Statlab Mobile

Summary Statement of Deficiencies D0000 An unannounced recertification survey, was conducted on 08/02/19 to 08/07/19 at Statlab Mobile. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Clinical Laboratories. Based on the survey findings an Immediate Jeopardy situation was identified and the laboratory was notified at 3:30 PM 08/07/19. The laboratory failed to do quality control prior to patient testing (Beckman CoulterAcT 5diff CP) since at least 06/2017. Failed to validate new equipment prior to patient testing (Beckman Coulter AcT 5diff CP, Advia Centaur CP, Carolina CLC 720). Used expired reagents for patient testing on Beckman Coulter AcT 5diff CP, Carolina CLC 720. No room temperature or humidity were documented on days testing occurred. No records of calibrations for Beckman Coulter AcT 5 diff CP). No quality assurance (See D5400). The Laboratory Director failed to have oversight of the laboratory, failed to conduct competency evaluations on testing personnel, and failed to ensure testing personnel were qualified to perform testing prior to patient testing (See D6000). The following Conditions were not met: D5200- General Laboratory Systems 493.1230 D5300-Preanalytic Systems 493.1240 D5400-Analytic Systems 493.1250 D5800-Postanalytic Systems 493.1290 D6000-Moderate Complexity Laboratory Director 493.1403 D6063-Laboratory Testing Personnel 493.1421 D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) and Medical Laboratory Evaluation (MLE) proficiency testing records and interview with Owner, the facility failed to have documentation of signed attestation by the laboratory director or Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- designee for 6 out of 6 events reviewed for Chemistry and Hematology. Findings Included: Review of MLE proficiency records (enrolled in this program till 2017) revealed that the laboratory failed to have documentation of the attestation signed by the Laboratory Director and the Testing Person for the 2nd and 3rd event of 2017 for the specialties of Chemistry and Hematology. Review of API (enrolled in this program since 2018 1st event) proficiency records revealed that the laboratory failed to have documentation of the attestation signed by the Laboratory Director and the Testing Person for 1st, 2nd and 3rd event of 2018, and 1st event 2019 for the specialties of Chemistry and Hematology. During an interview on 08/02/19 at 2:30 PM, the owner confirmed that the laboratory failed to sign the attestations of reference. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on lack of proficiency testing records and interview with laboratory owner, the facility failed to have documentation of preparation, processing, examination and each step in the testing and reporting of results for all proficiency testing samples for 6 out of 6 events reviewed for Chemistry and Hematology. Findings Included: Review of American Proficiency Institute and Medical Laboratory Evaluation proficiency records revealed that the laboratory failed to have documentation of preparation, processing, examination and each step in the testing and reporting of results for all proficiency testing samples for the 2nd and 3rd events of 2017; 1st, 2nd and 3rd events of 2018 and 1st event of 2019 for the specialties of Chemistry and Hematology. During an interview on 08/02/19 at 2:30 PM, the Owner confirmed that the laboratory failed to have the required documentation of the proficiency testing. 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. -- 2 of 14 -- This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) documentation and interview with the Owner, the laboratory failed to participate in proficiency testing (PT) program, which resulted in a score of zero (0) percent on the Hematology /Coagulation 1st event in 2019. Findings Included: Review of the API records for the 2019 Hematology/Coagulation, 1st event showed the laboratory received a score of 0% for all analytes to be tested. The notes on the API "Performance Summary" sheet stated "Failure to Participate". During an interview on 08/02/19 at 2:30 PM, the Owner acknowledged that the laboratory failed to get tests results submitted on time and confirmed that patient testing was being performed during this timeframe. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the American Proficiency Institute (API) documentation and interview with the Owner, the laboratory failed to participate in proficiency testing (PT) program, which resulted in a score of zero (0) percent on the Hematology /Coagulation 1st event in 2019. Findings Included: Review of the API records for the 2019 Hematology/Coagulation, 1st event showed the laboratory received a score of 0% for all analytes to be tested. The notes on the API "Performance Summary" sheet stated "Failure to Participate". During an interview on 08/02/19 at 2:30 PM, the Owner acknowledged that the laboratory failed to get tests results submitted on time and confirmed that patient testing was being performed during this timeframe. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the lack of documentation and interview with Laboratory Owner, the laboratory failed to document the annual competency assessment on 1 out of 1 testing personnel (TP); for a period of 3 out of 3 years (2017-2019) reviewed. Findings Included: The laboratory failed to have documentation of annual competency assessment on 2017, 2018, 2019 for TP. During an interview on 08/02/19 at 4:30 PM with the owner, he confirmed that there was no competency assessment documented for the period of above reference for the TP. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) -- 3 of 14 -- The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Owner, the laboratory failed to have a General Laboratory Systems Quality Assurance Policy for at least the period of 2 out of 2 years (2017-2019) reviewed. This is a repeated deficiency found during the 06/08/17 recertification survey. Findings Included: Review of the procedure manual revealed that there was no Quality Assurance Policy or program established to monitor and evaluate the ongoing and overall quality of total testing processes, to evaluate the quality of tests results, and to identify perform corrections of its problems as needed in the general laboratory systems. During an interview on 08 /05/19 at 3:24 PM, the Owner acknowledged that there was no quality assurance in the procedure manual and no documentation of the quality assurance activity. The recertification survey dated 06/08/19 stated in the

