Oncology & Hematology Specialists Pa

Summary Statement of Deficiencies 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 the Calibration records, Procedure Manual (PM), Beckman Coulter Act Diff 2 User Manual (UM) and interview with the Laboratory Manager (LM), the laboratory failed to perform and document Calibration procedures at least once every six months for Hematology Tests performed on the Beckman Coulter Act Diff 2 analyzer from 9/21/24 to 10/17/24. The findings include: 1. A review of calibration records revealed that the laboratory last performed calibration of the analyzer on 3/21/24. Calibration on the instrument was due in September 2024. 2. The PM and UM states "Calibrate the Act diff 2 Series Analyzer at least every 6 months." 3. The LM confirmed on 10/17/24 at 12:15 pm, the laboratory failed to perform and document calibration of the analyzer at least every six months. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory 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 -- performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on the surveyor review of the Final Reports (FR), Procedure Manual (PM),Test Records (TR) from the analyzer and interview with the Laboratory Manager (LM), the laboratory failed to have accurate Reference Intervals (RI) for Hematology tests from 7/7/23 to 10/17/24. The findings include: 1. The PM had two separate RI for both male and females that were verified. 2. Review of Patient FR and TR from the Beckman Coulter Act Diff 2 analyzer revealed that only the male RI were being used for both male and female patients test results. 3. The LM confirmed on 10/17/24 at 11: 00 am, the laboratory did not implement separate RI for both male and female patients. -- 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 Testing Personnel (TP), the laboratory failed to follow all procedures for Calibration Verification from 8/25/22 to the date of the survey. The findings include: 1. The procedure "Calibration Verification" stated "calibration verification/ linearity of analytical reportable range will be monitored by participating in CAP linearity proficiency test." 2. There was no documented evidence the above mentioned procedure was followed. 3. The TP #2 listed on the CMS-209 form confirmed on 7/27 /23 at 11:00 am that the PM was not followed. D5781

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, Manufacture Operator Manual (OM) and interview with the Clinical Consultant (CC), the laboratory failed to follow the OM for Hematology testing performed on the Beckman Coulter Act 2 from 5/16 /19 to the date of survey. The findings include: 1. The OM stated patient results with X flags (Aperture Alert. A problem was detected during counting that could compromise the integrity of the results.) The sample must be mixed thoroughly and rerun. 2. Four out of 50 patient work records reviewed had X flags but the laboratory did not rerun any samples. 3. The CC confirmed on 2/20/20 at 10:40 am the laboratory failed to follow the OM. D5781

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of the Competency Assessment (CA) records and interview with the Nurse Manager (NM), the laboratory failed to perform CA correctly on nine out of nine Testing Personnel (TP) from 2/29/16 to the date of survey. The findings include: 1. The laboratory did not document when testing personnel were observed, what records were reviewed and how assessment was done. 2. Assessment of problem solving skills was not documented on CA for nine out of nine TP. 3. The NM confirmed on 3/5/18 at 10:20 am that the CA procedure was not performed correctly. 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 Nurse Manager (NM), the laboratory failed to follow its calibration procedure for the Beckman Act 2 Diff in the calendar year 2017. The finding includes: 1. The PM stated calibration must be done every six months but the laboratory had no documentation of 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 -- calibration after March 3, 2017 in the calendar year 2017. 2. The NM confirmed on 3/5 /18 at 11:00 am that the PM was not followed. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report, Performance Specification records and interview with the Nurse Manager (NM), the laboratory failed to report patient test results accurately when test results were above the assay detectable limit for platelet tests performed on the Beckman Act 2 Diff from 2/29/16 to the date of survey. The findings include: 1. The laboratory reported a platelet value of 1291 on 2/15/18 and the FR also had 1221 (previous result) which were above the laboratory's linearity limit of 999. 2. The laboratory routinely reported values above or below the linearity limit when applicable. 2. The NM confirmed on 3/5/18 at 11:50 am that the laboratory reported values above the linearity limit. -- 2 of 2 --