North Shore Urogynecology, Ltd

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493. 1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: A) Based on review of laboratory policies and procedures, laboratory records, and interview with general supervisor (GS) #1; the laboratory failed to ensure positive and negative quality control (QC) materials for every target tested were performed each day of Urinary Tract Infection - Antibiotic Resistance (UTI-ABR) Polymerase Chain Reaction (PCR) molecular panel testing for six of six patient testing dates reviewed in the specialty of microbiology. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled, "Seqonce Quadruplex UTI-ABR", which stated, under: i. "Quality Control", "A Negative [Non-Template Control] (NTC) and a Positive Control must be included in each assay run to detect potential failure in specimen processing, amplification, or detection steps." ii. "Table 1", the following pathogen targets tested on the UTI (Lioness) PCR Panel: Pathogen Targets: Acinetobacter baumannii Escherichia coli Enterococcus faecalis Klebsiella oxytoca Klebsiella pneumoniae Enterobacter cloacae Citrobacter freundii Proteus mirabilis Morganella morganii Klebsiella aerogenes Enterococcus faecium Ureaplasma urealyticum Streptococcus agalactiae Staphylococcus saprophyticus Serratia marcesens Candida albicans Candida parapsilosis Candida tropicalis Candida glabrata 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 -- Staphylococcus aureus Pseudomonas aeruginosa Mycoplasma hominis Providencia stuartii Proteus vulgaris iii. "Table 2", the following antibiotic resistant targets tested on the ABR (Pongo) PCR Panel: ABR Targets: Erythromycin ribosome methyltransferase A (ErmA) Erythromycin ribosome methyltransferase B (ErmB) Methicillin-resistant Staphylococcus aureus (MRSA) gene (mecA) Tetracycline resistance determinant (Tet (A)) Beta-lactamase, Imipenemase (bla-IMP, IMP-7) Quinolone resistance gene A (qnrA) Quinolone resistance gene B (qnrB) Sulphydryl variable gene (SHV) Quinolone resistance gene S (qnrS) New Delhi Metallo-beta- Lactamase 1 (NDM-1) Oxacillinase-48 (OXA-48, bla-OXA) Klebsiella pneumoniae carbapenemase (KPC, bla-KPC) Verona integron-encoded metallo-beta-lactamase (VIM, bla-VIM) Cephamycin resistance gene (FOX) Ampicillin resistance gene (ampC) Azithromycin resistance gene (ACT) Cefotaximase-Munich group 9 (CTX-M group 9) Cefotaximase-Munich group 1 (CTX-M group 1) Temoniera beta-Lactamase (TEM) Cefotaximase-Munich group 2 (CTM-M group 2) Vancomycin resistance gene A1 and A2 (vanA1_vanA2) Sulphonamine resistance gene 2 (SUL2) Sulphonamine resistance gene 1 (SUL1) Vancomycin resistance gene B (vanB) iv. "Table 3", the following targets included in each of the subsequent positive control materials: UTI- CP (Control Positive)-1: Staphylococcus saprophyticus Streptococcus agalactiae Citrobacter freundii Proteus mirabilis Morganella morganii Proteus vulgaris Acinetobacter baumannii Staphylococcus aureus Enterococcus faecalis Escherichia coli UTI-CP-2: Klebsiella aerogenes Enterococcus faecium Mycoplasma hominis Ureaplasma urealyticum Enterobacter cloacae Klebsiella oxytoca Klebsiella pneumoniae Pseudomonas aeruginosa Providencia stuartii Serratia marcesens UTI-CP- 3: Candida albicans Candida parapsilosis Candida tropicalis Candida glabrata ABR Control 1: ACT mecA qnrA qnrB qnrS vanA1_vanA2 vanB SUL1 SUL2 ABR Control 2: NDM-1 OXA-48, bla-OXA VIM, bla-VIM bla-IMP, IMP-7 CTX-M Group 1 CTX-M Group 2 CTX-M Group 9 TEM ABR Control 3: ampC ErmA ErmB FOX KPC, bla-KPC SHV Tet (A) 3. Review of laboratory records revealed positive QC material was not performed for every target tested each day of UTI-ABR PCR molecular panel testing for six of six patient testing dates reviewed. Date of Testing: Patient: Positive QC Performed: 02/23/2024 NSU12347027 UTI-CP-2 & ABR Control 2 only 05/29/2024 NSU12347301 UTI-CP-1 & ABR Control 1 only 10/09 /2024 NSU12347585 