Xyz Medical, Llc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/08/2025. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the general supervisor and specimen processor at the conclusion of the survey. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records, written policies and procedures, and interview with the general supervisor, the laboratory failed to have a written policy to assess the competency of the general supervisor, based on the position responsibilities as listed in Subpart M, for one of one person. Findings include: (1) A review of the laboratory policy and procedure manual identified no evidence of a policy for assessing the competency of the general supervisor, including the frequency of the assessments; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of April 2023 through the current date identified competencies, based on job responsibilities, had not been performed for one of one person listed as the general supervisor; (3) The findings were reviewed with the general supervisor who stated on 01/08/2025 at 10:45 am, a policy had not been written and competencies had not been performed for the position as stated above. 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 D0000 The recertification survey was performed on 03/23,24/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory manager, testing person, and laboratory assistant at the conclusion of the survey. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory director and testing person failed to sign a proficiency testing attestation statement for one of three SARS-CoV-2 Molecular proficiency testing events reviewed in 2022. Findings include: (1) On 03/23/2023 a review of SARS-CoV-2 Molecular proficiency testing records for 2022 identified the following for one of three events: (a) Second COV2-B 2022 Event - The attestation statement had not been signed by the laboratory director and the testing person. (2) The findings were reviewed with the laboratory manager who stated on 03/23/2023 01:25 pm the attestation statement had not been signed by the laboratory director and testing person. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to evaluate the accuracy of testing when proficiency results had not been graded by the proficiency program for one of three MRS5M (Methicillin- Resistant Staphylococcus aureus Screen, Molecular) events reviewed. Findings include: (1) On 03/23/2024 a review of MRS5M proficiency testing records for 2022 identified the following for three of three events: (a) First 2022 Event - Five of five results had not been graded by the proficiency testing program (samples MRSM-01, MRSM-02, MRSM-03, MRSM-04, MRSM-05). There was no documentation to prove the laboratory performed a self-evaluation of the non-graded results; (b) Second 2022 Event - Five of five results had not been graded by the proficiency testing program (samples MRSM-06, MRSM-07, MRSM-08, MRSM-09, MRSM-10). There was no documentation to prove the laboratory performed a self-evaluation of the non- graded results; (c) Third 2022 Event - Five of five results had not been graded by the proficiency testing program (samples MRSM-11, MRSM-12, MRSM-13, MRSM-14, MRSM-15). There was no documentation to prove the laboratory performed a self- evaluation of the non-graded results; (2) The records were reviewed with the laboratory manager who stated on 03/23/2023 at 01:20 pm, the laboratory had not performed a self-evaluation to evaluate the results that were not graded by the proficiency testing program. 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 a review of records and interview with the laboratory manager and testing person, the laboratory failed to verify the accuracy of confirmatory urine drug testing at least twice annually during the review period of June 2021 through the current date. Findings include: (1) On 03/23/2023 at 09:40 am, the testing person stated the laboratory performed confirmatory urine drug testing using the AB Sciex 4500 analyzer; (2) A review of proficiency testing records and interview with the laboratory manager and testing person on 03/23/2023 at 11:40 am confirmed the laboratory did not participate in proficiency testing for the analytes Flurazepam, MDEA (Methyl diethanolamine), Nitrazepam, Tapetadol, and Triazolam; (3) A review of records from June 2021 through the current date identified the above testing had not been verified for accuracy at least twice annually between 06/29/2021 and 09/08/2022; (4) The records were reviewed with the laboratory manager and testing person. Both stated on 03/23/2023 at 01:30 pm, the testing had not been verified for accuracy at least twice annually as shown above. -- 2 of 4 -- D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the testing person, the laboratory failed to ensure the humidity was maintained as required by the manufacturer of the AB Sciex 4500 analyzer for nine of 14 months. Findings include: (1) On 03/23/2023 at 09:40 am, the testing person stated the laboratory performed confirmatory urine drug testing using the AB Sciex 4500 analyzer in the room denoted by the laboratory as "Room 3"; (2) A review of the Operator's Manual on page 34 under the heading, "Humidity Requirements" stated "Relative humidity from 35%-50%"; (3) A review of laboratory humidity records for Room 3 from January 2022 through February 2023 identified the humidity readings were less than 35% for nine of 14 months as follows: (a) January 2022 - 21 of 21 humidity readings were documented as less than 35%; (b) February 2022 - nine of 15 humidity readings were documented as less than 35%; (c) March 2022 - 12 of 23 humidity readings were documented as less than 35%; (d) April 2022 - two of 21 humidity readings were documented as less than 35%; (e) October 2022 - three of 21 humidity readings were documented as less than 35%; (f) November 2022 - eight of 20 humidity readings were documented as less than 35%; (g) December 2022 - 11 of 21 humidity readings were documented as less than 35%; (h) January 2023 - 15 of 20 humidity readings were documented as less than 35%; (i) February 2023 - five of 18 humidity readings were documented as less than 35%. (4) The records were reviewed with the testing person who stated on 03/23/2023 at 03:20 pm, the laboratory humidity in room 3 had not been maintained as required by the manufacturer as shown above. