Spartan Medical Men's Health Clinic

Summary Statement of Deficiencies D0000 Recertification survey was conducted on February 1, 2024 to February 5, 2024. Spartan Medical Men's Health Clinic clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 review of proficiency testing (PT) records, and interview, the laboratory failed to verify accuracy of the Prostate-Specific Antigen (PSA) and Testosterone test at least twice annually for 2022 and 2023. Findings: Review of American Proficiency Institute (API) PT records showed the laboratory performed PT for the third event of 2023. No other API PT documentation of PT was available for review. On 02/01/2024 at 10:18 AM, Testing Personnel A stated they did not perform any PT in 2022 and they only performed PT once in 2023. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This CONDITION is not met as evidenced by: Based on interview and review of quality control logs, patient logs, and the laboratory's Individualized Quality Control Plan (IQCP), the laboratory failed to follow their IQCP to run weekly (7 days) quality controls (QC) on the Qualigen FastPack IP System before reporting patient test results from 08/15/2021 to 11/30 /2023. This is a repeat deficiency from the initial survey performed 05/06/2022. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (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 interview and review of quality control logs, patient logs, and the laboratory's Individualized Quality Control Plan (IQCP), the laboratory failed to follow their IQCP to run weekly (7 days) quality controls (QC) on the Qualigen FastPack IP System before reporting patient test results from 08/15/2021 to 11/30 /2023. This is a repeat deficiency from the initial survey performed 05/06/2022. Findings: Review of the laboratory's IQCP showed "For all FastPack tests, Controls 1 and 2 will be performed at least once per week and after calibration." The procedure also noted, "run QC before testing patients once per week on the same day." Review of QC logs for PSA showed controls were run on 08/26/2022 and not run again until 09/15/2022. Review of patient logs showed patients were tested on the following dates: 09/02/2022 - 5 patients 09/05/2022 - 1 patient 09/06/2022 - 2 patients 09/14 /2022 - 2 patients Review of QC logs for PSA showed controls were run on 09/21 /2022 and not run again until 10/03/2022. Review of patient logs showed patients were tested on the following dates: 09/30/2022 - 3 patients 10/01/2022 - 1 patient Review of QC logs for PSA showed controls were run on 10/03/2022 and not run again until 10/13/2022. Review of patient logs showed a patient was tested on the following date: 10/10/2022 - 1 patient Review of QC logs for PSA showed controls were run on 10/16/2022 and not run again until 10/30/2022. Review of patient logs showed patients were tested on the following dates: 10/24/2022 - 1 patient 10/27/2022 - 2 patients 10/28/2022 - 6 patients Review of QC logs for PSA showed controls were run on 10/30/2022 and not run again until 11/10/2022. Review of patient logs showed a patient was tested on the following date: 11/09/2022 - 1 patient Review of QC logs for PSA showed controls were run on 04/21/2023. The previous controls were run on 04/14/2023. One patient was tested on 04/21/2023 before both levels of controls (C1, C2) were run. Patient was tested at 9:15 AM C1 run at 7:55 AM C2 run at 9:21 AM Review of QC logs for PSA showed controls were run on 09/09/2023 and not run again until 09/20/2023. Review of patient logs showed a patient was tested on the following date: 09/16/2023 - 1 patient Review of QC logs for PSA showed controls were run on 10/05/2023 and not run again until 10/19/2023. Review of patient logs showed a patient was tested on the following date: 10/12/2023 - 1 patient Review of QC logs for Testosterone showed controls were run on 08/07/2022 and not again until 08/23/2022. Review of patient logs showed patients were tested on the following -- 2 of 5 -- dates: 08/15/2022 - 1 patient 08/16/2022 - 3 patients Review of QC logs for Testosterone showed controls were run on 08/29/2022 and not run again until 09/11 /2022. Review of patient logs showed patients were tested on the following date: 09/05 /2022 - 3 patients Review of QC logs for Testosterone showed controls were run on 09 /11/2022 and not run again until 09/26/2022. Review of patient logs showed patients were tested on the following dates: 09/18/2022 - 1 patient 09/19/2022 - 1 patient 09/22 /2022 - 2 patients 09/23/2022 - 2 patients Review of QC logs for Testosterone showed