Caballero Family Healthcare Group, Pllc

Summary Statement of Deficiencies D5783

Summary Statement of Deficiencies 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 review of final patient test reports laboratory procedure, and staff interview, the laboratory failed to follow the urine microscopic reporting protocol for the white blood cell per high power field (WBC/hpf), red blood cell per high power field (RBC /hpf), and bacteria per high power field (Bact/hpf) for three of three patients reviewed from 2023. The findings include: 1. Review of final patient test reports for urine sediment microscopic exam revealed the following: Patient #50376 reported 09/15 /2023 WBC/hpf 10-20, Bact/hpf 10-20 Patient #10669 reported 03/08/2023 WBC/hpf 0-10, RBC/hpf 0-5 Patient #11615 reported 10/03/2023 WBC/hpf 0-10, RBC/hpf 0-5 2. Review of the laboratory procedure titled "Urine Sediment Microscopic Exam" section "Elements to Report" revealed the following: WBC: (average 10 hpf count) 0- 2, 5-10, 20-40, or >100. WBC clumps should be noted. RBC: (average 10 hpf count) 0-2, 5-10, 20-40, or >100. Bacteria: reported as few, moderate, or many (per hpf). 3. Interview on 11/16/2023 at 1:00 pm with the technical consultant confirmed the laboratory failed to follow the reporting protocol for urine sediment microscopic examination in 2023. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from 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 -- the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of the log used for recording wet prep results, the final patient test report, and staff interview, the laboratory failed to ensure manually entered test results for wet prep were accurately entered into the final patient test report for one of two patients reviewed from 2023. The findings include: 1. Review of the laboratory's manual log for recording wet prep revealed a hyphae result of 0/hpf on 05/03/2023 for patient 55726. 2. Review of the final patient test report revealed the hyphae was reported as 1+. 3. Interview on 11/16/2023 at 1:00 pm with the technical consultant confirmed the laboratory failed to ensure wet prep results were accurately entered from the manual patient log into the patient chart for patient 55726 on 05/03/2023. -- 2 of 2 --

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: The laboratory failed to maintain satisfactory proficiency testing (PT) performance for the red blood cell, hematocrit, hemoglobin, and white blood cell analytes and the hematology specialty in resulting in non-initial unsuccessful PT occurrence. (Refer to D2130 and D2131) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Center for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's 2021 and 2022 proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance in three out of four PT events for the red blood cell, hematocrit, hemoglobin and white blood cell analytes, resulting in non-initial unsuccessful PT occurrence. The findings include: 1. Review of the CMS 155 revealed the following unsatisfactory PT scores: Red Blood Cell: 2021 Event 1=0%, 2021 Event 2=40%, 2022 Event 1=60% Hematocrit: 2021 Event 1=0%, 2021 Event 2=40%. 2022 Event 1=40% Hemoglobin: 2021 Event 1=0%, 2021 Event 2=40%. 2022 Event 1=60% White Blood Cell: 2021 Event 1=0%, 2021 Event 2=40%. 2022 Event 1=60% 2. Review of the laboratory's American Association of Bioanalysts (AAB) PT performance evaluation records revealed the following: 2021 Event 1: Scored as 0% for red blood cell, hematocrit, hemoglobin and white blood cell for non-reporting. 2021 Event 2: Red blood cell: Sample numbers six, nine and ten scored as unacceptable resulting in an overall score of 40%. Hematocrit: Sample numbers six, nine and ten scored as unacceptable resulting in an overall score of 40%. Hemoglobin: Sample numbers six, nine and ten scored as unacceptable resulting in an overall score of 40%. White Blood Cell: Sample numbers six, nine and ten scored as unacceptable resulting in an overall score of 40%. 2022 Event 1: Red blood cell: Sample numbers four and five scored as unacceptable resulting in an overall score of 60%. Hematocrit: Sample numbers two, four and five scored as unacceptable resulting in an overall score of 40%. Hemoglobin: Sample numbers four and five scored as unacceptable resulting in an overall score of 60%. White Blood Cell: Sample numbers four and five scored as unacceptable resulting in an overall score of 60% and non-initial unsuccessful PT performance. D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Center for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's 2021 and 2022 proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance in three out of four PT events for the hematology specialty, resulting in non-initial unsuccessful PT occurrence. The findings include: 1. Review of the CMS 155 revealed the following unsatisfactory PT scores for the hematology specialty: 2021 Event 1=0%, 2021 Event 2=60%, 2022 Event 1= 57% 2. Review of the laboratory's American Association of Bioanalysts (AAB) PT evaluation records revealed the following for the hematology specialty: 2021 Event 1: Scored as 0% for non-reporting. 2021 Event 2: Scored of 60% for the hematology specialty. 2022 Event 1: Score of 57.8% for the hematology specialty and non-initial unsuccessful PT occurrence. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 2 of 3 -- 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 ensure the laboratory performed proficiency testing in such a manner as to achieve and maintain satisfactory performance with successful proficiency testing (PT) for the red blood cell, hematocrit, hemoglobin, and white blood cell analytes and the hematology specialty, resulting in non-initial unsuccessful PT occurrence. (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; This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Services Casper report 155 (CMS 155), the laboratory's 2021 and 2022 proficiency testing (PT) evaluation reports, and laboratory communication, the laboratory director failed to ensure the laboratory performed proficiency testing in such a manner as to achieve and maintain satisfactory performance, resulting in unsatisfactory performance for three out of four consecutive proficiency testing events for the red blood cell, hematocrit, hemoglobin and white blood analytes and the hematology specialty, resulting in non-initial unsuccessful PT occurrence. The findings include: 1. Review of the CMS 155 and the laboratory's American Association of Bioanalysts (AAB) PT evaluation reports revealed the following unsatisfactory scores: Red Blood Cell: 2021 Event 1=0%, 2021 Event 2=40%, 2022 Event 1=60% Hematocrit: 2021 Event 1=0%, 2021 Event 2=40%, 2022 Event 1=40% Hemoglobin: 2021 Event 1=0%, 2021 Event 2= 40%, 2022 Event 1=60% White Blood Cell: 2021 Event 1=0%, 2021 Event 2=40%, 2022 Event 1=60% Hematology Specialty: 2021 Event 1=0%, 2021 Event 2=60%, 2022 Event 1=57% 2. Review of a letter received April 4, 2022 revealed the following statement: "This letter is to notify the CLIA office that due to another PT failure we have voluntarily stopped testing for CBC's as of March 30th. We have currently ordered a new Hematology Analyzer and contacted a Technical Consultant [technical consultant name] to come work with us." The letter was signed by the laboratory director. -- 3 of 3 --

