D-Rad Mobile Imaging Services

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on January 29, 2024, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute evaluation reports, the laboratory failed to achieve satisfactory performance 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 -- in three of three consecutive testing events for Syphilis Serology, resulting in a non- initial unsuccessful performance. Refer to D2074. D2074 SYPHILIS SEROLOGY CFR(s): 493.835(e) 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute evaluation reports, the laboratory failed to achieve satisfactory performance for three of three events in 2023 for Syphilis Serology. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile report, the laboratory received the following unsatisfactory performances for the Syphilis Serology in three of three consecutive events: 2023 API 1st event 0% 2023 API 2nd event 0% 2023 API 3rd event 0% 2. Based on review of the American Proficiency Institute (API) Comparative Evaluations, the laboratory received the following unsatisfactory performances for the Syphilis Serology in three of three consecutive events: 2023 API 1st event 0% 2023 API 2nd event 0% 2023 API 3rd event 0% 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute evaluation reports, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for Syphilis Serology for three of three events in 2023. 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 desk review of the Certification and Survey Provider Enhanced Reporting -- 2 of 3 -- (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute evaluation reports, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program Syphilis Serology for three of three events in 2023, resulting in a non-initial unsuccessful performance. Refer to D2074. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on October 24, 2023, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute evaluation reports, the laboratory failed to achieve satisfactory performance 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 -- in two of two consecutive testing events for Syphilis Serology, resulting in an initial unsuccessful performance. Refer to D2074. D2074 SYPHILIS SEROLOGY CFR(s): 493.835(e) 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute evaluation reports, the laboratory failed to achieve satisfactory performance for two of two events in 2023 for Syphilis Serology. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile report, the laboratory received the following unsatisfactory performances for the Syphilis Serology in two of two consecutive events: 2023 API 1st event 0% 2023 API 2nd event 0% 2. Based on review of the American Proficiency Institute (API) Comparative Evaluations, the laboratory received the following unsatisfactory performances for the Syphilis Serology in two of two consecutive events: 2023 API 1st event 0% 2023 API 2nd event 0% 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute evaluation reports, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for Syphilis Serology for two of two events in 2023. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency -- 2 of 3 -- Institute evaluation reports, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program Syphilis Serology for two of two events in 2023, resulting in an initial unsuccessful performance. Refer to D2074. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on July 25, 2023, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute evaluation reports, the laboratory failed to achieve satisfactory performance 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 -- in two of two consecutive testing events in 2023 for the analytes Alkaline Phosphatase and Sodium, resulting in an initial unsuccessful performance. Refer to D2096. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute evaluation reports, the laboratory failed to achieve satisfactory performance in two of two consecutive testing events in 2023 for the analytes Alkaline Phosphatase and Sodium, resulting in an initial unsuccessful performance. The finding included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile for the first and second events of 2023, the laboratory received the following unsatisfactory scores for the analyte Alkaline Phosphatase and Sodium. 2023 1st Event Alkaline Phosphatase - 0 percent Sodium - 0 percent 2023 2nd Event Alkaline Phosphatase - 0 percent Sodium - 20 percent 2. Based on review of the American Proficiency Institute evaluation reports for the first and second events of 2023, the laboratory received the following unsatisfactory scores for the analytes Alkaline Phosphatase and Sodium 2023 1st Event Alkaline Phosphatase - 0 percent Sodium - 0 percent 2023 2nd Event Alkaline Phosphatase - 0 percent Sodium - 20 percent 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute evaluation reports, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for analytes Alkaline Phosphatase and Sodium in the specialty of Routine Chemistry for two of two events in 2023. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute evaluation reports, the laboratory director failed to ensure successful performance in a HHS approved proficiency testing program for analytes Alkaline Phosphatase and Sodium for two of two events in 2023. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493. 1250 Condition: Laboratories Performing Moderate Complexity Testing; Analytic Systems 493. 1403 Condition: Laboratories Performing Moderate Complexity Testing; Laboratory Director 493. 