or scope of practice at the facility. DON #5 stated they did not have direct oversight over the nurses in the infusion center or LPN#4, although they would have been available as a resource. They stated if an LPN had accessed a port in the infusion center, this should have been under the direct oversight of an RN. DON #5 stated only trained staff with appropriate scope of practice should have accessed ports because ports were central lines with a high potential for hospital-acquired infections. DON #5 stated there would have been a risk of patient harm if an RN or LPN utilized the wrong size syringe or lumen when accessing a port.

iv. An interview was conducted on 6/18/2024 at 8:43 a.m. with the chief operational officer (COO) #9. COO#9 stated when the facility hired LPN #4, Director #7 researched the LPN scope of practice. COO #9 stated Director #7 informed the facility that LPN #4 was not permitted to perform initial assessments or to administer chemotherapy. COO #9 stated they had no concerns about LPN #4's scope of practice at the facility. COO #9 stated the risk of practicing outside the scope of practice would have been patient harm if LPN #4 had not used resources well.

v. An interview was conducted on 6/17/2024 at 3:37 p.m. with the director of oncology, infusion, and pharmacy (Director) #7. Director #7 stated the LPN scope of practice did not specify which medications would have been in the scope of practice for LPN #4. Director #7 stated they based LPN #4's scope of practice for medication administration on whether the medication was new for a patient or whether the medication would have required an initial assessment by an RN. Director #7 stated there were high-risk medications, such as chemotherapy (a drug treatment that uses powerful chemicals to kill fast-growing cells, such as cancer cells), that would have been unsafe for an LPN to administer. Director #7 stated it was unsafe for an LPN to administer high-risk medications because these required an understanding of the anatomy and physiology of a patient and involved complex processes. Director #7 stated it was within the LPN scope of practice to reconstitute antibiotics by adding saline to a vial of powdered antibiotics. Director #7 stated patients receiving IV Ketamine in the infusion center would have been on the cardiac monitor during the infusion. Director #7 stated RNs would have been available while LPN #4 administered Ketamine to a patient. Director #7 stated there could be a concern if an LPN performed cardiac monitoring for a patient instead of an RN. Director #7 stated DON #5 and COO #9 created the scope of practice for LPN #4 for the infusion center, and that RNs were available to answer LPN #4's questions. Director #7 stated the risk of an LPN administering medications outside the scope of practice would have been patient harm from a lack of knowledge of patient anatomy and physiology or how to handle an emergency situation.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.640 Infection Prevention and Control and Antibiotic Stewardship Programs was out of compliance.

C-1206 - The infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the CAH and between the CAH and other healthcare settings. Based on observations, document reviews, and interviews, the facility failed to follow instructions for use (IFU), national guidelines, and facility policy for the use of detergent solution and the decontamination of surgical instruments to prevent the spread of infection in one out of one observation in the sterile processing department (SPD).

Based on observations, document reviews, and interviews, the facility failed to follow instructions for use (IFU), national guidelines, and facility policy for the use of detergent solution and the decontamination of surgical instruments to prevent the spread of infection in one out of one observation in the sterile processing department (SPD).

Findings include:

Facility policies:
The Inspection and Sorting of Instruments Policy read, inspection and sorting of instruments should be done simultaneously during the decontamination/cleaning and prep/packaging for High-Level Disinfection and/or Sterilization process. Instruments must be completely cleaned per the manufacturers instruction for use to ensure proper function and effective re-processing.
References:

According to the Association for the Advancement of Medical Instrumentation (AAMI) Sterile Processing - Knowledge, Skills, Competencies, cleaning is the most important step in sterile processing; thorough cleaning removes most microorganisms and other organic material from contaminated items. Unless an item is clean, it cannot be effectively disinfected or sterilized. Any soil, no matter how little, can prevent disinfectant or sterilant from contacting the surface of an item. We can assess visible contamination by examining items carefully, but microorganisms are invisible so we consider items contaminated even when we cannot see any soil. The best resource for determining how best to manage an item is the manufacturer's IFU.

