Summary:
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 review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS approved proficiency testing program for the chemistry analyte: carbon dioxide (CO2). Findings include: Review of the CMS database and the API proficiency testing reports showed unsatisfactory performance for 2 of 3 proficiency testing events. Refer to 2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the chemistry analyte: carbon dioxide (CO2) for 2 of 3 consecutive testing events. Findings include: Unsatisfactory performance for 2 of 3 consecutive proficiency testing events constitutes unsuccessful performance for CO2. CO2 PT event Score 1st event 2021 40% 3rd event 2021 0% 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 observation, record review, and interview with Testing Personnel (TP) #1, the laboratory failed to retain the chemistry Mindray BS 200 quality control documents for 2 (11/17/2019 to 11/17/2021) of 2 years. Findings include: 1. The surveyor observed while reviewing chemistry and endocrinology quality control records a break from 9/16/2020 to 2/04/2021 in the records. 2. When queried on 11/17 /2021 at 12:14 pm, TP1 stated that she had deleted the files on 2/18/2021. 3. A record review for 1 (#492) of 13 patient final reports tested on 12/16/2020 revealed the laboratory did not have any documentation of the quality control records for that testing date. 4. An interview on 11/17/2021 at 12:14 pm, TP1 confirmed the quality control records were not maintained for 2 years. 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 record review and interview, the laboratory failed to ensure written competency policies were implemented for 2 (Clinical Consultant and the Technical Consultant) of 2 non-testing technical personnel based on the federal regulatory responsibilities. Findings include: 1. A record review of the CMS-209 revealed for 2 of 2 non-testing technical positions, the laboratory did not implement the federal regulatory responsibilities competency assessment for 2020 and 2021. 2. An interview on 11/17/2021 at 9:15 am, Testing Personnel #1 confirmed the lab did not implement competency assessments in 2020 and 2021. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE -- 2 of 4 -- CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on record review, lack of documentation, and interview with Testing Personnel (TP) #1, the laboratory failed to verify the accuracy of the chemistry and endocrinology testing at least twice annually for 3 (2nd of 2020 and 1st and 2nd of 2021) of 5 testing events in 2 years. Findings include: 1. A record review of the twice a year verification of accuracy (linearity) documents revealed for 3 of 5 events in 2 years a lack of documentation of the process being performed and documented for the following analytes: a. chemistry analytes: sodium, potassium, chloride, carbon dioxide, albumin, alkaline phosphatase, asparate transamine, alanine transaminase, total bilirubin, calcium, creatinine, glucose, total protein, and urea nitrogen b. endocrinology analytes: vitamin D, thyroid stimulating hormone, and free thyroxine 2. An interview on 11/17/2021 at 10:31 am, TP1 confirmed there was no verification of accuracy performed or documented for 3 of 5 events. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of