Family Medical Centre

Summary Statement of Deficiencies D0000 A recertification survey was conducted from September 4th to 6th, 2024. FAMILY MEDICAL CENTRE clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 failed to sign attestation for the Proficiency Testing (PT) Hematology in 2023 2nd and 3rd events, in 2024 1st and 2nd events, for 4 out of 6 events reviewed (3rd of 2022, 1st /2nd /3rd of 2023 and 1st /2nd of 2024). Findings included: 1-Review of the PT records 2024 American Association of Bioanalysts (AAB) revealed that the testing personnel (TP1) failed to sign attestation for the 1st and 2nd event in 2024. 2-Review of the PT events in 2023 of the AAB revealed that the TP1, failed to sign attestation for the 2nd event performed on 06/02/2023, and for 3rd event performed on 9/15/2023. 3-Review of the AAB General Program Instructions under the Reporting Results, Step 2 stated "Be sure to keep all attestations printed from your online reporting form. We do not require this for grading. The attestation statements must be signed for each analyte by the analyst performing the procedure and keep in your files for inspection purposes." 4-Interview on 09/04/2024 at 11:45 AM the laboratory medical assistant admitted to not having paper attestation since the attestation is done with electronic submission of results and the laboratory director's electronic signature. The laboratory did not provide electronic record of attestation for the analyst (TP1) performing the procedure. 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 -- 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 perform competency evaluations on 2 testing personnel who perform Complete Blood Count (CBC) in the specialty of Hematology for one out of two (2023 and 2024) years reviewed. Findings included: 1- Review of the CMS-209 form signed by laboratory director on 09/04 /2024 revealed the laboratory has two testing personnel (TP1 & TP2) 2-Review of competency records found no competency evaluation was performed on TP1 due in 7 /2024 and TP2 due in April 2024. 3-Interview on 09/04/2024 at 2:48 PM the laboratory medical assistant confirmed that there was no documented competency evaluation for each TP1 and TP2 in 2024. 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. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to complete verification for Sysmex XN-330 Series Complete Blood Count (CBC) Hematology analyzer. Findings included: 1-Review of the laboratory's verification records for the Sysmex XN-330 Serial Number 15864, found that the laboratory had not completed correlation studies and reference range verification. 2-Review of the XN-Series XN-L Method Verification Manual #1251-12SS, Rev 2, Dec 2016 stated "It is the customer's responsibility to perform additional studies following the requirements of their accrediting agency." 3-Interview on 09/04/2024 at 2:48 PM the laboratory medical assistant confirmed that the laboratory did not perform the correlation studies and reference range verification -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted from 09/26/2022 to 09/30/2022 found the FAMILY MEDICAL CENTRE clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. Cited the following Conditions: -D5400. Analytic Systems. -D6000. Moderate Complexity Laboratory Director. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory did not meet the condition for analytic systems. Findings include: -Failed to perform Sysmex XP-300 Complete Blood Cell Analyzer instrument calibration verification at least every six months from 01/01/2021 to 09/30/2022. Refer to 5439. This is a repeated deficiency form the survey on 2020. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. 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 -- (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 record review and staff interview, refrigerator temperatures were outside the acceptable range for the Sysmex Hematology Controls storage for 103 out of 188 days in 2022. The findings include: -Review of temperature refrigerator log revealed an acceptable range of 35 to 46 Fahrenheit degrees. -Temperature log record review for 2022 from January to September revealed the following dates, the temperature were outside of the acceptable range: 01/03/2022, 01/04/2022, 01/07/2022, 01/10/2022, 01 /11/2022, 01/12/2022, 01/18/2022, 01/25/2022, 01/28/2022, 02/14/2022, 02/15/2022, 02/16/2022, 02/18/2022, 02/22/2022, 02/23/2022, 02/24/2022, 02/25/2022, 02/28 /2022, 03/02/2022, 03/03/2022, 03/08/2022, 03/10/2022, 03/11/2022, 03/14/2022, 03 /15/2022, 03/16/2022, 03/18/2022, 04/04/2022, 04/05/2022, 04/06/2022, 04/11/2022, 04/12/2022, 04/13/2022, 04/20/2022, 04/22/2022, 04/25/2022, 04/26/2022, 04/27 /2022, 05/02/2022, 05/04/2022, 05/05/2022, 05/06/2022, 05/09/2022, 05/10/2022, 05 /11/2022, 05/12/2022, 05/16/2022, 05/19/2022, 