The AAMI Point of Use and Transporting Soiled Instruments section Instrument Care read, all instruments, instrument trays, and sets that are opened for a sterile procedure are considered contaminated, even if they did not come in direct contact with the patient. At the end of a procedure in the operating room (OR), both used and unused instruments are returned to the set from which they came, and the entire set is considered contaminated and returned for processing. Infectious microorganisms are invisible so we cannot always determine contamination by visual inspection.
The Association of periOperative Registered Nurses (AORN) (2012-2023), Guidelines for Perioperative Practice: Instrument Cleaning read, failure to clean, inspect, disinfect or sterilize an item may lead to transmission of pathogenic microorganism from a contaminated device and create risk for patient injury, including surgical site infection. Follow the cleaning product manufacturer's written IFU for water quality, solution concentration and dilution, water temperature, contact time, conditions of storage and shelf life and use life.
The AORN (2013-2019) Guidelines for Perioperative Practice: Guideline for Instrument Cleaning read, facilities were to provide education and verify competency for specific knowledge and skills related to the cleaning and care of surgical instruments including the following: location and understanding of manufacturers' IFUs for the reusable surgical instrument or medical device, decontamination equipment, cleaning chemicals and disinfectants, inspection equipment, and cleaning verification tools; organizational procedures for decontamination and cleaning verification. Ongoing development of knowledge and skills and documentation of personnel participation is a regulatory requirement for both hospital and ambulatory settings.
The Integra Miltex IFU read, personnel should follow accepted guidelines as recommended in ANSI/AAMI ST79. Precleaning instructions read, Remove gross contaminants with a steady stream of lukewarm/cool water (below 110°F/43°C). Rinse each instrument thoroughly. Rinse instruments thoroughly under warm distilled or demineralized water. Do not use steel wool, wire brushes, pipe cleaners or abrasive detergents to remove soil as these will damage the instrument and lead to corrosion.

Stryker Video Devices Processing IFU read, rinse the device with critical water until all detergent residue is removed. Once all detergent residue is removed, continue to rinse for 10 seconds. Drain excess water from the device and dry it using a clean, lint-free cloth or pressurized air. Visually inspect the device for cleanliness, paying close attention to hard-to-reach areas.

The Revital-Ox 2X Concentrate Enzymatic Detergent read, the detergent is a low foaming, neutral pH, free rinsing detergent formulated for cleaning of flexible and rigid endoscopes, related accessories and other reusable medical devices prior to high level disinfection or sterilization. After soaking, rinse the device thoroughly with warm water including lumens/channels

1. The facility failed to ensure surgical instruments were cleaned and processed in accordance with facility policies and manufacturers' IFU. Specifically, the facility failed to manually clean and soak all surgical instruments in an enzymatic detergent prior to sterilization.

A. Observations

i. On 6/11/24 at 2:37 p.m., observations were conducted in the SPD. Observations revealed surgical instruments from a laparoscopic surgery set tray were processed and cleaned by sterile processing technician (Tech) #1. Tech #1 placed surgical instruments from the surgical instrument tray directly into the automatic washer. Tech #1 stated it was the facility's policy to not manually clean surgical instruments that were not used in the surgical case. Tech #1 submerged the remaining surgical instruments (the soiled instruments used during the surgical procedure), in a detergent solution before being scrubbed. Multiple surgical instruments were grossly soiled with blood during the manual cleaning process. Tech #1 stated that the instruments should have been pre-cleaned in the OR prior to being transported to SPD. Tech #1 used a metal wire brush to manually clean the instruments. Surgical instruments were not rinsed before or after being soaked in the detergent solution, and before being placed in the automatic washer. Tech #1 stated that the instruments did not need to be rinsed prior to being placed in the automatic washer. Tech #1 placed the remaining instruments in a metal basket and placed the instruments in the automatic washer. Multiple hinged surgical instruments overlapped and were in a closed position.

Further observation revealed Tech #1 reprocessing a Skriker AIM HD laparoscope. The laparoscope was grossly soiled with blood during the manual cleaning process. Tech #1 submerged laparoscopes in a detergent solution before scrubbing them with a surgical sponge. Tech #1 removed the laparoscopes from the detergent and placed them on a nearby counter to dry. Tech #1 stated the laparoscopes did not need to be rinsed before being placed in the autoclave for sterilization. Tech #1 stated they did not know what national standards the facility used to process surgical instruments or how to access the IFUs.

ii. The observations conducted on 6/11/24 revealed surgical instruments were processed incorrectly per the facility's policy, national guidelines, and manufacturers' IFU. Examples included:

Observations on 6/11/24 were in contrast to the AAMI Point of Use and Transporting Soiled Instruments section Instrument Care which read, all instruments, instrument trays, and sets that were opened for a sterile procedure were considered contaminated, even if they did not come in direct contact with the patient. At the end of a procedure in the operating room (OR), both used and unused instruments were returned to the set from which they came, and the entire set was considered contaminated and returned for processing.

