Care Station Medical Group

Summary Statement of Deficiencies 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 the surveyor review of the Procedure Manual (PM) and interview with the Technical Consultants (TC) the PM lacked a correlation procedure for Virology tests performed from 9/1/24 to 2/5/25. The findings include: 1. The PM lacked a procedure for instrument correlation between the Solana and Cepheid GeneXpert analyzers which both perform FLU A/B, Respiratory Syncytial Virus and SARS-COV2 testing. 2. The TC confirmed on 2/5/25 at 12:20 pm, the above mentioned procedure was not available for review. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation of Quality Control (QC) material in use, review of the Liquichek Immunoassay Plus Control Kit Manufactuers Package Insert (MPI) and 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 -- interview with the Techincal Consultant (TC), the laboratory failed to put correct expiration dates on QC material for the routine chemistry tests on 2/5/25. The findings include: 1. The expiration date of the QC material shortens once opened. 2. The laboratory had an open date of 2/3/25 and expiration date of 2/10/25 (seven days of stability) on QC material in use. 3. The MPI states Folate had 3 days stability. 4. The TC confirmed on 2/5/25 at 11:45 am the laboratory failed to put correct expiration dates on the control material. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation of Beckman coulter Cleaning Solution,and interview with the Techincal Consultant (TC), the laboratory failed to discard expired reagent from 1/5/25 to 2/5/2025. The findings include: 1. Beckman Coulter Cleaning Solution Lot# 2772 expired 1/5/25. 2. The TC confirmed on 10/3/24 at 10:30 am that the laboratory failed to discard expired reagent. 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 the lack of Quality Control Verification (QCV) records and interview with the Technical Consultants (TC), the laboratory failed to verify commercially assayed QC material with each new lot and/or shipment used on the Cepheid GeneXpert analyzer for Bacteriology and Virology testing from 2/1/23 to 2/5/25. The finding includes: 1. There were no QCV records available for review for the Cepheid GeneXpert analyzer. 2. The TC confirmed on 2/5/25 at 12:20 pm, the assayed values of QC material were not verified before patient testing. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e)(5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on surveyors observation of Quality Control (QC) material in use, review of Zeptometrix Manufacturers package inserts (MPI) and interview with the Technical Consultants (TC), the laboratory failed to follow Manufacturers Specifications (MS) for Zeptometrix QC material used for Bacteriology and Virology tests performed on the Cepheid GeneXpert analyzer from 2/1/23 to 2/5/25. The finding includes: 1. Zeptometrix QC material used in Virology tests was observed to be aliquotted and stored in a freezer at a temperature of-23 to -25C. 2. The MPI states "positive control should be stored at 2-8C upon arrival" 3. Zeptometrix QC material used in Bacteriology tests was observed to stored in a freezer at a temperature of -23 to -25C. 4. The MPI states "controls should be stored at 2-8C", "Each vial is intended for single use." 5. The TC confirmed on 2/5/25 at 1:20 pm that MS were not followed. D5807 TEST REPORT CFR(s): 493.1291(d) (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 surveyor review of the Finial Report (FR), Procedure Manual (PM), and interview with the Techincal Consultant (TC), the laboratory failed to ensure that the Reference Interval (RI) was accurate for Cholesterol run on the AU480 analyzer form May 2024 to 2/5/25. The finding includes: 1. There was no RI on the FR for Cholesterol. 2. The TC confirmed on 2/5/25 at 11:30 am that the laboratory failed to ensure the RI was accurate. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) (b)(3) Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed; This STANDARD is not met as evidenced by: Based surveyor review of the Quality Control Records (QCR) and interview with the Technical Consultants (TC), TP failed to document all Quality Control (QC) information on the QCR for Bacteriology and Virology tests performed on the Cepheid GeneXpert analyzer from 2/1/23 to 2/5/25. The findings include: 1. TP did not document the lot number and expiration dates of QC material used on the QCR performed on 1/27/25 for Virology tests. 2. TP did not document the lot number and expiration dates of QC material used on the QCR performed on 1/16/25 for Bacteriology tests. 3. The TC confirmed on 2/5/25 at 11:50 am, the laboratory did not document all QC information on the QCR for the Cepheid GeneXpert analyzer. -- 3 of 3 --

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 surveyor review of the Proficiency Testing (PT) records and interview with the Laboratory Manager (LM), the Laboratory Director failed to sign attestation statements for the 2020 and 2021 Hematology/Coagulation and Chemistry Core events with the American Proficiency Institute (API). The LM confirmed on 12/21/21 at 10:00 am that PT records were not maintained. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance 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 -- characteristics of the method; This STANDARD is not met as evidenced by: Based on surveyor review of the Linearity/Calibration Verification (CV) report and interview with the Laboratory Manager (LM), the Laboratory Director (LD) failed to ensure that CV procedures performed on the Abbott Architect c 4000 analyzer were adequate on 1/10/20. The findings include: 1. The LD did not review and sign the CV results. 2. The LM confirmed on 12/21/21 at 11:00 am that CV records were not adequate. -- 2 of 2 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor review of Manufactures Package Insert, observation of the Quality Control (QC) material, and interview with the General Supervisor (GS), the laboratory failed to put new expiration dates on endocrinology Controls from (other survey) to the date of survey. The findings include. 1. The MPI for Lyphochek Immunoassay Plus Controls stated that QC material for Prostate-Specific Antigen expired 3 days after opening if stored at 2 to 8 degrees Celsius. 2. The GS was not aware that QC material expired 14 days after opening. 3. The GS on CMS form 209 confirmed on 3 /28/19 /19 at 3:00 pm the laboratory failed to put new expiration dates on the control material. 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. 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Performance Specification (PS) records and interview with the Technical Supervisor (TS), the laboratory failed to verify the Manufacturer's Reference Interval (MRI) for routine chemistry, and Hematology tests performed on Tosho AIA-2000 and Sysmex XSi1000 analyzer respectively from April 2018 to the date of survey. The TS confirmed on 3/28/19 at 12:30 pm that MRI was not verified for routine chemistry, and hematology testing. 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: a) Based on surveyor review of the Final Report (FR), Manufacturer Package Insert (MPI) and interview with the General Supervisor (GS), the laboratory failed to identify the source of the Reference Intervals (RI) used for Folate, Vitamin B12 (vitB12), and Prostate-Specific Antigen (PSA) from April 2018 to the date of survey. The findings include: 1. The GS stated the laboratory used the RI listed in the MPI. 2. The RI in the PM differed from the FR as follows: a. Folate: FR: 3-17 ng/dL - MPI: 3- 16 ng/dL b. vitB12: FR 230-1050 pg/mL - MPI 173-700 pg/mL c. PSA: FR 0-4.3 ng /mL - >4.0 ng/mL 3. The GS confirmed on 3/28/19 at 1:00 pm that the RI on the FR was not that of the RI in the MPI. b) Based on the surveyor review of the Final Reports (FR) and interview with the GS, the laboratory failed to have a Reference Range (RR) for rapid plasma reagin test on the FR from (other survey) to the date of the survey. The GS confirmed on 3/28/19 at 2:20 pm that the above test did not have a RR on the FR. -- 2 of 2 --