Family Medical, Pc

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 laboratory observation, a review of the manufacturer instructions for use (IFU), laboratory policy, lack of documentation, and staff interview, the laboratory failed to follow the manufacturer's instructions for performing quality control on the McKesson Consult Diagnostics 120 Urine Analyzer used for 1562 urine microalbumin and creatinine patient tests from June 2023 to June 2024. The findings include: 1. An observation of the laboratory on 07/31/2024 at 8:30 a.m. revealed that it used a McKesson Consult Diagnostics 120 Urine Analyzer (ID: 197T10083EE) and McKesson Consult Diagnostics Microalbumin/ Creatinine Urine Reagent Strips (Lot: UR84030111) for patient testing. 2. A review of the McKesson Consult Diagnostics Microalbumin/ Creatinine Urine Reagent Strips IFU revealed the following statement: "Test known controls (i.e., McKesson Liquid Urine Controls) in case of any of the following events, following local, state, and/or federal requirements: - A new canister of strips is opened - A new operator uses the analyzer - Test results seem wrong - After performing maintenance or service on the analyzer" 3. A review of the laboratory's policy titled "Urinalysis" revealed the following statement: "Quality Control Procedure: Positive and Negative controls are to be tested anytime a new bottle of reagent strips is opened and with every 20 uses of each control bottle" 4. No documentation of quality control testing for the McKesson Consult Diagnostics Microalbumin/ Creatinine Urine Reagent Strips was available for review. 5. An interview with the laboratory lead tech, technical consultant, and office manager on 07 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 -- /31/2024 at 1:00 p.m. confirmed the laboratory had not performed urine microalbumin and creatinine QC from June 2023 to June 2024, with 1562 urine microalbumin and creatinine patient tests reported. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of laboratory instrumentation records, quality control (QC) records, laboratory policies, and staff interviews, the laboratory failed to retain complete blood count (CBC) QC records for six of the fourteen months reviewed in 2023 and 2024. The findings include: 1. A review of laboratory instrumentation records revealed the laboratory used a Horiba ABX Micros 60 (ID: 402CS93724) for patient CBC testing from their last recertification survey (05/10/2023) to 10/25/2023. 2. The laboratory could not provide CBC QC records for the Horiba ABX Micros analyzer from May to October 2023. 3. A review of the laboratory's "Systems Management" policy revealed the following statement in the "Quality Control Procedures" section under "Documentation": - "All documentation, including unacceptable results and all instrument printouts, is kept for at least two years." 4. An interview with the laboratory lead tech and technical consultant on 07/31/2024 at 12:30 p.m. confirmed that the laboratory did not maintain the Horiba ABX Micros 60 CBC QC records for two years. 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 laboratory observation, review of the manufacturer's operator's manual, patient test records, lack of documentation, and staff interview, the laboratory failed to perform daily maintenance on the Medonic M-Series complete blood count (CBC) instrument for 3 of 4 testing dates reviewed in 2023 and 2024. The findings include: 1. Observation of the laboratory on 07/31/2024 at 8:30 a.m. revealed a Medonic M- Series CBC analyzer (ID: 62294). The technical consultant stated the laboratory began using the Medonic analyzer for patient testing on 10/26/2024. 2. A review of the manufacturer's operator's manual revealed a requirement for daily cleaning of the aspiration and pre-dilute probes, probe rinse cup, and sampling device probe inlet with a disinfecting solution. 3. A random review of patient test records revealed the laboratory performed patient CBC testing on the following dates: - 11/14/2023 (Patient: 67077) - 04/01/2024 (Patient: 43711) - 07/06/2024 (Patient: 74077) - 07/30 /2024 (Patient: 74752) 4. The laboratory did not document daily cleaning for the Medonic analyzer on 11/14/2023, 04/01/2024, and 07/06/2024. 5. An interview with the laboratory lead tech and technical consultant on 07/31/2024 at 12:30 p.m. confirmed the findings. -- 2 of 4 -- 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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on laboratory observation, review of laboratory instrumentation records, laboratory policies, quality control (QC) records, and staff interviews, the laboratory failed to monitor complete blood count (CBC) QC performance over time in 2023 and 2024 (14 of 14 months reviewed). The findings include: 1. Observation of the laboratory on 07/31/2024 at 8:30 a.m. revealed a Medonic M-Series CBC analyzer (ID: 62294). The technical consultant stated the laboratory began using the Medonic analyzer for patient testing on 10/26/2024. 