Corona Pathology Cps 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 review of the American Proficiency Institute (API) proficiency testing (PT) records, randomly chosen patient results' review, and interview with the general supervisor (GS) and testing personnel (TP); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for the following Routine Chemistry analytes: CO2 and TIBC measured; for the second event 2020 (Q2- 2020), Calcium Total and Sodium; for the third event 2020 (Q3-2020), and Bilirubin Total, Ferritin, and Folate for the first event of 2021 (Q1-2021). 1. Based on review of PT records, API reported the following unsatisfactory scores: Analyte Event Score CO2 Q2-2020 40% TIBC Q2-2020 40% Calcium Q3-2020 60% Sodium Q3-2020 40% Bilirubin Q1-2021 60% Ferritin Q1-2021 50% Folate Q1-2021 50% 2. Based on the laboratory testing declaration submitted at the time of the survey on May 5, 2022, the laboratory analyzed and reported approximately 15,437 Routine Chemistry tests during the time the laboratory had unsatisfactory proficiency testing results. 3. The GS affirmed on 7/21/2022 2at approximately 1:30 p.m.. that the laboratory received the above unsatisfactory proficiency testing scores. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records, random patient sampling test results, and interview with the general supervisor (GS) and laboratory testing personnel (TP); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Parathyroid Hormone (PTH) and PSA analytes PT for the first event of 2021 (Q1- 2021). The findings included: 1. Analyte Event Performance PTH Q1-2021 50% PSA Q1-2021 50% 2. For three (3) out of three (3) random patient sampling test results reviewed covering period from 12/30/2020 to 2/18/2021, the laboratory analyzed and reported approximately 700 PTH and PSA test results during the period the laboratory received the unsatisfactory proficiency testing score. 3. The GS and TP confirmed on July 21, 2022, at approximately 11:15 a.m. that the laboratory received the above unsatisfactory proficiency testing scores for PTH and PSA. D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation of the laboratory testing area and interview with the general supervisor (GS) and testing personnel (TP); it was determined that the laboratory testing area failed to be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the clinical testing process. The findings included: 1. The laboratory area consisted of three small rooms (approximately 1,500 square feet) which serves to house the automated testing instruments for the Chemistry and Endocrinology analyzers, Toxicology GC/MS instruments, two Biofire instruments, two Air Clean Biosafety cabinets, PCR processing and analyzing; testing personnel's office, as well as storage area for reagents, documents, and patients' results and data. 2. The space designated for the laboratory appears to be insufficient. The room is crowded, difficult to maintain, inappropriate for proper traffic flow, and fails to provide sample integrity and quality for testing, in addition to increase risk of contamination of paperwork and possible cross-contamination of samples. 3. The GS and TP affirmed on July 21, 2022, at approximately 1:00 p.m. that the laboratory failed to be constructed, arranged and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. 4. The laboratory's testing declaration form, signed by the laboratory director on July 7/20/2022, stated that the laboratory performs approximately 1,326,549 tests annually. D3005 FACILITIES CFR(s): 493.1101(a)(3) Molecular amplification procedures that are not contained in closed systems have a uni-directional workflow. This must include separate areas for specimen preparation, amplification and product detection, and, as applicable, reagent preparation. This STANDARD is not met as evidenced by: Based on direct observation of the facilities layout, observation of the of the laboratory's SARS-CoV-2 RNA (COVID-19) Polymerase Chain Reaction (PCR) -- 2 of 3 -- testing, and interviews with the laboratory's general supervisor (GS) and testing personnel (TP) on July 21, 2022 on its molecular amplification procedure; it was determined that the laboratory failed to ensure that the PCR procedures which are not contained in closed systems have a unidirectional flow with separate areas for specimen preparation, master mix and reagents preparation, amplification, and product detection. The findings included: 1. The laboratory performed PCR testing for the presumptive detection of SARS-CoV-2 using automated extraction and manual methods for preparation of the master-mixes, controls and reagents, and addition of template. 2. During the laboratory tour on July 21, 2022, at approximately 12:15 p.m. the surveyor observed that processing of the specimens, preparation of reagents, and sample template addition were all performed in the same room without unidirectional flow in the same room and Biosafety cabinet where samples were processed and tested for Toxicology. 