Cardiology Associates Of Altoona Llp

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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: Based on review of laboratory temperature records, lack of documentation and interview with the Laboratory Manager, the laboratory failed to monitor and document temperatures to ensure proper storage of reagents and test system operating conditions were met for instrumentation used to perform hematology testing for 400 of 728 days from 03/13/2023 to 03/10/2025. Findings include: 1. On the day of survey, 03/10/2025, review of the laboratory's temperature logs revealed the laboratory failed to monitor and document the following temperatures for 400 of 728 days from 03/13/2023 to 03/10/2025: - refrigerator temperature (laboratory's acceptable range 35 to 46 degrees Fahrenheit) to ensure proper storage of reagents. - room temperature (laboratory's acceptable range 64 to 86 degrees Fahrenheit) to ensure test system operating conditions were met for 1 of 1 i-Stat blood analyzer used to measure Activated clotting time. 2. The hours of laboratory testing are Monday- Friday 07:30 am to 05:00 pm (CMS 116). The laboratory could not provide documentation of temperatures taken on days the laboratory was closed. 3. The Laboratory Manager confirmed the above findings on 03/10/25 at 2:10 pm. D6032 LABORATORY DIRECTOR RESPONSIBILITIES 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 -- CFR(s): 493.1407(e)(14) (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Laboratory Manager, the Laboratory Director (LD) failed to specify in writing the responsibilities and duties of 4 of 4 individual laboratory positions involved in the preanalytic, analytic, and postanalytic phases of moderate complexity testing in hematology from 03/13/2023 to date of survey. Findings include: 1. On the day of survey, 03/10/2025, the laboratory failed to provide documentation of the job responsibilities written by the LD for the following laboratory positions involved in the preanalytic, analytic, and postanalytic phases of moderate complexity testing in hematology (Activated clotting time) from 03/13/2023 to 03/10/2025: - Laboratory Director (LD) - Clinical Consultant (CC) - Technical Consultant (TC) - Testing Personnel (TP) 2. The Laboratory Manager confirmed the above findings on 03/10/2025 at 2:10 pm. -- 2 of 2 --

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 review of the American Proficiency Institute (API) Proficiency Testing (PT) records and interview with the Technical Consultant (TC)#2, the laboratory failed to test 6 of 6 API PT Hematology/Coagulation samples with the laboratory's regular patient workload by personnel who routinely performed the testing in the laboratory in 2021 and 2022. Findings include: 1. On the day of survey 03/13/2023 at 09:15 am., review of the attestation statements revealed, that 3 of 3 API PT samples in 2021 and 3 of 3 API PT samples in 2022 were tested only by Testing Personnel #1. Testing Personnel# 2, # 3, #4 and #5 who routinely performed patient testing in 2021 and 2022 did not take part in the PT testing. 2. The TC confirmed the finding above on 03 /13/2023 around 09:30 am. 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 competency assessment records and interview with Technical Consultant #2 (TC), the laboratory failed to establish a procedure to assess the 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 -- competency of 1 of 2 Technical consultants for their supervisory responsibilities in 2021 and 2022. Findings include: 1. On the day of survey, 03/13/2023 at 09:20 am, TC #2 could not provide a procedure for the competency assessment for 1 of 2 TC (CMS 209 personnel # 3) for their supervisory responsibilities in 2021 and 2022. 2. No documentation was provided that competency assessments were performed for 1 of 2 TC (TC#2) for their supervisory responsibilities from 01/12/2021 to 03/13/2023 3. TC #2 confirmed the findings above on 03/13/2023 around 09:30 am. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on the review of test requisitions and interview with the Technical Consultant (TC), the laboratory failed to include the sex of the patient for Activated clotting time (ACT) examinations from 01/12/2021 to 03/13/2023. Findings Included: 1. On the day of survey 03/13/2023 at 09:20 am, a review of the patient test requisition revealed that the test requisition did not include the sex of the patient for ACT examinations from 01/12/2021 to 03/13/2023. 2. TC#2 confirmed the above finding on 03/13/2023 at 09:30 am. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on the review of patient test reports and interview with Technical Consultant (TC), the laboratory failed to include the laboratory's address on patient test reports for Activated clotting time (ACT) examinations from 01/12/2021 to 03/13/2023. Finding Include: 1. On the day of survey, 03/13/2023 at 09:20 a.m., review of ACT -- 2 of 3 -- test reports revealed, the final test reports did not include the laboratory's address from 01/12/2021 to the day of survey. 2. The TC confirmed the finding above on 03/13 /2023 around 09:30 am. -- 3 of 3 --

Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control records and interview with Testing Person (TP) # 1 and (TP) # 2, the laboratory failed to perform external liquid quality controls (QC) of different concentration, each day of patient testing for Activated Clotting Time (ACT) test analyzed on the i-STAT analyzer in 2020. Findings include: 1. On the day of survey, 01/12/2021, review of ACT quality control records revealed that the laboratory performed external quality control for the i-STAT analyzer, on new shipments, new lot numbers and every month. 2. From 01-01-2020 through the date of survey laboratory performed the ACT test on 135 patient specimens. 4. TP # 1 and # 2 confirmed the findings above on 01/12/2021 around 13:30 pm. 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 --