Family Medical Associates West

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) 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. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing (PT) records and an interview with Testing Personnel #1, the laboratory failed to maintain copies of all relevant records for Proficiency Testing events. This was noted for 2 out of 5 events reviewed from the date of the last survey, 12/28/2021, to the date of the current survey, 12/06/2023. The findings include: 1. A review of PT records revealed no evidence of signed attestation statements, program report forms, or instrument print outs for 2023 Hematology Event 1 and 2023 Hematology Event 2. 2. During an interview on 12/6/2023 at 11:00 AM, Testing Personnel #1 confirmed the above findings. 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 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 -- through 493.1236. This STANDARD is not met as evidenced by: Based on a review of Policies and Procedures and an interview with Testing Personnel #1, the laboratory failed to establish a written policy for an ongoing Quality Assessment mechanism. This was noted from the date of the last survey, 12/28/2012, to the date of the current survey, 12/6/2023. The findings include: 1. A review of Policies and Procedures revealed no evidence of a Quality Assessment policy. 2. During an interview on 12/06/2023 at 2:00 PM, Testing Personnel #1 confirmed the above findings. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of Policies and Procedures, Sysmex XP-300 Hematology Quality Control (QC) records, and an interview with Testing Personnel #1, the laboratory failed to follow policies approved and set forth by the Laboratory Director. The findings include: 1. A review of Policies and Procedures revealed the following text under "A,B,C's of QC", "...At the end of each lot of quality control material the Levy Jennings Graph Chart and all the values will be printed and placed in the same binder...". 2. A review of Hematology QC revealed only daily instrument print outs and background checks were being retained. No evidence of Levy Jennings charts were available for review at the time of survey. 3. During an interview on 12/06/2023 at 11:00 AM, the Surveyor inquired about the laboratory monitoring Levy Jennings charts over a period of time. Testing Personnel #1 replied, "I have not been shown that". 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 a review of Policies and Procedures, Sysmex XP-300 calibration records, and an interview with Testing Personnel #1, the laboratory failed to perform -- 2 of 3 -- calibration at least every six months. This was noted for two out of two calibration opportunities in the year 2023. The findings include: 1. A review of Policies and Procedures revealed the following under the procedure for Sysmex, "...Calibration verification is performed according to the laboratory Standard Operating Procedure and accreditation agency requirements...". 2. A review of Sysmex calibration records revealed the following: a) Calibration performed 2/10/2022. Calibration Certificate expired 8/09/2022. b) Calibration performed 8/09/2022. Calibration Certificate expired 2/05/2023. c) No evidence of documented calibration in 2023. 3. During an interview on 12/6/2023 at 2:00 PM, Testing Personnel #1 confirmed the above findings. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a review of Personnel records and an interview with Testing Personnel #1, the Laboratory Director failed to ensure all testing personnel had appropriate education documented prior to patient testing. This was noted for one out of two testing personnel from the date of the last survey, 12/28/2021, to the date of the current survey, 12/6/2023. The findings include: 1. A review of Personnel records revealed Testing Personnel #1 to have a phlebotomy certificate on file. No evidence of any official diplomas or transcripts were available for review day of survey. 2. During an interview on 12/6/2023 at 2:00 PM, Testing Personnel #1 confirmed the above findings. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of Personnel records and an interview with Testing Personnel #2, the Technical Consultant failed to assess competency annually for Testing Personnel performing non waived patient testing. This was noted for one out of one Testing Personnel previously qualified at the date of the last survey, 12/28/2021. The findings include: 1. A review of Personnel records revealed no evidence of annual competency assessments in 2022 or 2023 for Testing Personnel #2. 2. During an interview on 12/6 /2023 at 2:00 PM, Testing Personnel #2 provided the surveyor with Clinical Consultant and Technical Consultant competency assessment forms for themselves. Neither form assessed competency for Sysmex XP-300. -- 3 of 3 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) 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 a review of API (American Proficiency Institute) proficiency testing (PT) records, CMS-209 (Laboratory Personnel Report) along with personnel records, and an interview with Testing Personnel #1 and #2, the surveyor determined the laboratory failed to ensure proficiency testing samples were rotated between all personnel who performed patient testing. This was noted on three out of five Testing Personnel listed on the CMS-209 (Laboratory Personnel Report) for the six events reviewed by the surveyor. The findings include: 1. A review of API attestation statements revealed Testing Personnel #1 and #3 performed 2020 Hematology 1st Event through 2021 Hematology 3rd Event. 2. A review of the CMS-209 and personnel records revealed Testing Personnel #2 and #4 were listed as Testing Personnel during the previous survey and Testing Personnel #5 started patient testing in June 2020. 2. During an interview on 12/28/2021 at 1:25 PM, Testing Personnel #1 and #2 confirmed the proficiency testing was not rotated to the other three testing personnel since the 1st Event 2020. . 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. 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 -- This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing records and an interview with Testing Personnel #1 and #2, the Laboratory Director failed to sign the attestation statement provided by American Proficiency Institute (API). This was noted on four out of six 2020 - 2021 Hematology Proficiency Testing Events. The findings include: 1. A review of Proficiency Testing records revealed that Hematology Event #2 2020, Event #3 2020, Event #2 2021, and Event #3 2021 attestation statement were not signed by the Laboratory Director/delegate. 2. During an interview on 12/28/2021 at 1:25 PM, Testing Personnel #1 and #2 confirmed the above attestations were not signed by the Laboratory Director/delegate. 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 a review of Proficiency Testing records and an interview with Testing Personnel #1 and #2, the laboratory failed to review and evaluate the results received from American Proficiency Institute (API). This was noted on one out of six 2020 - 2021 Hematology Proficiency Testing Events. The findings include: 1. A review of the Proficiency Testing records revealed 2021 1st Event was not reviewed and evaluated by the laboratory. The lymphocytes were scored as 80%, resulting in a score of 93% for the WBC (White Blood Cell) Differential;

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --