Family Medical Centre

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at FAMILY MEDICAL CENTRE from 09/05/2025 to 09/24/2025. The laboratory was not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D6063 CFR 493.1421 Condition: Laboratory Testing Personnel D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) 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. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Laboratory failed to keep records of the testing of Proficiency Testing (PT) in the Specialty of Hematology for one (M1 2024) out of three events (M1, M2, M3) in 2024. Findings included: 1-Review of FORM CMS-209 Laboratory Personnel Report dated and signed by the Laboratory Director on 08/26/2025 listed six TP (TP#1, TP#2, TP#3, TP#4, TP#5 and TP#6). 2- Review of American Association of Bioanalysts /Medical Laboratory Evaluation (AAB/MLE) PT records for M1 2024 revealed that the laboratory did not maintain instrument testing records and kit instructions for the first event in 2024. 3- Review of American Association of Bioanalysts /Medical Laboratory Evaluation (AAB/MLE) PT records for M1 2024 revealed attestation was signed by laboratory director and analyst (TP1) on 02/20/2024. 4-During an interview on 09/05/2025 at 2:30 PM, TP#1 did not provide the instrument printed records for M1 2024. Records were requested via email on 09/09/2025 but not provided by the laboratory. 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 -- D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, record review and staff interview, the laboratory failed to establish appropriate storage criteria at the appropriate temperature requirements to assure performance of the Hematology Sysmex XN controls as per manufacturer instructions for nine (9) out of 22 days in December 2023, 13 out of 23 days in April 2024, 16 out of 21 days in September 2024. Findings included: 1- During a tour of the laboratory on 09/05/2025 at approximately 10:30AM, observed in use vials XN-L1, L2, L3 and a box of the Sysmex XN-L Check containing six unopened new vials of controls with storage requirement of +2C to +8C (Celsius). Conversion to Fahrenheit (F) was 35.6 F to 46.4 F. 2- Review of the Monthly Thermometer Log for random months of December 2023, April 2024, and September 2024 stated at the bottom of the form " ...the acceptable temperature for the refrigerator ranges from 35 F to 46 F." 3 - Monthly Thermometer Log for random months of December 2023, April 2024, and September 2024 revealed that refrigerator temperature was not at 2 to 8C (35 F to 46 F) for the dates listed: 12/04/2023 recorded 30 degrees F, 12/07/2023 recorded 30 degrees F, 12/08/2023 recorded 30 degrees F, 12/11/2023 recorded 32 degrees F, 12 /13/2023 recorded 34 degrees F, 12/18/2023 recorded 34 degrees F, 12/19/2023 recorded 34 degrees F, 12/20/2023 recorded 32 degrees F, 12/21/2023 recorded 34 degrees F, 04/01/2024 recorded 34 degrees F, 04/05/2024 recorded 34 degrees F, 04 /09/2024 recorded 34 degrees F, 04/10/2024 recorded 34 degrees F, 04/11/2024 recorded 32 degrees F, 04/12/2024 recorded 34 degrees F, 04/15/2024 recorded 34 degrees F, 04/16/2024 recorded 32 degrees F, 04/18/2024 recorded 32 degrees F, 04 /19/2024 recorded 34 degrees F, 04/23/2024 recorded 34 degrees F, 04/25/2024 recorded 34 degrees F, 04/30/2024 recorded 34 degrees F, 09/03/2024 recorded 34 degrees F, 09/04/2024 recorded 34 degrees F, 09/06/2024 recorded 34 degrees F, 09 /09/2024 recorded 34 degrees F, 09/13/2024 recorded 34 degrees F, 09/16/2024 recorded 34 degrees F, 09/17/2024 recorded 32 degrees F, 09/19/2024 recorded 34 degrees F, 09/20/2024 recorded 34 degrees F, 09/21/2024 recorded 32 degrees F, 09 /23/2024 recorded 34 degrees F, 09/24/2024 recorded 34 degrees F, 09/26/2024 recorded 34 degrees F, 09/27/2024 recorded 34 degrees F, 09/28/2024 recorded 32 degrees F, 09/30/2024 recorded 32 degrees F 5- Interview on 09/05/2024 at 12:58 PM the TP1 confirmed that the refrigerator was out of range for storage of hematology controls. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to obtain at least two out of three levels of Hematology control on 02/08/2025 as required for the complete blood counter (CBC) Sysmex XN-330 quantitative analyzer. The laboratory tested and released results for two patients on February 08, 2025. Findings included: 1. Review of the quality control (QC) records for the three levels of QC during February of 2025 revealed that the monthly QC Charts for lot 43481401, 43481402, and 43481403 did not have runs recorded for 02/08/2025 out of 20 listed. 2. Review of the Quality Control Policies and Procedure stated, "Control are to be run daily before any patient testing are run." 3. Interview on 09/05/2024 at 12:25 PM the TP1 confirmed that the hematology controls were not run on 02/08/2025. 4. Email received on 09/24 /2025 at 8:57 AM from TP1 confirmed that two patients were tested and reported on Saturday 02/08/2025. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on record review and staff interview, the Laboratory failed to verify the education of 1 out of 6 Testing Personnel performing the Hematology Complete Blood Count (CBC) test. See D6065 D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to verify the education of one out of six testing personnel (TP). Findings included: 1-Review of FORM CMS-209 Laboratory Personnel Report dated and signed by the Laboratory Director on 08/26/2025 listed six TP (TP#1, TP#2, TP#3, TP#4, TP#5 and TP#6). 