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager and testing person, the laboratory failed to ensure three of three urine centrifuges were functioning properly for during the review period of 2022. Findings include: (1) On 03 /23/2023 at 01:00 pm, the testing person stated the following: (a) Urinary Tract -- 3 of 4 -- Infection (UTI) Panel testing was performed using the Qiagen QiaCube and Roche LC 480 Lightcycler. The following centrifuges were used to process urine specimens for analysis: (i) Thermo Scientific Legend Micro21 - Used in the extraction process for urine specimens at a speed of 14,800 rpm (revolutions per minute) for five minutes; (ii) Eppendorf 5810 - Used to concentrate urines for testing at a speed of 4000 rpm for 10 minutes. (b) Urine Drug Confirmatory testing was performed using the AB Sciex 4500 analyzer and the following centrifuge was used to process urine specimens for analysis: (i) Thermo Scientific ST8 - Used for spinning plates containing urine specimens, calibrators, and standards at a speed of 3700 rpm for 15 minutes. (2) A review of the policy titled, "Centrifuge Use and Maintenance" required the centrifuges be checked on an annual basis; (3) A review of centrifuge records for 2022 identified the following for the checks performed on 12/12/2022: (a) Thermo Scientific Legend Micro21 - Although the centrifuge speed had been checked at 14,798 rpm, there was no documentation the timer had been checked for accuracy; (b) Eppendorf 5810 - Although the centrifuge speed had been checked at 3998 rpm, there was no documentation the timer had been checked for accuracy; (c) Thermo Scientific ST8 - Although the centrifuge speed had been checked at 3699 rpm, there was no documentation the timer had been checked for accuracy. (4) The records were reviewed with the laboratory manager and testing person. Both stated on 02/23/2023 at 02:30 pm, the laboratory had not ensured the centrifuge timers had been checked for accuracy as shown above. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The initial survey was performed on 09/30/2020 and 10/01/2020. The findings were reviewed with the general supervisor at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1447; D6108: Technical Supervisor D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of records and interview with the general supervisor, the laboratory failed to have a written competency policy for the technical supervisor and general supervisor based on the job responsibilities as listed in Subpart M. Findings include: (1) On 09/30/2020, surveyor #2 reviewed personnel records for competency assessments performed during 2019 through 09/30/2020. There was no evidence competencies had been performed for the technical supervisor and general supervisor based on their job responsibilities; (2) On 10/01/2020, surveyor #2 asked the general supervisor if a written policy to evaluate the positions based on job responsibilities was available and if competencies had been performed during the review period. The general supervisor stated on 10/01/2020 at 1:15 pm a policy to evaluate the clinical consultant based on job responsibilities had not been written; and competencies had not been performed. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on a review of the procedure manual and interview with the general supervisor, the laboratory failed to have a written procedure for specimen submission, handling and processing of turbid specimens for urine drug confirmatory testing. Findings include: (1) On 09/30/2020, surveyor #1 reviewed the sections of the procedure manual titled, "LCMS" and "General Laboratory Operations". A specimen submission, handling and processing procedure could not be located for how to submission, handling, and processing of turbid specimens received in the laboratory for testing; (2) Surveyor #1 explained to the general supervisor, that a specimen submission, handling and processing procedure could not be located. The general supervisor stated on 09/30/2020 at 03:45 pm that a procedure had not been written. 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 a review of a written policy and procedure manual and interview with the general supervisor, the laboratory failed to have written procedures that explained the current practices and procedures of stock solution preparation being perfomed in the laboratory for urine drug confirmatory testing. Findings include: (1) On 09/30/2020 at 01:00 pm, the general supervisor stated urine drug confirmatory testing was performed using the AB Sciex 4500 analyzer; (2) Surveyor #2 reviewed the manual titled, "LCMS Guide Standard Operation Procedure: XYZ Panel-55 section titled, "Stock Solution Preparation", stated the following: (a) "....Total volume of combined stocks at the step is 10.34 mL of solution in Methanol." (b) "Complete to 20 mL by adding 9.66mL of Methanol into the tube." (c) "Vortex to mix." (3) On 10/01/2020 surveyor #2 was not able to locate a vortex in the laboratory. Surveyor #2 asked the general supervisor if the solution was vortexed. On 10/01/2020 at 10:10 am the general supervisor stated the solution was inverted not vortexed as indicated above. 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 12 -- 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)