Trinity Pediatric Medicine Of Fayetteville, Llc

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on March 8, 2022. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two consecutive events ( 2nd and 3rd events of 2021), resulting in 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 3 -- second unsuccessful occurrence for hematocrit (HCT) #785. (First unsucessful 2020 events #1 and #2) Findings include: Refer to D 2130 D2130 HEMATOLOGY 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 review of the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three testing events (2021 #2 & #3), resulting in the second unsuccessful performance for hematocrit (HCT), analyte # 785. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #785, HCT on Event 2 of 2021 with a score of 40%, Event 3 of 2021 with a score of 60%. 2. Desk review of the laboratory's proficiency testing reports from Medical Laboratory Evaluation (MLE) confirms the laboratory failed HCT on Event 1 and 2 of 2020 resulting in the first unsuccessful performance and reveals the laboratory also failed Event 2 and 3 of 2021, resulting in the second unsuccessful performance. 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: The laboratory director failed to ensure the laboratory participated in PT on 2020 events one and two, and failed to maintain compliance with successful Hematocrit (HCT) proficiency testing (PT) for two of three consecutive events of 2021 (#2 & #3), resulting in the second unsuccessful PT occurrence for HCT. Findings include: Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2020 and 2021 proficiency testing (PT) Medical Laboratory Evaluation (MLE) evaluation reports, the laboratory director failed to -- 2 of 3 -- ensure the laboratory maintained satisfactory performance for two of three consecutive proficiency testing events for the Hematocrit (HCT) #785 resulting in the second unsuccessful PT occurrence for HCT #785. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #785, HCT on Event 2 of 2021 with a score of 40%, Event 3 of 2021 with a score of 60%. 2. Review of the 2020 event one and two MLE evaluation reports revealed unacceptable scores for HCT for 'Failure to Participate', resulting in the first PT occurrence for HCT #785 with scores of 0%. 3. Review of the 2021 event two and three MLE evaluation reports revealed unacceptable scores for HCT. The reports revaled the following unsatisfactory HCT scores: 2021 event two 40% and 2021 event three 60%. Resulting in the second PT occurrence for HCT #785. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on January 25, 2021. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's Medical Laboratory Evaluation (MLE) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of three consecutive events (Events 1 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 -- and 2 of 2020), resulting in the first unsuccessful occurrence for Hematology #0760, Cell I.D./WBC Diff #0765, Red Blood Cells (RBC) #0775, Hematocrit (HCT) #0785, Hemoglobin (HGB) #0795, White Blood Cell (WBC) #0805, Platelets #0815. The findings include: Refer to D2130 D2130 HEMATOLOGY 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's Medical Laboratory Evaluation (MLE) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of three consecutive events (Events 1 and 2 of 2020), resulting in the first unsuccessful occurrence for Hematology #0760, Cell I.D./WBC Diff #0765, Red Blood Cells (RBC) #0775, Hematocrit (HCT) #0785, Hemoglobin (HGB) #0795, White Blood Cell (WBC) #0805, Platelets #0815. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte Hematology #0760, Cell I.D./WBC Diff #0765, Red Blood Cells (RBC) #0775, Hematocrit (HCT) #0785, Hemoglobin (HGB) #0795, White Blood Cell (WBC) #0805, Platelets #0815, for Events 1 and 2 of 2020 with a score 0% for both events. 2. The criteria for acceptable performance for the specialty of Hematology is a score of 80%. 3. Desk review of the laboratory's proficiency testing reports from Medical Laboratory Evaluation (MLE) confirmed the laboratory failed Hematology #0760, Cell I.D./WBC Diff #0765, Red Blood Cells (RBC) #0775, Hematocrit (HCT) #0785, Hemoglobin (HGB) #0795, White Blood Cell (WBC) #0805, Platelets #0815 on Events 1 and 2 of 2020 resulting in the first unsuccessful performance. 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's Medical Laboratory Evaluation (MLE) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in four consecutive events (Events 1 and 2 of 2020), resulting in the first unsuccessful occurrence for Hematology #0760, Cell I.D./WBC Diff #0765, Red Blood Cells (RBC) #0775, Hematocrit (HCT) #0785, Hemoglobin (HGB) #0795, White Blood Cell (WBC) #0805, Platelets #0815 in the specialty of Hematology. The findings include: Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) -- 2 of 3 -- 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. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's Medical Laboratory Evaluation (MLE) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in four consecutive events (Event 3 of 2019 and Events 1, 2 and 3 of 2020), resulting in the first unsuccessful occurrence for Hematology #0760, Cell I.D./WBC Diff #0765, Red Blood Cells (RBC) #0775, Hematocrit (HCT) #0785, Hemoglobin (HGB) #0795, White Blood Cell (WBC) #0805, Platelets #0815 in the specialty of Hematology. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte Hematology #0760, Cell I.D./WBC Diff #0765, Red Blood Cells (RBC) #0775, Hematocrit (HCT) #0785, Hemoglobin (HGB) #0795, White Blood Cell (WBC) #0805, Platelets #0815, for Events 1 and 2 of 2020 with a score 0% for both events. 2. The criteria for acceptable performance for the specialty of Hematology is 80%. 3. Desk review of the laboratory's proficiency testing reports from Medical Laboratory Evaluation (MLE) confirmed the laboratory failed Hematology #0760, Cell I.D./WBC Diff #0765, Red Blood Cells (RBC) #0775, Hematocrit (HCT) #0785, Hemoglobin (HGB) #0795, White Blood Cell (WBC) #0805, Platelets #0815 on Events 1 and 2 of 2020 resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on April 17, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on operator guide reviews of the ABX Micros 60 and Piccolo Xpress and staff interview, the laboratory failed to monitor room temperature (RT) and relative humidity (RH) in the lab testing area per manufacturers requirements. Findings include: 1. Review of the ABX Micros 60 operators guide revealed the RT is required to be 18 - 32 degrees Celsius and the RH is required to be less than 80 %. 2. Review of the Piccolo Xpress operator's guide revealed the RT is required to be between 15 - 32 degrees Celsius and the RH is required to be between 8 - 80 %. 3. Interview with the lab director (CMS 209) on 4/17/19 at 11:50 AM in the lab area, confirmed the RT and RH were not monitored in the lab area. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) 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 -- (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) document review and staff interview, the lab failed to monitor over time the accuracy and precision of test performance. Findings include: 1. Review of the Micros 60 hematology analyzer quality control records revealed no long term monitoring has been performed since August 2017. 2. Interview with the lab director (LD)(CMS 209) on 4/17/19 in the patient room across from the LD's office at approximately 12 Noon, confirmed the lack of long term QC monitoring. -- 2 of 2 --