Montgomery Mens Health, Llc

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 a review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with the Director of Compliance (DoC), the laboratory failed to ensure the Laboratory Director (or designee) and the analyst signed the PT attestation statements. This was noted for one of the six events reviewed from 2023- 2025. The findings include: 1. A review of the 2023-2025 API PT records revealed the Laboratory Director (or designee) and the analyst did not sign the attestation statement for the 2024 Chemistry Core 3rd Event. 2. The DoC confirmed the above findings during the exit conference on 05-08-2025 at 1:30 PM. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 -- This STANDARD is not met as evidenced by: Based on a review of the 2023-2025 Daily Environmental and Quality Control (DEQC) logs, and an interview with the Director of Compliance (DoC), the laboratory failed to ensure room temperature, refrigerator temperature and humidity were recorded each day of patient testing. The surveyor noted the room temperature, refrigerator temperature and humidity were not recorded for two of the 31 days in January 2024. The findings include: 1) A review of the January 2024 DEQC log revealed the laboratory failed to monitor and record the temperature, refrigerator temperature and humidity of the laboratory on 01-17-2024 and 01-18-2024 when nine patients tests were performed. 2. A further review of the January 2024 DEQC log revealed the laboratory's specified acceptable ranges, as follows: A) RT (15-32 degrees Celsius) B) Humidity (10-80 Percent) C) Refrigerator (2-8 degrees Celsius) 3) The DoC confirmed the above findings during the exit conference on 05-08-2025 at 1: 30 PM. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 the Qualigen Fast Pack System (QFPS) Testosterone calibration procedure, the Calibration-Verification (C-V) records, and an interview with the Director of Compliance (DoC), the laboratory failed to perform and document C-V procedures at least once every six months as required by CLIA regulations. The surveyor noted no documentation for three of the five C-Vs due from 2023-2025. The findings include: 1. A review of the QFPS calibration procedure revealed Testosterone was calibrated with one calibrator. All analytes calibrated with less than three calibrators must have a semi-annual C-V, as per CLIA regulatory requirements. 2. A review of the Testosterone records revealed documentation of C-V's performed on 03- 31-2023 and 02-29-2025 only. There was no documentation of Testosterone C-V due during the following periods: A) September 2023 B) March 2024 C) September 2024 3. During an interview on 05-08-2025 at approximately 11:34 AM, the DoC stated the previous laboratory management failed to ensure C-Vs were performed every six months, as per CLIA requirements. D5445 CONTROL PROCEDURES -- 2 of 4 -- CFR(s): 493.1256(d)(1)(2)(g) (d) 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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493. 1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on reviews of the Qualigen Fast Pack System Quality Control (QC) logs, the laboratory's Individual Quality Control Plan (IQCP) and an interview with the Director of Compliance (DoC), the laboratory failed to ensure two levels of QC were performed and documented each week of patient testing as per the Quality Control Plan in the IQCP. The surveyor noted there was no documentation of QC the week of March 10-14, 2025, one out of full four weeks in March 2025. The findings include: 1. A review of the Qualigen Fast Pack System QC logs revealed the laboratory failed to perform the required QC prior to patient testing from March 10-14, 2025. There were 14 patient tests performed during this period. 2. A review of the IQCP revealed a requirement to perform two levels of QC once per week or whenever calibration was performed. 3. The DoC confirmed the above findings during the exit conference on 05- 08-2025 at 1:30 PM. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of Personnel records and an interview the Director of Compliance (DoC), the Technical Consultant (TC) failed to assess competency at least semi- annually during the first year of patient testing. This was noted for one of three Testing Personnel (TP) listed on the CMS 209 (Laboratory Personnel Report) performing moderate complexity testing from 2023-2025. The findings include: 1. A review of Personnel records revealed TP3 had no evidence of semi-annual competency assessment completed by the TC for 2023-2025. 2. The DoC confirmed the above findings during the exit conference on 05-08-2025 at 1:30 PM. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on a review of Personnel records and an interview the Director of Compliance -- 3 of 4 -- (DoC), the Technical Consultant (TC) failed to assess competency of Testing Personnel (TP) at least annually. This was noted for one of the three TP listed on the CMS 209 (Laboratory Personnel Report) performing moderate complexity testing from 2023-2025. The findings include: 1. A review of Personnel records revealed TP3 had no evidence of annual competency assessment completed by the TC for 2023- 2025. 2. The DoC confirmed the above findings during the exit conference on 05-08- 2025 at 1:30 PM. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) (b)(6)(ii) Have documentation of laboratory training appropriate for the testing performed prior to analyzing patient specimens. Such training must ensure that the individual has- (b)(6)(ii)(A) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation, and storage of specimens; (b)(6)(ii) (B) The skills required for implementing all standard laboratory procedures; (b)(6)(ii) (C) The skills required for performing each test method and for proper instrument use; (b)(6)(ii)(D) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(6)(ii) (E) A working knowledge of reagent stability and storage; (b)(6)(ii)(F) The skills required to implement the quality control policies and procedures of the laboratory; (b) (6)(ii)(G) An awareness of the factors that influence test results; and (b)(6)(ii)(H) The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on reviews of personnel records, American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with the Director of Compliance (DoC), the laboratory failed to ensure required initial training documentation was completed for one of the three Testing Personnel (TP) listed on the CMS 209 (Laboratory Personnel Report) prior to performing moderate complexity patient testing. The findings include: 1. A review of the 2023-2025 personnel records revealed TP3 had no documentation of initial training appropriate for the moderate complexity testing performed in the laboratory. 2. A review of the API PT records revealed TP3 performed the 2024 API First Event as indicated on the attestation form. 2. During the exit conference on 05-08-2025 at 1:30 PM, the DoC confirmed the above findings. -- 4 of 4 --

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the Qualigen FastPack System records, a review of the calibration policy, and an interview with Testing Personnel #1, the laboratory failed to perform quality controls (QC) after the performance of a calibration, and before performing patient testing. This was noted on four out of eleven days between 11/8 /2022 and 2/23/2023. The findings include: 1. A review of the Qualigen FastPack System records revealed eleven Testosterone calibrations performed between 11/8 /2022 and 2/23/2023. However, the laboratory failed to perform Testosterone QC after the calibration and before patient testing on the following dates: A) Calibration on 11/8 /2022 with one patient tested on 11/9/2022, and no QC performed until 11/10/2022. B) Calibration on 12/2/2022 with 26 patients tested between the date of calibration and 12/8/2022, the date QC was next performed. C) Calibration on 12/21/2022 with seven patients tested afterward; QC was performed on 12/22/2022. D) Calibration on 2 /1/2023 with four patients tested afterward; QC was performed on 2/2/2023. 2. A review of the "CALIBRATION/CALIBRATION VERIFICATION" policy on page 1 under "CALIBRATION" revealed, "...Successful Quality Control performance 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 -- following calibration is also required prior to implementation of patient testing." 3. During a review of the calibration procedure and an interview on 3/30/2023 at 1:35 PM, Testing Personnel #1 confirmed he did not run QC after a calibration unless it was a Thursday, when the weekly QC was performed. . D5439 CALIBRATION AND CALIBRATION VERIFICATION 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 a review of the Qualigen FastPack System records, a review of the laboratory policy, and an interview with Testing Personnel #1, the laboratory failed to perform calibration verification (C-V) every six months as per the policy. The laboratory failed to provide documentation for one of three C-V's due in the 2022- 2023 review period. The findings include: 1. A review of the Qualigen FastPack System records revealed Testosterone test packs were calibrated with Calibrator A and B every 14 days. 2. A review of the "CALIBRATION/CALIBRATION VERIFICATION" policy on page 1 under "CALIBRATION VERIFICATION" revealed, "For ...analytes that are not calibrated with a minimum of three calibrators verifying the low, mid-point and high end of the reportable range, calibration verification must be performed minimally every six months ... ." 