Children's Clinic Of Rusk, Pllc

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, 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 recertification is recommended. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, the laboratory's American Proficiency Institute (API) proficiency testing records for 2019, 2020 and 2021, and staff interview, it was revealed that the laboratory failed to test proficiency testing samples the same number of times that it would test its patient samples for six of six proficiency testing events reviewed from 2019, 2020, and 2021. Findings include: 1. A review of the laboratory's policy titled 'Horiba Micros 60 Procedure Manual' revealed the following: "Running Patient Samples: - if a flag appears go to Main Menu then to Service and Back Flush- run the sample again" 2. A review of the laboratory's API proficiency testing records from 2019, 2020, and 2021 revealed the following proficiency testing samples had flags on the reports and there was no documentation of the sample being re-run: a) 2019 Hematology/Coagulation second event: HEM-06 Flag: G3 HEM-07 Flag: G1 and G3 HEM-08 Flag: G1 and G3 HEM- 09 Flag: G3 HEM-10 Flag: G3 b) 2019 Hematology/Coagulation third event: HEM- 11 Flag: G3 HEM-12 Flag: G3 HEM-13 Flag: G3 HEM-14 Flag: G3 HEM-15 Flag: L1 and G3 c) 2020 Hematology/Coagulation first event: HEM-01 Flag: G3 HEM-02 Flag: G1 and G3 HEM-03 Flag: G1 and G3 HEM-04 Flag: G3 HEM-05 Flag: G3 d) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 2020 Hematology/Coagulation second event: HEM-06 Flag: G1 and G3 HEM-07 Flag: L1 and G3 HEM-08 Flag: G3 HEM-09 Flag: G3 HEM-10 Flag: G3 e) 2020 Hematology/Coagulation third event HEM-11 Flag: G1 and G3 HEM-12 Flag: L1, G1 and G3 HEM-13 Flag: G3 HEM-14 Flag: G1 and G3 HEM-15 Flag: G1 and G3 f) 2021 Hematology/Coagulation second event HEM-06 Flag: G3 HEM-07 Flag: G1 and G3 HEM-08 Flag: G1 and G3 HEM-09 Flag: G3 HEM-10 Flag: G1 and G3 3. An interview with the technical consultant (as indicated on the CMS 209 form, signed by the laboratory director on 9/6/21) on 9/10/21 at 9:35 a.m. in the break room, after review of the records, confirmed the above findings. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's American Proficiency Institute (API) proficiency test results and staff interview, it was revealed that the laboratory failed to attain a score of at least 80 percent for the analyte White Blood Cell Differential for one of three testing events in 2020. Findings include: 1. A review of the laboratory's API proficiency test results for the 2020 Hematology/Coagulation third event revealed the laboratory received an unacceptable score of 47% for the analyte White Blood Cell Differential. 2. Further review of the laboratory's API proficiency test results for the 2020 Hematology/Coagulation third event revealed the laboratory received a grade of unacceptable for three out of five samples, resulting in a 40 percent for the analyte Monocytes. The following three unacceptable results were submitted: Sample: HEM- 11 Reported result: 13.5 Expected result: 4.5 - 10.0 Sample: HEM-13 Reported result: 24.1 Expected result: 3.9 - 18.8 Sample: HEM-15 Reported result: 13.9 Expected result: 4.9 - 9.6 3. Further review of the laboratory's API proficiency test results for the 2020 Hematology/Coagulation third event revealed the laboratory received a grade of unacceptable for five out of five samples, resulting in a 0 percent for the analyte Lymphocytes. The following five unacceptable results were submitted: Sample: HEM- 11 Reported result: 21.0 Expected result: 22.4 - 30.7 Sample: HEM-12 Reported result: 11.2 Expected result: 11.6 - 15.7 Sample: HEM-13 Reported result: 38.0 Expected result: 43.8 - 60.3 Sample: HEM-14 Reported result: 11.7 Expected result: 12.1 - 16.0 Sample: HEM-15 Reported result: 22.0 Expected result: 24.4 - 32.2 * The 40 percent for Monocytes and the 0% for Lymphocytes constituted the overall score of 47 percent for the analyte White Blood Cell Differential. 4. An interview with the technical consultant (as indicated on the CMS 209 form, signed by the laboratory director on 9/6/21) on 9/10/21 at 9:35 a.m. in the break room, after review of the records, confirmed the above findings. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: I. Based on a review of the laboratory's policies, quality control (QC) records for the Horiba Micros 60 hematology analyzer, and staff interview, it was revealed that the laboratory failed to follow its own written procedure for performing

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: . Based on review of American Proficiency Institute (API) proficiency testing (PT) documentation for 2018 and 2019, confirmed y staff interview, laboratory testing personnel failed to attest to the routine integration of PT samples into the patient workload using the laboratory's routine methods. Findings: 1. API PT documentation for 2018 and 2019 was reviewed. Attestation statements for microbiology, 2nd event 2018 and hematology, 3rd event 2018, though signed by the laboratory director, lacked the signature of the individual performing the test. 2. In an interview at the site on 06-19-2019, testing person 1 (CMS form 209) stated that he had performed the testing in both events but failed to sign the attestation forms. . 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 laboratory procedures, confirmed by staff interview, the laboratory failed to provide a written procedure for operation of the Horiba Micro 60 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- hematology analyzer. Findings: 1. Review of the laboratory procedure manual showed no approved procedure for operation of the Horiba Micro 60 hematology analyzer. On request, the manufacturer's user manual was offered. Review of the user manual revealed no indication of director review or approval. 2. In an interview at the site on 06-19-2019, the clinic manager confirmed that no approved laboratory procedure for operation of the Micro 60 analyzer was available. . D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)