Mycare Medical Of Texas, Pllc

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, review of patient test records, and staff interview, it was revealed the laboratory failed to follow its own policy for addressing flags on complete blood count (CBC) results for 4 of 30 patient results reviewed from June 1, 2022 to July 13, 2022. The findings include: 1. A review of the laboratory's policy titled "Actions Protocol for WBC Differential FLAGS" (signed by the laboratory director on 12/20/2020) stated: "...If the flags persist, then send an EDTA tube that may be transported for testing at a reference laboratory." and; "Alternate Action: The auto diff section exhibiting the flags may be blocked off and not reported. The provider will make assessment of the patient without that portion of the report only using the hemogram parameters." 2. A sampling of 30 patient test results from June 1, 2022 to July 13,2022 identified the following patient results with flags for which the laboratory did not have documentation of sending out to the reference laboratory or crossing out the flags prior to their release to the healthcare provider according to its own policy: a) test date: 06-15-2022 Sequence #: 80 Patient initials: RM Flagged results: GRA %: OM MID %: OM LYM%: OM GRAN: OM MID: OM LYM: OM b) a) test date: 07-06-2022 Sequence #: 1495 Patient initials: CG Flagged results: GRA %: BD MID %: BD LYM%: BD GRAN: BD MID: BD LYM: BD c) a) test date: 07/07/2022 Sequence #: 1553 Patient initials: MG Flagged results: GRA %: BD MID %: BD LYM%: BD GRAN: BD MID: BD LYM: BD d) a) test date: 07-07- 2022 Sequence #: 1596 Patient initials: JV Flagged results: GRA %: BD MID %: BD LYM%: BD GRAN: BD MID: BD LYM: BD 3. An interview with the technical Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- consultant on 07/14//2022 at 10:30 hours in the conference room - after her review of the records- confirmed the findings. Key: WBC - white blood cell EDTA - ethylenediaminetetraacetic acid -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representatives at the entrance and exit conferences. The facility representatives were given an opportunity to provide evidence of compliance with the noted deficiency, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and certification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCY: D6063 - 42 C.F.R. 493.1412 Condition: Testing Personnel; moderate complexity Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representative was given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. Note: The CMS- 2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the