3. The GS and TP confirmed by interview on 7/21/2022 that the laboratory's molecular PCR testing for the presumptive detection of SARS-CoV-2 RNA was not set up in a unidirectional flow area. 4. Based on laboratory records, the laboratory performed and reported approximately 186,300 SARS-CoV-2 Real Time PCR molecular diagnostic tests annually. D6083 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. This STANDARD is not met as evidenced by: Based on the surveyor's direct observations of the laboratory's size for the testing volume, number of instruments, SARS-CoV-2 PCR testing processes, and interview with the laboratory's general supervisor and testing personnel on July 21, 2022; the laboratory director failed to ensure that the size of the physical plant and environmental conditions of the laboratory were appropriate for the number of personnel, volume of testing, and PCR testing performed. Findings include: See D3001 and D3005. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on interviews with the techncal supervisor, general supervisor, and testing personnel, proficiency test reports documents for Routine Chemistry and Endocrinology and policies and procedures record review on July 21, 2022; the laboratory director failed to ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. See D2087 and D2098. -- 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: 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 specialty of Endocrinology constituting unsuccessful PT performances. (See D2107) 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 -- 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. 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, Thyroid Stimulating Hormone (TSH), resulting in an non-initial 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, TSH, as follows: 2020 Q3 2021 Q1 2021 Q2 TSH 20% 20% 40% 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 an subsequent unsuccessful performance for the analyte, TSH. 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, TSH, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performances. (See D2016 and D2107) -- 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: 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 specialty of Endocrinology constituting unsuccessful PT performance. (See D2107) 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 -- 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. 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, Thyroid Stimulating Hormone (TSH), resulting in an "initial" (first) unsuccessful performances. 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, TSH, as follows: 2020 Q3 2021 Q1 TSH 20% 20% Q1 = First 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 an initial unsuccessful performance for the analyte, TSH. 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, TSH, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2107) -- 2 of 2 --

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 reviews of analyte performance of the American Proficiency Institute (API) proficiency testing performance summary records, seven (7) randomly selected patients' test requisitions from 02/05/2018 to 02/18/2020 and test results (medical records), quality control reviewed, proficiency testing (PT) result reports, and interview with the laboratory personnel, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Q3/2018 for the phosphorus (P) analyte. The findings included: a. API reported Proficiency Testing scores 60%: Event Analtye Sample Results Exp. Results Q3 2018 P CH-14 2.4 3.0- 3.8 Q3 2018 P CH-15 3.4 4.1-5.3 b. Patient test results reviewed covering the period of Q3, 2018, the laboratory analyzed and reported phosphorus testing during this time. c. The laboratory personnel confirmed (03/10/2020, 12:30 PM) that the laboratory received the above unsatisfactory proficiency testing score. d. The laboratory annual testing declaration (03/09/2020) for routine chemistry (phosphorus included) estimated that a total test volume of 1,397,368. 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: 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 -- Based on reviews of analyte performance of the American Proficiency Institute (API) proficiency testing performance summary records, seven (7) randomly selected patients' test requisitions from 02/05/2018 to 02/18/2020 and test results (medical records), quality control reviewed, proficiency testing (PT) result reports, and interview with the laboratory personnel, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Q2/2018 Free T3 (FT3). The findings included: a. API reported Proficiency Testing scores 20%: Event Analtye Sample Results Exp. Results Q2 2018 FT3 CH-06 7.0 3.8-6.6 Q2 2018 FT3 CH-07 6.6 3.6-5.1 Q2 2018 FT3 CH-09 6.2 3.3-4.7 Q2 2018 FT3 CH-10 7.4 4.3-7.2 b. Patient test results reviewed covering the period of Q2, 2018, the laboratory analyzed and reported Free T3 tests during this time. c. The laboratory personnel confirmed (03/10/2020, 12:30 PM) that the laboratory received the above unsatisfactory proficiency testing score. d. The laboratory annual testing declaration (03/09/2020) for Endocrinology (Free T3 included) estimated that a total test volume of 1,397,368. -- 2 of 2 --

