Lodestar Diagnostic Laboratory Inc

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] D2017 - 42 C.F.R. 493.807 (a) - Reinstatement After Failure 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- Based on a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Board 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 Red Cell Count (RBC); Hematocrit (HCT); Hemaglobin (Hgb); White blood count (WBC); Platelet (PLT); and Cell ID. (Refer to D2130, D2131) The laboratory did not successfully participate in the specialty of chemistry for the analytes: ALT (alanine aminotransferase); ALBUMIN; ALP (Alkaline phosphatase); AST (aspartate aminotransferase); TBILI (total Bilirubin); CA (Calcium); CL (Chloride); CHOLESTEROL; HDL (high-density lipoprotein); CK (Creatine kinase); TOTAL CREATINE; GLUCOSE; MG (Magnesium); K (potassium); NA (Sodium); TOTAL PROTEIN; TRIGL (Triglyceride); BUN (Urea nitrogen); URIC ACID; and subspecialty of ENDOCRINOLOGY for the analytes: FREE TY (Free thyroxine); HCG (Human chorionic gonadotropin); and TSH ( thyroid stimulating hormone). (Refer to D2096, D2097, D2107, D2108) D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: I. Based on a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2018-2020, it was determined the laboratory had not successfully participated in proficiency testing for the satisfactory performance in the specialty of hematology for the analytes: Red Cell Count (RBC), Hematocrit (HCT), Hemaglobin (Hgb), White blood count (WBC), Platelet (PLT), and Cell ID resulting in a non- initial PT failure. Findings were: 1. Review of AAB PT records for 2018-2020 for Red Cell Count (RBC), Hematocrit (HCT), Hemaglobin (Hgb), White blood count (WBC), Platelet (PLT), and Cell ID revealed the laboratory received the following scores for the 2018 Hematology 3rd event, and 2019 2nd and 3rd events, and 2020 1st event: AAB 3rd event 2018 = 0% AAB 2nd event 2019 = 0% AAB 3rd event 2019 = 0% AAB 1st event 2020 = 0% 2. A review of the performance summary reports from AAB proficiency testing agency confirmed the laboratory failed to submit proficiency testing results which resulted in a grade of 0 for the analytes Red Cell Count (RBC), Hematocrit (HCT), Hemaglobin (Hgb), White blood count (WBC), Platelet (PLT), and Cell ID. AAB 3rd event 2018 = 0% AAB 2nd event 2019 = 0% AAB 3rd event -- 2 of 11 -- 2019 = 0% AAB 1st event 2020 = 0% 3. The laboratory must demonstrate sustained satisfactory performance (>/= 80%) on two consecutive testing events for reinstatement. II. Based on a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019-2020, it was determined the laboratory had not successfully participated in proficiency testing for the satisfactory performance in the specialty of chemistry for the analytes: ALT (alanine aminotransferase); ALBUMIN; ALP (Alkaline phosphatase); AST (aspartate aminotransferase); TBILI (total Bilirubin); CA (Calcium); CL (Chloride); CHOLESTEROL; HDL (high-density lipoprotein); CK (Creatine kinase); TOTAL CREATINE; GLUCOSE; MG (Magnesium); K (potassium); NA (Sodium); TOTAL PROTEIN; TRIGL (Triglyceride); BUN (Urea nitrogen); URIC ACID; and subspecialty of ENDOCRINOLOGY for the analytes: FREE TY (Free thyroxine); HCG (Human chorionic gonadotropin); and TSH ( thyroid stimulating hormone) resulting in a non-initial PT failure. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" for the analytes in 3 of 3 Chemistry testing events for the analytes: ALT (alanine aminotransferase); ALBUMIN; ALP (Alkaline phosphatase); AST (aspartate aminotransferase); TBILI (total Bilirubin); CA (Calcium); CL (Chloride); CHOLESTEROL; HDL (high-density lipoprotein); CK (Creatine kinase); TOTAL CREATINE; GLUCOSE; MG (Magnesium); K (potassium); NA (Sodium); TOTAL PROTEIN; TRIGL (Triglyceride); BUN (Urea nitrogen); and URIC ACID. 2019 AAB 3rd event 2020 AAB 1st event 2020 AAB 2nd event 2. A proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019-2020 confirmed that the laboratory received a chemistry score of 0% for 3 of 3 consecutive testing events for the following analytes: ALT (alanine aminotransferase); ALBUMIN; ALP (Alkaline phosphatase); AST (aspartate aminotransferase); TBILI (total Bilirubin); CA (Calcium); CL (Chloride); CHOLESTEROL; HDL (high-density lipoprotein); CK (Creatine kinase); TOTAL CREATINE; GLUCOSE; MG (Magnesium); K (potassium); NA (Sodium); TOTAL PROTEIN; TRIGL (Triglyceride); BUN (Urea nitrogen); and URIC ACID. 2019 AAB 3rd event 2020 AAB 1st event 2020 AAB 2nd event 3. The laboratory must demonstrate sustained satisfactory performance (>/= 80%) on two consecutive testing events for reinstatement. 4. A review of the CMS national proficiency testing database revealed a score of "0" in 3 of 3 consecutive Chemistry testing events for the analytes: FREE TY (Free thyroxine); HCG (Human chorionic gonadotropin); and TSH ( thyroid stimulating hormone). 