Rm Lab Llc Dba Express Lab

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 an off-site Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (0155D), graded results from the College of American Pathologists (CAP) and a telephone interview with testing personnel on 8/10 /2022, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3)consecutive testing events for the specialty of General Immunology. See D2077, D2085 D2077 GENERAL IMMUNOLOGY CFR(s): 493.837(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 2 -- 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 an off-site Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded PT results from the College of American Pathologists (CAP) and a telephone interview with testing personnel on 8/10/2022, the laboratory failed to participate in two (2) of three (3) testing events in 2021 and 2022 for the specialty of general immunology. The findings include: 1. An off-site PT desk review of Report 155D and graded PT results from CAP identified that the laboratory failed to participate in testing for events three (3) in 2021 and one (1) in 2022 for the specialty of general immunology for the analyte Rubella. 2. A telephone interview with testing personnel on 8/10/2022 at 11:13 am confirmed the above findings. D2085 GENERAL IMMUNOLOGY CFR(s): 493.837(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 an off-site Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded PT results from the College of American Pathologists (CAP) and a telephone interview with testing personnel on 8/10/2022, the laboratory failed to participate in two (2) of three (3) testing events in 2021 and 2022 for the specialty of general immunology. The findings include: 1. An off-site PT desk review of Report 155D and graded PT results from CAP identified that the laboratory failed to achieve overall satisfactory scores for events one (1) and three (3) in 2021 for the specialty general immunology analyte rubella. Analyte Year Event Score rubella 2021 3 0% rubella 2022 1 0% 2. A telephone interview with testing personnel on 8/10/2022 at 11:13 am confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies 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: Based on a review of the Sure-Vue rapid plasma reagin (RPR) package insert, patient test results and quality control (QC) logs and an interview with the general supervisor (GS) on 12/8/2021, the laboratory failed to follow the manufacturer's instructions for Syphilis Serology testing. The findings include: 1. A review of the Sure-Vue RPR package insert, patient test results and QC log identified that the laboratory failed to perform and document an accuracy check on the antigen dispensing needle to ensure that the correct volume of antigen was used as required by the manufacturer. 2. A review of the Sure-Vue RPR package insert, patient test results and QC log identified that the laboratory failed to verify and document that the rotator speed used for testing met the manufacturers requirements. 3. An interview with the GS on 12/8/2021 at 9: 12 am confirmed the above findings. 4. The laboratory reports performing 84 RPR tests annually. D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 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 -- (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a random record review of immunohematology quality control (QC), patient testing logs and an interview with the general supervisor (GS) on 12/8/2021, the laboratory failed to document control material results with graded or titered reactivity and include negative control material for ABO grouping and Rh typing . The findings include: 1. A random record review of immunohematology QC and immunohematology patient testing logs for 2020 and 2021 identified that the laboratory failed to document QC for ABO grouping and Rh typing with a graded or titered reactivity and a negative control on 6/23/2021. 2. ABO grouping and Rh typing was performed and reported on three patients on 6/23/2021. 3. An interview with the GS on 12/8/2021 at 9:27 am confirmed the above findings. 4. The laboratory reports performing 1297 ABO grouping and Rh typing tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) record review and an interview with the general supervisor, the laboratory failed to retain the 2018 cytology PT records and signed attestation statements from the College of American Pathologist (CAP) for two out of three cytotechnologists. Findings: 1. A review of the 2018 CAP cytology PT records revealed 2 out of 3 cytotechnologists failed to maintain the signed attestations statements and proficiency records from 2018. 2. An interview on September 11, 2019 at 10:35 AM, with the general supervisor, confirmed the laboratory failed to retain 2 out of 3 cytologist PT records from CAP. 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 a record review of personnel competency assessments, a review of the procedure manual, and an interview with the laboratory general supervisor, the laboratory failed to establish and follow procedures to evaluate the competency assessments for testing personnel, general supervisor, and technical supervisor in the specialties and subspecialties of bacteriology, mycology, parasitology, virology, immunology, Syphilis serology, chemistry, endocrinology, toxicology, hematology, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- immunohematology, and histopathology since the last survey on November 30, 2017. Findings: 1. A review of the procedure manual revealed the laboratory failed to establish a policy or procedure to evaluate the competencies for 15 out of 15 testing personnel, 1 general supervisor, and 2 technical supervisors as listed on the CMS-209 Personnel Report form. 2. A review of personnel competency assessments revealed the laboratory failed to evaluate the competencies of the testing personnel, the general supervisor, and the technical supervisors for the laboratory since the last survey. 3. An interview on September 12, 2019 at 3:35 PM, with the general supervisor, confirmed the laboratory failed to establish in writing and failed to evaluate the competency assessments for the testing personnel and the supervisors. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a record review and an interview with the general supervisor, the laboratory failed to verify the accuracy of 52 out of 52 immunohistochemical (IHC) stains, 20 out of 20 special stains, and brain natriuretic peptide (BNP) analyte at least twice a year since the last survey on November 30, 2017. This is a repeat deficiency from the last survey on November 30, 2017. Findings: 1. A document review revealed the laboratory failed to verify the accuracy of IHC stains, special stains, and BNP at least twice a year since the last survey. 2. The laboratory performed approximately 34 BNP tests during the past year. 3. The laboratory performed approximately 5700 IHC and special stains during the past year. 4. An interview on September 13, 2019 at 12:35 PM, with the general supervisor, confirmed the laboratory failed to document the accuracy of the stains and BNP at least twice a year. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on a procedure manual review and an interview with laboratory staff member A, the laboratory failed to establish in writing a procedure or policy for the acceptability criteria when receiving client's specimens since the last survey on November 30, 2017. Findings: 1. A review of the specimen processing procedure revealed the laboratory failed to include the client specimen acceptability criteria such as specimen labeling, specimen source, processing, and referral. 2. An interview on September 12, 2019 at 3:35 PM, with laboratory staff member A, confirmed the client specimen processing procedure failed to include criteria for acceptability of specimens. -- 2 of 8 -- 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 No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --