Mercy Hospital Paris

Summary Statement of Deficiencies D3023 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(2) The facility must establish and follow policies to ensure positive identification of a blood or blood product recipient. This STANDARD is not met as evidenced by: Based upon review of the laboratory policy and procedure "PRSAR LABBB Blood Bank Armband System" , directions for use of Typenex barcode blood band for pre- printed labels, and interview with laboratory staff members, the laboratory failed to follow the policy to ensure positive identification of a blood product recipient. Findings follow: A) Step #2 in the laboratory policy and procedure states; "check with Blood Bank Tech to determine if a specimen must be collected". B) Step #2 in the 8- step directions for use of the Typenex barcode blood band for pre-printed labels is to attach the arm band to the patient immediately prior to obtaining the specimen for crossmatching. C) In an interview on 6/12/25 at 08:40 a.m., the laboratory staff member (# 3 on the form CMS 209) was asked why a specimen might not need to be collected for a crossmatch. The laboratory staff member stated that if a specimen was in the laboratory for other testing, as an example for a complete blood count or electrolyte assay, that specimen would be taken to the blood bank, labeled with the Typenex system, and the arm band then be affixed to the patient. This practice does not conform to the procedure provided in the directions for use of the Typenex Barcode Blood Band system. D5783

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Through observation, review of the manufacturer's package insert and interview with laboratory staff members it was determined that the laboratory failed to re-assign an amended expiraton date for one of one box of arterial blood gas control material as required by the manufacturer. Findings follow: A) During a tour of the laboratory on 9 /27/23 at 2:09 p.m., one of one box of Opti - Check Plus arterial blood gas control with a storage temperature requirement of 2 degrees C. to 8 degrees C. noted on manufacturer's box and with a hand written label of "3-14" was observed in a storage cabinet at room temperature. B) Review of the manufacturer's package insert revealed that the material could be stored "up to 2 months at room temperature" and the expiration date should be amended as appropriate if stored at room temperature. C) In an interview on 9/27/23 at 2:09 p.m, when asked when the material was placed at room temperature the laboratory staff member (# 3 on the CMS 209 form) replied "I don't know". D) In an interview on 9/27/23 at 2:09 p.m., the laboratory staff member (# 3 on the CMS 209 form) stated that the control material identified above should have been labeled with the date it was placed at room temperature and the expiration date amended. D5783

Summary Statement of Deficiencies D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Through a review of laboratory policies and procedures, hematology quality control documentation for January, May, and August 2021, lack of documentation, and interviews with laboratory staff, it was determined the quality assessment failed to identify and correct the incorrectly entered hematology quality control ranges in May 2021 (one of three months reviewed). Survey findings include: A. The laboratory quality control policy states "For new lot numbers of Sysmex E-check XS series controls, the laboratory will establish its own target values. This will be done by collecting at least 10 data points per control over at least 5 days. QC limits will then be established using Sysmex Evidence Based X-S control limits." B. Through a review of hematology quality control documentation for May 2021, it was determined the acceptable ranges were incorrectly entered into the system. Control lots #10960804, #10960805, and #10960806 were documented in use for Low, Normal, and High hematology daily controls. The ranges for all constituents of the controls were entered as a target value plus or minus the same target value so that each control range was from zero to twice the target value. C. In an interview, at 1:27 p.m. on 10/19 /2021, laboratory employee #2 (as listed on the form CMS-209) confirmed the ranges in May 2021 did not represent the Sysmex Evidence Based control limits and that the limits were entered incorrectly. She further confirmed that there was no documentation of quality assessment identifying the incorrect ranges on daily, weekly, 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 -- or monthly reviews. Employee #2 also confirmed that quality control results had not been evaluated to determine if any would have been unacceptable if quality control ranges had been entered correctly. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Through a review of personnel records for six employees listed as testing personnel, lack of documentation, and interviews with laboratory staff, it was determined that one of six employees lacked documented training prior to analyzing patient samples. Survey findings include: A. During a review of personnel records for six employees listed as testing personnel on the form CMS-209, it was determined there was no documentation of training in the personnel record of employee #6 as listed on the form. B. In an interview, at 1:27 p.m. on 10/19/2021, laboratory employee #2 (listed as the general supervisor) confirmed the laboratory had no documentation of training for employee #6. -- 2 of 2 --

Summary Statement of Deficiencies 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 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: Through observation, review of manufacturer package insert, laboratory temperature records, and interview with laboratory staff it was determined that the laboratory failed to properly define storage requirements for chemistry quality control material and maintain an acceptable storage temperature on 13 of 365 days in 2018. Findings follow: A. During a tour of the laboratory on 2/7/19 at approximately 09:30 AM, six boxes of Multiqual Level 1 quality control material lot # 45791, expiraton date 2020- 03-31 and six boxes of Multiqual Level 3 quality control material lot # 45793 expiration date 2020-03-31 were observed in the reagent freezer in the blood bank area. B. Review of the manufacturer's package insert for the Multiqual quality control material revealed a storage temperature requirement of -20 degrees C. to -70 degrees C. C. Review of daily temperature records for the reagent freezer in the blood bank area revealed that the acceptable temperature range is defined as -10 degrees C. to -20 degrees C. and the temperature was recorded as: * -14 on 1/20/18, * -18 on 1/19/18, * -18 on 9/20/18, * -18 on 9/24/18, * -18 on 9/25/18, * - 18 on 9/26/18, * -18 on 9/27 /18 * - 18 on 9/28/18, * - 16 on 9/29/18, * -18 on 9/30/18 * -18 on 10/1/18, * - 18 on 10/2/18, and * -18 on 10/3/18. All of the temperatures documented above are warmer than the manufacturer defined requirements for Multiqual quality control material. D. In an interview on 2/7/19 at approximately 11:00 AM the general supervisor identified 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 -- as number 3 on the CMS 209 form confirmed that the reagent freezer does not maintain an appropriate temperature range for the storage of Multiqual quality control material. 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: Through review of the blood bank refrigerator temperature recording charts, lack of documentation and interview with staff it was determined that the temperature of the blood bank refrigerator was not recorded in one of twenty weeks examined when blood products were stored in the refrigerator. Findings follow: A. During the review of the blood bank refrigerator chart from July 2018 through January 2019 it was revealed that a chart for the week of January 1, 2019 through January 7, 2019 was not included. B. Upon request, the laboratory was unable to produce a recording chart for the time period identified above. C. In an interview on 2/7/19 at approximately 11:00 AM, the General Supervisor, identified as number three on the CMS 209 form, confirmed that the Blood Bank refrigerator recording chart for January 1, 2019 through January 7, 2019 was not available. -- 2 of 2 --