T Lab Inc

Summary Statement of Deficiencies D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: No deficiency details available. D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) The laboratory director must ensure that the laboratory is enrolled in an HHS- approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: 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 --

Summary Statement of Deficiencies 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 observation and interview, the laboratory did not have competency check records for the technical supervisor and the technical consultant. Findings: 1. The laboratory did not have competency check records for the technical supervisor and technical consultant for the years 2021 and 2020; and 2. Testing person number three stated during interview on the afternoon of February 25, 2022, that the laboratory did not have competency records for the two laboratory staff. 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 review of "Appendix O" received on 05/12/2022, Quality Management Plan (QMP), and interview with the laboratory director, the laboratory failed to verify the accuracy of the Biofilm, Neutrophil Lysis, Red Blood Cell Inclusions (BNR) slide analysis performed at least twice annually. Findings: 1. "Appendix O" is titled "BNR Split Specimen QA Summary and Log." This summary states that 1 out of every 20 specimens is to undergo a split specimen QA analysis. The data that was reviewed was from June 2019 through February 2022. 2. The proficiency testing section of the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- QMP stated "These formal reviews are done at least twice a year, however, our team does meet with our independent reviewers every 1-3 weeks to review any unusual image findings or other irregularities." 3. During the survey on 05/13/22 at 3:00 PM, the LD confirmed that the records reviewed show that the split samples were not being reviewed twice a year. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the spreadsheet used to document proficiency checks for the biofilm, neutrophil, red blood cell test (BNR) made by an independent reviewer (for proficiency or accuracy checks), the laboratory records were incomplete and did not include intermediate records made by the outside independent reviewer. Findings: 1. The spread sheet documenting the split sampling of patient specimens for BNR with an outside independent reviewer as a proficiency check (dated June 19, 2019 to March 24, 2022) did not include the dates the outside reviewer examined the split samples, the name of the outside reviewer, or intermediate worksheets showing the outside reviewer's findings and interpretations. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) 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 review of the written policies and procedures and interview with the laboratory director (LD), the laboratory failed to have written policies and procedures for the investigation of specimens that failed to meet the laboratory's criteria for acceptability. Findings 1. The laboratory used a worksheet titled "Specimen Incident Report" to document the findings of investigations of specimen issues. The laboratory documented the "specimen identification number, incident description and adverse events, outcome, and actions, if any" on the "Specimen Incident Report." 2. During the survey on 05/13/22 at 3:00 PM, the LD confirmed that there were no established policies and procedures that instruct the laboratory personnel to collect information and document the description of the problem, reasons for the deviation, actions taken and implementation of protocols to prevent reoccurrence of the problem. 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 -- 2 of 10 -- rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the procedure, stability studies, and specimen incident reports, and interview with the testing personnel (TP) and laboratory director (LD), the laboratory failed to establish a procedure and validate the criteria for specimen acceptability for the age of the specimens received for the laboratory developed test (LDT). Findings: 1. The laboratory performed a LDT that evaluated peripheral blood slides for morphological features to characterize and semi-quantify the presence of biofilms, neutrophil extracellular trap formation and red blood cell inclusions. 2. Patient results were reported as either Indeterminate, Positive-Low or Positive-High based on defined criteria. 3. The procedure titled "Receiving and Accessioning of Shipped Blood Samples" included specimen rejection criteria for the temperature of received blood specimens but did not address acceptability for the age of the blood specimens. 4. In documentation that was received via email on 05/12/2022, the laboratory stated that specimens were viable for at least 24 hours after collection and referred to a stability study. The stability study compared specimen imaging results from directly after collection to 24 hours later when stored at different temperatures. The stability study results stated "it was determined that time after draw and temperature effected red blood cell morphology in a way that made quantitative scoring more difficult. To account for this, the scoring guidelines were amended to include fewer possible results." 5. An incident report dated 02/07/2022 stated that specimen 4596 was received four days after specimen collection due to shipping delays and "The integrity of the specimen was not compromised. Therefore, the specimen was viable for testing. The specimen was processed as normal." There was no documentation explaining how it was determined that the integrity of the specimen was not compromised. 6. There was no documentation of stability studies performed to assess whether the observed morphological features and final result interpretation would be affected in a specimen received four days after collection. 7. During the survey on 05/13/2022 at 3: 00 PM, the TP and LD confirmed that the specimen acceptability procedure did not include criteria for age of specimen and the stability studies did not include an evaluation of specimens older than 24 hours. 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 D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) record review and interview with the laboratory staff and the laboratory director (LD), the laboratory did not record the results of the "Jorvet Dip Quick Stain" hematology QC, documenting that the staining characteristics observed on patient slides were acceptable each day of testing. Findings: 1. The laboratory uses the "Jorvet Dip Quick Stain" to stain patient blood slides for hematology testing. During an interview at 11:30 AM on the day of the survey, the laboratory staff stated that a "QC slide" is stained with each batch of patient slides, and the QC slide is evaluated for acceptable staining characteristics when the doctor performs patient testing. Laboratory staff stated that patient testing is performed "every 1-2 weeks." 2. A review of slide QC logs from July, 2017 to June, 2019 showed that slide QC was recorded once a month. 3. During an interview on 6/28 /19 at 12:45 PM, the LD confirmed that slide QC was not documented on each day of patient testing. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. 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 -- This STANDARD is not met as evidenced by: Based on standard operating procedure manual (SOPM) and quality assurance (QA) record review and interview with the laboratory director (LD), the LD did not ensure that the QA review included updating written laboratory procedures to reflect the actual practice in the laboratory. Findings: 1. The procedure, "Slide Interpretation," "Quality Control" states that "Each batch of slides stained will contain as controls" a "Blind Control," "Negative Control," and a "Positive Control." During an interview at 11:30 AM, laboratory staff stated that they "run a positive slide only"; and 2. The procedure, "Slide Interpretation," "Interpretation Guidelines" states, "All results will be qualitatively reported as positive or negative. Quantitative reporting is not allowed." The procedure, "Split Specimen Analysis" states that 5 slides are sent to an external lab for proficiency testing purposes and that the slides are to be evaluated as "Negative" or "Positive." During an interview at 9:30 AM, the LD stated that the slides are graded numerically as 0, 1, 2, or 3, not as "negative" or "positive." 3. During an interview, laboratory staff stated that after making patient blood slides, the slides are placed on a slide warmer to dry, and that the temperature should be 40 degrees Celsius. The SOP did not state a temperature range and the LD confirmed that slide warmer temperatures were not recorded. 4. The procedure, "Quality Assurance" states, "a chart review will be conducted quarterly on a random sampling of patient charts to verify that all test ordered have been reported and filed correctly in the EMR. Staff will review at least 20 patient charts and present their findings to the Lab Director." The LD stated that this procedure is not followed because each patient is checked as they are read. A review of "Lab Director QA Summary-Quarterly" report forms from June, 2017 to June, 2019 showed that this chart review was not documented. 5. During an interview on 6/28/19 at 12:45 PM, the LD confirmed that the laboratory SOPM did not reflect the current practice of the laboratory. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on standard operating procedure manual (SOPM) review and interview with the laboratory director (LD), the laboratory did not ensure that all of the written procedures in the SOPM were signed and dated by the LD. Findings: 1. A review of the current SOPM showed that approximately 20 of 24 procedures were not approved (signed and dated) by the LD. 2. During an interview on 6/28/19 at 12:45 PM, the LD confirmed that all of the written procedures in the current SOPM were not signed and dated. -- 2 of 2 --