Synergy Medical Laboratories Inc

Summary Statement of Deficiencies 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. In addition, retain the following: This STANDARD is not met as evidenced by: A) Based on surveyor review of the Test Records (TR), Quality Control (QC) and interview with the General Supervisor (GS), the laboratory failed to retain documentation of all analytical system activities records for two years for Chemistry testing performed on the Beckman Coulter AU480 from 3/31/21 to 10/9/25. The findings includes. 1. The hard drive for the Beckman Coulter AU480 crashed on 10/9 /25. 2. The data on the hard drive was not backed up and was lost. 3. The GS confirmed on 10/22/25 at 12:45 PM the laboratory did not retain all analytical system activities records. B) Based on surveyor review of the Quality Control Records (QCR) and interview with the General Supervisor (GS), the laboratory failed to document all Quality Control (QC) information for Chemistry tests performed on the Beckman Coulter AU480 analyzer from to 3/31/21 to 10/22/25 . The finding includes: 1. The laboratory did not document the lot numbers and expiration dates of QC material used on QCR for the Beckman Coulter AU480 analyzer. 2. The GS confirmed on 10/22/25 at 1:30 pm, the laboratory did not document all QC information. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the General Supervisor (GS), the laboratory failed to review and evaluate PT results obtained from the American Proficiency Institute (API) for Chemistry in the calendar year 2025 . The findings include: 1. The laboratory did not evaluate "Not Graded 1", "See Data Summary" responses from API in event 1, 2025 for the following: a) Bilirubin, Direct (mg/dL) samples CH-01,02,03,04,and 05. 2. The laboratory did not evaluate "Not Graded 1", "See Data Summary" responses from API in event 3, 2025 for the following: a) Bilirubin, Direct (mg/dL) samples CH-11,13,13,14 and 15 3. The GS confirmed on at 10:30 am on 10/21/25 that the laboratory failed to evaluate the above mentioned coded results. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the General Supervisor (GS) laboratory failed to verify the accuracy and received a score that did not reflect the performance of Total Bilirubin test results obtained from the American Proficiency Institute (API) for the Chemistry-Core 3rd event 2025. The findings include: 1. The laboratory received a score of 100% but received a "Not Graded 1" for Total Bilirubin samples CH-12 and CH-15. 2. API reported the range for Total Bilirubin sample CH-12 as 1.4 - 2.3 mg/dL. 3. The laboratory reported Sample CH-12 as out of range for Total Bilirubin with 2.5 mg/dL. 4. API reported the range for Total Bilirubin sample CH-15 as 1.0 - 1.9 mg/dL. 5. The laboratory reported Sample CH-15 as out of range for Total Bilirubin with 2.0 mg/dL. 6. After evaluation of the "Not Graded 1" results the laboratory obtained a score of 60% 7. The GS confirmed on 10/21/25 at 10:20 am the laboratory received a PT score that did not reflect the laboratories performance of Total Bilirubin testing. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Quality Control (QC) and interview with the General Supervisor (GS) the laboratory failed to follow the laboratories procedure "Establishment of Control Ranges" for the Advia Centaur XP analyzer used to perform Endocrinology and Virology testing from 3/31/21 to 10/21 /25. The findings include: 1. The procedure "Establishment of Control Ranges" stated -- 2 of 5 -- "4. Compare received values (i.e. mean and SD) for new control to the manufacturer's published value sheet for the respective analyzer or method utilized. Recovered values must be within +/- 10% for the manufacturer's published range depending on the assay being evaluated (e.g. some enzyme assays may vary by +/- 30%)" 2. There was no documented evidence that the above mentioned procedure was performed prior to putting new QC lots into use. 3. The GS confirmed on 10/21/25 at 10:55 am, the laboratory failed to follow the above menrioned prcoudre. