Conrad Pearson Clinic (The)

Summary Statement of Deficiencies D0000 During a recertification survey completed on 05/06/26, the laboratory was found out of compliance with the following conditions: D5016 - 42 C.F.R. 493.1210 Condition: Routine chemistry; D5018 - 42 C.F.R. 493.1211 Condition: Urinalysis; D5020 - 42 C. F.R. 493.1212 Condition: Endocrinology; D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel; D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report (CLIA) (FORM CMS-209), a review of proficiency testing (PT) records, and staff interviews, the laboratory failed to ensure that personnel who routinely performed patient testing performed proficiency testing when five of six PT events for the urine microscopy and urine dipstick on the Clinitek Advantus were performed by the lead testing person in 2024, 2025, and 2026. The findings include: 1. Laboratory observation on 05/05/26 at approximately 9:00 a.m. revealed moderately complex patient testing for the following test systems: Urine microscopy, dipstick urinalysis on the Clinitek Advantus (backup system), the Roche Cobas e411 used for Prostate Specific Antigen (PSA), Sex Hormone Binding Globulin (SHBG), and Testosterone, and the Beckman Coulter DxC 700 AU used for automated urinalysis/urine chemistry. During observations, the lead testing person stated that she performed testing on all platforms, and the other testing personnel performed urine microscopy and urine dipstick testing on the Clinitek Advantus. 2. A review of the FORM CMS-209 revealed six testing personnel listed who performed moderately complex patient testing. 3. A review of the laboratory's PT records Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- revealed that the urine microscopy and urinalysis (performed on the Clinitek Advantus) PT surveys were performed by the lead testing person (testing person three as listed on FORM CMS-209) for 2024 event three, 2025 event one, 2025 event two, 2025 event three, and 2026 event one (five of six events reviewed). 4. The interim technical consultant confirmed the survey findings during an interview on 05/05/26 at approximately 2:10 p.m. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on laboratory observation, a review of the laboratory procedure manual, a review of the laboratory's calibration verification records, laboratory communication, review of quality control records, review of patient test reports, review of analytic records, review of the laboratory's quality assessment plan, review of staff communications, and staff interview, the laboratory failed to follow the procedure for performing calibration verification every six months for the PSA analyte (Refer to D5401), failed to verify the quality control ranges used for urine chemistry analytes on the Beckman Coulter DxC 700 AU (Refer to D5469), and failed to ensure the quality assessment procedure for review of analytic records was followed (Refer to D5791). D5018 URINALYSIS CFR(s): 493.1211 If the laboratory provides services in the subspecialty of Urinalysis, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on laboratory observations, a review of the manufacturer reagent package insert, a review of the manufacturer calibrator package insert, a review of calibration records, patient test reports, observation of instrument calibration configuration, a review of quality control records, a review of laboratory records, a review of the quality assessment plan, staff communications and staff interview, the laboratory failed to perform daily calibration of the urine hemoglobin analyte in 2024, 2025, and 2026 (Refer to D5437), the laboratory failed to verify the quality control ranges used for monitoring urinalysis analytes on the Beckman Coulter DxC 700 AU were consistent with the manufacturer package insert (refer to D5469), and failed to follow the quality assessment procedure for review of analytic records (Refer to D5791). D5020 ENDOCRINOLOGY CFR(s): 493.1212 If the laboratory provides services in the subspecialty of Endocrinology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. -- 2 of 12 -- This CONDITION is not met as evidenced by: Based on laboratory observations, a review of the laboratory procedure manual, a review of the laboratory's calibration verification records, laboratory communication, review of the laboratory's analytic records, review of the laboratory's quality assessment plan, and staff interview, the laboratory failed to follow the procedure for performing calibration verification every six months for the Sex Hormone Binding Globulin (SHBG) and Testosterone analytes (Refer to D5401), and failed to follow the quality assessment procedure for review of analytic records (Refer to D5791). 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 laboratory observation, review of testing personnel records, review of the laboratory's testing personnel policy, and staff interview, the laboratory failed to follow the policy for training of testing personnel for one of five new testing persons. The findings include: 1. Laboratory observation on 05/05/26 at approximately 9:00 a. m. revealed moderately complex patient testing for the following test systems: Urine microscopy, urinalysis on the Clinitek Advantus (backup system), the Roche Cobas e411 used for PSA, SHBG, and Testosterone analytes, and the Beckman Coulter DxC 700 AU used for automated urinalysis and urine chemistry. 2. A review of testing personnel records revealed no documentation of training for performance of urinalysis on the Clinitek Advantus for testing person six, with a date of hire listed as 01/12/26. 3. A review of the Testing Personnel section of the policy titled "Quality Management System" revealed that "all testing personnel are properly trained and are competent prior to performing patient specimens." The procedure listed the training requirements for each non-waived test system. 4. The technical consultant confirmed the survey findings during an interview on 05/05/26 at approximately 12:50 p.m. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on laboratory observation, a review of the laboratory's procedure manual, alternative assessment proficiency testing (PT) records, and staff interview, the laboratory failed to follow the policy for performing