2019 AAB 3rd Chemistry event 2020 AAB 1st Chemistry event 2020 AAB 2nd Chemistry event 5. A proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019-2020 confirmed that the laboratory received an endocrinology score of 0% in 3 of 3 consective testing events for the following analytes: FREE TY (Free thyroxine); HCG (Human chorionic gonadotropin); and TSH ( thyroid stimulating hormone). 2019 AAB 3rd Chemistry event 2020 AAB 1st Chemistry event 2020 AAB 2nd Chemistry event 6. The laboratory must demonstrate sustained satisfactory performance (>/= 80%) on two consecutive testing events for reinstatement. 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. -- 3 of 11 -- 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 Board of Bioanalysts (AAB) proficiency testing records from 2019-2020, it was revealed the laboratory failed to achieve satisfactory performance (80% or greater) for the following analytes in 3 of 3 consecutive testing events: ALT (alanine aminotransferase); ALBUMIN; ALP (Alkaline phosphatase); AST (aspartate aminotransferase); TBILI (total Bilirubin); CA (Calcium); CL (Chloride); CHOLESTEROL; HDL (high-density lipoprotein); CK (Creatine kinase); TOTAL CREATINE; GLUCOSE; MG (Magnesium); K (potassium); NA (Sodium); TOTAL PROTEIN; TRIGL (Triglyceride); BUN (Urea nitrogen); and URIC ACID. Findings were: 1. A review of the CMS (Center for Medicare Services) national database revealed the laboratory received a score of '0' for the following analytes: ALT (alanine aminotransferase); ALBUMIN; ALP (Alkaline phosphatase); AST (aspartate aminotransferase); TBILI (total Bilirubin); CA (Calcium); CL (Chloride); CHOLESTEROL; HDL (high-density lipoprotein); CK (Creatine kinase); TOTAL CREATINE; GLUCOSE; MG (Magnesium); K (potassium); NA (Sodium); TOTAL PROTEIN; TRIGL (Triglyceride); BUN (Urea nitrogen); and URIC ACID for the following chemistry testing events. 2019 AAB 3rd event 2020 AAB 1st event 2020 AAB 2nd event 2. A proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019-2020 confirmed the laboratory received a score of '0' for the following analytes: ALT (alanine aminotransferase); ALBUMIN; ALP (Alkaline phosphatase); AST (aspartate aminotransferase); TBILI (total Bilirubin); CA (Calcium); CL (Chloride); CHOLESTEROL; HDL (high-density lipoprotein); CK (Creatine kinase); TOTAL CREATINE; GLUCOSE; MG (Magnesium); K (potassium); NA (Sodium); TOTAL PROTEIN; TRIGL (Triglyceride); BUN (Urea nitrogen); URIC ACID for the following chemistry testing events. 2019 AAB 3rd event 2020 AAB 1st event 2020 AAB 2nd event D2088 ROUTINE CHEMISTRY CFR(s): 493.841(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 a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019-2020, it was revealed that the laboratory failed to attain an overall testing event score of at least 80 % for each Chemistry event which constitutes unsatisfactory performance. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" for Chemistry on the 3rd event of 2019 and 1st and 2nd event of 2020 for this facility. 2. A proficiency desk review of proficiency testing records for 2019-2020 revealed the facility to attain an overall testing event score of at least 80 % for 3 of 3 Chemistry events. 2019 AAB 3rd event - 0% 2020 AAB 1st event - 0% 2020 AAB 2nd event - 0% D2089 ROUTINE CHEMISTRY CFR(s): 493.841(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 -- 4 of 11 -- 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 Board of Bioanalysts (AAB) proficiency testing records from 2018 - 2020, it was revealed that the laboratory failed to participate in the 3rd chemistry testing event of 2019 and 1st and 2nd chemistry events of 2020. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" for the specialty of Chemistry on the 3rd event of 2019 and 1st and 2nd events of 2020 for this facility. 2. A proficiency desk review of AAB PT records revealed the laboratory received a 0% for the 2019-3rd Chemistry event; 2020-1st Chemistry event PT for "Failure to Participate." The PT summary was rated by the provider as unsatisfactory performance for all analytes for testing events 2019-3; 2020-1; and 2020-2 Chemistry. 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 a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019-2020, it was revealed the laboratory failed to achieve satisfactory performance (80% or greater) for the following analytes in 3 of 3 consecutive testing events: ALT (alanine aminotransferase); ALBUMIN; ALP (Alkaline phosphatase); AST (aspartate aminotransferase); TBILI (total Bilirubin); CA (Calcium); CL (Chloride); CHOLESTEROL; HDL (high-density lipoprotein); CK (Creatine kinase); TOTAL CREATINE; GLUCOSE; MG (Magnesium); K (potassium); NA (Sodium); TOTAL PROTEIN; TRIGL (Triglyceride); BUN (Urea nitrogen); and URIC ACID. