Pediatric Associates Of Davidson County

Summary Statement of Deficiencies D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of quality control (QC) package inserts, and staff interviews, the laboratory failed to label three of three QC vials with an open date and updated expiration date on the date of the survey. The findings include: 1. Observation of the laboratory on 01/03/24 at 09:10 a.m. revealed an Abbot Cell-Dyn Emerald (SN: 030123-010597) in use for patient CBC testing utilizing three levels of Cell-Dyn 18 Plus QC material (Lot: 3289). The vials were not labeled with either an open date or corrected expiration date. 2. Review of the Cell-Dyn 18 Plus Control assay sheet revealed the control material has an "8 Consecutive-Day Open- Tube Stability". 3. Interview with the Laboratory Director and the office manager on 01/03/24 at 12:15 p.m. confirmed that quality control materials observed in the laboratory were not labeled with an open date and updated expiration date. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 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), and staff interview, the laboratory director failed to ensure compliance with regulation 493.51(a)(4) by not notifying the department of Health and Human Services (HHS) state agency within 30 days of when the laboratory director personnel changed on 01/01/22. 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 and CMS-209 completed for the survey conducted on 01/03/24. 2. Interview on 01/03/24 at 12:15 p.m. with the Laboratory Director and the office manager confirmed the laboratory failed to notify the HHS state agency within 30 days of when the Laboratory Director changed on 01/01/22. -- 2 of 2 --

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: Hematology: Based on the review of the CASPER 153 and CASPER 155 reports, the laboratory failed to maintain satisfactory participation in two out of three events for the specialty Hematology leading to a first unsuccessful performance for Hematocrit (HCT) in 2015. Also, the laboratory failed to maintain satisfactory participation in the third event 2016 and two out of three events for automated hematocrit (HCT), resulting in the non-initial (subsequent) unsuccessful proficiency testing (PT) occurrence for the specialty Hematology for 2018. (Refer to D2130) D2130 HEMATOLOGY 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 -- CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Casper Report 153 and Casper 155 reports and telephonic interview with the laboratory director, the laboratory failed to maintain satisfactory performance for the specialty Hematology for the first unsuccessful PT performance for Hematocrit (HCT) in the first and third events 2015. Also, the laboratory failed to maintain satisfactory participation in the third event 2016 and two out of three events for automated hematocrit (HCT), resulting in the non-initial (subsequent) unsuccessful occurrence. The findings include: 1) Review of the Casper 153 and 155 reports revealed the specialty Hematology revealed first unsuccessful PT performance for Hematocrit (HCT) in the first (20%) and third (60%) events 2015. 2) Review of the Casper 153 and 155 reports revealed the specialty Hematology revealed an unsatisfactory PT performance for Hematocrit (HCT) in the third event 2015 (40%). 3) Review of Casper 153 and 155 reports revealed the specialty Hematology revealed a non-initial (subsequent) unsuccessful occurrence performance for Hematocrit (HCT) in the first (0%) and third (0%) events 2018. 4) During a telephonic interview with the laboratory director on July 18, 2018, at 9:07am, revealed the laboratory failed to submit the specialty Hematology PT results for first and second events 2018 in a timely manner resulting in a score of 0% for Hematocrit (HCT) for the first and second events 2018, resulting in the non-initial (subsequent) unsuccessful occurrence. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a review of the laboratory's unsatisfactory performance of proficiency testing (PT) unsuccessful performance in the specialty Hematology for Hematocrit (HCT) in the first and third events 2015 and subsequent non-initial PT unsuccessful performance in the specialty Hematology for Hematocrit (HCT) in first and second events 2018, the laboratory director failed to ensure director responsibilities were met in PT for Hematocrit (HCT) for 2015 and 2018. (See D6004) 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 -- 2 of 3 -- 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 a review of the CASPER 153 and 155 reports for 2015-2018 and telephonic interview with the laboratory director, the laboratory director failed to ensure compliance with successful participation in proficiency testing (PT) for Hematocrit (HCT) in the first and third events 2015 and subsequent non-initial PT unsuccessful performance in the specialty Hematology for Hematocrit (HCT) in first and second events 2018. Findings include: 1. Review of the CASPER 153 and 155 reports for 2015-2018 revealed the specialty Hematology for Hematocrit (HCT) in the first (20%) and third (60%) events 2015 and subsequent non-initial PT unsuccessful performance in the specialty Hematology for Hematocrit (HCT) in first (0%) and second (0%) events 2018 2. During a telephonic interview with the laboratory director on July 18, 2018, at 9:07am, revealed the laboratory failed to submit the PT results for Hematocrit (HCT) for the first and second events 2018 in a timely manner (0%) resulting in the non-initial (subsequent) unsuccessful performance. -- 3 of 3 --

