University Of Iowa Health Care

Summary Statement of Deficiencies D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of laboratory procedures, personnel and proficiency testing records and lack of quality assessment records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report); the laboratory director failed to meet the responsibilities for the overall operation and administration of the laboratory, including: to ensure proficiency testing samples are tested as required under subpart H refer to D6016; to ensure quality assessment programs are established and maintained refer to D6021; to ensure prior to testing patients' specimens, all personnel have documented training refer to D6029; and to ensure all testing personnel have documented competency refer to D6030. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: 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 -- Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 8: 45 am on 11/11/2021; the laboratory director failed to ensure that the testing personnel and laboratory director attested to the routine integration of PT samples into the patient workload for three out of three proficiency testing events (2020 events 1 and 2, and 2021 event 1) from 1/1/2020 - 11/11/2021. The findings include: 1. For 2020 event 1, the laboratory director failed to sign the PT attestation statement. 2. For 2020 event 2, the laboratory director and testing personnel failed to sign the PT attestation statement. 3. For 2021 event 1, the laboratory director failed to sign the PT attestation statement. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on lack of quality assessment records, the Quality Assessment procedure and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 9:35 am on 11/11/2021, the laboratory director failed to ensure the laboratory maintained a quality assessment program for 23 out of 23 months from 1/1/2020 - 11/11/2021. The findings include: 1. The Quality Assessment procedure stated that, "Laboratory Chart Auditing is performed to validate adherence to policies and procedures with feed back provided as applicable. The following will be audited on a random basis, minimally one chart monthly by the Laboratory Compliance Coordinator with results provided to clinic leadership." 2. At the time of the survey, the laboratory did not have documented chart audits from 1/1/2020 - 11/11 /2021. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of personnel records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report, CMS-209) at approximately 8: 30 am on 11/11/2021, the laboratory director failed to ensure prior to testing patients' specimens all personnel received documented training for two out of two testing -- 2 of 3 -- personnel (identifiers #5 and #6) in 2020. The findings include: 1. On 9/29/2020, the laboratory employed testing personnel identifier #5 to perform complete blood cell count testing. 2. On 12/28/2020, the laboratory employed testing personnel identifier #6 to perform complete blood cell count testing. 3. At the time of the survey, the laboratory did not have training records for testing personnel identifiers #5 & #6. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on review of personnel records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report, CMS-209) at approximately 8: 30 am on 11/11/2021, the laboratory director failed to ensure that the laboratory established and maintained annual and six month competency assessments for six out of six testing personnel (identifiers #1 - #6) from 11/11/2019 - 11/11/2021. The findings include: 1. Testing personnel identifiers #1 - #4 did not have documented annual competency assessments performed in 2019 or 2020. 2. Testing personnel identifiers #5 and #6 did not have six month competency assessments performed in 2021. 3. At the time of the survey, the laboratory did not have documented annual or six month competency assessments for any of the listed testing personnel. -- 3 of 3 --

Summary Statement of Deficiencies 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 least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: A. Based on review of Sysmex XP-300 hematology analyzer maintenance records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 10:30 am on 09/20/2019, the laboratory failed to document daily maintenance as defined by the manufacturer for one out of three days of patient testing (03/30/2019) reviewed in March 2018. The findings include: 1. Patient A had a complete blood count (CBC) performed on 03/30/2019. 2. Patient B had a CBC performed on 03/07/2019. 3. Patient C had a CBC performed on 03/29/2019. 4. The XP-300 maintenance log indicated that the following tasks are to be performed and documented daily: *Perform Shutdown *Verify Background *Verify Vacuum /Pressure *Check Trap Chamber *Perform Quality Control 5. Review of the XP-300 maintenance log revealed that the laboratory documented each daily maintenance task on 03/07/2019 and 03/29/2019. 6. At the time of the survey, personnel identifier #1 confirmed that the laboratory did not document daily maintenance on 03/30/2019. B. Based on review of Sysmex XP-300 hematology analyzer maintenance records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 10:30 am on 09/20/2019, the laboratory failed to document weekly maintenance as defined by the manufacturer for two out of four weeks (03/20 /2019 and 03/27/2019) of patient testing in March 2018. The findings include: 1. The XP-300 maintenance log indicated that the following task is to be performed and documented weekly: Clean SRV Tray. 2. Review of the XP-300 maintenance log 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 -- revealed that the laboratory documented weekly maintenance on 03/06/2019 and 03/13 /2019. 3. At the time of the survey, personnel identifier #1 confirmed that the laboratory did not document weekly maintenance on 03/20/2019 and 03/27/2019. 