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 review of the laboratory's proficiency testing records for 2016 and 2018, the laboratory had subsequent successful performance in proficiency testing for the analyte, sodlim, found in the subspecialty of routine chemistry. Refer to D2096. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on November 9, 2018 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, sodium for seven out of nine testing events in 2016, 2017, and 2018. 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 -- 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 the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory had subsequent unsuccessful participation in proficiency testing for the analyte, sodium, found in the subspecialty of routine chemistry. Findings include: On November 9, 2018 on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory had unsuccessful proficiency testing scores for seven out of nine testing events in 2016, 2017, and 2018 for the analyte, sodium, as shown below. 2016 Proficiency Testing Results Event #1, 2016 Sodium-0% Event #2, 2016 Sodium-0% Event #3, 2016 Sodium-0% 2017 Proficiency Testing Results Event #1, 2017 Sodium- 0% Event #2, 2017 Sodium-60% 2018 Proficiency Testing Results Event #2, 2018 Sodium-60% Event #3, 2018 Sodium-60% 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 review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing for the analyte, sodium, in the subspecialty of routine chemistry. Findings include: On November 9, 2018, on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had subsequent unsatisfactory proficiency testing score for the analyte, sodium, in the subspecialty of routine chemistry. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2096. 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 the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing for the analyte, sodium, in the subspecialty of routine chemistry. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on November 9, 2018 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores for seven out of nine testing events as shown below. 2016 Proficiency Testing Results Event #1, 2016 Sodium-0% Event #2, 2016 Sodium-0% Event #3, 2016 Sodium-0% 2017 Proficiency Testing Results Event #1, 2017 Sodium- 0% Event #2, 2017 Sodium-60% 2018 Proficiency Testing Results Event #2, 2018 Sodium-60% Event #3, 2018 Sodium-60% -- 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 review of the laboratory's proficiency testing records for 2017 and 2018, the laboratory had subsequent unsuccessful performance in proficiency testing for the subspecialty of routine chemistry. Refer to D2096. Findings include: Review of the American Proficiency Institute (API) and Medical Laboratory Evaluation (American Society of Internal Medicine) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on August 29, 2018 at 10:00 AM, showed that the laboratory had subsequent unsatisfactory testing scores for the analytes total bilirubin (Tbili) and chloride (CL) for three out of four testing events in 2017 and 2018. 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 -- 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 the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory had subsequent unsuccessful participation in proficiency testing in the subspecialty of routine chemistry. Findings include: On August 29, 2018 on or about 10:00 AM the American Proficiency Institute (API) and American Society of Internal Medicine (MLE) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory had unsuccessful proficiency testing scores for three out of four testing events for the analytes of total bilirubin (Tbili) and chloride (Cl) as shown below. Total bilirubin (Tbili) Testing event #1, 2017 Tbili-40% Testing Event #3, 2017 Tbili-0% Testing Event #1, 2018 Tbili-60% Chloride (Cl) Testing event #1, 2017 Cl-20% Testing Event #3, 2017 Cl-40% Testing Event #1, 2018 Cl- 40% 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 review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the subspecialty of routine chemistry Findings include: On August 29, 2018, on or about 10:00 AM, the American Proficiency Institute (API) and the American Society of Internal Medicine (MLE) proficiency testing records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had subsequent unsatisfactory proficiency testing score for the analytes, total bilirubin and chloride, in the subspecialty of routine chemistry. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D 2096. 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 the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing for the analytes total bilirubin and chloride both of which are in the subspecialty of routine chemistry. Findings Include: On August 29, 2018, on or about 10:00 AM, the American Proficiency Institute (API) and the American Society of Internal Medicine (MLE) proficiency testing records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the the laboratory had subsequent unsuccessful performance in proficiency testing for the analytes total bilirubin (Tbili) and chloride (Cl) as shown below. Total bilirubin (Tbili) Testing event #1, 2017 Tbili-40% Testing Event #3, 2017 Tbili-0% Testing Event #1, 2018 Tbili-60% Chloride (Cl) Testing event #1, 2017 Cl-20% Testing Event #3, 2017 Cl- 40% Testing Event #1, 2018 Cl-40%. -- 3 of 3 --