F697 42 CFR § 483.25(k) Pain Management. The facility must ensure that pain management is provided to residents who require such services, consistent with professional standards of practice, the comprehensive person-centered care plan, and the residents’ goals and preferences.
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42 CFR § 483.45(a) Procedures. A facility must provide pharmaceutical services (including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals) to meet the needs of each resident.
22 CCR § 72353 Pharmaceutical Service. (a) Arrangements shall be made to assure that pharmaceutical services are available to provide patients with prescribed drugs and biologicals.
22 CCR § 72355 Pharmaceutical Service Requirements.
(a) Pharmaceutical service shall include, but is not limited to, the following:(1) Obtaining necessary drugs including the availability of 24-hour prescription service on a prompt and timely basis as follows: (D) Refill of prescription drugs shall be available when needed.
22 CCR § 72313 Administration of Medications and Treatments. (a) Medications and treatments shall be administered as follows: (2) Medications and treatments shall be administered as prescribed.
22 CCR § 72311 Nursing Service. (a) Nursing service shall include, but not be limited to, the following: (2) Implementing of each patient’s care plan according to the methods indicated. Each patient's care shall be based on this plan.
22 CCR § 72523 Patient Care Policies and Procedures. (a) Written patient care policies and procedures shall be established and implemented to ensure that patient related goals and facility objectives are achieved.
On 12/28/2023 the California Department of Public Health (CDPH) received a complaint alleging a Resident (Resident 1), who was discharged from a General Acute Care Hospital (GACH) following back surgery and admitted to a Skilled Nursing Facility (SNF), did not receive pain medication for two days, and Resident 1 had to be transferred back to the GACH for pain management.
On 1/11/2024, at 11:52 a.m., CDPH conducted an unannounced visit to the facility to investigate the complaint. Upon investigation, CDPH determined Resident 1, who was in severe back pain, following back surgery, and was admitted to the facility for pain management with an order for Hydrocodone-Acetaminophen ([Norco] a combination medication used to relieve moderate to severe pain) 10/325 milligrams ([mg] a unit of measurement) for severe pain, did not receive pain medication as ordered. Resident 1’s pain medication was unavailable and an order to refill Resident 1’s pain medication was not carried out in a timely manner. Instead, Resident 1 was administered Tylenol 325 mg ordered for mild pain due to unavailable Norco.
The facility failed to:
1. Ensure licensed nurses ordered a refill of Norco 10/325 mg to be available when needed for Resident 1’s moderate to severe pain management before its quantity was depleted.
2. Make arrangements for pharmaceutical services when Registered Nurse Supervisor (RNS 1) did not request authorization to obtain necessary the medication, Norco 10/325 mg, from the facility’s emergency kit ([E-Kit] a kit that contains a small quantity of medications that can be dispensed when pharmacy service is not available) where six Norco 10/325 mg tablets were available to administer to Resident 1 for severe back pain in order to provide the resident with prescribed drugs.
3. Provide medication and treatment as prescribed.
Resident 1 was not medicated to control her severe pain per Resident 1’s care plan and as ordered by Resident 1’s physician.
4. Implement care plan interventions to anticipate Resident 1’s need for pain relief and respond immediately to any complaint of pain and administer analgesics (pain medications) as ordered by the physician.
5. Ensure the licensed nurses followed the facility’s Policy and Procedure (P&P) titled, “Medication Orders, Controlled Substance Prescriptions,” to obtain emergency medication from the facility’s supply and refill Norco and send the request form to the pharmacy five days in advance to assure an adequate supply of Norco was on hand for administration to Resident 1.
As a result of these deficient practices, Resident 1 experienced uncontrolled severe back pain for approximately 22 hours without relief and was eventually transferred to a GACH on 12/25/2023 at 10 a.m., for evaluation of uncontrolled back pain. Resident 1 was administered intravenous ([IV] in the vein) Morphine (a narcotic medication used to treat severe pain) to relieve her uncontrolled severe pain.
A review of Resident 1’s Admission Record (Face Sheet) indicated Resident 1, a 68 year-old female, was admitted to the facility on 12/14/2023, with diagnoses including orthopedic (a medical specialty that deals with the treatment of bones that did not grow correctly or that sustained damaged) aftercare, arthrodesis status (surgery in which two or more bones in a joint are joined together to become one larger bone), and difficulty in walking.
A review of Resident 1’s Minimum Data Set ([MDS] a standardized assessment and care planning tool), dated 12/19/2023, indicated Resident 1 was able to make independent decisions that were reasonable and consistent and was able to understand and be understood by others. The MDS indicated Resident 1 experienced severe pain frequently over the last five days making it hard to sleep.