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" for the analytes in 3 of 3 testing events for the analytes: ALT (alanine aminotransferase); ALBUMIN; ALP (Alkaline phosphatase); AST (aspartate aminotransferase); TBILI (total Bilirubin); CA (Calcium); CL (Chloride); CHOLESTEROL; HDL (high-density lipoprotein); CK (Creatine kinase); TOTAL CREATINE; GLUCOSE; MG (Magnesium); K (potassium); NA (Sodium); TOTAL PROTEIN; TRIGL (Triglyceride); BUN (Urea nitrogen); and URIC ACID. 2019 AAB 3rd event 2020 AAB 1st event 2020 AAB 2nd event 2. A proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019-2020 confirmed that the laboratory received a chemistry score of 0% for 3 of 3 consecutive testing events for the following analytes: ALT (alanine aminotransferase); ALBUMIN; ALP (Alkaline phosphatase); AST (aspartate aminotransferase); TBILI (total Bilirubin); CA (Calcium); CL (Chloride); -- 5 of 11 -- CHOLESTEROL; HDL (high-density lipoprotein); CK (Creatine kinase); TOTAL CREATINE; GLUCOSE; MG (Magnesium); K (potassium); NA (Sodium); TOTAL PROTEIN; TRIGL (Triglyceride); BUN (Urea nitrogen); and URIC ACID. 2019 AAB 3rd event 2020 AAB 1st event 2020 AAB 2nd event D2097 ROUTINE CHEMISTRY CFR(s): 493.841(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 review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019-2020, it was revealed the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for 3 of 3 consecutive testing events for the specialty of chemistry. Two out of three overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" for the 2019 AAB Chemistry 3rd event and 2020 AAB Chemistry 1st and 2nd events. 2. A proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019-2020 confirmed that the laboratory received a chemistry score of 0% for the 2019 AAB Chemistry 3rd event and 2020 AAB Chemistry 1st and 2nd events. D2098 ENDOCRINOLOGY CFR(s): 493.843(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 Board of Bioanalysts (AAB) proficiency testing records from 2019-2020, it was revealed the laboratory failed to achieve satisfactory performance (80% or greater) for the following analytes in 3 of 3 consecutive testing events: FREE TY (Free thyroxine); HCG (Human chorionic gonadotropin); and TSH ( thyroid stimulating hormone). Findings were: 1. A review of the CMS (Center for Medicare Services) national database revealed the laboratory received a score of '0' for the following analytes: FREE TY (Free thyroxine); HCG (Human chorionic gonadotropin); and TSH ( thyroid stimulating hormone). 2019 AAB 3rd event 2020 AAB 1st event 2020 AAB 2nd event 2. A proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019-2020 confirmed the laboratory received a score of '0' for the following analytes: FREE TY (Free thyroxine); HCG (Human chorionic gonadotropin); and TSH ( thyroid stimulating hormone). 2019 AAB 3rd event 2020 AAB 1st event 2020 AAB 2nd event D2099 ENDOCRINOLOGY CFR(s): 493.843(b) -- 6 of 11 -- 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 a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019-2020, it was revealed that the laboratory failed to attain an overall testing event score of at least 80 % for 3 of 3 Endocrinology events which constitutes unsatisfactory performance. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" for Endocrinology on the 3rd event of 2019 and 1st and 2nd events of of 2020 for this facility. 2. A proficiency desk review of proficiency testing records for 2019-2020 revealed the facility to attain an overall testing event score of at least 80 % for 3 of 3 Endocrinology events. 2019 AAB 3rd event - 0% 2020 AAB 1st event - 0% 2020 AAB 2nd event - 0% D2100 ENDOCRINOLOGY CFR(s): 493.843(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 Board of Bioanalysts (AAB) proficiency testing records from 2019 - 2020, it was revealed that the laboratory failed to participate in the 3rd endocrinology testing event of 2019 and 1st and 2nd endocrinology events of 2020. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" for the subspecialty of endocrinology on the 3rd event of 2019 and 1st and 2nd events of 2020 for this facility. 2. A review of AAB PT records revealed the laboratory received a 0% for the subspecialty of endocrinology for the 2019-3rd Chemistry event; 2020-1st Chemistry ; 2020-2 event PT for "Failure to Participate." The PT summary was rated by the provider as unsatisfactory performance for all analytes for testing events 2019-3; 2020- 1; and 2020-2 endocrinology. D2107 ENDOCRINOLOGY CFR(s): 493.843(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. -- 7 of 11 -- 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 Board of Bioanalysts (AAB) proficiency testing records from 2019-2020, it was revealed the laboratory failed to achieve satisfactory performance (80% or greater) for the following analytes in 3 of 3 consecutive testing events: FREE TY (Free thyroxine); HCG (Human chorionic gonadotropin); and TSH ( thyroid stimulating hormone). Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" in 3 of 3 consecutive testing events for the analytes: FREE TY (Free thyroxine); HCG (Human chorionic gonadotropin); and TSH ( thyroid stimulating hormone). 2019 AAB 3rd Chemistry event 2020 AAB 1st Chemistry event 2020 AAB 2nd Chemistry event 2. A proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019-2020 confirmed that the laboratory received an endocrinology score of 0% in 3 of 3 consective testing events for the following analytes: FREE TY (Free thyroxine); HCG (Human chorionic gonadotropin); and TSH ( thyroid stimulating hormone). 2019 AAB 3rd Chemistry event 2020 AAB 1st Chemistry event 2020 AAB 2nd Chemistry event D2108 ENDOCRINOLOGY CFR(s): 493.843(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 review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019-2020, it was revealed the laboratory failed to achieve an overall testing event score of satisfactory performance (80% or greater) for 3 of 3 consecutive testing events for the subspecialty of Endocrinology. Two out of three overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" for subspecialty of Endocrinology for the 2019 AAB 3rd Chemistry event and 2020 AAB Chemistry 1st and 2nd events. 2. A proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2019-2020 confirmed that the laboratory received an Endocrinology score of 0% for the 2019 AAB Chemistry 3rd event and 2020 AAB Chemistry 1st and 2nd events. 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 Board 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: analyte Red Cell Count (RBC), Hematocrit (HCT), Hemaglobin (Hgb), -- 8 of 11 -- White blood count (WBC), Platelet (PLT), and Cell ID for 4 of 5 consecutive testing events in 2018, 2019, and 2020. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" for the analytes: RBC, HCT, Hgb, WBC, PLT, and Cell ID for 4 of 5 consecutive testing events in 2018, 2019, and 2020 for the following test events: 2018 AAB 3rd event 2019 AAB 2nd & 3rd event 2020 AAB 1st event 2. A proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2018-2020 confirmed that the laboratory received a hematology score of 0% on for the following analytes: RBC, HCT, Hgb, WBC, PLT, and Cell ID for the following testing events: 2018 AAB 3rd event 2019 AAB 2nd & 3rd event 2020 AAB 1st event 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 a review of the CMS (Center for Medicare Services) national database and a proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2018-2020, it was determined the laboratory failed to attain an overall testing event score of at least 80 % for 4 of 5 Hematology test events which constitutes unsatisfactory performance. Findings were: 1. A proficiency desk review of 4 of 5 AAB Hematology proficiency testing records from 2018-2020 revealed a hematology event score of less than 80% (unsatisfactory performance) for the following testing events: 2018 AAB 3rd event Hematology: 0% 2019 AAB 2nd & 3rd event Hematology: 0% 2020 AAB 1st event: Hematology: 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 Board of Bioanalysts (AAB) proficiency testing records from 2018 - 2020, it was revealed that the laboratory failed to participate in the 3rd hematology testing events of 2018; 2nd and 3rd hematology event of 2019; and 1st hematology event of 2020. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" on the 3rd event of 2018; 2nd and 3rd hematology event of 2019; and 1st event of 2020 for this facility. 2. A proficiency desk review of AAB PT records revealed the laboratory received a 0% for the Hematology 2018-3rd event; 2019-2nd and 2019-3rd event; 2020-1st event PT -- 9 of 11 -- for "Failure to Participate." The PT summary was rated by the provider as unsatisfactory performance for all analytes for testing events 2018-3, 2019-2; 2019-3; and 2020-1 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 Board of Bioanalysts (AAB) proficiency testing records from 2018-2020, it was determined the laboratory failed to achieve satisfactory performance for the same analyte in 4 of 5 consecutive testing events. The laboratory failed to achieve satisfactory performance (at least 80%) in the specialty of hematology for the analytes: Red Cell Count (RBC), Hematocrit (HCT), Hemaglobin (Hgb), White blood count (WBC), Platelet (PLT), and Cell ID for 4 of 5 consecutive testing events in 2018, 2019, and 2020. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" for the analytes: RBC, HCT, Hgb, WBC, PLT, and Cell ID for 4 of 5 consecutive testing events in 2018, 2019, and 2020 for the following test events: 2018 AAB 3rd event 2019 AAB 2nd & 3rd event 2020 AAB 1st event 2. A proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2018-2020 confirmed that the laboratory received a hematology score of 0% on for the following analytes: RBC, HCT, Hgb, WBC, PLT, and Cell ID for 4 of 5 consecutive testing events in 2018, 2019, and 2020 for the following test events: 2018 AAB 3rd event 2019 AAB 2nd & 3rd event 2020 AAB 1st event 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 review of the CMS (Center for Medicare Services) national database and a desk review of proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the specialty of hematology in 4 of 5 consecutive testing events. Two out of three overall testing event scores of unsatisfactory performance results in unsuccessful PT performance. Findings were: 1. A review of the CMS national proficiency testing database revealed a score of "0" for 4 of 5 consecutive Hematology testing events in 2018, 2019, and 2020 for the following test