Observations on 6/11/24 were in contrast to the AORN (2013-2019) Guidelines for Perioperative Practice: Guideline for Instrument Cleaning which read, facilities were to provide education and verify competency for specific knowledge and skills related to the cleaning and care of surgical instruments including the following: location and understanding of manufacturers' IFUs for the reusable surgical instrument or medical device.
Observations on 6/11/24 were in contrast to the Integra Miltex IFU which read, personnel should have followed accepted guidelines as recommended in ANSI/AAMI ST79. Precleaning instructions read, removed gross contaminants with a steady stream of lukewarm/cool water (below 110°F/43°C). Instruments were rinsed thoroughly under warm distilled or demineralized water. Cleaning instructions read, do not use steel wool, wire brushes, pipe cleaners or abrasive detergents to remove soil as these will damage the instrument and lead to corrosion.

Observations on 6/11/24 were in contrast to the Stryker Video Devices Processing IFU which read, rinse the device with critical water until all detergent residue was removed. Once all detergent residue was removed, continue to rinse for 10 seconds.

Observations on 6/11/24 were in contrast to the Revital-Ox 2X Concentrate Enzymatic Detergent which read, after soaking, rinse the device thoroughly with warm water including lumens/channels.

B. Interviews

i. On 6/11/24 at 3:02 p.m., an interview was conducted with Tech #1. Tech #1 stated the instruments brought from the OR earlier that day were soiled and not precleaned at the point of use. Tech #1 stated they were unaware they needed to manually clean instruments that were not visibly soiled. Tech #1 stated they were not informed on how to reprocess the instruments per the manufactures' IFU.

ii. On 6/11/24 at 3:02 p.m., an interview was conducted with infection prevention nurse (IP) #2. IP #2 stated they were new to the facility and did not have the opportunity to assess the SPD. IP #2 stated they did not have experience in the SPD and requested additional training with the facilities leadership. IP #2 stated the surgical instruments were to be cleaned and processed per the manufacturers' IFU. IP #2 stated that it was important to follow the manufacturers' IFUs to ensure that instruments were cleaned properly. IP #2 stated instruments that were not cleaned properly would put the patient at risk for a surgical site infection (SSI).

iii. On 6/13/24 at 7:55 a.m., an interview was conducted with Manager #3. Manager #3 stated the facility followed AAMI and AORN guidelines in the SPD. Manager #3 stated surgical instruments should have been precleaned in the OR to remove visible contamination. Manager #3 stated all surgical instruments should have been cleaned per the manufacturers' IFU. Manager #3 stated they were unaware all surgical instruments were to be manually cleaned. Manager #3 stated the facility would only manually clean surgical instruments that were used in the surgical case and that unused instruments were placed directly in the automatic washer to be cleaned. Manager #3 stated hinged instruments should have been opened and not overlapping with other instruments before being placed in the automatic washer. Manager #1 stated when surgical instruments were not correctly manually cleaned after the procedure, the instruments could have been contaminated with bioburden (organic material from a prior procedure) and potentially caused a surgical infection.

Manager #1's interview was in contrast to the observations on 5/2/24 which showed surgical instruments were not processed per the manufacturers' IFU.

Manager #1's interview was in contrast to the AAMI Point of Use and Transporting Soiled Instruments section Instrument Care which read, all instruments, instrument trays, and sets that were opened for a sterile procedure were considered contaminated, even if they did not come in direct contact with the patient. At the end of a procedure in the operating room (OR), both used and unused instruments were returned to the set from which they came, and the entire set was considered contaminated and returned for processing.