A review of Resident 1’s Care Plan, dated 12/14/2023, indicated Resident 1 had acute/chronic pain related to lumbar stenosis (a narrowing of the spinal canal in the lower part of the back) with five prior lumbar surgeries with misplaced plates, rods, and screws, removal of hardware decompression (a release of physical pressure from plates, rods, and screws used to keep spine stable), laminectomy (a surgical procedure to relieve pressure on the nerves by removing the arched back piece of the backbone) and fusion (surgery to connect two or more bones together) of the thoracic 11 (the middle section of the spine) vertebrae through the sacrum bone 1 (a triangle shaped bony structure at the base of the lumbar vertebrae). The care plan goal for Resident 1 was to verbalize adequate pain relief or the ability to cope with incompletely relieved pain. The Care Plan interventions included to anticipate Resident 1’s need for pain relief and respond immediately to any complaint of pain and administer analgesics as ordered by the physician.
A review of Resident 1’s Physician’s Orders indicated the following:
1. An order dated 12/14/2023 for Tylenol 325 mg, two tablets every four hours as needed for mild pain (rated one to three on a zero to 10 pain scale).
2. An order dated 12/24/2023 for Norco 10/325 mg one tablet every four hours as needed for moderate pain (4-6) to severe pain (7-10).
A review of Resident 1’s Progress Note, dated 12/14/2023 and timed at 12:52 p.m., indicated Resident 1 was admitted to the facility from a GACH after an elective surgery to remove misplaced back hardware with severe stenosis, had hardware decompression with a history of multiple back surgeries. The Progress Note indicated Resident 1 was transferred to the facility on 12/14/2023 for observation and management of physical condition/symptoms, and medication management for pain.
A review of Resident 1’s Controlled Medication Count Sheet, dated 12/23/2023 and timed at 9:20 a.m., indicated Resident 1 had one tablet of Norco 10/325 mg left.
A review of Resident 1’s Pharmacy Medication Order form, dated 12/23/2023 indicated, Resident 1’s refill order for Norco 10/325 mg was faxed to the pharmacy on 12/23/2023 at 11:56 p.m., when Resident 1 had only one tablet of Norco remaining available.
A review of Resident 1’s Medication Administration Record (MAR), dated 12/2023 indicated Resident 1’s last dose of Norco10/325 mg was administered at 1:01 p.m., on 12/24/2023. The MAR indicated on 12/25/2023, at 8:36 a.m. Resident 1 was administered Tylenol 650 mg (usually given for mild pain rating 1-3) for a pain level rated a 10 on a pain scale from one to 10.
A review of Resident 1’s Change in Condition Evaluation (COC), dated 12/25/2023 and timed at 10:05 a.m., indicated at 9:30 a.m., Resident 1 had an uncontrolled severe pain rated at 10. The COC indicated Resident 1 was tearful and had decreased mobility. The COC indicated there was no pain medication available, and the facility was waiting for Resident 1’s pain medication (Norco 10/325 mg) to be delivered from the pharmacy. The COC indicated Resident 1’s physician was notified of Resident 1’s pain level and an order was obtained to transfer Resident 1 to the GACH’s emergency room (ER) for uncontrolled severe back pain.
A review of Resident 1’s physician order dated 12/25/2023, indicated to transfer Resident 1 to the GACH ER for uncontrolled severe back pain.
A review of Resident 1’s Transfer Form, dated 12/25/2024 indicated Resident 1 was transferred to the GACH on 12/25/2023 at 10 a.m. for uncontrolled severe back pain.
A review of Resident 1’s Narcotic Prescription Form Long Term Care Facility Patient, indicated a fax confirmation indicating the order for Norco (Hydrocodone-Acetaminophen) refill was faxed to the pharmacy on 12/25/2023 at 3:59 a.m.
A review of Resident 1’s GACH ER records, dated 12/25/2023 and timed at 11:13 a.m., indicated Resident 1’s chief complaint was uncontrolled severe back pain that started on 12/24/2023, and radiated down Resident 1’s right leg. The ER record indicated Resident 1 received IV Morphine to relieve her uncontrolled severe pain.
During a concurrent interview and record review, on 1/11/2024, at 3:34 p.m., with Registered Nurse Supervisor (RNS 1), Resident 1’s MAR dated 12/2023 was reviewed. The MAR indicated on 12/25/2023 Tylenol 650 mg was given at 8:36 a.m., for a pain level of 10 out of 10. RNS 1 stated Tylenol 650 mg was administered to Resident 1 because Norco was not available. RNS 1 stated Norco had been ordered (12/24/2023) and was expected to be delivered to the facility at any time. RNS 1 stated there were six tablets of Norco available in the facility’s E-Kit but because Resident 1 was being transferred to the GACH, she (RNS 1) did not think to call the Medical Director to obtain an order to retrieve Norco from the E-Kit and instead gave Resident 1 Tylenol 650 mg. RNS 1 stated she should have called the Medical Director to get authorization to access the Norco from the E-Kit earlier so that Resident 1’s pain could have been under control sooner.
