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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 a review of the CMS (Centers for Medicare and Medicaid Services) CASPER reports and a review of the API (American Proficiency Institute) proficiency testing evaluations, the surveyor determined the laboratory failed to successfully participate in Hematology testing for RBC (Red Blood Cell Count), Hematocrit (Hct), Hemoglobin (Hgb) and Platelet Count (Plts) for two consecutive testing events, Event #1 and Event #2, 2021. These failures resulted in an initial unsuccessful proficiency testing failure for the laboratory. The findings include: 1. A review of the CMS CASPER reports revealed the laboratory scored: (a) Hematology Event #1, 2021 [overall score = 12 % (percent)]: 20 % (percent) for RBC, 0 % for Hgb and Hct, and 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 -- 20 % for Plts. The laboratory also scored a 0 % for the White Blood Cell Count, which contributed to the overall failure of the specialty, Hematology. (b) Hematology Event #2, 2021 (overall score = 64 %): 40 % for RBC, and 60 % for Hgb, Hct, and Plts. 2. A review of the API proficiency testing evaluations confirmed the above noted failures. D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of the CMS CASPER reports and a review of the API proficiency testing evaluations, the surveyor determined the laboratory failed to satisfactorily perform in Hematology testing for: RBC (Red Blood Cell Count), Hematocrit (Hct), Hemoglobin (Hgb) and Platelet Count (Plts) for two consecutive testing events, Event #1 and Event #2, 2021. These failures resulted in overall failing scores for Hematology and an initial unsuccessful proficiency testing failure. The findings include: 1. A review of the CMS CASPER reports revealed the laboratory scored: (a) Hematology Event #1, 2021 [overall score = 12 % (percent)]: 20 % (percent) for RBC, 0 % for Hgb and Hct, and 20 % for Plts. The laboratory also scored a 0 % for the White Blood Cell Count, which contributed to the overall failure of the specialty, Hematology. (b) Hematology Event #2, 2021 (overall score = 64 %): 40 % for RBC, and 60 % for Hgb, Hct, and Plts. 2. A review of the API proficiency testing evaluations confirmed the above noted failures. -- 2 of 2 --

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on initial laboratory tour observations, a review of the qualitative quality control (QC) records and patient logs, and interviews with the Owner/Administrator and the Laboratory Manager (also Testing Personnel #1), the surveyor determined the laboratory failed to perform QC on ten out of thirteen days of patient testing for Mycoplasma and Infectious Mononucleosis (Mono) in 2019 and 2020 The findings include: 1. During the initial tour of the laboratory on 9/30/2020 at approximately 2: 15 PM, Mycoplasma testing (currently using the Immuno Card kit for the detection of IgM to Mycoplasma pneumonia, a moderate complexity qualitative test) was included on the test menu. The Laboratory Manager also stated he performed patient testing for Mono using a serum sample. The surveyor explained using serum or plasma for Mono makes the test moderate complexity. 2. During an interview with the Laboratory Manager on 9/30/2020 at 6:25 PM, the surveyor asked how often the laboratory ran QC for Mycoplasma and Mono; the Manager stated positive and negative QC was performed on each new kit lot number, as per manufacturer's instructions. The surveyor explained CLIA required two levels of quality control each day of moderate complexity patient testing. However, if the manufacturer only required QC on each new lot number, the laboratory had the option of implementing an IQCP (Individualized Quality Control Plan). The laboratory procedure manual did not include an IQCP, and the Laboratory Manager could not provide an IQCP for the surveyor's review. 3. A review of the Mycoplasma QC log revealed positive and 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 -- negative QC was performed on 11/23, 12/7 and 12/8/2019, along with the patient testing. However, patients were also tested on five days when no QC was run (12/12 /19, 12/21/19, 1/1/20, 2/3/20 and 3/10/20). 4. A review of the Mono QC log revealed positive and negative QC was performed on 11/14/19 and 1/27/20 (on new kits). However, patient testing (using serum, per the Laboratory Manager) was performed on five days when no QC was run (12/15/19, 1/8/20, 1/27/20, 2/5/20 and 2/16/20). 5. During the exit interview on 9/30/2020 at 6:40 PM, the above noted deficiencies were reviewed and confirmed with the Owner/Administrator. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 2 of 2 --