Fulton County Medical Center

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted by the Pennsylvania State Agency for Fulton County Medical Center on 06/24/2025 and 6/25/2025. The laboratory was found out of compliance with the following conditions: 493.1217 Condition: Immunohematology. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director. 493.1447 Condition: Laboratories performing high complexity testing; laboratory technical supervisor. D3035 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(ii) (a)(3)(ii) Immunohematology records, blood and blood product records, and transfusion records as specified in 21 CFR 606.160(b)(3)(ii), (b)(3)(iv), (b)(3)(v), and (d). This STANDARD is not met as evidenced by: Based on review of laboratory procedures, record review, and interview with the Technical Supervisor (TS) #5, the laboratory failed to ensure that 2 of 4 immunohematology records related to the emergency release of blood products were retained for the appropriate period of time for testing performed from 8/15/2025 to 6 /25/2025. Findings include: 1. On the day of survey 6/25/2025 at 10:30 am, review of the laboratory's policy titled Emergency Requisition of Uncrossmatched Blood revealed that"If time permits, do a quick ABO and RH using the tube method. Give type specific blood if possible and record results on the Blood Bank log and on the Blood Bank Slips." 2. The laboratory failed to provide documentation of the quick type performed for 2 of 4 (Spec #: 0727:BB0002S, Spec # 1128:BB0000S) emergency released transfusions that were issued type specific red blood cell units from 8/15/2025 to 6/25/2025. 3.TS #5 confirmed the above findings on 6/25/2025 at 2: 30 pm. D5026 IMMUNOHEMATOLOGY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- 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 record review, and interviews with Technical Supervisors (TS) #1 and #5, the laboratory failed to meet the requirements for the specialty of Immunohematology specified in 493.1230 through 493.1256 and 493.1281 through 493.1289 from 8/15 /2023 to the time of survey. Refer to: D3035, D5553, and D5555. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records and interview with Technical Supervisor #1 (TS), the laboratory failed to verify the accuracy of the PT results obtained for 3 of 3 API Microbiology testing events in 2024. Findings Include: 1. On the day of survey, 06/24/2024 at 11:00 am., review of the laboratory's API Microbiology PT records revealed that the laboratory did not verify the accuracy for the following analytes that were not graded by the PT agency for 3 of 3 API Microbiology events in 2024: 1st event: - CSF Culture MIC /Zone Diameter Value - Gram Stain: nonconsensus - Urine Culture MIC/Zone Diameter Value 2nd event: - Blood Culture Susceptibility Interpretation - Urine Culture MIC/Zone Diameter Value 3rd event: - Additonal Antimicrobial Testing 2. The API Proficiency Testing performance Evaluation form states "Laboratories are responsible for documenting and performing

Summary Statement of Deficiencies D2179 COMPATIBILITY TESTING CFR(s): 493.863(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unsatisfactory testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute's (API) proficiency testing (PT) records and interview with technical supervisor #2 (TS), the laboratory failed to document the remedial action taken for the unsatisfactory score received for 1 of 3 API Immunology/Immunohematology PT events in 2022. Findings Included: 1. On the day of inspection, 08/15/2023 at 10:10 AM, review of API PT records revealed that the laboratory received a 60% score for compatability testing performed for the 1st API Immunology/Immunohematology event in 2022. 2. The laboratory could not provide documentation of the remedial action taken for the unsatisfactory score received for compatibility testing performed in the 2022 API PT Event #1. 3. GS #1 confirmed the above findings on 08/16/2023 at 3:45 PM. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's competency assessment records and interview with technical supervisor #2 (TS), the laboratory failed to establish a competency assessment procedure to assess the competency of 1 of 3 technical supervisors, 3 of 4 technical consultants (TC), and 6 of 8 general supervisors (GS) for their supervisory responsibilities from 09/17/2021 to the date of survey. Findings include: 1. On the day of survey, 08/15/2023 at 10:45 am, the laboratory could not provide a competency assessment policy to assess the competency of the following personnel for their supervisory skills from 09/17/2021 to 08/16/2023: - 1 of 3 TS (CMS 209, personnel #4) - 3 of 4 TC (CMS 209, personnel #4, #5, #7) - 6 of 8 GS (CMS 209, personnel #4, #5, #7, #8, #10, #13 ) 2. The laboratory could not provide competency assessment documents for 1 of 3 TS, 3 of 4 TC, and 6 of 8 GS. 3. TS #2 confirmed the findings above on 08/16/2023 at 03:45 pm. D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records and interview with testing personnel # 3 (TP), the laboratory failed to perform one level of control material every 8 hours of operation for manual cells counts perfomed using a hemocytometer from 09/17 /2021 to the date of the survey. Findings Include: 1. On the day of the survey, 08/16 /2023 at 11:30 am, the laboratory could not provide documentation of the QC performed for the following 1 of 1 manual cell counts performed in hematology from 09/17/2021 to 08/16//2023: - Complete semen analysis performed using a hemocytometer. 2. TP #3 confirmed the findings above on 08/16/2023 at 03:45 pm. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with technical supervisor #2 (TS), the laboratory failed to evaluate twice a year the relationship between test results using different methodologies and instrumentation in microbiology, and hematology from 09 /17/2021 to the date of the survey. Findings included: 1. On the date of the survey, 08 /15/2023 at 02:17 PM, the laboratory failed to provide documentation of the biannual comparison studies for the following 3 of 3 tests performed from 09/17/2021 to 08/15 /2023: - Clostridium difficil (Immunocard vs. Cepheid GeneExpert) - manual -- 2 of 10 -- differentials vs. automated differentials (Sysmex) - manual cell counts (hemacytometer) vs. automated cell counts (Sysmex) 2. TS #2 confirmed the findings above on 08/16/2023 at 03:45 PM. D5783