Based on interviews and document review, the facility failed to ensure the quality assessment and performance improvement (QAPI) program identified and implemented performance improvement activities, including high-risk, problem-prone areas. This failure affected the provision of services, infection control, and emergency services. (Cross-reference C-0886, C-0888, C-1006, C-1046, C-1048, C-1049, C-1206)

Findings include:

References:

According to the Quality Assurance and Performance Improvement Program, the mission is to ensure the provision of quality healthcare by identifying and acting upon performance improvement (PI) opportunities. QAPI establishes the clinical and support service quality assurance and performance improvement structure. The facility ensures a planned, continuous, and systematic method for collecting and analyzing data and developing performance improvement activities that will positively impact patient outcomes. Quality of care and patient safety are foundational components of the QAPI Program.

The facility will continuously assess and improve quality utilizing the Plan Do Study Act (PDSA) model of improvement to evaluate processes and systems, having a multidisciplinary team approach for PI projects, aggregating and analyzing data to identify improvement opportunities, and evaluating improvement opportunities based on the assessed value of each opportunity.

To accomplish its objectives, the facility has developed a formal QAPI reporting structure that includes key entities. Each entity has specific responsibilities in the governance of the QAPI Program. The Board of Directors (Board) adopts the QAPI Program and Plan and provides input and direction. Leadership ensures that the facility has adequate resources to support the QAPI program and ensures that the QAPI program properly identifies and corrects areas of needed improvement. The Quality Council receives and analyzes periodic QAPI data/reports to ensure that the QAPI process is ongoing and effective.

Leadership supports an effective framework for planning, directing, providing, and improving the quality of healthcare services and providing the right number of competent staff to meet the needs of the organization. QAPI staff develop and administer the QAPI Program to meet all regulatory requirements, present periodic summary reports to the Board, implement evidence-based, best practices, and collect, aggregate, and analyze information to improve patient outcomes. QAPI staff also assist in choosing performance indicators that promote ongoing measurement and assessment of quality and patient safety. Clinical staff understand and protect patient rights to provide safe and effective care while being responsive to individual patient needs.

The facility identifies areas for improvement from continuous monitoring of current practices. PI projects may also be suggested by staff. Strategic operational decisions may result in performance improvement activities. Expansion or creation of new services or regulatory compliance can result in the need to improve processes.

According to the Colorado Revised Statutes (CRS) intravenous (IV) Therapy/Venous Blood Sampling Scope of Practice, licensed professional nurses (LPNs) with IV authority may perform the following procedures under the supervision of a professional nurse or physician: utilize peripheral veins for intravenous access with a peripheral short catheter, and administer intravenous fluids, including dextrose 5%, normal saline, lactated ringers, sodium chloride 0.45%, sodium chloride 0.2%, premixed intravenous fluids containing electrolytes and vitamins, and pre-mixed (meaning IV solution prepared and labeled by a pharmacist or manufacturer) antibiotics, and monitor the systemic effects of intravenous therapy. LPNs are not authorized to perform access or deaccess of implanted central venous access ports (ports).

According to the Infusion LPN job description, the LPN must be proficient in IV insertions for adults and management of ports. The LPN's essential duties, functions, and responsibilities include accessing ports, completing dressing changes, performing injections and IV therapy, and administering medications according to pharmacy guidelines.

1. The facility failed to ensure the QAPI program identified and implemented performance improvement activities, including high-risk, problem-prone areas.

A. Observations

i. On 6/18/24, observations of the infusion center revealed staff were unable to continuously monitor patients receiving ketamine infusions, and a crash (emergency) cart was not available for patient emergencies. Observations revealed an exam room without windows, any other means of visualizing patients when the exam room door was closed, or a call light for patients to be able to contact staff during their medical treatments. During an interview with LPN #4 on 6/18/24 at 11:12 a.m., LPN #4 stated clinical staff left patients alone in the room and the staff re-entered at 10-minute intervals to assess vital signs. Observations at this time did not reveal a crash (emergency) cart or suctioning equipment located within the infusion department which LPN #4 verified in her interview. (Cross-reference C-1046).

