Main Street Family Medicine Inc

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: CITATION ONE: Based on laboratory observation, a review of the laboratory procedure manual, competency assessment documentation, lack of documentation, and staff interview, the laboratory failed to follow the established policy for competency assessment for three of three testing personnel (TP) who performed wet prep testing in 2024 and 2025. The findings include: 1. Laboratory observation on 02 /24/26 at 8:30 a.m. revealed a microscope used for performing urine microscopic and wet prep examination, and a Sysmex XN 330 used for performing Complete Blood Count with Automated White Blood Cell Differential (CBC w/Diff) instrument. 2. A review of the laboratory's testing personnel competency assessment policy revealed that "The following six competency procedures are the minimum regulatory requirements for making sure personnel are performing non-waived testing correctly:" The policy listed the six elements required in Subpart M of the Clinical Laboratory Improvement Amendments (CLIA) regulations. 3. A review of the 2024 and 2025 wet prep competency assessment documentation for TP1, TP2, and TP3 revealed that the documentation did not include direct observation of patient testing, review of patient test records, documentation of evaluation of blind testing, or documentation of evaluation of problem-solving skills. 4. The lead testing person confirmed the survey findings during an interview on 02/24/26 at approximately 3:00 p.m. CITATION TWO: Based on laboratory observation, a review of patient test records, lack of documentation, a review of the laboratory's procedure manual, and staff interview, the laboratory policy for competency assessment was not in compliance with Subpart M of the CLIA regulations when the policy did not require reassessment of competency 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 -- when test methods changed, resulting in seven of seven established testing personnel that did not have reassessment of competency when the laboratory implemented a new CBC w/Diff instrument. The findings include: 1. Laboratory observation on 02/24/26 at 8:30 a.m. revealed the Sysmex XN 330 used for patient testing for CBC w/Diff (new since the last survey date). 2. A review of patient test records revealed that patient testing began on 07/24/23 with patient 26803. 3. The laboratory failed to provide documentation of reassessment of competency for seven of seven established testing personnel for the use of the new Sysmex XN 330 CBC w/Diff methodology. 4. A review of the laboratory's testing personnel competency assessment policy revealed no requirement that reassessment of competency was required when a test methodology changed. 5. The laboratory lead confirmed the survey findings during an interview on 02/24/26 at approximately 3:00 p.m. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. This STANDARD is not met as evidenced by: Based on a review of the manufacturer's operator's manual, the laboratory procedure manual, the laboratory's reagent change records, the laboratory's quality control (QC) records, patient Complete Blood Count with automated White Blood Cell Differential (CBC w/Diff) records and staff interview, the laboratory's QC procedure for the Sysmex XN 330 CBC w/Diff instrument was not consistent with the manufacturer's requirements, resulting in the laboratory performing patient testing (nine patients) after a reagent change that occurred on 10/28/25 without first performing QC. The findings include: 1. A review of the manufacturer's operator's manual for the Sysmex XN 330 titled "Basic Operation" revealed the following under section "3.2.2 When QC analysis is performed. QC is performed at the following times. Before sample analysis, After replacement/replenishment of reagent, After instrument maintenance, When there is a concern about the accuracy of analysis values." 2. A review of the laboratory's procedure for the Sysmex XN 330 CBC w/Diff instrument revealed that the laboratory's QC policy was not consistent with manufacturer requirements when it did not require that QC was performed after replacement of reagents, after instrument maintenance, or when there was a concern about patient results. 3. A review of the laboratory's reagent change records revealed that a change in the Cellpack DCL that occurred on 10/24/25 at 10:48 a.m. 4. A review of the laboratory's QC records revealed that QC was not performed after the Cellpack DCL was changed. 5. A review of patient test records revealed that nine patients were reported after the reagent change without QC being performed (Patient numbers 26677, 40455, 31608, 42710, 30468, 37717, 43209, 43776, 26270). 6. The lead testing person confirmed the survey findings during an interview on 02/24/26 at approximately 3:00 p.m. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT -- 2 of 4 -- CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: CITATION ONE: Based on a review of the laboratory procedure manual, a review of patient test records, lack of documentation, and staff interview, the laboratory failed to perform

