Tennessee Medicine & Pediatrics Pc

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 a review of the Centers for Medicare and Medicaid Laboratory Personnel Report (form CMS-209), competency documents, American Proficiency Institute (API) proficiency testing (PT) record attestation statements, and staff interview, the laboratory failed to ensure the PT samples were tested by all three testing personnel (TP) that routinely perfrom complete blood count (CBC) patient testing in 2021 and 2022. The findings include: 1. Review of the form CMS-209 and laboratory competency documents revealed three testing personnel that routinely perform CBC patient testing. (listed on form CMS-209 TP numbers two, three, and four). 2. Review of the API PT attestation statements revealed TP three and four failed to perform PT testing in 2021 or 2022 (six events reviewed). 3. Interview on 04/21/2023 at 2:30 p.m. with TP two and laboratory director confirmed that testing person two performed the PT samples in 2021 and 2022. Subsequent email interview on 04/24/2023 with TP two confirmed TP three and four routinely performed CBC patient testing in 2021 and 2022. 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 4 -- This STANDARD is not met as evidenced by: Based on review of Medonic complete blood count (CBC) instrument printouts and staff interview, the laboratory failed to test American Proficiency Institute (API) proficiency testing (PT) samples the same number of times it routinely tested patient samples in 2022 events one and three (two of six events reviewed) for seven of 30 samples reviewed for 2021 and 2022. The findings include: 1. Review of the Medonic M Series (serial 19761) CBC instrument printouts for PT samples in events 2022 revealed the following: 2022 event one samples tested as follows: HSY-01 03/29 /2022, 03/22/2022, and 03/16/2022 HSY-02 03/29/2022, 03/22/2022, and 03/16/2022 HSY-03 03/29/2022, 03/22/2022, and 03/16/2022 HSY-04 03/29/2022, 03/22/2022, 03 /16/2022, and 03/16/2022 HSY-05 03/29/2022, 03/22/2022, and 03/16/2022 2022 event three samples tested as follows: HSY-12 11/08/2022, 11/08/2022 HSY-14 11/08 /2022, 11/08/2022, 11/08/2022, 11/08/2022 2. Interview with laboratory testing person two at 2:00 p.m. confirmed the PT samples were repeated multiple times for 2022 events one and three to ensure the results were "accurate" and that patient samples were not repeated in that manner. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records, and staff interview, the laboratory failed to ensure accuracy of results that were Not Graded by API for wet prep and vaginal potassium hydroxide (KOH) samples in 2021 and 2022. The findings include: 1. Review of the API PT comparative evaluation forms revealed: 2022 Event 2 sample VA-02 (Wet Prep) with a "Not Graded" result due to "No Consensus" 2021 Event 3 sample VKP-03 (Vaginal Wet Prep (KOH)) with a "Not Graded" result with annotation of "See Data Summary". 2. Review of the API PT performance evaluation documents revealed no documentation of review for the "Not Graded" samples (2022 event 2 VA-02 and 2021 event 3 VKP-03) in 2021 and 2022 (two of six events reviewed). 3. Interview with testing person two and laboratory director on 04/21/2023 at 2:00 p.m. confirmed the laboratory failed to ensure accurate results for PT samples that were not graded in 2021 and 2022. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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 review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, lack of records, and staff interview, the laboratory failed to verify accuracy twice annually for urine sediment, potassium hydroxide (KOH), and wet prep tests, that are not listed in subpart I in 2021 and 2022. The findings include: 1. Review of the API PT performance summaries for 2021 and 2022 revealed: Urine -- 2 of 4 -- Sediment 2021 events two and three, 2022 event one (three of six events reviewed) all with performance evaluation scores of 50% resulting in unsuccessful participation for tests not included in subpart I. KOH 2022 events one, two and three (three of six events reviewed) all with performance evaluation scores of 0% resulting in unsuccessful participation for tests not included in subpart I. Wet Prep 2022 events one and three (two of six events reviewed) with performance evaluation scores of 0% resulting in unsuccessful participation for tests not included in subpart I. 2. Request for documentation of accuracy from a secondary method to verify accuracy was not available. 3. Interview on 04/21/2023 at 2:00 p.m. with testing person two and the laboratory director confirmed the laboratory failed to verify accuracy of tests not included in subpart I with API PT enrollment or secondary method when PT evaluations were unsuccessful in 2021 and 2022 for urine sediment, KOH, and Wet Prep testing and the laboratory did not participate in any other activities to verify accuracy twice annually. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the Clinical Laboratory Improvement Amendments (CLIA) certificate of compliance, CLIA Application for Certification (form CMS-116), Laboratory Personnel Report CLIA (form CMS-209), Disclosure of Ownership, and staff interview, the laboratory director failed to notify the department of Health and Human Services (HHS) state agency within 30 days when the laboratory director personnel changed in October 2021 according to the regulation 493.51 (a)(4). The findings include: 1. Review of the CLIA certificate of Compliance revealed the laboratory director was not the same as the laboratory director listed on the forms CMS-116, CMS-209, Disclosure of Ownership and Control Interest Statement-TN completed for the survey conducted on 04/21/2023. 2. Interview on 04/21/2023 at 1: 30 p.m. with laboratory director and testing person two confirmed the laboratory director failed to notify the HHS state agency within 30 days when the laboratory director change occurred in October 2021. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: -- 3 of 4 -- Based on review of laboratory personnel records, laboratory policy, and staff interview, the technical consultant failed to perform annual competency for eight of nine testing personnel (TP) that routinely performed urine sediment microscopy, potassium hydroxide (KOH), and wet prep patient testing in 2022. The findings include: 1. Review of laboratory's personnel records for competency assessments revealed the following TP one had no documentation of annual competency assessments for urine sediment microscopic testing, KOH, or wet prep testing for 2022. TP five had no documentation of annual competency assessments for KOH, urine sediment microscopic, or wet prep testing in 2022. TP six had no documentation of annual competency assessments for urine sediment microscopic testing in 2022. TP seven had no documentation of annual competency assessments for urine sediment microscopy, KOH, or wet prep testing in 2022. TP eight had no documentation of annual competency assessments for urine sediment microscopy, KOH, or wet prep testing in 2022. TP nine had no documentation of annual competency assessments for urine sediment microscopy, KOH, or wet prep testing in 2022. TP ten had no documentation of annual competency assessments for urine sediment microscopy, KOH, or wet prep testing in 2022. TP eleven had no documentation of annual competency assessment for urine sediment microscopy, KOH, or wet prep testing in 2022. 2. Review of the laboratory policy titled "Quality Assurance" revealed the following: "Ensure laboratory personnel are adequately trained and evaluated their performance after six months and annually thereafter." 3. Interview on 04/21/2023 at 2:00 p.m. with the laboratory director and TP two confirmed the technical consultant failed to evaluate competency for eight of nine TP that routinely perform patient testing for urine microscopic, KOH, and wet prep in 2022. -- 4 of 4 --

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 the testing personnel records (TP), and an interview with the Technical Consultant, determined the laboratory failed to evaluate annual competency for testing personnel number 5-11 for Potassium Hydroxide (KOH), Wet Preps, and Urine Microscopy procedures for 2017 and 2018. The findings include: 1. A review of the personnel records revealed the laboratory failed to evaluate annual competency for testing personnel number 5-11 for (KOH), Wet Preps, and Urine Microscopy procedures for 2017 and 2018. 3. An interview with the Technical Consultant at approximately 12:30 p.m. December 6, 2018 confirmed the laboratory failed to evaluate annual competency for testing personnel number 5-11 for (KOH), Wet Preps, and Urine Microscopy procedures for 2017 and 2018. 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 --