Radiance Diagnostics

Summary Statement of Deficiencies D0000 Based on review of laboratory records and a proficiency testing review of the College of American Pathologists (CAP) Proficiency Testing (PT) records provided by CAP via email on 08/05/2026 at 3:28 pm; the laboratory was out of compliance with the 42 C.F.R. Part 493 CLIA requirements for the following CONDITION level deficiencies: 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 review of laboratory records and a proficiency testing review of the College 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 -- of American Pathologists (CAP) Proficiency Testing (PT) records provided by CAP via email on 08/05/2026 at 3:28 pm; the laboratory failed to successfully participate in their PT program for the routine chemistry analytes Ferritin, Low-Density Lipoprotein (LDL), Lactate Dehydrogenase (LDH), and Uric Acid; and for the subspecialty of Endocrinology overall and endocrinology analytes Free Thyroxine (FT4), Thyroid Stimulating Hormone (TSH), Total Triiodothyronine (TT3), and Cortisol for the following PT events in 2025 and 2026. See D2096 (a and b), D2107, and D2108. 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: A) Based on review of laboratory records, a proficiency testing review of the College of American Pathologists (CAP) Proficiency Testing (PT) records provided by CAP, and interview with the laboratory owner; the laboratory failed to achieve satisfactory performance for the routine chemistry analytes Lactate Dehydrogenase (LDH) for two consecutive PT events in 2026 (Event 1 of 2026 and Event 2 of 2026) and Uric Acid for two consecutive PT events in 2025 (Event 1 of 2025 and Event 2 of 2025) resulting in the initial unsuccessful PT performances for LDH and Uric Acid analytes in the subspecialty of routine chemistry. Findings include: 1. Review of laboratory CAP PT records revealed the laboratory received the following unsatisfactory scores for routine chemistry analytes LDH and Uric Acid. LDH Event 1 of 2026 - 60% Unsatisfactory Event 2 of 2026 - 0% Unsatisfactory Uric Acid Event 1 of 2025 - 0% Unsatisfactory Event 2 of 2025 - 0% Unsatisfactory 2. Review of CAP PT evaluation reports for Routine Chemistry Event 1 (C-A) 2025, Event 2 (C-B) 2025, Event 1 (C- A) 2026, and Event 2 (C-B) 2026, received via email from CAP on 08/05/2026, at 3: 28 pm, confirmed the above unsatisfactory scores that resulted in the initial unsuccessful PT performance for the routine chemistry analytes LDH and Uric Acid. 3. Interview with the laboratory owner on 07/29/2025, at 11:03 am, revealed that the laboratory had not tested PT samples because the laboratory failed to procure the required reagents at the time of PT events and that the laboratory had continued to test patient samples during this time when the laboratory was able to obtain the required reagents. B) Based on review of laboratory records, a proficiency testing review of the College of American Pathologists (CAP) Proficiency Testing (PT) records provided by CAP, and interview with the laboratory owner; the laboratory failed to achieve satisfactory performance for the routine chemistry analytes Ferritin for three consecutive PT events in 2025 (Event 1 of 2025, Event 2 of 2025, and Event 3 of 2025) and Low-Density Lipoprotein (LDL) for three consecutive PT events in 2025 and 2026 (Event 3 of 2025, Event 1 of 2026, and Event 2 of 2026) resulting in the subsequent unsuccessful PT performances for Ferritin and LDL analytes in the subspecialty of routine chemistry. Findings include: 1. Review of laboratory CAP PT records revealed the laboratory received the following unsatisfactory scores for routine chemistry analytes Ferritin and LDL. Ferritin Event 1 of 2025 - 0% Unsatisfactory Event 2 of 2025 - 0% Unsatisfactory Event 3 of 2025 - 0% Unsatisfactory LDL Event 3 of 2025 - 0% Unsatisfactory Event 1 of 2026 - 0% Unsatisfactory Event 2 of 2026 - 0% Unsatisfactory 2. Review of CAP PT evaluation reports for Routine Chemistry Event 1 (C-A) 2025, Event 2 (C-B) 2025, Event 3 (C- C) 2025, Event 1 (C-A) 2026, and Event 2 (C-B) 2026, received via email from CAP -- 2 of 5 -- on 08/05/2026, at 3:28 pm, confirmed the above unsatisfactory scores that resulted in the subsequent unsuccessful PT performance for the routine chemistry analytes Ferritin and LDL. 3. Interview with the laboratory owner on 07/29/2025, at 11:03 am, revealed that the laboratory had not tested PT samples because the laboratory failed to procure the required reagents at the time of PT events and that the laboratory had continued to test patient samples during this time when the laboratory was able to obtain the required reagents. