Summary:
Summary Statement of Deficiencies D0000 A recertification survey was completed on 3/12/2021 at PEDIATRIC MEDICINE ASSOCIATES PROVIDER GROUP INC. The laboratory was not compliance with 42 CFR Part 493, Requirements for Laboratories. The following conditions were not met: 5400 -Analytic Systems D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to participate in American Association of Bioanalyst (AAB) Hematology proficiency testing (PT) for the second event of 2020. Findings Included: Review of 2020 AAB PT record revealed 0% in the speciality Hematology for the second PT event of 2020. There was no documentation of the laboratory contacting AAB stating no participation. During an interview on 3/15 /2020 at 3:11 pm, the laboratory technician confirmed that the laboratory did not participate in Hematology AAB PT testing for the second event in 2020. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 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 -- Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to follow their policy regarding running three level (Low, Medium, and High) quality controls for complete blood count (CBC) before patient testing. The lab failed to run these controls during 3 days out of 30 days in June 2020; two days out 31 days in October 2020; and 2 days out of 31 days in January 2021; for hematology patients. (see 5441) D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (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 record review and interview, the laboratory failed to follow their Quality Control policy running three level (Low, Medium, High) quality controls for complete blood count (CBC) before patient testing during 2 out 31 days in October 2020; in 3 out of 30 days in June 2020 and during 2 days out of 31 days in January 2021; for hematology patients. Findings Included: Review of Daily Quality Control policy states that the Beckman Coulter must pass the three different levels (low, medium and high), this is indicated in the Beckman Coulter manual as the adequate technique. For each month we receive from Beckman coulter the control run (Coulter 4Cplus Cell Control), we start up the machine and program the machine based on the parameters. Review of CBC Controls record revealed no documentation for CBC high, medium and low quality controls were run in 6/22/2020, 6/25/2020, 6/29/2020, 10/1/2020, 10 /20/2020, 1/29/2021 and 1/30/2021. Review of Hematology Patient records revealed patients were tested for CBC without controls : 1. Patient 7308 was tested on 6/4 /2020. 2. Patient 7330 was tested on 6/22/2020. 3. Patient 7335 was tested on 6/29 /2020. 4. Patient 7417 and 7419 was tested on 10/1/2020. 5. Patient 7424 was tested on 10/20/2020. 6. Patient 7458 was tested on 1/29/2021. 7. Patient 7459 was tested on 1/30/2021. During an interview on 3/15/2020 at 3:11 pm, the laboratory technician confirmed CBC controls were not run before patient testing for 2 out 31 days in October 2020; in 3 out of 30 days in June 2020 and in 2 out of 31 days in January 2021 for hematology patients. -- 2 of 2 --