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Tag No.: A0385
Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.23 NURSING SERVICES, was out of compliance.
A-0405 (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient's care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. Based on observations, interviews, and document review, the facility failed to ensure medications were administered in accordance with provider orders, facility policy, and national guidelines. This failure was identified in one of one observations of medication administration.
Tag No.: A0405
Based on observations, interviews, and document review, the facility failed to ensure medications were administered in accordance with provider orders, facility policy, and national guidelines. This failure was identified in one of one observations of medication administration.
Findings include:
Facility policies:
The Medication Administration Record and Medication Administration policy read, prior to administering medication, the nurse will verify against the Medication Administration Record (MAR) the patient's name and date of birth, the name of the drug, the dose strength on the package or unit dose package, the route of administration, and the time of administration.
The Medication Orders policy read, medications will be prepared and administered in accordance with the orders of a licensed independent practitioner responsible for the patient's care, and in accordance with law and regulation.
The Pain Management policy read, all patients have the right to appropriate assessment and management of pain. Pain will be assessed on admission, on a routine basis, and as needed (PRN). Pain reassessment will occur within four hours of administration and be documented in the medical record. Pain scale utilization will be tailored to the patient's needs, to include a numerical rating scale, visual analog scales, and a verbal rating scale.
Reference:
According to the Wolter Kluwer Nursing 2025-2026 Drug Handbook, "How to Use the Nursing 2025-2026 Drug Handbook", the handbook contains medication summaries and the most pertinent clinical information nurses must know to administer medications safely. The "Contraindications and Cautions" section contains any diseases or conditions in which the use of the drug is undesirable or should be given with caution. The "Nursing Considerations" section provides guidance on patient monitoring and nursing practices for preventing and managing adverse reactions. The "Adverse Reactions" section contains adverse reactions and life-threatening adverse reactions that are known to occur.
The Contraindications and Cautions section for oxycodone hydrochloride (Oxy IR- pain medication) read, patients with the following medical conditions are at an increased risk for oversedation and respiratory depression and require close monitoring: sleep apnea and preexisting pulmonary or cardiac disease. The Nursing Considerations section read, may cause life-threatening or fatal respiratory depression at any time during therapy. Carefully monitor vital signs, pain level, respiratory status, and sedation level. Reassess the patient's level of pain at least 15 minutes and 30 minutes after administration.
The Contraindications and Cautions section for hydrocodone bitartrate-acetaminophen read, patients with the following medical conditions are at an increased risk for oversedation and respiratory depression and require close monitoring: sleep apnea and preexisting pulmonary or cardiac disease. The Nursing Considerations section read, may cause life-threatening or fatal respiratory depression at any time during therapy. Carefully monitor vital signs, pain level, respiratory status, and sedation level. Regularly monitor blood pressure and pulse.
Chapter 3, Safe Drug Administration, Medication Administration Process section, the eight rights of medication administration read, verify the route by which the drug is to be given, verify the drug prescribed is appropriate to the patient's condition, and completely and accurately document in the patient's medical record the drug administered.
1. Nursing staff failed to administer medications in accordance with provider orders, facility policy, and national guidelines.
a. Medical record review revealed Patient #2 was admitted on 8/14/25 after a left middle cerebral artery ischemic stroke (a blood clot blocked blood flow in the brain). Patient #2 had a history of obstructive sleep apnea (OSA, when breathing stops during sleep because of a windpipe blockage), hypertension (high blood pressure), congestive heart failure (CHF, a condition where the heart muscle cannot pump blood effectively), chronic hypercapnic respiratory failure (inability to remove carbon dioxide from the blood), and pulmonary hypertension (elevated blood pressure in the pulmonary arteries that increases cardiac workload and causes difficulty breathing). Additionally, Patient #2 had aphasia (inability to speak and understand words, read, and write).
b. On 8/19/25, from 4:26 p.m. to 5:36 p.m., an observation was conducted in Patient #2's room.
During the observation, licensed practical nurse (LPN) #1 entered Patient #2's room and informed the patient and their caregiver they would need to collect a urine sample. Before leaving to gather the supplies, Patient #2's caregiver requested pain medication for the patient.
LPN #1 asked Patient #2 to rate their pain on a scale of 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain. Patient #2 attempted to respond. However, their response was unintelligible. LPN #1 asked the patient's caregiver to provide a pain score for the patient. Patient #2's caregiver told LPN #1 they did not know the patient's current pain level. Patient #2's caregiver further told LPN #1 the patient suffered from chronic pain and took prescription pain medication. LPN #1 then stated they felt a pain score of 7 would accurately reflect the patient's current level of pain.
This observation contrasted with the facility's Pain Management policy, which required staff to use numerical, visual, or verbal pain scales based on patient needs.
The facility provided Patient #2's medication orders and medication administration records during the observation. Review of the medication administration record revealed Patient #2 was prescribed 5 mg immediate-release oxycodone by mouth three times daily as needed for a pain score between 4-10. Further review of the medication administration record revealed, at 4:41 p.m., LPN #1 administered 5 mg of immediate-release oxycodone to the patient and documented a pain score of 7. LPN #1 administered the oxycodone to Patient #2 without using a pain scale tailored to their inability to communicate pain verbally.
Upon request, the facility was unable to provide evidence Patient #2's vital signs, respiratory status, or sedation level had been assessed, and a pain reassessment had been completed after the oxycodone had been administered.