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: Based on review of the laboratory's competency and evaluation process policy, review of competency assessment (CA) records, and interview with the Laboratory Manager (LM), the laboratory failed to follow the Laboratory's written policies and procedures to assess the competency of 12 of 13 testing personnel (TP) for each test performed in the departments of Chemistry, Microbiology, Hematology, Immunology, and immunohematology in 2019, 2020 and 2021. Findings Include: 1. The laboratory's competency and evaluation process policy (page 2) states the following: - "Competency assessment, which includes the six procedures, must be performed for testing personnel for each test that the individual is approved by the laboratory director to perform." - "all new staff members will need to demonstrate competency at 6 months, 12 months and yearly thereafter." 2. On the day of survey, 06/22/2021 at 09: 00 am, the laboratory could not provide completed CA records for the following TP: a. - 1 of 9 TP (TP#11) in 2019. - 9 of 11 TP (TP #1, 2, 3, 4, 5, 7, 8, 10, and 11) in 2020. b. CA not performed for each test: - 8 of 9 TP (TP #1, 2, 3, 4, 5, 7, 8, and 9) in 2019. - 02 of 11 TP (TP #6 and #9) in 2020. - 10 of 13 TP (TP #1, 2, 4, 5, 6,7, 8, 10, and 13) in 2021. c. Incomplete CA records: - 2 of 2 new TP (TP#6 and TP#9) were not assessed for 5 of 6 competency assessment required procedures at 6 months from hired. 3. The LM confirmed the findings above on 06/23/2021 at 02:00 p.m. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's Quality Assurance Plan procedure, review of Quality Assurance records, and interview with the Laboratory Manager (LM), the laboratory failed to follow the Laboratory's written policies and procedures for the completion of Quality Assessment (QA) forms in 2019, 2020, and 2021. Findings Include: 1. The laboratory's Quality Assurance Plan procedure (page 6) states: "A quality assessment form will be completed by the lab manager monthly." 2. On the day of survey, 06/22/2021 at 12:47 pm, review of the QA records revealed the LM did not complete the QA forms monthly in 2019, 2020, and 2021. - 2019: a. June QA form was completed on August 01, 2019. b. July, August, and September QA forms were completed on November 05, 2019. c. October and November QA forms were completed on January 12, 2020. - 2020: a. January and February QA forms were completed on May 22, 2020. b. March, April, and May QA forms were completed on July 29, 2020. c. July, August, and September QA forms were completed on May 2, 2021. d. October QA form was completed on May 18, 2021. e. November and December QA forms were completed on May 13, 2021. -2021: a. January and February QA forms were completed on April 27, 2021. 3. The LM confirmed the findings above on June 23 at 02:00 p.m. 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 review of laboratory records and interview with the laboratory manager (LM) and testing personnel (TP), the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283, that provides equivalent quality testing and 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 for June 2019 to the day of survey. Refer to: D5401, D5403, D5421, D5421, D5429, D5445, D5449, D5555 and D5775. 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. -- 2 of 6 -- This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual and interview with Testing Personnel (TP) #3, the laboratory failed to have written procedures for bacteriology culture examinations analyzed from 06/23/2019 to the day of survey. Findings include: 1. On the day of survey, 06/23/2021 at 12:00 am, the laboratory could not provide written procedures for urine, sputum, wounds, stool, and cerebral spinal fluid (CSF) culture examination performed in 2019, 2020 and 2021. 2. The following bacteriology culture examinations were performed: - 2019: 3,818 specimens. - 2020: 3,943 specimens. - 2021: 1,627 specimens. 3. TP#3 confirmed the findings above on 06/23/2019 around 12:15 p.m. 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 D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory quality assurance (QA) policy, proficiency testing (PT)