controls were run on 10/03/2022 and not run again until 10/13/2022. Review of patient logs showed a patient was tested on the following date: 10/10/2022 - 1 patient Review of QC logs for Testosterone showed controls were run on 10/13/2022 and not run again until 10/27/2022. Review of patient logs showed patients were tested on the following dates: 10/20/2022 - 1 patient 10/21/2022 - 5 patients 10/24/2022 - 1 patient Review of QC logs for Testosterone showed controls were run on 10/30/2022 and not again until 11/10/2022. Review of patient logs showed a patient was tested on the following date: 11/07/2022 - 1 patient Review of QC logs for Testosterone showed controls were run on 12/15/2022 and not run again until 12/29/2022. Review of patient logs showed patients were tested on the following dates: 12/22/2022 - 3 patients 12/23/2022 - 4 patients Review of QC logs for Testosterone showed controls were run on 01/25/2023 and not run again until 02/04/2023. Review of patient logs showed patients were tested on the following dates: 02/01/2023 - 1 patient 02/02/2023 - 3 patients Review of QC logs for Testosterone showed controls were run on 06/01 /2023. The previous controls were run on 05/17/2023. One patient was tested on 06/01 /2023 before both levels of controls (C1, C2) were run. Patient was tested at 10:06 AM C1 run at 12:31 PM C2 run at 12:45 PM Review of QC logs for Testosterone showed controls were run on 06/15/2023. The previous controls were run on 06/08 /2023. One patient was tested on 06/15/2023 before both levels of controls (C1, C2) were run. Patient was tested at 10:32 AM C1 run at 10:08 AM C2 run at 10:46 AM Review of QC logs for Testosterone showed controls were run on 06/15/2023 and not run again until 06/29/2023. Review of patient logs showed patients were tested on the following dates: 06/22/2023 - 2 patients 06/23/2023 - 5 patients Review of QC logs for Testosterone showed controls were run on 06/15/2023 and not again until 06/29 /2023. Review of patient logs showed patients were tested on the following dates: 06 /22/2023 - 2 patients 06/23/2023 - 5 patients Review of QC logs for Testosterone showed controls were run on 07/13/2023 and not run again until 08/10/2023. Review of patient logs showed patients were tested on the following dates: 07/20/2023 - 3 patients 07/21/2023 - 3 patients 07/27/2023 - 3 patients 07/28/2023 - 3 patients 07/31 /2023 - 2 patients 08/03/2023 - 1 patient Review of QC logs for Testosterone showed controls were run on 10/05/2023 and not run again until 10/19/2023. Review of patient logs showed a patient was tested on the following date: 10/12/2022 - 1 patient Review of QC logs for Testosterone showed controls were run on 11/30/2023. The previous controls were run on 11/16/2023. Two patients were tested on 11/30/2023 before both levels of controls (C1, C2) were run. Patients were tested at 12:52 PM and 1:57 PM C1 run at 4:22 PM C2 run at 4:35 PM On 02/01/2024 at 11:30 AM, Testing Personnel A stated he thought controls were run but could not locate the missing documentation. 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. -- 3 of 5 -- This CONDITION is not met as evidenced by: Based on review of Quality Assurance Assessment (QA) forms, and interview, the Laboratory Director failed to identify failures in the quality of laboratory services from 07/04/2022 to 01/012023. (See D6022) D6022 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the Quality Assurance Assessment (QA) forms, and interview, the Laboratory Director failed to identify failures in the quality of laboratory services from 07/04/2022 to 01/01/2023. Review of the Quality Assurance Assessment forms showed the forms were signed by the Laboratory Director on 07/04/2022, 08/01/2022, 09/05/2022, 10/03/2022, 11/07/2022, 01/02/2023, 02/06/2023, 03/06/2023, 04/03 /2023, 05/01/2023, 06/05/2023, 07/03/2023, 08/07/2023, 09/04/2023, 10/02/2023, 11 /06/2023, and 01/01/2024. Review of the laboratory's procedure titled Quality Assurance Assessment Program noted, "The laboratory director oversees the implementation of this QA Assessment plan and helps identify and correct problems as they occur." The laboratory's QA plan failed to identify the laboratory was not performing proficiency testing (See D5217), and failed to identify the laboratory failed to follow their Individual Quality Control Plan (IQCP) by not performing quality controls on Prostate-Specific Antigen (PSA) and Testosterone weekly (See D5445) On 02/01/2024 at 10:18 AM, Testing Personnel A stated they did not perform any PT in 2022 and they only performed PT once in 2023. On 02/01/2024 at 11:30 AM, Testing Personnel A stated he thought controls were run but could not locate the missing documentation. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY 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 interview, review of job descriptions, review of the laboratory's Allegation of Compliance from the initial survey on 05/06/2022, review of quality control logs, patient logs, and the Daily Environment and Quality Control Log, the Technical Consultant failed to ensure acceptable levels of analytic performance were maintained from June 2022 to January 2024. (See D6042) D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) -- 4 of 5 -- (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on interview, review of job descriptions, review of the laboratory's Allegation of Compliance from the initial survey on 05/06/2022, review of Quality Control (QC) logs, patient logs, and the Daily Environment and Quality Control Log, the Technical Consultant failed to ensure acceptable levels of analytic performance were maintained from June 2022 to January 2024. Findings: Review of the Technical Consultant Responsibilities and Job Description noted the Technical Consultant was responsible to "Establish a quality control program appropriate for the testing performed, establish the acceptable levels of analytical performance, and ensure these levels were maintained throughout the testing process. Review of the Allegation of Compliance, signed by the Laboratory Director on 06/16/2022, from the initial survey on 05/06 /2022 noted "All controls will be performed, at the latest, seven days apart. If this does not occur, for supply reasons, no patient testing will be performed, until recalibration and two controls have first been performed. Control performance dates will be documented on current Lab Environmental Log Sheet allowing for all staff to document this information, to see if/when it is time to perform controls." The Allegation of Compliance also noted the "Technical consultant will review each week, to confirm compliance." Review of the quality control logs and patient logs revealed the quality control for Prostate-Specific Antigen (PSA) and Testosterone were not performed weekly as indicated in the laboratory's Individual Quality Control Plan. (See D5445) Review of the laboratory's quality control logs and the Daily Environmental and QC Log revealed the quality controls for PSA and Testosterone were not documented each time the controls were run. Review of the Daily Environmental and QC Logs showed there was no documentation to indicate the Technical Consultant reviewed the logs. On 02/01/2024 at 11:30 AM, Testing Personnel A stated he thought controls were run but could not locate missing documentation. On 02/01/2024 at 12:00 PM, Testing Personnel A stated he did not record every time controls were run on the Daily Environmental and QC Log. -- 5 of 5 --

Summary Statement of Deficiencies D0000 An initial certification survey was conducted on May 6, 2022. Spartan Medical Men's Health Clinic laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 record review and interview, the laboratory failed to document the initial competency assessment for one of one Technical Consultant from 10/25/2021 to 05/06 /2022. Findings: Review of the Laboratory Personnel Report dated and signed by the Laboratory Director on 04/18/2022 showed there was one Technical Consultant. Review of the binder with patient test results showed patient testing started 10/25 /2021. Review of personnel records revealed there was no initial competency evaluations for the Technical Consultant. On 05/06/2022 at 11:14 AM, Testing Personnel A stated there was no competency evaluation for the Technical Consultant. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. 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 CONDITION is not met as evidenced by: Based on record review, observation, and interview, the laboratory's quality assessment program failed to monitor and evaluate the overall quality of the analytic system and identify problems. Findings: Cross Reference D5445. Based on record review, observation, and interview, the laboratory failed to follow their IQCP (Individualized Quality Control Plan) to run weekly (7 days) quality controls (QC) on the Qualigen FastPack IP System before reporting patient test results from 12/06/2021 to 05/06/2022. