Lab-All Inc

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 Surveyor review of laboratory's proficiency testing (PT) evaluation reports from American Association of Bioanalysts (AAB), and interview with the laboratory testing person #1 on October 12, 2021 at 10:45 am, the laboratory failed to attain a score of at least 80 percent of acceptable responses for the analyte Iron at the 1st event (Q1) of 2020 resulting in an unsatisfactory analyte performance for the testing event. The unsatisfactory PT performance suggesting that the laboratory might have reported inaccurate test results for the analyte Iron to the patient during the PT event and thus had harmed patients. The findings include: 1. The laboratory enrolled in the PT program with AAB for assessing laboratory's performance and verifying the accuracy and reliability of its test results, however it received an unsatisfactory performance for the analyte Iron at the 1st event of 2020. The laboratory received a score of 40 % for Iron at the Q1 2020 PT event, which was unsatisfactory analyte performance. Q1 2020 Iron result accepted range Specimen 1 48 27 to 40 Specimen 4 230 120 to 180 Specimen 5 346 182 to 272 Overall score: 40% Unacceptable 2. The laboratory testing person #1, on October 12, 2021 at 10:45 am, affirmed that the laboratory received a score of 40% for Iron at the Q1 2020 PT event. 3. Based on the laboratory's annual test volume declaration form signed by the laboratory director, the laboratory analyzed and reported approximately 542 Iron tests, annually. . D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of American Association of Bioanalysts (AAB) proficiency testing records, lack of laboratory's remedial action records, and interview with the testing person #1 on October 12, 2021 at 10:50 am, it was determined that the laboratory failed to take any remedial action to correct problems after receiving an unsatisfactory proficiency testing (PT) performance for the analyte Iron at the 1st event of 2020. The findings include: 1. The laboratory received an unsatisfactory score (40%) for the analyte Iron at the 1st PT event of 2020 PT. See D2087. However, it did not take any remedial action to correct the PT failure and continued to test patient causing inaccurate test results which might had harmed patients. 2. The laboratory testing person #1, on October 12, 2021 at 10:50 am, affirmed that the laboratory did not take any remedial action for the Iron PT failure and thus did not have any documentation. However, it had documentation of remedial action taken for the PT failure of some other analytes including Potassium. 3. Based on the laboratory's annual test volume declaration form signed by the laboratory director, the laboratory analyzed and reported approximately 542 Iron tests, annually. . D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) evaluation reports from American Association of Bioanalysts (AAB), and interview with the laboratory testing person #1 on October 12, 2021 at 11:15 am, the laboratory failed to attain a score of at least 80 percent of acceptable responses for the Hematology analytes WBC, RBC, Hemoglobin, Hematocrit and Platelets at the 2nd event (Q2) of 2021 resulting in an unsatisfactory analyte performance for the testing event. The unsatisfactory PT performance suggesting that the laboratory might have reported inaccurate test results for the above analytes to the patient during the PT event and thus had harmed patients. The findings include: 1. The laboratory received the following unsatisfactory PT scores for WBC, RBC, Hemoglobin, Hematocrit and Platelets at the 2nd event (Q2) of 2021: WBC Overall score 60% Sample Reported Expected Score 1 7.3 7.9 - 10.7 U 4 9.5 6.1 - 8.2 U RBC Overall score 60% Sample Reported Expected Score 1 4.69 5.83 - 6.57 U 4 6.25 4.29 - 4.84 U Hemoglobin Overall score 60% Sample Reported Expected Score 1 13.4 17.1 - 19.7 U 4 8.4 12.5 - 14.4 U Hematocrit Overall score 60% Sample Reported Expected Score 1 39.2 49.1- 55.4 U 4 52.4 36.1 - 40.8 U Platelet Overall score 60% Sample Reported Expected Score 1 239 63 -105 U 4 77 180-299 U 2. The laboratory testing person #1, on October 12, 2021 at 11:15 am, affirmed that the laboratory received an unsuccessful PT score of 60% for WBC, RBC, Hemoglobin, Hematocrit and Platelets at the 2nd event (Q2) of 2021. 3. According to the laboratory testing declaration form signed by -- 2 of 6 -- the laboratory director, the laboratory performed approximately 9,000 Hematology tests, quarterly. . D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on Surveyor review of American Association of Bioanalysts (AAB) proficiency testing records, lack of laboratory's remedial action records, and interview with the testing person #1 on October 12, 2021 at 11:20 am, it was determined that the laboratory failed to take any remedial action to correct problems after receiving an unsatisfactory proficiency testing (PT) performance for the Hematology analytes WBC, RBC, Hemoglobin, Hematocrit and Platelets at the 2nd event (Q2) of 2021. The findings include: 1. The laboratory received an unsatisfactory score (60%) for the Hematology analytes WBC, RBC, Hemoglobin, Hematocrit and Platelets at the 2nd PT event (Q2) of 2021. See D2122. However, it did not take any remedial action to correct the PT failure and continued to test patient causing inaccurate test results which might had harmed patients. 