Gmg Pottsville

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Laboratory Director (LD), the laboratory failed to evaluate twice annually the relationship between the automated blood differential (Sysmex XS1000i) and the manual blood differential from 12/21 /2020 to 02/15/2023. Findings: 1. On the day of Survey 02/15/2023 at 12:35 pm, the laboratory could not provide comparison of test results between the automated blood differential (Sysmex XS1000i) and the manual blood differential from 12/21/2020 to 02/15/2023. 2. Review of the CMS116 form showed annual testing for hematology was 13000. 3. The LD confirmed the above finding on 02/15/2023 around 01:35 pm. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the CASPER Report 155 report and graded results from the proficiency testing organization College of American PAthologists (CAP), the laboratory failed to successfully participate in proficiency testing for the analyte Creatinine, and Urea Nitrogen Refer to D2096 and D2097. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from the proficiency testing organization College of American Pathologists (CAP), the laboratory failed to successfully participate in a proficiency testing for the analytes: Creatinine, and Urea Nitrogen which are in the subspecialty of Routine Chemistry. The laboratory had unsatisfactory scores for the 1st and 2nd events of 2021. Findings include: Analyte Year Event Score Creatinine 2021 1 0%. Creatinine 2021 2 0%. Urea Nitrogen 2021 1 0%. Urea Nitrogen 2021 2 0%. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER Report 155 report and graded results from the proficiency testing organization College of American Pathology (CAP), the laboratory failed to achieve an overall testing score of satisfactory performance in the subspecialty Routine Chemistry. The laboratory had unsatisfactory scores for the 1st event of 2021, and 2nd event of 2021. Findings include: Subspecialty Year Event Score Routine Chemistry 2021 1 0% Routine Chemistry 2021 2 0% -- 2 of 2 --