Baxter Health Fulton County Hospital

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the 2025 CMS Casper Reports 0153D and 0155D, and the American Proficiency Institute (API) proficiency testing results, the laboratory failed to have initial successful participation in proficiency testing for the analytes compatibility testing and antibody detection. Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance as cited at D2181 and D2172. D2172 UNEXPECTED ANTIBODY DETECTION 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 -- CFR(s): 493.861(e) (e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of 2025 CMS Casper Reports 0153D and 0155D, and the American Proficiency Institute (API) proficiency testing results, the laboratory failed to achieve satisfactory performance in two consecutive proficiency testing events for the analyte antibody detection as evidenced by: A. The Laboratory received a score of 60% for antibody detection in the fist proficiency testing event of 2025. B. The Laboratory received a score of 0% for antibody detection in the second proficiency testing event of 2025. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) (e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of 2025 CMS Casper Reports 0153D and 0155D, and the American Proficiency Institute (API) proficiency testing results, the laboratory failed to achieve satisfactory performance in two consecutive proficiency testing events for the analyte compatibility testing as evidenced by: A. The Laboratory received a score of 80% for compatibility testing in the first proficiency testing event of 2025. B. The Laboratory received a score of 0% for compatibility testing in the second proficiency testing event of 2025. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of CMS 0155D, 0153D reports and API performance evaluation for 2025 the laboratory director failed to provide overall management and direction to the lab for successful participation in proficiency testing. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on record review of CMS 0155D, 0153D, and API performance evaluation from 2025, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for compatibility testing and antibody detection. Refer to D2181 and D2172. -- 3 of 3 --

Summary Statement of Deficiencies 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: Through review of the CMS 209 form, personnel records, and interview conducted on 1/22/2025 it was determined that the competency of the testing personnel was not assessed by the laboratory director on an annual basis. Findings follow: A) Review of certified respiratory therapist (CRT) personnel files on the CMS 209 form, six of seven testing personnel revealed that the annual evaluation of the competency of the testing personnel was documented only once dated May 2023 and no other documentation of testing personnel competency was presented. B) Upon request, the laboratory was unable to provide other competency evaluations of the CRT testing personnel on the CMS 209 form, no 2024 competency evaluation identified above. C) In an interview on 1/22/2025 at 8:53 a.m. the technical supervisor (TS) number one on the CMS 209 form, said that no other competency evaluations were present and available. D) Review of Technical Consultant (TC) personnel files on the CMS 209 form, two of two personnel revealed that the annual evaluation of the TC competency was not documented for 2023 and 2024. E) Upon request, the laboratory was unable to provide other competency evaluations of the TC personnel on the CMS 209 form. F) In an interview on 1/22/2025 at 8:53 a.m. the technical consultant (TC) number one on the CMS 209 form, said that no other competency evaluations were present and available. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) 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 -- (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Through a review of the laboratory procedure manual, lack of documentation, and interviews with laboratory staff, it was determined the laboratory director failed to approve, sign, and date all the laboratory procedures. Survey findings include: A. During a review of the laboratory procedures, it was determined the procedure manual and individual procedures lacked the director's approval signature and date of approval. B. In an interview at 08:48 1/22/2025, Technical Consultant #1 (as listed on the form CMS-209) confirmed the laboratory director's written approval of the laboratory procedures was not available. -- 2 of 2 --

Summary Statement of Deficiencies D0000 This is the CLIA recertification survey of the laboratory conducted on 5/3/2023. The laboratory was not in compliance with the following conditions: 493.1217 - Immunohematology 493.1250 - Analytic Systems 493.1441 - Laboratory Director D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of proficiency test documentation and interviews with laboratory staff, the laboratory director failed to sign proficiency testing attestation statements for six of twenty proficiency events reviewed from 2022 and 2023. Survey findings include: A. A review of proficiency testing documentation from 2022 and 2023 it was determined the laboratory director failed to sign the attestation statement on the Second Hematology Testing Event of 2022, the Second and Third Microbiology Testing Events of 2022, The First Immunology and Immunohematology Testing Event of 2022, The First Hematology Testing Event of 2023, and the First Immunology and Immunohematology Testing Event of 2023. B. In an interview, at 2: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- 26 p.m. on 5/2/2023, laboratory employee #2 (as listed on the form CMS-209) confirmed the attestation statements listed above had not been signed by the laboratory director. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of laboratory policies and procedures for blood bank, a review of the Bloodbank ID_MTS Daily QC Record, a review of the blood bank log, and interviews with laboratory staff, it was determined the laboratory failed to meet requirements for the specialty of Immunohematology as evidenced by: 5401 - the laboratory failed to follow written procedures for Antibody Detection Method - Two Cell Screen 5551 - the laboratory failed to perform and document quality control for immunohematology testing on five days of patient testing D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of laboratory policies and procedures for blood bank, a review of the Bloodbank ID_MTS Daily QC Record, a review of the blood bank log, a review of quality control documentation, and interviews with laboratory staff, the laboratory failed to meet analytic systems requirements as evidenced by: 5401 - the laboratory failed to follow written procedures for Antibody Detection Method - Two Cell Screen 5441 - the laboratory failed to monitor over time the accuracy and precision of test performance. 5551 - the laboratory failed to perform and document quality control for immunohematology testing on five days of patient testing 5783 - the laboratory failed to document