Summary Statement of Deficiencies D2076 GENERAL IMMUNOLOGY CFR(s): 493.837(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 review of Q1-2017 proficiency testing reports from CMS (report 155D, Individual Laboratory Profile) the laboratory failed to attain an overall General Immunology testing event score of at least 80 percent, constituting unsatisfactory performance. Findings include: a. The laboratory performed four tests in the specialty Immunology. b. CMS reported scores of 100% for ANA (Anti-nuclear Antiboday) and ASO (Anti-Streptolysin O Titer); and scores of 0% for HBsA (Hepatitis B Surface Antigen) and Anti-HBc (Hepatitis B Core Antibody). And thus, the laboratory had the overall score of 52% for General Immunology. b. See D2077. . D2077 GENERAL IMMUNOLOGY CFR(s): 493.837(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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- This STANDARD is not met as evidenced by: Based on review of Q1-2017 proficiency testing reports from CMS (report 155D, Individual Laboratory Profile) and AAB (American Association of Bioanalysts), the lack of laboratory proficiency testing documents, and interviews with laboratory personnel and AAB personnel, the laboratory failed to participate in Non-chemistry/ Immunology proficiency testing for HBsAg (Hepatitis B Surface Antigen) and Anti- HBc (Hepatitis B Core Antibody). Findings include: a. CMS and AAB reported scores of 0% for hepatitis testing: HBsA and Anti-HBc. b. The laboratory was unable to provide for review proficiency testing documents for Q1-2017 Non-chemistry. c. The Technical Consultant affirmed (12/15/17) that the laboratory failed to participate in hepatitis proficiency testing for Q1-2017. d. The reliability and quality of HBsA and Anti-HBc results reported during the timeframe January to April, 2017, could not be assured. Based on the stated estimate of 137 tests per year, the laboratory reported approximately 11 results each month for these two tests. . 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 reviews of proficiency testing reports from CMS (report 155D, Individual laboratory profile) and AAB (American Association of Bioanalysts), laboratory proficiency testing documents, and patients test records; and interview with laboratory personnel, the laboratory failed to attain a score of at least 80% for Magnesium for Q3- 2016, constituting unsatisfactory analyte performance. Findings include: a. CMS reported the score of 20% for Magnesium. b. AAB reported the score of 20% for Magnesium, mg/dL, with the comments "Reagent code not reported. Instrument code not reported"; and the score of 100% for Magnesium MEq/L using Roche Cobas Integra. c. The Technical Consultant affirmed (12/15/17) the root cause for the score of 20% was due to data entry error in reporting to AAB. d. The reliability and quality of results reported for Magnesium during the timeframe September to December 2016 could not be assured. A few examples are as follows: Date Accession ------------ ------------- 9/21/16 16001135 10/19/16 16001195 11/03/16 16001221 12/03/16 16001292 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 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: -- 2 of 7 -- Based on review of 2017 proficiency testing reports from CMS (report 155D, Individual Laboratory Profile) and AAB (American Association of Bioanalysts), the lack of laboratory proficiency testing documents, and interviews with laboratory personnel and AAB personnel, the laboratory failed to participate in proficiency testing for Chemistry for Q2-2017. Findings include: a. The laboratory was unable to provide for review proficiency testing documents for Q2-2017 Chemistry. b. AAB proficiency testing reports for Q2-2017 Chemistry revealed "No data received" for all of the analytes. AAB personnel affirmed (1/12/18) no results were received from the laboratory, and that the scores were reported as "100% Er (Exclusion requested)". c. The CMS reporting system didn't recognize "100% Er", and thus reported false scores of 100% for individual chemistry tests: ALT (SGPT) Glucose Albumin Iron Alkaline phosphatase LDH Amylase Magnesium AST (SGOT) Potassium Total Bilirubin Sodium Calcium Total protein Chloride Triglycerides Total Cholesterol BUN HDL (cholesterol) Uric acid Creatine kinase d. The Technical Consultant affirmed (12/15 /17) that the laboratory failed to participate in proficiency testing for Q2-2017 Chemistry. e. The reliability and quality of results reported during the timeframe May to August, 2017, could not be assured. Based on the stated estimated total annual chemistry test volume of 26,000; the laboratory reported approximately 2,166 results each month. 