Dermatology Realm And Family Practice

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medical Services Laboratory Personnel Report (Form CMS-209), proficiency testing records, patient test records, and interviews with the laboratory director and lead testing person, proficiency testing samples were not performed by personnel who routinely perform patient testing in 2018, 2019, 2020, and 2021. The findings include: 1. Review of the Form CMS-209 revealed three personnel who perform patient testing for Testosterone, Prostate Specific Antigen (PSA) and Thyroid Stimulating Hormone (TSH). 2. Review of the laboratory's proficiency testing records revealed eleven of twelve proficiency testing events were performed by the lead testing person. 3. Review of patient test records from May 2019, September 2020, and March 2021 revealed patient testing performed by testing personnel other than the lead testing person. 4. Interviews with the laboratory director and lead testing person on May 27, 2021 at 10:30am confirmed the lead testing person performed eleven of twelve proficiency testing events. Other testing personnel perform patient testing. Proficiency testing was not rotated among personnel who routinely perform patient testing in 2018, 2019, 2020 and 2021. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. 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 review of the laboratory's proficiency testing records and interviews with the laboratory director and lead testing person, the laboratory failed to test proficiency testing samples the same number of times as patient samples in 2018. The findings include: 1. Review of the laboratory's proficiency testing records for 2018 event two for miscellaneous chemistry revealed proficiency testing samples were tested once on 10.19.18 and again on 10.22.18 prior to the event cutoff date of 11.02.2018. 2. Interview with the laboratory director and the lead testing person on May 27, 2021 at 10:30am confirmed the proficiency testing samples for 2018 event two for miscellaneous chemistry were tested twice. The interviews also confirmed that patient samples are not routinely tested more than once. The laboratory failed to test proficiency testing samples the same number of times it tests patient samples for one of twelve proficiency testing events. 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 review of laboratory quality control records for Testosterone, Thyroid Stimulating Hormone (TSH), and Prostate Specific Antigen (PSA), and interviews with the laboratory director and lead testing person, the laboratory failed to retain quality control records to include expiration dates and dates the controls were in use for patient testing in 2018, 2019, 2020, and 2021. The finding include: 1. Review of the laboratory's quality control records for Testosterone, TSH, and PSA revealed the following: No expiration date or inclusive dates of use was retained for control kit lots 1801022-5, 1801022-6R,1801022-8, 1903003-4, 1903003-7, 1903003-8, 1910046-1, and 2007010-1. 2. Interviews with the laboratory director and lead testing person on May 27, 2021 at 11:00am confirmed the laboratory failed to retain expiration dates and dates in use for multiple lots of quality control materials in 2018, 2019, 2020, and 2021. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing (PT) records and interviews with the laboratory director and lead testing person, the laboratory failed to retain all proficiency testing records in 2018, 2019, 2020 and 2021. The findings include: 1. Review of the laboratory's proficiency testing records revealed the performance evaluation reports were not retained for the following events: Miscellaneous chemistry: 2018 event two and 2019 event two. Core Chemistry: 2019 events one, two and three, 2020 events two and three and 2021 event one. 2. Interviews with the -- 2 of 5 -- laboratory director and lead testing person on May 27, 2021 at 11:00 am confirmed the laboratory failed to retain proficiency testing performance evaluations in 2018, 2019, 2020 and 2021 (seven of twelve PT events reviewed). 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

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 the laboratory's proficiency testing attestation statements for chemistry group 2 2016 events two and three and interview with the laboratory director, the laboratory director failed to sign the attestation statements for 2016 events one and three. The findings include: 1. Review of the laboratory's proficiency testing attestation statements for 2016 chemistry group 2 events two and three revealed no laboratory director signature on the attestation statements. 2. Interview with the laboratory director on August 14, 2018 at 2 pm confirmed the laboratory director failed to sign the attestation statements for 2016 events two and three. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2017 and 2018 and interview with the laboratory director, the laboratory failed to retain all proficiency testing records for at least two years in 2017. The findings include: 1. Review of the laboratory's 2017 proficiency testing records revealed no retention of attestation statements for the following events: 2017 event one core chemistry, 2017 event one miscellaneous chemistry, 2017 event two core chemistry, 2017 event two 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 -- miscellaneous chemistry, 2017 event three core chemistry. 2. Review of the laboratory's 2017 proficiency testing records revealed no retention of the data submission reports for the following events: 2017 event one core chemistry, 2017 event one miscellaneous chemistry, 2017 event two core chemistry. 3. Interview with the laboratory director on August 14, 2018 at 2:00 pm confirmed the laboratory failed to retain all proficiency testing records in 2017. 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: Based on observation of the laboratory, review of the laboratory's thyroid stimulating hormone (TSH) quality control (QC) records for February 2018, the patient test log for TSH for February 2018, the laboratory's quality assessment monitoring form for February 2018, and interview with the laboratory director the laboratory's quality assessment process was ineffective when it failed to detect and correct problems with TSH quality control in February 2018 with patient testing reported. The findings include: 1. Observation of the laboratory on August 14, 2018 at 8:45 am revealed the Qualigen FastPak instrument on the counter in use for patient testing. 2. Review of the laboratory's quality control records for the TSH analyte for February 2018 revealed that the level one control was out of range (high) on February 9, 2018, with no