2- Review of employee files revealed that TP#4 had Competency evaluations in 05/23 /2024 and 06/16/2025 and there was no diploma submitted. 3-During an interview on -- 3 of 4 -- 09/05/2025 at 12:35 PM with TP#1, laboratory lead (TP#1) confirmed that the laboratory failed to have documentation to proof that the TP#4 fulfill the minimum education requirement. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A recertification survey conducted from 10/12/2023 to 10/18/2023 found the FAMILY MEDICAL CENTRE clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and staff interview, the laboratory received an unsatisfactory score in the second event of 2023 for the specialty of Hematology. Findings included: Review of American Association of Bioanalysts (AAB) revealed a score of 8 % for Cell identification or White Blood Cell Differential, 60 % for Red Blood cells, 40 % for Hematocrit, 40 % for Hemoglobin, and 20 % for White Blood Cell count resulting in an overall score of 21 % in the second event of 2023. During an interview on 10/12/2023 at 12:30 PM, testing person #A confirmed that the laboratory failed the PT event of reference. 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 D0000 A recertification survey conducted on 11/02/2021 found that the FAMILY MEDICAL CENTRE clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2121 HEMATOLOGY CFR(s): 493.851(a) 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 review of American Association of Bioanalysts (AAB) proficiency testing (PT) records and staff interview, the laboratory received an unsatisfactory score in the 1st event of 2020 for the White Blood Cell Differential (WBC DIFF) in the specialty of Hematology. Findings include: Review of AAB PT records revealed a score of 66 % for WBC DIFF in the 1st event of 2020. During an interview on 11/02/2021 at 2:25 PM, the testing personnel A confirmed the proficiency testing failure. D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of American Association of Bioanalysts (AAB) proficiency testing (PT) records and staff interview, the laboratory received an unsatisfactory score in the 1st event of 2021 for the specialty of Hematology. Findings include: Review of AAB PT records revealed a score of 26 % for White Blood Cell differential, 20% for Red 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 -- Blood Cells, 20 % Hematocrit, 20% Hemoglobin, 20 % White Blood Cells, 20 % Platelets tests resulting in an overall score of 21 % in the 1st event of 2021. During an interview on 11/02/2021 at 2:30 PM, the testing personnel A confirmed the proficiency testing failure. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document remedial action for unsatisfactory proficiency testing (PT) results for White Blood Cells Differential (WBC DIFF) analyte in 1st event of 2020 and for the Hematology specialty in 1st event of 2021. Findings include: - Refer to D2121 and D2122 -No documentation of the remedial and

Summary Statement of Deficiencies D0000 A recertification survey was conducted on October 23, 2019. Family Medical Centre clinical laboratory was found not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 record review and interview, the laboratory failed to enroll in proficiency testing with an approved proficiency testing (PT) program for 2019 in the specialty of hematology. Findings: Review of PT record from American Association of Bioanalysts (AAB) showed that there was no proficiency testing performed in 2019. The laboratory performs testing on the following analytes: Erythrocytes Count (RBC), Hematocrit, Hemoglobin, Leukocyte Count (WBC), Platelet Count, and WBC Differential. During an interview on 10/23/19 at 9:56 AM, Testing Personnel A stated they were not enrolled in proficiency testing for 2019 and reinstated their enrollment about a week ago with AAB. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(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 -- The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to have all testing personnel rotate through the testing of proficiency testing (PT) samples for 2018 (1st, 2nd and 3rd event). Findings: Review of the American Association of Bioanalysts (AAB) PT computer generated attestation forms showed that Testing Personnel A performed all the PT for 2018 (1st, 2nd and 3rd event). Review of the CMS-209 form title "Laboratory Personnel Report (CLIA)" that was signed and dated by the Laboratory Director on 10/15/19 listed 5 testing personnel. Review of competency evaluations showed that 4 (A, B, C, E) out of 5 (A, B, C, D, E) testing personnel listed on the CMS-209 worked in the laboratory in 2018. During an interview on 10/23/19 at 10:01 AM, the Testing Personnel A stated that all of the proficiency testing for 2018 was performed by a Former Testing Personnel and that she failed to change the name of the Testing Personnel A to the name of the Former Testing Personnel in the computer. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory Testing Personnel and Laboratory Director failed to sign the attestation forms for proficiency testing (PT) for the 1st, 2nd and 3rd event in 2018 for the specialty of hematology. Review of the American Association of Bioanalysts (AAB) PT records showed that the laboratory failed to verify that PT samples were run in the same manner as patients by signing the attestation statement. Attestation statements for the 2018 hematology 1st, 2nd, and 3rd event were not signed by the Former Testing Personnel or the Laboratory Director. During an interview on 10/23/19 at 9:45 AM, the Testing Personnel A stated that all of the proficiency testing for 2018 was performed by the Former Testing Personnel, and that the Former Testing Personnel and the Laboratory Director had not signed the attestations. