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Based on interview and record review, the facility failed to ensure critical test results were communicated to the physicians and were properly documented in accordance with the facility's policies and procedures, for two of 34 sampled patients (Patients 7 and 8).

This failure had the potential to lead to delayed intervention and treatment of patients with laboratory results that required immediate clinical attention.

Findings:

1. A review of Patient 7's "History and Physical (H&P)," dated September 18, 2023, conducted on September 27, 2023, at 2:25 p.m., indicated Patient 7 was admitted with diagnoses which included sepsis (a life-threatening illness caused by the body's response to an infection) and a moderate and large right pleural effusion (a buildup of fluid around the right lung lobe). The "H&P" further indicated Patient 7's white cells blood (WBC, normal is between 4,000 and 11,000 cells per microliter [unit of measurement], increased WBCs may indicate an injury or infection) was 28.2 cells per microliter.

A concurrent interview and record review on September 28, 2023, at 2:25 p.m., was conducted with Director of Nursing (DON) 1. An untitled document indicating Patient 7's laboratory flowsheet for critical laboratory results from September 18, 2023 through September 28, 2023, was reviewed. The document indicated, "...9/26/2023 [September 26, 2023] 0901 [9:01 a.m.]...Critical Lab [laboratory result]...YES...WBC...33.6..." The document indicated the field on the flowsheet indicating "Provider Notified [Time]" was blank.

There was no documented evidence when the physician was notified of the critical WBC laboratory result for Patient 7 on September 26, 2023.

DON 1 stated, per policy, the staff who receives the critical lab value is required to document the result, the time the result was received, who received the result, the physician's name, and time the physician was notified.

2. A review of Patient 8's "History and Physical (H&P)," dated September 13, 2023, conducted on September 27, 2023, at 3:26 p.m., indicated, Patient 8 was admitted for STEMI (ST-segment elevation myocardial infarction, a severe type of heart attack that requires rapid diagnosis and treatment to reduce the risk of death and permanent injury).

A concurrent interview and record review on September 28, 2023, at 10:10 a.m., was conducted with the DON 1. An untitled document showing Patient 8's laboratory result flowsheet for critical laboratory results, from September 8, 2023 through September 27, 2023, was reviewed. The document indicated,

- "...9/23/2023 [September 23, 2023] 0352 [3:52 a.m.]...Critical Lab...YES...TROPONIN [a protein released into the bloodstream during a heart attack]...821 [normal is less than or equal to 15 pg/ml (picograms per milliliter, unit of measurement) for females and less than or equal to 20 pg/ml for males]..." The document indicated the fields on the flowsheet indicating "Provider Notified [Last Name, First Initial]" and "Provider Notified [Time]" were blank;

- "...9/23/2023 0900 [9 a.m.]...Critical Lab...YES...TROPONIN...824..." The document indicated the fields on the flowsheet indicating "Provider Notified [Last Name, First Initial]" and "Provider Notified [Time]" were blank; and

- "...9/23/2023 0942 [9:42 a.m])...Critical Lab...YES...TROPONIN...855..." The document indicated the fields on the flowsheet indicating "Provider Notified [Last Name, First Initial]" and "Provider Notified [Time]" were blank.

There was no documented evidence a physician was notified of the critical troponin results of Patient 8 on September 23, 2023.

DON 1 verified there was no documentation the physician was notified of the critical laboratory results for Patient 8 on September 23, 2023, at 3:52 a.m., 9 a.m., and 9:42 a.m. DON 1 stated there was no documentation a physician was notified about the critical laboratory results during the dates and times indicated. DON 1 stated the staff who received the critical laboratory results should notify the physician and document notification of the critical laboratory results in the patient's medical record per the facility's policy.