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: A. Based on review of Sysmex XP-300 complete blood count (CBC) analyzer printouts, patient test reports, quality assessment records, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 10: 00 am on 09/20/2019, the laboratory failed to establish a written quality assessment policy to monitor, assess and correct problems related to inconsistently entering a positive patient identifier into the Sysmex XP-300 hematology analyzer for three out of three patients (patient identifiers A, B, and C) having CBC testing performed in March 2019. The findings include: 1. When performing a CBC, the laboratory inputs a sample ID into the Sysmex XP-300 analyzer to identify the current sample being analyzed. Once analysis is complete, the instrument prints a report of the results and laboratory personnel handwrite the patient's full name and date of birth (DOB) on it. 2. Patient A had a CBC performed on 03/30/2019. The laboratory entered 04-23-10 as the sample ID. Upon completion, the laboratory wrote Patient A's name and DOB on the printout. 3. Patient B had a CBC performed on 03/07/2019. The laboratory entered BH as the sample ID. Upon completion, the laboratory wrote Patient B's name and DOB on the printout. 4. Patient C had a CBC performed on 03/29/2019. The laboratory entered 1 as the sample ID. Upon completion, the laboratory wrote Patient C's name and DOB on the printout. 5. Quality assessment activities performed in March 2019 did not identify problems related to laboratory personnel inconsistently entering a positive patient identifier into the Sysmex XP-300 hematology analyzer. B. Based on review of Sysmex XP-300 complete blood count (CBC) analyzer printouts, patient test reports, quality assessment records, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 10:00 am on 09/20/2019, the laboratory failed to establish a written quality assessment policy to monitor, assess and correct problems related to incorrectly writing two positive patient identifiers on Sysmex XP-300 analyzer printouts for one out of three patients (patient identifier A) having CBC testing performed in March 2019. The findings include: 1. When performing a CBC, the laboratory inputs a sample ID into the Sysmex XP-300 analyzer to identify the current sample being analyzed. Once analysis is complete, the instrument prints a report of the results and laboratory personnel handwrite the patient's full name and date of birth (DOB) on it. 2. Patient A had a CBC performed on 03/30/2019. Upon sample completion, the laboratory wrote Patient A's name and DOB of 04/23/10 on the Sysmex XP-300 result printout. 3. Review of Patient A's electronic medical record (EMR) indicated the laboratory had written the patient's name correctly. The EMR had Patient A's DOB as 04/23/2018. 4. At the time of the survey, personnel identifier #1 confirmed that Patient A's DOB had been incorrectly written on the Sysmex XP-300 result printout. 5. Quality assessment activities performed in March 2019 did not identify problems related to laboratory personnel writing patient DOBs incorrectly on Sysmex XP-300 result printouts. -- 2 of 3 -- D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of Sysmex XP-300 instrument printouts, patient test reports, the laboratory's test resulting procedure,quality assessment records, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 10:00 am on 09/20/2019, the laboratory failed to have a system in place to monitor, assess, and correct problems associated with inconsistently reporting complete blood count (CBC) test results and units of measure in the patient's electronic medical record (EMR) for three out of three patients (Patients A, B, and C) having CBC testing in March 2019. The findings include: 1. Patient A had a CBC performed on 03/30/2019. Comparison of the Sysmex XP-300 instrument printout and Patient A's EMR record indicated the laboratory entered correct test results for all analytes and/or indices, but incorrect, inconsistent, or missing units of measure for the following (see attachment A for correct units of measure and Patient A's EMR results): *White blood count (WBC) *Lymphocyte count *Mean corpuscular hemoglobin (MCH) *Mean corpuscular hemoglobin concentration (MCHC) *Platelet histogram *Granulocyte count *Monocyte count *Monocytes per 100 leukocytes *Red cell distribution width, standard deviation (RDW-SD) *Red cell distribution width, coefficient of variation (RDW-CV) *Mean platelet volume (MPV) 2. Patient B had a CBC performed on 03/07/2019. Comparison of the Sysmex XP-300 instrument printout and Patient B's EMR record indicated the laboratory entered correct test results for all analytes and/or indices, but incorrect, inconsistent, or missing units of measure for the following (see attachment B for correct units of measure and Patient B's EMR results): *WBC *Lymphocyte count *Monocyte count *Granulocyte count *MCH *MCHC *Platelet histogram *RDW-SD *RDW-CV 3. Patient C had a CBC performed on 03/29/2019. Comparison of the Sysmex XP-300 instrument printout and Patient C's EMR record indicated the laboratory entered correct test results for all analytes and/or indices, but incorrect, inconsistent, or missing units of measure for the following (see attachment C for correct units of measure and Patient C's EMR results): *WBC *Lymphocyte count *MCH *MCHC *Platelet histogram *Monocyte count *Granulocyte count *RDW-SD *RDW-CV 4. The laboratory's procedure, "Resulting In-House Labs," instructs personnel to do the following: 1- Select correct patient 2- Click on the NOTES tab 3- Click on the FORMS section 4- Use CLINIC TEAM or STANDARD CLINIC TEAM 5- Click on LABS/TESTS 6- Select the correct tab 7- Type in result from instrument or instrument print-off 8- Click save 5. CBC test results and units of measure appeared differently in the EMR for each of the patients A, B, and C. Refer to attachments A, B, and C. 6. Quality assessment activities performed in March 2019 did not identify problems related to laboratory personnel inconsistently reporting CBC test results and units of measure in patient EMR records. -- 3 of 3 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 No Tags No deficiency details available. 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 --