Mea Medical Clinic-Spillway

Summary Statement of Deficiencies 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 review of preventive maintenance logs for the CDS Medonic hematology analyzer from 3/30/2021 through 12/31/2021 and 6/1/2022 through 11/30/2022 and lack of documentation of daily maintenance for five months, monthly maintenance for ten months, and six-month maintenance from 3/30/2021 until 5/27/2022, the laboratory failed to perform and document maintenance as defined by the manufacturer, with at least the frequency specified by the manufacturer. Findings include: Review of preventive maintenance logs for the CDS Medonic hematology analyzer since the last survey on 3/30/2021 revealed no documentation of the following maintenance procedures for the months listed: (1) Daily maintenance procedure "Clean Probe with alcohol" for the months of January through May 2022. (2) Monthly maintenance procedures "Monthly Cleaning" and "Clot Prevention" for the months of July, August, September, November, and December of 2021 and January, March, April, June, and July of 2022. (3) Six-month maintenance "Boule Cleaning Kit Procedure" from 3/30/2021 until 5/27/2022. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's Quality Assessment (QA) Plan and review of quality assessment documentation since the last survey on 3/30/2021, the laboratory failed to follow its written policy for performing a weekly chart review of test results from 3/30/2021 until a new Quality Assessment Plan was implemented on 10/1/2022. Findings include: Review of the laboratory's Quality Assessment (QA) Plan in the laboratory procedure manual revealed the "Relationship of Patient Information to Patient Test Results" policy states, "Our laboratory will do one chart review a week to ensure efficiency. The laboratory testing personnel will pull one chart a week to monitor the relationship of the test results to other test results, the relationship of test results to diagnosis, and the distribution of test results." There was no documentation available on the day of the survey, 12/27/2022, of a weekly chart review for the eighteen months from 3/30/2021 until 10/1/2022. 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 review of personnel records since the last survey on 3/30/2021, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, and interview with the technical consultant on 12/27/2022 at 2:30 p.m., the laboratory director failed to ensure that, prior to testing patients' specimens, Testing Personnel #4 and #5 had received the appropriate training for moderate complexity testing and had demonstrated performance of all testing operations reliably to provide and report accurate results. Findings include: Review of personnel records since the last survey on 3/30/2021 and the CMS 209 personnel form revealed the laboratory director failed to ensure that Testing Personnel #4, date of hire 8/20/2021, and Testing Personnel #5, date of hire 8/27/2021, received appropriate training for performing moderate complexity testing prior to testing patients' specimens. In an interview on 12/27/2022 at 2:30 p.m., the technical consultant confirmed there was no documentation of training available for Testing Personnel #4 and #5. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of preventive maintenance logs for the CDS Medonic hematology -- 2 of 4 -- analyzer from 3/30/2021 through 12/31/2021 and from 6/1/2022 through 11/30/2022 and lack of documentation of review by the technical consultant, the technical consultant failed to document review of the CDS Medonic preventive maintenance logs for April through December of 2021 and June through August of 2022, until the current technical consultant was hired on 10/1/22. There was also no documentation to indicate that the previous technical consultant detected a lack of documentation of daily maintenance on the CDS Medonic hematology analyzer from 1/1/2022 through 5 /31/2022. Findings include: Review of preventive maintenance logs for the CDS Medonic hematology analyzer from 3/30/2021 through 12/31/2021 and 6/1/2022 through 11/30/2022 revealed no documentation of review by the technical consultant for twelve months, for the evaluation of the competency of the staff, until the current technical consultant was hired on 10/1/2022. There was also no documentation to indicate that the previous technical consultant detected a lack of documentation of daily maintenance on the CDS Medonic hematology analyzer from 1/1/2022 through 5 /31/2022. Refer to D5429 (Failure to document daily, monthly, and six-month maintenance. ) D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of personnel records since the last survey on 3/30/2021, the CMS 209 personnel form, and lack of documentation of competency assessments, the technical consultant failed to evaluate and document the performance of Testing Personnel #4, date of hire 8/20/2021, and #5, date of hire 8/27/2021, at least semiannually, during the first year these individuals tested patient specimens. Findings include: Review of personnel records since the last survey on 3/30/2021 and the CMS 209 personnel form revealed the technical consultant failed to evaluate and document the performance of Testing Personnel #4, date of hire 8/20/2021, and Testing #5, date of hire 8/27/2021, responsible for moderate complexity testing, at least semiannually during the first year these individuals tested patient specimens. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of personnel records since the last survey on 3/30/2021, the CMS 209 personnel form, and lack of documentation of competency assessments, the technical consultant failed to evaluate and document the performance of Testing Personnel #5, date of hire 8/27/2021, at least annually, after the first year. Findings include: Review of personnel records since the last survey on 3/30/2021 and the CMS -- 3 of 4 -- 209 personnel form revealed the technical consultant failed to evaluate and document the performance of Testing Personnel #5, who was responsible for moderate complexity testing, at least annually since this individual's date of hire on 8/27/2021. -- 4 of 4 --

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: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 8/26/2022, the laboratory has not successfully participated in proficiency testing for WHITE BLOOD CELL (WBC) DIFFERENTIAL. Findings include: Our records indicate the following proficiency testing scores for your laboratory for WHITE BLOOD CELL (WBC) DIFFERENTIAL (Lymphocyte, Monocyte, Granulocyte): PROFICIENCY TESTING PROVIDER: American Academy of Family Physicians (AAFP): WHITE BLOOD CELL (WBC) DIFFERENTIAL: Year 2022 1st Event 0% Year 2022 2nd Event 0% 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 -- Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 8/26/2022, the laboratory has not successfully participated in proficiency testing for WHITE BLOOD CELL (WBC) DIFFERENTIAL. Findings include: Our records indicate the following proficiency testing scores for your laboratory for WHITE BLOOD CELL (WBC) DIFFERENTIAL (Lymphocyte, Monocyte, Granulocyte): PROFICIENCY TESTING PROVIDER: American Academy of Family Physicians (AAFP): WHITE BLOOD CELL (WBC) DIFFERENTIAL: Year 2022 1st Event 0% Year 2022 2nd Event 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --