Summary:
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: Through review of the College of American Pathologists (CAP) Proficiency Test docuemtnation for 2023, lack of documentation, and interview with laboratory staff it was determined that the laboratory director failed to sign the attestation forms in seven of seven events surveyed for 2023. Finding follow: A) Review of the attestion forms from seven CAP 2023 proficiency test events revealed that the laboratory staff member (# 1 on the CMS form 209) signed the forms as laboratory director or designee. B) Upon request the laboratory could not produce documentation of laboratory staff member (# 1 on CMS form 209) having the designation to sign proficiency testing attestation forms for the laboratory director. C) In an interview on 1 /23/24 at 01:10 p.m., when asked if she had been delegated by the laboratory director to sign the attestations as the designee, the laboratory staff member (# 1 on the CMS form 209) replied, "no". 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- 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 2023 College of American Pathologist (CAP) proficiency testing results, it was determined the laboratory failed to have initial successful participation in proficiency testing for the analyte Alcohol. Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance as cited at D2118. D2118 TOXICOLOGY CFR(s): 493.845(f) Failure to achieve satisfactory performance for the same analyte or test in 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 2023 CAP proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analyte Alcohol. Survey Findings follow: A) A review of the proficiency testing results revealed the laboratory received a score of 40% for the analyte Alcohol on the second proficiency testing event of 2023. B) A review of the proficiency testing results revealed the laboratory received a score of 0% for the analyte of Alcohol in the third proficiency testing event of 2023. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Through review of laboratory reagent package inserts, patient records, and interview it was determined that the laboratory failed to follow policy pertaining to preanalytic handling of patient samples for Ammonia testing. Findings follow: A) Review of the laboratory package insert for Ammonia Ultra (6K89-30, 307237/R04, B6K8Q0, rev -- 2 of 11 -- July 2017) revealed that for Ammonia specimens "the standard recommendation id no motr yhsn 15 minutes from sample collection to start of centrifugation." B) Review of patient records for October 2024 showed one of two patent samples was accepted by the laboratory over 15 minutes from sample collection. Specimen # 1012:C00771S was collected on 10/12/23 at 22:00 and was accepted by the laboratory on 10/12/23 at 22:38. C) In an interview on 1/24/24 at 22:11 , Testing Person #1, as listed on the CMS 209 form, confirmed that the specimen identified above were accepted for testing despite having been collected over 30 minutes prior to it's arrival at the laboratory. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Through reveiw of "Sysmex CA-660 QC (Quality Control) Print Outs", instrument validation data, patient reports, and "QAP" peer user group report for Dade Citrol QC03 material lot number 556569, documentation of