During an interview on 1/11/2024 at 4:25 p.m., the Assistant Director of Nursing (ADON) stated, when medications are close to running out and get down to approximately 7-10 tablets, a medication order should be placed to refill the medication. The ADON stated in order to obtain a refill for a narcotic, the licensed nurse has to call the physician, the physician then calls the pharmacy to authorize the refill. Then ADON stated if the medication needed to be retrieved from the E-Kit, the licensed nurse has to call the physician, the physician then calls the pharmacy to authorize the medication to be taken from the E-kit, then the pharmacy calls the facility to authorize the licensed nurse to retrieve the medication from the E-Kit. The ADON stated the nursing staff should have ordered Resident 1’s pain medication before it was completely out of stock and called the physician and/or the Medical Director to get access to the Norco in the E-Kit so Resident 1’s pain could be controlled This would have prevented a delay in Resident 1’s pain medication administration and prevented the transfer to the GACH.
During an interview on 1/12/2024 at 12:59 p.m., Licensed Vocational Nurse (LVN 2) stated, it was important to order the pain medication before its quantity became too low, so the facilities staff would not run out of the medication leaving Resident 1 in severe pain. LVN 2 stated she did not realize Resident 1’s pain medication was running out.
During an interview on 1/12/2024 at 4:24 p.m., a Certified Nurse Assistant (CNA 1) stated Resident 1 was in a lot of pain during the night of 12/24/23. The resident was moaning, crying, and had shooting pain down both of her hips. CNA 1 stated he (CNA 1) approached the charge nurse (CN 1) three to four times during her shift (11 p.m.-7 a.m.) to ask if Resident 1’s pain medication had been approved, and the charge nurse told him no it had not.
During an interview on 1/16/2024 at 3 p.m., the Director of Nursing (DON) stated the nurse should have sent the refill order for Norco at least three days ahead, so there was no delay in Resident 1 receiving pain medication.
A review of the facility’s P&P, titled “Medication Orders, Controlled Substance Prescriptions,” dated 8/2019 indicated emergency pharmacy service is available on a 24-hour basis. Emergency needs for medication are met by using the facility’s approved emergency medication supply or by special order from Med-Plus Pharmacy LTC (Long Term Care). Med-Plus Pharmacy LTC supplies emergency medications including emergency drugs, antibiotics, controlled substances, products for infusion in limited quantities in portable, sealed containers in compliance with applicable State regulation. To access medication from the emergency kit secondary to a new order or when medication for which there is a current prescription is not readily available, the nurse confers with the prescriber to determine whether the order is a true emergency., i.e., order cannot be delayed util the scheduled pharmacy delivery. If the medication is a controlled substance, the prescriber either faxes a complete prescription to the facility and pharmacy or communicates the verbal order to both the nurse and directly to the pharmacist along with details about the situation to verify that it meets the criteria of an “emergency situation.”
A review of the facility’s P&P, titled, “Medication Orders, Controlled Substance Prescriptions,” dated 8/2019, indicated if a partial fill quantity of schedule II medication (drugs that require additional care because of the potential for abuse) remains, refills are written on a medication order form or ordered by peeling the top label from the label and placing it in the appropriate area on the order form provided by the pharmacy for that purpose and requested from the pharmacy five days in advance of need to assure an adequate supply is on hand.
The facility failed to:
1. Ensure licensed nurses ordered a refill of Norco 10/325 mg to be available when needed for Resident 1’s moderate to severe pain management before its quantity was depleted
2. Make arrangements for pharmaceutical services when RNS 1 did not request authorization to obtain necessary the medication, Norco 10/325 mg, from the facility’s E-Kit, where six Norco 10/325 mg tablets were available to administer to Resident 1 for severe back pain in order to provide the resident with prescribed drugs.
3. Provide medication and treatment as prescribed when Resident 1 was not medicated to control her severe pain per Resident 1’s care plan and as ordered by Resident 1’s physician.
4. Implement care plan interventions to anticipate Resident 1’s need for pain relief and respond immediately to any complaint of pain and administer analgesics as ordered by the physician.
5. Ensure the licensed nurses followed the facility’s P&P titled, “Medication Orders, Controlled Substance Prescriptions,” to obtain emergency medicati