events: 2018 AAB 3rd event 2019 AAB 2nd & 3rd event 2020 AAB 1st event 2. A proficiency desk review of the American Board of Bioanalysts (AAB) proficiency testing records from 2018-2020 confirmed that the laboratory received a hematology score of 0% for 4 of 5 consecutive testing events in 2018, 2019, and 2020 for the following test events: 2018 AAB 3rd event 2019 AAB 2nd & 3rd event 2020 AAB 1st event -- 10 of 11 -- 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. Findings were: 1. A review of the laboratory proficiency testing results revealed that the laboratory director failed to ensure that the laboratory participated successfully. (refer to D6016) By not providing overall management and direction of the laboratory, the laboratory director could not ensure the accuracy or reliability of all laboratory services provided by the facility. 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 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 D2097, D2108, D2131, D2096, D2107, and D2130) -- 11 of 11 --

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6033 - 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of Association of Bioanalysts (AAB) proficiency testing from 2017 and 2018 and confirmed in interview, the laboratory failed to ensure that proficiency testing was performed by all personnel who performed testing. Findings were: 1. A review of the laboratory's submitted Form CMS 209 revealed the laboratory identified 3 testing personnel. 2. Review of the 2017 and 2018 American Association of Bioanalysts (AAB) proficiency testing for Chemistry revealed all specimens for 4 of 4 PT events were tested by the same testing person (TP#1). 2017 Chemistry 1st event 2017 Chemistry 2nd event 2017 Chemistry 3rd event 2018 Chemistry 1st event 3. Review of the 2017 and 2018 American Association of Bioanalysts (AAB) proficiency testing for Hematology revealed all specimens for 4 of 4 PT events were tested by the same testing person (TP#1). 2017 Hematology 1st event 2017 Hematology 2nd event 2017 Hematology 3rd event 2018 Hematology 1st event 4. An interview with the technical consultant on 6/21/18 at 1030 hours in the office confirmed the above findings. key: CMS - Centers of Medicare and Medicaid Services Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- 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: A review of the laboratory's Association of Bioanalysts (AAB) proficiency testing from 2017 and 2018 and confirmed in interview, the laboratory quality assessment policies and procedures failed to identify, monitor and correct problems in the general laboratory systems. Refer to D2007 D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on review of the laboratory policy, laboratory patient records, and confirmed in interview, the laboratory failed to ensure the date and time of collection transcribed onto the laboratory information system matched the information on the patient requisition. Findings were: 1. Review of the laboratory policy Quality Plan Policy approved 11/11/15 revealed "if the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately." 2. Random sampling review of the specimens and specimen requisition (req) received in the laboratory on 06/20/18 revealed 10 of 10 samples when the collection date and time were not transcribed accurately to the laboratory information system. ID Req collection Final report date/time collection date/time 29144 06/20/18 1630 06/20/18 1836 29145 06/20/18 1000 06/20/18 1837 29146 06/20/18 1345 06/20/18 1838 29147 06/20/18 0855 06/20/18 1839 29139 06/20/18 1640 06/20/18 1750 29138 06/19/18 1500 06/20/18 1748 29136 06/20/18 1300 06/20/18 1744 29137 06/20/18 1040 06/20 /18 1746 29135 06/20/18 1440 06/20/18 1743 29134 06/20/18 1500 06/20/18 1741 3. An interview with the technical consultant on 6/21/18 at 1505 hours in the laboratory confirmed the above findings. He was unaware the collection date and time were not transcribed accurately. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. -- 2 of 10 -- This CONDITION is not met as evidenced by: Based on review of laboratory policies, review of quality control records, review of patient final reports, and confirmed in interview, the laboratory failed to monitor and evaluate the overall quality of its analytic systems as evidenced by: 1. The laboratory failed to follow its own policy for reagent handling. Refer to D5415 2. The laboratory failed to ensure that expired reagents were not used to perform patient testing on the Beckman Access2. Refer to D5417A 4. The laboratory failed to follow the manufacturer's instructions for the storage and handling of Audit MicroControls linearity materials for the Olympus AU400. Refer to D5411A 5. The laboratory failed to establish the type, number, and acceptable limits for the calibration verification on the Olympus AU400. Refer to D5437 6. The laboratory failed to follow the manufacturer's instructions to establish it's own mean and ranges for the quality controls on the Sysmex XT-2000i hematology analyzer. Refer to D5469 7. The laboratory