Summary Statement of Deficiencies D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Through lack of documentation and interview it was determined that the laboratory failed to provide written instructions for specimen collection and handling for clients who submit specimens to the laboratory. Findings follow: A. In an interview on 04/16 /21 at 0900 AM the laboratory staff member, identified as number two on the CMS 209 form, said that the laboratory accepted specimens from three home health agencies and requested tests included CBC's, Urine Cultures, Prothrombin Times, CMP's and A1C Hemoglobin and the specimens were transported by agency personnel. B. Upon request, the laboratory could not produce a specimen collection, handling and transportation manual that it supplied to the laboratory's clients. C. In an interview on 4/16/21 at 0900 AM, the laboratory staff member identified as number two on the CMS 209 form, confirmed that the laboratory failed to provide a specimen collection and handling manual to the laboratory's clients. 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. 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: Through observation and interview with laboratory staff it was determined that the laboratory failed to label the contents of one of one containers of deionized water. findings follow: A) During a tour of the laboratory on 4/16/21 at 01:15 PM a plastic container containing a liquid substance was observed on the counter labeled as only "4 /15". B) When asked during an interview on 4/16/21 at 01:15 PM what the identity of the contents of the container were, the laboratory staff member, identified as number two on the CMS 209 form, said the container held deionized water and the container was not labeled as to contents. 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 it was determined that one of one KOH solution used to perform KOH microscopic preparations was expired in the laboratory microscopy area. Findings follow: A) During a tour of the laboratory on 4/16/21 at 01; 15 PM one of one bottles of MCG KOH, lot # 8506-01 expiration date 2020-07-31, was observed in the cabinet in the laboratory microscopy area. B) In an interview on 04/16/21 at 01:15 PM the laboratory staff member, identified as number two on the CMS 209 form, said that the bottle of KOH solution identified above had exceeded its expiration date and was available for use. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Through review of proficiency testing attestation forms, API proficiency testing instructions and interview with laboratory staff it was determined that the laboratory director did not attest that the proficiency testing was performed in the same manner as patient testing in seven of seventeen events reviewed. Survey findings follow: A. The instructions for API proficiency testing states, "signatures required: testing personnel and the laboratory director must physically sign an attestation statement for all proficiency testing results". B. Review of API proficiency testing documentation revealed that API Chemistry Core first event 2017, API Chemistry Core second event 2017, API Chemistry Core and API Chemistry Miscellaneous third event 2017, API Chemistry Core first event 2018, API Hematology Coagulation second event 2018, and API Immunohematology second event 2018 all lacked the signature of the laboratory director (or designee) attesting that testing was performed in the same manner as patient testing . E. In an interview at 10:45 AM on 10/24/18, the technical consultant identified as number two on the CMS 209 form confirmed that the laboratory director's signature was not present on the API proficiency testing events identified above. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and 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 -- test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: 1) Through observation, review of the manufacturer's instrument manual, lack of documentation and interview it was determined that the laboratory failed to document humidity levels in one of two rooms in which equipment with an operating humidity requirement was located. Findings follow: A. In a tour of the laboratory on 10/25/18 at approximately 09:00 AM a Gem 3500 Arterial Blood Gas analyzer was observed in the laboratory. B. Review of the manufacturer's manual for the Gem 3500 Arterial Blood Gas analyzer revealed that the analyzer has an operational humidity requirement of 5% to 90%. C. Upon request, the laboratory was unable to provide humidity records for the years of 2017 and 2018. D. In an interview on 10/25/18 at approximately 09:00 AM, the testing personnel identified as number 13 on the CMS 209 form confirmed that the laboratory had not documented the humidity level in the laboratory room in 2017 or 2018. 2) Through observation, review of the manufacturer's package insert, and interview it was determined that 37 of 37 Hemochron Prothrombin Time cuvettes, lot # J201 C, were stored at room temperature without an amended date of expiration or date of when the cartridges were placed at room temperature noted, Findings follow: A. In a tour of the laboratory on 10/25/18 at approximately 10:00 AM, 37 Hemochron Prothrombin Time cuvettes were observed on the counter adjacent to the Hemochron Jr. coagulation instrument and no date of when they were placed at room temperature or amended expiration date was noted on the box in which the cuvettes were stored. B. Review of the manufacturer's package insert for the Hemochron Prothrombin Time cuvettes revealed that "when refrigerated, the foil pouched cuvettes are stable until the marked expiration date". The cuvettes may be stored at room temperature (15 to 30 degrees C.) but "re-dating is necessary if stored at room temperature and should be indicated by completing the storage information section on the side panel of each cuvette box". C. In an interview on 10/25/18 at approximately 10:00 AM, the technical consultant, identified as number 2 on the CMS 209 form, confirmed that the Hemochron Prothrombin Time cuvettes were stored at room temperature and had not been re- dated. 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 one of two containers of Gem plastic capillary tubes had exceeded the expiration date and was available for use. Findings follow: A. During a tour of the laboratory on 10/25/18 at approximately 09:00 AM, one container of Gem capillary tubes, lot number 90772103 with an expiration date of 2013-03 was observed in the supply drawer under the Gem 3500 arterial blood gas analyzer. B. In an interview on 10/25/18 at -- 2 of 5 -- appropximately 09:00 AM, the testing personnel identified as number thirteen on the CMS 209 form confirmed that the capillary tubes identified above had exceeded the expiration date and were available for use. D5783