Ross D Nochimson Md Pa

Summary Statement of Deficiencies D0000 A recertification survey conducted on 05/28/2024 found the ROSS D NOCHINSOM MD PA clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 record review and interview, the laboratory failed to follow manufacturer's instructions for storage temperature of the NOVA-ONE Diagnostics (NOD) FREND Immunoassay Control Kits (controls Level 1 and Level 2) for 22 out of 22 months reviewed. Findings included: Review of the manufacturer instructions revealed the following statement in the section "STORAGE AND STABILITY" "Unopened NODFREND Immunoassay Controls Kits are stable until the expiration date when stored frozen at -20C." Level 1 Lot 631A23002 and Level 2 6362A23002. -Review of the Freezer temperature log revealed an acceptable temperature range of -10 to -30 C. This range does not meet the storage requirement for controls which were below -20 C. -Review of documented temperature logs from 08/01/2022 to 05/28/2024 (22 months) revealed that the temperature had not reached the requirement of -20C or colder for all the 81 days that the temperature was recorded. During an interview on 05 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 -- /28/2024 at 12:30 PM, the Testing Person confirmed that temperature records of the freezer used for the storage of the controls were outside of the acceptable temperature ranges in the period reviewed. 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, the laboratory failed to perform at least two levels of quality control (QC) each day of patient testing for the last 22 months for Vitamin D, Thyroid Stimulating Hormone (TSH) and Free Thyroxine (FT4). Findings included: -Review of QC records from August 2022 to May 2024 for Vitamin D, TSH and FT4 using the FREND Immunoassay, revealed that the laboratory tested two levels of external QC every thirty days. Review of patient charts and QC records revealed the following: a)Patient #1 (10/02/2022), tested for TSH, FT4 and Vitamin D. No controls tested that day. b)Patient #2 (07/30/2023) tested for TSH, FT4 and Vitamin D. No controls tested that day. c)Patient #3 (12/31/2023) tested for TSH, FT4 and Vitamin D. No controls tested that day. d)Patient #4 (01/21/2024) tested for TSH, FT4 and Vitamin D. No controls tested that day. -Based on review of FORM CMS- 116, the annual testing volume for Vitamin D was 420 tests and the annual volume for TSH and FT4 was 720 tests. During an interview on 05/28/2024 at 11:30 AM, the Testin Personnel stated that they followed manufacturer instructions of doing QC every thirty days and confirmed that the laboratory did not have an Individualized Quality Control Plan. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 07/14/2020 found that Ross D Nochimson MD PA clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2100 ENDOCRINOLOGY CFR(s): 493.843(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 of Proficiency Testingand staff interviews, the laboratory failed to participate in 1 (1st event 2020) out of 6 events reviewed (3rd event 2028, 3 events 2019 and 2 events 2020) for Endocrinology specialty resulting in a 0% score and for the tests of Free Thyroxine ( FTY) and Thyroid Stimulating hormone (TSH). Findings include: Records reviewed of American Proficiency Institute (API) PT, revealed that the laboratory failed to perform the 1st Event of 2020 for Endocrinology Specialty for the tests FTY and TSH resulting in a score of 0 %. During an interview on 7/14/2020 at 1:30 PM, the Laboratory Director confirmed that the laboratory failed to participate in the PT event of above-reference. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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 -- 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 records review and interviews with the laboratory director (LD), the laboratory failed to fully document the competency assessment for 1 out of 1 testing personnel (TP) for 2 out of 2 years reviewed (2019 and 2020) Findings include: Review of CMS form 209, Laboratory Personnel Report dated and signed by the Laboratory Director (LD) on 07/14/2020 revealed that there was 1 TP. -Review of Test Menu revealed that the laboratory perform test for TSH, FTY, Testosterone, vitamin D and PSA using the Nano Frend System and allergens tests using the Hitachi CLA-1. -Review of TP competency assessment for the years 2019 and 2020, revealed that the evaluation failed to assess the competency on the tests of reference. During an interview on 07/14/2020 with Laboratory Director at 1:00 pm confirmed that the competency for the TP failed to evaluate the competency for each test that the TP performed. 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 records review and staff interviews, the laboratory failed to follow manufacturer instructions (MI) to perform Verification of Linearity and Precision for the Frend System from NanoEntek for the new analyzer received on 2/10/2020. The laboratory perform the FTY, TSH, Vitamin D, PSA and Testosterone tests with this analyzer. Findings include: -Review of the MI instructions for the Frend System analyzer revealed that when a new analyzer is put into use, it is required to perform a linearity verification. - Review of Controls print out revealed that the laboratory used analyzer with serial number (S/N)F10U140804-017 at least from 2018 to 2/09/2020. The laboratory started using a new analyzer with S/N F10U190703-110 from 2/10 /2020 to 7/13/2020. -No documentation of Verification of Linearity and Precision for the new analyzer was found. -The following tests were performed: FTY, TSH, Vitamin D, PSA and testosterone. The lab tested 198 patients with the new analyzer from 2/10/2020 to 7/13/2020. During an interview on 7/14/2020 at 1:30 PM, with the laboratory director confirmed that the laboratory failed to perform the verification of linearity and precision for the new analyzer that the laboratory started to use since 2/10 /2020. -- 2 of 2 --

Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to establish and maintain the accuracy of its testing procedures for Prostate-Specific Antigen (PSA), Testosterone, and Allergy testing. Findings include: Review of the laboratory's proficiency testing with American Proficiency Institute showed that the laboratory failed to perform proficiency testing (PT) on PSA and testosterone from 8/1/17 to 6/13 /18, and allergy testing from 10/28/16 to 6/13/18. The laboratory performs allergy testing using the Moderate Food Panel and Southeastern Inhalant Panel. Allergy testing for the Moderate Food Panel includes tomato, wheat, vegetable mix, tuna, soybean, shellfish mix, rice, potato, pork, peanut, orange, onion mix, oat, milk, garlic, whole egg, corn, chocolate, chicken, beef, white bean, barley, bakers yeast, apple and almond. Allergy testing for the Southeastern Inhalant Panel includes acacia, white ash, beech, birch alder mix, box elder mix, mountain cedar, east cottonwood, white elm, melaleuca, mulberry mix, white oak, pine mix, privet, American sycamore, walnut /hickory/pecan, Bahia grass, Bermuda grass, cocklebur, English plantain, lamb's quarters, marshelder rough, pigweed, short ragweed, sheep sorrel, Timothy grass, waterhemp, cat, dog, cockroach mix, house dust, farinae mite, alternaria, aspergillus, candida, cladosporium, and penicillium. During an interview on 6/13/18 at 10:15 AM, Testing Personnel A stated they had just added PT for PSA and testosterone on 6/8 /18. During an interview on 6/13/18 at 10:25 AM, Testing Personnel A stated he did not know they needed to perform PT for their allergy testing. 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 --