A review of the facility's policy and procedure (P&P) titled, "Reporting Critical Results of Tests and Diagnostic Procedures by Telephone and Verbally," revision date of December 2022, indicated, "...Policy...Notification to responsible caregiver (physician/practitioner) of critical results of tests will be done within one hour or sooner if possible, by the caregiver receiving the results...Purpose...This policy is designed to enhance patient safety by establishing guidelines to ensure that there is a process for identifying critical test results which require prompt notification to the responsible caregiver of abnormal results that may indicate a life-threatening situation...Responsibilities of the Person Receiving the CR [critical result] of tests...The nurse shall document in the medical record the test results received, the time the physician was notified, and the orders (if applicable) received, or the actions taken...The physician is to be notified within one hour..."

Based on observation, interview, and record review, the facility failed to ensure all controlled substances received by the Pharmacy was accurately tracked and any discrepancies in the count of controlled substances were promptly identified and reconciled.

The inventory count of one injectable medication, midazolam (medication used for sedation) 100 milligram (unit of measurement) in 100 milliliter (unit of measurement) of normal saline (a type of fluids administered through the vein) was identified as not accurate since March 2023 and was not resolved.

This failure had the potential for loss and diversion of controlled substances.

Findings:

On September 27, 2023, at 8:30 a.m., the Pharmacy was toured. In the Pharmacy Narcotic Room, it was noted there were two boxes outside the Pyxis CII Safe (Automated drug dispensing device for secure storage and dispensing of federally scheduled controlled substances) containing 147 infusion bags of midazolam 100 mg per (in) 100 ml in normal saline.

The review of the inventory record indicated there should have been 162 bags instead of 147 bags, a difference of 15 bags of midazolam.

Review of the document titled, "Review Discrepancy Resolution Report," for midazolam showed four discrepancies were identified and resolved on March 3, 2023, April 28, 2023, May 2, 2023, and September 1, 2023.

In an interview on September 27, 2023, at 10:15 a.m., conducted with the Director of Pharmacy (DOP), the DOP stated the overstock midazolam bags were stored outside the CII Safe due to storage space inside it. The DOP stated the Pharmacy kept a separate inventory for overstock midazolam from the working inventory.

The DOP further explained the Pharmacy received the preservative free (PF) midazolam bags instead of non-PF midazolam which was mixed and counted as one product. The DOP stated the Pharmacy was in the process of separating the inventory of the PF midazolam and non-PF midazolam bags.

In an interview on September 28, 2023, at 9:20 a.m., conducted with the DOP, the DOP stated Pharmacy Supervisor (PS) 1 was clearing the above discrepancies in midazolam count instead of correcting the transactions which was not the right process. Also, the DOP stated PS 1 was not resolving the discrepancies with a witness.

The DOP stated PS 1, in June 2023, fixed the midazolam discrepancies which remained unresolved. The DOP stated he had to follow up with PS 1 weekly since the end of July.

The DOP also stated the secured (overstock) inventory of midazolam was not maintained until the end of July, when the Pharmacy started taking inventory of secured stock monthly.

The hospital's policy and procedure titled, "Pyxis Procedures: Monitoring Controlled Substances Usage Patterns (e.g., Pandora, CII-Safe)," last reviewed April 2021, indicated, "...The Inpatient Pharmacy Director has oversight over the disposition and use of controlled substances in the hospital and has the ultimate responsibility to ensure all issues associated with the storage, dispensing, and administration of medications are resolved..."

The hospital's policy and procedure titled, "Pyxis Procedures: CII Safe Medication Access - Resolving Discrepancies," last reviewed April 2021, indicated, "...A discrepancy is created when the CII Safe expected count does not match the actual, physical count of the medication. When a discrepancy is discovered, a discrepancy bulletin will print, and the use should correct the discrepancy as soon as possible...CII Safe discrepancies may be resolved using three methods/features of the system...Recount the medication...Run the Vault Access report...Determine the transaction where the discrepancy was created...Reverse the transaction...
If the cause of the discrepancy is unknown, the Resolve Discrepancy feature should be used immediately. This feature is not to be used simply to change the count and explain the problem...Only the CII Safe system SuperUsers, Managers, and System Administrators have access to the Resolve Discrepancy feature...This feature should be used as a last alternative only and is to be used in conjunction with the DEA form 106 to report the loss of a controlled substance to the DEA..."