Iyengar Hematology Oncology Medical Ctr Pa

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of Patient Work Records (WR), review of the Manufacture Operator Manual (OM) and interview with the Testing Personnel (TP), the laboratory failed to follow the OM for Hematology testing performed on the Medonics analyzer from May 2022 to the date of survey. The findings include: 1. Ten out of Ten WR revived had an SCH flag on the Platelet count (PLT). 2. The OM Section "6.3 Morphology Flags, 6.3.1 Flags on PLT Distribution Curve"states "3- If the number of particles between 18fl and 25fl are too high, the "SCH" flag will be triggered. Suspect abnormalities include: Presence of Schizocytes, Presence of Platelet aggregates: Verify the Platelet results on a stained blood smear". 3. There was no evidence that the laboratory "Verified the Platelet results on a stained blood smear". 4. The TP confirmed on 1/30/24 at 1:40 pm the laboratory failed to follow the OM. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value 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 -- of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the lack of Quality Control Verification (QCV) records and interview with the Testing Personnel (TP), the laboratory failed to verify Minotrol-16 lot # MX445 before use for Complete Blood Count (CBC) tests from 2/8/22 to the date of survey. The TP confirmed 1/30/24 at 2:15 pm that QC material was not verified before putting in use. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyors observation of Qualitry Control (QC) material in use and interview with the Testin Personnel (TP), the laboratory failed to follow Manufacturers Specifications (MS) for controls from 2/8/22 the time of the survey. The finding includes: 1. Controls in use did not have an open or expiration dates documented as per MS. 2. The TP confirmed on 1/30/24 at 1:20 pm that MS were not followed. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with Testing Personnel (TP) the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems from 2/8/22 the date of survey. The finding includes: 1. The laboratory failed to have a Quality Control Verification (QVC) procedure that stated how to verify new lots of controls before they were put in use. 2. The TP confirmed on 1/30/24 at 1:40 pm that the laboratory failed to have the aforementioned procedure. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) -- 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on surveyor review of the Performance Specification (PS) records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure that PS procedures performed for Complete Blood Count (CBC) tests performed on the Modonic analyzer were adequate from May 2022 to the date of survey. The findings include: 1. There was no raw adequate for the method comparison. 2. There was no source for the patient Reference Range. 3. The analyzer that the laboratory used in the method comparison was not defined. 4. The TP confirmed on 1/30/24 at 1:15 pm that PS records were not adequate. -- 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: Based on an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve a score of 80% or more for Hematology tests performed with the American Association of Bioanalysts (AAB). The finding includes: 1) The laboratory scored 60% for Hematocrit (HCT) for the 2nd event - 2023 with AAB. 2) The laboratory scored 0% for (HCT) for the 1st event- 2023 with AAB. D2123 HEMATOLOGY CFR(s): 493.851(c) 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 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 an in office review of the CASPER reports 153, 155 and the performance summary form American Association of Bioanalysts (AAB) hematology event 1, 2023. The laboratory failed to participate in event 1, 2023 for hematology tests with AAB. 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 an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve a score of 80% for Hematology tests performed with the American Association of Bioanalysts (AAB). The finding includes: 1) The laboratory scored 60% for Hematocrit (HCT) for the 2nd event - 2023 with AAB. 2) The laboratory scored 0% for (HCT) for the 1st event- 2023 with AAB. 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 an office review of the laboratory's performance in Proficiency Testing (PT) surveys, the laboratory director failed to provide appropriate direction to the laboratory personnel to ensure that the PT surveys are performed satisfactorily and compliance with the CLIA regulations are maintained. -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Techincal Consultant (TC), the laboratory failed to follow their procedure for "Policy for Repeat CBC" from 10/20/250 to 12/14/20. The finding include: 1. The "Policy for Repeat CBC" states "Repeat CBC is an asterisk appears". 2. One out of three patient results had an analyte flagged with and asterisk. 3. There was no documented evidence that the patient sample was rerun. 2. The TC confirmed on 2/8/22 at 11:21 am the "Policy for Repeat CBC" was not being followed. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of the Manufacturers Instructions (MI), Quality Control (QC) records and interview with the Techincal Consultant (TC), the laboratory failed to follow the MI for "What Flags Mean" from 8/10/21 to 10/06/21. The finding 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 -- includes: 1. COULTER 4C Plus Cell Control Low Lot # 068300 Flagged "*" for White Blood Cell Count (WBC) and Differential 10 out of 35 days from 8/10/21 to 10 /06/21. 2. The MI stated "If * on WBC and Differential # only, 35 fL count interference check failed. Possible interference with WBC count.", "1. Thoroughly mix and rerun the sample. 2. If the voteout repeats, zap apertures" 3. There was no documented evidence that the aforementioned procedure was performed. 4. The TC confirmed on 2/8/22 at 10:00 am the laboratory did not follow the MI. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of Calibration (CAL) records, Procedure Manual (PM) and interview with the Technical Consultant (TC), the laboratory failed to perform and document Calibration procedures at least once every six months for Hematology Tests performed on the Beckman Coulter Act 2 analyzer from January 2020 to the date of survey. The findings include: 1. A review of Cal records revealed that the laboratory performed Cal once in the calendar years 2021 and 2020. 2. The TC confirmed on 2/8 /22 at 10:32 am that the laboratory failed to perform and document Cal once every six months. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with the Technical Consultant (TC), the laboratory failed to verify that the assayed QC -- 2 of 4 -- materials were within the acceptable ranges before they were put into use for tests performed on the Beckman Coulter AcT from 5/29/19 to the date of survey. The TC confirmed on 2/8/22 at 11:10 am that the laboratory did not verify QC material. D5783