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: The laboratory failed to maintain satisfactory performance for the red blood cell, hematocrit, hemoglobin, and white blood cell analytes and the specialty of hematology for two consecutive proficiency testing events, resulting in the first unsuccessful PT occurrence for the red blood cell, hematocrit, hemoglobin and white blood cell analytes and the specialty of hematology. (Refer to D2130 and D2131) D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 desk review of the Centers for Medicare and Medicaid Services Casper Report 155 (CMS 155) and the laboratory's 2021 proficiency testing (PT) records, the laboratory failed to maintain satisfactory performance for the red blood cell, hematocrit, hemoglobin and white blood cell analytes in two consecutive PT events, resulting in the first unsuccessful PT occurrence for the red blood cell, hematocrit, hemoglobin and white blood cell analytes. The findings include: 1) Review of the CMS 155 revealed the following unsatisfactory PT scores for the red blood cell, hematocrit, hemoglobin and white blood cell analytes: 2021 event one: 0% for red blood cell, hematocrit, hemoglobin and white blood cell 2021 event two: 40% for red blood cell, hematocrit, hemoglobin and white blood cell 2) Review of the laboratory's proficiency testing records revealed the following: 2021 event one: 0% score for red blood cell, hematocrit, hemoglobin and white blood cell for non-reporting. 2021 event two: Sample numbers six, nine and ten scored as unacceptable for red blood cell, hematocrit, hemoglobin and white blood cell, resulting in an overall score of 40% for each of the analytes and the first unsuccessful PT occurrence for the red blood cell, hematocrit, hemoglobin and white blood cell analytes. D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Services Casper report 155 (CMS 155) and the laboratory's proficiency testing (PT) evaluation reports, the laboratory failed to maintain a satisfactory overall testing event score for the Hematology specialty in 2021 event one and 2021 event two, resulting in the first unsuccessful PT occurrence for the Hematology specialty. The finding include: 1) Review of the CMS 155 revealed the following scores for the specialty of hematology: 2021 Event one = 0% 2021 Event two = 60% 2) Review of the laboratory's 2021 event one PT evaluation report for hematology revealed a score of 0% for non-reporting. 3) Review of the laboratory's 2021 event two PT evaluation report for hematology revealed failing scores of 40% for the red blood cell, hematocrit, hemoglobin, and white blood cell analytes, resulting in an overall event score of 60% and the first unsuccessful PT occurrence for the hematology specialty. -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual, employee personnel records for 2017 and 2018, and interview with the lead testing personnel, the laboratory failed to have a procedure to include all six criteria for assessing personnel competency. The findings include: 1) Review of the laboratory procedure manual revealed the following six criteria were not included in the procedure and competency documentation: direct observation of routine patient test performance; monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results and preventative maintenance records; direct observation of performance of instrument maintenance and function checks; assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and assessment of problem solving skills. 2) Review of the 2017 and 2018 employee personnel records revealed no documentation of competency assessment for the six required criteria. 3) Interview on January 10, 2019 at 3:00 pm with the lead testing personnel confirmed the testing personnel competency procedure did not include the six criteria for testing personnel competency assessment required by Centers for Medicare and Medicaid Services (CMS). D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty 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 -- 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). This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records and interview with the lead testing personnel, the laboratory failed to evaluate non-graded proficiency scores in 2017. The findings include: 1) Review of the laboratory's proficiency testing records for urine microscopy revealed the following: 2017 2nd quarter - Non-graded scores with no evaluation to determine the laboratory's accuracy of reported results. 2017 3rd quarter - Non-graded scores with no evaluation to determine the laboratory's accuracy of reported results. 2) Interview with the lead testing personnel on January 10, 2019 at 11:00 am confirmed the laboratory failed to evaluate the accuracy of non- graded scores for urine microscopy for 2017 events two and three. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of