2. The laboratory testing person #1, on October 12, 2021 at 11:20 am, affirmed that the laboratory did not take any remedial action for the failed PT event and thus did not have any documentation. 3. According to the laboratory testing declaration form signed by the laboratory director, the laboratory performed approximately 9,000 Hematology tests, quarterly. . D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) evaluation reports from American Association of Bioanalysts (AAB), test verification records, and interview with the laboratory testing person #1 on October 12, 2021 at 12:15 pm, the laboratory failed to verify the accuracy of Folate in 2019 and 2020, and Testosterone in 2020. The laboratory's failure in the verification of test accuracy suggesting that the laboratory might have reported inaccurate test results for the analytes Folate and Testosterone to the patient during the PT event and thus had harmed patients. The findings include: 1. The laboratory had participated in the AAB PT program in 2019 and 2020 to verify the accuracy of Folate and Testosterone tests. However, the verification was unsuccessful. a) During review of laboratory documentation from AAB, there were 3 consecutive events where folate was tested unsuccessfully. The laboratory received the following AAB scores for Folate: Q3 2019 Folate overall result 0% Q1 2020 Folate overall result 50% Q2 2020 Folate overall result 50% b) -- 3 of 6 -- The laboratory received a score of 50% for Testosterone at the Q1 2020 PT event, which was unsatisfactory analyte performance. Q1 2020 Testosterone result accepted range Specimen 1 49 88 to 164 Overall score 50% Unacceptable c) The laboratory did not verify the Folate and Testosterone test accuracy by any other method. 2. The laboratory testing person #1, on October 12, 2021 at 12:15 pm, affirmed that the laboratory was unsuccessful in verifying the Folate and Testosterone test accuracy in 2019 and 2020. 3. According to the laboratory testing declaration form signed by the laboratory director, the laboratory performed approximately 77 Testosterone and 542 Folate tests, annually. . 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 through 493.1236. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policies and procedures, proficiency testing (PT) evaluation reports from American Association of Bioanalysts (AAB), and interview with the laboratory testing person #1 on October 12, 2021 at 12:45 pm, the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems associated with the evaluation of proficiency testing performance and verification of test accuracy. The findings include: 1. The laboratory failed to verify the accuracy of Folate and Testosterone tests and lacked in the evaluation of proficiency testing results. See D2094, D2128 and D5217. However, laboratory's quality assessment program was not sufficient to find and correct the problems in the general laboratory system. 2. The laboratory testing person #1, on October 12, 2021 at 12:45 pm, affirmed that the laboratory did not have an ongoing mechanism to identify and correct problems associated with the general laboratory system. 3. Based on the laboratory's annual test volume declaration form signed by the laboratory director, the laboratory analyzed and reported approximately 529 Folate and 77 Testosterone tests, annually. . D5783

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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the subspecialty of Routine Chemistry constituting unsuccessful PT performances. (See D2096) 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Chloride (CL), resulting in an "non-initial" (subsequent) unsuccessful performance. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, CL, as follows: 2017 Q3 (40%) 2018 Q1 (20%) 2018 Q2 (60%) Q1 = First Testing Event Q2 = Second Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in a subsequent unsuccessful performance for the analyte, CL. 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 the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory director was not met. The laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See 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 CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, CL, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in subsequent unsuccessful PT performance. (See D2016 and D2096) -- 2 of 2 --