1421 Condition: Laboratories Performing Moderate Complexity Testing; Testing Personnel D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Review of the manufacturer's instructions, CMS 116, patient reports, Personnel files and interview of facility personnel found the laboratory failed to follow the manufacturer's instructions for disseminating all authorized fact sheets when using the Clarity COVID-19 Antigen Rapid Test Cassette for patient testing in 2020 and 2021. The findings included: 1. Review of the manufacturer's instructions found under the heading CONDITIONS OF AUTHORIZATION FOR LABORATORY: A. " Authorized laboratories using the Clarity COVID-19 Antigen Rapid test kit must include with test results reports of the COVID-19, all Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these fact sheets may be used, which may include mass media. F. Al Operators using your product must be appropriately trained in performing and interpreting the results of your product." 2. Review of the CMS 116 found the laboratory recorded an annual volume of 4,920 Covid tests performed. 3. Review of patient reports found the laboratory did not include instructions to providers on where to obtain the fact sheets or included copies of the authorized fact sheets. 4. Review of personnel files found no documentation of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- training for the Clarity COVID-19 Antigen Rapid test cassette. 5. Interview of the Laboratory owner conducted on March 9, 2022 at 1:09 PM confirmed that the laboratory did not include the authorized Fact Sheets with the patient test results for COVID-19 and did not have documented training of testing personnel performing the tests. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of policies and procedures, verification studies, quality control records, maintenance records, patient test records and interview of facility personnel, the laboratory failed to meet the analytic systems requirements to monitor and evaluate the overall quality of analytic systems and correct problems identified in Hematology, Virology, Syphilis Serology and Chemistry. ( See D5411, D5421, D5441, D5449, D5469 and D5791) D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Review of the manufacturer's instructions, CMS 116, patient reports and interview of facility personnel found the laboratory failed to follow the manufacturer's instructions for disseminating all authorized fact sheets when using the FaStep COVID-19 IgG /IgM Rapid Test Device as defined in the Conditions of Authorization for Use. The findings included: 1. Review of the manufacturer's instructions found under the heading CONDITIONS OF AUTHORIZATION FOR LABORATORY " Authorized laboratories using the FaStep COVID-19 IgG/IgM Rapid Test Device must include with result reports of the COVID-19 IgG/ IgM all authorized Fact Sheets." 2. Review of the CMS 116 found the laboratory recorded an annual volume of 4920 COVID tests performed. 3. Review of patient reports found the laboratory did not include instructions to providers on where to obtain the fact sheets or included copies of the authorized fact sheets. 4. Interview of the General Supervisor on the CMS report 209 Laboratory Personnel Report conducted on January 18, 2022 at 11:59 AM confirmed that the laboratory did not include the authorized Fact Sheets with the patient test results for COVID-19 using the FaStep COVID-19 IgG/IgM Rapid Test Device. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) -- 2 of 9 -- Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: I. Review of Laboratory records and interview of facility personnel found the laboratory failed to verify the reference ranges were appropriate for the patients when using the ABX Pentra 60 C+ Hematology Analyzer for testing patient Complete Blood Counts. The findings included: 1. Review of verification records found no verification studies for reference ranges available for review. 2. The laboratory reported an annual volume of 8,208 Hematology procedures tested on the ABX Pentra C+. 3. Interview of Testing Person one on the Form 209- Laboratory Personnel Report conducted March 9, 2022 at 12:25 PM confirmed there were no additional records for review. II. Review of Laboratory records and interview of facility personnel found the laboratory failed to verify the reference ranges were appropriate for the patients when using the Beckman AU 400 Chemistry analyzer and the Beckman Coulter Access 2 Analyzer for testing patient specimens. The findings included: 1. Review of verification records found no records available for review to verify reference ranges were appropriate for the patient population served. 2. The laboratory reported an annual volume of 20, 748 Chemistry procedures without reference range verifications prior to patient testing. 3. Interview of Testing Person one on the Form 209- Laboratory Personnel Report conducted March 9, 2022 at 12:25 PM confirmed there were no additional records for review. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Review of policies and procedures, quality control records and interview of facility personnel found the laboratory failed to have a quality control procedure in place that monitored the accuracy and precision of analytic process in Chemistry, Virology, Hematology and Syphilis Serology. The findings included: 1. Review of the policy titled Quality Review ( approved 01/21/2021) found under the heading PURPOSE: " The object of our Quality Review plan is to improve the reliability , efficiency and quality of laboratory services." Further review found under the heading POLICY: " -- 3 of 9 -- Quality control is the sum of those procedures by which the routine precision and accuracy of each test can be assured. Action taken will depend on the type of test and equipment or material and may include any or all of the following: Correct Procedure followed Calibration and QC of instruments are in range Check stability of reagents Assurance of proper temperature requirements assurance of not interchanging original kit components with current or new kit component lot numbers. Repeat testing All quality control records will be reviewed on a monthly basis and