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 review of 2017 proficiency testing reports from CMS (report 155D, Individual Laboratory Profile) and AAB (American Association of Bioanalysts), the lack of laboratory proficiency testing documents, and interviews with laboratory personnel and AAB personnel, the laboratory failed to participate in proficiency testing for Endocrinology for Q2 -2017. Findings include: a. The laboratory was unable to provide for review proficiency testing documents for Q2-2017 Endocrinology. b. AAB proficiency testing reports for Q2-2017 Endocrinology revealed "No data received" for all of the analytes. AAB personnel affirmed (1/12/18) no results were received from the laboratory, and that the scores were reported as "100% Er (Exclusion requested)". c. The CMS reporting system didn't recognize "100% Er", and thus reported false scores of 100% for individual tests in endocrinology: Free T4 (Thyroxine) hCG (pregnancy hormone) Total T3 (Triiodothyronine) TSH (Thyroid Stimulating Hormone) Total T4 (Thyroxine) d. The Technical Consultant affirmed (12/15/17) that the laboratory failed to participate in proficiency testing for Q2-2017 Endocrinology. e. The reliability and quality of results reported during the timeframe May to August, 2017, could not be assured. Based on the stated estimated total annual endocrinology test volume of 2,830; the laboratory reported approximately 235 results each month. -- 3 of 7 -- 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 2016 - 2017 proficiency testing reports from CMS (report 155D, Individual Laboratory Profile) and AAB (American Association of Bioanalysts), laboratory proficiency testing documents, and patients test records; and interview with laboratory personnel, the laboratory failed to attain scores of at least 80% for PTT (Partial Thromboplastin Time for coagulation) in Q2-2016; and for Cell ID (White Blood Cell Identification, microscopic hematology) in Q3-2017, constituting unsatisfactory analyte performances. Findings include: a. PTT 1) CMS reported the score of 60% for Q2-2016; and AAB reported the score of 60% based on the laboratory's reporting of 2 unacceptable results out of 5. 2) The Technical Consultant affirmed (12/15/17) the aforementioned unsatisfactory score, and thus, unsatisfactory analyte performance in testing for PTT. 3) The reliability and quality of results reported for PTT during the timeframe May to August 2016 could not be assured. A few examples are as follows: Date Accession ------------ ------------------ 6/30/16 16000947 7/27/16 16000990 8/10 /16 16001016 b. Cell ID 1) CMS reported the score of 40% for Q3-2017; and AAB reported the score of 40% based on the laboratory's reporting of 3 unacceptable identifications out of 5. 2) The Technical Consultant affirmed (12/15/17) the aforementioned unsatisfactory score, and thus, unsatisfactory analyte performance in microscopic examination of Cell Identification. 3) The reliability and quality of results reported for Manual Differentials during the timeframe October to December 2017 could not be assured. Based on the stated estimated annual test volume of 200, approximately 16 Manual Differentials with Cell Identification were reported each month. A few examples are as follows: Date Accession ------------ ------------- 10/04 /17 22019 11/03/17 29446 12/04/17 37600 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 review of 2017 proficiency testing reports from CMS (report 155D, Individual Laboratory Profile) and AAB (American Association of Bioanalysts), the lack of laboratory proficiency testing documents, and interviews with laboratory personnel and AAB personnel, the laboratory failed to participate in proficiency testing for hematology coagulation tests PTT (Partial Thromboplastin Time) and PT (Prothrombin Time). Findings include: a. CMS reported 2017 scores for PTT and PT -- 4 of 7 -- as follows [ NR*, No results reported]: Event 1 Event 2 Event 3 ------------- ---------------- ------------- PTT 0% No score 0% NR* PT 0% 100% 0% NR* b. AAB proficiency testing reports revealed "No data received" for PTT for Q1 and Q2 of 2017; as well as for PT for Q1-2017. AAB personnel affirmed (1/12/18) no results were received from the laboratory. c. The Technical Consultant affirmed (12/15/17) the aforementioned scores and lack of participation. d. The reliability and quality of PTT and PT results reported in 2017 could not be assured. . 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 review of 2016- 2017 proficiency testing reports from AAB (American Association of Bioanalysts), and interview with laboratory personnel, the laboratory failed to verify the accuracy of H. pylori Antibody, Hepatitis C virus Antibody, Hepatitis A Antibody, CO2, PTH (Parathyroid Antibody), and Urinalysis, microscopic examination of sediment. Findings include: a. The laboratory chose to participate in AAB's proficiency testing programs as the means to satisfy the requirement to verify the accuracy of testing. b. AAB reported unsatisfactory scores as follows based on the laboratory's unacceptable results: Event / year Test Score ----------------- --------------------- ----------------- Q2- 2016 H pylori 50% Q2- 2017 Anti-HCV 40% Q3- 2017 Anti-HAV 60% Q3- 2017 CO2 40% Q3- 2017 PTH 50% Q3- 2017 Urinalysis, sediment 50% c. The Technical Supervisor affirmed (12/15/17) the aforementioned unsatisfactory scores; and thus, accuracy of testing failed to be verified. d. The reliability and quality of results reported during the timeframes of unsatisfactory testing could not be assured. Based on the stated estimates of annual test volumes, the laboratory reported approximate monthly volumes as follows: H pylori ................................. 