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory procedure manual, and interview with the lab lead, the laboratory failed to establish written policies and procedures for collection of blood samples, urine specimens, wet prep, and failed to have a procedure for specimen labeling. The findings include: 1. Observation of the laboratory on 05/17/23 at 8:15 am revealed a Complete Blood Count instrument and microscope on the counter in use for patient testing for Complete Blood Count wth automated white blood cell differential (CBC w/Diff), wet prep, and urine microscopy. 2. Review of the laboratory procedure manual revealed no procedures were available for performance of venipuncture and fingerstick blood collection, collection of urine samples, wet prep samples, and no specimen labeling policy. 3. Interview with the lab lead on 05/17/23 at 12:45 pm confirmed the laboratory failed have written procedures for specimen collection for wet prep, urine specimens, venipuncture, fingerstick blood samples and no policy for labeling specimen. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 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 -- 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 observation of the laboratory, review of patient test reports, the laboratory procedure manual and interview with the lab lead, the laboratory failed to have a procedure for wet prep on the date of the survey (05/17/23) with patient testing reported on 02/10/23. The findings include: 1. Observation of the laboratory on 05/17 /23 at 8:15 am revealed a microscope on the counter in use for performing patient wet prep procedures. 2. Review of patient test reports revealed patient testing for wet prep performed on 02/10/23 for patient #11. 3. Review of the laboratory procedure manual revealed the complete wet prep procedure could not be located. 4. Interview with the lab lead on 05/17/23 at 12:45 pm confirmed the laboratory did not have a procedure for wet prep. 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)

Summary Statement of Deficiencies D0000 493.51 Notification requirements for laboratories issued a certificate of compliance. Laboratories issued a certificate of compliance must meet the following conditions: (a) Notify HHS or its designee within 30 days of any change in --(1) Ownership. This standard is not met as evidenced by: Based on review of the laboratory's ownership form from the December 5, 2017 recertification survey, the current ownership form, review of the Aspen Web 116 System and interview with testing personnel number two, the laboratory failed to notify the state agency of change in ownership within thirty days of the change in 2018. 1. Review of the laboratory's ownership form from the December 5, 2017 recertification survey revealed a different owner than the one listed on the current ownership form. 2. Review of the Aspen Web 116 System revealed no documentation that the state agency was notified of the ownership change. 3. Interview with testing personnel number two on October 9, 2019 at 12:00 p. m. confirmed the laboratory failed to notify the state agency of the change in ownership within thirty days in 2018. The ownership of the laboratory changed in June 2018. 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 review of the laboratory procedure manual, employee personnel records for 2018 and 2019, and interview with testing personnel number two, the laboratory failed to have a procedure to include all six criteria for assessing personnel competency. The findings include: 1) Review of the laboratory procedure manual revealed the following six criteria were not included in the competency assessment procedure: direct observation of routine patient test performance; monitoring the recording 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 2 -- reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results and preventative maintenance records; direct observation of performance of instrument maintenance and function checks; assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and assessment of problem solving skills. 2) Review of the 2018 and 2019 employee personnel records revealed no documentation of competency assessment for the six required criteria. 3) Interview on October 9, 2019 at 12:00 p.m. with testing personnel number two confirmed the testing personnel competency procedure did not include the six criteria for testing personnel competency assessment required by the Centers for Medicare and Medicaid Services (CMS). 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 observation of the laboratory and interview with testing personnel number two, the laboratory failed to label saline with open date and expiration date in 2019. The findings include: 1. Observation of the laboratory on October 9, 2019 at 8:15 a.m. revealed a dropper bottle labeled Normal Saline 0.9% Sodium Chloride. No open date or expiration date was recorded on the vial. 2. Interview with testing personnel number two confirmed the laboratory failed to label saline with open date and expiration date in 2019. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of patient complete blood count (CBC) test reports and interview with testing personnel number two, the laboratory failed to maintain a record of testing personnel for three of four patient CBCs in 2018 and 2019. The findings include: 1. Review of the laboratory's instrument printout for CBC for patient numbers one, two, and four revealed no identity of the person who performed the patient testing. 2. Interview with testing personnel number two on October 9, 2019 at 12:00 p.m. confirmed the identify of the testing personnel performing CBC patient testing for three of four patients (patient numbers one, two, and four) was not maintained in 2018 and 2019. -- 2 of 2 --