failed to evaluate all patient test results obtained since the last acceptable quality control run when controls failed to meet the laboratory's established criteria for acceptability. Refer to D5783 D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: A. Based on review of the manufacturer's instructions, surveyor observations, laboratory records, and confirmed in interview, the laboratory failed to follow the manufacturer's instructions for the storage and handling of Audit MicroControls linearity materials for the Olympus AU400. Findings were: 1. Review of the laboratory Audit MicroControls Linearity FD General Chemistry Beckman AU (Ref K820M-5) lot 0633A, exp 03/21/2020 package insert revealed under storage and stability: "Linearity FD General Chemistry Beckman AU is stored at 2-8C and will remain stable in the unopened vial until the expiration date. After opening, the contents should be used according to the instrument manufacturer ' s instructions and immediately returned to 2-8C. When used to monitor the precision of laboratory testing procedures for its assays, Linearity FD General Chemistry Beckman AU has a reconstituted stability of up to 3 days under the proper storage conditions. Leaving the vial uncapped, or prolonging its time at room temperature, will void this open vial stability claim. Make sure the contents of the vial are well mixed before use." 2. Surveyor observations on 6/21/18 in the laboratory revealed 1 set of reconstituted Audit MicroControls Linearity FD General Chemistry Beckman AU (Ref K820M-5) lot 0633A, exp 03/21/2020 stored in the laboratory freezer with a notation 'o:11/5/17 RA' on the outside of the box. 3. Review of the 2017 and 2018 calibration verification records revealed the laboratory performed calibration verication for the Beckman AU chemistry analyzer on 5/4/17, 11/3/17, and 5/1/18 using the above lot number of Audit MicroControls Linearity. 4. An interview with testing person #1 on 6/21/18 at 1305 hours acknowledged that the laboratory used 1 set of calibration verification materials opened on 11/5/17, stored frozen, and thawed for the calibration verfication performed on 5/1/18. He was unaware that it couldn't be stored frozen after reconstitution and then resused. B. Based on a review of Association of Bioanalysts -- 3 of 10 -- (AAB) proficiency testing from 2017 and confirmed in interview, the laboratory failed to follow the manufacturer's instructions that required an active calibration curve for testing Chemistry proficiency samples. Findings were: 1. Review of the laboratory policy Proficiency Testing Handling approved 11/11/15 revealed "all proficiency tests will be handled and tested as routine patient specimens." 2. Review of the laboratory policy for PSA, Total (prostate specific antigen) effective 06/2014 revealed under calibration "an active calibration curve is required for all tests." 3. Review of the 2017 AAB Chemistry PT events laboratory records revealed 1 of 3 events when the laboratory used an expired calibration curve when performing PSA testing. 2017 3rd event PSA-1 9.07 ng/mL CEX (curve expired) PSA-2 17.98 ng/mL CEX (curve expired) 4. An interview with the technical consultant on 6/21/18 at 1045 hours in the office confirmed the above findings. He stated that they don't run patients so did not calibrate. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on review of the laboratory policy, surveyor observations, and confirmed in interview, the laboratory failed to follow its own policy for reagent handling on the Olympus AU400. Findings were: 1. Review of the lab policy Reagent Policy effect 07 /2014 revealed "'date opened' must be indicated, along with the initials of the technologist when new reagents are put into use." 2. Random sampling review of the reagents on board the Olympus AU400 chemistry analyzer revealed 5 of 5 reagents with no documentation of the date opened nor the initials of the technologist on the opened reagents. Uric Acid (Ref OSR6098) lot 2523, exp 11/1/2018 Total Protein (Ref OSR6155) lot 2549, exp 5/1/19 Bicarbonate (Ref OSR6137) lot 2553, exp 12/1 /18 HDL (Ref OSR6295) lot 2514, exp 11/1/19 ALT (Ref OSR6107) lot 2525, exp 7/1 /19 The laboratory performs 40,000 chemistry tests annually. 3. An interview with the testing person #1 on 6/21/18 at 1540 hours in the laboratory confirmed the above findings. key: HDL - High-density lipoproteins ALT - Alanine transaminase D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: A. Based on review of the manufacturer's instructions, laboratory records, and confirmed in interview, the laboratory failed to ensure that expired reagents were not used to perform patient testing on the Beckman Access2 immunoassay analyzer. Findings were: 1. Review of the instructions for use for the following Beckman Coulter reagents revealed under reagents "Stable until the expiration date stated on the -- 4 of 10 -- label when stored at 2 to 10C. Stable at 2 to 10C for 28 days after initial use." Access2 FT3 (Free triiodothyronine) (A33730L EN, May 2018) Access2 TSH (Thyroid- stimulating hormone) (B83033 G, June 2017) Access2 FT4 (Free thyroxine) (B01902 H, April 2018) Access2 Testosterone (A33261 M, October 2017) Access2 Estradiol (A56077 M, October 2017) Access2 FSH (Follicle-stimulating hormone) (A83734 H, August 2017) Access2 LH (Luteinizing hormone) (A83753 H, October 2017) Access2 Prolactin (A83772 G, October 2017) 2. Review of the Beckman Coulter Access Substrate instructions for use (386966 H, May 2018) revealed under stability "maximum 14 days (in use)." 