This lack of patient monitoring and emergency equipment in the infusion center was in contrast to the QAPI plan which read, the facility continuously monitored current practices to identify areas for improvement which would positively impact patient outcomes.

ii. On 6/13/24, observations of the infusion center revealed several powdered antibiotics in the Pyxis (automated medication dispenser) which required reconstitution by staff, including LPN #4, although only pre-mixed IV solutions are within the LPN scope of practice. During an interview on 6/17/24 at 1:43 p.m. with LPN #4, LPN #4 stated they reconstituted antibiotics with IV fluids as this was within the LPN scope of practice. During an interview on 6/17/24 at 3:37 p.m. with the director of infusion, oncology, and pharmacy (Director) #7, they stated LPN #4's job duties had been approved by facility leadership and Director #7 provided oversight to LPN #4. (Cross-reference C-1048, C-1049)

The observations and interviews with LPN #4 and Director #7 were in contrast to the QAPI plan which read, the facility provided the right number of competent staff to meet the facility's needs and continuously monitored current practices to identify areas for improvement which would positively impact patient outcomes.

iii. On 6/11/24, observations of the sterile processing department (SPD) revealed staff failed to follow manufacturers' instructions for use (IFUs) when processing surgical instruments and devices. Observations revealed sterile processing technician (Tech) #1 incorrectly processed a tray of surgical instruments by failing to follow multiple steps of the instruments' IFUs during the pre-cleaning and cleaning steps. Observations also revealed Tech #1 incorrectly processed a laparoscope (an instrument inserted through the abdominal wall to enable viewing of the organs) when they failed to follow all of the IFUs, namely failing to rinse detergent from the soaked and scrubbed device. At this time, Tech #1 stated they did not know what national standards the facility used to process surgical instruments or how to access the instrument IFUs. (Cross-reference C-1206)

This failure to follow the IFUs in the SPD was in contrast to the QAPI plan which read, the facility provided the right number of competent staff to meet the facility's needs and continuously monitored current practices to identify areas for improvement which would positively impact patient outcomes.

iv. On 6/10/24, observations in the radiology department revealed the adult crash cart (a wheeled container carrying medicine and equipment for use in emergency resuscitations) contained expired emergency supplies, including devices to ensure an open airway. (Cross reference C-0888)

This observation of expired emergency supplies was in contrast to the QAPI plan which read, the facility continuously and systematically monitored current practices, collected and analyzed data, and developed performance improvement activities to positively impact patient outcomes, quality of care, and patient safety.

v. On 6/10/24, observations in trauma bay #1 revealed the adult crash cart contained expired emergency medications which included amiodarone (a medication used to treat a fast or irregular heartbeat), naloxone (a medication used to reverse an opioid overdose), and lidocaine (a medication used to treat sudden cardiac arrest caused by dangerous heart rhythms). (Cross reference C-0886)

These observations of expired emergency medications were in contrast to the QAPI plan which read, the facility continuously and systematically monitored current practices, collected and analyzed data, and developed performance improvement activities to positively impact patient outcomes, quality of care, and patient safety.

vi. From 6/10/24 to 6/13/24, observations revealed expired medical supplies in multiple areas within the facility. (Cross reference C-1006)

a. Observations conducted in the inpatient supply area revealed expired surgical gowns.
b. Observations conducted in operating room (OR) #1 revealed expired tissue control devices and sterile gloves.
c. Observations conducted of the OR malignant hyperthermia (dangerous elevation of body temperature) cart revealed expired IV tubing.
d. Observations conducted of the post-anesthesia care unit (PACU) pain cart revealed an expired hypodermic needle.
e. Observations conducted in the infusion center supply area revealed expired bone marrow aspirate kits (tools needed to extract bone marrow from the body).

These observations of expired medical supplies were in contrast to the QAPI plan which read, the facility continuously and systematically monitored current practices, collected and analyzed data, and developed performance improvement activities to positively impact patient outcomes, quality of care, and patient safety.

