Precision Diagnostics Llc

Summary Statement of Deficiencies D0000 A Recertification survey was performed on May 18, 2022 through May 20, 2022 at Precision Diagnostics, LLC, CLIA ID # 19D2018360. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on review of patient test requisitions, patient final reports, and interview with personnel, the laboratory failed to have a written request for Trichomonas vaginalis test performed for two (2) of two (2) patients reviewed. Findings: 1. Review of random selection of patient test requisitions and patient test final reports revealed the laboratory reported Trichomonas vaginalis results without a written request for the following two (2) patients: Patient PD2021-030606.1 Patient PD2021-029325 2. In interview on May 19, 2022 at 2:54 pm , the Technical Consultant confirmed the laboratory reported the identified two (2) patient's test results for a test that did not have a written requisition/order. . D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's polices and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's policies revealed the laboratory did not have written policies and procedures that included the following: a) Performance specification: detailed procedures for performing accuracy and precision (day-to-day, run-to-run, and within-run, as well as, operator variance), reportable and reference range studies, and actions to take when data from the studies fail to meet acceptability criteria b) Twice a year instrument comparison of test results for the same tests performed on multiple instruments 2. In interview on May 20, 2022 at 9:06 am, the Technical Consultant confirmed the laboratory did not have a written policy for the identified items. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 A Certification survey was performed at Precision Diagnostics,LLC, CLIA ID 19D2018360 on January 29, 2020. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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: *** Repeat deficiency from previous survey February 7, 2018 *** Based on record review and interview with personnel, the laboratory failed to establish complete written policies and procedures to assess competency for testing personnel. Findings: 1. Review of the laboratory's "Employee Competency and Annual Performance Evaluation" policy revealed "Employee competency may be monitored by blind sample testing, direct observation and/or written assessments." 2. Further review of the laboratory's "Employee Competency and Annual Performance Evaluation" policy and "Employee Performance Evaluation" form revealed the laboratory did not include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel performing laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- of problem solving skills. 3. In interview on January 29, 2020 at 10:17 am, the General Supervisor confirmed the laboratory's policy and evaluation form did not include the identified six (6) procedures. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to establish complete detailed written instructions for providers to maintain the integrity of samples. Findings: 1. Review of the laboratory's "Client Procedures" for Group B Streptococcus (GBS), BD MAX Vaginal Panel, and BD MAX CT/GC/TV assay revealed the laboratory did not include sample stability limitations in their rejection criteria. 2. Review of the BD Max "CLSI Laboratory Procedures" revealed the following specimen stability requirements: a) BD Max Vaginal Panel: " Specimens in BD MAX UVE Sample Buffer Tubes can be stored for a maximum of 8 days at 2-30 degrees C or for a maximum of 14 days at 2-8 degrees C before testing." b) BD MAX CT/GC/TV: "Sample Stability in BD MAX UVE Sample Buffer Tube prior to Pre- Warm 5 days at 2-30 degrees Celsius or 30 days at -20 degrees Celsius. 3. In interview on January 29, 2020 at 10:17 am, the General Supervisor confirmed the laboratory did not include sample stability limitations in their written client procedures. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the laboratory failed to follow their method verification procedure for precision studies for the BD MAX instrument. Findings: 1. Observation by surveyor during the laboratory tour on January 29, 2020 revealed the laboratory utilizes the BD MAX for testing of the following: Group B Streptococcus (GBS), Chlamydia/Gonorrhea, and Trichomonas (CT/GC/TV), and Bacterrial Vaginitis (BV) panel. 2. In interview on January 29, 2020 at 9:07 am, the General Supervisor stated the laboratory started patient testing on the BD MAX on December 30, 2019. 3. Review of the laboratory's Verification (Validation) procedure for Precision revealed the following: "Most sources agree that a minimum of 2 negative samples and 2 positive samples run in triplicate for 5 days will provide data or within run and between-run components to estimate precision." 4. Review of the laboratory's Precision studies revealed the laboratory did not test samples in triplicate for five (5) days per their policy. 5. In interview on January 29, 2020 at 11:01 am, the General Supervisor confirmed the laboratory did not test samples for precision studies as stated in their policy. -- 2 of 5 -- D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to perform and document visual inspections, sterility checks, and ability to support growth for each batch/shipment of BBL Lim Broth. Findings: 1. Review of the laboratory's policies and procedures revealed the laboratory failed to include quality control procedures for Microbiology media testing, that includes the following: a) Visual inspection b) Ability to support growth, select or inhibit specific organisms or produce biochemical response c) Sterility checks 2. Review of the "BBL Lim Broth" package insert revealed a"Performance Test Procedure" and "Additional Quality Control" procedures. 