3. Random sampling review of Beckman Coulter Access 2 patient printouts from January 2017 - June 2018 revealed 13 of 36 patient printouts with LEX (lot expired); PEX (pack expired); and EXS (substrate expired) flags. acc Analyte Result Access2 flag 28990 FT3 3.12 pg/mL LEX, PEX 26560 TSH 2.39 uIU/mL EXS 26560 FT4 0.68 ng/dL EXS 26449 TSH 2.81 uIU/mL EXS 26449 FT4 0.67 ng/dL EXS 26449 FT3 3.45 pg/mL EXS 26449 Testo 843 ng/dL EXS 26449 Estradiol 67 pg/mL EXS 25569 FSH 11.8 mIU/mL PEX 25046 TSH 2 uIU/mL EXS 25046 Testo 314 ng/dL EXS 25046 Estradiol 72 pg/mL PEX, EXS 25046 FSH 9.53 mIU/mL EXS 25046 LH 7.15 mIU/mL PEX, EXS 24914 Estradiol 107 pg/mL EXS 24738 Estradiol 115 pg/mL EXS 24738 Testo 1575 ng/dL EXS 24603 Estradiol 25 pg /mL EXS 24603 Testo 918 ng/dL EXS 24340 Estradiol 25 pg/mL PEX 24139 TSH 2.83 uIU/mL PEX 23666 Prolactin 9.56 ng/mL LEX, PEX 23382 FSH 1.77 mIU/mL PEX 23382 LH 2.31 mIU/mL PEX 21148 FSH 3.55 mIU/mL PEX 21148 LH 4.05 mIU/mL PEX 4. An interview with testing person #1 on 6/21/18 at 1305 hours in the laboratory confirmed the above findings. B. Based on review of laboratory policy, laboratory records, laboratory patient records, and confirmed in interview, the laboratory failed to ensure expired calibration were not used for patient testing on the Beckman Access 2 immunology analyzer. Findings were: 1. Review of the laboratory policy Quality Plan Policy approved 11/11/15 under calibration and calibration verification revealed "for each applicable test system, the lab will do the following: Perform and document calibration procedures Following the manufacturer's test system instructions, using calibration materials provided or specified and with at least the frequency recommended by the manufacturer." 2. Review of the laboratory policy for the Beckman Access 2 Immunology reagents revealed 5 of 7 assays that require "an active calibration curve is required for all tests..calibration is required every 28 days." Access hTSH (approved 06/2014) Access hFSH (approved 06/2014) Access hLH (approved 06/2014) Access Free T4 (approved 06/2014) Access Free T3 (approved 06/2014) 3. Review of the laboratory policy for the Beckman Access 2 Immunology reagents revealed 2 of 7 assays that require "an active calibration curve is required for all tests..calibration is required every 14 days." Access Testosterone (approved 06/2014) Access Estradiol (approved 06/2014) 4. Random review of the Beckman Coulter Access 2 patient printouts from 2017 and 2018 revealed 10 of 30 patient specimens which were analyzed with expired calibration (CEX). PT accession Analyte Result flag 26993 TSH 0.13 uIU/mL CEX 25728 Testo 167 ng/dL CEX 25728 Estradiol 40 pg/mL CEX 25569 FSH 11.8 mIU/mL CEX 25046 TSH 2 uIU /mL CEX 25046 Testo 314 ng/dL CEX 25046 Estradiol 72 pg/mL CEX 25046 FSH 9.53 mIU/mL CEX 25046 LH 7.15 mIU/mL CEX 24914 Estradiol 107 pg/mL CEX 24340 Testo 241 ng/dL CEX 24340 Estradiol 25 pg/mL CEX 24139 TSH 2.83 uIU /mL CEX 24139 Testo 53 ng/dL CEX 24139 Estradiol 98 pg/mL CEX 23382 FSH 1.77 mIU/mL CEX 23382 LH 2.31 mIU/mL CEX 23056 FT4 0.94 ng/dL CEX 23056 FT3 3.03 pg/mL CEX 23056 TSH 0.99 uIU/mL CEX 21148 FSH 3.55 mIU/mL CEX 21148 LH 4.05 mIU/mL CEX 21148 Testo 28 ng/dL CEX 5. An interviw with testing person #1 on 6/21/18 at 1330 hours in the office confrrmed the above findings. He assumed that if the controls were within acceptable range, he didn't need to recalibrate prior to testing. key: key: Testo - Testosterone LH - Luteinizing hormone FSH - -- 5 of 10 -- Follicle-stimulating hormone FT3 - Free triiodothyronine FT4 - Free Thyroxine D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of the laboratory records and confirmed in interview, the laboratory failed to establish the type, number, and acceptable limits for the calibration verification on the Olympus AU400 chemistry analyzer. Findings were: 1. Review of the laboratory policy Quality Plan Policy (effective 07/2014) under calibration and calibration verification revealed no documentation of the type, number, and acceptable limits when performing calibration verification on the Olympus AU400. 2. Review of the 2017 and 2018 calibration verification records revealed the laboratory performed calibration verication with Audit MicroControls, lot 06633, exp 3/21/2020 for the Olympus AU400 chemistry analyzer on 5/4/17, 11/3/17, and 5/1/18 with no documentation of the acceptable limits for each analyte. 