05/26/2022, 05/30/2022, 06/07/2022, 06/08/2022, 06/13/2022, 06/20/2022, 06/21/2022, 06/22/2022, 06/23/2022, 06/24 /2022, 06/28/2022, 06/29/2022, 07/01/2022, 07/05/2022, 07/06/2022, 07/07/2022, 07 /08/2022, 07/12/2022, 07/13/2022, 07/15/2022, 07/19/2022, 07/21/2022, 07/22/2022, 07/26/2022, 07/28/2022, 08/01/2022, 08/02/2022, 08/04/2022, 08/08/2022, 08/09 /2022, 08/12/2022, 08/15/2022, 08/16/2022, 08/17/2022, 08/18/2022, 08/22/2022, 08 /23/2022, 08/24/2022, 08/25/2022, 08/29/2022, 08/30/2022, 08/31/2022, 09/06/2022, 09/07/2022, 09/08/2022, 09/09/2022, 09/12/2022, 09/15/2022, 09/16/2022, 09/19 /2022, 09/20/2022, 09/21/2022, 09/22/2022, 09/23/2022 and 09/26/2022, During an interview on 09/26/2022 at 01:02 PM, the testing personnel A confirmed that the refrigerator temperatures were outside the acceptable range in the days listed above. 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 and staff interview, the laboratory failed to label complete blood cells (CBC) controls currently in use with the open and new expiration dates. Findings include: - During the laboratory tour on 09/30/2022 at 10:00 AM, the surveyor observed that the laboratory had in use SYSMEX EIGHTCHECK- 3WP X-TRA CBC controls with Lot # 2193. The controls in use failed to have the opening date and the new expiration date. -Review of EIGHTCHECK- 3WP X-TRA controls insert revealed that opened controls are stable for 14 days if stored at 2-8 Degree Celsius. During an interview on 09/30/2022 at 10:35 AM, the Testing Personnel # A, confirmed that controls in use were not label as described above and she explained that they started using the current control vials on 09/20/2022. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) -- 2 of 5 -- For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to repeat a rejected background check in the Sysmex complete blood analyzer (CBC) in seven (7) days out of two months reviewed (July and August of 2021). Findings include: -Review of Background checks for Sysmex XP-300 revealed that in the months of July and August of 2021, the laboratory had 7 seven days with background check rejected. The laboratory failed to repeat the background check in the days of reference. The days that the background check failed were: 07/27/2021, 08/12/2021, 08/16/2021, 08/17 /2021, 08/18/2021, 08/19/2021 and 08/20/2021. -Review of patients tested revealed that on 08/12/2021, 08/16/2021 and 08/20/2021 the laboratory tested one patient each day and on 08/19/2021 the laboratory tested two patients. During an Interview on 09 /26/2022 at 1:30 PM, TP A confirmed that the laboratory failed to repeat the background check for the days of reference. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (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 record review and staff interview, the laboratory failed to document calibration verification procedures of the Sysmex XP-300 analyzer at least every 6 months from 01/01/2021 to 09/26/2022. This is a repeated deficiency from previous survey. Findings include: -Review of the Sysmex XP-300 calibration records revealed that the laboratory performed calibration verification on 12/30/2020 and 06/17/2022. -- 3 of 5 -- During an interview on 09/26/2022 at 1:05 p.m., Testing Person A confirmed that there was no documentation to indicate the laboratory performed instrument calibration verification every 6 months in the period of 01/01/2021 to 09/26/2022. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT 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. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on record review and interview, the Quality Assessment (QA) failed to correct that the refrigerator temperature for complete blood controls (CBC) storage was in range for 103 days in 2022, failed to ensure the Sysmex XP-300 instrument was ready before patient testing in seven days in 2021 and failed to do the calibration to Sysmex XP-300 at least every six months since 2021. Findings include: -Review of the Monthly Quality Assurance Checklist records revealed no documentation of the QA activity since December 2020. -No documentation of

