Conrad Pearson Clinic (The)

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 --