North Shore Urogynecology, Ltd

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory policies, bi-annual method accuracy (proficiency testing) records, lack of documentation and interview with the laboratory representative; the laboratory failed to perform method accuracy evaluations for histopathology testing from May of 2022 through the date of survey, 05/08/2024, as required per 493.1236. Findings include: 1. Review of the laboratory test volume records revealed 34 histopathology tests had been performed from May of 2023 to April of 2024. 2. Review of laboratory policies, under "Pathology Quality Assessment Monitoring", under "Procedure", revealed, "Bi-annually 3-5 cases (histopathology slides) are randomly chosen to be sent for quality assessment." 3. Review of laboratory records revealed a lack of bi-annual method accuracy records for histopathology testing in the years of 2022 through date of survey, 05/08/2024. 4. An interview with the laboratory representative at 1:53 pm on 05/08/2024 confirmed the above findings. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory competency records, CMS-209 (Laboratory Personnel Report), and interview with a laboratory representative; the laboratory director (LD) failed to ensure four of four histopathology testing personnel (TP) were competent to conduct histopathology testing in the years of 2022 through the date of survey, 05/08 /2024. Findings include: 1. Review of the CMS-209 (Laboratory Personnel Report), signed by the LD on 05/03/2024, revealed four TP (TP #1, TP #2, TP #3, and TP #4) qualified to perform histopathology testing on the date of the survey, 05/08/2024. 2. Review of the "Pathology Interpretation Training and Competency" worksheet revealed, "This competency checklist fulfills the requirements for the following delegated responsibilities as performed by the clinical consultant, technical supervisor, general supervisor, and testing personnel for histopathology slide interpretation." 3. Review of "Pathology Interpretation Training and Competency" forms found no competency assessments were documented for four of four histopathology TP (TP #1, TP #2, TP #3, and TP #4) from May of 2022 through the date of survey, 05/08/2024. 4. An interview with the laboratory representative at 1:53 pm on 05/08/2024 confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's Clinical Laboratory Improvement Amendments application (CMS 116), manuals, records, and an interview with the office staff; the laboratory failed to ensure the specimen requisitions solicit the required information as define in 493.1241(c)(1)-(c)(8), affecting 300 tests performed. Findings: 1. Review of specimen submission documents revealed that the laboratory's requisitions does not include the following information: (8). Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. The name and address of the laboratory that patients' tissue surgery specimens are referred to for Histology slide processing is not provided on 6 out of 6 specimen requisitions printed for review. 2. The laboratory's manual does not include a test requisition form for specimen submissions. 3. The CMS 116 signed by the laboratory director attests that 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 -- the laboratory has performed 300 tests. 4. On a Recertification survey conducted on 03 /08/2018 at 12:30 PM, the laboratory director confirmed the above findings. -- 2 of 2 --