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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 proficiency testing (PT) data report (CASPER Report 155), graded results from American Proficiency Institute (API), and staff interview, the laboratory failed to successfully participate in PT for the specialty of Hematology. The laboratory had unsatisfactory scores for the 2nd event in 2021 and 1st event in 2022. Refer to D2131. D2131 HEMATOLOGY CFR(s): 493.851(g) 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 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 proficiency testing (PT) data report (CASPER Report 155), graded results from American Proficiency Institute (API), and staff interview, the laboratory failed to achieve satisfactory performance white blood blood cell differentials in the 2nd event in 2021 and 1st event in 2022. Findings include: 1. Desk review conducted on 5/9/2022 of the CASPER Report 155 and graded results from API revealed the laboratory obtained the following unsatisfactory scores: API 2021 2nd Event White Blood Cell Differential 73% API 2022 1st Event White Blood Cell Differential 0% 2. Interview on 5/9/2022 at 8:00 a.m. with the Technical Consultant confirmed the laboratory's unsuccessful PT participation in the events listed above. -- 2 of 2 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to label 3 of 3 hematology control materials with the revised expiration date upon opening. Findings include: 1. Observation on 10/7/2021 at 10:05 a.m. of the 3 control materials used for complete blood counts (CBC) revealed no revised expiration date on the 3 vials of control material. The 3 CBC control material vials were opened on 9/28/2021. 2. Interview on 10/7/2021 at 10:05 a.m. with the technical consultant (TC) confirmed the 3 opened vials of control material were not labeled with the expiration date upon opening. The TC revealed the CBC control material has a 14 day expiration when opened. This is a repeat deficiency from the recertification survey completed on 8/21 /2019. D6021 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 and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. 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 record review, observation and staff interview, the laboratory director (LD) failed to ensure quality assessment programs implemented as a result of previous deficiency citations are maintained to assure the quality of hematology testing in 2019, 2020, and 2021. Findings include: 1) The laboratory failed to label control materials used for complete blood counts (CBC) in 2021; refer to tag D5415. This is a repeat deficiency from the recertification survey completed on 8/21/2019. 2) The technical consultant failed to ensure competency assessments were performed in 2019, 2020, and 2021; refer to tag D6053. This is a repeat deficiency from the recertification survey completed on 8/21/2017. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and staff interview, the technical consultant (TC) failed to ensure 3 of 3 new testing personnel were evaluated for competency semiannually in their first year of performing hematology testing in 2019, 2020, and 2021. Findings include: 1) Review on 10/7/2021 of testing personnel records revealed 4 new testing personnel trained to perform complete blood count (CBC) testing. Further review revealed 3 out of the 4 testing personnel have been trained greater than 1 year and 2 (TP #1, TP #2) out of these 3 testing personnel failed to have evaluations for competency semiannually in their first year, and 1 (TP #3) out of the 3 failed to be evaluated for competency in the first year. Competencies performed in the first year are: TP #1 - trained 7/2019, annual assessment 7/2020. TP #2 - trained 3/2020, annual assessment 6/2021. TP #3 - trained 7/2020, no competency assessments performed. 2) Interview on 10/7/2021 at 9:30 a.m. with the TC confirmed the above finding. This is a repeat deficiency from the recertification survey completed 8/21/2017. -- 2 of 2 --

Summary Statement of Deficiencies 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)