Gene K Hodges Md

Summary Statement of Deficiencies 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 training documentation and competency assessments, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and an interview on 6/7/2021 with the laboratory lead, the technical consultant (TC) failed to evaluate the competency of all testing personnel in accordance with 42 C.F.R. 493. 1413(b)(8)(9). The findings include: 1. A review of training and competency records identified that two (2) of two (2) testing personnel listed on the CMS 209 failed to have documentation of annual competency for performing complete blood counts (CBC) on the Horiba ABX Micros 60 for 2020 which included the six parameters as listed in 493.1413(b)(8)(9). 2. An interview with the laboratory lead on 6/7/2021 at 1: 10 pm confirmed that the TC failed to assess and document annual competencies for two (2) of two (2) testing personnel for CBC testing for 2020. 3. This is a repeat deficiency from the survey performed on 6/25/2019 in which the TC failed to assess and document annual competency for 2017 and 2018. 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 --

Summary Statement of Deficiencies 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 quality control records and an interview with the laboratory lead, the laboratory failed to retain the Horiba ABX complete blood count (CBC) quality control test results and the manufacturer's quality control assay reference sheets from August 2018 through June 2019. Findings: 1. A review of quality control records from the Horiba ABX analyzer revealed the laboratory failed to retain the manufacturer's quality control assay reference sheets prior to June 2019. 2. A review of the quality control test results from the Horiba ABX analyzer revealed the laboratory failed to retain the quality control test results from the analyzer between August 2018 through December 2018 and March 2019 through June 2019. 3. The laboratory performed approximately 200 CBC tests since August 2018. 4. An interview with the laboratory lead on June 25, 2019 at 10:50 AM, confirmed the laboratory failed to retain the quality control assay reference sheets and the quality control test records. 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). 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 a review of proficiency testing (PT) records from the American Proficiency Institute (API) and an interview with the laboratory lead, the laboratory failed to evaluate the test results from API for 5 out of 5 complete blood count (CBC) samples that were not reported nor self-evaluated for the 2018 event 3 program. Findings: 1. A review of the API CBC results from the 2018 event 3 program revealed the laboratory failed to submit the laboratory CBC PT scores and failed to self-evaluate the test results received from API. 2. An interview with the laboratory lead on June 25, 2019 at 9:05 AM, confirmed the laboratory failed to evaluate and assess the results for accuracy for the 2018 event 3 CBC program. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of quality control records and an interview with the laboratory lead, the laboratory failed to have daily test records for at least 2 levels of quality control material for the Horiba ABX complete blood count (CBC) analyzer prior to reporting patient CBC results between August 2018 and June 24, 2019. Findings: 1. A review of the quality control records from August 2018 through December 2018 and March 2019 through June 2019 for the Horiba ABX analyzer revealed the laboratory failed to have test records for at least 2 levels of quality control material performed prior to reporting patient test results. 2. The laboratory performed approximately 200 patient CBC tests between August 2018 and June 24, 2019. 3. An interview with the laboratory lead on June 25, 2019, at 10:25 AM, confirmed the laboratory failed to have records of quality control material performed prior to reporting patient CBC results. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: The laboratory director failed to provide overall management for the testing of complete blood counts performed on the Horiba ABX since the last survey on September 19, 2017. Refer to D6004, D6020, and D6021. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) -- 2 of 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on a review of records, the laboratory director failed to provide overall management for the operation of the laboratory and competency of the testing personnel since the last survey on September 19, 2017. Findings: 1. A record review of competency assessments for 2 out of 2 testing personnel, revealed the laboratory director, who is also the technical consultant, failed to perform competency assessments. 2. A review of the quality control records revealed the laboratory director failed to ensure that at least 2 levels of quality control were performed prior to patient testing, as well as, ensure that quality control records were retained. Refer to D3031 and D5447. 3. A review of the proficiency testing records revealed the laboratory director failed to ensure the self-evaluation of test results from the American Proficiency Institute were evaluated for accuracy. Refer to D5215. 4. An interview with the laboratory lead on June 25, 2019, at 10:25 AM, confirmed the laboratory director failed to ensure overall management of the laboratory operations was performed. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of quality control records and an interview with the laboratory lead, the laboratory director failed to ensure the quality control program for the Horiba ABX complete blood count (CBC) analyzer meets the CLIA requirements since the last survey on September 19, 2017. Refer to D3031 and D5447. Findings: 1. A review of quality control records for the Horiba ABX complete blood count (CBC) analyzer revealed the laboratory director failed to ensure quality control test records and manufacturer quality control assay reference sheets were maintained and retrievable. 2. A review of quality control records revealed the laboratory failed to have daily test records for at least 2 different concentrations of quality control material performed prior to reporting patient CBC results. 3. An interview with the laboratory lead on June 25, 2018, at 10:30 AM, confirmed the laboratory director failed to meet CLIA the requirements for quality control testing and retention. D6021 LABORATORY DIRECTOR RESPONSIBILITIES -- 3 of 4 -- CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of records and an interview with the laboratory lead, the laboratory director failed to ensure the establishment of a quality assessment program for laboratory performing complete blood counts (CBCs) the Horiba ABX analyzer since the last survey on September 19, 2017. Findings: 1. A review of the procedure manual revealed the laboratory director failed to establish and write a policy or procedure for a system to monitor, assess, and correct problems in the preanalytic, general laboratory system, analytic, and post-analytic processes in the laboratory. 2. An interview with the laboratory lead on June 25, 2017 at 10:35 AM, confirmed the laboratory director failed to establish and write a policy or procedure to monitor all quality assessments activities for the laboratory's test performance in CBC. 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 record review of personnel competency assessments and an interview with the laboratory lead, the laboratory director, who is also the technical consultant, failed to evaluate the competency for 2 out of 2 testing personnel performing complete blood counts (CBCs) on the Horiba ABX analyzer since the last survey on September 19, 2017. Findings: 1. A review of personnel documents revealed the laboratory director failed to evaluate the competency for 2 out of 2 nursing assistants performing CBCs since the last survey. 2. An interview with the laboratory lead on June 25, 2019 at 9:30 AM, confirmed the laboratory director failed to assess and document the competency for the 2 testing personnel. -- 4 of 4 --