Smith Lake Family Care

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on reviews of the Hematology records, the "Customer Training Manual", and an interview with the Technical Consultant and Testing Personnel #1, the laboratory failed to perform and document calibrations on the Horiba ABx Micros E-60 Hematology analyzer as required by the manufacturer's instructions. The surveyor noted three of four 2021-2023 calibrations were missing documentation of repeatability/precision checks. The findings include: 1. A review of the Micros E-60 Hematology System Customer Training Manual under "Preparation for Calibration" on page 61 revealed, "...3) Perform a repeatability/precision by running a normal sample ten times ... Calculate the coefficient of variation". [The surveyor noted the last sentence was underlined.] 2. A review of the Horiba ABx Micros E-60 Hematology records revealed calibrations were performed on 9/1/2021, 2/5/2022, 10 /28/2022, and 6/8/2023. However, on the first two calibrations there was no documentation of the ten repeatability/precision runs or an analysis of the data. 3. A review of the 6/8/2023 calibration revealed the laboratory had performed the ten repeatability/precision runs, however the coefficient of variation had not been 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 -- calculated, as of the day of the survey. 4. During an interview on 7/27/2023 at 12:15 PM, the Technical Consultant and Testing Personnel #1 reviewed the calibration records, and confirmed the above findings. . 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 reviews of the Horiba ABx Micros E-60 Hematology Quality Control (QC) records, the "Customer Training Manual", and an interview with the Technical Consultant and Testing Personnel #1, the laboratory failed to implement a mechanism to track for shifts and trends over time in the Hematology QC. This was noted from the previous survey on 8/24/2021 to the day of the current survey on 7/27/2023. The findings include: 1. A review of the Hematology QC records revealed only the daily instrument printouts were retained. There was no evidence of Levy-Jennings (L-J) charts printed periodically or any other mechanism to track for shifts and trends over time in the Hematology QC, such as submission of QC data to an IQAP (Interlaboratory Quality Assurance Program). 2. A review of the Micros E-60 Hematology System Customer Training Manual revealed the instrument did have the capability to print L-J charts. The manual included instructions under "Review QC Result History" on pages 32-34. 3. During an interview on 7/27/2023 at 11:30 am, the Technical Consultant and Testing Personnel #1 confirmed the laboratory did not have a mechanism to track for shifts and trends over time in the Hematology QC. The laboratory did not print the L-J charts, and was not enrolled in an IQAP. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 2 of 2 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of a patient test report and an interview with the Laboratory Director, the laboratory failed to include the name and address of the laboratory location where the test was performed. This was noted on one of one patient test report for Complete Blood Count (CBC) reviewed by the surveyor. The findings include: 1. A review of a patient test report revealed the name and address of the laboratory location where the test was performed was not on the CBC patient test report performed on 08/24/2021. 2. During an interview on 08/24/2021 at 1:00 PM, the Laboratory Director confirmed that the name and address was not on the patient test report. 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 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 -- 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 a lack of Proficiency Testing records and an interview with the Laboratory Director, the Laboratory Director failed to ensure the laboratory was enrolled in an approved proficiency testing program for Hematology - Complete Blood Count when patient testing started. This noted from April 21, 2021 (date patient testing started) to August 23, 2021 (date Proficiency Testing was ordered). The findings include: 1. A review of CMS-116 Clinical Laboratory Improvement Amendments (CLIA) Application for Certification revealed that the laboratory is performing Complete Blood Counts (CBC) on the Horiba ES 60. A CBC includes the following moderate complexity, regulated analytes: White Blood Count (WBC) Differential, Erythrocyte Count, Hematocrit, Hemoglobin, Leukocyte Count, and Platelet Count. 2. During an interview on 08/24/2021 at 11:30 AM, the Laboratory Director confirmed the Proficiency Testing was delayed on being ordered until August 23, 2021 due to lack of oversight in getting ordered in April 2021. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on a review of personnel records and an interview with the Laboratory Director, the Laboratory Director failed to have in writing the duties/responsibilities to each person involved in all phases of the testing process. This was noted for seven out of seven employees listed on the Laboratory Personnel Report (CMS-209). The findings include: 1. A review of personnel records revealed the Laboratory Director , Clinical Consultant, Technical Consultant, and Testing Personnel duties /responsibilities are not in writing. 2. During an interview on 08/24/2021 at 11:05 AM, the Laboratory Director confirmed the responsibilities/duties (job descriptions) for the positions listed above were not in writing. -- 2 of 2 --