Summary:
Summary Statement of Deficiencies 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 record review and interview the laboratory failed to ensure testing personnel number one have documented training prior to performing transfusion medicine testing, (Refer to D5209); failed to follow the procedure manual (Refer to D5401), and failed to ensure the laboratory's quality assessment process effective to correct problems with recording transfusion medicine testing (Refer to D5791), resulting in a condition level deficiency. 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 Transfusion Service Testing Record, testing personnel number one employee records and interview with the general supervisor, the laboratory failed to ensure testing personnel number one have documented training prior to performing transfusion medicine testing, in 2019. The findings include: 1. Review of the laboratory's Transfusion Service Testing Record revealed patient testing for ABO and Rh for patient number four performed by testing 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 -- personnel number one on 02.04.2019. 2. Review of testing personnel number one employee records revealed a hire date of 01.16.19 with no documented training for performing transfusion medicine testing to include ABO/Rh type, antibody screen and crossmatch testing. 3. Interview with the general supervisor on October 7, 2019 at 3: 30 p.m. confirmed testing personnel number one performed transfusion medicine testing in 2019 with no documented training. 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. This STANDARD is not met as evidenced by: Based on review of the Component Ordering Process procedure, patient number one history card and interview with testing personnel number one, testing personnel number one failed to follow the procedure for releasing blood units for transfusion, in 2019. The findings include: 1. Review of the Component Ordering Process procedure revealed, "After order is placed, a product order sheet will print in the lab. This order will contain the first and last name of the patient, date of birth, medical record number, ordering physician, type and number of units, and indications for the transfusion. At this point, check to see if patient has a history card in the blood bank. ... Crosscheck history card against component order with first and last names, date of birth, and medical record number." 2. Review of patient number one blood bank history card revealed no documentation of transfusion on 09-27-19 by testing personnel number one. 3. Interview on October 7, 2019 at 2:45 p.m. with testing personnel number one, via telephone, confirmed the blood bank history card was not reviewed to crosscheck the component order, the blood transfusion log containing each patient results was reviewed. The result on the line above patient number one was looked at (O positive), the O positive unit W040819104617 was removed from the refrigerator, the immediate spin crossmatch was compatible. The paperwork was completed with the patient type as O positive, the history card was not reviewed and the unit was released to the nurse staff for transfusion. The laboratory received a call from the surgery department shortly after transfusion began, inquiring of the patient blood type. This time testing personnel reviewed the blood transfusion log along with the patient history card and determined the patient was O Negative, resulting in administration of the wrong blood type to patient number one. 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: Based on review of hospital patient records, the laboratory's document titled "Transfusion Service Testing Record," the Blood Bank Reagent Usage Sheets and -- 2 of 3 -- interview with the laboratory supervisor, the laboratory's quality assessment process was ineffective when it failed to correct problems with recording transfusion medicine testing in 2019. The findings include: 1. Review of hospital records for patient number two revealed an order for "Type and screen preadmit." 2. Review of the laboratory procedure for ABO reverse group revealed the laboratory uses A1 cells to confirm ABO blood group. 3. Review of the "Transfusion Service Testing Record" revealed the following: Patient number two tested for blood type and antibody screen by testing personnel number one on 04.18.2019. No results were recorded for antibody screen on the Transfusion Service Testing Record. Review of the Transfusion Service Testing Record was performed by the general supervisor on 04.23.2019 with no