3. A review of the Qualigen FastPack records revealed a C-V was performed on 4/8/2022 (during the installation validation) and 8/31/2022, however there was no documentation of the C- V due in early 2023. 4. During an interview on 3/30/2023 at 1:55 PM, Testing Personnel #1 stated he had just performed a C-V the day before on 3/29/2023, however he was unable to locate the record. Testing Personnel #1 stated he would e- mail the C-V, however as of 9:00 AM on 4/3/2023, the document was not received in the CLIA office. . D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations -- 2 of 4 -- Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the Qualigen FastPack System records, a review of the Quality Control Assessment policy, and an interview with the Regional Director, the laboratory failed to ensure the optional IQCP (Individualized Quality Control Plan) was valid before reducing the frequency of QC, and performing patient testing from 10 /28/2022 through March 2023. The surveyor noted the document failed to included one of three required elements for a valid IQCP. The findings include: 1. A review of records for the Qualigen FastPack System (used for Testosterone testing) revealed the laboratory ran Level 1 and 2 quality controls (QC) on test packs every Thursdays starting on 10/27/2022 due to the implementation of an optional IQCP. 2. A review of the IQCP revealed approval by the Laboratory Director on 10/27/2022, however the document failed to include a "QC Plan", as per the laboratory policy. 3. A review of the "Quality Control Assessment" policy on page 6 revealed, "...Establish the "right" QC Plan for the test to detect and control potential sources of error ...The new QC Plan must at least include the number, type, frequency of testing, and criteria for acceptable result(s) of the quality control(s)." 4. A review of patient results printouts revealed the laboratory performed testosterone testing on 365 patients between 10/28 /2022 through 3/29/2023 on days when no QC was tested. 5. During an interview on 3 /30/2023 at 10:00 AM, the Regional Director reviewed and confirmed the IQCP did not include a QC Plan. . 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 a review of the Qualigen FastPack System records, and an interview with the Regional Director, the laboratory failed to ensure two levels of quality control were run each day of patient testing as per laboratory policy from 10/28/2022 through March 2023. The findings include: 1. A review of records for the Qualigen FastPack System (used for Testosterone testing) revealed the laboratory ran Level 1 and 2 quality controls (QC) on test packs every each day of patient testing until 10/27/2022 when an optional IQCP (Individualized Quality Control Plan) was implemented. However, a review of the document revealed it was not a valid IQCP. [Refer to D5445.] 2. A review of the "Quality Control Assessment" policy on page 1 revealed, "...Two valid levels of quality control results must be obtained ... prior to running patient samples ..." "...two levels of control are required each day of patient testing." 3. A review of patient results printouts revealed the laboratory performed testosterone -- 3 of 4 -- testing on 365 patients between 10/28/2022 through 3/29/2023 on days when no QC was tested. 4. During the exit summation, the above noted findings were reviewed and confirmed with the Regional Director. . D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of a patient test report and an interview with the Regional Director, the laboratory failed to ensure patient reports included the name and the address of the laboratory location where the testing was performed. This was noted on one of one patient report reviewed. The findings include: 1. On 3/30/2023 at 2:20 PM, the surveyor reviewed the post-analytical process in the facility. The Regional Director explained Testosterone results are manually entered in the AdvancedMD EMR (Electronic Medical Record) system, and the instrument printouts are retained for two years in the monthly binders. The surveyor requested a patient report for review. 2. A review of the Testosterone report for patient "X" revealed the following: A) No laboratory or clinic name B) No street address, city or state; only the suite number and zip code were printed 3. During a review of the report and an interview on 3/30/2023 at 2:30 PM, the Regional Director stated there must be a "glitch" in the report printing. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 4 of 4 --