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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 review of 35 laboratory policies and procedures, laboratory records and interviews the laboratory failed to follow two written policies and procedures. Findings include: 1. The laboratory failed to follow the procedure CYTOPATHOLOGY GYN CORRELATIONS, which stated: "Pap tests with concurrent HPV tests will be correlated monthly and discordant cases will be reviewed." a. The Survey Team reviewed laboratory records titled PAP/HPV CORRELATIONS 2023. The records failed to document the date the cases were correlated and discordant cases were reviewed. b. The Survey Team reviewed laboratory records titled HPV CORRELATIONS 2024. The records documented the correlations were correlated and discordant cases reviewed in December 2024. (The day of the month was illegible.) c. The Laboratory failed to correlate Pap tests with concurrent HPV tests and review discordant cases monthly. Refer to D5787 2. The laboratory failed to follow the procedure DPS VALIDATION AND MAINTENANCE, which stated: "At least 60 cases are required for one application or use (FFPE H&E, frozen sections, Hematology, Cytology) that represent the spectrum of specimen types that the evaluating pathologist will be signing out." a. During an interview on December 16, 2024 at 8:30 AM, the Cytology Manager stated all cytology slides were digitally imaged on the Aperio GT450 #2 (SN# 12401) Slide Scanner. b. The Survey Team reviewed validation records titled VALIDATION: LEICA APERIO GT450 #2 (SN# 12401) SLIDE SCANNER. The records documented that nine cytology cases were reviewed as part of the validation study. c. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- During an interview on December 18, 2024 at 9:35 AM, the Quality Assurance Specialist confirmed the laboratory failed to include 60 cytology cases to validate the Leica Aperio GT450 #2 (SN# 12401) Slide Scanner. 3. During an interview on December 18, 2024 at 11:30 AM, these findings were confirmed with the Cytology Manager and Quality Assurance Specialist. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies 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: Through observation and interview with laboratory staff it was determined that the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 9/27/24 at 3:18 pm, one (of seven) opened container of Methanol (StatLab, lot 163901, 40380-1, expiration date 9/21/24) was observed in the laboratory, available for use beyond the expiraton date. B) During a tour of the laboratory on 9/27/24 at 3:20 pm, one (of one) unopened container of 37% Formaldehyde (StatLab, lot 121812, 28530-1, expiration date 5/31/23) was observed in the laboratory, available for use beyond the expiraton date. C) In an interview on 9 /27/24 at 3:21 pm the general supervisor, confirmed that the items, identified above, had exceeded the expiration date and were available for use. 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 D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on the lack of cytology proficiency testing (PT) enrollment records and interview it was determined that the laboratory failed to enroll in an approved PT program for gynecologic examination (refer to D2001). D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; This STANDARD is not met as evidenced by: Based on the lack of cytology PT enrollment records and interviews it was determined that the laboratory failed to enroll in a CMS-approved cytology PT program 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 14 -- gynecologic examination for 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide records of enrollment in an approved cytology PT program for 2021. 2. During an interview on March 7, 2022 at 2:30 PM, when asked if the laboratory had enrolled in an approved cytology PT program for 2021, the Cytology Manager replied "no." 3. During a telephone interview on March 7, 2022 at 4:15 PM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. D2133 CYTOLOGY CFR(s): 493.855(a) The laboratory must ensure that each individual engaged in the examination of gynecologic preparations is enrolled in a proficiency testing program approved by CMS by January 1, 1995, if available in the State in which he or she is employed. This STANDARD is not met as evidenced by: Based on the lack of cytology PT enrollment records and interviews it was determined that the laboratory failed to ensure that two of three Technical Supervisors who examined gynecologic preparations were enrolled in a CMS-approved cytology PT event in 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide 2021 PT enrollment records for two of three Technical Supervisors who examined gynecologic preparations in 2021 and to the date of the survey in 2022.. Technical Supervisors include: -Technical Supervisor B -Technical Supervisor C 2. During an interview on March 7, 2022 at 2:00 PM, the Cytology Manager stated: "We began gyn testing in February of 2021. All of our gyn were rescreened by the pathologists." 3. During a telephone interview on March 7, 2022 at 4:15 PM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. D2136 CYTOLOGY CFR(s): 493.855(b) The laboratory must ensure that each individual participates in an annual testing event that involves the examination of a 10-slide test set as described in 493.945. This STANDARD is not met as evidenced by: Based on review of cytology PT participation records and interviews it was determined that the laboratory failed to ensure that two of three Technical Supervisors participated in an annual cytology PT event in 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide 2021 cytology PT participation records for two of three Technical Supervisors. Technical Supervisors include: - Technical Supervisor B -Technical Supervisor C 2. During an interview on March 7, 2022 at 11:15 AM, the Cytology Manager provided records of cytology PT events for staff that occurred at other facilities in 2021. The records failed to include the participation of Technical Supervisor B and Technical Supervisor C. 3. During a telephone interview on March 7, 2022 at 4:15 PM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory -- 2 of 14 -- must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on the review of laboratory policies and procedures, laboratory records and interviews it was determined that the laboratory failed to follow two written policies and procedures (refer to D5401); failed to establish written policies and procedures for the evaluation and comparison of six of six laboratory statistics, and failed to document six of six required annual statistics (refer to D5629); failed to establish written policies and procedures for the establishment and reassessment of individual workload limits at least every six months for the Technical Supervisors (refer to D5633 and D5637); failed to establish written policies and procedures to ensure the laboratory maintained records of the total number of slides examined per 24-hour period, and the total number of hours spent examining slides per 24-hour period (refer to D5645); failed to establish written policies and procedures to document the workload limit for each Technical Supervisor (refer to D5647); and failed to follow written policies and procedures to ensure unsatisfactory slide preparations were identified and reported as unsatisfactory (refer to D5655). 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 review of 27 laboratory policies and procedures, lack of laboratory records and interviews it was determined that the laboratory failed to follow two written policies and procedures. Cross refer to D2001 and D2133 Findings include: 1. The laboratory failed to follow the written policy and procedure CYTOLOGY PROFICIENCY TESTING which stated: -"C. The Cytology Lab participates in the following programs: 2. CAP PAP PT-if gyn testing commences" (See D2001, D2133). 2. The laboratory failed to follow the written policy and procedure LABORATORY QUALITY MANAGEMENT PLAN-ANALYTIC QUALITY CONTROL which stated: -"C. Semi-Annual Proficiency Testing i. CAP PAP PT-if gyn testing commences" (See D2001, D2133). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in -- 3 of 14 -- 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies 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: Through a review of personnel records for laboratory personnel, lack of documentation, and interviews with laboratory staff, it was determined the Laboratory Director failed to specify, in writing, the procedures three of six testing personnel are authorized to perform, and whether supervision is required. Survey findings follow: A) Personnel records for clinical laboratory employees # five, # six, and # eight , as listed on the form CMS-209, failed to include written authorization to perform testing, signed by the laboratory director. B) Upon request, the laboratory was unable to provide written authorization to perform testing for the personnel identified above. C) In an interview at 1:30 PM on 3/17/21, laboratory staff members, identified as numbers one and three on the CMS 209 form, confirmed that lack of signed authorizations for laboratory testing personnel. 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 --