Pediatric Associates Of Dearborn

Summary Statement of Deficiencies 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 record review and interview with Testing Personnel #1, the laboratory failed to test two control materials at least each date of its Complete Blood Count patient testing for 1 (12/27/22) of 14 patient testing dates reviewed. Findings include: 1. A review of 14 patient testing dates revealed only one of three control levels was performed on 12/27/22 for Complete Blood Count testing performed on the Beckman Coulter AcT Diff analyzer and four patients received testing on that date. 2. An interview on 11/20/23 at 11:36 am with Testing Personnel #1 confirmed the laboratory did not use at least two control materials of different concentrations on 12 /27/22. D5781

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 observation and interview with Testing Personnel #1 (TP1), the laboratory failed to retain all abnormal, out of range quality control records for at least two years for 2 (March 2020 to March 2022) of 2 years. Findings include; 1. The surveyor observed a sticky note taped on the laboratory's Beckman Coulter AcT Diff hematology analyzer stating, "If control is abnormal please delete it and rerun" on 3/23 /22 at 9:07 am. 2. An interview on 3/23/22 at 9:09 am with TP1 revealed controls that are not in range are deleted and the information is not retained. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: . Based on record review and interview with Testing Personnel #1, the laboratory failed to ensure Testing Personnel #1, performing the duties of a Technical Consultant, met the qualification requirements at 493.1411. Findings include: 1. The laboratory failed to ensure the personnel performing the Technical Consultant duty of performing testing personnel competency assessments were qualified. Refer to 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 -- D6035. ***This is a repeated Condition-Level deficiency from the 2/12/20 recertification survey*** D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #1, the laboratory failed to ensure personnel performing the Technical Consultant duty of performing testing personnel competency assessments was qualified for 1 (Testing Personnel #1) of 4 testing personnel listed on the CMS-209 form. Findings include: 1. A review of the laboratory's personnel competency records revealed Testing Personnel1#1 had performed a competency assessment for Testing Personnel #2 on 3/15/22. 2. A review of the qualifications for Testing Personnel #1 revealed they did not meet the qualification requirements to perform Technical Consultant responsibilities. 3. A review of the laboratory's "Quality Assurance Plan" revealed a section stating, "At least annually, the laboratory director and/or technical consultant will review the performance of each staff member working in the lab to assure employee competency, The written result of the review will be filed in the individual's personnel file." 4. An interview with Testing Personnel #1 on 3/23/22 at 9:34 am confirmed Testing -- 2 of 3 -- Personnel #1 had performed the competency assessment for Testing Personnel #2 and did not meet the qualification requirements to be a Technical Consultant. . 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 record review and interview with Testing Personnel #1 (TP1), the Technical Consultant failed to evaluate the performance at least semiannually in the first year of employment for 1 (Testing Personnel #3) of 4 testing personnel on the CMS-209 form. Findings include: 1. A review of the laboratory's personnel records revealed Testing Personnel #3 was hired on 10/20/20 and had competency assessments performed on 10/22/20 and 10/5/21. 2. A review of the laboratory's "Competency Requirements" revealed a section stating, "Regulation 493.1413 b (9) refers to the frequency of the competency evaluations. Evaluating and documenting the performance of individuals responsible for moderate complex testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least annually." 3. An interview on 3/23/22 at 11:18 am with TP1 confirmed the Technical Consultant did not assess the competency of Testing Personnel #3 at least semiannually during the first year of patient specimen testing. -- 3 of 3 --

Summary Statement of Deficiencies D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on record review and interview, the laboratory failed to meet the requirements for the specialty in Hematology as specified in 493.1230 through 493.1256, 493.1269, and 493.1281 through 493.1299. Findings include: 1. The laboratory failed to ensure control procedures were followed according to laboratory-established requirements. Refer to D5445. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on observation, record review and interview with Testing Personnel #1 (TP1), the laboratory failed to ensure control procedures were followed according to 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 -- laboratory-established requirements for 35 testing days out of 2 years reviewed. Findings include: 1. An observation made by the surveyor on 2/12/2020 at 9:08 am revealed a Beckman Coulter AcT Diff hematology analyzer present in the laboratory. 2. A review of the laboratory's established "QC procedures" revealed a section stating, "Each day of testing: Test three levels of 4C cell controls (low, normal, and high) prior to testing patient samples on each day of testing according to the instructions in the AcT Diff Operator's Guide. Those who perform patient tests must perform QC." "Compare control results to the expected results. (located on the Coulter 4C PLUS cell control package insert). All control results must be in expected ranges before patient test results are reported." 3. A review of the laboratory's quality control records for the Beckman Coulter AcT Diff hematology analyzer revealed the following days had only two levels of controls ran: a. 2/8/19 normal control was not performed. b. 2 /15/19 high control was not performed. c. 2/22/19 normal control was not performed. d. 3/13/19 high control was not performed. e. 3/14/19 normal control was not performed. f. 3/20/19 low control was not performed. g. 3/23/19 low control was not performed. h. 6/26/19 low control was not performed. 3. A review of the laboratory's quality control records for the Beckman Coulter AcT Diff hematology analyzer revealed one control out of range for the following testing days: a. 2/12/19 White Blood Cell count (WBC), Red Blood Cell Count (RBC), and Hemoglobin (HGB) were out of range for the low control. b. 2/13/19 WBC was out of range for the normal control. c. 2/25/19 Platelet count (PLT) was out of range for the low control. d. 3/6/19 RBC was out of range for the high control. e. 4/13/19 PLT was out of range for the high control. f. 5/4/19 Mean Corpuscular Hemoglobin (MCH) and Mean Corpuscular Hemoglobin Concentration (MCHC) were out of range for the normal control. g. 5/6/19 MCHC was out of range for the low control. h. 5/7/19 MCH and MCHC were out of range for the low control. i. 5/8/19 RBC was out of range for the high control. j. 5/23/19 MCH and MCHC were out of range for the low control. k. 6/7 /19 MCHC was out of range for the low control. l. 6/8/19 PLT was our of range for the high control. m. 6/24/19 HGB, MCH, and MCHC were out of range for the low control. n. 6/25/19 RBC was out of range for the high control. o. 6/27/19 RBC was out of range for the normal control. p. 6/28/19 RBC was out of range for the high control q. 7/8/19 RBC, HGB, Hematocrit (HCT), PLT, WBC, absolute lymphocyte count, and absolute granulocyte count were out of range on the high control. r. 7/9/19 HGB was out of range for the low control, RBC was out of range for the normal control. s. 7/10 /19 PLT and WBC were out of range for the low control. t. 7/12/19 PLT was out of range for the low control. u. 7/15/19 HGB, MCH, and MCHC were out of control for the low control. 4. A review of the laboratory's quality control records for the Beckman Coulter AcT Diff hematology analyzer revealed at least two levels of control out of range for the following testing days: a. 2/27/19 PLT was out of range for both low and high controls. b. 3/11/19 RBC was out of range for both the normal and high controls. c. 4/10/19 RBC and WBC were out of range for both the normal and high controls. d. 5/6/19 RBC was out of range for the normal and high controls, MCH was out of range for low and normal controls e. 5/8/19 MCH and MCHC were out of control for both the low and normal controls. f. 5/9/19 HGB was out of control for both normal and high controls, MCHC was out of control for all three levels of control, and MCH was out of control for both the low and normal controls. g. 5/23/19 HGB was out of range for both low and normal controls. h. 7/9/19 MCH and MCHC were out of range for both the low and normal controls. i. 7/10/19 HGB, MCH, and MCHC were out of range for all three levels of control. j. 7/12/19 HGB, MCH, and MCHC were out of range for all three levels of control. 5. A review of the laboratory's "Lab Testing Log (CBC)" revealed patient testing was reported on the dates listed above. 6. An interview on 2/12/2020 at 11:57 am with TP1 confirmed all levels of control were required to be in range before reporting patient results. -- 2 of 3 -- D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: . Based on record review and interview, the Testing Personnel #1 (TP1)and Testing Personnel #5 (TP5) do not meet the Technical Consultant qualification requirements at 493.1411. Findings include: 1. The laboratory failed to have a qualified Technical Consultant evaluate the competency of testing personnel performing hematology testing. Refer to D6046. 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: . Based on record review and interview with Testing Personnel #1 (TP1), the laboratory failed to have a qualified Technical Consultant evaluate the competency of testing personnel performing hematology testing for 5 (Testing Personnel #1-5) of 5 testing personnel listed on the CMS-209 form. Findings include: 1. A review of the laboratory's personnel competency assessments revealed TP1 and Testing Personnel #5 (TP5) were performing and evaluating the competency assessments for Testing Personnel #1-5 listed on the CMS-209 form for 2018 and 2019. 2. The surveyor requested credentials for TP1 and TP5 to determine if they met the requirements to be Technical Consultants on 2/12/2020 at 10:45 am and they were not made available. 3. An interview on 2/20/2020 at 10:45 am with TP1 confirmed TP1 and TP5 were not qualified to perform duties as Technical Consultants. -- 3 of 3 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --