Huntsville Mens Clinic

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the laboratory's proficiency testing provider, American Proficiency Institute (API). The laboratory was found to be out of compliance with CONDITION LEVEL DEFICIENCIES, as follows: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on proficiency testing (PT) desk reviews of the CASPER Reports 0153D and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for the specialty Chemistry and PSA (Prostate Specific Antigen), an analyte in the specialty of Chemistry. The laboratory failed two PT events in 2025, resulting in initial unsuccessful proficiency testing performance. Refer to D2096 and D2097. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory failed to successfully participate (achieve scores of 80% or greater) in proficiency testing for PSA (Prostate Specific Antigen). The laboratory failed two PT events in 2025, resulting in initial unsuccessful proficiency testing performance. The findings include: 1. A review of the CASPER Reports revealed the laboratory received failing scores for PSA in two API PT events, as follows: A) 2025 Event 1: PSA 20% B) 2025 Event 3: PSA 20% 2. A review of the laboratory's proficiency testing evaluation reports provided by API confirmed these findings. D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) (g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) CASPER Reports and American Proficiency Institute (API) testing evaluations, the laboratory failed to satisfactorily perform for two Chemistry testing events (Event #1 and #3, 2025), for PSA (Prostate Specific Antigen). These failures resulted in an unsuccessful performance. The findings include: 1. A review of the CASPER #155 revealed the laboratory scored 20% for Chemistry Event #1 and #3, 2025. 2.The API proficiency testing evaluations confirmed the above noted score. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and proficiency testing evaluation reports from the American Proficiency Institute (API), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on proficiency testing (PT) desk reviews of the CASPER Reports 0153D and 0155D (Individual Laboratory Profiles from the Centers of Medicare and Medicaid Services [CMS]), and PT evaluation reports from the American Proficiency Institute (API), the laboratory director failed to ensure the laboratory had successful participation in an HHS approved proficiency testing program for the specialty Chemistry and the analyte PSA (Prostate Specific Antigen) in the specialty of Chemistry for two 2025 API PT events. Refer to D2096 and D2097. -- 3 of 3 --

Summary Statement of Deficiencies D6033 TECHNICAL CONSULTANT-MODERATE COMPLEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of laboratory records and an interview with the current Laboratory Manager, the laboratory failed to fill the position of Technical Consultant after the previous Technical Consultant was terminated. This was noted from January 2023 to the date of the current survey on 4/8/2025. The findings include: 1. Refer to D6036. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. The technical consultant is not required to be onsite at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide consultation, as specified in paragraph (a) of this section. This STANDARD is not met as evidenced by: Based on a review of the CMS 209 form (Laboratory Personnel Report) and an interview with the Laboratory Manager, the laboratory failed to fill the position of Technical Consultant after the previous Technical Consultant was terminated. This was noted from January 2023 to the date of the current survey on 4/8/2025. The findings include: 1. A review of the 209 Laboratory Personnel Report revealed the Laboratory Director was also listed as the Technical Consultant, however, the Laboratory Director does not have at least one year of laboratory training or 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 -- experience in the designated specialty area of service for which the Technical Consultant is responsible. 2. During an interview on 4/11/2025 at 11:02 AM, the Laboratory Manager confirmed the Laboratory Director does not have the one year experience. -- 2 of 2 --

Summary Statement of Deficiencies 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 the 2021 - 2022 API (American Proficiency Institute) proficiency testing (PT) records, and an interview with the Clinic Manager, the surveyor determined the laboratory failed to ensure signed attestation statements and program forms were retained for at least two years for two of four surveys reviewed. The findings include: 1. A review of the API PT records revealed missing records for the following Chemistry / Endocrinology surveys: A) 2021 Event #3 had no program (results) forms, and no signature by the Laboratory Director on the attestation statement. B) 2022 Event #1 had no program forms, and no signed attestation statement. 2. A review of the instructions on the attestation statement revealed, "SIGNATURES REQUIRED - For all PT results, an attestation statement must be signed by the testing personnel and the laboratory director, and retained for two years". 3. In an interview on 10/18/2022 at 12:35 PM, the Clinic Manager reviewed and confirmed the above findings. . D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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 -- 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 environmental records and an interview with the Clinic Manager, the laboratory failed to ensure room temperature, room humidity, and refrigerator temperatures were monitored and documented for four of nineteen months reviewed from March 2021 through September 2022. The findings include: 1. A review of environmental records revealed the laboratory failed to monitor and document room temperature, room humidity, and refrigerator temperatures from March 2021 through June 2021. 2. During and interview on 10/18/2022 at 2:24 PM, the Clinic Manager confirmed the previous Testing Personnel (no longer employed) had not recorded any environmental parameters in the laboratory. . D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of maintenance records for the FastPack IP System Qualigen 1 (Serial Number 0978) and an interview with the Clinic Manager, the laboratory failed to ensure maintenance was performed and documented as per the frequency required by the manufacturer for five of nineteen months reviewed from March 2021 through September 2022. The findings include: 1. A review of FastPack IP System Qualigen 1 maintenance records revealed the laboratory failed to perform and document the daily and weekly maintenance as required by the manufacturer from March 2021 through July 2021. 2. During and interview on 10/18/2022 at 2:24 PM, the Clinic Manager confirmed the previous Testing Personnel (no longer employed) had not performed and documented the Qualigen maintenance. . 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 -- 2 of 6 -- 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 FastPack IP System Qualigen 1 (Serial Number 0978) and Qualigen 2 (SN0192) records and an interview with the Clinic Manager, the laboratory failed to ensure calibration verification (C-V) was performed every six months as required by the laboratory policy. The surveyor noted three of three C-V's performed in 2021 - 2022 exceeded the six-month timeframe. The findings include: 1. A review of records for PSA (Prostatic Specific Antigen) and Testosterone performed on the FastPack IP System Qualigen 1 and 2 revealed the tests are calibrated with two calibrators, A and B. Analytes calibrated with less than three calibrators must have a calibration verification every six months. 2. A review of the C-V records for the two Qualigen instruments revealed the following: A) Qualigen 1: 1) 3/1/2021-PSA and Testosterone validation 2) Eight months later on 11/22/2021 the laboratory performed a C-V on PSA and Testosterone 3) Ten and a half later on 10/7/2022 the laboratory performed a C-V on Testosterone B) Qualigen 2: 1) 11/22/2021- PSA validated 2) Ten and a half later on 10/7/2022 the laboratory performed a C-V on PSA 3. A review of the procedure "Calibration and Calibration Verification" revealed, C-V "... performed minimally every six months, utilizing 3 or more calibrators across the reportable range". 4. During an interview on 10/18/2022 at 2:10 PM, the Clinic Manager confirmed the C-V's were late, and should be performed every six months. . 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 Quality Control (QC) records for the FastPack IP System Qualigen 1 (Serial Number 0978) and an interview with the Clinic Manager, the laboratory failed to ensure QC was performed and documented before patient testing four of nineteen months reviewed from March 2021 through September 2022. The findings include: 1. A review of FastPack IP System Qualigen 1 QC records revealed the following months of PSA (Prostatic Specific Antigen) and Testosterone patient testing when the laboratory failed to performed and document QC: A) March 2021; 135 patients affected B) April 2021; 171 patients affected C) May 2021; 157 patients affected D) June 2021; 215 patients affected 2. The laboratory provided a "