Tri-County Memorial Hospital

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 surveyor review of laboratory procedures and competency assessment records and interview with the general supervisor, the laboratory did not follow written procedures to assess employee competency for one of three new testing personnel. Findings include: 1. Review of "Quality Assessment for Laboratory Testing" procedure stated "The supervisor, technical leader or designee if responsible for competency of all testing personnel. " 2. Review of "New Hire Laboratory Tech Competency" form for testing personnel, staff A, showed a comment "Staff A is authorized to perform all testing in those areas competency has been documented." This comment was signed by staff A with no other signatures or initials indicating competency was assessed by the laboratory director, technical consultant, technical supervisor or general supervisor. 3. Interview with the general supervisor on July 9, 2024, at 10:15 AM confirmed the laboratory did not follow written procedures to assess employee competency. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. 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: Based on surveyor review of procedures, quality control (QC) records, and patient testing report from the laboratory information system (LIS) and interview with the general supervisor, testing personnel did not test hematology controls every 24 hours for one of ninety-two patient testing days between February 21, 2023, and May 23, 2023, as required in the procedure. Findings include: 1. Review of "Sysmex XN-450 /XN-550 Complete Blood Count and Parameters-Whole Blood" stated "XN-L CHECK control levels 1, 2 and 3 will be run at least once every 24 hours prior to patient testing". 2. Review of QC records on the Sysmex Insight Raw Data Report for lot 3041 from February 21 to May 23, 2023, showed QC material was not tested on May 3, 2023. Further review showed QC was tested May 2, 2023, at 4:45 AM and May 4, 2023, at 3:51 AM. 3. Review of patient testing reports from the LIS showed fifteen patient samples were tested on May 3, 2023. 4. Interview with the general supervisor on July 10, 2024, at 10:05 AM confirmed testing personnel did not follow the procedure to test hematology controls every 24 hours of patient testing. This is a repeat deficiency from July 12-13, 2022. -- 2 of 2 --

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 surveyor review of immunohematology and general laboratory records and interview with the general supervisor, the laboratory MTS (Micro Typing System) diluent 2 available for blood bank testing was expired ten of the thirty days in September 2021. Testing personnel performed testing on three patients during the ten days the reagent was expired. Findings include: 1. Review of the "Blood Bank Gel Card Quality Control Record" from September 2021 showed testing personnel put MTS diluent 2 lot number MD143 into use on July 31, 2021; the diluent expiration date was September 9, 2021. The record also showed testing personnel put a new lot, MD152, into use on September 20, 2021. The general supervisor initialed and dated the record on October 7, 2021, the record showed no sign the general supervisor found the expired reagent was available for use during the record review. 2. Review of the "Blood Bank Worksheet" in use from September 3 through 23, 2021 showed testing personnel performed patient testing on September 13, 17 and 19 when the expired MTS diluent 2 was available for use. 3. Review of the "Overnight Shift" checklist showed testing personnel checked the expiration dates of Blood Bank cards, diluent, and reagents on September 12 and 19, 2021. 4. Interview with the general supervisor on July 13, 2022 at 10:00 AM confirmed the MTS diluent 2 was available for testing of three patients after the reagent had expired on September 9, 2021. This is a repeat deficiency previously cited on December 22, 2020. D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) 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 -- (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (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 surveyor review of laboratory procedures, transfusion records, and interview with the general supervisor, testing personnel did not follow laboratory procedures and did not obtain the signature of the physician ordering an emergency blood release for transfusion for one of one patient reviewed. Findings include 1. Review of the procedure, "Emergency Blood Release, Lab-8677", showed the 'Procedural Notes' section included the following, "When blood is released before pretransfusion testing is complete, the records must contain a signed statement from the requesting physician indicating that the clinical situation was sufficiently urgent to require release of blood". The 'Limitations' section stated, "Ideally, the "Emergency Transfusion Request" form should be signed before the unit is released if the crossmatch has not been completed. In the event that it is impossible for the physician to sign immediately, the Emergency Transfusion Request MUST be signed within 24 hours." 2. Review of transfusion records for patient 1 showed the physician ordered and transfused one unit of blood as an emergency transfusion on June 5, 2022. No "Emergency Transfusion Request" form was with the records. 3. Interview with the general supervisor on July 13, 2022 at 10:00 AM confirmed testing personnel did not ensure completion of the "Emergency Transfusion Request" form for the transfusion for patient 1 on June 5, 2022 and the laboratory had not obtained the physician's signature as required in 21 CFR 606.160(b)(3)(v). D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on surveyor review of procedures, quality control (QC) records, and instrument logs and interview with the general supervisor, testing personnel did not test hematology controls each morning on twelve of sixty-one days between October 13 and December 13, 2021 as required in the procedure. Findings include: 1. Procedure "Sysmex XN-450/XN550 Complete Blood Count and Parameters - Whole Blood" stated, "XN-L CHECK controls levels 1, 2, and 3 will be run each morning before reporting patient results." 2. Review of QC records on the Sysmex Insight Raw Data Report for lot 1267 from October 13 to December 13, 2021 showed QC material was not tested in the morning but was tested in the afternoon or evening on November 18, 19, 20, 21, 29 and 30, and December 1, 2, 3, 4, and 5. The record showed controls were tested at 4:15 PM on December 5, 2021 and no controls were tested on December 6, 2021. 3. Review of instrument logs showed five patient samples were tested on December 6, 2021 between 1:39 AM and 8:16 AM. 4. Interview with the -- 2 of 3 -- general supervisor on July 13, 2022 at 11:30 AM confirmed testing personnel did not follow the procedure to test hematology controls in the morning prior to reporting patient results. -- 3 of 3 --

