Thomasville Regional Medical Center

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: Based on a review of the Hematology Quality Control (QC) records, Blood Bank (BB) QC records, and an interview with General Supervisor (GS), the laboratory utilized expired Hematology QC and BB reagent prior to patient testing. This was noted for 1 of the 30 days reviewed in June 2023 for the expired Hematology QC, 15 patients Complete Blood Count (CBC) were affected; Expired BB reagents were utilized for 4 of the 31 days in March of 2024, 3 patients were affected. The findings include: 1. A review of the Hematology QC logs revealed the laboratory performed CBC QC on 12-17-2023 using levels one (lot 123175130) and two (lot 133185130) with expiration date of 12-16-2023. A review of the patient records indicated 15 patients were affected. 2. A review of the BB QC logs revealed the laboratory utilized an anti-B on 06-29-2024 with expiration date of 06-25-2024. BB worksheet indicated one patient was affected. 3. Additional review of the BB QC logs revealed the laboratory utilized an anti-A on 03-19-2024, 03-22-2024 and 03-23-2024 with expiration date of 03-16-2024. BB worksheet indicated two patients were affected. 4. During the exit interview on 9/18/24 at 12:16 PM, the GS confirmed the above findings. 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 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 -- least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the Sysmex CS 2500 analyzer maintenance records, Sysmex CS 2500 user manual, Opti-CCA analyzer maintenance records, Opti-CCA user manual, microscopes maintenance records, and an interview with the General Supervisor (GS), the laboratory failed to perform and document maintenance according to the manufacturer's established requirements and the laboratory's policy and procedures. This was noted for: a) The Sysmex CS 2500 Coagulation analyzer monthly maintenance was not performed for 5 out of 20 months reviewed in 2023 through 2024. b) The Opti-CCA Blood Gas analyzer weekly maintenance was not performed from the date of the last survey (10/5/2022) to the current survey (9/17/2024) c) The microscope maintenance was not performed from the date of the last survey (10/5 /2022) to the date of the current survey (9/17/2024). The findings include: 1. A review of the maintenance logs for the Sysmex CS 2500 Coagulation analyzer revealed no evidence of documented monthly filter maintenance performed for the following months: A) 2023: February, March, July, and November. B) 2024: May. 2. A further review of the Sysmex CS 2500 user manual revealed on page 12-3, "Monthly Maintenance: Clean the filters and document...." 3. A review of the maintenance logs for the Opti-CCA Blood Gas analyzer revealed no documentation of weekly maintenance performed per the manufacturer's established requirements from the date of the last survey (10/5/2022) to the current survey (9/17/2024). 4. A further review of the Opti-CCA user manual revealed on page 7-1, "7.2 Weekly Maintenance: Once a week, the Sample Measurement Chamber (SMC) must be cleaned." 5. A review of the lack of microscope maintenance revealed no evidence of documented maintenance for the microscope from the time of the previous survey (10/5/2022) to the date of the current survey (10/5/2022). 6. During an interview with the GS on 9/17/24 at 2:44 PM, the GS stated the last preventative maintenance was performed on 2/5/23, no other maintenance was performed or documented since then. 7. The GS confirmed the above findings during the exit interview on 9/18/24 at 12:16 PM. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent -- 2 of 3 -- calibration verification. This STANDARD is not met as evidenced by: Based on a review of the Alere Triage D-Dimer Calibration Verification (CV) records, the policy and procedures, and an interview with the General Supervisor (GS), the laboratory failed to perform CV procedures on D-Dimer at least every six months as specified by laboratory's policy and procedure. This was noted for 1 of 4 possible CV's missed from 2022 through 2024. The findings include: 1. A review of the Alere Triage D-Dimer records revealed CV procedures were not performed according to the CLIA requirement for analytes calibrated with less than three calibrators for the following dates: a. The 1st CV was performed on 6/28/2022, 10 months later, b. The 2nd CV was performed on 4/20/2023, 9 months later, c. The 3rd CV was performed 1/4/2024, 8 months later, d. The 4th CV was performed on 9/4 /2024. 2. A further review of the D-Dimer Triage policy and procedure revealed, "Calibration verification studies: Perform semiannual calibration verification testing...." 3. During the exit interview on 9/18/2024 at 12:16 PM, the GS confirmed these findings. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the D-Dimer Quality Control (QC) logs, D-Dimer Quality Assessment Plan, and an interview with the General Supervisor (GS), the laboratory failed to ensure two levels of monthly QC were performed and documented as stated in the procedure manual. The surveyor noted the missing QC on 2 of the 12 months reviewed in 2023. The finding include: 1. A review of the D-Dimer Quality Control (QC) logs revealed no evidence of documented QC performed in November 2022 and June 2023 on the Alere Triage analyzer. 2. A further review of the D-Dimer Quality Assessment Plan revealed, "5. Review quality control results, including QC..." 3. During an interview on 9/18/2024 at 10:48 AM, the GS confirmed these findings. -- 3 of 3 --

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the Beckman Coulter DxH 600 calibration records and an interview with the General Supervisor, the laboratory failed to ensure calibration results were within the manufacturer's acceptable limits for one of four calibration procedures performed in 2021-2022. The findings include: 1. A review of calibration records for the Beckman Coulter DxH 600 Hematology analyzer revealed failures on the 7/29/2022 calibration for White Blood Cells (WBC) and Red Blood Cells (RBC). However, there was no documentation the unacceptable calibration was repeated. 2. During an interview on 10/5/2022 at 1:15 PM, the General Supervisor confirmed the above findings. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification 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 -- procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of Beckman Coulter DxC AU 700 calibration verification records and interviews with the General Supervisor, the laboratory failed to perform and document calibration verification procedures at least once every six months as specified by CLIA requirements. The surveyor noted the laboratory failed to perform and document one out of two calibration verifications due in 2021 on the Beckman Coulter DxC AU 700 chemistry analyzer. The findings include: 1. A review of Beckman Coulter DxC AU 700 chemistry analyzer records revealed calibration verifications were performed on 12/10/2020, 5/12/2021, and 7/19/2022. There was no documentation of a calibration verification performed the second half of 2021. 