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (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 record review, observation, and interview, the laboratory failed to follow their IQCP (Individualized Quality Control Plan) to run weekly (7 days) quality controls (QC) on the Qualigen FastPack IP System before reporting patient test results from 12/06/2021 to 05/06/2022 Findings: According to the Clinical Laboratory Improvement Amendment (CLIA) Application for Certification, signed and dated by the Laboratory Director on 04/18/2022, the laboratory performed testing on serum for PSA (Prostate-Specific Antigen) and Testosterone. The laboratory had an annual test volume of 9,000 tests. Review of the laboratory's IQCP showed that "For all FastPack tests, Controls 1 and 2 will be performed at least once per week and after calibration." The procedure also noted, "run QC before testing patients once per week on the same day." Review of the QC logs for PSA showed one patient was tested before the controls (C1, C2) were run on the following dates: 12/06/2021 1 patient tested at 11: 50 AM C1 run at 1:02 PM C2 run at 1:15 PM 02/02/2022 1 patient tested at 10:49 AM C1 run at 3:17 PM C2 ran at 3:31 PM Review of the QC logs for PSA showed controls were run on 02/02/2022 and then not again until 03/17/2022. Review of patient logs showed patients were tested on the following dates: 02/11/2022 - 1 patient 02/16/2022 - 1 patient Review of the QC logs for PSA showed controls were run on 03 /28/2022 and then not again until 04/19/2022. Review of the patient logs showed patients were tested on the following dates: 04/04/2022 - 2 patients 04/06/2022 - 1 patient 04/11/2022 - 3 patients 04/15/2022 - 1 patient Review of the QC logs for PSA showed the controls were run on 04/26/2022 and were not run as of the time of the survey on 05/06/2022. Review of the patient logs showed patients were tested on the following dates: 05/02/2022 - 2 patients 05/05/2022 - 1 patient Review of the QC logs for PSA showed the controls were run on 04/26/2022 and were not run as of the time of the survey on 05/06/2022. On 05/06/2022 at 11:30 AM, the Qualigen FastPack PSA test kit for two patients were observed on the counter with test results reported on the label with the patients' names. Review of the QC logs for Testosterone showed the controls were run on 03/13/2022 and then not again until 04/05/2022. Review of -- 2 of 4 -- the patient logs showed patients were tested on the following dates: 03/28/2022 - 4 patients 03/29/2022 - 2 patients 03/30/2022 - 2 patients 04/01/2022 - 2 patients 04/02 /2022 - 1 patient 04/04/2022 - 2 patients Review of the QC logs for Testosterone showed the controls were run on 04/18/2022 and then not again until 04/26/2022 (day 8). Review of the patient logs showed one patient was tested on 04/25/2022. On 05/06 /2022 at 11:15 AM, Testing Personnel A stated they did not run controls some of the times because they ran out. 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 record review and interview, the laboratory failed to include name and address of the laboratory, and the normal values for three of three patients' laboratory test reports, (#1, #2, #3). Findings: Review of patients' test reports with the "In-House Labs" showed the name and address of the laboratory, and the normal values were not listed on the reports. According to the Clinical Laboratory Improvement Amendment (CLIA) Application for Certification, signed and dated by the Laboratory Director on 04/18/2022, the laboratory performed testing on serum for PSA (Prostate-Specific Antigen) and Testosterone, and had an annual test volume of 9,000 tests. On 05/06 /2022 at 12:25 PM, Testing Personnel A confirmed the report with "In-House Labs" was the report given to patients if they requested their lab results. On 05/06/2022 at 12: 25 PM, Testing Personnel A confirmed the name and address of the laboratory, and normal values were not on the report. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the procedure manual, and interview, the Laboratory Director failed to specify in writing, the responsibilities and duties (job descriptions) of the -- 3 of 4 -- Technical Consultant, and Testing Personnel. Findings: Review of the laboratory's procedure manual, signed by the Laboratory Director on 10/25/2021, showed there was no job descriptions for the Technical Consultant and Testing Personnel. According to the Laboratory Personnel Report, signed and dated by the Laboratory Director on 04/18/2022, there was 1 Technical Consultant and 2 Testing Personnel. On 05/06/2022 at 11:14 AM, Testing Personnel A stated there were no job descriptions in writing for the Technical Consultant and Testing Personnel. -- 4 of 4 --