This contrasted with the Wolters Kluwer Nursing 2025-2026 Drug Handbook, which was provided by the facility. According to the handbook, patients with sleep apnea and preexisting pulmonary or cardiac disease required continuous monitoring of vital signs, pain level, respiratory status, and sedation level, as the medication could cause life-threatening or fatal respiratory depression. The handbook further stated the patient's pain level should be reassessed at least 15 and 30 minutes after administration.
At 4:50 p.m., LPN #1 was observed applying Voltaren gel 1 percent (%) (topical medication used to reduce pain, stiffness, and inflammation) to both of Patient #2's knees. Furthermore, during the observation, LPN #1 asked Patient #2's caregiver where on Patient #2's body the Voltaren gel should be applied.
The observation contrasted with the provider's order for the Voltaren gel. Review of the Voltaren gel order revealed the medication was to be applied topically to Patient #2's left hand four times daily for pain. Additionally, the observation was in contrast to the facility's Medication Administration Record and Medication Administration policy which stated, nurses verified the medication name, dose, route, and time of administration against the provider's order and the patient's MAR before administering medication.
This observation also contrasted with the Wolters Kluwer Nursing 2025-2026 Drug Handbook. According to the Safe Drug Administration, Medication Administration Process section, nursing staff were to confirm the medication order, verify the route of administration, and accurately document how the medication was administered in the patient's record. Additionally, LPN #1 failed to document the actual site where the medication was applied in Patient #2's medical record.
At 4:52 p.m., observations revealed Patient #2 brought their right hand to their chest and struck the area repeatedly. In response, LPN #1 retrieved a portable vital signs machine and conducted an assessment which showed Patient #2's oxygen saturation was 78%. Based on this finding, LPN #1 increased the flow rate of supplemental oxygen from 1 L to 3 L and then rechecked Patient #2's oxygen saturation level, which fluctuated between 88% and 91%.
At 5:03 p.m., respiratory therapist (RT) #3 entered Patient #2's room. RT #3 assessed Patient #2's breathing and placed the patient on continuous oxygen monitoring. At 5:21 p.m., RT #3 administered a hand-held nebulizer treatment (HHN-inhaled medication that opens the airway and lungs) to Patient #2. After the HHN treatment, RT #3 decreased the patients supplemental oxygen to 2.5 L, and Patient #2 had an oxygen saturation of 95%.
Medical record review for Patient #2 revealed on 8/14/25 at 8:03 a.m., nurse practitioner (NP) #6 documented the patient was on 3 L supplemental oxygen through nasal cannula (medical device used to deliver supplemental oxygen into the nose). Additionally, the patient's need for supplemental oxygen was documented in Patient #2's plan of care. However, from 8/14/25 to 8/20/25 (a total of six days) supplemental oxygen had not been ordered by a provider for Patient #2.
When requested, the facility was unable to provide evidence supporting the administration of oxygen without a provider order or verification of the required amount. This observation and medical record review contrasted with the Medication Orders policy, which stated, medications were to be administered in accordance with provider orders.
c. Review of the facility's Pain Management policy required nurses to perform a pain reassessment within four hours of administering pain medication.
This contrasted with the Wolters Kluwer Nursing 2025-2026 Drug Handbook which stated, the patient's pain level should be reassessed at least 15 and 30 minutes after medication administration.
Upon request, the facility was unable to provide evidence of how the Pain Management policy aligned with national guidelines.
d. On 8/21/25 at 4:23 p.m., an interview was conducted with LPN #2. LPN #2 stated at shift change, nurses performed handoff reports. LPN #2 stated the outgoing nurse reviewed the patient's oxygen use, medications, and physician orders with the oncoming nurse. However, LPN #2 further stated in addition to the handoff report, nurses were still expected to verify the patient's orders in the patient's electronic medical record. LPN #2 stated patient orders were reviewed to ensure the medications administered, and the care interventions implemented, matched the provider's orders and treatment plan for the patient.
LPN #2 stated the nurse was required to administer medication and care interventions according to the provider's orders and treatment plan. LPN #2 stated when a patient's pain score was fabricated, a complete and accurate pain assessment had not been performed. LPN #2 stated accurate pain scores helped to understand the severity of the patient's condition and guided the pain management treatment and interventions. LPN #2 stated administering pain medication using an inaccurate pain score placed patients at risk of overdosing from an excessive dose or experiencing uncontrolled pain from an inadequate dose.
e. On 8/19/25 at 5:45 p.m. an interview was conducted with chief nursing officer (CNO) #4. CNO #4 stated during the observation conducted in Patient #2's room, they had reviewed Patient #2's medication orders and noted concerns with the manner in which LPN #1 administered the medications. CNO #4 stated nurses were required to review medication and physician orders for each patient under their care. CNO #4 stated before administering medication, nurses were to confirm the medication, its indication, and the method of administration to ensure what was being administered was in accordance with the provider's order.
Additionally, CNO #4 stated a provider's order was required for patients on supplemental oxygen. CNO #4 stated oxygen orders included the oxygen flow rate, the delivery method, the target oxygen level, how often the oxygen should be given, and the reason oxygen was needed. CNO #4 further stated Patient #2 did not have an order for oxygen, despite having received continuous supplemental oxygen.