Laboratorio Clinico Chegar

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on General Immunology (Mycoplasma pneumoniae test) quality control records review from January 16, 2021 to October 7, 2021 and interview with the laboratory supervisor on October 19, 2021 at 10:30 AM, it was determined that the laboratory did not include each day of testing an external positive and negative control material when 332 out of 332 patients specimens were tested and reported for Mycoplasma pneumoniae test from January 16, 2021 to October 7, 2021 . The findings include: a. The laboratory use the Immuno Card Mycoplasma Test Cassette to perform the Mycoplasma pneumoniae qualitative tests. b. On October 19, 2021 at 10:30 AM, review of Mycoplasma pneumoniae quality control and patient results record showed that the laboratory performs patient testing January 16, 2021 to October 7, 2021. The laboratory did not include each day of testing the external control materials. c. The laboratory supervisor confirmed on October 19, 2021 at 10: 30 AM, that the laboratory failed to include each day of testing the external negative and positive control material . She stated that the laboratory run the external control when it received a new kit reagent or shipping. d. The laboratory processed and reported 332 patient samples for Mycoplasma pneumoniae test from January 16, 2021 to October 7, 2021. D6093 LABORATORY DIRECTOR RESPONSIBILITIES 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 -- CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on General Immunology (Mycoplasma pneumoniae test) quality control records review from January 16, 2021 to October 7, 2021 and interview with the laboratory supervisor on October 19, 2021 at 10:30 AM, it was determined that the laboratory director failed to establish the quality control procedures for the Mycoplasma pneumoniae test. Refer to D 5449 (The laboratory did not include each day of testing an external positive and negative control material when 332 out of 332 patients specimens were tested and reported for Mycoplasma pneumoniae test from January 16, 2021 to October 7, 2021). -- 2 of 2 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the proficiency samples testing, patients testing records and interview with the laboratory director on August 29, 2019 at 1:00 PM, it was found that the laboratory did not test the proficiency sample in the same manner as the patient samples. The findings include: a. The proficiency samples testing records for the first immunology testing event of year 2019 was reviewed on August 29, 2019 at 1:00 PM. b. The testing records showed that the HbsAg (Hepatitis B Surface Antigen) proficiency samples numbers 2019-211 and 2019-214 and the Human Immunodeficiency Virus (HIV) sample 2019-211 were repeated three times. c. The patient samples testinrecords showed that the patient's were tested only one time. c. The laboratory director stated that the patient's samples were not routinely repeated three times. Based on review of Proficiency Testing records in Bacteriology and interview with the general supervisor on August 29, 2019 at 12:45 pm, the laboratory failed to test the proficiency testing samples of event 1 2019 in the same manner as patient samples. the findings included: a. Vitek 2 worksheets showed PT sample # p2019633 was test three times on Aug. 6, 2019 at the following hours: 17:11, 18:25, and 17:12. b. Vitek 2 worksheets showed PT sample #p2019634-1 was tested 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 6 -- times on August 8, 2019 @15:18 and August 9, 2019 @16:16 c. Vitek 2 worksheets showed PT sample #p2019634-1, Antimicrobial Sensitivity testing (AST), was tested two times on August 9, 2019 @ 1:13 and August 10, 2019 @1:17. d. Vitek 2 worksheets showed PT sample 2019635-1 was tested two times on August 8, 2019 @ 16:50 and August 9, 2019 @17.03 e. Vitek 2 Worksheets showed PT sample p2019635-1, Antimicrobial Sensitivity testing, was test two times on August 8, 2019 @21:34 and August 9, 2019 @22:16. f. The general supervisor stated she selected a colony from each plate to perform identification and AST. D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on Anti-HCV manufacturer's insert (Abbott) review on August 29, 2019 at 10: 30 AM and lack of performance verification procedures, it was determined that the laboratory failed to meet the requirements for Anti-HCV tests. Refer to: D5423- the laboratory did not establish the performance characteristics of the Anti-HCV test prior to use it with infants and children samples. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on non-routine proficiency testing review and general supervisor interview on August 29, 2019 at 1:45 PM, it was determined that the laboratory failed to have and follow written procedures to verify the accuracy of the sperm motility and morphology since August 2017. The findings include: a. During the survey the written procedures to verify the accuracy of the sperm motility and morphology were requested. b. The general supervisor stated that there were no written procedures to verify the accuracy of the sperm motility and morphology. She also stated that in order to verify the accuracy of the test they used a proficiency testing samples (images) supplied from the WSLH proficiency testing program dated from years 2014 and 2015. The images were being used since year 2017. 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 -- 2 of 6 -- 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)