Kp Holy Cross Cardiology And Vascular

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and interview with the technical consultant (TC), the laboratory failed to ensure that all the testing personnel (TP) who tested patient samples performed the PT. Findings: 1. The laboratory currently has three TP listed on the "Laboratory Personnel Report" (CMS-209) who perform hematology and chemistry testing. 2. A review of hematology PT attestation worksheets from five PT events from 2023 through 2025 showed that PT was performed by the same TP in five of five events; and 3. A review of chemistry PT attestation worksheets from five PT events from 2023 through 2025 showed that PT was performed by the same TP in four of five events. 4. During an interview on 03/27 /2025 at 2:00 PM, the TC confirmed that PT samples were not tested each year by all the staff who perform patient testing to ensure accurate and reliable patient test results. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. 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 4 -- Based on proficiency testing (PT) record review and interview with the technical consultant (TC), the laboratory failed to ensure that the laboratory director (LD) or their designee and the individual testing the samples (TP) signed PT attestation statements, attesting to the routine integration of the PT samples into the patient workload using the laboratory's routine methods. Findings: 1. A review of hematology PT records for five PT events from 2023 through 2025 showed that the attestation statement for the 3rd event of 2023 for the activated clotting time (ACT) was not signed by the LD or their designee or the TP; and 2. A review of chemistry PT records for five PT events from 2023 through 2025 showed that the attestation statement for the 1st event of 2024 for "BloodGas1" was not signed by the LD or their designee. 3. During an interview on 03/27/2025 at 2:00 PM, the TC confirmed that not all of the PT attestation statements were signed by the LD, their designee, or the TP, attesting that PT specimens were run in the same way as patient samples. 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: Note: This is a repeat deficiency. The laboratory was cited during the initial certification survey on 09/06/2023 for failing to establish written procedures for assessing testing personnel and technical consultant competency. The

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on review of the Code of Maryland Regulations (COMAR), review of the laboratory's procedure, and interview with the technical consultant (TC), the laboratory failed to be in compliance with COMAR 10.10.06.06(B)(6)(a)(ii) regulations for performing quality control (QC) on single-use test devices at least weekly when patient testing was performed. Findings: 1. COMAR 10.10.06.06(B)(6) states that "A licensee shall ensure that quality control testing for a quantitative test system is performed and documented using at least two levels of control material before patient testing ...At least weekly for each lot of single-use test device used for patient testing." 2. The laboratory performed testing using an Abott i-STAT analyzer which fit the criteria for a single-use test device. 3. Section 6.2.1 of the laboratory procedure titled "i-STAT Portable Clinical Analyzer POCT" stated that "QC is performed once every 30 days, with the receipt of every new shipment of test cartridges, and when training a new test performer." 4. During the survey on 09/06 /2023 at 12:40 PM, the TC confirmed that the laboratory was not performing QC on the i-STAT at least weekly when patients were run as required by COMAR. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on review of the procedure manual and interview with the technical consultant (TC), the laboratory failed to establish written procedures for assessing testing personnel (TP) and TC competency. Findings: 1. The laboratory's "Point of Care Quality Assurance Policy" stated that competency would be assessed initially, at six- months, and then annually. 2. There were no procedures describing the six procedures required for assessing competency of TP: 1) Direct observation of routine patient test performance, 2) Monitoring the recording and reporting of test results, 3) Review of intermediate test results or worksheets, quality control records, proficiency testing (PT) results, and preventive maintenance records, 4) Direct observations of performance of instrument maintenance and function checks, 5) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external PT samples, and 6) Assessment of problem solving skills. 3. There were no procedures describing the competency assessment of the TC based on their regulatory responsibilities. 4. During the survey on 09/06/2023 at 12:40 PM, the TC confirmed that there was no procedure detailing how to perform competency assessments for the TP and TC. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on review of instrument results and interview with the technical consultant (TC), the laboratory failed to use written or electronic requests for patient testing. Findings: 1. The laboratory performed testing using an Abbott i-STAT handheld analyzer. 2. Results from three patients were observed directly from the i-STAT analyzer: accession numbers 96331495 tested on 08/31/2023, 51216899 tested on 06 /19/2023, and 14195998 tested on 06/08/2023. 3. During the survey on 09/06/2023 at 12:30 PM, the TC confirmed that there were no written or electronic requisitions for the testing performed on the three patients. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)