Havasu Regional Medical Center

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on the number and severity of deficient practices identified during the survey, the Condition: Facility Administration was found to be not met. The laboratory failed to follow established policies to ensure positive identification of blood product recipients, which may have resulted in serious patient harm. (See D3023) 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 on review of patient test records, review of laboratory policies and procedures and interview with the facility personnel, the laboratory failed to follow policies to ensure positive identification of a blood or blood product recipient. Findings include: 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 -- 1. The laboratory performs ABO/Rh testing, manually or automated on the Galileo Echo analyzer, in the specialty of Immunohematology, with an approximate annual test volume of 6,212. 2. The laboratory's established policy titled "Blood Bank General Procedure,", PolicyStat ID: 5087854 states: "Before testing, verify that the information on the order form matches with the label on the sample and the computer. Any discrepancies must be resolved with a redraw if necessary." 3. The general supervisor confirmed that 2 tubes of blood are collected for each patient with blood transfusion test orders. The specimens are labeled with a house label prior to the receipt and accessioning of the sample into the laboratory. The house label includes the following information: patient's first and last name, Medical Record (MR) number, date of birth, patient's physician, date and time of draw, initials of the phlebotomist and initials of the verifier. Blood Bank specimens have order labels that are generated upon entry of the order and the order labels then follow the specimen through all testing processes performed in Blood Bank. There are 4 order labels per specimen which are contained on one perforated sheet, two labels containing a barcode and two labels without a barcode. The order labels contain the following information: patient's first and last name, date of birth, patient's physician, patient number (which is different from MR #), specimen ID#, test ordered, and a barcode on two of the four order labels. The labels that contain the barcode do not contain the patient's date of birth. The barcode label is affixed to the specimen for testing on the Echo analyzer, while the order label that does not contain the barcode is affixed to the Echo instrument printout once testing is complete. 4. During the survey conducted on April 1, 2019 at approximately 11:15, the facility personnel, including the general supervisor, lead testing personnel of Blood Bank, and the hospital's Director of Quality, demonstrated how a specimen was mislabeled during the ABO/Rh type and screen testing process that occurred on 01/01/19 for patient MR# 2003702. The events that occurred on that day were described as follows: An order was placed on 01/01/19 at 05:53 for a 'Type and Screen, Packed Red Blood Cell (PRBC) Unit with Crossmatch' for female patient MR# 2003702. A lab technician pulled a specimen for male patient MR# 2305223 out of the refrigerator and placed it in a rack on the counter which is located directly next to a centrifuge. The female's specimen was already in the centrifuge with the female's order labels placed on the counter in front of the centrifuge. The testing personnel grabbed the male specimen out of the rack and placed the female's order sticker (barcoded label - specimen ID# 4936976) on the male specimen and placed the mislabeled specimen on the Echo analyzer for ABO/Rh type and screen testing. The test was completed at 08:20, resulted as "A positive", the testing personnel entered the test results in the female's electronic medical record (EMR) at 08:25 and the specimen was placed back in the refrigerator. The original instrument printout generated on 01/01/19 for this test was not retained by the testing personnel, however a copy was reprinted from the analyzer and showed the test was performed by user ID ewr6708. Based on the test result entered in the EMR, the female patient was transfused with one unit of "A positive" PRBC. Another order for 'Type and Screen, Packed Red Blood Cell (PRBC) Unit with Crossmatch' was placed for the same patient (MR# 2003702) on 01/01/19 at 10:37. The same testing personnel performed the second test. The facility personnel interviewed during the survey concluded that the testing personnel retrieved the correctly labeled specimen (containing the house label) from the refrigerator and labeled it with the correct order (barcoded) label and placed the specimen on the Echo analyzer for testing. The test result from the second ABO/Rh Type and Screen test for patient MR# 2003702 (specimen ID# 4936976) indicated "O positive". The facility personnel stated that at some point during the second testing process, the testing personnel identified the error and removed the order label from the mislabeled tube used during the first ABO/Rh type and screen test. The instrument printout from the Echo analyzer indicated the test -- 2 of 11 -- result from the ABO/Rh Type and Screen test performed for specimen ID# 4936976, completed at 11:47am by user ID ewr6708, was "O Positive". The test result from the second test was never entered into the patients EMR. Based on the test result from the second Type and Screen test, the female patient was transfused with one unit of "O positive" PRBC. The testing personnel failed to notify anyone of the error. The error was not discovered until 01/03/19 by the blood bank lead during a routine quality review. The correct patient sample was tested on 01/03/19 by the blood bank lead and the test result confirmed the patient's blood type as "O positive". 5. The testing personnel failed to follow established patient/sample identification policies to ensure the positive identification of blood or blood products and the intended recipient, resulting in the error of issuing the incorrect blood type unit, A positive, to patient (MR# 2003072) whose correct blood type is O positive. 6. The facility personnel confirmed that the testing personnel mislabeled a patient's specimen resulting in the transfusion of an incompatible unit of A positive packed red blood cells to a patient with a blood type of O positive. 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 the number and severity of deficiencies cited for services provided in the specialty of Immunohematology, the laboratory failed to meet the requirements specified in 493.1230 through 493.1256 and 493.1281 through 493.1299. See D5311, D5777, D5789, D5800, D5801, D5821, and D5891 for findings. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on direct inspection of the laboratory's specimen labeling process for Blood Bank specimens that are tested on the Galileo Echo analyzer, review of the laboratory's policy and procedure manual and interview with the facility personnel, the laboratory failed to establish policies and procedures for labeling samples that are tested on an automated analyzer. Findings include: 1. The laboratory performs ABO /Rh testing, manually or automated on the Galileo Echo analyzer, in the specialty of Immunohematology, with an approximate annual test volume of 6,212. 2. On April 1, 2019 at approximately 11:30, the laboratory personnel stated that a separate barcode label specific to the Echo analyzer must be affixed to the patient specimen which already contains a hospital house label, prior to testing the sample on the analyzer. Lab staff stated that the separate barcode label contains the patient name and sample -- 3 of 11 -- accession number, while the hospital house label on the specimen contains the patient name, medical record number, date of birth (DOB), date and time drawn and the collectors initials. Facility personnel demonstrated the process of affixing the barcode label to the labeled specimen and stated that the top of the barcode label must be placed directly under the patient name on the specimen label and the barcode label was to be folded in such a way that it that only the top portion of the label was attached to the tube. Lab staff stated that during the labeling process, the testing personnel attaching the barcode label is responsible for visually ensuring the patient names match on both labels. 3. No documentation was presented for review during the survey to indicate the laboratory established policies and procedures specific to the labeling process referenced above. 4. The facility personnel confirmed that the laboratory did not have established policies and procedures detailing the labeling process of blood bank specimens that are tested on the Echo analyzer. D5777 COMPARISON OF TEST RESULTS CFR(s): 493.1281(b)(c) (b) The laboratory must have a system to identify and assess patient test results that appear inconsistent with the following relevant criteria, when available: (b)(1) Patient age. (b)(2) Sex. (b)(3) Diagnosis or pertinent clinical data. (b)(4) Distribution of patient test results. (b)(5) Relationship with other test parameters. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, review of patient test records from the instrument and test results entered into the Laboratory Information System (LIS), and interview with the facility personnel, the laboratory failed to assess patient test results that appeared inconsistent with regard to pertinent clinical data. Findings include: 1. The laboratory's established policy titled, "Blood Bank General Procedure", PolicyStat ID: 5087854, states under the 'Procedure' section: "Check previous record or history of the patient for unexpected antibodies, transfusion reaction, special instructions (i.e. irradiated, leukocyte-reduced, CMV negative) in SafeTrace before starting testing." 2. The laboratory's established policy titled, "SafeTrace TX Applications for BloodBank Technologists", PolicyStat ID: 5087881 states: "Compare and confirm ABO group and Rh Type. Identify, compare and/or confirm the presence of clinically significant unexpected antibodies...Identify, compare and/or confirm difficulties encountered in blood typing; review previous adverse transfusion reactions. All Blood Bank requests and results will be kept for 10 years." 3. Review of patient test records for patient ID# 18765 revealed the patient had two ABO/Rh type and screen tests performed on the Galileo Echo analyzer on 01 /01/19, completed at 08:20 and 11:47, respectively, by user ID ewr6708. 4. The facility personnel stated that the test results from the Echo analyzer do not interface into the Blood Bank LIS, referred to as SafeTrace, therefore testing personnel must manually enter test results from the Echo analyzer to Safetrace. 5. Review of patient test results in Safetrace indicated the testing personnel entered the ABO/Rh type and screen test result into Safetrace as "A Positive" for the test completed at 08:20. No ABO/Rh type and screen test result was entered into Safetrace for the test completed at 11:47 for the patient referenced above, and the corresponding Echo printout indicated the test result as "O Positive". See D3023 and D6175 for findings. 6. No evidence was presented for review during the survey to indicate the testing personnel assessed patient test results at the time of testing to identify inconsistencies in the patient's blood type prior to issuing blood products for transfusion. 7. The facility -- 4 of 11 -- personnel confirmed that the testing personnel failed to identify and assess inconsistent type and screen test results for the patient referenced above prior to issuing blood products for transfusion purposes. D5789 TEST RECORDS CFR(s): 493.1283(b) Records of patient testing including, if applicable, instrument printouts, must be retained. This STANDARD is not met as evidenced by: Based on lack of patient test records, review of laboratory policy and interview with facility personnel, the laboratory failed to retain instrument printouts for patient testing that was performed on the Galileo Echo analyzer. Findings include: 1. The laboratory's established policy titled, "SafeTrace Tx Applications for BloodBank Technologists", PolicyStat ID: 5087881, states: "All Blood Bank requests and results will be kept for 10 years." 2. The facility personnel confirmed that it is the practice of the laboratory to retain the Echo instrument printout after testing, and the order label must be placed on the original copy since the instrument printout does not contain the patients name but the order label does, and labeled printout is required for quality reviews. 3. No evidence was presented for review to indicate the laboratory retained the original instrument printout with the patient's order label affixed to it, for specimen ID# 4936976, performed on the Echo analyzer on 01/01/2019 and entered into the patients EMR at 08:25. See D3023 for findings. 4. The facility personnel confirmed that the laboratory did not have record of the original Echo instrument printout generated on 01/01/2019 for the testing referenced above and indicated that the testing personnel stated the copy was lost when questioned about it. D5800 POSTANALYTIC SYSTEMS CFR(s): 493.1290 Each laboratory that performs nonwaived testing must meet the applicable postanalytic systems requirements in 493.1291 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 postanalytic systems and correct identified problems as specified in 493. 1299 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the number and severity of the deficiencies cited herein, the Condition: Postanalytic Systems was not met. The laboratory failed to ensure that ABO/Rh test results were accurately and reliably sent from the instrument printout to the blood transfusion product ID tag (See D5801). The laboratory failed to report errors for ABO /Rh patient test results to an authorized person ordering the test, and, if applicable, the individual using the test result (See D5821). The laboratory's