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control (QC), review of the Liquichek Assayed Multiqual manufactuers Assay Value Sheet (AVS) and interview with the General Supervisor (GS), the laboratory failed to follow the AVS for the Routine Chemistry testing performed on the Beckman Coulter AU480 analyzer from 3/31/21 to 10/22/25. The findings include: 1. The laboratory used QC values outside the manufactuersAVS range for the following analytes. a. Amylase b. High-density lipoprotein c. Phosphate d. Uric Acid e. Calcium 2. The GS confirmed on 10/22/25 at 2:00 pm that the laboratory failed to follow the manufactuers AVS. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 the lack of Calibration Verification (CV) records and interview with the General Supervisor (GS), the laboratory failed to perform and document CV procedures at least every six months on the Adiva Centaur XP analyzer from 3/31/21 to 10/22/25. The findings include; 1) The laboratory is running two levels of Quality -- 3 of 5 -- Control (QC) on the Adiva Centaur XP analyzer for Endocrinology, Virology and Chemistry testing. 2) There was no documented evidence that a linearity was performed every six months. 3) The GS confirmed on 10/22/25 at 1:30 pm that a linearity was not performed every six months on the Adiva Centaur XP analyzer. D5783

Summary Statement of Deficiencies 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 an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve a score of 80% or more for Routine Chemistry tests performed with the American Proficiency Institute (API). The finding includes: 1) The laboratory scored 60% for Aminotransferease (ALT) for the 1st event - 2023 with API. 2) The laboratory scored 60% for ALT for the 2nd event- 2023 with API. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) 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 -- Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve at least 80% for Aminotransferease (ALT) test. The finding includes: 1) The laboratory scored 60% for ALT for the 1st event - 2023 with API. 2) The laboratory scored 60% for ALT for the 2nd event- 2023 with API. 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 an office review of the laboratory's performance in Proficiency Testing (PT) surveys, the laboratory director failed to provide appropriate direction to the laboratory personnel to ensure that the PT surveys are performed satisfactorily and compliance with the CLIA regulations are maintained. -- 2 of 2 --

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on the surveyor review of the Final Reports (FR) and interview with the General Supervisor (GS), the laboratory failed to have accurate Reference Ranges (RR) for Prothrombin Time (PT), International Normalized Ratio (INR) from 9/18/19 to the date of the survey. The findings include: 1. A review of the FR revealed the RR for PT was 12-15 seconds, but the laboratory did not establish a normal patient mean.. 2. A review of the FR revealed the RR for INR was 2-3 ratio, but the FR has interpretation of normal as 0.9-1.1. 3. The GS confirmed on 4/26/21 at 11:00 am that these tests did not have accurate Reference Ranges on the FR. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on the review of Proficiency Testing (PT) records and interview with the General Supervisor (GS), the laboratory failed to enroll in an approved PT program for Prothrombin Time and International Normalized Ratio (PTT/INR) test from November 2019 to the date of survey. The GS confirmed on 3/31/21 at 1:00 pm the laboratory was not enrolled in PT testing for PTT/INR. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- 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 surveyor review of the Proficiency Testing (PT) records and interview with the Technical Supervisor (TS), the laboratory failed to maintain the Work Records (WR) and Attestation Statements (AS) signed by the laboratory director for Chemistry and Hematology tests performed with the American Proficiency Institute (API) in 2019 and 2020. The findings include: 1. The laboratory did not document handling, processing and each step in the testing and reporting of PT samples. 2 . There were no PT WR available for the Beckman Coulter AU 480 for 2019 and 2020. 