3. Review of the 5/4/17 calibration verification records revealed the values for each analyte from the package insert (PI) values, lab result, and peer mean for each level and each analyte. The % difference between the peer mean value and lab value revealed varying degrees of percentage from -50% to 218 %. Calibration verification 5/4/17 with Audit Microcontrols lot 06633 Level A PI lab peer % diff ALB 2.5 2.5 2.5 -0.8 ALP 21.0 8.0 16.8 -52.4 ALT 11.7 15.0 11.8 26.7 AST 12.5 31.0 14.5 113.6 TBIL 0.3 0.2 0.2 -18.7 DBIL 0.1 0.1 0.1 -15.9 BUN 4.0 2.0 4.0 -49.6 CAL 4.0 5.8 5.7 2.3 CL 66.3 73.0 74.6 2.1 CHOL 29.9 30.0 29.2 2.8 CO2 3.7 7.0 3.1 129.4 CK 17.5 19.0 17.4 9.4 CREA 0.4 0.6 0.4 49.3 GLU 14.0 47.4 14.9 218.7 HDL 14.5 18.0 17.5 2.7 MG 1.2 1.3 1.3 1.6 PHOS 1.3 1.9 1.3 46.5 K 1.6 1.6 1.5 4.2 NA 75.8 74.0 74.8 -1.0 TP 2.9 3.4 3.2 6.8 TRIG 14.0 20.0 14.8 34.9 UA 1.7 1.7 1.6 3.8 Level B PI lab peer %Diff ALB 3.8 3.8 3.8 -0.3 ALP 423.0 290.0 506.9 -42.8 ALT 133.0 144.0 146.9 -2.0 AST 294.0 288.0 323.9 -11.1 TBIL 8.5 6.9 7.3 -6.1 DBIL 4.0 3.2 3.7 -13.7 BUN 40.0 40.0 40.5 -1.3 CAL 9.0 9.5 9.6 -1.4 CL 105.0 110.0 108.6 1.3 CHOL 205.0 194.0 198.8 -2.4 CO2 11.3 16.0 11.5 38.9 CK 577.0 497.0 637.7 -22.1 CREA 8.9 8.3 8.8 -5.9 GLU 208.0 95.0 205.5 -53.8 HDL 89.5 87.0 101.2 -14.0 MG 3.2 3.4 3.3 1.5 PHOS 6.5 6.9 6.4 8.3 K 3.8 4.0 3.7 8.8 NA 106.0 106.0 106.1 -0.1 TP 5.5 5.4 5.2 4.2 TRIG 281.0 306.0 289.8 5.6 UA 8.8 8.9 9.0 -0.8 Level C PI lab peer %Diff ALB 4.9 4.8 4.9 -2.1 ALP 796.0 774.0 974.7 -20.6 ALT 241.0 250.0 269.8 -7.3 AST 545.0 551.0 600.5 -8.2 TBIL 15.2 11.0 13.5 -18.6 DBIL 6.9 4.5 6.4 -29.9 BUN 73.0 74.0 74.5 -0.6 CAL 12.0 12.7 13.1 -3.3 CL 131.0 148.0 143.5 3.1 CHOL 363.0 359.0 358.0 0.3 CO2 23.8 29.0 20.0 45.2 CK 1049.0 875.0 1170.0 -25.2 CREA 16.3 15.5 16.2 -4.3 GLU 387.0 368.0 383.0 -3.9 HDL 164.0 167.0 177.0 -5.7 MG 5.1 5.2 5.3 -1.3 PHOS 11.3 12.3 11.3 9.2 K 6.0 6.2 5.8 6.7 NA 139.0 141.0 138.0 2.0 TP 7.4 7.5 7.0 6.5 TRIG 518.0 581.0 543.0 7.0 UA 15.2 15.3 15.6 -1.7 Level D PI lab peer %Diff ALB 5.9 5.9 5.8 -- 6 of 10 -- 1.3 ALP 1156.0 1167.0 1411.0 -17.3 ALT 346.0 335.0 384.2 -12.8 AST 750.0 727.0 826.0 -12.0 TBIL 22.0 14.3 19.0 -24.8 DBIL 9.6 5.5 8.7 -36.9 BUN 104.0 104.0 106.0 -1.9 CAL 14.7 15.7 16.3 -3.8 CL 167.0 185.0 176.9 4.6 CHOL 515.0 511.0 505.8 1.0 CO2 37.5 37.0 27.9 32.7 CK 1484.0 1165.0 1645.0 -29.0 CREA 22.9 22.0 22.6 -2.7 GLU 561.0 640.0 549.7 16.4 HDL 224.0 232.0 236.9 -2.1 MG 6.4 7.0 7.0 -0.3 PHOS 15.8 18.1 15.9 13.7 K 8.2 8.6 7.9 8.6 NA 171.0 175.0 169.0 3.5 TP 9.4 9.7 8.8 10.8 TRIG 744.0 891.0 770.0 15.6 UA 21.3 21.4 21.5 0.3 Level E PI lab peer %Diff ALB 7.2 6.5 6.6 -0.8 ALP 1444.0 1441.0 1753.0 -17.8 ALT 436.0 414.0 474.3 -12.7 AST N /A 813.0 914.4 -11.1 TBIL 27.8 17.2 23.3 -26.1 DBIL N/A 6.4 10.4 -38.9 BUN 130.0 127.0 131.3 -3.3 CAL 16.7 18.1 18.8 -3.5 CL N/A 218.0 205.0 6.3 CHOL 639.0 635.0 617.4 2.9 CO2 N/A 43.0 35.2 22.2 CK 1802.0 1547.0 1982.0 -22.0 CREA 30.9 27.4 27.9 -1.7 GLU 702.0 663.0 683.3 -3.0 HDL N/A 287.0 270.4 6.1 MG N/A 8.5 8.4 1.6 PHOS 19.5 22.3 19.7 13.3 K 10.0 10.6 9.7 9.3 NA 197.0 205.0 196.0 4.4 TP 11.1 10.9 10.0 8.6 TRIG 924.0 1079.0 941.0 14.5 UA 26.2 26.6 26.0 2.4 4. An interview with the technical consultant on 6/21/18 at 1340 hours in the laboratory confirmed the above findings. He acknowledged that the laboratory policy should specify the acceptable criteria for the calibration verification. key: ALP - Alkaline Phosphatase TBIL - Total Bilirubin DBIL - Direct Bilirubin CHOL - Cholesterol CL - Chloride CAL - Calcium CK - Creatine Kinase CREA - Creatinine HDL - HDL Cholesterol MG - Magnesium PHOS - Phosphorus K - Potassium NA - Sodium TP - Total Protein TRIG - Triglycerides UA - Uric Acid GLU - Glucose ALB - Albumin D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, laboratory quality control (QC) records, and confirmed in interview, the laboratory failed to follow the manufacturer's instructions to establish it's own mean and ranges for the quality controls on the Sysmex XT-2000i hematology analyzer. Findings were: 1. Review of the package insert for the Sysmex echeck hematology controls for Sysmex X-series (CG808126) revealed "the mean assay values for each parameter of e-Check are derived from replicate analyses on whole blood calibrated instrumentation. The mean values obtained on e-Check should be within the expected ranges. The expected ranges listed on the assay sheet represent estimates of inter-laboratory variation for each parameter. These expected ranges should not be used as QC file limits." 2. Review of the laboratory QC records from 03/18 to 05/18 revealed the laboratory used the manufacturer expected range for the following QC lot numbers Level 1 80520801, exp 05/14/18 Level 2 80520802, exp 05/14/18 Level 3 80520803, exp 05/14/18 Level -- 7 of 10 -- 1 81080801, exp 07/09/18 Level 2 81080802, exp 07/09/18 Level 3 81080803, exp 07 /09/18 3. Random sampling review of the laboratory patient records from 03/2018 to 05/2018 revealed the laboratory performed patient testing. 03/22/18 26993 03/30/18 27168 05/08/18 28180 4. An interview with the testing person #1 on 06/25/18 at 1530 hours in the laboratory confirmed the above findings. D5783