North East Medical Services Inc

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the AAB-MEDICAL LABORATORY EVALUATION proficiency testing records, and interview with the Technical Supervisor (TS) on January 6, 2026, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for routine chemistry for each analyte in 2024 and 2025. The findings included: 1. The laboratory enrolled in the AAB-MEDICAL LABORATORY EVALUATION proficiency testing program for routine chemistry testing using Abbott Alinity analyzer. According to the AAB evaluation, the laboratory attained the following unsatisfactory scores: Q1- 2024: CREATININE = 40% Q1- 2025: CREATININE = 60% Q3- 2024: ALBUMIN = 40% 2. On January 6, 2026, at approximately 10:00 am, the TS confirmed that the laboratory received the above unsatisfactory proficiency scores. 3. The laboratory's testing declaration form, signed by the laboratory director on December 10, 2025, stated that the laboratory performed approximately 86,804 routine chemistry tests including albumin and creatinine annually. 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 D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's records for evaluation laboratory proficiency reporting from AAB (American Association of Bioanalysts), and an interview with the LP (laboratory personnel) on 4/6/2022 between 3:30 p.m. and 5:00 p.m., it was determined that there were three unacceptable (below 80 %) proficiency testing (PT) results for Hematology in 2020 and 2021 related to Semen Analysis. Findings include: 1. On 4/6/2022, an inspection was conducted between 3:30 p.m. and 4:30 p.m. 2. During a review of the laboratory documentation from AAB , it was noted at approximately 4:00 p.m. that there were three unacceptable PT results for Hematology. The LP recognized these atypical results. 3. The findings and acceptable ranges were as follows: Cycle S1 Hematology 2020 Analyte: Sperm Viability % Digital Sample Actual Result Expected Result (range) HEM 1 55 39-59 HEM 2 34 1- 21 Cycle S2 Hematology 2020 Analyte: Sperm Count, Video Sample Actual Result Expected Result (range) HEM 1 66 83-155 HEM 2 31 39-72 Cycle S1 Hematology 2021 Analyte: Sperm Viability Digital Sample Actual Result Expected Result (range) HEM 1 53 0-16 HEM 2 58 0-20 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 --