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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 test analyte Sodium. The following scores were assigned: 2019 first event = 0% [non-participation] 2019 second event = 0% This is considered unsuccessful PT performance. Refer to D2096. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) 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 -- 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 eighteen chemistry test analytes. The following scores were assigned: 2019 first event = 0% [failure to participate] This is considered unsatisfactory PT performance. 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 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 Sodium. The following scores were assigned: 2019 first event = 0% [non-participation] 2019 second event = 0% This is considered unsuccessful PT performance. 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 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 subspecialty Endocrinology and test analytes Cortisol, Free Thyroxine (FT4), Triiodothyronine (T3) and Thyroid Stimulating -- 2 of 4 -- Hormone (TSH). The following scores were assigned: 2019 first event = 0% [failure to participate] This is considered unsatisfactory PT performance. 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 test analyte Hemoglobin (Hgb) The following scores were assigned: 2019 first event = 40% This is 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 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 Sodium, Hgb and the specialty Chemistry eighteen chemistry test analytes and for the subspecialty Endocrinology and test analytes Cortisol, FT4,T3 and 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; 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 Sodium, Hgb and for the specialty Chemistry and eighteen chemistry test analytes and the subspecialty Endocrinology and test analytes Cortisol, FT4, T3 and TSH) The following scores were assigned: Sodium 2019 first event = 0% [non-participation] 2019 second event = 0% This is considered unsuccessful PT performance. Specialty Chemistry and eighteen chemistry -- 3 of 4 -- test analytes. 2019 first event = 0% [failure to participate] Hemoglobin (Hgb) 2019 first event = 40% Subspecialty Endocrinology & analytes Cortisol, FT4, T3 and TSH 2019 first event = 0% [failure to participate] This is considered an unsatisfactory PT performance. -- 4 of 4 --

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 test analyte Red Blood Cell Count (RBC)/Erythrocyte count. The following scores were assigned: 2018 third event = 0% This is considered an unsatisfactory PT performance. Refer D2121 D2121 HEMATOLOGY CFR(s): 493.851(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 2 -- 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 Red Blood Cell Count (RBC) /Erythrocyte Count. The following scores were assigned: 2018 third event = 0% This is 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 test analyte Red Blood Cell Count (RBC) /Erythrocyte Count. -- 2 of 2 --

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 surveyor's review of the procedure manual, random QC & calibration records, validation studies, temperature logs and an interview with the current technical consultant, the laboratory failed to retain QC & calibration records and temperature logs from January 2, 2017 through July 28, 2018. FINDINGS: 1. The current technical consultant confirmed on October 16, 2018 at approximately 11:45 AM the surveyor's findings that the laboratory failed to retain QC & calibration records and temperature logs from January 2, 2017 through July 28, 2018. Approximately 300 patient samples for both chemistry and endocrinology were tested and reported during this time period. a. temperature policy requires that the temperature records be retained for 2 years. 2. The current technical consultant could not locate the backup files for the QC & calibration records for the following analyzers: a. Beckman Coulter AcT Diff II hematology analyzer, Elite Envoy 500 chemistry analyzer and TOSOH AIA-900 endocrinology analyzer 3. The laboratory's information system (LIS) using LABDAQ software was down during this survey and the records were not available for review from January 2, 2017 through July 28, 2018. THIS IS A REPEATED DEFICIENCY FROM THE SURVEY CONDUCTED ON MARCH 15, 2016. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an 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 -- ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's Quality Assessment (QA) policies and procedures and confirmed in an interview with the current technical consultant, at the time of this survey, the laboratory failed to follow their established QA policy and perform a QA review for the 2017 calendar year. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's temperature policy, revised temperature sheets and an interview with the current technical consultant, the laboratory failed to follow the manufacturer's instructions for monitoring and maintaining room and refrigerator temperatures from July 28, 2018 through survey date. FINDINGS: 1. The current technical consultant confirmed on October 16, 2018 at approximately 10:30 AM, the surveyor's findings that the laboratory failed to record the five refrigerator's and room temperatures for storing the analyzers reagents, calibrators and substrate materials. a. the staff failed to record the temperatures from July 28, 2018 through survey date. Since the laboratory director had signed the cease testing letter on July 28, 2018, therefore no patient test results were jeopardized during this time period. 2. The following reagents, calibrators and substrate materials were stored in these refrigerators and laboratory area room: Chemistry Envoy 500 Reagents: Albumin (2 boxes); BUN (3 boxes); Uric Acid (1 box); Alkaline Phosphorous (2 boxes); ALT (2 boxes); AST (2 boxes); Calcium (2 boxes); CK (2 boxes); T. Bilirubin (3 boxes); D. Bilirubin (2 boxes); Creatinine (3 boxes); Glucose (2 boxes); HDL Cholesterol (3 boxes); GGT (2 boxes); Iron (2 boxes); Triglyceride (2 boxes); Phosphorus (2 boxes); Calibrators (6 boxes); Vital controls (1 box); wash solution (2 boxes); Cleaner (2 boxes); ISE solution (3 boxes); ISE diluents (3 boxes); Conditioner (3 boxes). Hematology Coulter AcT Diff 4-C controls (1 box) and calibrator (1 box) TOSOH AIA 900 Reagents: Cortisol (1 box); TSH (1 Box); FT4 (1 box); T3 (1 box); substrate II (12 bottles & 2 boxes); calibrators (10 boxes) THIS IS A REPEATED DEFICIENCY FROM THE SURVEY CONDUCTED ON MARCH 15, 2016. 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. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on surveyor's findings and an interview with the current technical consultant, the laboratory director failed to provide overall management of the laboratory. THIS IS A REPEATED DEFICIENCY FROM THE SURVEY'S CONDUCTED ON MARCH 15, 2016 AND APRIL 22, 2014. D6021 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 quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on lack of QA records and an interview with the current technical consultant, the laboratory director failed to follow the established QA procedures and identify issues, take and document remedial and