Summary Statement of Deficiencies D0000 During a recertification survey completed on July 31, 2024, the laboratory was found OUT OF COMPLIANCE with the following conditions: 493.1210 Condition: Routine chemistry 493.1212 Condition: Endocrinology 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant 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 laboratory's American Proficiency Institute (API) Proficiency Testing (PT) records and staff interview, the laboratory director failed to sign the attestation statements for two of the nine PT events reviewed. The findings include: 1. A review of the laboratory's API PT records revealed the laboratory director failed to sign the PT attestation statements for 2024 Hematology Event One and 2024 Hematology Event Two. 2. Testing Person One (TP #1) confirmed the survey findings during an interview on 07/26/24 at 4:00 p.m. D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of the laboratory procedure manual, review of calibration verification records, lack of records, observation of the Roche Cobas e411 quality control (QC) files, staff interviews, electronic mail (email) communication, review of QC data, review of patient test reports, and review of the Form CMS-116, the laboratory failed to follow the calibration verification procedure (Refer to D5401 Citation One), failed to follow the procedure for printing and evaluating Levy Jennings QC graphs (Refer to D5401 Citation Two), failed to ensure the manufacturer QC ranges were verified for QC lot numbers 699257 and 699260, and failed to ensure the laboratory performed and evaluated QC data using the correct QC lots in the correct QC files for the Prostate Specific Antigen (PSA) (Refer to D5469). D5020 ENDOCRINOLOGY CFR(s): 493.1212 If the laboratory provides services in the subspecialty of Endocrinology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of the laboratory procedure manual, review of calibration verification records, lack of records, observation of the Roche Cobas e411 quality control (QC) files, staff interviews, electronic mail (email) communication, review of QC data, review of patient test reports, and review of the Form CMS-116, the laboratory failed to follow the calibration verification procedure (Refer to D5401 Citation One), failed to follow the procedure for printing and evaluating Levy Jennings QC graphs, (Refer to D5401 Citation Two), failed to ensure the manufacturer QC ranges were verified for QC lot numbers 699257 and 699260, and failed to ensure the laboratory performed and evaluated QC data using the correct QC lots in the correct QC files for the Sex Hormone Binding Globulin (SHBG) and Testosterone analytes (Refer to D5469). 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 observation of the laboratory, review of the laboratory procedure manual and staff interview, the laboratory policy for testing personnel training and competency was not in compliance with the requirements in Subpart M. The findings include: 1. Observation of the laboratory on 07/26/24 at 8:30 a.m. revealed the -- 2 of 8 -- following non-waived test systems used for patient testing: Roche Cobas e411 instrument (serial # 1246-29) used for patient testing for Prostate Specific Antigen (PSA), Testosterone, and Sex Hormone Binding Globulin (SHBG) Siemens Clinitek Advantus instruments used for Urinalysis dipstick testing Microscopes used for microscopic examination of urine sediment 2. A review of the laboratory policy titled "Quality Assessment Plan Summary" under the section titled "Personnel Assessment" revealed the personnel policy did not include the following: Elements required in the training of testing personnel. A requirement for re-assessment of competency if test methodology or instrument changes. The six criteria required for competency assessment: direct observation of routine patient test performance; monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results and preventative maintenance records; direct observation of the performance of instrument maintenance and function checks; assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and assessment of problem-solving skills. 3. TP #1 confirmed the survey findings during an interview on 07/26/24 at 4:00 p.m. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 review of the laboratory's 2016 American Proficiency Institute (API) Chemistry Group 2 proficiency testing attestation statements for events one, two, and three and interview with testing personnel number one, the testing personnel failed to sign the attestation statement for one of three proficiency testing events, and the laboratory director failed to sign the attestation statement for three of three proficiency testing events in 2016. The findings include: 1. Review of the laboratory's 2016 API proficiency testing attestation statements revealed that testing personnel did not sign the attestation statement for 2016 Chemistry Group 2 event one. 2. Review of the laboratory's 2016 API proficiency testing attestation statements revealed that the laboratory director did not sign the attestation statements for 2016 Chemistry Group 2 events one, two, and three. 3. Interview with testing personnel number one on March 22, 2018 at 9:45 am confirmed that testing personnel failed to sign one of three attestation statements in 2016 and the laboratory director failed to sign three of three proficiency testing attestation statements in 2016. 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) 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 -- -- (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 observation of the laboratory, review of the calibrator package inserts for testosterone, SHBG, and PSA, calibration verification records and interview with testing personnel number one, the laboratory failed to verify calibration at least every six months for testosterone, sex-hormone binding globulin (SHBG), prostate specific antigen (PSA) in 2017. The findings include: 1. Observation of the laboratory on March 22, 2018 at 8:30 am revealed the Roche Cobas e411 in use for patient testing for testosterone, SHBG, and PSA. 2. Review of the calibrator package inserts for testosterone, SHBG, and PSA revealed only two calibrator levels for each of the assays. 3. Review of the calibration verification records for 2017 revealed that calibration verification was performed on January 4, 2017 with the next calibration verification performed on November 3, 2017 for each of the assays. 4. Interview with testing personnel number one on March 22, 2018 at 11:00 am confirmed that the laboratory's calibration for the testosterone, SHBG, and PSA only includes two levels of calibrator and the laboratory failed to perform calibration verification at least every six months in 2017. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the Food and Drug Administration (FDA) website for test complexity, and interview with testing personnel number one, the laboratory failed to compare results between urinalysis instruments twice a year in 2016, 2017 and 2018. 1. Observation of the laboratory on March 22, 2018 at 8:30 am revealed three Siemens Clinitek Status Advantus instruments in use for patient testing for dipstick urinalysis. 2. Review of the FDA website revealed the Clinitek Status Advantus instrument has a complexity status of moderate. 3. Interview with testing personnel number one on March 22, 2018 at 10:45 am confirmed that the laboratory -- 2 of 3 -- uses three moderately complex instruments for patient testing for dipstick urinalysis and did not compare results between instruments twice a year in 2016, 2017, and 2018. -- 3 of 3 --