Savida Health Pc

Summary Statement of Deficiencies 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 record review and staff interview with the Laboratory Director (LD) the laboratory failed to verify at least twice annually the accuracy of Xylazine in the subspecialty of Toxicology. Findings include: 1. Record review on 2/10/2025 of the laboratory's CMS form 116 and test list revealed the laboratory is now performing Xylazine testing. 2. Record review on 2/10/2025 of the laboratory's validation records for Xylazine revealed: a. The Xylazine testing procedure was signed by the LD on 7/3 /2023 and the laboratory began Xylazine testing on 7/3/2023. b. The accuracy of the Xylazine test was performed once in 2023 as part of the validation. 3. Record review on 2/10/2025 of the laboratory's 2023, 2024 and 2025 to date Toxicology College of American Pathologists (CAP) proficiency testing (PT) records revealed the laboratory was not enrolled in PT for Xylazine testing because CAP does not offer PT testing for Xylazine. 4. Staff interview with the LD on 2/10/2025 at 11:00 AM confirmed the above findings. The LD stated, "There isn't any PT for Xylazine and we did not check the accuracy twice annually by any other method after the validation in 2023." 5. The laboratory performs 1, 980,000 Toxicology tests annually. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. 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 -- Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on record review and staff interview with the Laboratory Director (LD), the laboratory did not define a function check protocol for all equipment to ensure test system performance that is necessary for accurate and reliable test results in the subspecialty of Toxicology. Findings include: 1. Record review on 2/10/2025 of the laboratory's maintenance and function check records revealed, the laboratory did not have documented function checks for laboratory pipettes. 2. Record review on 2/10 /2025 of the laboratory's procedure manual revealed the laboratory did not have a procedure for the calibration of laboratory pipettes. 3. Staff interview with the LD on 2 /10/2025 at 12:00 PM, the LD stated, "Laboratory pipettes are purchased every year. We purchased new 8 channel pipettes, consisting of (1) 100 to 300 uL and (1) 50- 1250 uL in March of 2022 and single channel pipettes, consisting of (1) 20-200 uL and (1) 100-1000 uL in October of 2022. The laboratory did not calibrate or check the function of the pipettes in 2023 or 2024. We do not have a procedure in place to calibrate the pipettes. I am not sure what the manufacturer's requirements are for calibrating the pipettes." 4. The laboratory performs 1,980,000 Toxicology tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the SAvida Health, PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. Please refer to Conditions of Participation for Clinical Laboratories 42 CFR Part 493. . 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) -- (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 record review and interview, the laboratory failed to perform calibration 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 -- verifications that covered the reportable range of all analytes as evidenced by the following: a) A review of urinary specific gravity calibration records for calendar year 2022 was performed. b) The review revealed that the calibration verifications performed did not cover the reportable range of 1.0010 to 1.0020. The calibration verifications performed on 4/12/22 and 10/12/22 had three (3) points. The three points were all listed as 1.0002 so did not cover the middle and upper range of the reportable range. c) The laboratory director one confirmed in an interview on 2/8/23 at 10:50 AM that the calibrations performed had not covered the reportable range of the method. d) The laboratory performs approximately 103,000 urinary specific gravity tests annually. . -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Savida Health, PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (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 record review and interview, the laboratory failed to perform complete validation studies for twelve (12) of twelve (12) unmodified, FDA-cleared, or approved newly implemented test systems, prior to reporting out patient testing results as evidenced by the following: Within run precision: a) A review of validation studies for the Routine Chemistry and Toxicology analytes performed on the Beckman DxC 700 AU chemistry analyzer. revealed that the laboratory failed to include within run precision studies as part of the validation for twelve (12) of the moderate complexity test analytes being performed (creatinine, urinary pH, urine specific gravity, amphetamine, benzodiazepine, buprenorphine, cannabinoid, cocaine metabolite, ethanol, methadone, opiates, and oxycodone). b) The technical supervisor confirmed in an interview on 4/7/21 at 10:33 a.m. that the within run precision studies had not been completed for the 12 moderate complexity analytes. The laboratory performs 1,066,000 Routine Chemistry and Toxicology assays on the analyzer annually. . 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 -- D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to establish performance specifications for one (1) of one (1) newly implemented test systems not subject to FDA clearance as evidenced by the following: Fentanyl Within run precision: a) A review of validation studies for the Routine Chemistry and Toxicology analytes performed on the Beckman DxC 700 AU chemistry analyzer revealed that the laboratory failed to include within run precision studies as part of the validation for one (1) of the high complexity, non FDA categorized, analytes being performed (fentanyl) prior to reporting out patient testing results. b) The technical supervisor confirmed in an interview on 4/7/21 at 10:33 AM that the within run precision studies for fentanyl had not been completed. The laboratory performs 82,000 fentanyl assays annually. Specificity and selectivity: a) A review of validation studies for the Beckman DxC 700 AU revealed that the laboratory failed to address specificity and selectivity as part of the validation for the high complexity, non FDA categorized, fentanyl analyte. b) The technical supervisor confirmed in an interview on 4/7/21 at 10:33 a.m. that specificity and selectivity studies had not been included as part of the validation. The laboratory performs 82, 000 fentanyl assays annually. . -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Savida Health, PC laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years as evidenced by the following: a) A review of quality control records for calendar year 2017 and 2018 revealed that the lot number and acceptable ranges of past and present quality control material, utilized in Liquid Chromatography- Mass Spectrometry (LC-MS) confirmatory drug testing, was not retained by the laboratory. b) Technical supervisor number 2 confirmed in an interview on 2/8/19 at 10:50 AM that lot numbers and control ranges were not being routinely retained. c) The laboratory performs approximately 753,194 confirmatory drug test utilizing LC- MS annually. . 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; 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 -- (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(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 record review and interview, the laboratory failed to perform calibration verifications every six months or, as appropriate, as evidenced by the following: a) A review of quality control records for calendar years 2017 and 2018 was performed. The review revealed that calibration verifications of at least 3 points were not performed once every six months for one (1) of one (1) chemistry analytes requiring calibration verification on the Biolis 24i chemistry analyzer. Six month calibration verifications for urinary creatinine were not available for calendar years 2017 and 2018. b) General supervisor number 1 interviewed on 2/8/19 11:40 AM confirmed that calibration verifications of at least 3 points had not been performed at least once every six months for urinary creatinine. c) The laboratory performs approximately 22,824 urinary creatinines annually. . -- 2 of 2 --