13 Anti-HCV................................. 5 Anti- HAV................................. 5 CO2.......................not provided PTH.......................................16 Urinalysis, microscopic...........8 e. A few examples of results reported are as follows: Date Accession Test ------------- ------------------- ---------- 5/25/16 16000746 H pylori 7/27/16 16000990 " 8/10/16 16001016 " 5/26/17 1356 Anti-HCV 6/15/17 1647 " 7/26/17 4982 " 8/02/17 5705 " 10/24/17 26602 Anti- HAV 11/07/17 30285 " 9/19/17 18144 CO2 10/04/17 22019 " 11/03/17 29446 " 12/04 /17 37600 " 9/05/17 14264 PTH 10/02/17 21304 " 11/06/17 29929 " 12/13/17 39969 " 9/11/17 15753 Urinalysis 10/09/17 22727 " 11/14/17 32064 " 12/08/17 38700 " D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation of six BioFire FilmArray muliplex PCR instruments in the -- 5 of 7 -- laboratory, review of patients test results, manufacturer's instructions for Respiratory Panel and GI (Gastrointestinal) Panel, and the laboratory written policy for quality control; the lack of quality control documents, and interviews with a BioFire technical representative and the Technical Consultant, the laboratory failed to include a Negative and a Positive control material each day of testing patients specimen. Findings include: a. The Respiratory Panel includes 20 tests for bacteria and virus as follows: Adenovirus Coronavirus: 229E; HKU1; NL63; OC43 Human Metapneumovirus Human Rhinovirus/ Enterovirus Influenza A; H1; H3, H1-2009 Influenza B Parainfluenza: 1, 2, 3, 4 Respiratory syncytial virus Bordetella pertussis Chlamydia pneumoniae Mycoplasma pneumoniae b. The GI Panel includes 22 tests for bacteria, parasites, and virus as follows: Enteroaggregative E. coli (EAEC) Enterpathogenic E. coli (EPEC) Enterotoxigenic E. coli (ETEC) It/st Shiga-like toxin- producing E. coli (STEC) E. coli O157 Shigella/Enterovinvasive E. coli (EIEC) Campylobacter (jejuni / coli / upsaliensis) Clostridium difficile Toxins A/B Plesiomonas shigelloides Salmonella Vibrio (parahaemolyticus / vulnificus / cholerae) Vibrio cholerae Yersinia enterocolitica Cryptosporidium Cyclospora cayetanensis Entamoeba histolytica Giardia lamblia Adenovirus F 40/41 Astrovirus Norovirus GI/ GII Rotavirus A Sapovirus (I, II, IV, V) c. The manufacturer's Instruction Booklets states the following: 1) Each test pouch includes two internal controls to monitor the testing process. A BioFire technical representative affirmed (1/18/18) that the pouch control named "RNA Process Control" is a yeast organism that undergoes lysis (extraction) and all phases of amplification, analysis, and detection; that the "PCR2 Control" is DNA, and that neither are specific to the organisms being tested in the panels. 2) The instructions recommend including "external positive and negative controls regularly", to use transport medium as the external Negative Control, and "previously characterized positive samples" or samples" spiked with well characterized organisms as external Positive Controls. External controls should be used in accordance with" (CLIA). d. The laboratory failed to provide for review documents for external Negative and Positive Controls each day of testing patients specimen. e. IQCP 1) The laboratory document titled "BioFire FilmArray Individualized Quality Control Plan (IQCP)", effective 5/28/17, stated that external controls were to be performed Monthly and limited to 2 out of 6 analyzers, on a rotating basis. 2) However, the laboratory failed to have documents for external QC data demonstrating the stability of the BioFire test systems to provide accurate and reproducible positive and negative results each day of testing for a Month (30 - 31 consecutive days), prior to implementing the practice of reduced frequency when testing patients specimen. f. The Technical Consultant affirmed (1/19/18) that historical QC data was limited to 20 days of testing. g. The reliability and quality of results reported for BioFire Respiratory and BioFire GI panels could not be assured. Based on the stated estimates of annual test volumes, the laboratory reported approximately 43,333 repiratory results and 18,200 GI results each month beginning in May 2017. A few examples of results reported without QC are as follows: Date Accession Test ------------- ---------------------- --------------- 6/07/17 1433 Respiratory 7 /25/17 4596 " 8/07/17 6311 " 9/08/17 15338 " 10/18/17 24433 " 11/30/17 35554 " 12 /27/17 43449 " 6/07/17 1434 GI 7/25/17 4622 " 8/04/17 6179 " 9/11/17 15290 " 10/18 /17 23753 " 11/29/17 35527 " 12/19/17 41580 " D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently -- 6 of 7 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on survey findings and deficiency cited, the Laboratory Director is herein cited for deficient practice in ensuring the quality control program for molecular based assays is established to include positive and negative controls each day of testing to assure the quality of results obtained or that the Individualized Quality Control Plan included appropriate historical QC studies See D5449. . D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on survey findings and deficiency cited, the Technical Consultant is herein cited for deficient practice in establishing a quality control program appropriate for the molecular testing performed to include positive and negative controls each day of testing specimen or that the Individualized Quality Control Plan included appropriate historical QC studies. See D5449. -- 7 of 7 --