Bridges Clinic Llc

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory proficiency testing records and interview with the technical consultant, the laboratory failed to retain all proficiency testing records to include attestation statements, submitted results and analyzer printouts for five of six hematology proficiency testing events reviewed for 2023 and 2024. Findings include: 1. Review of the proficiency testing records for the 1st, 2nd and 3rd events of 2023 and the 1st, 2nd and 3rd events of 2024 revealed the laboratory did not retain the following records: a. Attestation statements for the 1st and 2nd events of 2023 and the 1st event of 2024. (3 of 6 events attestation statements not retained) b. Submitted result sheets for the 1st and 2nd events of 2023 and the 3rd event of 2024. (3 of 6 events submitted result sheets not retained) c. Analyzer printouts for the 1st, 2nd and 3rd events of 2023, and the 1st event of 2024 (4 of 6 events analyzer printouts not retained) 2. The technical consultant confirmed on 3/27/2025 at 11:00 a.m. the listed proficiency records were not retained after completion of each proficiency testing event. 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: 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 -- Based on review of proficiency testing records since the last survey on 1/26/2023 and lack of documentation of verification of accuracy for parathyroid hormone (PTH), prostate-specific antigen (PSA), testosterone, and Vitamin D performed on the Tosoh AIA-900 chemistry analyzer, the laboratory failed to verify the accuracy of these analytes for the 2nd event of 2024 (1 of 4 events) when proficiency testing scores were unsatisfactory. The laboratory must verify the accuracy of tests not listed in subpart I twice annually. Findings include: 1. Review of proficiency testing records for 2024 revealed the following scores for 2nd event: a. Parathyroid hormone (PTH) - 50% b. Prostate-specific antigen (PSA) - 50% c. Testosterone - 0% d. Vitamin D - 0% 2. The technical consultant confirmed in an interview on 3/27/25 at 11:45 a.m. the laboratory failed to verify the accuracy of parathyroid hormone (PTH), prostate- specific antigen (PSA), testosterone, and Vitamin D twice annually for 2024 as required by the CLIA regulations. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on an interview with the technical consultant, review of Orthoclinical Diagnostic Vitros XT 3400 system verification validation records used as the procedure manual for chemistry testing and lack of documentation of review by the laboratory director, the laboratory director failed to approve, sign, and date the procedure manual before the Orthoclinical Diagnostic Vitros XT 3400 was put into use for patient testing. Findings include: 1. An interview with the Technical Consultant on 3/27/25 at 10:30 a.m., revealed the validation records were not signed and approved by the laboratory director. 2. Review of the Vitros XT 3400 validation records emailed on 3/27/25 at 10:47 a.m., revealed no documentation of the laboratory director's approval and signature. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of quality control records, patient test counts, and review of verification of performance specifications for the Tosoh AIA-900 chemistry system from 9/19/2023 (date of installation) through 3/27/2025, the laboratory failed to verify the manufacturer's performance specifications for three of nine analytes before reporting patient test results. The laboratory must verify the performance specifications of each nonwaived test system it introduces prior to reporting patient results. Findings include: Review of verification of performance specifications for the -- 2 of 4 -- Tosoh AIA-900 chemistry system revealed on the day of the survey, 3/27/2025, there was no documentation of verification of performance specifications for parathyroid hormone (PTH), luteinizing hormone (LH), and cortisol testing available for review to include accuracy, precision, reportable range of test results, and verification of the manufacturer's reference intervals for the laboratory's patient population. The laboratory's annual patient test count for PTH, LH and cortisol testing was 167. . D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 review of the Orthoclinical Diagnostic Vitros XT 3400 analyzer maintenance logs from 10/1/23 through 3/27/25 and review of Orthoclinical Diagnostic Vitros XT 3400 periodic maintenance activity list printed from the instrument, the laboratory failed to document, as performed, weekly maintenance for seventy-four of seventy-eight weeks and monthly maintenance for fifthteen