Physician Laboratory Services

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 a proficiency testing (PT) desk review, the laboratory failed to successfully participate in a proficiency testing program approved by the Department of Health and Human Services (HHS). The laboratory failed to attain a satisfactory performance for the analyte Albumin in two out of three testing events, resulting in an unsuccessful participation. Refer to D2096 _ D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- (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 a desk review of the College of American Pathologists (CAP) proficiency testing (PT) results, the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D, and email communications with the technical supervisor (TS), the laboratory failed to achieve satisfactory performance for the analyte Albumin in two consecutive testing events in 2025. _ The findings include: 1. CAP 1st event 2025. a) Albumin = 60% 2. CAP 2nd event 2025. a) Albumin = 20% 3. Casper Report 0155D 1st event 2025. a) Albumin = 60% 4. Casper Report 0155D 2nd event 2025. a) Albumin = 20% 5. The TS confirmed these findings during email communications on August 19, 2025. 6. The laboratory performs approximately 331,784 chemistry tests annually. -- 2 of 2 --

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 of personnel competency documentation and interview with the general supervisor (GS), the laboratory failed to establish and follow written policies and procedures to assess competency testing for one of one technical supervisors (TS) and one of one general supervisors (GS), since the last survey was conducted on 02/10/2021. Findings: 1. Review of personnel competency documentation revealed the laboratory failed establish and follow written policies and procedures to assess competency for the positions of TS and GS since the last survey was conducted on 20/10/2021. 2. Interview with the GS on May 23, 2024, at 11:10 AM confirmed the laboratory failed to document competency for one of one TS and one of one GS for 2021, 2022, 2023, and 2024. 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) 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 -- 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 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 proficiency testing records review, lack of documentation and confirmation by the technical supervisor, the laboratory failed to retain complete blood count (CBC) instrument printouts from 1 of 5 events reviewed, the 3rd event of 2019; pentra 400 routine chemistry instrument printouts for 1 of 5 events reviewed, the 3rd event of 2020, and attestation statements 2 of 5 hematology testing events the 2nd and 3rd of 2019. Findings include: 1. Proficiency records review failed to include documentation the laboratory retained ABX Micros 60 instrument printouts from the 3rd Hematology CBC event of 2019; pentra 400 routine chemistry instrument printouts from the 3rd event of 2020, and attestation statements from the 2nd and 3rd hematology testing events of 2019. 2. In an interview conducted on 02/20/2021 at approximately 6:00 P. M. the technical supervisor confirmed some of the proficiency testing records could be missing from those provided for review. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) 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 -- 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 lack of documentation and confirmation by the technical supervisor, the laboratory failed to verify test accuracy twice annually for approximately 34 of 44 drugs and 10 of 10 antinuclear antibodies for 2 years of testing reviewed (2019 and 2020). The laboratory performed approximately 1625 drug assays per year and 1040 Antinuclear antibody (ANA) tests per year. Findings include: 1. The laboratory participation in College of American Pathology (CAP) urine drug testing UT module failed to include detection of approximately 34 of the drugs reported each year of testing. 2. The laboratory performed reflex testing for ANA testing for the subgroups Anti: IgA, IgG, and IgM, SM-96, RnP 96, SB-20, Jo 1, Centromere 96CE, Sci-70, 96 SC, SS-B, SS-A, and DNA 96 DS. Proficiency testing for these subgroups if included in the testing events for the CAP - S module were not graded by the proficiency testing agency and not self graded by the laboratory in 2019 and 2020. 3. In an interview on 02/10/2021 at approximately 6:15 P.M. the technical supervisor confirmed the laboratory did not self grade proficiency test results when not graded by the proficiency testing agency and did not have a method to verify test accuracy for reflex ANA tests. , D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on direct observation, lack of documentation, and interivew with the technical supervisor, the laboratory failed to establish a maintenance protocol to verify they followed the manufacturer's requirement that Quantiferon specimens be vortexted using 30 RPM'S. The laboratory performed approximately 10 to 15 Quantiferon TB Gold tests per week. Findings include: 1. Direct observation of the Vortemp vortex mixer on 02/10/2021 at approximately 8:45 A.M. lead to an interview with the technical supervisor for the test the instrument was used for. 2. In an interivew on 02 /10/2021 at approximately 1:00 P.M. the technical supervisor stated the vortex mixer was used for TB Quantiferon and the laboratory did not document instrument maintenance that included verification of the 30 RPM rotations of the flat bed used to mix microtiter trays containing the specimen, reagents, and antibody coated tests wells. D5467 CONTROL PROCEDURES CFR(s): 493.1256(d)(9)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations -- 2 of 5 -- Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- When using calibration material as a control material, use calibration material from a different lot number than that used to establish a cut-off value or to calibrate the test system. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) records review, lack of documentation, and interivew with the technical supervisor, the laboratory failed to ensure they used calibration materials from different lot numbers as the standards used for standard curve determination for approximately 64 of 64 drugs the laboratory reported. The laboratory performed approximately 10 to 30 drug concentration analyses twice a week. Findings include: 1. Quality control records review included the lot numbers of quality control materials in use from February 2019 to February 2021. Quality control records review included documentation for stock solution verification of control concentrations made from dilutions of Cerilliant drug standards used to establish a standard curve for each day of gas chromatography, tandem mass spectrometry testing. 2. The laboratory lacked documentation they used two different lot number of standards to make controls and standard curve dilutions points used to compare instrument reading for the calculation of drug concentrations for the determination of the presence or absence (by cut off concentrations) of drugs in patient's urine specimens. 3. In an interivew conducted on 02/10/2021 the technical supervisor confirmed at approximately 6:15 P.M. the laboratory used the same lot numbers of standards for creating the standard curve and for controls. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on lack of test specification verification of analytical specificity and sensatory for Anti: nuclear antibody, Cyclic Citrulinated Peptide, dsDNA, P, S-SA, S-SB Sm, Sm RNP, Sci-70, Jo-1. Centromere, and RNP 70 reflex tests following a positive Anti nuclear Antibody test; and Qiagen QfTB Gold Quantiferon test for the presence or absence of Mycobacterium Tuberculosis, the director failed to ensure verification procedures were adequate to determine analytic sensitivity and specificity. (See D5423) D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on proficiency testing records review, lack of documentation, quality assessment plan review, and interview with the general immunology technical -- 3 of 5 -- supervisor, the laboratory failed to maintain their quality assessment policy the end of 2019 and the first of 2020 when the laboratory failed to self grade Antinuclear antibody (ANA) proficiency tests. Findings include: 1. College of American Pathology (CAP) failed to actually grade ANA tests for the S-C event of 2019 and for event S-A of 2020 due to less than 10 participants using the same methodology for the tests. 2. The quality assessment plan included acceptable participation in proficiency testing that is sent 3 times per year. 3. In an interview conducted on 02/10/2021 at approximately 6:30 P.M. staff confirmed the proficiency company did not grade the ANA test results and the laboratory did not have a procedure for lack of a graded proficiency test acceptable participation. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on lack of documentation and confirmation by the technical supervisor the laboratory failed to ensure 1 of 2 high complexity testing personnel met the requirements for high complexity testing personnel for mass spectrometry and immunoassay testing. (See D6171) D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical -- 4 of 5 -- laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on personnel records review, lack of documentation, and interview with the laboratory technical supervisor for toxicology, routine chemistry, and endocrinology, one of two testing personnel failed to have at least six semester hours in chemistry to qualify as a high complexity testing person for toxicology, general immunology, or hematology testing. Findings include: 1. Personnel records review of the transcript presented for qualification included zero chemistry credit hours for test person 2. 2. Training records included documentation the laboratory trained test person 2 for immunoassay testing on 10/06/2020 and mass spectrometry testing on 01/26/2021. 3. In an interview conducted on 02/10/2021 at approximately 10:30 A.M. the laboratory technical supervisor for routine chemistry, endocrinology, and toxicology confirmed the transcript did not include 6 semester hours of chemistry to qualify test person 2 as a high complexity test person. The laboratory technical supervisor confirmed test person 2 was trained for high complexity testing and stated that to date had not performed any mass spectrometry high complexity tests. The number of high complexity immunoassay tests performed was not determined. -- 5 of 5 --

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. This STANDARD is not met as evidenced by: Based on lack of documentation and confirmation by staff, the laboratory failed to record the lot numbers and expiration dates of reagents used on the hematology cell counter from March of 2019 when testing began, to October 2019. The laboratory performed approximately 10 complete blood counts (CBCs) per day. Findings include: 1. The laboratory failed to record the lot number, manufacturer's expiration date, the date the reagent was placed into use and the modified expiration date (if applicable) for complete blood count reagents used on the ABX Micros 60 instrument. 2. In an interview with the laboratory technical supervisor on 10/28/2019 at approximately 4:30 P.M. the supervisor confirmed the laboratory did not maintain the reagent log for CBC test's reagents from the time the laboratory started reporting CBC results to the day of survey. 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 D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on semi annual Toxicology test accuracy verification record review, lack of documentation, and interview with staff, the laboratory failed to establish a policy to assess and document