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: Hematology: Based on the review of the CASPER 153 and CASPER 155 reports, the laboratory failed to maintain satisfactory participation in two out of three events for the specialty Hematology leading to a first unsuccessful performance for regulated analytes including cell I.D. or automated white blood cell (WBC) differential, automated red blood cell (RBC), automated hemoglobin (HGB), automated WBC and automated platelets for 2018 (Refer to D130). D2130 HEMATOLOGY CFR(s): 493.851(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 2 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Casper Report 153 and Casper 155 reports and telephonic interview with the laboratory director, the laboratory failed to maintain satisfactory performance for the specialty Hematology for the first unsuccessful PT performance for regulated analytes including cell I.D. and white blood cell (WBC) diff, automated RBC, HGB, WBC, and PLT for the first and second events 2018, resulting in the first unsuccessful performance. Findings include: 1) Review of the Casper 153 and 155 reports revealed the specialty Hematology and all regulated analytes including cell I.D. and white blood cell (WBC) diff, automated RBC, HGB, WBC, and PLT with a score of 0% (first and second events 2018, respectively). 2) During a telephonic interview with the laboratory director on July 18, 2018, at 9: 07am, revealed the laboratory failed to submit the specialty Hematology PT results for first and second events 2018 in a timely manner resulting in a score of 0% for regulated analytes cell I.D. and white blood cell (WBC) diff, automated RBC, HGB, WBC, and PLT for the first and second events 2018, resulting in the first unsuccessful performance. -- 2 of 2 --

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 review of daily Hematology quality control records and interview with the lead testing person determined that the laboratory failed to retain daily Hematology quality control records for the Abbott Celldyn complete blood count (CBC) analyzer for 2016 and 2017. The findings include: 1. Lack of review of daily Hematology quality control records determined that the laboratory failed to retain daily Hematology quality control records for the Abbott Celldyn CBC analyzer for 2016 and 2017. 2. Interview with the lead testing person on March 22, 2018 at 13:00 confirmed that the laboratory failed to retain daily Hematology quality control records for the Abbott Celldyn CBC analyzer for 2016 and 2017. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Hematology quality control records and interview with the lead Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- testing person determined that the laboratory failed to perform daily Hematology quality control prior to patient testing for complete blood count (CBC) in April 2017. The findings include: 1. Review of patient chart audit revealed daily Hematology quality control was not performed on April 3, 2017 on the Hematology Abbott Celldyn 1800 prior to testing and reporting patient results. 2. Interview on March 22, 2018 at 12:30 confirmed that on April 3, 2017 the lead testing person confirmed the laboratory failed to perform daily Hematology quality control for the Hematology Abbott Celldyn 1800 analyzer. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of Testing Personnel (TP) records, personnel report (CMS 209) and interview with the lead testing person determined the Technical Consultant failed to perform new hire semiannual TP competencies for complete blood counts (CBC) in 2017-18. The findings include: 1. Review of TP records revealed the Technical Consultant failed to perform new hire semiannual competencies in CBCs for TP# 1, 3, 7 and 10 due from August 2017-January 2018. 2. Review of the laboratory personnel report revealed 10 testing persons performing CBCs in 2017-18. 3. Interview with the lead testing person on March 22, 2018 at 13:45 confirmed that the Technical Consultant failed to perform new hire semiannual competencies in CBCs for TP# 1, 3, 7, and 10 in 2017-18. -- 2 of 2 --