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 review of laboratory records, a proficiency testing review of the College of American Pathologists (CAP) Proficiency Testing (PT) records provided by CAP, and interview with the laboratory owner; the laboratory failed to achieve satisfactory performance for the endocrinology analytes Free Thyroxine (FT4) for five consecutive PT events in 2025 and 2026 (Event 1 of 2025, Event 2 of 2025, Event 3 of 2025, Event 1 of 2026, and Event 2 of 2026), Thyroid Stimulating Hormone (TSH) for three consecutive PT events in 2025 (Event 1 of 2025, Event 2 of 2025, and Event 3 of 2025), Total Triiodothyronine (TT3) for four of five consecutive PT events (Event 1 of 2025, Event 2 of 2025, Event 3 of 2025, and Event 2 of 2026), and Cortisol for three consecutive PT events in 2025 (Event 1 of 2025, Event 2 of 2025, and Event 3 of 2025) resulting in the subsequent unsuccessful PT performances for FT4, TSH, TT3, and Cortisol analytes in the subspecialty of endocrinology. Findings include: 1. Review of laboratory CAP PT records revealed the laboratory received the following unsatisfactory scores for endocrinology analytes FT4, TSH, TT3, and Cortisol. FT4 Event 1 of 2025 - 0% Unsatisfactory Event 2 of 2025 - 0% Unsatisfactory Event 3 of 2025 - 0% Unsatisfactory Event 1 of 2026 - 0% Unsatisfactory Event 2 of 2026 - 0% Unsatisfactory TSH Event 1 of 2025 - 0% Unsatisfactory Event 2 of 2025 - 0% Unsatisfactory Event 3 of 2025 - 0% Unsatisfactory TT3 Event 1 of 2025 - 0% Unsatisfactory Event 2 of 2025 - 0% Unsatisfactory Event 3 of 2025 - 0% Unsatisfactory Event 2 of 2026 - 0% Unsatisfactory Cortisol Event 1 of 2025 - 0% Unsatisfactory Event 2 of 2025 - 0% Unsatisfactory Event 3 of 2025 - 0% Unsatisfactory 2. Review of CAP PT evaluation reports for Endocrinology Event 1 (C-A) 2025, Event 2 (C-B) 2025, Event 3 (C-C) 2025, Event 1 (C-A) 2026, and Event 2 (C-B) 2026, received via email from CAP on 08/05/2026, at 3:28 pm, confirmed the above unsatisfactory scores that resulted in the subsequent unsuccessful PT performance for the endocrinology analytes FT4, TSH, TT3, and Cortisol. 3. Interview with the laboratory owner on 07/29/2025, at 11:03 am, revealed that the laboratory had not tested PT samples because the laboratory failed to procure the required reagents at the time of PT events and that the laboratory had continued to test patient samples during this time when the laboratory was able to obtain the required reagents. D2108 ENDOCRINOLOGY CFR(s): 493.843(g) (g) Failure to achieve an overall testing event score of satisfactory performance for -- 3 of 5 -- 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 review of laboratory records, a proficiency testing review of the College of American Pathologists (CAP) Proficiency Testing (PT) records provided by CAP, and interview with the laboratory owner; the laboratory failed to achieve satisfactory performance for the subspecialty of Endocrinology overall for four of five consecutive PT events (Event 1 of 2025, Event 2 of 2025, Event 3 of 2025, and Event 2 of 2026) resulting in the subsequent unsuccessful PT performance for Endocrinology. Findings include: 1. Review of laboratory CAP PT records revealed the laboratory received the following unsatisfactory scores for the subspecialty of Endocrinology. Endocrinology (OVERALL) Event 1 of 2025 - 0% Unsatisfactory Event 2 of 2025 - 0% Unsatisfactory Event 3 of 2025 - 0% Unsatisfactory Event 2 of 2026 - 57% Unsatisfactory 2. Review of CAP PT evaluation reports for Endocrinology Event 1 (C- A) 2025, Event 2 (C-B) 2025, Event 3 (C-C) 2025, and Event 2 (C-B) 2026, received via email from CAP on 08/05/2026, at 3:28 pm, confirmed the above unsatisfactory scores that resulted in the subsequent unsuccessful PT performance for the subspecialty of Endocrinology. 3. Interview with the laboratory owner on 07/29/2025, at 11:03 am, revealed that the laboratory had not tested PT samples because the laboratory failed to procure the required reagents at the time of PT events and that the laboratory had continued to test patient samples during this time when the laboratory was able to obtain the required reagents. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of laboratory records, a proficiency testing review of the College of American Pathologists (CAP) Proficiency Testing (PT) records provided by CAP, and interview with the laboratory owner; the laboratory director failed to ensure successful participation in their PT program for the routine chemistry analytes Ferritin, Low- Density Lipoprotein (LDL), Lactate Dehydrogenase (LDH), and Uric Acid; and for the subspecialty of Endocrinology overall and endocrinology analytes Free Thyroxine (FT4), Thyroid Stimulating Hormone (TSH), Total Triiodothyronine (TT3), and Cortisol for the following PT events in 2025 and 2026. See D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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 review of laboratory records, a proficiency testing review of the College of American Pathologists (CAP) Proficiency Testing (PT) records provided by CAP, and -- 4 of 5 -- interview with the laboratory owner; the laboratory director failed to ensure successful participation in their PT program for the routine chemistry analytes Ferritin, Low- Density Lipoprotein (LDL), Lactate Dehydrogenase (LDH), and Uric Acid; and for the subspecialty of Endocrinology overall and endocrinology analytes Free Thyroxine (FT4), Thyroid Stimulating Hormone (TSH), Total Triiodothyronine (TT3), and Cortisol for the following PT events in 2025 and 2026. See D2096, D2107, and D2108. -- 5 of 5 --

Summary Statement of Deficiencies 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, the Laboratory Personnel Report (CMS 209), and an interview with the laboratory director (LD), the laboratory failed to establish written policies and procedures that meet the personnel requirements in subpart M to assess employees performing General immunology testing for 2 out of 2 testing personnel (TP). Findings: 1. The employee files, the CMS 209, and competency policies and procedures were reviewed. 2. The CMS 209 lists 2 employees (TP1 and TP2) performing the following COVID-19 testing in the laboratory: *COVID-19 PCR by TaqPath Combo Kit; *COVID-19 PCR by NxTagCoV- Extended Panel Assay; *Access SARS-CoV2 IgG Assay *Access SARS-CoV2 IgM Assay *Rapid Diagnostic Test for the Detection of SAR-CoV2 Antigen; and *Rapid COVID-19 IgM /IgG Combo Test Kit. 3. The personnel documents presented revealed 2 out of 2 TP were evaluated and trained with procedures that failed to met the required criteria for personnel assessment of competency to perform both the moderately and highly complex testing for COVID-19. 4. The laboratory's competency policy and step-by- step procedure failed to include the following criteria as specified in the personnel requirements in subpart M: *Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; *Monitoring the recording and reporting of test results; *Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; *Direct observation of performance of instrument maintenance and function checks; *Assessment of test performance through testing previously analyzed specimens, internal blind testing samples 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 -- external proficiency testing samples; *Assessment of problem solving skills; and *Indicate whether the TP1 and TP2 assessment were "Satisfactory or Unsatisfactory"; and *Indicated whether the TP1 and TP2 required supervision or not. 5. On an Initial survey conducted on 03/31/2021 at 1:15 PM, the LD confirmed the above findings. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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 direct observations, record review, and an interview with the laboratory director (LD), the laboratory failed to ensure conditions that are essential for proper storage of reagents and specimens are performed as instructed by the manufacturer and in a manner that provides test results within the laboratory's stated performance specifications for coronavirus-19 (COVID-19) analysis, affecting all patients. "The laboratory failed to accurately monitor and document the laboratory's refrigerator temperature." Findings: 1. On 03/31/2021 at 11:00 AM during a tour of the laboratory, the surveyor observed in the refrigerator where patients' specimens were stored for digest. The thermometer used in the refrigerator did not indicate exact temperature readings but provided incremented ranges. 2. The procedure manual, temperature logs and calibration certifications were reviewed. 3. The procedure manual and the manufacturer's instructions revealed all refrigerators, freezers, and rooms temperatures are required to be monitored and documented to ensure optimal environmental conditions for patients specimens and testing. 4. Further review showed the laboratory failed to calibrate the above thermometer to ensure the accuracy of the color gradient ranges. 5. On an Initial survey conducted on 03/31 /2021 at 1:15PM, the LD confirmed the above findings. -- 2 of 2 --