Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on quality control (QC) record review and interview with the Laboratory Director (LD/TC) on March 23, 2023, the laboratory failed to retain quality control analyzer printouts for the Abbott PocH-100i for at least 2 years. The findings include: 1. A random record review of four patient reports conducted in 2021 and 2022, revealed that the laboratory did not have documentation of the PocH-100i QC printouts for one (1) of the four (4) months reviewed. Month Year June 2021- No analyzer printed records January 2022 September 2022 November 2022 2. The LD /TC confirmed by an interview on March 23, 2023 at 3:15 pm, the lack of retention of the quality control printouts for June of 2021. 3. The laboratory reports performing 40 Hematology patient specimens annually. 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 a record review of the laboratory's policy and procedures and an interview with the laboratory director/ Technical Consultant (LD/TC) on March 23, 2023, the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- laboratory failed to establish procedures to assess competency for the laboratory Technical consultant and laboratory testing personnel following 42 C.F.R. 493.1413 Subpart M. The findings include: 1. The laboratory did not have a policy or procedure for accessing the laboratory Technical Consultant (TC) competency. 2. The laboratory procedures did not include all of the required elements as listed in Subpart M, 493.1413 (8) (i-vi) for personnel competency. Three of the six critical elements were not included in the personnel competency assessments. Missing Elements: iii. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records v. Assessment of previously analyzed specimens, internal blind testing samples, or external proficiency testing vi. Assessment of problem-solving skills. 4. Six (6) of nine (9) testing personnel did not have semi-annual or annual competency assessments performed. 5. Three (3) of nine (9) testing personnel did not have semi-annual competency assessments performed. 6. The laboratory director confirmed by interview on March 23, 2023, the lack of establishing acceptable policies and procedures for assessing testing personnel and TC competency which included all elements as required by 42 C.F.R. 493.1413 Subpart M. 7. The laboratory reports performing approximately 2,620 patient tests annually. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of