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: -- 2 of 5 -- Based on record review and interview, the laboratory's quality assessment program failed to monitor and evaluate the overall quality of the general laboratory system and correct problems identified. Findings: Cross Reference D5209. Based on record review and interview, the laboratory failed to follow written policies and procedure to access testing personnel's competency. Cross Reference D5211. Based on record review and interview, the laboratory failed to document the review and evaluation of proficiency testing (PT) for the 3rd event in 2017, and the 1st, 2nd, and 3rd events in 2018 for the specialty of hematology. 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 and interview, the laboratory failed to follow written policies and procedures to access testing personnel's competency. Findings: The procedure titled "Quality Assurance Plan" states "Personnel are evaluated by the lab director semi-annually during the first year of employment and annually thereafter." 1. Review of the competency evaluations showed that documentation of initial training and evaluation for Testing Personnel D was not available for review. During an interview on 10/23/19 at 10:05 AM, the Testing Personnel D stated she started working the week of Thanksgiving in 2018. During an interview on 10/23/19 at 10:10 AM, the Testing Personnel A acknowledged that the initial training and evaluation was not done and that only one competency evaluation was performed on Testing Personnel A. 2. Review of the competency evaluation forms for 5 out of 5 (A, B, C, D, E) Testing Personnel showed that the competency evaluation were performed in 2018 and 2019 were signed by the Medical Assistant Supervisor. Review of the "State Operations Manual Appendix C - Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services" states a Technical Consultant can perform competency evaluations on testing personnel and that the Technical Consultant must have at least a Bachelor of Science degree. During an interview on 10/23/19 at 10:16 AM, the Testing Personnel A stated that Medical Assistant Supervisor performed the competency evaluations and that the Medical Assistant Supervisor did not have at least a Bachelor of Science degree. 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 record review and interview, the laboratory failed to document the review and evaluation of proficiency testing (PT) for the 3rd event in 2017, and the 1st, 2nd, and 3rd events in 2018 for the specialty of hematology Findings: Review of the American Academy of Family Physicians (AAFP)) PT showed that the laboratory director failed to sign proficiency testing evaluation forms for 3rd events in 2017. Review of the American Association of Bioanalysts (AAB) PT showed that the -- 3 of 5 -- laboratory director failed to sign proficiency testing evaluation forms for 1st, 2nd, and 3rd events in 2018. During an interview on 10/23/19 at 11:30 AM, the Manager acknowledged that the Laboratory Director did not sign the evaluation forms. 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 record review and interview, the Laboratory Director failed to provide overall management and direction. Findings: Cross Reference D6015. Based on record review and interview, the Laboratory Director failed to ensure that the laboratory was enrolled in proficiency testing for 2019. Cross Reference D6016. Based on record review and interview, the Laboratory Director failed to ensure that proficiency testing was performed according to CLIA regulations. Cross Reference D6030. Based on record review and interview, the Laboratory Director failed to ensure the testing personnel were competent. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to ensure that the laboratory was enrolled in proficiency testing for 2019. Findings: Based on record review and interview, the laboratory failed to enroll in proficiency testing with an approved proficiency testing (PT) program for 2019 in the specialty of hematology. (See D2000). D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to ensure that -- 4 of 5 -- proficiency testing was performed according to CLIA regulations. Findings: Based on record review and interview, the laboratory failed to have all testing personnel rotate through the testing of proficiency testing (PT) samples for 2018 (1st, 2nd and 3rd event). (See D2007). Based on record review and interview, the laboratory Testing Personnel and Laboratory Director failed to sign the attestation forms for proficiency testing (PT) for the 1st, 2nd and 3rd event in 2018 for the specialty of hematology. (See D2009). Based on record review and interview, the laboratory failed to document the review and evaluation of proficiency testing (PT) for the 3rd event in 2017, and the 1st, 2nd, and 3rd events in 2018 for the specialty of hematology. (See D5211). D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to ensure the testing personnel were competent. Findings: Based on record review and interview, the laboratory failed to follow written policies and procedure to access testing personnel's competency. (See D5209). -- 5 of 5 --