UTI-CP-1 & ABR Control 1 only 01/29/2025 NSU12347752 UTI-CP-3 & ABR Control 3 only 06/12/2025 NSU12347856 UTI-CP-1 & ABR Control 1 only 12/03/2025 NSU12348041 UTI-CP-3 & ABR Control 3 only 4. Interview with GS #1 on 02/24/2026, at 12:50 pm, confirmed the laboratory rotated the positive QC materials performed each day of testing and failed to ensure positive and negative QC materials for every target tested were performed each day of UTI- ABR PCR molecular panel testing for six of six patient testing dates reviewed in the specialty of microbiology. B) Based on review of laboratory policies and procedures, laboratory records, and interview with GS #1; the laboratory failed to ensure positive and negative QC materials for every target tested were performed each day of Women's Health (WH) PCR molecular panel testing for five of five patient testing dates reviewed in the specialty of microbiology. Findings include: 1. Review of laboratory policies and procedures revealed the procedure titled, "Seqonce Quadruplex Women's Health (Amur) Panel", which stated, under: i. "Quality Control", "A Negative [Non-Template Control] (NTC) and a Positive Control must be included in each assay run to detect potential failure in specimen processing, amplification, or detection steps." ii. "Table 1", the following pathogen and antibiotic resistance targets tested on the WH PCR Panel: Pathogen/ABR Targets: Herpes Simplex Virus 1 (HSV1) Herpes Simplex Virus 2 (HSV2) Treponema pallidum Gardnerella vaginalis Neisseria gonorrhoeae Chlamydia trachomatis Trichomonas vaginalis Haemophilus ducreyi Mycoplasma genitalium Ureaplasma urealyticum -- 2 of 3 -- Atopobium vaginae Streptococcus agalactiae Escherichia coli Enterococcus faecalis Prevotella bivia Staphylococcus aureus Bacteroides fragilis Mycoplasma hominis Bacterial Vaginosis-Associated Bacterium 2 (BVAB2) Lactobacillus crispatus Lactobacillus jensenii Lactobacillus iners Lactobacillus gasseri Megasphera 1 Megasphera 2 Mobiluncus curtisii Mobiluncus mulleris Candida krusei Candida tropicalis Candida galabrata Candida parapsilosis Candida albicans Candida Lusitania Candida auris Vancomycin resistance gene A (VanA) Vancomycin resistance gene B (VanB) Methicillin-resistant Staphylococcus aureus (MRSA) gene (mecA) iii. "Table 2", the following targets included in each of the subsequent positive control materials: STI (Sexually Transmitted Infection)-CP-1: HSV1 Treponema pallidum Chlamydia trachomatis Trichomonas vaginalis Mycoplasma genitalium Ureaplasma urealyticum STI-CP-2: HSV2 Neisseria gonorrhoeae Haemophilus ducreyi Gardnerella vaginalis Atopobium vaginae WH-CP-1: Streptococcus agalactiae Escherichia coli Enterococcus faecalis Prevotella bivia Staphylococcus aureus Bacteroides fragilis Mycoplasma hominis BVAB2 Lactobacillus crispatus Lactobacillus jensenii Lactobacillus iners Lactobacillus gasseri Megasphera 1 Megasphera 2 Mobiluncus curtisii Mobiluncus mulleris VanA VanB mecA UTI-CP3: Candida krusei Candida tropicalis Candida galabrata Candida parapsilosis Candida albicans Candida Lusitania Candida auris 3. Review of laboratory records revealed positive QC material was not performed for every target tested each day of WH PCR molecular panel testing for five of five patient testing dates reviewed. Date of Testing: Patient: Positive QC Performed: 02/23/2026 NSU12347028 STI-CP-1 only 05/29/2024 NSU12347302 WH-CP-1 only 10/09/2024 NSU12347581 WH-CP-1 only 01/29/2025 NSU12347753 WH-CP-1 only 06/12/2025 NSU12347857 STI-CP-2 only 4. Interview with GS #1 on 02/24/2026, at 12:50 pm, confirmed the laboratory rotated the positive QC materials performed each day of testing and failed to ensure positive and negative QC materials for every target tested were performed each day of WH PCR molecular panel testing for five of five patient testing dates reviewed in the specialty of microbiology. -- 3 of 3 --

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 --