3 . There was no AS for 2019 Chemistry - Core- 2nd and 3rd Event 4 . The TS confirmed on 3/31 /21 at 2:15 pm that the laboratory did not maintain complete records for PT. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Technical Supervisor (TS), it was revealed that the laboratory failed to review "not graded" results obtained for Chemistry PT performed with the American Proficiency Institute (API) in 2019. The finding includes: 1.Ungraded results were received for: 2019 Chemistry- Core- 1st Event: Alanine Transaminase- Sample CH-04, Gamma- Glutamyl Transferase- Samples CH-02 through CH-05 2. The TS confirmed on 03/31 /21 at 2:30 pm that the laboratory failed to evaluate "not graded" PT results. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) results and interview with the Technical Supervisor (TS), the laboratory failed to evaluate results when the laboratory received unacceptable scores for Chemistry and Hematology Testing performed with the American Proficiency Institute ( API ) in 2019 and 2020. The findings include: 1. The laboratory received unacceptable grades in the following events: a. 2019 Chemistry- Core- 1st Event : Albumin- Sample CH-02, LDL Cholesterol -Sample CH-02, Phosphorus- Samples CH-02 and CH-03 b. 2019 Chemistry- Core- 2nd Event : Albumin- Sample CH-06, Alkaline Phosphatase- Samples CH-06 through CH-10, ALT/SGPT- Sample CH-06, Chloride- Sample CH- 08, Creatine Kinase- Sample CH-09, Potassium- Sample CH-08, Sodium- Sample CH- 08, Thyroid Stimulating Hormone - Sample CH-07 c. 2019 Chemistry- Core- 3rd Event : ALT/ SGPT- Samples CH-11 and CH-12, Calcium Total - Samples CH-12 through CH-15, Creatinine- Samples CH-12 through CH-15, Iron, Total- Samples CH- 11 and CH-12, Phosphorus- Samples CH-12 through CH-15, Urea Nitrogen/ BUN- Sample CH-14, Thyroxine- Sample CH-15 d. 2020 Chemistry- Core - 1st Event : -- 2 of 9 -- Chloride- Sample CH-04, Iron/ Total- Sample CH-04,Phosphorus- Sample CH-01, Urea Nitrogen/ BUN- Sample CH-05 e. 2020 Chemistry - Core- 2nd Event : ALT/ SGPT- Sample CH-09, Glucose- Sample CH-09, Phosphorus- Samples Ch-07 and CH- 10, TIBC, measured- Samples CH-06 through CH-10 f. 2019 Hematology/ Coagulation - 1st Event: Basophils- Sample PNT-03 g. 2020 Hematology/ Coagulation- 1st Event: Monocytes- Sample PNT-05 2. No evaluation or

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: a) Based on surveyor review of the Proficency Testing (PT) records and interview with the Technical Supervisor (TS), the laboratory failed to evaluate results when they received Not Graded score in Chemistry - Core with American Proficiency Institute in the 1st and 2nd events of 2019. The findings include: 1. There was no evaluation documented when the laboratory received "Not Graded" for analytes Alkaline Phosphatase sample CH-01, Alanine Aminotransferease sample CH-04, Gamma- glutamyltransferase samples CH-02 through CH-05 for 1st event 2019. 2. There was no evaluation documented when the laboratory received "Not Graded" for analytes Albumin Sample CH-06, Alkaline Phosphatase Samples CH-06 through CH-10, Alanine Aminotransferease sample CH-06, Chloride sample CH-08, Creatine Kinase sample CH-09, Potassium sample CH-08, Sodium sample CH-08, Thyroid Stimulating Hormone sample CH-07 for 2nd event 2019. 3. There was no documented evidence the laboratory evaluated coded results. 4. The TS confirmed on 9/18/19 at 11: 00 am that the laboratory did not perform and document an evaluation of unacceptable PT results. 35471 b) Based on surveyor review of the PT records and interview with the TS, the laboratory failed to evaluate flagged and Unacceptable (U) results obtained with Pennsylvania Department of Health PT for Drugs of Abuse in Urine in the calendar year 2018. The findings include: 1. There was no evaluation documented when the laboratory received a "flag" on the Methadone result in the 1st event of 2018. 2. There was no evaluation documented when the laboratory received a U in the 3rd event of 2018. 3. There was no evidence the laboratory evaluated the failures. 4. The TS confirmed on 9/18/19 at 10:00 am that the laboratory did not perform and document an evaluation of unacceptable PT results. 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 -- 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)