Northlake Pathology Llc

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Northlake Pathology, LLC, CLIA ID 19D2016578, on October 22, 2025. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of the laboratory's policies, and interview with personnel, the laboratory failed to label stain solutions stored in ten (10) secondary containers with the identity of the contents, lot numbers, and expiration dates. Findings: 1. Observation by surveyor during the laboratory tour on October 22, 2025 at 9:07 am revealed three (3) secondary containers stored near the sink and one (1) secondary container stored in the refrigerator were not legibly labeled . Six (6) secondary containers were unlabeled with the identity of the contents, lot numbers, and expiration dates. 2. Review of the laboratory's "Anatomic Pathology-Accuracy of Analysis" policy revealed " Reagents must contain the following information: name of reagent, date of preparation, date of expiration, safety designations, and initials of technician/technologist preparing the solution." 3. In interview on October 22, 2025 at 9:17 am, Testing Personnel 2 stated the stickers for the identified secondary containers were not changed. Testing Personnel 2 confirmed the identified containers were not labeled with the identity of the contents, lot numbers, and expiration dates. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- D5781

Summary Statement of Deficiencies D0000 A Recertification survey was performed on March 30, 2022 at Northlake Pathology, CLIA ID # 19D2016578. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the laboratory's records and interview with personnel, the laboratory failed to have documentation of the annual performance of preventative maintenance for Histopathology equipment for one (1) of two (2) years reviewed. Findings: 1. Review of the laboratory's 2020 and 2021 records revealed the laboratory did not have documentation of performance of preventative maintenance for the Histopathology equipment for 2020. 2. In interview on March 30, 2022 at 12:07 pm the Testing Personnel confirmed the laboratory did not have documentation of the annual preventative maintenance for the Histopathology equipment for 2020. D5785

Summary Statement of Deficiencies D0000 A Certification survey was performed on November 5, 2019 at Northlake Pathology, LLC, CLIA ID # 19D2016578. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to follow their established competency assessment policy for testing personnel. Findings: 1. Review of the laboratory's "Personnel Competency Evaluation" policy under the "Procedure" section revealed "All new employees will be evaluated twice during the first year of employment and then once a year thereafter." 2. Review of the laboratory's CMS 209 (Laboratory Personnel Report) revealed the Laboratory Supervisor was listed as testing personnel. 3. In interview on November 5, 2019 at 9: 40 am, the Laboratory Supervisor stated she performs grossing of samples. The Laboratory Supervisor further stated she was hired in January 2018. 4. Review of personnel records for the Laboratory Supervisor revealed a semi-annual competency assessment, due July 2018, was not performed. 5. In interview on November 5, 2019 at 10:00 am, the Laboratory Supervisor confirmed a semi-annual competency assessment was not performed for her grossing duties. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for 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 -- 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 record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures were maintained for assessing personnel competency. Refer to D5209. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Certification Survey was conducted on January 16, 2018 at Northlake Pathology, LLC-CLIA ID # 19D2016578. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard deficiencies were cited. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 interview with personnel, the laboratory failed to ensure dyes have not exceeded their expiration date. Findings: 1. Observation by surveyor during the laboratory tour on January 16, 2018 revealed the following expired items: a) Cancer Diagnostics Sample Tissue Marking Red Dye, 0.5 ounces, Quantity: 1 bottle, Lot # 5272, Expiration date: March 2017 b) Cancer Diagnostics Sample Tissue Marking Blue Dye, 0.5 ounces, Quantity: 1 bottle, Lot # 6028, Expiration date: July 2017 c) Cancer Diagnostics Sample Tissue Marking Green Dye, 0.5 ounces, Quantity: 1 bottle, Lot # 5272, Expiration date: March 2017 c) Cancer Diagnostics Sample Tissue Marking Black Dye, 0.5 ounces, Quantity: 1 bottle, Lot # 6039, Expiration date: July 2017 d) Tissue Marking Yellow Dye, Quantity: 1 bottle, Batch code # 4363, Expiration date: June 2016 e) Tissue Marking Blue Dye, Quantity: 1 bottle, Lot # 5217, Expiration date: February 2017 2. In interview on January 16, 2018 at 9:21 am, Personnel 2 stated the laboratory does not use the identified dyes. Personnel 2 confirmed the identified dyes were expired. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) 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 director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation and interview with personnel, the Laboratory Director failed to ensure laboratory personnel performed test methods as required. Refer to D5417. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to provide a written job description for all Laboratory Personnel. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not have a written job description for the Laboratory Director that included responsibilities specific to the laboratory. 2. Review of the laboratory's CMS 209 (Personnel) form revealed the Laboratory Director also serves as the Clinical Consultant, Technical Supervisor, General Supervisor and Testing Personnel. 3. In interview on January 16,2018 at 11:00 am, Personnel 2 confirmed the laboratory did not have a written job description for the Laboratory Director. -- 2 of 2 --