Pima County Health Department

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with the technical consultant (TC-1), the laboratory failed to have the current laboratory director approve, sign and date test procedures before use. Findings include: 1. The current laboratory director assigned on the CMS-209, Laboratory Personnel Form presented for review during the survey has been serving as laboratory director since December 1, 2024. 2. The policy and procedure manual presented for review during the survey conducted on 1/21/2025 was not approved, signed and dated by the current laboratory director. 3. The TC-1 interviewed on 1/21/25 at 1:30 PM confirmed that the policy and procedure manual indicated above was not approved, signed and dated by the current laboratory director. 4. The laboratory performs patient testing under specialty of Microbiology with a reported annual test volume of 1,500. 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 D0000 Based on a proficiency testing desk review survey performed on November 14, 2024, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful Participation D6076 - 42 C.F.R. 493.1441 Condition: Laboratory Director, high complexity 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 the Certification and Survey Enhanced Reporting (CASPER) 155 report and College of American Pathologists (CAP) proficiency testing records, the laboratory failed to successfully participate in two of three consecutive testing events 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 -- in the subspecialty of Bacteriology in 2024 resulting in an initial unsuccessful performance. Refer to D2181. 1. The laboratory's PT performance was unsatisfactory for the first event of 2024 as indicated below: - Bacteriology - 60% 2. The laboratory's PT performance was unsatisfactory for the second event of 2024 as indicated below: - Bacteriology - 60% D2026 BACTERIOLOGY CFR(s): 493.823(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) Remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the CASPER 155 report and College of American Pathologists (CAP) PT records from 2024, it could not be determined if the laboratory underwent training and technical assistance and if remedial action was taken to correct the PT failure for the subspecialty of Bacteriology for the 1st and 2nd events of 2024. Refer to D2016. D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 the CASPER 155 report and College of American Pathologists (CAP) PT records from 2024, the laboratory failed to achieve satisfactory performance (80%) for two of three testing events in the subspecialty of Bacteriology. Findings include: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: 2024 event 1, subspecialty of Bacteriology 60% 2024 event 2, subspecialty of Bacteriology 60% 2. A review of the proficiency testing scores from CAP (2024) confirmed the above findings. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER-0155 Individual -- 2 of 3 -- Laboratory Report and College of American Pathologists (CAP) and 2024 records, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER-0155 and College of American Pathologists (CAP) 2024-1 and 2024-2, evaluation reports, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2026. -- 3 of 3 --

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 employee competency policies and procedures and interview with the technical consultant, (A) the laboratory failed to establish policies and procedures to assess the competency of the Technical Consultant and (B) the laboratory failed to follow established policies to assess the competency of testing personnel. Findings include: A1. The CMS-209, Laboratory Personnel form submitted for review during the survey conducted on February 8, 2023 listed one Technical Consultant who provides technical oversight for testing performed in the specialty of Microbiology. A2. No documentation was presented for review to indicate the laboratory established policies and procedures to assess the competency of the Technical Consultant. A3. The technical consultant interviewed on 2/08/23 at 2:10pm confirmed that the laboratory did not have policies and procedures established to assess the competency of the technical consultant. B1. The laboratory's established policy titled, "Quality Assurance Program (QA)" states, "Personnel performing laboratory tests must undergo an initial training and annual or bi-annual review of assigned tasks by the Technical Consultant." B2. The laboratory failed to follow their established policy indicated above to evaluate and document the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. See D6053 for specific findings. B3. The technical consultant interviewed on 2/08/23 at 4:35pm confirmed that the laboratory failed to follow the established policy referenced above to assess the competency of testing 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 -- personnel bi-annually during the first year the individuals tested patient specimens. B4. The laboratory performs Gram Stain and Wet Mount testing in the specialty of Microbiology with a reported annual test volume of 1,200. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: (A) Based on review of Proficiency Testing (PT) records from 2021 and 2022, review of established Quality Assessment (QA) policies and procedures and interview with the technical consultant, the laboratory failed to follow established QA policies to document

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 proficiency testing (PT) attestation statements for 2019 (kit #31824289) and 2020 (kit #33230629) and interview with the laboratory personnel, the laboratory failed to have the director (or designee) sign the attestation statements under the subspecialty of Bacteriology. Findings include: 1. The PT attestation statements noted above did not have the signature of the director or designee. 2. The laboratory personnel acknowledged that the attestation statements indicated above lacked the signature of the director or designee. 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 review of Proficiency Testing (PT) reports from 2019 and 2020. the laboratory failed to provide evidence of a review and evaluation for PT scores received for Gram Stain evaluation. Findings include: 1. The PT review page for PT kit #31824289 from the 3rd event of 2019 and kit #33237754 from the 2nd event of 2020 failed to indicate a reviewed by signature and date. 2. The laboratory personnel acknowledged that the PT scores were reviewed, but the review was not 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 2 -- D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on lack of competency evaluation documentation for review and interview with the laboratory personnel, the technical consultant failed to provide an evaluation of the performance of 1 out of 3 individuals responsible for moderate complexity testing at least annually. Findings include: 1. During the survey conducted on October 16, 2020, no 2019 annual competency evaluation documentation was presented for review for 1 out of 3 testing personnel for testing performed under the specialty of Microbiology. 2. The facility personnel acknowledged that the competency evaluation noted above was completed, but could not be located. -- 2 of 2 --