HospitalInspections.org

Based on review of documentation, the Facility neglected a patient when they failed to prevent patient harm or follow current standards of safe practice [ the Facility uses American Society of Health System Pharmacists (ASHP)] by way of giving a patient with chronic kidney disease (CKD) Toradol 60mg IM to Patient #9 without reviewing Patient #9's creatinine clearance or (glomerular filtration rate) GFR level.


The Findings were:
Review of the client record for Patient #9 on April 20, 2022, who has documented chronic kidney disease (CKD) and is chronically taking a diuretic [which is a known contributor in volume depletion], Toradol 60mg IM was given on April 20, 2022 without reviewing his creatinine clearance or (glomerular filtration rate) GFR level.


There is no documentation in Patient #9's record from April 20, 2022 of a creatinine clearance level or GFR being obtained. Record reviews of prior charts noted that Patient #9's last creatinine clearance level or GFR were obtained in November 2020. A further review of the client record for Patient #9 on April 29, 2022 revealed that Patient #9 suffered an Acute Kidney Injury (AKI) that can be correlated to the administration of the Toradol given on April 20, 2022 and the subsequent discharge medication, Indocin (an NSAID, or non-steroidal anti-inflammatory drug). The treating physician notes, in part, in the History and Physical, "He [Patient #9] reports a baseline creatinine of around 2.4 (last checked April 1 at [nephrologist's] office ...He [Patient #9] came here on April 20 and saw a nurse practitioner who gave him Toradol and prescription for indomethacin. He [Patient #9] took only about 5 days of the indomethacin and started feeling bad .....He [Patient #9] stopped taking those medications and spoke with [his nephrologist] who wanted him to come in for lab work ..."


The Standards utilized by this Facility are those of the American Society of Health System Pharmacists (ASHP) according to the Facility's Policy titled, "Adverse Drug Reaction and Medication Errors." Per ASHP guidelines on page 533 (copy included in this packet), "Ketorolac is contraindicated in patients with advanced renal impairment and in those at risk for renal failure due to volume depletion. If Cr Cl [creatinine clearance] is 10-29 mL/min, give 50% of the usual dose, and if Cr Cl is <10 mL/min, give 25% to 50% of the usual dose." An online review of ASHP guidelines on "Renal Dosing Concepts, sample chapter on page 5365", which states in part, "Renal function (Cr Cl and CRRT) clearance are required for dose individualization .... Dose reductions may be required in patients with CKD [chronic kidney disease] to avoid systemic accumulation and adverse drug events ..... based on the degree of reduction in Cr Cl ...."


In an interview with Staff #16 and #17 on the morning/afternoon of 01/03/2023, Staff # 16 and #17 verified that Patient #9 received the Toradol dose without the Pharmacist, Provider, or Nurse reviewing Patient #9's renal function. A further review of Patient #9's prior records shows that the last serum creatinine level or GFR level for Patient #9 prior to April 20, 2022's ED visit was from 2 years prior to the April 20, 2022's ED visit in November of 2020. The serum creatinine level was 2.59 and the GFR level was 26 at that time.

Based on a review of documentation and interviews with the Facility Staff, the Facility failed to adhere to its policy regarding preventing medication errors or follow acceptable standards of practice [the Facility uses American Society of Health System Pharmacists (ASHP)] by way of giving a patient with chronic kidney disease (CKD) Toradol 60mg IM to Patient #9 without reviewing Patient #9's creatinine clearance or (glomerular filtration rate) GFR level.


The Findings were:
Review of the client record for Patient #9 on April 20, 2022, who has documented chronic kidney disease (CKD) and is chronically taking a diuretic [which is a known contributor in volume depletion], Toradol 60mg IM was given on April 20, 2022 without reviewing his creatinine clearance or (glomerular filtration rate) GFR level.


According to the Facility's Policy titled, "Adverse Drug Reaction and Medication Errors", the Facility utilizes (American Society of Health System Pharmacists) ASHP guidelines. Per ASHP guidelines on page 533 (copy included in this packet), "Ketorolac is contraindicated in patients with advanced renal impairment and in those at risk for renal failure due to volume depletion. (2) If CrCl is 10-29 mL/min, give 50% of the usual dose, and if CrCl is <10 mL/min, give 25% to 50% of the usual dose."


Review of the Facility's records from the Automated Pharmacy System showed that the automated Pharmacy system authorized the dose of Toradol for Patient #9 without having a current creatinine clearance or GFR level obtained.


Review of an emailed "Clinical Review" from the Pharmacy Director/Staff #15 (the review was done on January 4, 2023 while this investigation was in progress), revealed that Staff #15 used a serum creatinine level and GFR level dated 9 days, 10 days, and 7 months after the medication error in its review. This Clinical Review" also notes that "ketorolac is contraindicated with GFR ? 30ml /mL/min and can contribute to acute kidney injury."


In an interview with Staff #16 and #17 on the morning/afternoon of 01/03/2023, Staff # 16 and #17 were asked, "What is the process with your pharmacy for verifying practitioner or physician orders for Toradol?" Staff #17 replied, "it is an automated system that uses an algorithm. I will print out an email in which the pharmacy completed a Clinical Review for the administration of Toradol to [Patient #9]. I received an email of the process from the pharmacy Director [Staff #15] by email. I will print it for you." It was noted that the serum creatinine level and GFR levels for Patient #9 were from after the date of his initial care [April 20, 2022]. This was pointed out to Staff #16 and #17 and both were asked how this could be possible. Staff #17 called Staff #15. Staff #17 then said, "The system couldn't find a creatinine level, so it auto approved the orders without it. "Staff #15 and Staff #17 were then asked, "Is this a system error?" Staff #17 replied, "I asked [Staff #15] about that. She [Staff #15] said that they [the Facility] would be modifying the process to put a stop to auto authorization of this type in future." A further review of Patient #9's prior records shows that the last serum creatinine level or GFR level for Patient #9 prior to April 20, 2022's ED visit was from 2 years prior to the April 20, 2022's ED visit in November of 2020. The serum creatinine level was 2.59 and the GFR level was 26 at that time.

Based on a review of documentation and interviews with the Facility Staff, the Facility failed to adhere to its policy regarding medication errors by way of not reporting a preventable event involving an administration error with serious consequences to Patient #9 to the attending physician, the hospital-wide Quality Assessment and Performance Improvement (QAPI) program, or identify systems vulnerabilities that could have prevented the drug administration.


The Findings were:
Review of the Facility's "Medication Variances" for March through May of 2022 revealed that giving Patient #9, who has documented chronic kidney disease (CKD) and is chronically taking a diuretic [diuretics are known contributors to volume depletion in all patients, not just renal patients], without reviewing his creatinine clearance or (glomerular filtration rate) GFR level was given Toradol 60mg IM and this was not reported as a medication variance.


Review of the Facility's QAPI records for 2022 revealed that the medication variance which was not reported was also not reviewed by the Facility's QAPI Committee.


Beginning on page 1 and ending on page 2 of the Facility's Policy titled, "Adverse Drug Reaction and Medication Errors" that was last revised on 10/2022, the policy stated, in part,

" .....
Policy:
A. All adverse drug reactions, medication errors and near misses shall be reported and reviewed in accordance with this policy .....


Definition:
D. Medication Error: Any preventable event that may cause or lead to inappropriate medication use or patient harm. The definition spans the entire scope of medication use. With this definition, an error does not have to reach the patient to be reportable .....


Procedure:
A. Upon the occurrence of all actual or potential drug reactions or medication errors, the following actions should occur:
1. Notify the provider immediately for further instructions or follow-up or supportive treatment. The offending medication shall not be administered until clarification has been obtained by the provider.
2. Nursing shall monitor the patient for signs and symptoms or reactions and immediately notify physician of any unexpected changes.
3. Nursing should update the ADR and/or allergy information in the eMAR as appropriate.
4. The caregiver that observed the ADR, medication error or near miss should submit a variance through the event reporting system before the end of the shift ... ...


Review of ADR's, Medication Errors, and Near Misses:
2. Once the variance is entered, all relevant departments shall review the risk notification report for accuracy and completeness ....
3. Pharmacy will trend and report all ADR's, medication errors, and near misses to the Pharmacy and Therapeutics (P&T) Committee. An annual summary will be presented to the Medical Executive Board ....."


Review of the Facility's record from the Automated Pharmacy System showed that the automated Pharmacy system authorized the dose of Toradol for Patient #9 without having a current creatinine clearance or GFR level obtained.


Review of an emailed "Clinical Review" from the Pharmacy Director/Staff #15 (the review was done on January 4, 2023 while this investigation was in progress), revealed that Staff #15 used a serum creatinine level and GFR level dated 9 days, 10 days, and 7 months after the medication error in its review. This Clinical Review" also notes that "ketorolac is contraindicated with GFR ? 30ml /mL/min and can contribute to acute kidney injury."


In an interview with Staff #16 and #17 on the morning/afternoon of 01/03/2023, Staff # 16 and #17 were asked, "What is the process with your pharmacy for verifying practitioner or physician orders for Toradol?" Staff #17 replied, "it is an automated system that uses an algorithm. I will print out an email in which the pharmacy completed a Clinical Review for the administration of Toradol to [Patient #9]. I received an email of the process from the pharmacy Director [Staff #15] by email. I will print it for you." It was noted that the serum creatinine level and GFR levels for Patient #9 were from after the date of his initial care [April 20, 2022]. This was pointed out to Staff #16 and #17 and both were asked how this could be possible. Staff #17 called Staff #15. Staff #17 then said, "The system couldn't find a creatinine level, so it [the automated system] auto approved the orders without it [the serum creatinine level]." Staff #16 and Staff #17 were then asked, "Is this a system error?" Staff #17 replied, "I asked [Staff #15] about that. She [Staff #15] said that they [the Facility] would be modifying the process to put a stop to auto authorization of this type in future." A further review of Patient #9's prior records shows that the last serum creatinine level or GFR level for Patient #9 prior to April 20, 2022's ED visit was from 2 years prior to the April 20, 2022's ED visit in November of 2020. The serum creatinine level was 2.59 and the GFR level was 26 at that time.