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 surveyor review of laboratory blood bank records and interview with the general supervisor, the laboratory performed blood bank quality control (QC) and patient testing using four expired reagents of fifty-one reagents used in three of five months in 2020. Findings include: 1. Review of "Blood Bank Gel Card Quality Control Record" worksheets from 2020 showed: a. A/B/D Card Lot# 083019053-01 expired on June 5, 2020 and the laboratory used the reagent for QC on June 9, 2020. b. Albumin Lot# 12020A expired on July 20, 2020 and the laboratory used the reagent for QC on July 22, 2020. c. Buffer Card Lot# 121019004-01 expired on October 6, 2020 and the laboratory used the reagent for QC on October 7, October 20, and October 26-28, 2020. d. A/B/D Card Lot # 121819053-021 expired on October 21, 2020 and the laboratory used for QC on October 26-28, 2020. 2. Review of the blood bank patient log and correlation with the quality control records showed the laboratory used the expired A/B/D and Buffer cards during unit retyping and patient cross match testing performed on: Patient One October 7, 2020/Buffer card Patient Two October 20,2020 and October 26, 2020/Buffer cards and A/B/D cards (Lot 121819053-021) Patient Three October 27-28, 2020/Buffer cards and A/B/D cards (Lot 121819053- 021) 3. Interview with general supervisor, staff A, on December 22, 2020 at 1:10 PM, confirmed the laboratory performed blood bank quality control and patient testing using four expired reagents of fifty-one reagents used in three of five months in 2020. This is a repeat deficiency from June 12, 2012. 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 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 surveyor review of blood bank testing records and procedures, and interview with the general supervisor, the laboratory could not show control testing was performed each day of testing as required. Findings include: 1. Review of blood bank testing records show quality control was not performed on each calendar day of testing. Further review showed no documentation of the time quality control testing was performed. 2. Review of blood bank procedure 'SOP Ortho MTS Gel Workstation Lab-8756' revealed blood bank controls need to be performed each day of testing. 3. Interview with the general supervisor on July 18, 2018 at 3:00 PM revealed blood bank controls are to be performed within 24 hours prior to patient testing, and confirmed sufficient documentation was not maintained to show the controls were performed as required. 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 --