2. A review of laboratory instrumentation records revealed the laboratory used a Horiba ABX Micros 60 (ID: 402CS93724) for patient CBC testing from the last survey (05/10/2023) to 10/25/2023. 3. A review of the laboratory's "Systems Management" policy revealed the following statement in the "Quality Control Procedures" section under "Documentation": - "Statistical analysis, including the obtained mean, standard deviation, and coefficient of variation are calculated monthly by the instrument and reviewed by the technical consultant and/or the director." - "Levey-Jennings depicting the day of the month and the obtained result are maintained if plotted by the analyzer. L-J graphs are then reviewed monthly by the technical consultant or the laboratory director." - "All documentation, including unacceptable results and all instrument printouts, is kept for at least two years." 4. The laboratory could not provide Levy-Jennings graphs or other evidence of statistical analysis monitoring of CBC QC by the technical consultant or lab director for either the Horiba ABX Micros (May to October 2023) or Medonic M-Series analyzers (October 2023 to June 2024). 5. An interview with the laboratory lead tech and technical consultant on 07/31/2024 at 12:30 p.m. confirmed the laboratory had not monitored hematology QC performance over time. 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: Based on a review of the laboratory's approved normal ranges, patient test records, and staff interviews, the laboratory failed to ensure that the complete blood count (CBC) final patient test reports for 3 of 5 reports reviewed contained the approved reference ranges. The findings include: 1. A review of the laboratory policies revealed -- 3 of 4 -- the following approved reference ranges for White Blood Cell Count (WBC), Red Blood Cell Count (RBC), Hemoglobin (HgB), Hematocrit (HCT), Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), Platelets (PLTS), Relative Lymphocytes (LYM), and Relative Granulocytes (GRAN): 6 months - 2 years ; Adult - WBC: 4.1 - 10.9 ; 4.8 - 10.8 - RBC: 4.20 - 6.30 ; 4.20 - 6.10 - HGB: 11 - 13 ; 12 - 18 - HCT: 37 - 51 ; 37 - 58 - MCV: 70 - 86 ; 80 - 100 - MCH: 26.0 - 32.0 ; 27.0 - 31.0 - MCHC: 31 - 34 ; 32 - 36 - PLTS: 140 - 440 ; 130 - 440 - LYM: 10.0 - 58.5 ; 20.5 - 51.1 - GRAN: 37.0 - 92.0 ; 42.2 - 75.2 2. A random review of five patient CBC test reports revealed the following reference ranges listed for patients 74752 (10 months), 74077 (1 year), and 67077 (68 years): - WBC: 3.5 - 10.0 - RBC: 3.50 - 5.50 - HGB: 11.5 - 16.5 - HCT: 35.0 - 55.0 - MCV: 75.0 - 100.0 - MCH: 25.0 - 35.0 - MCHC: 31.0 - 38.0 - PLTS: 100 - 400 - LYM: 15.0 - 50.0 - GRAN: 35.0 - 80.0 3. An interview with the laboratory lead tech and technical consultant on 07/31/2024 at 12:30 p.m. confirmed the reference ranges listed on the final patient test reports for patients 74752, 74077, and 67077 did not match the laboratory's approved reference ranges. -- 4 of 4 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality assurance plan, review of the laboratory's quality assurance records, and interview with the quality manager, the laboratory failed to follow their quality assurance policy in 2020, 2021 and 2022. The findings include: 1. Review of the laboratory's quality assessment plan revealed the following: a) Patient Test Management section states laboratory manager will observe if specimens are properly collected, labeled, processed, and results recorded accurately semi-annually. b) Comparison of Test Results section states laboratory will send split specimens to outside facilities for further verification of accuracy quarterly. 2. Review of the laboratory's Annual Quality Assurance Summary records revealed the following: a) Patient test management review was recorded 0 of 2 times in 2022. b) Comparison of test result was recorded 2 of 4 times in 2022 (May and August), 2 of 4 times in 2021 (June and October), and 3 of 4 times in 2020 (February, May, and September). 3. Interview on 05/10/23 at 11:15 am with the laboratory quality and office managers defined semi-annual to mean twice per year and quarterly as four times per year. 4. Interview on 05/10/23 at 1:30 pm with the laboratory quality manager and office manager confirmed the laboratory failed to follow it's own quality assessment plan when it did not perform patient test management reviews twice in 2022 and comparison of test results 4 times in 2020, 2021, and 2022. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) 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 -- 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. (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 of the laboratory, review of manufacturer's user manual, reagent package instructions, lack of documentation and interviews with the quality and office managers, the laboratory failed to monitor the ambient temperature and relative humidity in the area where the complete blood count (CBC) instrument was being used for patient testing in 2021, 2022, and 2023. The findings include: 1. Observation of the laboratory on 05/10/23 at 8:15 am revealed the following: a) Horiba ABX Micros 60 CBC instrument (serial #402CS93724) and for performing patient CBC testing. b) ABX Minoclair, Miniclean, Alphalyse, and Minidil LMG reagents used by the Horiba ABX Micros 60 stored in ambient conditions beneath the analyzer. 2. Review of the Horiba Micros 60 CS/CT User Manual's section titled "3.4 Humidity and Temperature conditions" revealed an operating ambient temperature range of 18 - 32 degrees Celsius (C) and a relative humidity range of up to 95%. 3. Review of the ABX Minoclair, Miniclean, Alphalyse, and Minidil LMG reagent package instructions revealed storage range for each reagent is between 18 - 25 degrees Celsius (C). 4. There were no environmental records for monitoring of ambient temperature and relative humidity for surveyor review. 5. Interviews with the quality and office managers on 05/10/23 at 1:30 pm confirmed the laboratory failed to monitor the ambient temperature and relative humidity in the area where the Horiba ABX Micros 60 CBC instrument was used for patient testing in 2021, 2022, and 2023. 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, review of manufacturer instructions for use, and interviews with the quality and office managers, the laboratory failed to label three of three controls observed on the date of the survey (05/10/23) with corrected expiration date after the controls were opened. The findings include: 1. Observation of the laboratory on 05/10/23 at 8:15 am revealed three levels of Minotrol 16 Tri-Level controls (Kit: MX441) in use for performing quality control on the Horiba ABX Micros 60 complete blood count (CBC) instrument. All three in-use controls were labeled with an open date (05/04/23) but no corrected expiration date. 2. Review of the Minotrol 16 Tri-Level controls manufacturer package inserts revealed CBC controls for the Horiba ABX Micros 60 are to be stored at 2-8 degrees Celsius (C) and are stable for 16 days after opening. 3. Interviews with with the quality and office -- 2 of 3 -- managers on 05/10/23 at 1:30 pm confirmed the laboratory controls in use had expiration dates that changed after opening and the laboratory failed to label the controls with the corrected expiration dates on the date of the survey for three of three controls observed. -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Hematology: The laboratory failed to maintain satisfactory participation in two out of three events for the specialty Hematology for all regulated analytes, resulting in the first unsuccessful proficiency testing (PT) occurrence for Hematology in 2017. (Refer to D2131) D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare & Medicaid Services (CMS) Casper report 155D, American Proficiency Institute (API) proficiency performance summary and interview with the lead testing person the laboratory failed to participate in two out of three events for the specialty Hematology for Complete Blood Count (CBC), which includes Red Blood Count (RBC), White Blood Cell (WBC), Hematocrit (HCT), Hemoglobin (HGB), Platelet count (PLT), Cell I.D or White Blood Cell Differential (WBC Diff) leading to the first unsuccessful performance in 2017. Findings include: 1. Review of the CMS Casper report 155D revealed the laboratory failed to participate in the 1st event resulting in a score of zero for the specialty Hematology for CBC to include RBC, WBC, HCT, HGB, PLT, Cell I.D. or WBC Diff, and failed to participate in the 3rd event for Cell I.D. or WBC Diff resulting in a score of zero in 2017. 2. Review of the API performance summary the laboratory failed to participate in the 1st event resulting in a score of zero for the specialty Hematology for CBC to include RBC, WBC, HCT, HGB, PLT, Cell I.D. or WBC Diff and failed to participate in the 3rd event for Cell I.D. or WBC Diff resulting in a score of zero 2017. 3. Interview with the lead testing person confirmed the laboratory failed to participate in the 1st event resulting in a score of zero for the specialty Hematology for CBC to include RBC, WBC, HCT, HGB, PLT, Cell I.D. or WBC Diff and failed to participate in the 3rd event for Cell I.D. or WBC Diff resulting in a score of zero in 2017. -- 2 of 2 --