Summary:
Summary Statement of Deficiencies D0000 Based upon the onsite initial survey conducted 08/09/2021, this facility was found NOT to be compliance with CLIA regulations found at 42 CFR for the specialties /subspecialties in which it was surveyed. 493.1421 Condition: Laboratories Performing Moderate Complexity Testing; Testing Personnel The laboratory director was advised the laboratory was out of compliance and advised of conditions and deficiencies found during the survey. An opportunity for questions and comments was provided. Note: the last day of this survey was 08/28/2021 due to requested documentation provided on that date via electronic mail. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of QC records and in interview with the laboratory director, the laboratory failed to retain FastPak System Control Range cards (included Testosterone QC ranges) for 1 of 4 control kit lot numbers in 2021. Findings included: 1. Review of Testosterone QC records analyzed on FastPack IP System Qualigen from 2019 through 2021 revealed the laboratory had used a total of four (4) control kits. The laboratory did not retain FastPak System Control Range card (with QC ranges) provided by the manufacturer for the following QC set: Lot #2001037 (Control 1) and Lot #2001038 (Control 2) - used between 02/2021 and 06/2021 2. During an interview on 08/09/2021 at 3:15 pm, the laboratory director stated FastPak System Control Range cards should be retained. The QC ranges card was not provided for the above QC set. D5439 CALIBRATION AND CALIBRATION VERIFICATION Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, calibration verification records, and in interview with the laboratory director, the laboratory failed to perform and document calibration verification for FastPack IP System Qualigen analyzers at least once every 6 months for 07/2020 and 01/2021. Findings included: 1 .Review of FastPack IP System Qualigen Testosterone manufacturer's instructions stated, "Every 6 months, verify calibration of the FastPack IP System using the FastPack Testo Method Verification Kit to verify that calibration is accurate to the limits of the reportable range specific by Qualigen, Inc." 2. Calibration verification records for FastPack IP System Qualigen analyzers, "Analyzer #1218" and "Analyzer #1220", revealed the last documented calibration verification was 01/2020. The laboratory had not performed and documented calibration verification every 6 months (07/2020 and 01 /2021) for the FastPack IP System Qualigen analyzers. 3. During an interview on 08 /09/2021 at 3:30 pm, the laboratory director confirmed the laboratory had not performed and documented calibration verification since 01/2020. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Individualized Quality Control Program (IQCP), quality control (QC) records, patient records, and in interview with staff, the laboratory reported 33 patient Testosterone test results when QC did not meet criteria for acceptability on the FastPack IP System Qualigen for 3 of 13 days reviewed on 11 /2019, 01/2020, and 02/2020. Findings included: 1. Review of the laboratory's IQCP -- 2 of 7 -- for the frequency of QC included analyzing two levels of QC material for Testosterone every 7 days. 2. Review of FastPack IP System Qualigen "Analyzer #1218" QC records from 11/2019 through 02/2020 revealed the following days Testosterone QC was not within the criteria for acceptability (QC range) and patient test results were reported: 11/05/2019 at 11:33 am- Control 2 (Lot #1809007) result was 448 ng/dL (manufacturer range: 460 - 1,060 ng/dL) and 9 patients were analyzed and reported between 11/06/2019 through 11/12/2019 (next acceptable QC run was on 11/13/2019). 01/29/2020 at 10:31 am - Control 2 (Lot #1809007) result was 1,064 ng /dL (manufacturer range: 460 - 1,060 ng/dL) and 24 patients were analyzed and reported between 01/29/2020 through 02/11/2020 (next acceptable QC run was on 02 /12/2020). 02/05/2020 at 9:17 am - Control 1 (Lot #1910047) result was 370 ng/dL (manufacturer range: 140 - 340 ng/dL) and 16 patients were analyzed and reported between 02/05/2020 through 02/11/2020 (next acceptable QC run was on 02/12 /2020). QC was not repeated and there was no documented