Summary Statement of Deficiencies D0000 A recertification survey conducted on 11/12/2020 found that the Family Medical Centre clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following conditions were cited: -D2000 -D5200 -D5400 - D6000 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 review of Casper report 96 Clinical Laboratory Improvement Amendments (CLIA) Application and Survey Summary and interview with Testing Personnel (TP) A, the laboratory failed to enroll in a Proficiency Testing (PT) program approved by the Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) for the specialty of hematology for 1st and 2nd event of 2019. Findings include: Review of Casper report 96 pulled on 11/11/2020 revealed blanks for the 3 events of 2019 for the specialty of hematology. American Association of Bioanalysts (AAB) PT records review revealed that the laboratory failed to participate in PT for 1st and 2nd event of 2019. During an interview on 11/12/2020 at 9:30 a.m. TP A confirmed that the facility failed to enroll in PT for 2019 for the specialty of reference during 1st and 2nd event 2019. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 failed to score at least 80 % on Red Blood Cell (RBC), Hematocrit (HCT) and Hemoglobin (HGB) analytes for 1 (2nd event of 2020) out of 4 events for Hematology reviewed. Findings include: Review of AAB PT records revealed a score of 60 % for RBC, HCT and HGB in the 2nd event of 2020. During an interview on 11/12/2020 at 12:30 PM, the testing staff 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 staff interview, the laboratory failed to document remedial action for 3 out of 3 Hematology analyte unsatisfactory scores in 2nd event of 2020: Red Blood Cells (RBC), Hematocrit (HCT) and Hemoglobin (HGB) in proficiency testing (PT). Findings include: -Review of American Association of Bioanalysts (AAB) proficiency testing results in 2019 and 2020, showed that the laboratory had analyte unsatisfactory score for RBC, HCT and HGB of 60 % for the 2nd event of 2020. -No documentation of the remedial and

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on record review and interview with testing personnel (TP) # A, the laboratory failed to follow manufacturer's instructions of performing quality control for waived tests. There was no documented record of quality control for the following waived tests: Urispec 11 Way (Urine Reagent Strips) (URS), Immuno /hCG detector for human chorionic gonadotropin (hCG) in urine, Immuno/Strep A Detector for Streptococcus (Strep) A antigen for throat swabs, Alere afinion HbA1c for measuring hemoglobin A1c in whole blood test from 2016 to 2018. Findings include: Record review from 2016 to 10/22/2018 showed that the laboratory was not following manufacturer instructions of performing quality control for the following waived tests: - URS test, manufacturer instructions stated that user should do confirmation of performance of reagent strips by testing known positive and negative specimen or controls whenever a new bottle is opened, with each new lot. -Urine hCG test, as per manufacturer instructions it is recommended that a positive and negative control tested to verify a proper test performance with each new shipment or lot is received. - Strep A it is recommended that a positive and negative control be run once per kit as per manufacturer instruction. -Alere HbA1c controls to be run with each new shipment, new lot, at least every 30 days, when training new users or unexpected results is obtained. During an interview on 10/22/2018 at 12:00 pm, the TP#A, confirmed that the laboratory was not documenting quality control on the waived tests listed above for the period of reference. D2127 HEMATOLOGY 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 -- CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on record review of AAB (American Association of Bioanalysts) Hematology proficiency testing (PT) results and interview with Testing Personnel # A (TPA), the laboratory failed to submit PT results in the specified timeframe for 2nd event of 2018 for the specialty of Hematology resulting in a score of 0% for all hematology analytes. Findings include: Review of AAB Hematology PT records revealed that the laboratory failed to submit the results for the second event of 2018 on time resulting in a score of 0 % score for Hematology, Cell Identification or White Blood Differential, Red Blood Cell, Hematocrit, Hemoglobin, White Blood Cells and Platelets. During an interview on 10/22/2018 at 11:30 AM, the TP#A confirmed that the laboratory failed to submit on time the results for the 2nd event of 2018. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) 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 record review and interview with Testing Personnel # A (TPA), the laboratory failed to verify the accuracy of Urine Microscopic Analysis at least twice annually from 2016 through October 22 2018. Findings include: Review of laboratory's proficiency testing records from 2016 to 2018 showed that the laboratory was not enrolled in proficiency testing for this test and had not done verification of accuracy by other method for Urine Microscopic Analysis at least twice annually since 2016 to October 22 2018. During an interview with the TP#A on 10/22/2018 at 11:30 a.m., the TP#A confirmed that the laboratory was not enrolled in proficiency testing for the above analyte and had not verified the accuracy of the test by another method during the period of reference. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of