Far Northeast Surgical Center

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 review of American Association of Bioanalysts/ Medical Laboratory Evaluation (AAB/MLE) proficiency testing (PT) records and interview with the Director of Clinical Services (DCS), the laboratory director (LD)/designee and testing personnel (TP) failed to attest to the routine integration of samples into the patient workload for 1 of 3 Immunohematology PT events performed in 2023. Findings include: 1. The AAB/MLE PT Program Guide General Instructions for reporting results states, " The attestation statements must be signed for each analyte by the analyst performing the procedure and kept in your files for inspection purposes. In addition to the analysts' signatures, the director or the director's designee must sign only once for each reporting form." 2. On the day of survey, 12/14/2023 at 08:29 am., review of AAB/MLE PT records revealed the following attestation statement was not signed by the LD/designee or TP: -2023 Nonchemistry 3rd event - D (Rho) Typing, slide methods: RH11, RH12, RH13, RH14, RH15 3. The DCS confirmed the findings above on 12/14/2023 at 11:25 am. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. 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 review of the laboratory procedures and interview with Director of Clinical Services (DCS), the laboratory failed to ensure that 1 of 1 laboratory procedure manual in use for Immunohematology was approved, signed and dated by the current Laboratory Director (LD) from 09/07/2023 to 12/14/2023. Findings include: 1.The laboratory procedure manual in use for Immunohematology reviewed at the time of inspection on 12/14/2023 at 08:39 am, revealed the procedures were not approved, signed, and dated by the current LD. 2. The laboratory's annual volume for Immunohematology is 2,533 (CMS-116). 3. DCS confirmed the above findings on 12 /14/2023 around 11:25 am. -- 2 of 2 --

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 CASPER Report 155 report and graded results from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in proficiency testing for the analyte D (RHO). Subspecialty ABO/RHO) Refer to D2162. D2162 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER Report 0155D and performance evaluations from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in proficiency testing for the anayte: D (RHO). The laboratory had unsatisfactory scores for the 3rd event of 2021 and 1stevent of 2022. Findings include: Analyte Year Event Score % D (RHO) 2021 3 0 D (RHO) 2022 1 80 D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) Failure to achieve an overall testing event score of satisfactory 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 a review of the CASPER Report 0155D and performance evaluations from the proficiency testing organization American Association of Bioanalysts (AAB), the laboratory failed to achieve an overall testing event score of satisfactory performance in proficiency testing for ABO/D(RHO). The laboratory had unsatisfactory scores for the 3rd event of 2021 and 1st event of 2022. Findings include: Analyte Year Event Score% ABO/D(RHO) 2021 3 0 ABO/D (RHO) 2022 1 80 -- 2 of 2 --

Summary Statement of Deficiencies D2154 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(b) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on the review of the American Association of Bioanalysts (AAB) proficiency testing (PT) records and the interview with the Center Manager (CM), the laboratory failed to obtain a 100 percent score in 1 of 3 PT events for Immunohematology in 2020. Findings Include: 1. On the day of survey, 03/17/2022 at 09:50 a.m., review of AAB PT records revealed, the laboratory received a score of 60% for D (Rho) Typing Event 2 in 2020. 2. The CM confirmed the finding above on 03/17/2022 at 12:00 p.m. D2159 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on the review of the American Association of Bioanalysts (AAB) proficiency testing (PT) records and the interview with the Center Manager (CM), the laboratory failed to submit proficiency testing results within the appropriate time frame for 1 of 3 PT events for Immunohematology in 2021. Findings Include: 1. On the day of survey, 03/17/2022 at 09:50 a.m., review of AAB PT records revealed, the laboratory received a score of 0% for D (Rho)Typing Event 3 in 2021. 2. The CM confirmed the finding above on 03/17/2022 at 12:00 p.m. 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 -- D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(4)(iv) Ensure that an approved

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 review of laboratory procedure manuals and interview with the center manager and surgical center assistant, the laboratory failed to establish a complete competency assessment procedure to assess 1 of 1 technical consultant for competency from 2018 to 2019. Findings Include: 1. On the day of survey, 11/06 /2019, the laboratory could not provide a complete competency assessment procedure to assess 1 of 1 technical consultant for competency in 2018 and 2019. 2. The center manager and surgical center assistant confirmed the findings above on 11/06/2019 around 9:20 am. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require