Family Care Center

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a recertification survey completed on September 15, 2025. The following condition was not met: D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel; 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 review of laboratory personnel files, laboratory documents, and confirmed in interview, the laboratory failed to ensure one of four new testing personnel had documentation to meet the education requirements to perform moderate complexity testing. See 6065. 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 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 -- (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 review of laboratory paperwork, laboratory procedures, laboratory personnel files, and confirmed in interview, the laboratory failed to ensure one of four new testing personnel had documentation to meet the education requirements found at 493.1423(b)(1) through 493.1423(b)(6) to perform moderate complexity testing. The findings included: 1. Review of the laboratory provided CMS-209 personnel form included four new testing personnel performing CBC testing on the Sysmex XP-300 hematology analyzer. 2. Review of laboratory personnel files did not include education documentation for the following testing personnel: Testing personnel (TP) 6: hire date November 2024, Sysmex training completed 11/21/2024. 3. Review of the laboratory document titled "Job Description and Performance Evaluation" signed by TP 6 on 1/30/2025, included the following qualification statement: "B. Qualifications: 1. Education/ Skills. High School diploma or equivalent ..." 4. In an interview on 9/15 /2025 at 13:25, in the conference room, the laboratory manager confirmed TP 6 did not provide the educational documentation needed to meet the education qualifications to perform moderate complexity testing. Key: CMS: Centers for Medicare & Medicaid Services CBC: Complete blood count -- 2 of 2 --

Summary Statement of Deficiencies D0000 An onsite survey conducted 10/26/2023 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of laboratory policy, laboratory quality control (QC) records, patient test reports, and confirmed in interview the laboratory failed to ensure that QC met the laboratory's acceptability criteria before testing and reporting 87 of 87 patients when CBC QC for the Sysmex XP-300 hematology analyzer did not meet the acceptable criteria in April 2023. The findings included: 1. Review of the laboratory policy titled "Family Care Center CBC Procedure", section "Quality Control" had the following statement: "Every parameter of QC must have at least two levels within range. If not, control must be repeated ...No patient results will be reported until all parameters of quality control are within the determined ranges for two levels." Subsection "QC Documentation": "2. ... The acceptable SD and mean for each lot is entered into the analyzer so that parameters that are out of range flag on the analyzer. If any of the parameters are out of range,

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory policy, American Proficiency Institute proficiency test records from 2019 to 2021, and confirmed in interview, the laboratory failed to test the proficiency testing samples the same manner as it tests patient specimens for one of six PT events reviewed. Findings included: 1. Review of the laboratory policy Proficiency Survey Policies under Receipt of Surveys revealed "testing personnel will test the specimen in the same manner as any other patient specimen." 2. Review of 2019 to 2021 API test events revealed one of six test events when the laboratory repeated PT samples days after the initial run--unlike a patient sample. 2019 Hematology/Coagulation 3rd test event Sample HSY11, analyzed on 11/18/19, and repeated on 11/21/19 Sample HSY12, analyzed on 11/18/19, and repeated on 11/21 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 -- /19 Sample HSY13, analyzed on 11/18/19, and repeated on 11/19/21 sample HSY14, analyzed on 11/18/19, and repeated on 11/19/19 Sample HSY15, analyzed on 11/18 /19, and repeated on 11/19/19 3. An interview with the laboratory manager on 9/8/21 at 1120 hours in the conference room confirmed the above findings. She acknowledged that they do not repeat a patient sample a day or so after the initial run. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute's (API) proficiency testing reports from 2019 to 2021 and confirmed in an interview, the laboratory failed to document the self-evaluation of proficiency testing results returned ungraded by the proficiency testing agency for 1 of 6 API test events reviewed. Findings included: 1. A review of the API user guide under Grading Standards for Not Graded analytes revealed the following: "Whenever a result is not graded, you should perform a self- evaluation. To do this, you would compare your result to the expected result(s). If your result falls within the expected range, you may conclude that your lab obtained the correct response. If your result does not fall within the expected range, you may want to troubleshoot to determine the cause. In most cases, the expected result is printed on your evaluation next to your reported result for each sample. If the expected result is not printed on your evaluation, to find the result or range of results that is the most appropriate for you to use for comparison." 2. Review of the API test records from 2019 to 2021 revealed 1 of 6 test events with "not graded" 2019 Hematology/Coagulation 1st event Urine Sediment US-02 - not graded Vaginal Wet Preparation (KOH) VKP-01 - not graded 3. Review of the laboratory records available revealed no self-evaluation of the above test event. 4. An interview with the laboratory manager on 9/8/21 at 1120 hours in the conference room confirmed the above findings. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of Sysmex XP-300 Instruction for use, review of the laboratory's maintenance records, patient records, and confirmed in an interview revealed the laboratory failed to document the required maintenance procedures for six of thirty- five weekly maintenance from January to August 2021 for Sysmex XP-300. The findings were: 1. Review of Sysmex XP-300 Instruction for use (Code No: AU553517, Date of Last Revision: February 2013, Software Version: 00-10 and onwards) under Chapter 12 Cleaning and Maintenance revealed "To ensure proper -- 2 of 4 -- functioning of the instrument, it is necessary to periodically clean and service the instrument. Perform maintenance according to the schedule below and record the results in the Maintenance checklist." Weekly Clean SRV tray 2. Random review of the laboratory's maintenance records revealed the laboratory had no documentation of performing the required maintenance procedures on Sysmex XP-300 (SN# A3957) for six of thirty-five weekly maintenance from January to August 2021. Weekly: 1/24/21- 1/30/21 4/11/21-4/17/21 5/23/21-5/29/21 5/30/21-6/5/21 6/27/21-7/3/21 7/25/21-7/31 /21 3. Random review of patient records from 1/1/21-8/31/21 revealed the following 14 patient testing without required maintenance procedures performed on Sysmex XP- 300 (SN# A3957). 1/28/21 Sample ID: 1000058372 1/28/21 Sample ID: 1000058428 4/15/21 Sample ID: 1000109608 4/15/21 Sample ID: 1000109643 4/15/21 Sample ID: 1000109552 4/16/21 Sample ID: 1000110452 4/16/21 Sample ID: 1000110479 5/28 /21 Sample ID: 1000214375 5/28/21 Sample ID: 1000214101 5/30/21 Sample ID: 1000216646 6/27/21 Sample ID: 1000289387 6/27/21 Sample ID: 1000289484 7/26 /21 Sample ID: 1000369157 7/26/21 Sample ID: 1000367475 4. An interview with testing person #1 (TP#1) on 7/9/21 at 11:30 am in the conference room confirmed the above findings. D5781