B. Document review

i. Upon request, the facility was unable to provide policies on assessment and reassessment and cardiac monitoring within the infusion center. (Cross reference C-1046)

This lack of patient care policies within the infusion center was in contrast to the QAPI plan which read, the facility continuously monitored current practices to identify areas for improvement which would positively impact patient outcomes.

ii. Medical record review

a. A review of medical records revealed clinical staff in the infusion center failed to safely monitor patients during ketamine (a controlled substance used to make people sleepy, relaxed, reduce pain, and improve mood) infusions. The nursing progress notes read Patients #29, #31, and #32 were placed on cardiac monitors and their vital signs were assessed every 10 minutes while receiving ketamine infusions. However, the medical record did not reveal evidence of electrocardiogram (EKG) (records the electrical signals in the heart) monitoring throughout treatment or any assessment or interpretation of heart rhythms. The review also failed to reveal changes in monitoring or additional interventions made for Patient #31, who had a history of hypertension (elevated blood pressure) and had an increase in blood pressure during at least one of their treatments. (Cross reference C-1046)

This review of the medical records was in contrast to the QAPI plan which read, the facility continuously and systematically monitored current practices, collected and analyzed data, and developed performance improvement activities to positively impact patient outcomes, quality of care, and patient safety.

b. A review of medical records revealed LPN #4 assessed and treated patients outside of the LPN scope of practice. Medical records revealed LPN #4 administered IV solutions, including a controlled substance, and performed patient assessments and monitoring. For example, LPN #4 administered and monitored Patient #29's, #31's, and #32's ketamine (a controlled substance) infusions on multiple occasions, even during induction (the beginning phase) when increased monitoring was required. The review of records revealed LPN #4 also reconstituted and administered ceftriaxone (an antibiotic) to Patient #28. During an interview with Director #7 on 6/17/24 at 3:37 p.m., they stated LPNs were allowed to administer Ketamine and reconstitute and administer antibiotics. (Cross-reference C-1046, C-1048, C-1049)

This review of the medical records was in contrast to the QAPI plan which read, the facility provided the right number of competent staff to meet the facility's needs and continuously and systematically monitored current practices, collected and analyzed data, and developed performance improvement activities to positively impact patient outcomes, quality of care, and patient safety.

c. A review of the medical records failed to reveal registered nurse (RN) supervision or oversight of LPN #4. A review of the records for Patients #28, #29, #31, and #32 revealed LPN #4 practiced independently without oversight by an RN or medical provider. During an interview with Director #7 on 6/17/24 at 3:37 p.m., they stated they provided oversight to LPN #4. (Cross-reference C-1048)

This review of the medical records and interview with Director #7 was in contrast to the QAPI plan which read, the facility provided the right number of competent staff to meet the facility's needs and continuously monitored current practices to identify areas for improvement which would positively impact patient outcomes.

C. Interviews

i. On 6/12/24 at 3:39 p.m., an interview was conducted with the director of quality (Director) #17. Director #17 stated members of the quality program continuously monitored the facility and staff's practices for performance improvement opportunities. This was in contrast to the multiple observations of expired medications and supplies, lack of proper patient monitoring in the infusion center, lack of a crash cart in the infusion center, staff practicing outside their scope of practice, and a lack of LPN supervision.

Director #17 stated the quality team asked staff members "why" questions and observed departmental practices to identify problem-prone areas. They stated they had provided ongoing education to staff on quality's role within the facility and had encouraged staff members to report incidents to identify quality improvement opportunities. Director #17 stated they had identified high-risk, high-volume, or problem-prone areas by encouraging staff to report incidents, keeping open lines of communication with staff, and rounding on the floor which was in contrast to multiple observations, interviews, and document review which revealed concerns with infection control, nursing services, and emergency services.

Director #17 stated the facility failed to monitor for expired medications and supplies. They stated the quality and leadership team had started rounding with a checklist but recognized staff needed more support to ensure they removed expired medications and supplies.

Director #17 stated the concerns identified survey helped identify opportunities to improve in the SPD, including aligning SPD policies with current, evidence-based practices. They stated proper oversight of the SPD was important to ensure SPD staff were compliant with regulations and leadership trusted but verified staff's competencies and adherence to guidelines. Director #17 stated leadership was responsible for ensuring compliance with regulations and the goals of the quality program.

This interview was in contrast to the QAPI plan which read, the facility continuously monitored current practices to identify areas for improvement which would positively impact patient outcomes. The quality team ensured the QAPI process was ongoing and effective.

ii. On 6/24/24 at 9:51 a.m. an interview was conducted with DON #5. DON #5 stated they provided oversight to Director #17 in their role as the quality director and were part of the quality team. They stated quality was responsible for identifying areas of improvement within the facility. DON #5 stated the quality team met with staff members from different departments each month to ensure issues were identified and addressed. They stated quality identified low volume, high risk quality improvement opportunities in a similar fashion; leadership staff rounded throughout the different departments, observed facility processes, and encouraged two way communication with staff. This statement was in contrast to the multiple observations, interviews, and document review which revealed concerns with infection control, nursing services, and emergency services.

