Shore Institute For Reproductive Medicine, Pc

Summary Statement of Deficiencies D2123 HEMATOLOGY CFR(s): 493.851(c) (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 surveyor review of the Proficiency Testing (PT) records and interview with the Office Manager (OM), the laboratory failed to participate in the Medical Laboratory Evaluation (MLE) PT for the 1st event of 2024 for Andrology tests. The findings include: 1. The laboratory failed to participate in MLE Embryology, Andrology & Fetal S1 2024. 2. The OM confirmed on 3/19/25 at 11:00 am that the laboratory did not participate in the above mention PT event.. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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. 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 surveyor review of the Procedure Manual (PM), Final Reports (FR) and interview with the Office Manager (OM), the laboratory failed to follow the PM for "Semen Analysis" "Instructions" from 4/15/24 to 3/19/25. The findings include: 1. The PM stated "2. Analysis should start within 60 minutes of ejaculation" 2. Five out of five FR's had sample analysis times over one hour after the specimen was colleted. a) Sample 34389 had a collection date and time of 3/5/25 8:00am. Analysis time of 9: 15am. b) Sample 33464 had a collection date and time of 5/24/24 7:55am. Analysis time of 9:49am. c) Sample 32642 had a collection date and time of 5//6/24 9:34am. Analysis time of 11:10am. d) Sample 33256 had a collection date and time of 4/15/24 6:15am. Analysis time of 7:45am. e) Sample 33249 had a collection date and time of 4 /17/24 8:00am. Analysis time of 10:00am 3. The OM confirmed on 3/19/25 at 11:30 am that the laboratory did not follow the PM. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of the Test Reports (TR) for Semen Analysis and interview with the Office Manager (OM) the laboratory failed to ensure the TR included all the required information from 11/15/23 to 3/19/25. The findings include: 1. TR did not include the name address of the laboratory where Routine Semen analysis was performed. 2. Routine Semen analysis and Krueger Strict Morphology testing are performed at two different laboratories. 3. The FR did not delineate where Routine Semen analysis and Krueger Strict Morphology testing are performed 4. The OM confirmed on 3/19/25 at 12:00 pm, the laboratory failed to ensure the TR included all the required information. -- 2 of 2 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to verify the accuracy of Endocrinology test results obtained from the College of American Pathologists (CAP) in the Calendar years 2022 and 2023. The findings include: 1. The PT program assigned an artificial score of 100%, results were reported with the comments "See Note 20", "Response was not formally graded due to insufficient peer group data. Please see the participant summary for additional information" 2. There was no documented evidence the laboratory verified human chorionic gonadotropin (hCG), Estradiol (E2), Follicle-stimulating hormone(FSH), Luteinizing Hormone (LH), and Progesterone (PRG) in the calendar years 2022, and 2023. 3. The TP confirmed on 11 /15/23 at 1:20 pm that the accuracy of the PT results were not verified and the PT program assigned an artificial score of 100%, 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. 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Manufacturers Package Insert (MPI), the Quality Control Records (QC) and interview with theTesting Personnel (TP), the laboratory failed to follow the MPI for ACCU-Beads "Manual Counting Procedures" for Semen Analysis from 4/26/21 to the date of the survey. The finding includes: 1. The MPI states: "5. Count another aliquot of the same sample. The results should be within 10% of each other to be considered valid" The TP stated the laboratory does not count another aliquot of the same sample. 2. The TP confirmed on 11/15/23 at 2:30 pm that the laboratory did not follow the MPI. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the lack of Quality Control Verification (QCV) records and interview with the Testing Personnel (TP), the laboratory failed to verify Accu-beads Lot # 232908351 before use for Semen Analyses (SA) tests on the date of survey. The TP confirmed 11/15//23 at 1:15 pm that QC material was not verified before putting in use. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on the lack of a Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to establish a procedure for verifying manually entered results from 4/26/21 to the date of survey. The TP confirmed on 11/15/23 at 1: 00 pm that the laboratory did not have the procedure mentioned above. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) -- 2 of 3 -- 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. This STANDARD is not met as evidenced by: Based on the lack of a Procedure Manual (PM) and interview with the testing Personnel (TP), the Laboratory Director (LD) failed to establish a Competency Assessment (CA) procedure with all the required elements for Testing Personnel at the time of survey. The TP confirmed on 11/15/23 at 3:00 pm that a CA procedure was not established. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on lack of a Procedure Manual (PM) and interview with the Testing Personnel (TP), Laboratory Director (LD) failed to have an approved PM for Endocrinology and Semen Analysis testing from 4/26/21 to the date of the survey. The TP confirmed on 11/15/23 at 1:10 pm that the LD did not ensure an approved PM was available. -- 3 of 3 --

Summary Statement of Deficiencies 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 surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), it was revealed that the laboratory failed to review code 20 "No appropriate target/response could not be graded" results obtained for Endocrinology PT performed with the College of American Pathologists (CAP) in 2020. The finding includes: 1. Code 20 results were received for: Y-B 2020 Ligand- Special event 2: Follicle-Stimulating Hormone sample Y-04,through 06, Luteinizing Hormone Y-04,through 06, and Progesterone Y-04,through 06. 2. The TP #1 listed on CMS from 209 confirmed on 4/26/21 at 10:30 am that the laboratory failed to evaluate code 20 PT results. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: 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 -- Based on surveyor review of the Maintenance Records (MR) and interview with the Testing Personnel (TP), the laboratory failed to ensure that microscope maintenance was performed for the calendar years 2019, and 2020. The finding includes: 1. The microscope MR stated maintenance was required June 2019. 2. There was no evidence that maintenance was performed from June 2019 to the date of survey. 3. The TP #1 listed on CMS form 209 confirmed on 4/29/21 at 11:30 am that the laboratory did not ensure maintenance was performed. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review Quality Control (QC) records and interview with the Testing Personnel, the laboratory failed to perform and document QC on each day of patient testing for Semen analysis From November 2020 date of the survey. The findings include; 1. QC was not performed on 11/10/20, 12/16/20, 1/11/21, 1/13/21, 1 /28/21, and 2/8/21. 2. Six patients were run and reported. 3. The TP #1 listed on CMS from 209 confirmed on 4/29/2021 at 9:45 am that the laboratory did not perform QC on each day of patient testing. -- 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 and interview with the Testing Personnel (TP), the laboratory did not complete the "Out of Control form" (OCF) from 6/28/16 to the date of survey. The findings include: 1.The OCF had a five-step procedure for any control outside 2 Standard Deviations (SD). 2. The laboraotry had two controls over 2 SD in March of 2018. 3. The laboratory did not complete the OCF for any controls over 2 SD from 6/28/16 to the date of survey. 4. The TP # 1 listed on CMS form 209 confirmed on 6/14/18 at 11:00 am that the laboratory did not complete the OCF. 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 surveyor observation of the Quality Control (QC) material and interview 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 -- with the Testing Personnel (TP), the laboratory failed to put open and new expiration dates on Endocrinology controls from 6/28/16 to the date of survey. The findings include. 1. The MPI stated that QC material for Estradiol expired 5 days after opening if stored at 2 to 8 Celsius. a) The TP was not aware that QC material expired 5 days after opening. b) The laboratory did not put open and new expiration dates on Lyphocheck Immunoassay Plus Controls Lot# 40930. 2. The TP #1 listed on CMS form 209 confirmed on 6/14/18 at 11:30 am the laboratory failed to put new and open expiration dates on the control material. -- 2 of 2 --