3. In interview on January 29, 2020 at 9:07 am, the General Supervisor stated the laboratory began patient testing on the BD Max for Group B streptococci on December 30, 2019. 4. In further interview on January 29, 2020 at 11:03 am, the General Supervisor stated the laboratory does not perform any type of testing on the Lim Broth prior to use. 5. Review of the laboratory's test menu revealed the laboratory performs seventy five (75) Group B Streptococci tests annually. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Findings: 1. The laboratory failed to establish complete detailed written instructions for providers to maintain the integrity of samples. Refer to D5317. 2. The laboratory failed to follow their method verification procedure for precision studies for the BD MAX instrument. Refer to D5401. 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 -- 3 of 5 -- 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 record review and interview with personnel, the Laboratory Director failed to ensure that quality control programs are established to assure the quality of laboratory testing. Refer to D5477. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure Testing Personnel had appropriate training documentation prior to patient testing. Findings: 1. Review of the laboratory's "Employee Competency and Annual Performance Evaluation" policy revealed "It is the Director's responsibility to determine if and when an employee is competent to perform patient sample testing." 2. In interview on January 29, 2020 at 9:40 am, the General Supervisor stated Testing Personnel 1 was hired in October 2018. 3. Review of the BD Max initial training documents for Testing Personnel 1 revealed no documentation of the Laboratory Director's approval/signature for patient testing. 4. In interview on January 29, 2020 at 11:23 am, the General Supervisor stated the Laboratory Director did not sign off on Testing Personnel 1's initial training. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed -- 4 of 5 -- to ensure complete policies and procedures were established for assessing personnel competency. Refer to D5209. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures were maintained for assessing personnel competency. Refer to D5209. -- 5 of 5 --

Summary Statement of Deficiencies D0000 A Certification Survey was performed on February 7, 2018 at Precision Diagnostics LLC - CLIA #19D2018360 and was found in compliance with 42 CFR 493, Requirements for Laboratories. However, standard level deficiencies were cited. 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 record review and interview with personnel, the laboratory failed to ensure the Laboratory Director signed the proficiency attestation statements for three (3) of twelve (12) proficiency testing (PT) results. Findings: 1. Review of College of American Pathologist (CAP) proficiency testing records for 2016 through 2017 revealed the following three (3) attestation statements did not include the signature of the Laboratory Director: 2017 Human Papillomavirus (CHPV) - 2nd Event. 2017 Human Papillomavirus (CHPV) - 3rd Event. 2107 Trichomonas vaginalis (TVAG) - 2nd Event. 2. Interviews with Personnel 1 and 2 on February 7, 2017 confirmed the Laboratory Director failed to sign the attestation statements. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel the laboratory failed to have a system in place to ensure that it documents all complaints and problems reported to the laboratory. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to have written policies and procedure for addressing complaints and problems reported to the laboratory. The policy should include a detailed procedure on how to address, document and handle complaints or problems reported to the laboratory. 2. Interview with the Laboratory Director on February 7, 2018 confirmed the laboratory failed to have a complete policy and procedure manual. D5207 COMMUNICATIONS CFR(s): 493.1234 The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel the laboratory failed to have a system in place to ensure that it identifies and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to have written policies and procedure to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. 2. Interview with the Laboratory Director on February 7, 2018 confirmed the laboratory failed to have a complete policy and procedure manual. 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 review of laboratory policy and procedure manual, and interview with personnel, the laboratory failed to establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to establish written policies and procedures that include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel involved in any phase of laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing -- 2 of 5 -- samples or external proficiency testing samples. f) Assessment of problem solving skills. 2. Interview with the Laboratory Director on February 7, 2018 confirmed the laboratory failed to have a complete policy and procedure manual. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)