DON #5 stated they did not provide oversight to the infusion center or the infusion center staff as this was the responsibility of Director #7. DON #5 stated with the absence of a nurse manager in the infusion center, creating a lack of oversight, and a lack of communication between infusion center staff and the quality team, the facility failed to identify opportunities for performance improvement. They stated they were not aware patients receiving ketamine infusions failed to receive the monitoring needed to ensure safe and quality patient care. DON #5 stated they were also unaware LPN #4's job duties exceeded the LPN scope of practice and LPN #4 was not supervised by an RN. DON #5 stated nurses were responsible for overseeing nurses. DON #5 also stated it was necessary for the infusion center to have a crash cart as patients who received ketamine infusions were at a higher risk of dissociation and hemodynamic changes. They stated additionally, any infusion patient could develop anaphylaxis (a severe allergic reaction resulting in difficulty or loss of breathing) for which emergency medications and supplies would be necessary.

DON #5 stated the SPD needed strong leadership to identify quality concerns. They stated OR manager (Manager) #3 currently provided oversight to the SPD but did not have a sterile processing background. DON #5 stated the facility needed an SPD supervisor with a background in sterile processing to ensure the SPD technicians followed national guidelines and facility policies.

This interview was in contrast to the QAPI plan which read, the facility continuously monitored current practices to identify areas for improvement. The quality team ensured the QAPI process was ongoing and effective. Leadership ensured the facility had adequate resources to support the QAPI program and ensured the QAPI program properly identified areas of needed improvement to positively impact patient outcomes.

iii. On 6/18/24 at 8:42 a.m., an interview was conducted with chief operating officer (COO) #9. COO #9 stated their background was in nursing and they were an RN. They stated they were part of the quality team and governing body. COO #9 stated continuous leadership rounding and encouraging communication with floor staff were key components in the quality program. COO #9 stated the QAPI program and quality team were important for the facility to provide the best patient care. They stated the quality department identified concerns before they negatively impacted patient care, which was in contrast to the multiple observations of expired medications and supplies, lack of proper patient monitoring in the infusion center, lack of a crash cart in the infusion center, staff practicing outside their scope of practice, and a lack of RN supervision.

COO #9 stated they oversaw Director #7 and the infusion center. They stated they had not had concerns with the quality or frequency of patient monitoring in the infusion center nor did they feel a crash cart was necessary in the infusion center as emergency department (ED) staff were close by. They stated Director #7 had researched the LPN scope of practice and created a job description for LPN #4, which COO #9 then approved. In contrast to interviews with DON #5, COO #9 stated DON #5 was also involved in the creation of the LPN job description and role. In contrast to the CRS for the LPNs scope of practice and a review of the medical records, COO #9 stated LPN #4 practiced within their scope and was always overseen by the infusion center RNs. Also in contrast to the interview with DON #5, COO #9 stated the director of infusion, oncology, and pharmacy (Director) #7 provided adequate supervision to LPN #4.

COO #9 stated the infection control concerns identified in the SPD were due to inadequate staffing in the SPD. They stated the staff shortage had led to a decrease in quality control. COO #9 stated it was important to follow national guidelines and manufacturers' IFUs to ensure patients received the best care.

This interview was in contrast to the QAPI plan which read, the facility provided the right number of competent staff to meet the facility's needs and continuously monitored current practices to identify areas for improvement which would positively impact patient outcomes.

iv. On 6/24/24 at 11:45 a.m. an interview was conducted with chief executive officer and chief medical officer (CEO) #19. CEO #19 stated the facility had expanded their quality program recently as quality of care was central to the facility's operations. They stated they had not previously been aware of quality concerns which impacted patient safety. CEO #19 stated the quality program was important to ensure the facility provided the best patient care.

This interview was in contrast to the QAPI plan which read, leadership ensured the facility had adequate resources to support the QAPI program and ensured the QAPI program properly identified areas of needed improvement to positively impact patient outcomes.