Goodman Neil F Md Pa

Summary Statement of Deficiencies D0000 A recertification survey conducted on 03/16-24/2022 found the clinical laboratory GOODMAN NEIL F MD PA not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to label controls currently in use with the new expiration date. Findings include: - During the laboratory tour on 03/16/2022 at 10:00 AM, the surveyor observed that the laboratory had in use Alere (Trademark) Human Chorionic Gonadotropin Hormone (hCG) Positive (lot CCO1327) and Negative (lot N00198) controls with no open date and no new expiration date registered. Photographic evidence collected. - Review of the package insert for the controls in the section for Storage & Stability revealed that: When stored refrigerated (2-8 C), the unopened controls are stable until the expiration date. Once opened, the controls are stable at refrigerated storage temperatures for 90 days from the date of opening or until the expiration date, whichever comes first. - Review of patients log revealed that the controls first use was 01/05/2022. During an interview on 03/16/2022 at 11:30 AM, the Testing Personnel A, confirmed that controls in use were not label as described above. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to ensure the immersion oil was not expired prior to patient testing from 01/11/2020 to 03/16/2022. Findings include: -During the laboratory tour on 03/16/2022 at 10:05 AM, the surveyor observed that the laboratory had in use immersion oil (lot 7347) used for semen microscopic analysis with an expiration date of 01/10/2020. Photographic evidence collected. -According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification signed and dated by the Laboratory Director on 03/15/2022, the laboratory had an estimate annual test volume of 387 semen analysis tests per year. During an interview on 03/16/2022 at 11:30 AM, Testing Personnel A, confirmed that the immersion oil in use was expired. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on November 19, 2019. Goodman Neil MD PA clinical laboratory was found not in compliance with 42 CFR 493, requirements for clinical laboratories. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to run proficiency testing (PT) samples the same number of times, as it routinely tests patient samples for 2018 (2nd event) and 2019 (1st and 2nd event) for the specialty of Hematology. Findings: Review of the laboratory's proficiency testing records with American Association of Bioanalysts (AAB) for 2018 2nd event and 2019 1st and 2nd events showed that the laboratory performed the manual semen counts on the PT samples more than once. Handwritten results of the semen counts showed more that one testing personnel record results for each sample. Review of the laboratory's Proficiency Testing procedure states "The person performing the testing must attest the samples have been tested as the patient's samples." During an interview on 11/19/19 at 10:30 AM, Testing Personnel B stated that all testing personnel performed the semen counts for the proficiency testing and that each patient sample was not tested by all testing personnel. 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 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to enroll in proficiency testing for serum human chorionic gonadotropin (hCG) for the 1st and 2nd event of 2018. Findings: Review of the laboratory's proficiency testing with American Association of Bioanalysts (AAB) showed that the laboratory failed to re-enroll in proficiency testing for serum hCG for the 1st and 2nd events in 2018. During an interview on 5/10/18 at 12:03 PM, Testing Personnel C acknowledged that the laboratory failed to re-enroll in proficiency testing for serum hCG. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency 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 5 -- samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain the proficiency testing documents used to record the test results for serum human chorionic gonadotropin (hCG). Findings: Review of the laboratory's proficiency testing with American Association of Bioanalysts (AAB) showed that the laboratory failed to retain the test result records for hCG for the 2nd and 3rd events in 2016, and 1st, 2nd and 3rd events in 2017. During an interview on 5/10/18 at 10:36 AM, Testing Personnel C acknowledged that the laboratory recorded the hCG results but did not keep the paper the results were recorded on. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: The laboratory's quality assessment program failed to correct identified problems in proficiency testing in 2016 and 2017, and failed to retain quality assessment review forms. Findings: Cross Reference D5211 and D5293. Based on record review and interview, the laboratory failed to document that the results of proficiency testing scores were reviewed (D5211), and the laboratory failed to retain documentation of quality assessment activity (D5293). D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document that the results of proficiency testing scores were reviewed. Findings: Review of the laboratory's proficiency testing with American Association of Bioanalysts (AAB) showed that the laboratory director failed to sign proficiency testing performance evaluation forms for proficiency testing for Embryology, Andrology, and Fetal (semen count and semen morphology) for the 2nd event in 2016 and 1st and 2nd events in 2017 and for Chemistry (serum human chorionic gonadotropin - hCG) for 2nd and 3rd events in 2016, and 1st, 2nd and 3rd events in 2017. During an interview on 5/10/18 at 10:10 AM, Testing Personnel C acknowledged that the laboratory director had not signed the performance evaluation forms. -- 2 of 5 -- D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of