HospitalInspections.org

Based on document review and interview, it was determined that for 6 of 11 clinical records (Pt #11, Pt #12, Pt #13, Pt #14, Pt #15, & Pt #35 ) reviewed for patients who's labs required a pathology review (hematology and body fluids), it was determined that the Hospital failed to adhere to policy, by ensuring that the pathology review was confirmed by a licensed pathologist, as required.

Findings include:

1. The Hospital's policy titled, "Cerebrospinal Fluid and Other Body Fluids with WBC Diff Count" (dated 6/28/2021), was reviewed on 2/7/2022, and required, "Biological fluids arise from many sources ...Cell counts and chemical tests performed on body fluids provide diagnostic information concerning disease and treatment ...Reporting results ...All questionable cells [outside of range] should be shown to the lead technologist and to the pathologist for confirmation. A comment must be entered into the hospital computer that the slide was reviewed by the pathologist ..."

2. On 2/7/2022, the clinical records (Pt #15 and Pt #35) of patients that required a "Body Fluid Worksheet" for non-critical labs, were reviewed. Pt #15's form (dated 11/19/21) indicated that Peritoneal Body Fluid was obtained for lab processing. Pt #35's form (dated 11/16/21), included CSF (cerebrospinal) fluid for lab processing. E #1 (Clinical Laboratory Manager) stated that both Pt #15 and Pt #35 had questionable labs and that is why the form was completed. The lab processing for both patients was performed by the technician and then co-signed by E #1. The clinical records for Pt #15 and Pt #35, lacked signatures from the Pathologist indicating review and confirmation of the lab.

3. On 2/7/2022, four clinical records (Pt #11, Pt #12, Pt #13, & Pt #14), were reviewed for patients with non-critical labs that required an additional "Hematology Slide for Pathology Review" form to be completed. According to E #1, these forms are to be completed as an additional review for patients that labs come back "questionable" and require a Pathologist review. Pt #11's form (dated 11/17/2021), and documented by E #1 on 12/6/2021, included, "Moderate Left Shift (could indicate presence of infection or inflammation)." Pt #12' s form (dated 11/20/2021) and documented by E #1 on 12/7/2021, included, "Toxic granulation (could indicate bacterial infection or inflammation)...Consistent with tech manual count." E #1 stated that the Pathologist (MD #1) usually reviews the Hematology Pathology form, but he has been reviewing them in MD #1's absence. The four clinical records reviewed, included signatures from E #1, and lacked the required Pathologist's signature. MD #1 was present in the hospital after 12/7/2021.

4. The Clinical Laboratory Manager's job description was reviewed on 2/8/2022. E #1's job description did not include reviewing and signing "questionable" lab results, without obtaining the Pathologist's final review.

5. On 2/8/2022 at 9:40 AM, an interview was conducted with the Chief Medical Officer (MD #2). MD #2 stated that there are labs and specimens (including the "Hematology Slide for Pathology Review" and the "Body Fluid Worksheet") that are required to be reviewed by the Pathologist. MD #2 stated that if the results are not critical, then they could be signed off by the Pathologist when he does come in. MD #2 stated that if these forms are reviewed by the Clinical Lab Manager (E #1), then the forms should also be co-signed by the Pathologist when he comes in.

6. On 2/8/2022 at 11:40 AM, an interview was conducted with a Pathologist (MD #3/newly contracted). MD #3 stated that, regarding reviewing "questionable" labs, this should be done by the Pathologist.