Androlab Inc

Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Quality Control (QC) procedures; (QC) records; patients' test records; patient test reports; and interview with testing personnel #3 as listed on Laboratory Personnel Report (Form 209), the laboratory failed to perform QC at least once a day patient specimen is examined. Findings: 1. QC procedures reads as follows: "On the day of semen analysis thaw both QC vials and determine sperm concentration using a makler." 2. Review of QC records revealed that there was no QC performance of semen analysis on 05/05/2020. 3. On January 13, 2021 at 11:00 AM, the surveyor reviewed 6 patient test records along the corresponding QC records for the dates of patient testing. There was no documentation to show QC performance on 05/05/2020 for 1 of 6 patients whose test results were recorded and reported on 05 /05/2020. 4. On January 13, 2021 at 11:30 AM, testing personnel #3 (as listed on Form 209) confirmed the surveyor's findings. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. 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 -- This STANDARD is not met as evidenced by: Based on review of the lab's test volume; procedures manual; patient testing logs; patient work sheets; quality control (QC) records; patient test reports; and interview with testing personnel #3 as listed on Laboratory Personnel Report (Form 209), the laboratory failed to assess and correct problems identified in the post analytic systems specified in 493.1291. Findings include: 1. The laboratory listed an annual test volume of 46 on its application for CLIA Certification. 2. In a procedure titled, "QUALTIY ASSURANCE PLAN," it reads as follows: "Perform a random audit of patient record and review work sheet with the final report for pre-analytical, analytical and post-analytical documentation." 3. On January 13, 2021, the surveyor selected 6 random patients names from the patient testing logs. 4. The following information is documented on the patients work sheets for Macroscopic Analysis: a. Complete Liquification (Yes/No) b. Color: Pearl White, Yellow, Reddish c. Viscosity: Normal, Slight, Marked d. Volume 5. Review of corresponding work sheets for the 6 patients names selected by the surveyor revealed, an incorrect date of 05/05/2020 was entered on the worksheet of 1 of 6 patients work sheets reviewed. According to the patient testing log, the date should have been entered as 05/06/2020. 6. Review of 6 patients test reports revealed, there is no documentation to show that the laboratory recorded the results of "Complete Liquification" for 4 of 6 patients test reports reviewed. 7. On January 13, 2021 at 12:30 PM, testing personnel #3 confirmed the surveyor's findings. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of laboratory records and interview with testing personnel (TP) #1; the laboratory failed to test proficiency testing (PT) samples the same number of times as patient samples for 1 of 2 PT events in 2017 for the specialty of hematology. Findings Include: 1. Review of American Association of Bioanalysts (AAB) Sperm Count PT records from event 2 of 2017 found documentation of the PT samples being performed in duplicate by two different testing personnel (TP#2, TP#3) on 11-8-2017. 2. Review of the laboratory procedure, "Proficiency Testing (PT)", stated "All proficiency testing will be conducted as if it were an unknown patient sample." 3. Interview with TP#1 on survey date 10-23-2018, at 2:20 pm, confirmed patient samples are not tested in duplicate by multiple testing personnel routinely and the PT procedure was not followed for AAB PT event 2, 2017, sperm counts. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) 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 establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. 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 -- This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory records, and interview with testing personnel (TP) #1; the laboratory failed to establish a maintenance protocol for the Gilson Pipetman P100 (Identification # N-1874) and document the calibrations of the pipette to ensure accurate and reliable test performance for hematology testing. Findings Include: 1. Direct observation on 10-23-2018, at 11:45 AM, identified a Gilson Pipetman P100 (Identification # N-1874) pipette. 2. Interview with TP#1 on 10-23-2018, at 11:45 AM, confirmed the pipette is used for is used for semen analysis testing performed in the laboratory. 3. Review of the laboratory's policy and procedure manual failed to identify a maintenance protocol for the Gilson Pipetman P100 (Identification # N-1874) pipette. 4. On survey date 10-23-2018, at 12:25 PM, TP#1 confirmed no maintenance protocol had been established for the Gilson Pipetman P100 (Identification # N-1874) and no calibrations had been documented. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require