Dba Alabama Oncology

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of the API (American Proficiency Institute) proficiency testing (PT) records and an interview with Testing Personnel #8, the laboratory failed to enroll in an approved Proficiency Testing program for iStat Chemistry 8 panel catridge, a moderate complexity test. This was noted for three of three events starting from the date of implementation, 4/11/2023, to the date of the current survey, 5/2 /2024. The findings include: Refer to D2001. Refer to D6041. D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on a review of the API (American Proficiency Institute) proficiency testing (PT) records and an interview with Testing Personnel #8, the laboratory failed to enroll in an approved Proficiency Testing program for the i-STAT Chemistry 8 panel cartridge. This was noted for three of three events starting from the i-STAT implementation date, 4/11/2023, to date of survey, 5/2/2024. The findings include: 1. A review of the API PT records revealed no evidence of enrollment in a proficiency testing program for 2023 Event 2, 2023 Event 3, and 2024 Event 1 for the i-STAT Chemistry 8 panel cartridge. No evidence of alternative accuracy verification procedures were available for review. 2. During an interview at 1:00 PM on 5/2/2024, Testing Personnel #8 confirmed the above findings. 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 a review of the API (American Proficiency Institute) proficiency testing (PT) records,

Summary Statement of Deficiencies D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on a review of personnel records and an interview with Testing Personnel (TP) #10, the Technical Supervisor failed to evaluate and document the performance of high complexity testing in the Flow Cytometry Laboratory for TP #10 and TP #11 at least annually after the first year. This was noted for 2020 and 2021. The findings include. 1. A review of the personnel records revealed the following: a) TP #10 had an annual competency documented on 3/8/22 (evaluation was performed by TP #1 who is not qualified to perform high complexity testing). No annual evaluations were provided for 2020 and 2021, and TP #10 was previously listed on the CMS 209 - Laboratory Personnel Report. b) TP #11 had an annual competency documented on 3/8 /22. No annual evaluations were provided for 2020 and 2021, and TP #11 was previously not listed on the CMS 209 - Laboratory Personnel Report. 2. During a phone interview on April 26, 2022 at 3:02 PM, TP #10 (also the Technical Supervisor) stated "in the past we have used proficiency testing as competencies". The surveyor explained proficiency testing is only one of the six criteria required for competency evaluation. Also, the surveyor asked when TP #11; TP #10 confirmed TP #11 began working three years ago as a part-time employee. 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 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 a review of AAB (American Association of Bioanalysts) proficiency testing records and an interview with the laboratory supervisor (also testing personnel #1), the surveyor determined the laboratory staff failed to implement and document