Marina Diagnostic Lab Llp

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of TOSOH AIA-900 instrument tapes and an interview with the testing person the laboratory had no compilation of quality control (qc) records enabling the surveyor to review qc records for more than a single day. Findings: It was confirmed by the testing person at 11:30 AM on 3/28/19 that the only way to review qc for all chemistry and endocrinology and immunology tests run on the TOSOH -900 analyzer was by going through the rolled printouts on the TOSOH analyzer. 1. The laboratory had no system to track and record qc results over time to look for shifts and trends and to ensure results were within acceptable ranges. 2. Lot numbers for QC material were also unable to be matched with the package insert acceptable values. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on the surveyor's review of American Proficiency Institute (API), College of American Pathologists (CAP) and Center for Medicaid and Medicare Services (CMS) Proficiency Testing (PT) reports, and an interview with the testing person at 3:30PM 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 -- on 3/28/19, the laboratory failed to evaluate, perform and document remedial action for the PT scores of less than 100% for the following analytes: 2017 second event Total Calcium = 80% Free T4 = 80% WBC Differential + 93% 2017 third event: TSH = 80% WBC Differential + 93% 2018 first event: Total Calcium = 80% Total Iron = 80% 2018 third event: WBC Differential = 87% D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory's procedure manual and the maintenance records for the laboratory's instruments and interview with the testing person, the laboratory failed to establish a procedure that allows for a reduction of certain maintenance requirements for their analyzers based on their limited use. Findings: 1. During the review of maintenance sheets on the Pentra 400 Chemistry analyzer and the TOSOH Immunoassay analyzer and confirmed in an interview with the testing person at approximately 3:00 PM on March 28, 2019, the laboratory had spread out the weekly and monthly requirements based on the limited use of the analyzers which was limited to once or twice a week. 2. The laboratory had no procedure allowing for a reduction of the maintenance schedule. 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 surveyor's review of the laboratory's Quality Control (QC) records for hematology, chemistry, endocrinology and general immunology and confirmed in an interview with the supervisor/testing person, the laboratory failed to perform a lot to lot comparison of assayed QC materials. Findings: 1. The supervisor/testing person confirmed at 3:30 PM on 3/28/18 that the laboratory does not test new lots of control -- 2 of 3 -- against the current lot before using the new lot as primary QC. 2. This was noted for the Horiba controls used for general immunology, chemistry, endocrinology and hematology. 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 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 surveyor's review of the laboratory records and an interview with the laboratory testing person, the laboratory director failed to ensure that the QC program for endocrinology testing was maintained to assure quality of laboratory services. Refer to: D3031, D5433 and D5469. -- 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 proficiency testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT data reports and PT records from the American Proficiency Institute (API) PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Cortisol. The following scores were assigned: 2018 second event = 0% 2018 third event = 100% 2019 first event = 0% This is considered unsuccessful PT performance. Refer to D2107 D2098 ENDOCRINOLOGY CFR(s): 493.843(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 PT desk review of the CMS PT reports and PT records from the API PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analyte Thyroid Stimulating Hormone (TSH). The following scores were assigned: 2018 second event = 60% This is considered unsatisfactory PT performance. 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 PT desk review of the CMS PT data reports and PT records from the API PT program, the laboratory failed to participate successfully in proficiency testing for the test analyte Cortisol. The following scores were assigned: 2018 second event = 0% 2018 third event = 100% 2019 first event = 0% This is considered unsuccessful PT performance 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 PT desk review of the PT CMS data reports and API PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, for the test analytes Cortisol and Thyroid Stimulating Hormone (TSH). Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on PT desk review of the PT CMS data reports and API PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, for the test analytes Cortisol and Thyroid Stimulating Hormone (TSH). The following scores were assigned: Cortisol 2018 second event = 0% 2018 third event = 100% 2019 first event = 0% This is considered unsuccessful PT performance. Thyroid Stimulating Hormone (TSH). 2018 second event = 60% This is considered unsatisfactory PT performance. -- 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 a proficiency testing ( PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT reports and PT records from the American Proficiency Institute (API) PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the specialty Endocrinology and the test analytes Cortisol, Serum Human Chorionic Gonadotropin (HCG), Thyroid Stimulating Hormone (TSH). The following scores were assigned: Endocrinology 2018 second event = 72% 2018 third event = 0% [failure to participate] Cortisol 2018 second event = 0% 2018 third event = 0% [failure to participate] Serum HCG 2018 first event = 40% 2018 second event = 100% 2018 third event = 0% [failure to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- participate] TSH 2018 second event = 60% 2018 third event = 0% [failure to participate] This is considered unsuccessful PT performance. Refer to D2107 and D2108. 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: Based on a PT desk review of the CMS PT reports and PT records from the API PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the specialty Chemistry and twenty five chemistry test analytes. The following scores were assigned: 2018 third event = 0% [failure to participate] This is considered unsatisfactory PT performance. 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 a PT desk review of the CMS PT reports and PT records from the API PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the test analytes Cortisol, Serum HCG and TSH. The following scores were assigned: Cortisol 2018 second event = 0% 2018 third event = 0% [failure to participate] Serum HCG 2018 first event = 40% 2018 second event = 100% 2018 third event = 0% [failure to participate] TSH 2018 second event = 60% 2018 third event = 0% [failure to participate] This is considered unsuccessful PT performance. 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 PT desk review of the CMS PT reports and PT records from the API PT -- 2 of 4 -- program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the specialty Endocrinology. The following scores were assigned: 2018 second event = 72% 2018 third event = 0% [failure to participate] 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 PT desk review of the CMS PT reports and PT records from the API PT program, the laboratory failed to participate and perform successfully in a PT program, approved by CMS, for the Cell Identification (ID)/White Blood Cell differential (WBC Diff). The following scores were assigned: 2018 first event = 67% This considered an unsatisfactory PT performance. 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 PT desk review of the CMS PT and API PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the specialty Endocrinology and the test analytes Cortisol, Serum HCG, TSH, and the specialty Chemistry and twenty five chemistry test analytes and the test analyte Cell ID/WBC Diff. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on PT desk review of the CMS PT and API PT program records, the laboratory director failed to fulfill the laboratory director's responsibilities and ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the specialty Endocrinology and the test analytes Cortisol, Serum HCG, TSH, and the specialty Chemistry and twenty five chemistry test analytes. Endocrinology 2018 second event = 72% 2018 third event = 0% [failure -- 3 of 4 -- to participate] Cortisol 2018 second event = 0% 2018 third event = 0% [failure to participate] Serum HCG 2018 first event = 40% 2018 second event = 100% 2018 third event = 0% [failure to participate] TSH 2018 second event = 60% 2018 third event = 0% [failure to participate] This is considered unsuccessful PT performance. Chemistry and twenty five chemistry test analytes. 2018 third event = 0% [failure to participate] Cell Identification /WBC Diff 2018 first event = 67% This is considered unsatisfactory PT performance. -- 4 of 4 --