Lawndale Medical Clinic

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of participation of the CLIA program The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; 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 a review of the CMS (Center for Medicare Services) national database and a 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 -- proficiency desk review of the American Association of Bioanalysts (AAB) proficiency testing records from 2018-2020, it was determined the laboratory has not successfully participated in a proficiency testing program, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of hematology for the analyte Cell ID. (Refer to D2121, D2130) D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Association of Bioanalysts (AAB) proficiency testing records from 2018-2020, it was determined the laboratory failed to achieve satisfactory performance (at least 80%) in the specialty of hematology for the analytes White Blood Cell Differential for 2 of 3 consecutive testing events in 2020. Findings were: 1. A review of the CMS national proficiency testing database revealed the following scores White Blood Cell Differential for the following hematology testing events in 2020. A score of less than 80% is unsatisfacory performance. 2020 AAB 1st event - 73% 2020 AAB 3rd event - 0% 2. A proficiency desk review of the AAB proficiency testing records from 2018-2020 confirmed that the laboratory received a hematology score of 73% and 0% for the analyte White Blood Cell Differential for the following testing events: 2020 AAB 1st event WBC ID - 73% Lymphocytes - 60% Sample 1 - lab result 16.5 (acceptable range 10.8 - 15.1) Sample 5 - lab result 17.3 (acceptable range 10.4 - 15.8) Neutrophils - 60% Sample 1 - lab result 80.6 (acceptable range 81.7 - 87.5) Sample 5 - lab result 80.0 (acceptable range 81.3 - 87.7) 2020 AAB 3rd event - 0% D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Association of Bioanalysts (AAB) proficiency testing records from 2018 - 2020, it was revealed that the laboratory failed to participate for the analytes: Red Cell Count (RBC); Hematocrit (HCT); Hemaglobin (Hgb); White blood count (WBC); Platelet (PLT); and Cell ID in 1 of 3 hematology hematology testing events of 2020 (3rd event). Findings were: 1. A -- 2 of 4 -- review of the CMS national proficiency testing database revealed a score of "0" for the analytes Red Cell Count (RBC); Hematocrit (HCT); Hemaglobin (Hgb); White blood count (WBC); Platelet (PLT); and Cell ID on the 3rd event of 2020 for this facility. 2. A proficiency desk review of AAB PT records revealed the laboratory received a 0% for the 2020-3rd event Hematology for "Failure to Participate." The PT summary was rated by the provider as unsatisfactory performance for all analytes for testing events 2020-3rd event Hematology. 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 a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Association of Bioanalysts (AAB) proficiency testing records from 2018-2020, it was determined the laboratory failed to achieve satisfactory performance for the same analyte in 2 of 3 consecutive testing events. The laboratory failed to achieve satisfactory performance (at least 80%) in the specialty of hematology for the analyte White Blood Cell Differential for 2 of 3 consecutive testing events in 2020. Findings were: 1. A review of the CMS national proficiency testing database revealed the following scores White Blood Cell Differential for the following hematology testing events in 2020. A score of less than 80% is unsatisfactory performance. 2020 AAB 1st event - 73% 2020 AAB 3rd event - 0% 2. A proficiency desk review of the AAB proficiency testing records from 2018- 2020 confirmed that the laboratory received a hematology score of 73% and 0% for the analyte White Blood Cell Differential for the following 2 of 3 consecutive testing events in 2020. 2020 AAB 1st event - 73% 2020 AAB 3rd event - 0% 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: Based on a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an approved proficiency testing program. (refer to D2121 and D2130) -- 4 of 4 --