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Summary Statement of Deficiencies 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 a review of proficiency testing (PT) from the provider American Proficiency Institute (API) performed 5/1/19 to 9/23/21 and interview with General Supervisor #1 (GS#1) revealed that the laboratory director (LD) or designee failed to attest on 6 of 30 events that proficiency testing samples were handled in the same manner as patient samples. Findings: 1. Review of the attestation page for PT from API revealed the LD or designee signature was not present on: a. API 2020 SARS Supplemental 3rd Event b. API 2021 Chemistry Miscellaneous 1st Event c. API 2021 Immunology /Immunohematology 1st Event d. API 2021 Microbiology 2nd Event e. API 2021 Hematology/Coagulation 2nd Event f. API 2021 Chemistry Core 2nd Event 2. Interview with GS #1 on 9/23/21 at 10:30 a.m. confirmed, the LD or designee failed to attest on 6 of 30 events that proficiency testing samples were handled in the same manner as patient samples. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of PT performance evaluation records from API and interview with Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- technical supervisor #1 (TS#1), the laboratory failed to evaluate its proficiency testing results for 2 events from 4/30/19 to 9/23/21. Findings: 1. 2020 SARS-CoV2 2nd Event. a. All results scored acceptable. b. No evidence of evaluation was available at the time of survey. 2. 2021 Immunology/Immunohematology 1st Event a. All results scored acceptable. b. No evidence of evaluation was available at the time of survey. 3. Interview with TS#1 9/23/21 at 12:15 p.m. confirmed, the laboratory failed to evaluate its proficiency testing results for 2 events from 4/30/19 to 9/23/21. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the laboratory's 2019, 2020, and 2021 to date of survey API PT documentation and interview with TS#1, the laboratory failed to verify the accuracy of hematology analytes that were assigned a ungraded proficiency testing score for one event from 4/30/19 to 9/23/21. Findings: 1. Review of the laboratory's 2019, 2020, and 2021 to date of survey API PT documentation for hematology analytes found the following ungraded results: 2019 Hematology/Coagulation 1st Event a. Blood Cell Identification samples: DIF-01, ECI-01, 02, 03, 04 and 05 b. Fecal Leukocytes sample FW-01 2. Review of the laboratory's API PT Performance Review and

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: A Proficiency Testing desk review on 2/12/2019 revealed the lab failed to successfully participate in proficiency testing from American Proficiency Institute (API) PTT testing. Findings as follows: 1. Based on review of proficiency testing from API for 0835 PTT revealed the laboratory received the scores for 2018 event 2 and event 3 as follows: Event 2 PPT testing result 60% Event 3 PTT testing result 40% D2130 HEMATOLOGY CFR(s): 493.851(f) 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 satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: A Proficiency testing desk review on 2/12/2019 revealed the laboratory failed successfully participate in proficiency testing from American Proficiency Institute (API) for subspecialty Hematology. Findings are as follows: 1. Based upon review of proficiency testing from API for 0835 PTT revealed the laboratory received the scores for 2018 event 2 and event 3 as follows: Event 2 2018 PTT testing 60% Event 3 2018 PTT testing 40% -- 2 of 2 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) records and confirmed by laboratory testing personnel #1 (refer to the Laboratory Personnel Report) at 9:00 am on 4/5/2018, the laboratory failed to perform a self- evaluation of ungraded PT scores for three out of six PT testing events in 2016-2017 (2016 events 1 and 3 and 2017 event 1). The findings include: 1. For 2016 testing event 1, the laboratory received ungraded PT test scores for the following: *Hematology / Coagulation Survey - APTT, specimen COA-04 and COA-05 2. For 2016 testing event 3, the laboratory received ungraded PT test scores for the following: *Hematology / Coagulation Survey - APTT, specimen COA-15 *Chemistry Group 2 - Free Thyroxine, specimen CH-13 *Chemistry Group 2 - Thyroid Stimulating Hormone, specimen CH-13 3. For 2017 testing event 1, the laboratory received ungraded PT test scores for the following: *Chemistry Core - Triglycerides, specimen CH-01 *Chemistry Core - Free Thyroxine, specimen CH-01 D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) records and confirmed by laboratory testing personnel #1 (refer to the Laboratory Personnel Report) at approximately 10:00 am on 4/5/2018, the laboratory failed to ensure that evaluation of an unacceptable proficiency testing event was documented. The Findings include: 1. API 2016 Chemistry Group 2, 3rd Event - Gentamicin specimen CH-13 reported 0.5 acceptable range 0.7 - 1.3. No