of sixteen months. Findings include: 1. The Orthoclinical Diagnostic Vitros XT 3400 analyzer defines the following weekly and monthly maintenance procedures: Weekly Maintenance: 1. Clean Tip Sealer 2. Clean Sample Supply 3. Clean Tip locator 4. Clean Dispense Blade and Sensors 5. Clean Leak Pad 6. Clean touchscreen monitor and keyboard 7. Process VITROS MicroSensor Check Fluids I and II Monthly Maintenance: 1. Clean PM Discard Chute 2. Clean/Replace PM Evaporation Caps 3. Clean PM Incubator Slot and Insert Balde Channels 4. Clean MicroSensor Cover 5. Perform System Backup 6. Inspect/Clean master Computer Filter 7. Perform Correction Factors 8. Replace System Filter 9. Perform Pad Reflectance Test 2. Review of the Orthoclinical Diagnostic Vitros XT 3400 analyzer maintenance logs from 10/1/23 through 3/27/25 revealed the laboratory failed to document, as performed, the weekly maintenance procedure for 74 of 78 weeks. 3. Review of the Orthoclinical Diagnostic Vitros XT 3400 analyzer maintenance logs from 10/1/23 through 3/27/25 revealed the laboratory failed to document, as performed, the monthly maintenance procedure for 15 of 16 months. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records for the Orthoclinical Diagnostic Vitros XT 3400 system, manufacturer's Performance Verifier's (PV) package inserts -- 3 of 4 -- for lot #T1396, lot #U1398 and lot #X1901, and interview with the technical consultant, the laboratory failed to document, as performed, the establishment of statistical parameters for acceptable ranges for Chemistry testing for thirteen of thirteen months. Findings include: 1. Review of quality control records from 10/1/23 through 11/30/24 revealed no documentation of acceptable ranges on the QC reports for PV I lot #T1396, PV II lot #U1398 and lot #X1901. Testing Personnel used Range of Means listed on Performance Verifier's package insert as statistical parameters for acceptable ranges. 2. The technical consultant confirmed in an interview on 3/27/25 at 12:30 p.m., there were no establishment of statistical parameters for acceptable ranges for thirteen of thirteen months while using PV I and PV II. Approximately 1,592 patients were tested during this time. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) (e)(4)(iv) An approved

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 proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 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 surveyor desk review of the laboratory proficiency testing (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 3 -- (graded copies from the American Proficiency Institute (API) and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 3/25/2024, the laboratory failed to maintain satisfactory performance in two of two testing events (2023-Event 3 and 2024-Event 1) resulting in unsuccessful participation for the subspecialty ENDOCRINOLOGY and the analyte FREE THYROXINE. Refer to D2107, D2108 D2107 ENDOCRINOLOGY CFR(s): 493.843(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 surveyor desk review of the laboratory proficiency testing records (graded copies from the American Proficiency Institute and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 3/25/2024, the laboratory failed to achieve satisfactory performance for Free Thyroxine in two of two consecutive testing events. Findings include: A review of the laboratory records from the American Proficiency Institute (API) and the CMS CASPER reports 0153D /0155D revealed the laboratory scored the following for Free Thyroxine: : Free Thyroxine: Year 2023 - 3rd Event: 0% Year 2024 - 1st Evemt 20% D2108 ENDOCRINOLOGY CFR(s): 493.843(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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 3-25-24, the laboratory failed to achieve satisfactory performance for ENDOCRINOLOGY in two of two testing events. Findings include: Our records indicate the following proficiency testing scores for your laboratory for ENDOCRINOLOGY: PROFICIENCY TESTING PROVIDER: American Proficiency Institute YEAR 2023 - 3rd Event: 0% YEAR 2024 - 1st Event: 73% 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. This CONDITION is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing records (graded -- 2 of 3 -- copies from the American Proficiency Institute and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 3/25/2024, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing records (graded copies from the American Proficiency Institute and CASPER report 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 3/25/2024, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2107, D2108. -- 3 of 3 --