2. During an interview on 10/5/2022 at 10:30 AM, the General Supervisor explained the missing calibration verification occurred under a previous Laboratory Manager. 3. During an interview on 10/18/2022 at 4:30 PM, the General Supervisor confirmed only one calibrator was used to calibrate each analyte run on the DxC AU 700. The surveyor explained any analyte calibrated with less than three calibrators must have a semi-annual calibration verification. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on reviews of Serum Infectious Mononucleosis (Mono) Quality Control (QC) logs, the Policy and Procedure Manual and an interview with the General Supervisor, the laboratory failed to ensure two levels of QC were performed and documented each -- 2 of 4 -- day of patient testing in the absence of a valid Individualized Quality Control Plan (IQCP). The surveyor noted 33 patient tests were performed from January 2021 to October 5, 2022. The findings include: 1. A review of kit test logs revealed QC for Serum Mono was only performed with each new kit lot number. A review of logs from January 2021 to October 5, 2022 revealed the laboratory performed 33 patient Mono tests. 2. During an interview on 10/4/2022 at 2:00 PM, the General Supervisor confirmed QC for Serum Mono was performed each time a new kit was first opened. 3. A review of the Policy and Procedure Manual revealed a Risk Assessment for Serum Mono had been performed, however, the laboratory failed to implement a Quality Control Plan and a Quality Assessment Plan as required for a complete IQCP to allow for decreased QC frequency. Per CLIA regulations a valid IQCP must be implemented, or the laboratory must perform QC each day of patient testing. 4. During an interview on 10/5/2022 at 11:50 AM, the General Supervisor confirmed the laboratory did not have a Quality Control Plan or Quality Assessment in the IQCP available for the surveyor's review. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on a review of personnel evaluation records and an interview with the General Supervisor, the Technical Consultant failed to ensure testing personnel had documentation of training before performing patient tests. This was noted for three out of eight Testing Personnel listed on the Form CMS-209 (Laboratory Personnel Report) from the date of the last survey (9/2/2020) to the date of the current survey (10 /5/2022). The findings include: 1. A review of personnel evaluation records revealed the following: a) Initial training was not performed and documented for Testing Personnel #3 and Testing Personnel #6. b) Initial training for Testing Personnel #1 was performed by Testing Personnel #3 instead of the Technical Consultant. 2. During an interview on 10/5/2022 at 2:30 PM, the General Supervisor confirmed the above findings. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of personnel evaluation records and an interview with the General Supervisor, the Technical Consultant failed to evaluate and document the performance of individuals responsible for moderate complex testing at least semi annually during the first year of patient testing. This was noted for one out of eight Testing Personnel from the date of the last survey (9/2/2020) to the date of the current survey (10/5 /2022). The findings include: 1. A review of personnel records revealed the Technical -- 3 of 4 -- Consultant failed to perform and document the semi-annual competency evaluation (due February 2022) for all moderate complexity testing for Testing Personnel #6. 2. During an interview on 10/5/2022 at 2:30 PM, the General Supervisor confirmed the above findings. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An unannounced Complaint Survey (Intake #AL00039721) was conducted simultaneously with an Initial Survey for Thomasville Regional Medical Center on 9 /2 and 9/3/2020. None of the complaint allegations were substantiated. The two deficiencies cited were related to non-compliance issues discovered during the Initial Survey reviews. . D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of Blood Bank policies and procedures, an interview with the General Supervisor, and a lack of documentation for periodic alarm checks of the Blood Bank refrigerator (where blood products are routinely stored), the surveyor determined the laboratory failed to perform procedures to ensure the refrigerator would emit an audible alarm if temperatures were too low for safe storage of the blood products therein. This affected one of one refrigerators, used for storage of blood and blood products. The findings include: 1. A review of the Blood Bank procedures, "Equipment QC [Quality Control] Protocol" and "Blood Bank Refrigerator Maintenance", revealed checks of the Blood Bank refrigerator alarm should be performed monthly. 2. During an interview on 9/3/2020 at 11:20 AM, the surveyor asked for documentation of the monthly alarm checks. The General Supervisor explained the laboratory had routinely performed checks of the high temperature alarm by leaving the refrigerator door open. However, the laboratory had 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 -- not checked the low temperature alarm (by placing the temperature probe in ice water, as per procedure) since the hospital began patient testing in March 2020. . D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on a review of personnel records, and an interview with the Laboratory Supervisor, the surveyor determined the Technical Consultant (also the Laboratory Director) failed to ensure training documentation was complete for four out of eight Testing Personnel performing moderate-complexity testing. The findings include: 1. A review of Testing Personnel (TP) training records revealed incomplete documentation as follows: A) TP #3: Sysmex CS-2500-Not signed by the Laboratory Supervisor Access 2, DxH, and DxC-700-No Trainer initials specified B) TP #5: DxH- No training dates or trainer initials specified DxC-700 Access 2-No training dates specified C) TP #6: DxC and some Access 2 training initialed by TP #5 (whose own training was not properly documented) D) TP #9: DxH-No trainer initials specified Access 2-No training dates or trainer initials specified 2. During an interview on 9/2 /2020 at 2:30 PM with the Laboratory Supervisor, the surveyor reviewed and confirmed the above noted findings. SURVEYOR ID #32558 Licensure and Certification Surveyor -- 2 of 2 --